[Unified Agenda of Federal Regulations]
[Department of Health and Human Services Semiannual Regulatory Agenda]
[From the U.S. Government Printing Office, www.gpo.gov]
_______________________________________________________________________
Part VIII
Department of Health and Human Services
_______________________________________________________________________
Semiannual Regulatory Agenda
=======================================================================
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
20 CFR Ch. III
21 CFR Ch. I
42 CFR Chs. I-V
45 CFR Subtitle A, Chs. II, III, and XIII
Unified Agenda of Regulations
AGENCY: Office of the Secretary, HHS.
ACTION: Publication of unified agenda of regulations.
_______________________________________________________________________
SUMMARY: The President's September 30, 1993, Executive order (12866)
and the Regulatory Flexibility Act of 1980 require the Department to
publish an agenda of significant regulations being developed and an
indication of those regulatory actions that are being analyzed for
their effect on small businesses. The Department published its last
agenda on October 25, 1993.
FOR FURTHER INFORMATION CONTACT: For further inquiries or comments
related to specific regulations listed in the agenda, the public is
encouraged to contact the appropriate responsible individual. Questions
or comments on the overall agenda should be sent to: Ann White,
Regulations Coordinator, Office of the Secretary, Department of Health
and Human Services, 200 Independence Avenue SW., Washington, DC 20201;
telephone: (202) 690-6824.
SUPPLEMENTARY INFORMATION:
Health Care Financing Administration
Please note that many of the HCFA entries use acronyms and
public law citations that refer to popular titles of well-known
laws. As an aid to readers, we offer the following cross-reference
guide:
COBRA '85 -- Consolidated Omnibus Budget Reconciliation Act of
1985 (PL 99-272).
OBRA '86 -- Omnibus Budget Reconciliation Act of 1986 (PL 99-
509).
OBRA '87 -- Omnibus Budget Reconciliation Act of 1987 (PL 100-
93).
MCAA '88 -- Medicare Catastrophic Coverage Act of 1988 (PL 100-
360).
FSA '88 -- Family Support Act of 1988 (PL 100-485).
CLIA '88 -- Clinical Laboratory Improvement Amendments of 1988
(PL 100-578).
TMRA '88 -- Technical and Miscellaneous Revenue Act of 1988 (PL
100-647).
OBRA '89 -- Omnibus Budget Reconciliation Act of 1989 (PL 101-
239).
OBRA '90 -- Omnibus Budget Reconciliation Act of 1990 (PL 101-
508).
OBRA '93 -- Omnibus Budget Reconciliation Act of 1993 (PL 103-
66).
Claudia Cooley,
Executive Secretary to the Department.
Office of the Secretary--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1113 Nondiscrimination Requirements (Including on the Basis of Sex or Religion) Applicable
to Block Grants and Standard Nondiscrimination Procedures Applicable to Certain Other
Programs.............................................................................. 0991-AA02
1114 Civil Money Penalties (CMPs) for Certain Hospital Physician Incentive Plans........... 0991-AA45
1115 Civil Money Penalties (CMPs) for Certain Practices Relating to Medicare Supplemental
Policies.............................................................................. 0991-AA53
1116 Uniform Administrative Requirements for Grants and Cooperative Agreements............. 0991-AA56
1117 Revisions to the PRO Sanctions Process................................................ 0991-AA73
1118 Clarification of the OIG Safe Harbor Anti-Kickback Provisions......................... 0991-AA74
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Office of the Secretary--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1119 Civil Money Penalties and Exclusions for Assistants at Cataract Surgery............... 0991-AA37
1120 Civil Money Penalties and Intermediate Sanctions for HMOs and Competitive Medical
Plans................................................................................. 0991-AA44
1121 Block Grant Programs.................................................................. 0991-AA55
1122 Civil Money Penalties for Physician Ownership of and Referral to Certain Health Care
Entities.............................................................................. 0991-AA65
1123 Additional Safe Harbor Provisions Under the Anti-Kickback Statute..................... 0991-AA66
1124 Safe Harbors for Protecting Health Plans.............................................. 0991-AA69
1125 Governmentwide Guidance for New Restrictions on Lobbying; Interim Final Guidance...... 0991-AA70
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Office of the Secretary--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1126 Equal Opportunity in Employment: Public Broadcasting, Public Radio, and Public
Telecommunications Entities Receiving Federal Funds From the Corporation for Public
Broadcasting.......................................................................... 0991-AA22
1127 Title VI of the CRA of 1964, Subpart B--National Origin Discrimination in Programs
Receiving Fed. Financial Assistance From the DHHS Against Persons of Limited English
Proficiency........................................................................... 0991-AA72
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Departmental Management--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1128 Implementation of the Equal Access to Justice Act in Agency Proceedings............... 0990-AA02
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Social Security Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1129 Old-Age, Survivors, and Disability Insurance and Supplemental Security Income
Programs; Adjustments in SSI Benefits on Account of Retroactive Benefits Under Title
II (061P)............................................................................. 0960-AB38
1130 Old-Age, Survivors, and Disability Insurance and Supplemental Security Income
Programs; Evaluation Guides for Determining Substantial Gainful Activity (SGA) (147P). 0960-AB73
1131 Old-Age, Survivors, and Disability Insurance Program; Nonpayment of Benefits to
Prisoners, Vocational Rehabilitation Exception (166P)................................. 0960-AC16
1132 Old-Age, Survivors and Disability Insurance and Supplemental Security Income Programs;
Vocational Factors Regulations Restructuring and Clarification (207P)................. 0960-AC61
1133 Old-Age, Survivors, and Disability Insurance and Supplemental Security Income
Programs; Interim Disability Benefits (215P).......................................... 0960-AC76
1134 Old-Age, Survivors, and Disability Insurance and Supplemental Security Income
Programs; Appeals Council Notice Requirements (235P).................................. 0960-AC93
1135 SSI Program; Reduction in Time When Income and Resources of Separated Couples Must Be
Treated as Jointly Available for Purposes of SSI Eligibility and Benefits (254F)...... 0960-AC98
1136 Supplemental Security Income Program; Augmented Benefits (271P)....................... 0960-AD07
1137 Old-Age, Survivors, and Disability Insurance and Supplemental Security Income for the
Aged, Blind, and Disabled; Representative Payee Reforms (295F)........................ 0960-AD22
1138 Old-Age, Survivors, and Disability Insurance and Supplemental Security Income for the
Aged, Blind, and Disabled; Fees for Representation of Claimants (296P)................ 0960-AD23
1139 OASDI and SSI for the Aged, Blind and Disabled; Continuation of Benefits on Account of
Participation in a Non-State VR Program (299P)........................................ 0960-AD26
1140 Supplemental Security Income for the Aged, Blind, and Disabled; Exclusion From Income
and Resources of Victims' Compensation Payments and State Relocation Assistance (311P) 0960-AD36
1141 Supplemental Security Income for the Aged, Blind, and Disabled; Reimbursement for VR
Services Furnished During Certain Months of Non-payment (315P)........................ 0960-AD39
1142 Code of Conduct for Administrative Law Judges and Administrative Appeals Judges of the
Social Security Administration (341P)................................................. 0960-AD54
1143 Election of Benefits Based on Age by Disabled Widow, Widower, and Surviving Divorced
Spouse Beneficiaries (343P)........................................................... 0960-AD56
1144 Against Equity and Good Conscience (348P)............................................. 0960-AD62
1145 Old-Age, Survivors, and Disability Insurance Program; Revised Medical Criteria for
Determination of Disability; Hemic and Lymphatic System, and Malignant Neoplastic
Diseases (399P)....................................................................... 0960-AD67
1146 Procedures for Handling Earnings Reports (418P)....................................... 0960-AD70
1147 Federal OASDI and SSI; Computing Benefit Amounts, Disposing of Underpayments,
Resolving Overpayments, and Payment Restriction (428P)................................ 0960-AD72
1148 Conduct of Representatives Under Title II or Title XVI (431P)......................... 0960-AD73
1149 Statement of Earnings and Benefit Estimate (415P)..................................... 0960-AD74
1150 Fees for Federal Administration of State Supplementary Payments in the SSI Program
(376P)................................................................................ 0960-AD75
1151 Who May Protect a Potential Claimant's Filing Date or Application for Supplemental
Security Income Benefits (408P)....................................................... 0960-AD76
1152 Reliable Information Which is Currently Available for Determining Benefit Amounts in
the Supplemental Security Income Program (NEWMAN) (434P).............................. 0960-AD77
1153 Revised Medical Criteria for Determination of Disability, Endocrine System and Obesity
and Related Criteria (436P)........................................................... 0960-AD78
1154 Federal Old-Age, Survivors, and Disability Insurance; Evidence Required to Presume a
Person Is Dead (443P)................................................................. 0960-AD79
1155 Revised Medical Criteria for Determination of Disability, Growth Impairments (444P)... 0960-AD80
1156 Eligibility for Children of Armed Forces Personnel Residing Outside the United States
Other Than in Foreign Countries (452P)................................................ 0960-AD81
1157 Valuation of Certain In-Kind Support and Maintenance (ISM) Where There is a Cost-of-
Living Adjustment in SSI Benefits (454P).............................................. 0960-AD82
1158 Relationship/Coverage Actions Note Initial Determinations/SSI Corrections (455P)...... 0960-AD83
1159 Replacement of Lost, Damaged or Stolen Excluded Resources (Hurricane Andrew) (458I)... 0960-AD85
1160 Prevention of Adverse Effects on Eligibility and Benefit Amount When Spouse or Parent
Absent Due to Active Military Service (462P).......................................... 0960-AD86
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Social Security Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1161 Supplemental Security Income Program; Suspensions, Terminations, and Advance Notice of
Adverse Determinations (031F)......................................................... 0960-AA22
1162 Old-Age, Survivors, and Disability Insurance Program; Revised Medical Criteria for
Determination of Disability; Musculoskeletal System (143F)............................ 0960-AB01
1163 Old-Age, Survivors, and Disability Insurance and Supplemental Security Income Program;
Continued Payment of Benefits to Persons in Vocational Rehabilitation Programs (131F). 0960-AB05
1164 Supplemental Security Income Program; What Is Not Income (121F)....................... 0960-AB09
1165 Supplemental Security Income Program; Continuation of Benefits and Special Eligibility
for Certain Severely Impaired Recipients Who Work (171F).............................. 0960-AC22
1166 Supplemental Security Income Program; Proceeds of a Loan, Payment of Pro Rata Share of
Household Operating Expenses (180F)................................................... 0960-AC42
1167 Old-Age, Survivors, and Disability Insurance Program; Applicability of Government
Pension to Certain Federal Employees (188F)........................................... 0960-AC46
1168 Supplemental Security Income Program; Continuation of Full Benefit Standard for
Certain Persons Temporarily Institutionalized (198F).................................. 0960-AC55
1169 Old-Age, Survivors, and Disability Insurance Program; Medical Criteria for Evaluating
Mental Disorders for Adults (222F).................................................... 0960-AC74
1170 Supplemental Security Income Program; Treatment of Augmented Veterans' Benefits (231F) 0960-AC82
1171 Supplemental Security Income Program; Waiver of SSI Rule for Deeming to Children the
Income and Resources of Their Parents for Certain Disabled Children (252F)............ 0960-AC96
1172 Old-Age, Survivors, and Disability Insurance and Supplemental Security Income
Programs; Deemed Application Date Based on Misinformation (267F)...................... 0960-AD05
1173 Supplemental Security Income Program; Financial Institution Accounts in the SSI
Program (278F)........................................................................ 0960-AD10
1174 Old-Age, Survivors, and Disability Insurance and Supplemental Security Income for the
Aged, Blind, and Disabled; Updating Nomenclature (264F)............................... 0960-AD11
1175 Supplemental Security Income for the Aged, Blind, and Disabled; Treatment of Certain
Royalties and Honoraria (310F)........................................................ 0960-AD35
1176 Organization and Procedures; Procedures of the Office of Hearings and Appeals;
Authority of Appeals Officers to Deny a Request for Appeals Council Review (334F)..... 0960-AD45
1177 Supplemental Security Income Program; Treatment of Promissory Notes in Home
Replacement Situations (182F)......................................................... 0960-AD61
1178 OASDI and SSI; Testing Modifications to the Disability Determination Procedures (359F) 0960-AD63
1179 Reliable Information Which Is Currently Available for Determining Benefit Amounts in
the Supplemental Security Income Program (382F)....................................... 0960-AD65
1180 Appeal Rights Following State-Initiated Mass Change in Federally Administered State
Supplementary Payments Resulting in Reduction, Suspension, or Termination of State
Supplementary Payments (383F)......................................................... 0960-AD66
1181 Compensation of Qualified Organizations Serving as Representative Payees Under Title
II and Title XVI (423F)............................................................... 0960-AD71
1182 Temporary Increase in Sponsorship Period for Aliens Under the SSI Program (457F)...... 0960-AD84
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Social Security Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1183 Old-Age, Survivors, and Disability Insurance Program; Revised Medical Criteria for
Determination of Disability; Cardiovascular System (141F)............................. 0960-AA99
1184 Old-Age, Survivors, and Disability Insurance Program; Revised Medical Criteria for
Determination of Disability; Respiratory System (142F)................................ 0960-AB00
1185 Supplemental Security Income Program; Exclusions From Income and Resources of Indian
Judgment Funds and Per Capita Distributions (201F).................................... 0960-AB86
1186 Supplemental Security Income Program; Payment of Benefits Due Deceased Recipients
(174F)................................................................................ 0960-AC28
1187 Old-Age, Survivors, and Disability Insurance and Supplemental Security Income
Programs; Cancelled Consultative Examinations (181F).................................. 0960-AC40
1188 Old-Age, Survivors, and Disability Insurance and Supplemental Security Income
Programs; Determining Disability and Blindness; Fee Limitation Policy for Purchase of
Laboratory Tests (184P)............................................................... 0960-AC41
1189 Old-Age, Survivors and Disability Insurance and Supplemental Security Income Programs;
Determination of Disability-- Disability-Determining State Agency Substantial Failure
(206F)................................................................................ 0960-AC60
1190 Old-Age, Survivors, and Disability Insurance Program; Suspension of Benefits of
Deported Nazis; Exemption From Social Security Taxation Because of Religious Beliefs
(210F)................................................................................ 0960-AC68
1191 Supplemental Security Income Program; Redeterminations of Supplemental Security Income
Eligibility (223F).................................................................... 0960-AC77
1192 Old-Age, Survivors, and Disability Insurance and Supplemental Security Income
Programs; Medical Improvement Review Standard (MIRS)--Miscellaneous Changes (225P).... 0960-AC81
1193 Old-Age, Survivors, and Disability Insurance and Supplemental Security Income
Programs; Representation of Claimants for Benefits Under Title II or Title XVI (249F). 0960-AC87
1194 Old-Age, Survivors, and Disability Insurance and Supplemental Security Income
Programs; Standards Applicable in Determinations of Good Cause, Fault, and Good Faith
(247F)................................................................................ 0960-AC88
1195 Supplemental Security Income Program; Exclusion From Income of Domestic Commercial
Transportation Tickets Received as Gifts in Determining SSI Income (253F)............. 0960-AC97
1196 Old-Age, Survivors, and Disability Insurance and Supplemental Security Income for the
Aged, Blind, and Disabled; Reopening Determinations and Decisions (279F).............. 0960-AD12
1197 Old-Age, Survivors, and Disability Insurance; Suspension of Auxiliary Benefits When a
Disabled Worker Is in an Extended Period of Eligibility (303F)........................ 0960-AD30
1198 Old-Age, Survivors, and Disability Insurance; Continued Entitlement to Benefits of
Deemed Spouse Despite Entitlement of Legal Spouse (304F).............................. 0960-AD31
1199 Supplemental Security Income for the Aged, Blind, and Disabled; Exclusion From Income
and Resources of Earned Income Tax Credits (319F)..................................... 0960-AD41
1200 Old-Age, Survivors, and Disability Insurance and Supplemental Security Income;
Limitation of Travel Expenses for Representation of Claimants at Administrative
Proceedings (324F).................................................................... 0960-AD46
1201 Time Limit for Disposition of Resources in the Supplemental Security Income Program
(330F)................................................................................ 0960-AD48
1202 Old-Age, Survivors, and Disability Insurance and Supplemental Security Income for the
Aged, Blind, and Disabled; Payments for Vocational Rehabilitation Services (333F)..... 0960-AD50
1203 Old-Age, Survivors, and Disability Insurance and Supplemental Security Income
Programs; Reorganization of Medical Evidence Regulations (340P)....................... 0960-AD57
1204 Old-Age, Survivors, and Disability Insurance Program; Considering an Application Filed
Under the Railroad Retirement Act as an Application for Social Security Benefits
(342F)................................................................................ 0960-AD59
1205 SSI Program; SSI Maximum Payment Limit ($30) When Medicaid Is Not Paying Toward the
Cost of Institutional Care Because the Individual Transferred a Resource (345F)....... 0960-AD60
1206 OASDI and SSI Programs; Performance Standards Revisions and Other Changes Involving
Administrative Requirements and Procedures (381A)..................................... 0960-AD64
1207 Federal Old-Age, Survivors, and Disability Insurance Program; Technical Changes to
Requirement for Entitlement to Widow(er)'s Benefits (404F)............................ 0960-AD69
----------------------------------------------------------------------------------------------------------------
Public Health Service--Office of Assistant Secretary for Health (OASH)--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1208 Public Health Service Policies on Research Misconduct................................. 0905-AE02
----------------------------------------------------------------------------------------------------------------
Public Health Service--Office of Assistant Secretary for Health (OASH)--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1209 Privacy Act; Exempt System............................................................ 0905-AD31
1210 Standards of Compliance for Abortion-Related Services in Family Planning Service
Projects.............................................................................. 0905-AE03
----------------------------------------------------------------------------------------------------------------
Public Health Service--Substance Abuse and Mental Health Services Administration (SAMHSA)--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1211 Confidentiality of Substance Abuse Patient Records.................................... 0905-AD97
1212 Protection and Advocacy for Individuals With Mental Illness........................... 0905-AD99
1213 Community Mental Health Services Block Grants......................................... 0905-AE24
----------------------------------------------------------------------------------------------------------------
Public Health Service--Substance Abuse and Mental Health Services Administration (SAMHSA)--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1214 Block Grants for Prevention and Treatment of Substance Abuse.......................... 0905-AD98
1215 Block Grants for Prevention and Treatment of Substance Abuse (Tobacco Provisions)..... 0905-AE05
----------------------------------------------------------------------------------------------------------------
Public Health Service--Centers for Disease Control and Prevention (CDC)--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1216 Respiratory Protective Devices........................................................ 0905-AB58
----------------------------------------------------------------------------------------------------------------
Public Health Service--Centers for Disease Control and Prevention (CDC)--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1217 Interstate Shipment of Biological Material That Contains or May Contain Etiologic
Agents................................................................................ 0905-AC89
1218 Medical Examination of Aliens......................................................... 0905-AD29
----------------------------------------------------------------------------------------------------------------
Public Health Service--Food and Drug Administration (FDA)--Prerule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1219 Medical Foods......................................................................... 0905-AD91
1220 Specific Requirements on Content and Format of Labeling for Human Prescription Drugs;
Addition of ``Geriatric Use'' Subsection in the Labeling.............................. 0905-AE26
1221 Certification of Drugs Composed Wholly or Partly of Insulin; Fees for Certification of
Drugs Composed Wholly of Partly of Insulin............................................ 0905-AE28
1222 Sunglass Labeling..................................................................... 0905-AE35
1223 Investigational Device Exemption: Cost Recovery....................................... 0905-AE36
----------------------------------------------------------------------------------------------------------------
Public Health Service--Food and Drug Administration (FDA)--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1224 New Animal Drug Approval Process...................................................... 0905-AA96
1225 Policies Concerning Uses of Sulfiting Agents.......................................... 0905-AB52
1226 Infant Formula Act.................................................................... 0905-AC46
1227 Implementation of Title I of the Generic Animal Drug and Patent Term Restoration Act.. 0905-AD15
1228 Prescription Drug Marketing Act of 1987; Policy Information, Guidance, and
Clarifications........................................................................ 0905-AD44
1229 Implementation of the Safe Medical Devices Act of 1990................................ 0905-AD59
1230 Reporting of Errors and Accidents Relating to Blood Safety and Withdrawal of
Previously Proposed Rule.............................................................. 0905-AD67
1231 Proposed Labeling for Drug Products Based on False or Fraudulent Data................. 0905-AD71
1232 Review of Warnings, Use Instructions, and Precautionary Information Under Section 314
of the National Childhood Vaccine Injury Act of 1986.................................. 0905-AD72
1233 Medical Devices; Infant Apnea Monitor; Development of Mandatory Standard.............. 0905-AD83
1234 Mammography Quality Standards Act of 1992............................................. 0905-AE19
1235 Adverse Experience Reporting Requirements for Human Drug and Licensed Biological
Products.............................................................................. 0905-AE29
1236 Electronic Signatures................................................................. 0905-AE31
1237 Financial Disclosure by Clinical Investigators........................................ 0905-AE32
1238 Effective Date of Requirement for Submission of Premarket Approval Applications....... 0905-AE34
1239 Latex Condoms/Gloves: Expiration Date Labeling........................................ 0905-AE37
1240 Amalgam Ingredient Labeling........................................................... 0905-AE39
1241 Latex Warning......................................................................... 0905-AE40
1242 Premarket Approval Applications: Supplements.......................................... 0905-AE41
1243 Restricted Devices.................................................................... 0905-AE42
1244 Prescription Drug Product Labeling; Medication Guide.................................. 0905-AE43
1245 Substances Prohibited for Use in Ruminant Feed........................................ 0905-AE45
1246 Hearing Aids; Professional and Patient Labeling; Conditions for Sale.................. 0905-AE46
----------------------------------------------------------------------------------------------------------------
Public Health Service--Food and Drug Administration (FDA)--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1247 Over-the-Counter (OTC) Drug Review.................................................... 0905-AA06
1248 Abbreviated New Drug Application Regulations (Title I of the ``Drug Price Competition
and Patent Term Restoration Act of 1984'')............................................ 0905-AB63
1249 Current Good Manufacturing Practice for Blood and Blood Components; Notification of
Consignees Receiving Blood and Blood Components at Increased Risk for Transmitting HIV
Infection............................................................................. 0905-AC90
1250 Lead in Foods......................................................................... 0905-AC91
1251 Expediting Approval for Drugs Intended To Treat Life-Threatening and Severely
Debilitating Illnesses................................................................ 0905-AC94
1252 Fees for Certification Services; Insulin and Color Additive Certification Programs.... 0905-AD34
1253 Mandatory HACCP Seafood Inspection Program............................................ 0905-AD60
1254 Bottled Water......................................................................... 0905-AD65
1255 Specific Requirements on Content and Format of Labeling for Human Prescription Drugs;
Revision of ``Pediatric Use'' Subsection in the Labeling.............................. 0905-AD76
1256 Recordkeeping and Reporting: Electronic Products...................................... 0905-AD78
1257 General Biological Product Standards; Alternative Procedures and Exceptions........... 0905-AD82
1258 Medical Devices; Protective Restraints; Revocation of Exemptions From 510(k) Premarket
Notification Procedures and Current Good Manufacturing Practices Regulations.......... 0905-AD84
1259 Threshold of Regulation Policy for Components of Food Contact Articles................ 0905-AD86
1260 Food Labeling Review.................................................................. 0905-AD89
1261 Levo-Alpha-Methadol (LAAM) in Maintenance; Joint Proposed Revision of Conditions for
Use................................................................................... 0905-AD92
1262 Temporomandibular Joint Implant Classification........................................ 0905-AD93
1263 Clinical Investigator Disqualification................................................ 0905-AD94
1264 Revocation of Intraocular Lens Investigation Device Exemption......................... 0905-AD95
1265 Dietary Supplement Label Review....................................................... 0905-AD96
1266 Adverse Experience Reporting Required for Licensed Biological Products................ 0905-AE18
1267 Tamper-Evident Packaging Requirements for Over-The-Counter Human Drug Products........ 0905-AE27
----------------------------------------------------------------------------------------------------------------
Public Health Service--Food and Drug Administration (FDA)--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1268 Voluntary, Fee-for-Service Seafood Inspection Program................................. 0905-AD23
1269 Part 1260; Human Semen for Artificial Insemination.................................... 0905-AD80
1270 Investigational New Drug Applications................................................. 0905-AD85
1271 Dietary Supplements................................................................... 0905-AD90
1272 Proposal To Establish Procedures for the Safe Processing, Packaging, Storage, and
Distribution of Smoked Fish, Smoke-Flavored Fish, and Salted Fish..................... 0905-AE21
----------------------------------------------------------------------------------------------------------------
Public Health Service--Health Resources and Services Administration (HRSA)--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1273 National Health Service Corps Loan Repayment Program; Grants for State Loan Repayment
Programs.............................................................................. 0905-AC65
1274 Organ Procurement and Transplantation Network Rules................................... 0905-AD26
1275 Health Education Assistance Loan (HEAL) Program: Lenders' Performance Standards....... 0905-AD87
1276 Grants for Nurse Practitioner and Nurse-Midwifery Programs............................ 0905-AE11
1277 Grants for Faculty Training Projects in Geriatric Medicine and Dentistry.............. 0905-AE13
1278 Medical Facility Construction and Modernization Requirements for Provision of Services
to Persons Unable to Pay.............................................................. 0905-AE33
----------------------------------------------------------------------------------------------------------------
Public Health Service--Health Resources and Services Administration (HRSA)--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1279 National Vaccine Injury Compensation (NVIC) Program: Revisions to the Vaccine Injury
Table................................................................................. 0905-AD64
1280 Maternal and Child Health (MCH) Project Grants........................................ 0905-AD88
1281 Medical Facility Construction and Modernization; Requirements for Provision of
Services to Persons Unable To Pay..................................................... 0905-AE06
1282 Grants for the Establishment of Departments of Family Medicine........................ 0905-AE17
1283 National Practitioner Data Bank for Adverse Information on Physicians and Other Health
Care Practitioners: Amendment to Data Bank Regulations To Comply With Court Order..... 0905-AE38
----------------------------------------------------------------------------------------------------------------
Public Health Service--Health Resources and Services Administration (HRSA)--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1284 Health Education Assistance Loan (HEAL) Program: School Collection Assistance......... 0905-AC87
1285 Health Education Assistance Loan (HEAL) Program: Postjudgment Collections............. 0905-AD11
1286 National Practitioner Data Bank for Adverse Information on Physicians and Other Health
Care Practitioners: Authorized Agents................................................. 0905-AE10
1287 National Practitioner Data Bank for Adverse Information on Physicians and Other Health
Practitioners: Amendments to Collection of User Fees.................................. 0905-AE15
1288 Grants for Health Professions Projects in Geriatrics.................................. 0905-AE16
----------------------------------------------------------------------------------------------------------------
Public Health Service--Indian Health Service (IHS)--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1289 Indian Health Service Loan Repayment Program Regulations.............................. 0905-AC96
1290 Indian Health Service Catastrophic Health Emergency Fund Program...................... 0905-AC97
1291 Revision of Indian Self-Determination Regulations..................................... 0905-AC98
1292 Revision of Urban Indian Health Regulations........................................... 0905-AD20
1293 Acquisition Under the Buy Indian Act.................................................. 0905-AE09
----------------------------------------------------------------------------------------------------------------
Public Health Service--Indian Health Service (IHS)--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1294 Review of the Determination of an Indian Tribe's Resource Deficiency Level............ 0905-AD21
----------------------------------------------------------------------------------------------------------------
Public Health Service--National Institutes of Health (NIH)--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1295 Grants for Research Projects.......................................................... 0905-AC02
1296 National Institutes of Health AIDS Research Loan Repayment Program.................... 0905-AD18
1297 Hazardous Substances Basic Research and Training Grants............................... 0905-AD46
1298 National Institutes of Health Construction Grants..................................... 0905-AD49
1299 Training Grants....................................................................... 0905-AD56
1300 National Institutes of Health Center Grants........................................... 0905-AE00
1301 Responsibilities of Public Health Service Funded Institutions for Promoting
Objectivity in Research............................................................... 0905-AE01
1302 Grants for National Alcohol Research Centers.......................................... 0905-AE08
----------------------------------------------------------------------------------------------------------------
Public Health Service--National Institutes of Health (NIH)--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1303 Traineeships.......................................................................... 0905-AD28
1304 Standards for Bone Marrow Registries and Centers...................................... 0905-AD51
1305 National Institute of Environmental Health Sciences Hazardous Waste Worker Training... 0905-AD69
1306 National Heart, Lung, and Blood Institute Grants for Prevention and Control Projects.. 0905-AE25
----------------------------------------------------------------------------------------------------------------
Public Health Service--National Institutes of Health (NIH)--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1307 Special Volunteer Services at the National Institutes of Health....................... 0905-AC95
1308 Minority Biomedical Research Support Program.......................................... 0905-AD47
1309 National Heart, Lung, and Blood Institute Grants for Prevention and Control Projects.. 0905-AD48
----------------------------------------------------------------------------------------------------------------
Public Health Service--Agency for Health Care Policy and Research (AHCPR)--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1310 Health Services Research, Evaluation, Demonstration, and Dissemination Projects; Peer
Review of Grants and Contracts........................................................ 0905-AD30
----------------------------------------------------------------------------------------------------------------
Health Care Financing Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1311 Hospice Services (MB-7-P)............................................................. 0938-AC52
1312 Optional Payment System for Low Medicare Volume Skilled Nursing Facilities (BPD-409-P) 0938-AD02
1313 Medicaid Eligibility of Poverty Level Groups and Extended Coverage of Services (MB-13-
F).................................................................................... 0938-AD17
1314 Transfer of Resources for Less Than Fair Market Value (MB-10-P)....................... 0938-AD18
1315 Medicare Coverage of Outpatient Occupational Therapy Services (BPD-425-P)............. 0938-AD32
1316 Revisions to the Freedom of Information Regulations (OPA-1-P)......................... 0938-AD60
1317 New Minimum Standards for Medicare Supplemental (Medigap) Policies (BPD-491-P)........ 0938-AD82
1318 Clarification of ``Without Fault'' as It Applies to Physician Provider and Supplier
Liability (BPD-719-P)................................................................. 0938-AD95
1319 Protection of Income and Resources for Community Spouse (MB-23-P)..................... 0938-AE12
1320 Physician Certification and Plan of Care Requirements and Inspection of Care Reviews
(HSQ-178-P)........................................................................... 0938-AE17
1321 Medicaid Payment of Medicare Cost Sharing for Qualified Medicare Beneficiaries and
Qualified Disabled and Working Individuals and Specified Low-Income Medicare
Beneficiaries (MB-031-P).............................................................. 0938-AE38
1322 Post-Contract Beneficiary Protections and Other Provisions (OCC-011-F)................ 0938-AE63
1323 Coverage of Physician Assistant, Nurse Practitioner, and Clinical Nurse Specialist
Services (BPD-708-P).................................................................. 0938-AF00
1324 Utilization and Quality Control Peer Review Organizations (PRO): Confidential
Information (HSQ-190-P)............................................................... 0938-AF03
1325 Day Habilitation and Related Services (MB-37-P)....................................... 0938-AF10
1326 Medicaid Third Party Liability: Cost Effectiveness Waivers (MB-39-F).................. 0938-AF11
1327 OBRA '90 and Miscellaneous Managed Care Technical Amendments (MB-044-P)............... 0938-AF15
1328 Criteria for the Determination of Reasonable Costs for Medicare --Contracting Prepaid
Health Plans (OCC-018-F).............................................................. 0938-AF16
1329 Provider Reimbursement Determinations and Appeals Revisions (BPD-727-P)............... 0938-AF28
1330 Alternative Sanctions for Psychiatric Hospitals (HSQ-191-P)........................... 0938-AF32
1331 Medicare, Medicaid, and CLIA Programs: Inspection and Certification Procedures for
Laboratories (HSQ-193-P).............................................................. 0938-AF33
1332 Medicaid Payment for Obstetrical and Pediatric Services--Adequate Payment Level
Provision (MB-036-P).................................................................. 0938-AF62
1333 Requirements for Enrollment of Medicaid Recipients Under Cost Effective Employer Based
Group Health Plans (MB-047-P)......................................................... 0938-AF64
1334 Clarification of Coverage of Inpatient Psychiatric Services (MB-060-P)................ 0938-AF73
1335 National Coverage Decisions: Rules for Risk Contracting HMOs and CMPs (BPD-732-F)..... 0938-AF76
1336 Part B Advance Payments to Physicians/Suppliers or Other Entities Furnishing Items or
Services Under Medicare Part B (BPO-105-P)............................................ 0938-AF85
1337 Federally Qualified Health Center Services (Medicaid) (MB-043-P)...................... 0938-AF90
1338 Revisions to Rules on Health Care Prepayment Plans (OCC-032-P)........................ 0938-AF97
1339 Change in Provider Agreement Regulations Related to Federal Employee Health Benefits
(BPD-748-F)........................................................................... 0938-AG03
1340 Conditions of Participation for Rural Health Clinics (BPD-764-P)...................... 0938-AG05
1341 Intermediary and Carrier Functions (BPO-111-F)........................................ 0938-AG06
1342 Income and Eligibility Verification System (MB-66-P).................................. 0938-AG12
1343 Medicare Appeals of Individual Claims (BPD-453-P)..................................... 0938-AG18
1344 Criteria for Approval of End-Stage Renal Disease (ESRD) Payment Exception Requests
(BPD-763-P)........................................................................... 0938-AG20
1345 Standards for Quality of Water Used in Dialysis and Revised Guidelines on Reuse of
Hemodialyzer Filters for End-Stage Renal Disease Patients (BPD-766-F)................. 0938-AG21
1346 Appointment of Representatives for Appeal (BPO-120-P)................................. 0938-AG30
1347 Enforcement Requirements for Renal Dialysis Facilities (HSQ-204-P).................... 0938-AG31
1348 Disclosure of Confidential PRO Information for Research Purposes (HSQ-208-P).......... 0938-AG33
1349 Community Supported Living Arrangements Services (MB-070-P)........................... 0938-AG35
1350 Medicare Program: Limitations on Medicare Coverage of Intermittent Positive Pressure
Breathing Machine Therapy (BPD-781-PN)................................................ 0938-AG44
1351 Noncoverage of Electrostimulation of Salivary Glands for the Treatment of Xerostomia
(Dry Mouth) (BPD-782-PN).............................................................. 0938-AG45
1352 Medicare Program: Changes to the Inpatient Hospital Prospective Payment Systems and
Fiscal Year 1995 Rates (BPD-802-P).................................................... 0938-AG46
1353 Telephone Requests for Review of Initial Determinations (BPO-121-P)................... 0938-AG48
1354 Refinements to the Physician Fee Schedule Geographic Adjustment Factor Values and
Other Changes (BPD-789-P)............................................................. 0938-AG52
1355 Conditions for Payment for Physicians' Services in Teaching Settings (BPD-792-P)...... 0938-AG53
1356 Date for Filing Medicare Cost Reports (BPD-794-P)..................................... 0938-AG55
1357 Limitations on Revisions to Final Administrative Cost Proposals (BPO-122-P)........... 0938-AG57
1358 New Look Behind for Intermediate Care Facilities for the Mentally Retarded (ICFs/MR)
(HSQ-214-P)........................................................................... 0938-AG58
1359 Effect of Change of Ownership on Provider and Supplier Penalties, Sanctions, and
Overpayments (HSQ-215-P).............................................................. 0938-AG59
1360 Institutional Plan Amendment Findings (MB-078-P)...................................... 0938-AG60
1361 Medicare Program: Limitations on Medicare Coverage of Cataract Surgery (BPD-797-PN)... 0938-AG65
1362 Effects of Generally Accepted Accounting Principles (GAAP) on Reasonable Costs
Determinations (BPD-800-P)............................................................ 0938-AG66
1363 Expansion of the Definition of Eye and Ear Specialty Hospitals (BPD-804-P)............ 0938-AG67
1364 Salary Equivalency Guidelines for Physical and Respiratory Therapy Services Furnished
Under Arrangements (BPD-808-PN)....................................................... 0938-AG70
1365 Medicaid: Optional Coverage of TB-Related Services for Individuals Infected with
Tuberculosis (MB-082-P)............................................................... 0938-AG72
1366 Medicaid Program: Nurse-Midwife Services (MB-085-P)................................... 0938-AG73
1367 Proposed Payments to Disproportionate Share Hospitals for FY 1995 (MB-089-N).......... 0938-AG75
----------------------------------------------------------------------------------------------------------------
Health Care Financing Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1368 Medicaid Eligibility and Coverage Requirements (MB-001-F)............................. 0938-AA58
1369 Deduction of Incurred Medical Expenses (Spenddown) (MB-020-F)......................... 0938-AB07
1370 Payment for Clinical Diagnostic Laboratory Services (BPD-309-F)....................... 0938-AB50
1371 Home and Community-Based Services and Respiratory Care for Ventilator-Dependent
Individuals (MB-8-FC)................................................................. 0938-AC55
1372 Participation in CHAMPUS and CHAMPVA, Hospital Admissions for Veterans, Discharge
Rights Notice, and Hospital Responsibility for Emergency Care (BPD-393-FC)............ 0938-AC58
1373 Denial of Payment for Substandard Quality Care (HSQ-132-F)............................ 0938-AC84
1374 Revised Effective Date of Medicare/Medicaid Provider Agreement and Supplier
Participation (HSQ-139-F)............................................................. 0938-AC88
1375 Changes Concerning Suspension of Medicare Payments and Determinations of Allowable
Interest Expense (BPO-118-FC)......................................................... 0938-AC99
1376 Changes Concerning the Definition of Accrual Basis of Accounting (BPD-366-F).......... 0938-AD01
1377 Criteria and Procedures for Making Medical Services Coverage Decisions That Relate to
Health Care Technology (BPD-432-F).................................................... 0938-AD07
1378 Revisions to Conditions of Participation for Hospitals and Conditions for Coverage of
Suppliers of End-Stage Renal Disease Services (BPD-421-F)............................. 0938-AD11
1379 Prohibition on Unbundling of Hospital Outpatient Services (BPD-426-F)................. 0938-AD33
1380 Changes to Peer Review Organization Regulations (HSQ-135-F)........................... 0938-AD38
1381 Home and Community-Based Services for the Elderly (MB-019-F).......................... 0938-AD55
1382 Payment for Durable Medical Equipment and Orthotic and Prosthetic Devices (BPD-494-F). 0938-AD65
1383 Medicare Secondary Payer for Disabled Active Individuals (BPD-482-FC)................. 0938-AD73
1384 Medicare Coverage of Home Health Services, Medicare Conditions of Participation and
Home Health Aide Supervision (BPD-469-F).............................................. 0938-AD78
1385 Appeals for Enrollees of Prepaid Health Care Plans (OCC-020-F)........................ 0938-AD79
1386 Omnibus Nursing Home Reform Requirements (BPD-488-FC)................................. 0938-AD81
1387 Fee Schedule for Payment of Therapeutic and Diagnostic Services Other Than
Psychological Testing Provided by Clinical Psychologists and Clinical Social Workers
(BPD-495-IFC)......................................................................... 0938-AD84
1388 Survey and Certification of Skilled Nursing Facilities and Nursing Facilities and
Enforcement Procedures (HSQ-156-F).................................................... 0938-AD94
1389 HMO Organizational Structure and Services (OCC-019-F)................................. 0938-AE25
1390 ''Confined to the Home'' Requirements for Home Health Services (BPD-626-F)............ 0938-AE34
1391 Payment Adjustments for Hospitals That Serve a Disproportionate Number of Low-Income
Patients (MB-017-IFC)................................................................. 0938-AE35
1392 Survey Requirements and Alternative Sanctions for Home Health Agencies (HSQ-169-F).... 0938-AE39
1393 Hospital Standard for HIV Infectious Blood (BPD-633-F)................................ 0938-AE40
1394 Medicare, Medicaid, and CLIA Programs: Regulations Implementing the Clinical
Laboratory Improvement Amendments of 1988 (CLIA '88) (HSQ-202-F)...................... 0938-AE47
1395 Conditions of Coverage for Organ Procurement Organizations (BPD-646-FC)............... 0938-AE48
1396 Preadmission Screening and Annual Resident Review (BPD-661-F)......................... 0938-AE49
1397 Extended Medicaid Eligibility for Certain Individuals (MB-026-F)...................... 0938-AE51
1398 Resident Assessment in Long-Term Care Facilities (HSQ-180-F).......................... 0938-AE61
1399 Conforming Provisions for 1988 HMO Amendments (OCC-012-F)............................. 0938-AE64
1400 Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) Services (MB-28-F).... 0938-AE72
1401 Payment for Nursing and Allied Health Science Education (BPD-685-F)................... 0938-AE79
1402 Uniform Electronic Cost Reporting System for Hospitals (BPD-689-F).................... 0938-AE80
1403 Medicare Coverage of Prescription Drugs Used in Immunosuppressive Therapy (BPD-424-F). 0938-AE94
1404 Fire Safety Standards for Hospitals, Long-Term Care Facilities, and Intermediate Care
Facilities for the Mentally Retarded (BPD-650-F)...................................... 0938-AE97
1405 Coverage of Screening Pap Smears (BPD-705-F).......................................... 0938-AE98
1406 Medicare Coverage of Clinical Psychologist, Other Psychologist, and Clinical Social
Worker Services--Medicare (BPD-706-F)................................................. 0938-AE99
1407 Allowing Certifications and Recertifications by Nurse Practitioners and Clinical Nurse
Specialists for Certain Services (BPD-709-F).......................................... 0938-AF01
1408 Changes to the Long-Term Care Facility Survey Process (HSQ-175-FC).................... 0938-AF02
1409 Case Management (MB-27-F)............................................................. 0938-AF07
1410 Required Coverage of Nurse Practitioner Services--Medicaid (MB-41-F).................. 0938-AF12
1411 Payment for Federally Qualified Health Center (FQHC) Services (BPD-728-F)............. 0938-AF14
1412 Medicare Coverage of Screening Mammography (BPD-724-F)................................ 0938-AF26
1413 Physician Ownership of and Referrals to Health Care Facilities That Furnish Clinical
Laboratory Services and Financial Relationship Reporting Requirements (BPD-674-F)..... 0938-AF40
1414 Medicaid Payment for Covered Outpatient Drugs Under Rebate Agreements (MB-046-IFC).... 0938-AF42
1415 Medicare and Medicaid Programs; Advance Directives (BPD-718-F)........................ 0938-AF50
1416 Partial Hospitalization Services in Community Mental Health Centers (BPD-736-F)....... 0938-AF53
1417 Medicaid Drug Use Review Program and Electronic Claims Management System for
Outpatient Drug Claims (MB-050-F)..................................................... 0938-AF67
1418 Referral to Child Support Enforcement Agencies of Medicaid Families With an Absent
Parent (MB-051-F)..................................................................... 0938-AF68
1419 Medicaid: Outstationed Intake Locations for Certain Low-Income Pregnant Women, Infants
and Children (MB-052-IFC)............................................................. 0938-AF69
1420 Optional Spenddown (MB-055-IFC)....................................................... 0938-AF72
1421 Medicare and Medicaid Programs: Requirements for Physician Incentive Plans in Prepaid
Health Care Organizations (OCC-024-F)................................................. 0938-AF74
1422 Application of Interest Charges to Medicare Secondary Payer Recoveries (BPO-108-GN)... 0938-AF87
1423 Minimum Physician Qualifications for Certain Services (MB-059-P)...................... 0938-AF92
1424 Retroactive Enrollment (OCC-031-F).................................................... 0938-AF98
1425 Payment for Preadmission Services (BPD-731-F)......................................... 0938-AG00
1426 Payment for Extracorporeal Shock Wave Lithotripsy Services Furnished by Ambulatory
Surgical Centers (BPD-762-FN)......................................................... 0938-AG04
1427 Revised Medicaid Management Information Systems (MB-38-FN)............................ 0938-AG10
1428 Intermediary and Carrier Checks That Are Lost, Stolen, Defaced, Mutilated, Destroyed,
or Paid on Forged Endorsements (BPO-114-FC)........................................... 0938-AG16
1429 Revisions to the Definition of End-Stage Renal Disease and Resumption of Entitlement
(BPD-738-F)........................................................................... 0938-AG19
1430 Medicare Program: Proposed Additions to and Deletions From the Current List of Covered
Surgical Procedures for Ambulatory Surgical Centers (BPD-776-FN)...................... 0938-AG27
1431 Medicare Program: Special Payment Limits for Home Blood Glucose Monitors (BPD-778-FN). 0938-AG28
1432 General Evaluation Criteria and Standards for Evaluating Performance of Contract (HSQ-
207-GNC).............................................................................. 0938-AG32
1433 Changes in Physician Attestation Requirements (BPD-769-F)............................. 0938-AG34
1434 Withdrawal of Coverage of Diagnostic Nocturnal Penile Tumescence Testing (Impotence
Testing) (BPD-780-FN)................................................................. 0938-AG43
1435 Part A Premium for 1995 for the Uninsured Aged and for Certain Disabled Individuals
Who Have Exhausted Other Entitlement (OACT-046-N)..................................... 0938-AG49
1436 Medicare Program: Monthly Actuarial Rates and Monthly Supplementary Medical Insurance
Premium Rates Beginning January 1, 1995 (OACT-047-N).................................. 0938-AG50
1437 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance
Amounts for 1995 (OACT-048-N)......................................................... 0938-AG51
1438 Reductions in Payments for HHA Services (BPD-793-NC).................................. 0938-AG54
1439 Reductions in Payments for SNF Services (BPD-795-NC).................................. 0938-AG56
1440 Required Laboratory Procedures for Rural Health Clinics (BPD-783-FC).................. 0938-AG62
1441 Freedom of Choice Waiver; Conforming Changes (MB-68-IFC).............................. 0938-AG63
1442 Self-Implementing Coverage and Payment Provisions: 1993 Legislation (BPD-791-FC)...... 0938-AG64
1443 Payment to Swing Bed Hospitals (BPD-805-FC)........................................... 0938-AG68
1444 Physician Performance Standard Rates of Increase for FY 1995 and Physician Fee
Schedule Update for CY 1995 (BPD-807-FNC)............................................. 0938-AG69
1445 Categorization of CLIA Tests and Personnel Modifications (HSQ-216-FC)................. 0938-AG71
1446 Final Limitations on Aggregate Payments to Disproportionate Share Hospitals: Federal
Fiscal Year 1994 (MB-088-N)........................................................... 0938-AG74
1447 Small Business Innovation Research Grants for FY 95 (ORD-068-N)....................... 0938-AG76
1448 Medicaid Program: Fees for Vaccine Administration Under Pediatric Immunization Program
(MB-084-N)............................................................................ 0938-AG77
----------------------------------------------------------------------------------------------------------------
Health Care Financing Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1449 Payment for the Cost of Malpractice Insurance for Hospitals Excluded From the
Prospective Payment System (BPD-437-P)................................................ 0938-AC97
1450 Changes Concerning the Investment Income Offset Policy (BPD-481-P).................... 0938-AD72
1451 Diagnosis Codes on Physician Bills (BPD-610-F)........................................ 0938-AE06
1452 HMOs: Group Specific Ratings (OCC-009-F).............................................. 0938-AE24
1453 Aggregation of Medicare Claims for Administrative Law Judge (ALJ) Hearings and
Judicial Review (BPD-694-F)........................................................... 0938-AE93
1454 General Notice on Medicare Secondary Payment (BPO-94-GN).............................. 0938-AF05
1455 Granting and Withdrawal of Deeming Authority to National Accreditation Organizations
(HSQ-159-F)........................................................................... 0938-AF17
1456 Self-Implementing Coverage and Payment Provisions of Omnibus Budget Reconciliation Act
of 1990 (BPD-725-N)................................................................... 0938-AF27
1457 Preadmission Review and Authorization, Outpatient Surgery, Preadmission Diagnostic
Testing, and Same Day Surgery Under Medicaid (MB-021P)................................ 0938-AF35
1458 Durable Medical Equipment (DME) Medical Necessity Forms (BPD-734-FC).................. 0938-AF51
1459 Injectables for Osteoporosis (BPD-735-FC)............................................. 0938-AF52
1460 Medicare Coverage of EPO for Home Use by Home Dialysis Patients (BPD-737-F)........... 0938-AF54
1461 Designation of Regional Carriers To Process Claims for Durable Medical Equipment,
Prosthetics, Orthotics, and Supplies (BPO-102-F)...................................... 0938-AF59
1462 Uniform Payment Mechanism for Hospitals Under Part A of Medicare (BPO-104-FN)......... 0938-AF60
1463 Medicaid Qualifying Trusts (MB-011-P)................................................. 0938-AF61
1464 Exemption of Low-Income Pregnant Women From Eligibility Condition of Establishing
Paternity and Seeking Support (MB-048-F).............................................. 0938-AF65
1465 Home and Community-Based Care as an Optional Service (MB-053-IFC)..................... 0938-AF70
1466 Revisions to Criteria and Standards for Evaluating Intermediaries and Carriers (BP0-
083-F)................................................................................ 0938-AF84
1467 Medicare Program: Peer Review Organization; General Criteria and Standards for
Evaluating Performance of Contract Obligations (HSQ-200-NC)........................... 0938-AF89
1468 Computer Matching and Privacy Protection for Medicaid Eligibility (MB-057-F).......... 0938-AF91
1469 Medicare Program: Coverage of Certified Nurse-Midwife Services (BPD-496-P)............ 0938-AG02
1470 Medicaid Prescription Drug Coverage: Scope and Limitations (MB-067-P)................. 0938-AG13
1471 Use of Federally Standardized Claims Processing Forms and Procedures (MB-069-P)....... 0938-AG14
1472 Update of EPO Payment Rate for 1993 (BPD-768-PN)...................................... 0938-AG15
1473 Revisions to Payment Policies Under the Physician Fee Schedule (BPD-770-FC)........... 0938-AG22
1474 Physician Performance Standard Rates of Increase for 1994 (BPD-774-FC)................ 0938-AG25
1475 Medicaid Coverage of Personal Care Services Outside the Home (MB-071-P)............... 0938-AG36
1476 Medicaid Covered Outpatient Drugs Under Drug Rebate (DVA Law) (MB-072-P).............. 0938-AG37
1477 Part A Premium for 1994 for the Uninsured Aged and for Certain Disabled Individuals
Who Have Exhausted Other Entitlement (OACT-043-N)..................................... 0938-AG39
1478 Monthly Actuarial Rates and Monthly Supplementary Medical Insurance Premium Rates
Beginning January 1, 1994 (OACT-044-N)................................................ 0938-AG40
1479 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance
Amounts for 1994 (OACT-045-N)......................................................... 0938-AG41
1480 Schedule of Limits on Home Health Agency Costs Per Visit for Cost Reporting Periods
Beginning on or After July 1, l994 (BPD-786-NC)....................................... 0938-AG47
1481 Limitations on Aggregate Payments to Disproportionate Share Hospitals: Federal Fiscal
Year 1994 (MB-079-N).................................................................. 0938-AG61
----------------------------------------------------------------------------------------------------------------
Administration for Children and Families--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1482 Foster Care, Adoption Assistance, and Child Welfare Services.......................... 0970-AA97
1483 Amendments to Developmental Disabilities Rules........................................ 0970-AB11
1484 Child Abuse and Neglect State Grant Program........................................... 0970-AB23
1485 Standards for Safe Transportation..................................................... 0970-AB24
1486 Title IV-E Training................................................................... 0970-AB25
1487 State Legalization Impact Assistance Grant............................................ 0970-AB28
1488 Standards for Purchase of Facilities.................................................. 0970-AB31
1489 National Voter Registration Act of 1993 Provisions Affecting Public Assistance
Agencies.............................................................................. 0970-AB32
1490 Child Care--Revised Regulations....................................................... 0970-AB33
1491 Family Preservation and Support....................................................... 0970-AB34
1492 Notice of Proposed Rulemaking for the Administration of Native Americans 45 CFR Part
1336.................................................................................. 0970-AB37
1493 Interstate Case Closure............................................................... 0970-AB41
1494 Refugee Resettlement Program: Miscellaneous Changes................................... 0970-AB42
1495 Direct Payments to Indian Tribes and Tribal Organizations under Title IV-B, Subpart 1. 0970-AB44
1496 Repatriation - Advance Approval of Costs.............................................. 0970-AB45
----------------------------------------------------------------------------------------------------------------
Administration for Children and Families--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1497 Aid to Families With Dependent Children Program; Extension of Medicaid Eligibility
When Support Collections Result in Termination of AFDC Eligibility.................... 0970-AA07
1498 Revisions of Child Support Enforcement Program and Audit Regulations.................. 0970-AA74
1499 Head Start Performance Standards for Infants, Toddlers, and Pregnant Women............ 0970-AB04
1500 Technical Changes to the AFDC Program as Required by OBRA 90.......................... 0970-AB14
1501 Block Grant Programs (Low-Income Home Energy Assistance Program --LIHEAP) FY 91 and FY
92 Provisions......................................................................... 0970-AB15
1502 Block Grant Programs (Low-Income Home Energy Assistance Program--LIHEAP)--FY 93 and FY
94 Provisions......................................................................... 0970-AB16
1503 Family Violence Prevention and Services............................................... 0970-AB18
1504 Statewide Automated Child Welfare Information System.................................. 0970-AB38
1505 Automatic Data Processing Equipment and Services; Conditions for Federal Financial
Participation and General Administration - Public Assistance Programs................. 0970-AB39
1506 Paternity Establishment Provisions of the Omnibus Budget Reconciliation Act of 1993... 0970-AB40
----------------------------------------------------------------------------------------------------------------
Administration for Children and Families--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1507 Disregards of Income and Resources.................................................... 0970-AA70
1508 Essential Persons..................................................................... 0970-AA93
1509 Adoption and Foster Care Analysis and Reporting System................................ 0970-AB05
1510 Social Services Block Grant Information Collection.................................... 0970-AB06
1511 Refugee Cash Assistance and Refugee Medical Assistance................................ 0970-AB27
1512 Elimination of Enhanced Funding for AFDC.............................................. 0970-AB35
1513 Increase in Stepparent Income Disregard............................................... 0970-AB36
----------------------------------------------------------------------------------------------------------------
Administration on Aging--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1514 Grants for State and Community Programs on Aging, Intrastate Funding Formulas;
Training, Research and Discretionary Programs; Vulnerable Elder Rights; and Grants to
Indians & Native Hawaiians............................................................ 0985-AA00
----------------------------------------------------------------------------------------------------------------
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Office of the Secretary (OS)
_______________________________________________________________________
1113. NONDISCRIMINATION REQUIREMENTS (INCLUDING ON THE BASIS OF SEX OR
RELIGION) APPLICABLE TO BLOCK GRANTS AND STANDARD NONDISCRIMINATION
PROCEDURES APPLICABLE TO CERTAIN OTHER PROGRAMS
Significance:
Subject to OMB review: Yes
Regulatory Plan entry: Yes
Legal Authority: 42 USC 9906; 42 USC 300x-7; 42 USC 708; 42 USC 8625;
42 USC 9821; 42 USC 9849; 42 USC 1397; 42 USC 300w-7
CFR Citation: 45 CFR 94
Legal Deadline: None
Abstract: To implement the nondiscrimination requirements applicable to
block grants authorized by the Omnibus Budget Reconciliation Act of
1981, P.L. 97-35, as amended by the Omnibus Budget Reconciliation Act
of 1990, P.L. 101-508.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 01/21/86 51 FR 2806
NPRM Comment Period End 03/24/86 51 FR 2806
Second NPRM 06/00/94
Small Entities Affected: Businesses, Governmental Jurisdictions,
Organizations
Government Levels Affected: State, Local
Agency Contact: Marcella Haynes, Director, Policy & Special Projects
Staff, Office for Civil Rights, Department of Health and Human
Services, Office of the Secretary, 330 Independence Ave., SW., Rm.
5034, Washington, DC 20201, 202 619-0671
RIN: 0991-AA02
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Office of the Secretary (OS)
_______________________________________________________________________
1114. CIVIL MONEY PENALTIES (CMPS) FOR CERTAIN HOSPITAL PHYSICIAN
INCENTIVE PLANS
Significance:
Subject to OMB review: Undetermined
Legal Authority: PL 99-509, Sec 9313
CFR Citation: 42 CFR 1001; 42 CFR 1003
Legal Deadline: None
Abstract: This proposed rule would prohibit a hospital from knowingly
making incentive payments to a physician as an inducement to reduce or
limit services provided to Medicare or Medicaid beneficiaries who are
under the direct care of that physician. The rule would also set forth
standards governing the imposition of CMPs for each such individual for
whom payments are made.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 09/00/94
NPRM Comment Period End 11/00/94
Small Entities Affected: Undetermined
Government Levels Affected: None
Agency Contact: Joel Jay Schaer, Regulations Officer, Department of
Health and Human Services, Office of the Secretary, Office of Inspector
General, OMP, 330 Independence Avenue SW., Washington, DC 20201, 202
619-3270
RIN: 0991-AA45
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Office of the Secretary (OS)
_______________________________________________________________________
1115. CIVIL MONEY PENALTIES (CMPS) FOR CERTAIN PRACTICES RELATING TO
MEDICARE SUPPLEMENTAL POLICIES
Significance:
Subject to OMB review: Undetermined
Legal Authority: PL 100-360, Sec 428(b); PL 101-508, Sec 4351; PL 101-
508, Sec 4353(a); PL 101-508, Sec 4354; PL 101-508, Sec 4355(a); PL
101-508, Sec 4357
CFR Citation: 42 CFR 1003
Legal Deadline: None
Abstract: This proposed rule would authorize the imposition of CMPs
against individuals or entities who knowingly and willfully use
misleading and fraudulent practices in the advertisement, solicitation,
offering for sale, or delivery of Medicare supplemental health
insurance (Medigap) policies. Penalties would also be established for
failure to meet Medigap policy loss-ratio requirements, failure to
comply with policy simplification standards, and failure to obtain
Secretarial certification of Medigap policies in States with non-
approved regulatory programs.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: Businesses
Government Levels Affected: State
Agency Contact: Joel Jay Schaer, Regulations Officer, Department of
Health and Human Services, Office of the Secretary, Office of Inspector
General, OMP, 330 Independence Avenue SW., Washington, DC 20201, 202
619-3270
RIN: 0991-AA53
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Office of the Secretary (OS)
_______________________________________________________________________
1116. UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND COOPERATIVE
AGREEMENTS
Significance:
Subject to OMB review: Yes
Legal Authority: 5 USC 301
CFR Citation: 45 CFR 74
Legal Deadline: None
Abstract: On 11/29/93 OMB revised circular A-110 which contains
administrative requirements for grants to universities, hospitals, and
nonprofit organizations. 45 CFR Part 74 is being revised to implement
the circular. OMB will update rules for governmental grantees at a
future time.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 05/00/94
Final Action 09/00/94
45 CFR 74 NPRM 06/24/87 (52 FR 23729) NPRM Comment Period End 08/23/
87
45 CFR 92 NPRM 11/04/88 (53 FR 44715) NPRM Comment Period End 01/03/
89 NPRM Canceled 10/29/90 (55 FR 45289)
Small Entities Affected: None
Government Levels Affected: State, Local
Agency Contact: Charles Gale, Director, Division of Grants Policy and
Oversight, Department of Health and Human Services, Office of the
Secretary, Rm 517D, HHH Bldg., 200 Independence Avenue SW., Washington,
DC 20201, 202 690-6377
RIN: 0991-AA56
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Office of the Secretary (OS)
_______________________________________________________________________
1117. REVISIONS TO THE PRO SANCTIONS PROCESS
Significance:
Subject to OMB review: Yes
Legal Authority: 42 USC 1302; 42 USC 1320c-5; PL 100-93, sec 6; PL
100-93, sec 8; PL 100-93, sec 10; PL 100-203, sec 4095; PL 101-508, sec
4205
CFR Citation: 42 CFR 1004
Legal Deadline: None
Abstract: This rule will revise and update the procedures governing the
imposition and adjudication of sanctions predicated on recommendations
of State Peer Review Organizations. These changes are necessitated by
statutory revisions resulting from PL 100-93, PL 100-203, and PL 101-
508. This rule will also set forth new appeal and reinstatement
procedures that are presently codified in 42 CFR part 1004.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 02/28/94 59 FR 9452
NPRM Comment Period End 04/29/94
Final Action 12/00/94
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Joel Jay Schaer, Regulations Officer, Department of
Health and Human Services, Office of the Secretary, Office of Inspector
General, OMP, 330 Independence Avenue SW., Washington, DC 20201, 202
619-3270
RIN: 0991-AA73
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Office of the Secretary (OS)
_______________________________________________________________________
1118. CLARIFICATION OF THE OIG SAFE HARBOR ANTI-KICKBACK PROVISIONS
Significance:
Subject to OMB review: Undetermined
Legal Authority: PL 100-93, sec 14
CFR Citation: 42 CFR 1001
Legal Deadline: None
Abstract: This rule would clarify various aspects of the original set
of safe harbor provisions that were published on July 29, 1991 (56 FR
35953) and that are currently set forth in 42 CFR 1001.952(a)-(k). This
clarifying rule would modify the final safe harbor provisions to give
greater clarity to their original intent.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 08/00/94
NPRM Comment Period End 10/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Joel Jay Schaer, Regulations Officer, Department of
Health and Human Services, Office of the Secretary, Office of the
Inspector General, OMP, 330 Independence Avenue SW., Washington, DC
20201, 202 619-3270
RIN: 0991-AA74
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Office of the Secretary (OS)
_______________________________________________________________________
1119. CIVIL MONEY PENALTIES AND EXCLUSIONS FOR ASSISTANTS AT CATARACT
SURGERY
Significance:
Subject to OMB review: Undetermined
Legal Authority: PL 99-272, Sec 9307; PL 99-514, Sec 1895(b)(16)
CFR Citation: 42 CFR 1001; 42 CFR 1003
Legal Deadline: None
Abstract: These final regulations provide for the imposition of civil
money penalties and exclusions against physicians billing the Medicare
program or program beneficiaries for services of an assistant at
surgery for cataract operations where prior approval has not been
granted. This rule specifically responds to various comments raised as
a result of the interim final, and makes a number of technical
corrections to those final regulations.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Interim Final Rule 04/10/87 52 FR 11649
Final Action 10/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Joel Jay Schaer, Regulations Officer, Department of
Health and Human Services, Office of the Secretary, Office of Inspector
General, OMP, 330 Independence Avenue SW., Washington, DC 20201, 202
619-3270
RIN: 0991-AA37
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Office of the Secretary (OS)
_______________________________________________________________________
1120. CIVIL MONEY PENALTIES AND INTERMEDIATE SANCTIONS FOR HMOS AND
COMPETITIVE MEDICAL PLANS
Legal Authority: PL 99-509, Sec 9312; PL 99-509, Sec 9434; PL 100-203,
Sec 4014; PL 100-360, Sec 224; PL 100-360, Sec 411; PL 101-239, Sec
6411
CFR Citation: 42 CFR 1003; 42 CFR 417; 42 CFR 431; 42 CFR 434
Legal Deadline: None
Abstract: This final rule will broaden the Secretary's authority to
impose intermediate sanctions and civil money penalties against
eligible organizations that substantially fail to provide Medicare or
Medicaid enrollees with required medically necessary items and
services, or that practice certain marketing, enrollment, reporting or
claims payment abuses.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 07/22/91 56 FR 33403
NPRM Comment Period End 09/20/91
Final Action 08/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Joel Jay Schaer, Regulations Officer, Department of
Health and Human Services, Office of the Secretary, Office of Inspector
General, OMP, 330 Independence Avenue SW., Washington, DC 20201, 202
619-3270
RIN: 0991-AA44
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Office of the Secretary (OS)
_______________________________________________________________________
1121. BLOCK GRANT PROGRAMS
Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined
Regulatory Plan entry: Undetermined
Legal Authority: PL 100-485; PL 100-607; PL 100-690
CFR Citation: 45 CFR 96
Legal Deadline: None
Abstract: Recent legislation modified technical, administrative and
reporting requirements for several of the Department's block grants.
This notice would propose regulatory changes to reflect these statutory
changes and to clarify certain other block grant regulatory provisions.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 07/17/92 57 FR 31682
Next Action Undetermined
Small Entities Affected: None
Government Levels Affected: State
Agency Contact: Glenn Kamber, Department of Health and Human Services,
Office of the Secretary, 200 Independence Avenue SW., Washington, DC
20201, 202 690-7150
RIN: 0991-AA55
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Office of the Secretary (OS)
_______________________________________________________________________
1122. CIVIL MONEY PENALTIES FOR PHYSICIAN OWNERSHIP OF AND REFERRAL TO
CERTAIN HEALTH CARE ENTITIES
Legal Authority: PL 101-239, Sec 6204; PL 101-508, Sec 4207(e); PL
101-508, Sec 4207(m)(2)
CFR Citation: 42 CFR 1003
Legal Deadline: Final, Statutory, October 1, 1991.
Abstract: This rule will implement new civil money penalty authorities
regarding prohibited physician ownership and referral arrangements as
set forth in Section 1877 of the Social Security Act.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 10/20/93 58 FR 54096
NPRM Comment Period End 12/20/93
Final Action 10/00/94
Small Entities Affected: Undetermined
Government Levels Affected: None
Additional Information: This rulemaking is being developed in
conjunction with RIN 0938-AF40 and will be amended in accordance with
OBRA 1993 and the inclusion of designated health services.
Agency Contact: Joel Jay Schaer, Regulations Officer, Office of
Inspector General, OMP, Department of Health and Human Services, Office
of the Secretary, 330 Independence Avenue SW., Washington, DC 20201,
202 619-3270
RIN: 0991-AA65
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Office of the Secretary (OS)
_______________________________________________________________________
1123. ADDITIONAL SAFE HARBOR PROVISIONS UNDER THE ANTI-KICKBACK STATUTE
Significance:
Subject to OMB review: Yes
Regulatory Plan entry: Yes
Legal Authority: PL 100-93, Sec 2; PL 100-93, Sec 14
CFR Citation: 42 CFR 1001
Legal Deadline: None
Abstract: This final rule will set forth additional ``safe harbor''
provisions, as authorized by section 14 of PL 100-93. The final rule
delineates business and payment practices relating to the Medicare and
State health care programs that will be immunized from either criminal
or civil prosecution in accordance with the Medicare/Medicaid anti-
kickback statute.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 09/21/93 58 FR 49008
NPRM Comment Period End 11/22/93
Final Action 10/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Joel Jay Schaer, Regulations Officer, Office of
Inspector General, OMP, Department of Health and Human Services, Office
of the Secretary, 330 Independence Avenue SW., Washington, DC 20201,
202 619-3270
RIN: 0991-AA66
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Office of the Secretary (OS)
_______________________________________________________________________
1124. SAFE HARBORS FOR PROTECTING HEALTH PLANS
Significance:
Subject to OMB review: Yes
Regulatory Plan entry: Yes
Legal Authority: PL 100-93, Sec 2; PL 100-93, Sec 14
CFR Citation: 42 CFR 1001
Legal Deadline: None
Abstract: This rule establishes additional ``safe harbor'' provisions,
as authorized by section 14 of PL 100-93. This rule protects certain
health care plans, such as health maintenance organizations, that offer
incentives to enrollees or that enter into negotiated price reduction
agreements with contract health care providers.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Final Rule With Comment Period 11/05/92 57 FR 52723
Extension of Public Comment
Period 01/07/93 58 FR 2989
Interim Final Rule 11/05/93 57 FR 52723
Final Action 09/00/94
Small Entities Affected: None
Government Levels Affected: None
Additional Information: The OIG is currently assessing the public
comments received and will be issuing a revised final rule.
Agency Contact: Joel Jay Schaer, Regulations Officer, Office of the
Inspector General, OMP, Department of Health and Human Services, Office
of the Secretary, 330 Independence Avenue SW., Washington, DC 20201,
202 619-3270
RIN: 0991-AA69
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Office of the Secretary (OS)
_______________________________________________________________________
1125. GOVERNMENTWIDE GUIDANCE FOR NEW RESTRICTIONS ON LOBBYING; INTERIM
FINAL GUIDANCE
Significance:
Subject to OMB review: Yes
Legal Authority: 31 USC 1352
CFR Citation: 45 CFR 93
Legal Deadline: None
Abstract: This interim final rule is in response to section 319 of P.L.
101-121. Section 319 generally prohibits recipients of Federal
contracts, grants, and loans from using appropriated funds for lobbying
the Executive or Legislative Branches of the Federal Government in
connection with a specific contract, grant, or loan. Section 319 also
requires that each person who requests or receives a Federal contract,
grant, cooperative agreement, loan or a Federal commitment to insure or
guarantee a loan, must disclose lobbying activities.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Interim Final Rule 02/26/90 55 FR 6736
Next Action Undetermined
Small Entities Affected: None
Government Levels Affected: State, Local
Agency Contact: Charles Gale, Director, Division of Grants Policy and
Oversight, Department of Health and Human Services, Office of the
Secretary, Rm 517D, HHH Bldg., 200 Independence Avenue SW., Washington,
DC 20201, 202 690-6574
RIN: 0991-AA70
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Office of the Secretary (OS)
_______________________________________________________________________
1126. EQUAL OPPORTUNITY IN EMPLOYMENT: PUBLIC BROADCASTING, PUBLIC RADIO,
AND PUBLIC TELECOMMUNICATIONS ENTITIES RECEIVING FEDERAL FUNDS FROM THE
CORPORATION FOR PUBLIC BROADCASTING
CFR Citation: 45 CFR 87.1-40
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Withdrawn - The proposed
regulation is of low priority. 02/14/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Marcella Haynes, 202 619-0671
RIN: 0991-AA22
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Office of the Secretary (OS)
_______________________________________________________________________
1127. TITLE VI OF THE CRA OF 1964, SUBPART B--NATIONAL ORIGIN
DISCRIMINATION IN PROGRAMS RECEIVING FED. FINANCIAL ASSISTANCE FROM THE
DHHS AGAINST PERSONS OF LIMITED ENGLISH PROFICIENCY
CFR Citation: 45 CFR 80
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Withdrawn - If warranted based
on funding, may be reintroduced.02/14/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Marcella Haynes, 202 619-0671
RIN: 0991-AA72
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Departmental Management (HHSDM)
_______________________________________________________________________
1128. IMPLEMENTATION OF THE EQUAL ACCESS TO JUSTICE ACT IN AGENCY
PROCEEDINGS
Significance:
Subject to OMB review: Yes
Regulatory Plan entry: Yes
Legal Authority: 5 USC 504(c)(1)
CFR Citation: 45 CFR 13
Legal Deadline: None
Abstract: The Equal Access to Justice Act generally requires agencies
to pay attorney fees to parties prevailing against the Government in
certain types of administrative proceedings. It requires each agency to
issue rules implementing the Act as it applies to these proceedings. As
originally enacted, the Act had a sunset clause. A statutory amendment
eliminated the sunset provision and made other changes in the Act. The
instant regulation would amend 45 CFR part 13 (HHS's regulation
implementing the Act) to eliminate the corresponding sunset provision
and to make other changes conforming with the statutory changes.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/19/87 52 FR 23311
NPRM Comment Period End 08/17/87
Final Action 05/00/94
Final Action Effective 05/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Eileen Bradley, Associate General Counsel, Business and
Administrative Law Division, Department of Health and Human Services,
Room 5362, HHS Cohen Building, 330 Independence Avenue SW., Washington,
DC 20201, 202 619-0150
RIN: 0990-AA02
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1129. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL
SECURITY INCOME PROGRAMS; ADJUSTMENTS IN SSI BENEFITS ON ACCOUNT OF
RETROACTIVE BENEFITS UNDER TITLE II (061P)
Significance:
Subject to OMB review: Undetermined
Legal Authority: 42 USC 405; 42 USC 1320a-6; 42 USC 1302; 42 USC 1383;
PL 98-369, Sec 2615; 42 USC 1383b; 42 USC 1327
CFR Citation: 20 CFR 404.408b; 20 CFR 416.1123; 20 CFR 416.1402(m); 20
CFR 416.1123a; 20 CFR 404.902
Legal Deadline: None
Abstract: Sec. 2615 of Pub. L. 98-369 amended sec. 1127 of the Social
Security Act to eliminate windfalls that permitted some people who were
paid Old-Age, Survivors and Disability Insurance (OASDI) and
Supplemental Security Income (SSI) benefits retroactively to receive
more in total benefits for the same period than if they had been paid
the benefits when regularly due. The two main changes are: (1) SSI
benefits will be reduced where retroactive OASDI benefits have been
paid before the SSI benefits. Under prior law, reductions could be made
only in retroactive OASDI benefits and only when the retroactive SSI
had been paid first. (2) OASDI or SSI benefits payable upon
reinstatement following a period of suspension or termination will be
reduced by the amount of SSI benefits that would not have been paid if
the OASDI benefits had been paid when regularly due. We will amend our
regulations to conform to the statutory changes. Any costs/savings are
associated with the legislation being implemented and not with the
regulations themselves.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Jack Schanberger, Legal Assistant, Department of Health
and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, Maryland 21235, 410
965-8471
RIN: 0960-AB38
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1130. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL
SECURITY INCOME PROGRAMS; EVALUATION GUIDES FOR DETERMINING SUBSTANTIAL
GAINFUL ACTIVITY (SGA) (147P)
Significance:
Subject to OMB review: Undetermined
Legal Authority: PL 98-460, Sec 10; PL 99-643; PL 100-203; PL 101-508
CFR Citation: 20 CFR 404; 20 CFR 416
Legal Deadline: None
Abstract: These proposed changes will clarify how the Social Security
Administration evaluates a person's work activity. These regulations
also will increase the monthly earnings amount that constitutes
services for trial work period purposes and change the rules to allow
the value of any subsidy or impairment-related work expenses to be
deducted in determining that monthly earnings amount. These regulations
also reflect statutory changes with respect to the trial work period
and the re-entitlement period.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 04/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Cassandra Bond, Legal Assistant, Department of Health
and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1794
RIN: 0960-AB73
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1131. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE PROGRAM; NONPAYMENT OF
BENEFITS TO PRISONERS, VOCATIONAL REHABILITATION EXCEPTION (166P)
Legal Authority: 42 USC 402(x)(1); 42 USC 405
CFR Citation: 20 CFR 404.468; 20 CFR 404.469 (New)
Legal Deadline: None
Abstract: Existing regulations at 20 CFR 404.468(d) provide a
vocational rehabilitation exception to the nonpayment of benefits to
prisoners provision described at 20 CFR 404.468(a). Under the
exception, the nonpayment provision does not apply if a prisoner who is
entitled to benefits on the basis of disability is actively and
satisfactorily participating in a rehabilitation program which has been
specifically approved for the individual by a court of law. In
addition, the Secretary must determine that the program is expected to
result in the individual being able to do substantial gainful activity
upon release and within a reasonable time. No benefits will be paid to
the prisoner for any month prior to the approval of the program. The
proposed regulations would set out more definitive criteria for
applying the exception and would define terms, such as ``rehabilitation
program,'' ``court of law,'' and ``reasonable time,'' for purposes of
applying the exception.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Duane Heaton, Legal Assistant, Department of Health and
Human Services, Social Security Administration, Office of Regulations,
6401 Security Blvd., Baltimore, MD 21235, 410 965-8470
RIN: 0960-AC16
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1132. OLD-AGE, SURVIVORS AND DISABILITY INSURANCE AND SUPPLEMENTAL
SECURITY INCOME PROGRAMS; VOCATIONAL FACTORS REGULATIONS RESTRUCTURING
AND CLARIFICATION (207P)
Significance:
Subject to OMB review: Undetermined
Legal Authority: 42 USC 405; 42 USC 421; 42 USC 423; 42 USC 1302; 42
USC 1382c; 42 USC 1383
CFR Citation: 20 CFR 404.1520; 20 CFR 404.1550 to 404.1567; 20 CFR
416.920; 20 CFR 416.950 to 416.967
Legal Deadline: None
Abstract: Based upon adjudicative experience, we are proposing
clarifications and a restructuring of the disability vocational
evaluation regulations.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Harry J. Short, Legal Assistant, Department of Health
and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Blvd., Baltimore, MD 21235, 410 965-6243
RIN: 0960-AC61
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1133. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL
SECURITY INCOME PROGRAMS; INTERIM DISABILITY BENEFITS (215P)
Significance:
Subject to OMB review: Undetermined
Legal Authority: 42 USC 423(h); 42 USC 1383(a); PL 100-647, Sec 8001
CFR Citation: 20 CFR 404; 20 CFR 416
Legal Deadline: None
Abstract: These regulations implement a section of Pub. L. 100-647 that
authorizes interim benefit payments whenever an Administrative Law
Judge (ALJ) decides that a claimant is entitled to benefits based on
disability or blindness and the Secretary has not issued his final
decision within 110 days after the date of the ALJ's determination.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Lawrence V. Dudar, Legal Assistant, Department of
Health and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1759
RIN: 0960-AC76
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1134. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL
SECURITY INCOME PROGRAMS; APPEALS COUNCIL NOTICE REQUIREMENTS (235P)
Significance:
Subject to OMB review: Undetermined
Legal Authority: 42 USC 401(g); 42 USC 405(a); 42 USC 405(b); 42 USC
405(d) to 405(h); 42 USC 421(d); 42 USC 1302; 42 USC 1383; 42 USC 1383b
CFR Citation: 20 CFR 404.973; 20 CFR 416.1473
Legal Deadline: None
Abstract: These proposed regulations amend the existing regulations to
clarify the requirements that the Appeals Council (AC) notify the
parties of its reasons for reviewing a case and the issues to be
decided. The proposed regulations clarify the AC's procedures with
regard to providing the notice required by the regulations and do not
represent any change in policy. These regulations are intended to
remove any ambiguities in the current regulations concerning the
circumstances and the manner in which the AC provides notice to the
parties.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Philip Berge, Legal Assistant, Department of Health and
Human Services, Social Security Administration, Office of Regulations,
6401 Security Boulevard, Baltimore, MD 21235, 410 965-1769
RIN: 0960-AC93
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1135. SSI PROGRAM; REDUCTION IN TIME WHEN INCOME AND RESOURCES OF
SEPARATED COUPLES MUST BE TREATED AS JOINTLY AVAILABLE FOR PURPOSES OF
SSI ELIGIBILITY AND BENEFITS (254F)
Legal Authority: 42 USC 1382c(b)
CFR Citation: 20 CFR 416.120(c); 20 CFR 416.305; 20 CFR 416.430; 20
CFR 416.432; 20 CFR 416.532(c); 20 CFR 416.554; 20 CFR 416.1130(c); 20
CFR 416.1147; 20 CFR 416.1801(c); 20 CFR 416.1802(b); 20 CFR 416.1806;
20 CFR 416.1811; 20 CFR 416.1830(a); 20 CFR 416.1832(c) and (d)
Legal Deadline: None
Abstract: This proposed regulation requires that a married couple be
treated as separate individuals for purposes of SSI eligibility and
benefit determination beginning with the month after the month they
begin living apart. This change is effective October 1, 1990.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 03/08/94 59 FR 10766
NPRM Comment Period End 05/09/94
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Duane Heaton, Legal Assistant, Department of Health and
Human Services, Social Security Administration, Office of Regulations,
6401 Security Boulevard, Baltimore, MD 21235, 410 965-8470
RIN: 0960-AC98
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1136. SUPPLEMENTAL SECURITY INCOME PROGRAM; AUGMENTED BENEFITS (271P)
Significance:
Subject to OMB review: Undetermined
Legal Authority: 42 USC 1382a
CFR Citation: 20 CFR 416.1121; 20 CFR 416.1122
Legal Deadline: None
Abstract: These proposed regulations will state how benefits from other
programs that have been augmented to provide for dependents are treated
under the Supplemental Security Income program. Our current regulations
only explain the treatment of the primary beneficiary's portion of an
augmented Department of Veterans Affairs benefit.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Duane Heaton, Legal Assistant, Department of Health and
Human Services, Social Security Administration, Office of Regulations,
6401 Security Boulevard, Baltimore, MD 21235, 410 965-8470
RIN: 0960-AD07
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1137. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL
SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED; REPRESENTATIVE PAYEE
REFORMS (295F)
Significance:
Subject to OMB review: Yes
Regulatory Plan entry: Yes
Legal Authority: PL 101-508, Sec 5105
CFR Citation: 20 CFR 404.902; 20 CFR 404.2001; 20 CFR 404.2011; 20 CFR
404.2022; 20 CFR 404.2024; 20 CFR 404.2025; 20 CFR 404.2030; 20 CFR
404.2041; 20 CFR 404.2050; 20 CFR 416.601; 20 CFR 416.611; 20 CFR
416.622; 20 CFR 416.624; 20 CFR 416.625; 20 CFR 416.630; ...
Legal Deadline: None
Abstract: These regulations, which reflect certain provisions of PL
101-508, modify existing representative payee procedures by requiring
the Social Security Administration (SSA) to do a more extensive
investigation of representative payee applicants; generally limit to 1
month the deferral or suspension of direct payment of benefits pending
selection of a payee; provide stricter standards in determining the
fitness of representative payee applicants to manage benefit payments
on behalf of beneficiaries; require SSA to repay to the beneficiary or
an alternate payee, an amount equal to any misused funds resulting from
SSA's negligent failure to investigate or monitor a representative
payee; and require SSA to compile and maintain a centralized file of
certain beneficiary and payee information.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 03/15/94 59 FR 11949
NPRM Comment Period End 05/16/94
Final Action 12/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Philip Berge, Legal Assistant, Department of Health and
Human Services, Social Security Administration, Office of Regulations,
6401 Security Boulevard, Baltimore, MD 21235, 410 965-1769
RIN: 0960-AD22
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1138. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL
SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED; FEES FOR
REPRESENTATION OF CLAIMANTS (296P)
Significance:
Subject to OMB review: Undetermined
Legal Authority: PL 101-508, Sec 5106
CFR Citation: Not yet determined
Legal Deadline: None
Abstract: We propose to amend the regulations to reflect section
5106(a) of Pub. L. 101-508 which modifies the manner in which past-due
benefits are calculated and the process by which SSA approves fees
charged by persons representing claimants before the Agency.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Philip Berge, Legal Assistant, Department of Health and
Human Services, Social Security Administration, Office of Regulations,
6401 Security Boulevard, Baltimore, MD 21235, 410 965-1769
RIN: 0960-AD23
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1139. OASDI AND SSI FOR THE AGED, BLIND AND DISABLED; CONTINUATION OF
BENEFITS ON ACCOUNT OF PARTICIPATION IN A NON-STATE VR PROGRAM (299P)
Significance:
Subject to OMB review: Undetermined
Legal Authority: PL 101-508, Sec 5113
CFR Citation: 20 CFR 404.316; 20 CFR 404.337; 20 CFR 404.352; 20 CFR
404.902; 20 CFR 404.1586; 20 CFR 404.1596; 20 CFR 404.1597; 20 CFR
416.1321; 20 CFR 416.1338; 20 CFR 416.1402
Legal Deadline: None
Abstract: These regulations will implement section 5113 of Pub. L. 101-
508, which amends sections 225(b) and 1631(a)(6) of the Act to extend
eligibility for continuation of benefits under these sections to
persons who are participating in a non-State VR program. Prior to these
amendments, the law only provided for continuation of benefits when a
person was participating in a State VR Program. These regulatory
changes will bring our regulations into conformity with the amendments
to the law.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Jack Schanberger, Legal Assistant, Department of Health
and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-8471
RIN: 0960-AD26
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1140. SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED;
EXCLUSION FROM INCOME AND RESOURCES OF VICTIMS' COMPENSATION PAYMENTS AND
STATE RELOCATION ASSISTANCE (311P)
Significance:
Subject to OMB review: Yes
Legal Authority: PL 101-508, sec 5031; PL 101-508, sec 5035; PL 103-
66, sec 13732
CFR Citation: 20 CFR 416.1124; 20 CFR 416.1161(a); 20 CFR 416.1204(a);
20 CFR 416.1210; 20 CFR 416.1229 (New); 20 CFR 416.1239 (New)
Legal Deadline: None
Abstract: These regulations will provide for the exclusion from income
and from resources (for nine months) in the Supplemental Security
Income Program payments received by a person from a State established
fund to aid victims of crime and payments received as State or local
government relocation assistance.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Additional Information: RIN 0960-AD37 has been merged with this action.
Agency Contact: Harry J. Short, Legal Assistant, Department of Health
and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1753
RIN: 0960-AD36
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1141. SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED;
REIMBURSEMENT FOR VR SERVICES FURNISHED DURING CERTAIN MONTHS OF NON-
PAYMENT (315P)
Significance:
Subject to OMB review: Undetermined
Legal Authority: PL 101-508, Sec 5037
CFR Citation: 20 CFR 416.1321; 20 CFR 416.1331; 20 CFR 416.1338; 20
CFR 416.1402; 20 CFR 416.2201
Legal Deadline: None
Abstract: These regulations reflect section 5037 of Pub. L. 101-508,
which amends section 1615 of the Act, to provide for reimbursement for
VR services furnished during certain months of nonpayment of
Supplemental Security Income benefits. Prior to these amendments there
was no provision in the law for such reimbursement.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Jack Schanberger, Legal Assistant, Department of Health
and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-8471
RIN: 0960-AD39
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1142. CODE OF CONDUCT FOR ADMINISTRATIVE LAW JUDGES AND ADMINISTRATIVE
APPEALS JUDGES OF THE SOCIAL SECURITY ADMINISTRATION (341P)
Significance:
Subject to OMB review: Undetermined
Legal Authority: EO 12674 as modified by EO 12731;; 42 USC 405
CFR Citation: Not yet determined
Legal Deadline: None
Abstract: These regulations would establish a Code of Conduct for OHA
Administrative Law Judges and Administrative Appeals Judges.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Philip Berge, Legal Assistant, Office of Regulations,
Department of Health and Human Services, Social Security
Administration, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-
1769
RIN: 0960-AD54
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1143. ELECTION OF BENEFITS BASED ON AGE BY DISABLED WIDOW, WIDOWER, AND
SURVIVING DIVORCED SPOUSE BENEFICIARIES (343P)
Significance:
Subject to OMB review: Undetermined
Legal Authority: 42 USC 405
CFR Citation: 20 CFR 404.335; 20 CFR 404.336; 20 CFR 404.337
Legal Deadline: None
Abstract: We propose to amend our regulations to permit the election of
benefits based on age by widows, widowers and surviving divorced
spouses (hereinafter, collectively widows) who are at least age 60 and
who are already entitled to widow's benefits based on disability. This
proposal would allow the widow to choose which of the two types of
widow's benefits is more advantageous. The estimated increase in
benefit payments is less than $500,000 per year for fiscal years 1992-
1995.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 07/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Cassandra Bond, Legal Assistant, Office of Regulations,
Department of Health and Human Services, Social Security
Administration, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-
1794
RIN: 0960-AD56
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1144. AGAINST EQUITY AND GOOD CONSCIENCE (348P)
Significance:
Subject to OMB review: Undetermined
Legal Authority: 30 USC 923; 42 USC 404; 42 USC 1383
CFR Citation: 20 CFR 404.509; 20 CFR 410.561d; 20 CFR 416.554
Legal Deadline: None
Abstract: These proposed regulations amend the existing regulations to
change how we determine when recovery of an overpayment would be
against equity and good conscience. Currently, regulations permit
determinations that recovery of an overpayment would be against equity
and good conscience under three specific conditions. The proposed
regulations will provide for the ``against equity and good conscience''
determination to be based on an examination and consideration of a
variety of factors such as cause and result of overpayment and fairness
as they affect both the beneficiary and the Social Security
Administration.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Duane Heaton, Legal Assistant, Office of Regulations,
Department of Health and Human Services, Social Security
Administration, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-
8470
RIN: 0960-AD62
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1145. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE PROGRAM; REVISED
MEDICAL CRITERIA FOR DETERMINATION OF DISABILITY; HEMIC AND LYMPHATIC
SYSTEM, AND MALIGNANT NEOPLASTIC DISEASES (399P)
Significance:
Subject to OMB review: Yes
Legal Authority: 42 USC 1302; 42 USC 1383; 42 USC 405
CFR Citation: 20 CFR 404.1500ff.appendix 1
Legal Deadline: None
Abstract: Sections 7.00 and 107.00 (hemic and lymphatic system), and
13.00 and 113.00 (malignant neoplastic diseases) of appendix 1 to
Subpart P of Part 404 of the Disability Regulations (404.1501 through
404.1599) describe those impairments which are considered severe enough
to prevent a person from engaging in any gainful activity, or in the
case of a child under age 18, age-appropriate activities. We are
proposing revisions to these sections to ensure that the medical
evaluation criteria are up-to-date and consistent with the latest
advances in medical knowledge and treatment. The Supplemental Security
Income program incorporates and uses the same medical criteria as the
Old-Age, Survivors, and Disability Insurance program.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 12/00/94
Interim Final Rule 10/00/95
Final Action 10/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Harry J. Short, Legal Assistant, Department of Health
and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-6243
RIN: 0960-AD67
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1146. PROCEDURES FOR HANDLING EARNINGS REPORTS (418P)
Significance:
Subject to OMB review: Undetermined
Legal Authority: 42 USC 405(a); 42 USC 1302(a); 42 USC 1320b-1
CFR Citation: 20 CFR 422.115; 20 CFR 422.120
Legal Deadline: None
Abstract: These regulations will update our current regulations to
reflect the procedures we use for handling employers' wage reports that
lack a correct social security number. Additionally, the regulations
will include our requirements for employers to file corrections of
erroneous wage reports. The regulations will also include a description
of our process for providing pension plan information under the
Employee Retirement Income Security Act of 1974. There are no
significant costs.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 09/00/94
Small Entities Affected: Businesses
Government Levels Affected: Local, Federal
Agency Contact: Jack Schanberger, Legal Assistant, Department of Health
and Human Services, Social Security Administration, 6401 Security
Boulevard, Baltimore, MD 21235, 410 965-8471
RIN: 0960-AD70
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1147. FEDERAL OASDI AND SSI; COMPUTING BENEFIT AMOUNTS, DISPOSING OF
UNDERPAYMENTS, RESOLVING OVERPAYMENTS, AND PAYMENT RESTRICTION (428P)
Significance:
Subject to OMB review: Undetermined
Legal Authority: 42 USC 405(a); 42 USC 415(a)(7); 42 USC 1302(a)
CFR Citation: 20 CFR 404.213; 20 CFR 404.460; 20 CFR 404.503; 20 CFR
404.510
Legal Deadline: None
Abstract: Current regulations on the windfall elimination provision do
not explain how SSA will treat the purchase of noncovered retroactive
service, e.g., the purchase of coverage for military service. The
regulations will state that we will accept such service in determining
whether an insured individual is exempt from the windfall provision
because he or she became eligible before 1986 for a pension based on
noncovered employment. The regulations will also include three
technical amendments. First, we will delete a cross reference which
erroneously indicates that a person otherwise eligible for an
underpayment of benefits must be the parent of an insured individual.
Second, we will change age 72 to age 70 regarding deductions for net
earnings from self-employment. Third, we will delete the German
Democratic Republic and Albania from the list of countries to which
payment of benefits is restricted.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 05/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Jack Schanberger, Legal Assistant, Department of Health
and Human Services, Social Security Administration, 6401 Security
Boulevard, Baltimore, MD 21235, 410 965-8471
RIN: 0960-AD72
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1148. CONDUCT OF REPRESENTATIVES UNDER TITLE II OR TITLE XVI (431P)
Significance:
Subject to OMB review: Undetermined
Legal Authority: 42 USC 405(a); 42 USC 406; 42 USC 1302(a); 42 USC
1383(d)(1); 42 USC 1383(d)(2)
CFR Citation: 20 CFR 404.1700ff; 20 CFR 416.1500ff
Legal Deadline: None
Abstract: These regulations explain who may serve as a representative,
how claimants appoint and discharge representatives, the necessary
qualifications which representatives must possess, and rules of conduct
and standards of responsibility that a representative must follow.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: Undetermined
Agency Contact: Philip Berge, Legal Assistant, Department of Health and
Human Services, Social Security Administration, 6401 Security
Boulevard, Baltimore, MD 21235, 410 965-1769
RIN: 0960-AD73
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1149. STATEMENT OF EARNINGS AND BENEFIT ESTIMATE (415P)
Significance:
Subject to OMB review: Yes
Legal Authority: 42 USC 405; 42 USC 1302; 42 USC 1320b-13
CFR Citation: 20 CFR 404.811; 20 CFR 404.812 (New); 20 CFR 422.125
Legal Deadline: None
Abstract: Section 1143(c) of the Social Security Act requires that by
not later than September 30, 1995, we must furnish a social security
account statement to each eligible individual who has attained age 60
by October 1, 1994, is not receiving social security benefits, and for
whom we can determine a current mailing address. During fiscal year
1995 through 1999, we must furnish such a statement to eligible
individuals attaining age 60 in the fiscal year they turn age 60.
Similarly, beginning no later than October 1, 1999, we must provide
such a statement annually to eligible individuals age 25 or over. In
these regulations, we provide who will be sent a statement, who will
not be sent a statement, how we will determine addresses, and the
contents of the statements. We have not yet compiled all the costs.
These regulations will benefit the public by implementing section
1143(c) which will help individuals verify that we have entered their
correct earnings into our records and by showing the benefits to which
such individuals may become entitled.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 08/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Jack Schanberger, Legal Assistant, Department of Health
and Human Services, Social Security Administration, 6401 Security
Boulevard, Baltimore, MD 21235, 410 965-8471
RIN: 0960-AD74
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1150. FEES FOR FEDERAL ADMINISTRATION OF STATE SUPPLEMENTARY
PAYMENTS IN THE SSI PROGRAM (376P)
Significance:
Subject to OMB review: Yes
Legal Authority: 42 USC 1302; 42 USC 1382(e); 42 USC 1383; PL 93-66,
sec 212
CFR Citation: 20 CFR 416.2010; 20 CFR 416.2090
Legal Deadline: None
Abstract: Section 13731 of Pub. L. 103-66 (the Omnibus Budget
Reconciliation Act of 1993) enacted August 10, 1993, requires the
Secretary to assess each State an administration fee for processing the
State's mandatory and optional supplementary payments. The fee will be
charged for all State supplementary payments issued on or after October
1, 1993. Also, the Secretary may charge a State an additional services
fee if, at the request of the State, the Secretary provides services
beyond the level customarily provided in the administration of such
payments.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: State
Agency Contact: Henry D. Lerner, Legal Assistant, Department of Health
and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1762
RIN: 0960-AD75
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1151. WHO MAY PROTECT A POTENTIAL CLAIMANT'S FILING DATE OR
APPLICATION FOR SUPPLEMENTAL SECURITY INCOME BENEFITS (408P)
Significance:
Subject to OMB review: Undetermined
Legal Authority: 42 USC 1302; 42 USC 1382; 42 USC 1383(a); 42 USC
1383(d); 42 USC 1383(e)
CFR Citation: 20 CFR 416.315ff
Legal Deadline: None
Abstract: These proposed regulations would make protecting a filing
date easier and protect potential claimants from losing SSI benefits if
an application is filed.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Lawrence V. Dudar, Legal Assistant, Department of
Health and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1759
RIN: 0960-AD76
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1152. RELIABLE INFORMATION WHICH IS CURRENTLY AVAILABLE FOR
DETERMINING BENEFIT AMOUNTS IN THE SUPPLEMENTAL SECURITY INCOME PROGRAM
(NEWMAN) (434P)
Significance:
Subject to OMB review: Undetermined
Legal Authority: 42 USC 1302; 42 USC 1382(a) to 1382(c); 42 USC 1383
CFR Citation: 20 CFR 416.420
Legal Deadline: None
Abstract: The Social Security Act (the Act) provides that if the
Secretary of Health and Human Services (the Secretary) determines that
reliable information is currently available concerning the income of an
individual, the Secretary may use that information to determine an
individual's current month's supplemental security income (SSI) benefit
amount. This method of determining SSI benefit amounts is an exception
to the use of income from a prior month, known as retrospective monthly
accounting (RMA). The Secretary has determined that no reliable
information exists which is currently available for determining SSI
benefit amounts for a current month using any method other than RMA.
These rules are applicable only in California pursuant to a court order
issued in Newman v. Shalala.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Henry D. Lerner, Legal Assistant, Department of Health
and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1762
RIN: 0960-AD77
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1153. REVISED MEDICAL CRITERIA FOR DETERMINATION OF DISABILITY,
ENDOCRINE SYSTEM AND OBESITY AND RELATED CRITERIA (436P)
Significance:
Subject to OMB review: Undetermined
Legal Authority: 42 USC 405; 42 USC 1302; 42 USC 1383
CFR Citation: 20 CFR 404.1500ff, appendix 1
Legal Deadline: None
Abstract: Sections 9.00 and 109.00 of appendix 1 to subpart P of part
404 of the Disability Regulations (404.1501 through 404.1599) describe
those impairments which are considered severe enough to prevent a
person from engaging in any gainful activity, or in the case of a child
under age 18, age-appropriate activities. We are proposing to revise
the criteria in these sections to reflect advances in medical
knowledge, treatment, and methods of evaluating endocrine impairments.
The Supplemental Security Income program incorporates and uses the same
medical criteria as the Old-Age, Survivors and Disability Insurance
program.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 12/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Cassandra A. Bond, Legal Assistant, Department of
Health and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1794
RIN: 0960-AD78
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1154. FEDERAL OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE;
EVIDENCE REQUIRED TO PRESUME A PERSON IS DEAD (443P)
Significance:
Subject to OMB review: Undetermined
Legal Authority: 42 USC 405(a); 42 USC 1102
CFR Citation: 20 CFR 404.720
Legal Deadline: None
Abstract: These proposed regulations reflect a new proposed policy
providing that the presumption of death arises when the claimant
establishes an individual has been absent from his or her residence and
not heard from for 7 years. Once the presumption is made, the burden
then shifts to us to rebut the presumption either by presenting
evidence that the missing individual is still alive or by providing an
explanation to account for the individual's absence in a manner
consistent with continued life rather than death. Policy concerning the
rebuttal of a presumption of death will also be provided in a new
section to the regulations.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 09/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Philip Berge, Legal Assistant, Department of Health and
Human Services, Social Security Administration, Office of Regulations,
6401 Security Boulevard, Baltimore, MD 21235, 410 965-1769
RIN: 0960-AD79
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1155. REVISED MEDICAL CRITERIA FOR DETERMINATION OF DISABILITY,
GROWTH IMPAIRMENTS (444P)
Significance:
Subject to OMB review: Undetermined
Legal Authority: 42 USC 1302; 42 USC 1383; 42 USC 405
CFR Citation: 29 CFR 404.1500ff appendix 1
Legal Deadline: None
Abstract: Section 100.00 of part B of appendix 1 to subpart P of part
404 of the Disability Regulations (404.1501 through 404.1599) describe
those impairments which are considered severe enough to prevent a child
under age 18 from engaging in age-appropriate activities. We are
proposing revisions to the criteria in Part B of the Listing of
Impairments that we use to evaluate growth impairments of persons under
the age of 18 who claim Social Security or Supplemental Security Income
benefits based on Disability under Title II and Title XVI of the Social
Security Act. The revisions contained in these regulations reflect
advances in medical knowledge, treatment, and methods of evaluating
growth impairments. The Supplemental Security Income program
incorporates and uses the same medical criteria as the Old-Age,
Survivors, and Disability Insurance program.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 12/00/94
Final Action 09/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Harry Short, Legal Assistant, Department of Health and
Human Services, Social Security Administration, Office of Regulations,
6401 Security Boulevard, Baltimore, MD 21235, 410 965-6243
RIN: 0960-AD80
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1156. ELIGIBILITY FOR CHILDREN OF ARMED FORCES PERSONNEL
RESIDING OUTSIDE THE UNITED STATES OTHER THAN IN FOREIGN COUNTRIES (452P)
Significance:
Subject to OMB review: Undetermined
Legal Authority: 42 USC 1382c
CFR Citation: 20 CFR 416.215
Legal Deadline: None
Abstract: Effective November 1, 1993, section 13734 of Pub. L. 103-66
provides that supplemental security income (SSI) benefits may continue
to be paid to blind or disabled children who are United States citizens
and accompany their military parents to assignments in Puerto Rico or
the territories and possessions of the United States. Prior
legislation, which allowed continuation of SSI payments to children
whose parents were stationed in foreign countries as of April 1990, did
not permit continuation of SSI payments to these children. This change
in the law requires that we revise the regulation at 20 CFR 416.215.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 05/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Henry D. Lerner, Legal Assistant, Department of Health
and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1762
RIN: 0960-AD81
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1157. VALUATION OF CERTAIN IN-KIND SUPPORT AND MAINTENANCE (ISM)
WHERE THERE IS A COST-OF-LIVING ADJUSTMENT IN SSI BENEFITS (454P)
Significance:
Subject to OMB review: Undetermined
Legal Authority: PL 103-66, sec 13735
CFR Citation: 20 CFR 416.420; 20 CFR 416.1130(a)
Legal Deadline: None
Abstract: These proposed regulation would reflect the amendment to
section 1611(c) of the Act, effective January 1, 1995, that the current
Federal benefit rate be used in determining the value of certain in-
kind support and maintenance for the first 2 months after there is a
cost-of-living adjustment in SSI benefits.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 12/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Lawrence V. Dudar, Legal Assistant, Department of
Health and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1759
RIN: 0960-AD82
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1158. RELATIONSHIP/COVERAGE ACTIONS NOTE INITIAL DETERMINATIONS/
SSI CORRECTIONS (455P)
Significance:
Subject to OMB review: Undetermined
Legal Authority: 42 USC 402; 42 USC 403(a); 42 USC 403(b); 42 USC
405(a); 42 USC 405(b); 42 USC 416; 42 USC 423; 42 USC 428(a); 42 USC
428(b); 42 USC 428(c); 42 USC 428(d); 42 USC 428(e); 42 USC 1302; 42
USC 401(j); 42 USC 405(a)
CFR Citation: 20 CFR 404.331; 20 CFR 404.332; 20 CFR 404.341; 20 CFR
404.357; 20 CFR 404.361; 20 CFR 404.366; 20 CFR 404.903; 20 CFR
416.1180
Legal Deadline: None
Abstract: This regulation will make technical changes to several
sections. Most of the changes correct problems with wording which
occurred during the 1980 recodification. One change corrects an obvious
clerical error in the wording of section 416.1180. Another change
expands section 404.903 to clarify that extending social security or
medical coverage in accordance with section 218 of the Act is a matter
between the individual and the State and is not subject to SSA's
administrative review process.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: Undetermined
Agency Contact: Lois Berg, Paralegal Specialist, Department of Health
and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1713
RIN: 0960-AD83
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1159. REPLACEMENT OF LOST, DAMAGED OR STOLEN EXCLUDED RESOURCES
(HURRICANE ANDREW) (458I)
Significance:
Subject to OMB review: Undetermined
Legal Authority: 42 USC 1302; 42 USC 1383
CFR Citation: 20 CFR 416.1232
Legal Deadline: None
Abstract: Some supplemental security income (SSI) recipients who were
victims of Hurricane Andrew in south Florida have not been able to
replace or repair their damaged homes and other excluded resources due
to circumstances beyond their control. This means that some SSI
recipients will be holding assets (insurance money) in amounts that
will disqualify them for SSI benefits if held for periods exceeding the
maximum 18-month period currently in regulations at section 416.1232.
Since Hurricane Andrew occurred in August 1992, SSI recipients could
become ineligible as early as March 1994. We are codifying in
regulations, interim final rules which provide additional time for
victims of Hurricane Andrew to replace or repair their damaged excluded
resources without suffering loss or interruption of their SSI benefits.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Interim Final Rule 03/17/94 59 FR 12544
NPRM Comment Period End 05/17/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Henry D. Lerner, Legal Assistant, Department of Health
and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1762
RIN: 0960-AD85
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1160. PREVENTION OF ADVERSE EFFECTS ON ELIGIBILITY AND BENEFIT
AMOUNT WHEN SPOUSE OR PARENT ABSENT DUE TO ACTIVE MILITARY SERVICE (462P)
Significance:
Subject to OMB review: Undetermined
Legal Authority: PL 103-66, sec 13733
CFR Citation: 20 CFR 416.1160ff
Legal Deadline: None
Abstract: These proposed regulations reflect the provisions of section
13733 of Pub. L. 103-66 which allows us to consider, absent evidence to
the contrary, an ineligible parent or spouse who is absent from a
deeming household due solely to an active duty military assignment, to
be living in the same household as the eligible individual for deeming
purposes. This will prevent possible adverse SSI effects which could
otherwise result when a military deemor is absent from the household.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Lawrence V. Dudar, Legal Assistant, Department of
Health and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1759
RIN: 0960-AD86
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1161. SUPPLEMENTAL SECURITY INCOME PROGRAM; SUSPENSIONS, TERMINATIONS,
AND ADVANCE NOTICE OF ADVERSE DETERMINATIONS (031F)
Significance:
Subject to OMB review: Undetermined
Legal Authority: 42 USC 1382; 42 USC 1382a; 42 USC 1382b; 42 USC
1382c; 42 USC 1382d; 42 USC 1383; PL 99-643, sec 3; PL 99-643, sec 4;
PL 100-203, sec 9103; PL 100-203, sec 9112; PL 100-203, sec 9115; PL
101-239, sec 8009; PL 101-508, sec 5038; PL 101-508, sec 5105
CFR Citation: 20 CFR 416B; 20 CFR 416G; 20 CFR 416M
Legal Deadline: None
Abstract: This regulation reorganizes, revises, and clarifies the rules
on stopping, reducing, suspending, and terminating an SSI beneficiary's
SSI benefits. This regulation's purpose is to make these rules easier
to read and understand. These rules also reflect the following
statutory enactments: (1) section 3 of Pub. L. 99-643, (2) section 4 of
Pub. L. 99-643, (3) section 9103 of Pub. L. 100-203, (4) section 9112
of Pub. L. 100-203, (5) section 9115 of Pub. L. 100-203, (6) section
8009 of Pub. L. 101-239, (7) section 5038 of Pub. L. 101-508, and (8)
section 5105 of Pub. L. 101-508.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Notice of Decision to Develop
Regs 06/19/79 44 FR 35241
NPRM 05/08/86 51 FR 17057
NPRM Comment Period End 07/07/86
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Lawrence V. Dudar, Legal Assistant, Department of
Health and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1759
RIN: 0960-AA22
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1162. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE PROGRAM; REVISED
MEDICAL CRITERIA FOR DETERMINATION OF DISABILITY; MUSCULOSKELETAL SYSTEM
(143F)
Significance:
Subject to OMB review: Yes
Legal Authority: 42 USC 1302; 42 USC 405; 42 USC 1383
CFR Citation: 20 CFR 404.1500ff, appendix 1
Legal Deadline: None
Abstract: Sections 1.00 and 101.00 of appendix 1 to the Disability
Regulations (404.1501 through 404.1599) describe those musculoskeletal
impairments which are considered severe enough to prevent a person from
doing any gainful activity or, in the case of a child under age 18,
age-appropriate activities. We are proposing comprehensive revisions to
these sections to ensure that the medical evaluation criteria are up to
date and consistent with the latest advances in medicine. The
Supplemental Security Income program incorporates by reference and uses
the same medical criteria as the Old-Age, Survivors, and Disability
Insurance program.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 12/21/93 58 FR 67574
NPRM Comment Period End 02/22/94
Final Action 12/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Richard M. Bresnick, Legal Assistant, Department of
Health and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Blvd., Baltimore, MD 21235, 410 965-1758
RIN: 0960-AB01
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1163. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL
SECURITY INCOME PROGRAM; CONTINUED PAYMENT OF BENEFITS TO PERSONS IN
VOCATIONAL REHABILITATION PROGRAMS (131F)
Significance:
Subject to OMB review: Undetermined
Legal Authority: 42 USC 405; 42 USC 425; 42 USC 1302; 42 USC 1383
CFR Citation: 20 CFR 404.316; 20 CFR 404.337; 20 CFR 404.352; 20 CFR
404.902; 20 CFR 404.1586; 20 CFR 404.1596; 20 CFR 404.1597; 20 CFR
416.1321; 20 CFR 416.1338; 20 CFR 416.1331; 20 CFR 416.1402
Legal Deadline: None
Abstract: These changes permit the continued payment of disability
benefits to persons who medically recover while participating in a
vocational rehabilitation (VR) program, without regard to whether the
person was expected at the onset of the VR program to medically recover
before the scheduled completion date of the program and without regard
to whether the person has any residual functional limitation. These
changes bring the regulations into conformity with certain court
decisions.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Interim Final Rule 05/14/86 51 FR 17616
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Jack Schanberger, Legal Assistant, Department of Health
and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Blvd., Baltimore, MD 21235, 410 965-8471
RIN: 0960-AB05
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1164. SUPPLEMENTAL SECURITY INCOME PROGRAM; WHAT IS NOT INCOME (121F)
Significance:
Subject to OMB review: Yes
Legal Authority: 42 USC 1382a
CFR Citation: 20 CFR 416.1103(a)
Legal Deadline: None
Abstract: The rule changes SSI policy to consider Department of
Veterans Affairs payments resulting from unusual medical expenses not
to be income for SSI purposes.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 08/24/88 53 FR 32252
NPRM Comment Period End 10/24/88
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Duane Heaton, Legal Assistant, Department of Health and
Human Services, Social Security Administration, Office of Regulations,
6401 Security Blvd., Baltimore, MD 21235, 410 965-8470
RIN: 0960-AB09
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1165. SUPPLEMENTAL SECURITY INCOME PROGRAM; CONTINUATION OF BENEFITS AND
SPECIAL ELIGIBILITY FOR CERTAIN SEVERELY IMPAIRED RECIPIENTS WHO WORK
(171F)
Significance:
Subject to OMB review: Undetermined
Legal Authority: PL 99-643, Sec 2; PL 99-643, Sec 4; PL 101-508, Sec
5032; PL 101-508, Sec 5033; 42 USC 1382a; 42 USC 1382h
CFR Citation: 20 CFR 416.260; 20 CFR 416.261; 20 CFR 416.262; 20 CFR
416.265; 20 CFR 416.268; 20 CFR 416.269; 20 CFR 416.1112; 20 CFR
416.1402; 20 CFR 416.264; 20 CFR 416.1403
Legal Deadline: None
Abstract: These proposed regulations will implement statutory changes
contained in sections 2 and 4 of PL 99-643. These provisions: (1) make
section 1619 of the Social Security Act permanent; and (2) simplify the
transitions among regular SSI status, special benefit status, and
special Supplemental Security Income status for Medicaid purposes. The
proposed regulations also will involve the statutory change contained
in sections 5032 and 5033 of Pub. L. 101-508 which eliminate the age-65
limit for eligibility for special Supplemental Security Income status
for Medicaid purposes and which liberalizes the impairment-related work
exclusion of section 1612(b)(4)(B)(ii).
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 10/08/93 58 FR 52458
NPRM Comment Period End 12/07/93
Final Action 12/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Richard M. Bresnick, Legal Assistant, Department of
Health and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Blvd., Baltimore, MD 21235, 410 965-1758
RIN: 0960-AC22
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1166. SUPPLEMENTAL SECURITY INCOME PROGRAM; PROCEEDS OF A LOAN, PAYMENT
OF PRO RATA SHARE OF HOUSEHOLD OPERATING EXPENSES (180F)
Legal Authority: 42 USC 1302
CFR Citation: 20 CFR 416.1103; 20 CFR 416.1133
Legal Deadline: None
Abstract: Money borrowed (a loan) is not income for SSI purposes and
therefore has no effect on a person's SSI benefits. These regulations
will state that only cash transactions may be considered loans. These
regulations will also provide that the one-third reduction rule which
applies when a person who lives in another's household and receives in-
kind support and maintenance will not apply if the SSI recipient pays
his or her pro rata share in cash and no later than the month under
consideration. No additional costs or savings are anticipated.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 08/20/90 55 FR 33922
NPRM Comment Period End 10/19/90
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Duane Heaton, Legal Assistant, Department of Health and
Human Services, Social Security Administration, Office of Regulations,
6401 Security Blvd., Baltimore, MD 21235, 410 965-8470
RIN: 0960-AC42
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1167. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE PROGRAM; APPLICABILITY
OF GOVERNMENT PENSION TO CERTAIN FEDERAL EMPLOYEES (188F)
Significance:
Subject to OMB review: Undetermined
Legal Authority: 42 USC 402(b); 42 USC 402(c); 42 USC 402(e); 42 USC
402(f); 42 USC 402(g); PL 100-203, Sec 9007; PL 100-647, Sec 8014
CFR Citation: 20 CFR 404.408a
Legal Deadline: None
Abstract: This final rule would reflect provisions of the Omnibus
Budget Reconciliation Act of 1987 (PL 100-203, sec 9007) on the
Government pension offset and provisions of the Technical and
Miscellaneous Revenue Act of 1988 (PL 100-647), which also contained
new rules on the government pension offset.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 12/12/89 54 FR 51036
NPRM Comment Period End 02/12/90
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Jack Schanberger, Legal Assistant, Department of Health
and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Blvd., Baltimore, MD 21235, 410 965-8471
RIN: 0960-AC46
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1168. SUPPLEMENTAL SECURITY INCOME PROGRAM; CONTINUATION OF FULL BENEFIT
STANDARD FOR CERTAIN PERSONS TEMPORARILY INSTITUTIONALIZED (198F)
Legal Authority: PL 100-203, Sec 9115; PL 99-643, Sec 3
CFR Citation: 20 CFR 416.211; 20 CFR 416.413; 20 CFR 416.414; 20 CFR
416.1149; 20 CFR 416.1167; 20 CFR 416.1325; 20 CFR 416.2040; 20 CFR
416.410; 20 CFR 416.412; 20 CFR 416.640; 20 CFR 416.1147
Legal Deadline: None
Abstract: These regulations conform to statutory amendments which
require continued payment for up to three months based on the full
payment rate to certain persons eligible for SSI payments under
sections 1619 or 1611 of the Social Security Act who enter certain
medical or psychiatric institutions. Without the provisions, SSI
benefits would be reduced or suspended.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 09/28/92 57 FR 44519
NPRM Comment Period End 11/27/92
Final Action 06/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Lawrence V. Dudar, Legal Assistant, Department of
Health and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Blvd., Baltimore, MD 21235, 410 965-1759
RIN: 0960-AC55
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1169. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE PROGRAM; MEDICAL
CRITERIA FOR EVALUATING MENTAL DISORDERS FOR ADULTS (222F)
Significance:
Subject to OMB review: Undetermined
Regulatory Plan entry: Yes
Legal Authority: 42 USC 405; 42 USC 1382c
CFR Citation: 20 CFR 404.1500ff, app 1; 20 CFR 404.1520a; 20 CFR
404.1528; 20 CFR 416.920a; 20 CFR 416.928
Legal Deadline: None
Abstract: These amendments revise the medical evaluation criteria for
mental disorders for the Social Security and Supplemental Security
Income disability programs. The revisions will reflect advances in
medical treatment and in methods of evaluating certain mental
impairments and will provide up-to-date medical criteria for use in the
evaluation of disability claims based on mental disorders.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 07/18/91 56 FR 33130
NPRM Comment Period End 09/18/91
Final Action 08/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Richard M. Bresnick, Legal Assistant, Department of
Health and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1758
RIN: 0960-AC74
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1170. SUPPLEMENTAL SECURITY INCOME PROGRAM; TREATMENT OF AUGMENTED
VETERANS' BENEFITS (231F)
Significance:
Subject to OMB review: Undetermined
Legal Authority: 42 USC 1382a
CFR Citation: 20 CFR 416.1123
Legal Deadline: None
Abstract: These regulations describe the treatment of the dependent's
portion of an augmented Department of Veterans Affairs benefit as
income to the dependent by the SSI program.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 05/18/90 55 FR 20612
NPRM Comment Period End 07/17/90
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Duane Heaton, Legal Assistant, Department of Health and
Human Services, Social Security Administration, Office of Regulations,
6401 Security Boulevard, Baltimore, MD 21235, 410 965-8470
RIN: 0960-AC82
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1171. SUPPLEMENTAL SECURITY INCOME PROGRAM; WAIVER OF SSI RULE FOR
DEEMING TO CHILDREN THE INCOME AND RESOURCES OF THEIR PARENTS FOR CERTAIN
DISABLED CHILDREN (252F)
Significance:
Subject to OMB review: Undetermined
Legal Authority: 42 USC 1382c(f)(2)
CFR Citation: 20 CFR 416.415; 20 CFR 416.1148; 20 CFR 416.1165; 20 CFR
416.1202
Legal Deadline: None
Abstract: These proposed regulations reflect the provisions of section
8010 of Pub. L. 101-239 which waive the SSI income and resource deeming
rules (which deem the income and resources of a disabled child's
parents to the child if the child is living at home) for disabled
children who were eligible for SSI benefits while in a medical
institution and who qualify for Medicaid under a State home care plan
authorized under title XIX when deeming parental income and resources
would make the disabled child ineligible for SSI benefits or eligible
for a payment of less than the personal needs allowance. This was
effective June 1, 1990.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 09/22/93 58 FR 49249
NPRM Comment Period End 11/22/93
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: State
Agency Contact: Cassandra Bond, Legal Assistant, Department of Health
and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1794
RIN: 0960-AC96
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1172. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL
SECURITY INCOME PROGRAMS; DEEMED APPLICATION DATE BASED ON MISINFORMATION
(267F)
Significance:
Subject to OMB review: Undetermined
Legal Authority: 42 USC 402(j); 42 USC 1383(e); PL 101-239, Sec 10302
CFR Citation: 20 CFR 404.612; 20 CFR 404.614; 20 CFR 404.615; 20 CFR
404.633 (New); 20 CFR 404.902; 20 CFR 404.903; 20 CFR 416.310; 20 CFR
416.325; 20 CFR 416.351 (New); 20 CFR 416.1402; 20 CFR 416.1403
Legal Deadline: None
Abstract: These regulations implement section 10302 of P.L. 101-239
which provides for the establishment of a deemed filing date of an
application for Social Security or Supplemental Security Income
benefits in any case where it is determined to the satisfaction of the
Secretary that an individual failed to apply for these benefits because
of misinformation provided to the individual by an officer or employee
of the Social Security Administration about the individual's
eligibility for the benefits.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 10/16/92 57 FR 47415
NPRM; Amendment 01/22/93 58 FR 5687
NPRM Comment Period End 03/23/93
Final Action 05/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Henry Lerner, Legal Assistant, Department of Health and
Human Services, Social Security Administration, Office of Regulations,
6401 Security Boulevard, Baltimore, MD 21235, 410 965-1762
RIN: 0960-AD05
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1173. SUPPLEMENTAL SECURITY INCOME PROGRAM; FINANCIAL INSTITUTION
ACCOUNTS IN THE SSI PROGRAM (278F)
Significance:
Subject to OMB review: Yes
Legal Authority: 42 USC 1383
CFR Citation: 20 CFR 416.1201(b); 20 CFR 416.1208 (New)
Legal Deadline: None
Abstract: Title XVI of the Act and SSI regulations are silent on the
issue of how funds held in accounts at financial institutions are
attributed for resource purposes. These regulations provide criteria to
be used for determining ownership of financial institution accounts.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 05/27/92 57 FR 22187
NPRM Comment Period End 07/27/92
Final Action 04/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Henry Lerner, Legal Assistant, Department of Health and
Human Services, Social Security Administration, Office of Regulations,
6401 Security Boulevard, Baltimore, MD 21235, 410 965-1762
RIN: 0960-AD10
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1174. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL
SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED; UPDATING NOMENCLATURE
(264F)
Significance:
Subject to OMB review: Undetermined
Legal Authority: 42 USC 405; 42 USC 1302; 42 USC 1383
CFR Citation: 20 CFR 404; 20 CFR 410; 20 CFR 416; 20 CFR 422
Legal Deadline: None
Abstract: This regulation amends current regulations to replace
outdated nomenclature and terminology, to eliminate little used rules
and provisions which are no longer in effect, and to correct technical
errors such as misspellings and incorrect cross-references.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Cassandra Bond, Legal Assistant, Department of Health
and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1794
RIN: 0960-AD11
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1175. SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED;
TREATMENT OF CERTAIN ROYALTIES AND HONORARIA (310F)
Significance:
Subject to OMB review: Undetermined
Legal Authority: PL 101-508, Sec 5034(a)(1)(B); 42 USC 1382a(a)(1)(E)
CFR Citation: 20 CFR 416.1110; 20 CFR 416.1111; 20 CFR 416.1121
Legal Deadline: None
Abstract: These regulations amend the Supplemental Security Income
regulations to reflect a statutory change in the treatment of royalties
in connection with any publication of the works of an individual and
that portion of honoraria received for services rendered, from unearned
income to earned income.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 10/08/93 58 FR 52464
NPRM Comment Period End 12/07/93
Final Action 09/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Duane Heaton, Legal Assistant, Department of Health and
Human Services, Social Security Administration, Office of Regulations,
6401 Security Boulevard, Baltimore, MD 21235, 410 965-8470
RIN: 0960-AD35
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1176. ORGANIZATION AND PROCEDURES; PROCEDURES OF THE OFFICE OF HEARINGS
AND APPEALS; AUTHORITY OF APPEALS OFFICERS TO DENY A REQUEST FOR APPEALS
COUNCIL REVIEW (334F)
Legal Authority: 42 USC 405; 42 USC 1302; 42 USC 1383
CFR Citation: 20 CFR 422.205
Legal Deadline: None
Abstract: We propose to amend our regulations to give Appeals Officers
of the Appeals Council authority to deny requests for review of hearing
decisions. Presently, this authority rests only with members of the
Appeals Council.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 01/10/94 59 FR 1363
NPRM Comment Period End 03/11/94
Final Action 12/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Philip Berge, Legal Assistant, Office of Regulations,
Department of Health and Human Services, Social Security
Administration, 6401 Security Boulevard, Baltimore, Maryland 21235, 410
965-1769
RIN: 0960-AD45
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1177. SUPPLEMENTAL SECURITY INCOME PROGRAM; TREATMENT OF PROMISSORY NOTES
IN HOME REPLACEMENT SITUATIONS (182F)
Significance:
Subject to OMB review: Undetermined
Legal Authority: 42 USC 1382; 42 USC 1382(b)
CFR Citation: 20 CFR 416.1212
Legal Deadline: None
Abstract: This proposed regulation explains how the Social Security
Administration (SSA) treats promissory notes and similar installment
sales contracts and the proceeds generated therefrom when received as a
result of the sale of a home which is excluded from resources under the
Supplemental Security Income (SSI) program. This proposed regulation
provides for application of the ``home replacement exclusion'' in these
situations where timely reinvestment of the installments into another
home, which is similarly excludable as the principal place of
residence, is made.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 10/13/93 58 FR 52943
NPRM Comment Period End 12/13/93
Final Action 10/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Henry Lerner, Legal Assistant, Office of Regulations,
Department of Health and Human Services, Social Security
Administration, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-
1762
RIN: 0960-AD61
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1178. OASDI AND SSI; TESTING MODIFICATIONS TO THE DISABILITY
DETERMINATION PROCEDURES (359F)
Significance:
Subject to OMB review: Undetermined
Regulatory Plan entry: Yes
Legal Authority: 42 USC 405(a); 42 USC 1302; 42 USC 1383
CFR Citation: 20 CFR 404.906; 20 CFR 416.1406
Legal Deadline: None
Abstract: We propose to add new rules which would establish authority
to test modifications to the disability determination procedures that
we follow under titles II and XVI of the Social Security Act. On a
limited basis, we may test procedures designed to improve the
disability claims process. These models are designed to provide us with
comprehensive information regarding the effect of these procedures on
the disability process. They would enable us to measure whether, and to
what degree, the disability process may be improved, especially with
respect to obtaining the correct decision earlier in the process and
shortening aggregate processing times. We would measure costs and
determine the feasibility of each model. The intended result of testing
these models would be to enable SSA to make recommendations for
national implementation of improvements to the disability process.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 10/22/93 58 FR 54532
NPRM Comment Period End 01/05/94
Final Action 09/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Henry D. Lerner, Legal Assistant, Office of
Regulations, Department of Health and Human Services, Social Security
Administration, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-
1762
RIN: 0960-AD63
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1179. RELIABLE INFORMATION WHICH IS CURRENTLY AVAILABLE FOR DETERMINING
BENEFIT AMOUNTS IN THE SUPPLEMENTAL SECURITY INCOME PROGRAM (382F)
Legal Authority: 42 USC 1302; 42 USC 1382(a) to 1382(c); 42 USC
1382(e); 42 USC 1382a; 42 USC 1382f; 42 USC 1383
CFR Citation: 20 CFR 416.420
Legal Deadline: NPRM, Judicial, March 16, 1993.
Abstract: Pursuant to the Court order in Gould, et al. v. Sullivan, No.
C2-87-964 (S.D. Ohio, October 2, 1992), we proposed a rule for
determining benefits in the SSI program. Under section 1611(c)(4)(A) of
the Social Security Act, if the Secretary determines that reliable
information is currently available concerning the income and other
circumstances of an individual for a month, the Secretary may use that
information to determine an individual's SSI benefit amount for that
month. This discretionary method of determining SSI benefit amounts is
an exception to the use of information from a prior month, known as
retrospective monthly accounting (RMA), as provided in section
1611(c)(1) of the Act. The proposed rule explained that the Secretary
has determined that no information exists which is reliable and
currently available to use in computing SSI benefit amounts pursuant to
section 1611(c)(4).
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 03/16/93 58 FR 14191
NPRM Comment Period End 05/17/93
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Henry Lerner, Legal Assistant, Department of Health and
Human Services, Social Security Administration, Office of Regulations,
6401 Security Boulevard, Baltimore, MD 21235, 410 965-1762
RIN: 0960-AD65
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1180. APPEAL RIGHTS FOLLOWING STATE-INITIATED MASS CHANGE IN FEDERALLY
ADMINISTERED STATE SUPPLEMENTARY PAYMENTS RESULTING IN REDUCTION,
SUSPENSION, OR TERMINATION OF STATE SUPPLEMENTARY PAYMENTS (383F)
Significance:
Subject to OMB review: Yes
Regulatory Plan entry: Yes
Legal Authority: 42 USC 405(a); 42 USC 1302(a); 42 USC 1382e; 42 USC
1383(d)(1)
CFR Citation: 20 CFR 416.1401; 20 CFR 416.1402; 20 CFR 416.1403
Legal Deadline: None
Abstract: The regulation addresses the problem of appeals filed by
supplemental security income recipients whose payments are reduced,
suspended or terminated because of a decrease in the amount of
federally administered State supplementary payments. The decrease
results from a State-initiated across-the-board reduction in the amount
of State supplementary payments due to legislative or executive action
by a State. The Social Security Administration cannot change the
State's decision to reduce the amount of State supplementary payments.
Therefore, in cases where State-initiated change in the amount of State
supplementary payments cause a reduction, suspension or termination of
those payments, only our calculation of the amount of the change in an
individual's State supplementary payment amount resulting from the
change is an initial determination subject to administrative and
judicial review and continuation of benefits. may be appealed.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 08/10/93 58 FR 42514
NPRM Comment Period End 10/12/93
Final Action 09/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Jack Schanberger, Legal Assistant, Department of Health
and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-8471
RIN: 0960-AD66
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1181. COMPENSATION OF QUALIFIED ORGANIZATIONS SERVING AS REPRESENTATIVE
PAYEES UNDER TITLE II AND TITLE XVI (423F)
Significance:
Subject to OMB review: Undetermined
Legal Authority: 42 USC 405(a); 42 USC 405(j); 42 USC 1302; 42 USC
1383(a)(2)
CFR Citation: 20 CFR 404.2040; 20 CFR 404.2040a; 20 CFR 416.640; 20
CFR 416.640a
Legal Deadline: None
Abstract: These additional changes to the final regulations which were
published on June 1, 1992 will require a representative payee to set
aside a personal needs allowance for all institutionalized
beneficiaries; preclude a qualified organization that serves as
representative payee from taking a fee from the personal needs
allowance of all institutionalized beneficiaries; and allow a qualified
organization to collect its fee for services from conserved benefits in
certain limited circumstances.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Philip Berge, Legal Assistant, Department of Health and
Human Services, Social Security Administration, 6401 Security
Boulevard, Baltimore, MD 21235, 410 965-1769
RIN: 0960-AD71
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1182. TEMPORARY INCREASE IN SPONSORSHIP PERIOD FOR ALIENS UNDER
THE SSI PROGRAM (457F)
Significance:
Subject to OMB review: Undetermined
Legal Authority: PL 103-152, sec 7
CFR Citation: 20 CFR 416.1160; 20 CFR 416.1204
Legal Deadline: None
Abstract: Section 7 of Pub. L. 103-152 amended section 1621 of the
Social Security Act to temporarily increase the sponsorship period for
aliens under the SSI program from 3 years to 5 years following the
alien's date of lawful admission to the U.S. The increase in the
sponsorship period is effective January 1, 1994. Beginning October 1,
1996, the 3-year sponsorship period will be reinstated. We will amend
our regulations to conform to the statutory changes. Any costs/savings
are associated with the legislation and not with the regulations
themselves.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Lois Berg, Paralegal Specialist, Department of Health
and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1713
RIN: 0960-AD84
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Social Security Administration (SSA)
_______________________________________________________________________
1183. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE PROGRAM; REVISED
MEDICAL CRITERIA FOR DETERMINATION OF DISABILITY; CARDIOVASCULAR SYSTEM
(141F)
Significance:
Subject to OMB review: Yes
Regulatory Plan entry: Yes
CFR Citation: 20 CFR 404.1500ff, appendix 1
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 02/10/94 59 FR 6468
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Irving Darrow, 410 966-0512
RIN: 0960-AA99
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Social Security Administration (SSA)
_______________________________________________________________________
1184. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE PROGRAM; REVISED
MEDICAL CRITERIA FOR DETERMINATION OF DISABILITY; RESPIRATORY SYSTEM
(142F)
CFR Citation: 20 CFR 404.1500ff, appendix 1
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 10/07/93 58 FR 52346
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Cassandra Bond, 410 965-1794
RIN: 0960-AB00
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Social Security Administration (SSA)
_______________________________________________________________________
1185. SUPPLEMENTAL SECURITY INCOME PROGRAM; EXCLUSIONS FROM INCOME AND
RESOURCES OF INDIAN JUDGMENT FUNDS AND PER CAPITA DISTRIBUTIONS (201F)
CFR Citation: 20 CFR 416K Appendix; 20 CFR 416.1234; 20 CFR 416.1236
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 02/23/94 59 FR 8530
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Duane Heaton, 410 965-8470
RIN: 0960-AB86
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Social Security Administration (SSA)
_______________________________________________________________________
1186. SUPPLEMENTAL SECURITY INCOME PROGRAM; PAYMENT OF BENEFITS DUE
DECEASED RECIPIENTS (174F)
Significance:
Subject to OMB review: Yes
CFR Citation: 20 CFR 416.340(d); 20 CFR 416.345(e); 20 CFR 416.533; 20
CFR 416.536; 20 CFR 416.537(b); 20 CFR 416.538(a); 20 CFR 416.538(b);
20 CFR 416.538(c); 20 CFR 416.538(d); 20 CFR 416.542(b); 20 CFR
416.542(c); 20 CFR 416.543; 20 CFR 416.1402(k); 20 CFR 416.1402(l); 20
CFR 416.1402(m); ...
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 10/13/93 58 FR 52909
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Lawrence V. Dudar, 410 965-1795
RIN: 0960-AC28
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Social Security Administration (SSA)
_______________________________________________________________________
1187. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL
SECURITY INCOME PROGRAMS; CANCELLED CONSULTATIVE EXAMINATIONS (181F)
CFR Citation: 20 CFR 404.1624; 20 CFR 416.1024
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
No Action Expected in Next 12
mos 02/14/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Richard M. Bresnick, 410 965-1758
RIN: 0960-AC40
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Social Security Administration (SSA)
_______________________________________________________________________
1188. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL
SECURITY INCOME PROGRAMS; DETERMINING DISABILITY AND BLINDNESS; FEE
LIMITATION POLICY FOR PURCHASE OF LABORATORY TESTS (184P)
CFR Citation: 20 CFR 404.1624a (New); 20 CFR 416.1024a (New)
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
No Action Expected in Next 12
mos 02/14/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Richard M. Bresnick, 410 965-1758
RIN: 0960-AC41
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Social Security Administration (SSA)
_______________________________________________________________________
1189. OLD-AGE, SURVIVORS AND DISABILITY INSURANCE AND SUPPLEMENTAL
SECURITY INCOME PROGRAMS; DETERMINATION OF DISABILITY--DISABILITY-
DETERMINING STATE AGENCY SUBSTANTIAL FAILURE (206F)
CFR Citation: 20 CFR 404.1641; 20 CFR 404.1670; 20 CFR 404.1680; 20
CFR 404.1682; 20 CFR 404.1683; 20 CFR 416.1041; 20 CFR 416.1070; 20 CFR
416.1080; 20 CFR 416.1082; 20 CFR 416.1083
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
No Action Expected in Next 12
mos 02/14/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Cassandra A. Bond, 410 965-1794
RIN: 0960-AC60
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Social Security Administration (SSA)
_______________________________________________________________________
1190. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE PROGRAM; SUSPENSION OF
BENEFITS OF DEPORTED NAZIS; EXEMPTION FROM SOCIAL SECURITY TAXATION
BECAUSE OF RELIGIOUS BELIEFS (210F)
CFR Citation: 20 CFR 404.305; 20 CFR 404.464; 20 CFR 404.1039 (New);
20 CFR 404.1068; 20 CFR 404.1075
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 12/10/93 58 FR 64886
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Lawrence V. Dudar, 410 965-1759
RIN: 0960-AC68
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Social Security Administration (SSA)
_______________________________________________________________________
1191. SUPPLEMENTAL SECURITY INCOME PROGRAM; REDETERMINATIONS OF
SUPPLEMENTAL SECURITY INCOME ELIGIBILITY (223F)
CFR Citation: 20 CFR 416.204
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 12/10/93 58 FR 64892
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Duane Heaton, 410 965-8470
RIN: 0960-AC77
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Social Security Administration (SSA)
_______________________________________________________________________
1192. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL
SECURITY INCOME PROGRAMS; MEDICAL IMPROVEMENT REVIEW STANDARD (MIRS)--
MISCELLANEOUS CHANGES (225P)
CFR Citation: 20 CFR 404.1579; 20 CFR 404.1594; 20 CFR 404.1598; 20
CFR 416.994; 20 CFR 416.994a; 20 CFR 416.998
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
No Action Expected in Next 12
mos 02/14/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Harry J. Short, 410 965-6243
RIN: 0960-AC81
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Social Security Administration (SSA)
_______________________________________________________________________
1193. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL
SECURITY INCOME PROGRAMS; REPRESENTATION OF CLAIMANTS FOR BENEFITS UNDER
TITLE II OR TITLE XVI (249F)
CFR Citation: 20 CFR 404.1705; 20 CFR 416.1505
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 12/10/93 58 FR 64883
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Philip Berge, 410 965-1769
RIN: 0960-AC87
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Social Security Administration (SSA)
_______________________________________________________________________
1194. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL
SECURITY INCOME PROGRAMS; STANDARDS APPLICABLE IN DETERMINATIONS OF GOOD
CAUSE, FAULT, AND GOOD FAITH (247F)
CFR Citation: 20 CFR 404; 20 CFR 416
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 01/12/94 59 FR 1629
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Philip Berge, 410 965-1769
RIN: 0960-AC88
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Social Security Administration (SSA)
_______________________________________________________________________
1195. SUPPLEMENTAL SECURITY INCOME PROGRAM; EXCLUSION FROM INCOME OF
DOMESTIC COMMERCIAL TRANSPORTATION TICKETS RECEIVED AS GIFTS IN
DETERMINING SSI INCOME (253F)
CFR Citation: 20 CFR 416.1124; 20 CFR 416.1161
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 12/03/93 58 FR 63887
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Irving Darrow, 410 966-0512
RIN: 0960-AC97
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Social Security Administration (SSA)
_______________________________________________________________________
1196. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL
SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED; REOPENING
DETERMINATIONS AND DECISIONS (279F)
CFR Citation: 20 CFR 404.987; 20 CFR 416.1487
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 02/23/94 59 FR 8532
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Henry Lerner, 410 965-1762
RIN: 0960-AD12
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Social Security Administration (SSA)
_______________________________________________________________________
1197. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE; SUSPENSION OF
AUXILIARY BENEFITS WHEN A DISABLED WORKER IS IN AN EXTENDED PERIOD OF
ELIGIBILITY (303F)
CFR Citation: 20 CFR 401a; 20 CFR 1529a
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 12/10/93 58 FR 64882
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Lawrence V. Dudar, 410 965-1795
RIN: 0960-AD30
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Social Security Administration (SSA)
_______________________________________________________________________
1198. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE; CONTINUED ENTITLEMENT
TO BENEFITS OF DEEMED SPOUSE DESPITE ENTITLEMENT OF LEGAL SPOUSE (304F)
CFR Citation: 20 CFR 404.331; 20 CFR 404.332; 20 CFR 404.336; 20 CFR
404.337; 20 CFR 404.340; 20 CFR 404.341; 20 CFR 404.346
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 12/10/93 58 FR 64890
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Lawrence V. Dudar, 410 965-1759
RIN: 0960-AD31
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Social Security Administration (SSA)
_______________________________________________________________________
1199. SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED;
EXCLUSION FROM INCOME AND RESOURCES OF EARNED INCOME TAX CREDITS (319F)
CFR Citation: 20 CFR 416.210; 20 CFR 416.1110; 20 CFR 416.1111; 20 CFR
416.1112; 20 CFR 416.1161; 20 CFR 416.1210; 20 CFR 416.1235 (New)
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 12/03/93 58 FR 63888
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Henry D. Lerner, 410 965-1762
RIN: 0960-AD41
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Social Security Administration (SSA)
_______________________________________________________________________
1200. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL
SECURITY INCOME; LIMITATION OF TRAVEL EXPENSES FOR REPRESENTATION OF
CLAIMANTS AT ADMINISTRATIVE PROCEEDINGS (324F)
CFR Citation: 20 CFR 404.999c(d); 20 CFR 416.1498(d)
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 03/08/94 59 FR 8529
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Philip Berge, 410 965-1769
RIN: 0960-AD46
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Social Security Administration (SSA)
_______________________________________________________________________
1201. TIME LIMIT FOR DISPOSITION OF RESOURCES IN THE SUPPLEMENTAL
SECURITY INCOME PROGRAM (330F)
CFR Citation: 20 CFR 416.1242
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 11/15/93 58 FR 60103
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Henry Lerner, 410 965-1762
RIN: 0960-AD48
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Social Security Administration (SSA)
_______________________________________________________________________
1202. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL
SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED; PAYMENTS FOR
VOCATIONAL REHABILITATION SERVICES (333F)
Significance:
Subject to OMB review: Yes
Regulatory Plan entry: Yes
CFR Citation: 20 CFR 404; 20 CFR 416
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 03/15/94 59 FR 11899
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Jack Schanberger, 410 965-8471
RIN: 0960-AD50
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Social Security Administration (SSA)
_______________________________________________________________________
1203. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL
SECURITY INCOME PROGRAMS; REORGANIZATION OF MEDICAL EVIDENCE REGULATIONS
(340P)
CFR Citation: 20 CFR 404; 20 CFR 416
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
No Action Expected in Next 12
Mos 02/14/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Alicia Matthews, 410 965-1713
RIN: 0960-AD57
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Social Security Administration (SSA)
_______________________________________________________________________
1204. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE PROGRAM; CONSIDERING
AN APPLICATION FILED UNDER THE RAILROAD RETIREMENT ACT AS AN APPLICATION
FOR SOCIAL SECURITY BENEFITS (342F)
CFR Citation: 20 CFR 404.611
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 11/16/93 58 FR 60381
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Jack Schanberger, 410 965-8471
RIN: 0960-AD59
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Social Security Administration (SSA)
_______________________________________________________________________
1205. SSI PROGRAM; SSI MAXIMUM PAYMENT LIMIT ($30) WHEN MEDICAID IS NOT
PAYING TOWARD THE COST OF INSTITUTIONAL CARE BECAUSE THE INDIVIDUAL
TRANSFERRED A RESOURCE (345F)
CFR Citation: 20 CFR 416.414
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 12/10/93 58 FR 64893
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Lawrence V. Dudar, 410 965-1759
RIN: 0960-AD60
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Social Security Administration (SSA)
_______________________________________________________________________
1206. OASDI AND SSI PROGRAMS; PERFORMANCE STANDARDS REVISIONS AND OTHER
CHANGES INVOLVING ADMINISTRATIVE REQUIREMENTS AND PROCEDURES (381A)
CFR Citation: 20 CFR 404.1640; 20 CFR 404.1641; 20 CFR 404.1642; 20
CFR 404.1643; 20 CFR 404.1644; 20 CFR 404.1645; 20 CFR 404.1650; 20 CFR
416.1040; 20 CFR 416.1041; 20 CFR 416.1042; 20 CFR 416.1043; 20 CFR
416.1044; 20 CFR 416.1045; 20 CFR 416.1050
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
No Action Expected in Next 12
Months 02/14/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Alicia Matthews, 410 965-1713
RIN: 0960-AD64
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Social Security Administration (SSA)
_______________________________________________________________________
1207. FEDERAL OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE PROGRAM;
TECHNICAL CHANGES TO REQUIREMENT FOR ENTITLEMENT TO WIDOW(ER)'S BENEFITS
(404F)
CFR Citation: 20 CFR 404.335
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 03/30/94 59 FR 14746
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Harry Short, 410 965-6243
RIN: 0960-AD69
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Office of Assistant Secretary for Health
(OASH)
_______________________________________________________________________
1208. PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT
Significance:
Subject to OMB review: Yes
Regulatory Plan entry: Yes
Legal Authority: 42 USC 289b; 42 USC 290aa
CFR Citation: 42 CFR 93
Legal Deadline: None
Abstract: The proposed regulation will revise the definition of
research misconduct, identify responsibilities of institutions
receiving allegations of research misconduct involving PHS-supported
research, provide a hearing opportunity for persons found to have
engaged in research misconduct, and set forth other policies of the
Department of Health and Human Services related to research integrity.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 03/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Dr. Lawrence Rhoades, Director, Division of Policy and
Education, Office of Research Integrity, Department of Health and Human
Services, Public Health Service, 5515 Security Lane, Suite 700,
Rockville, MD 20852, 301 443-5300
RIN: 0905-AE02
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--Office of Assistant Secretary for Health
(OASH)
_______________________________________________________________________
1209. PRIVACY ACT; EXEMPT SYSTEM
Significance:
Subject to OMB review: Yes
Legal Authority: 5 USC 552a; 5 USC 301
CFR Citation: 45 CFR 5b-11
Legal Deadline: None
Abstract: The Department of Health and Human Services proposes to
exempt a new system of records, 09-37-0021, ``Public Health Service
Records Related to Investigations of Scientific Misconduct'' from
certain requirements of the Privacy Act. The purpose of this exemption
is to protect records compiled in the course of an allegation
assessment and/or investigation and to protect the identity of the
confidential source of information. There are no known costs associated
with the NPRM. The benefits will be that the investigative files will
not be disclosed inappropriately and promises to withhold identities of
confidential sources will be honored.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/12/92 57 FR 25004
NPRM Comment Period End 07/13/92 57 FR 25004
Final Action 07/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Dr. Lawrence Rhoades, Director, Division of Policy and
Edcuation, Department of Health and Human Services, Public Health
Service, 5515 Security Lane, Suite 700, Rockville, MD 20852, 301 443-
5300
RIN: 0905-AD31
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--Office of Assistant Secretary for Health
(OASH)
_______________________________________________________________________
1210. STANDARDS OF COMPLIANCE FOR ABORTION-RELATED SERVICES IN FAMILY
PLANNING SERVICE PROJECTS
Significance:
Subject to OMB review: Yes
Regulatory Plan entry: Yes
Legal Authority: 42 USC 300a-4
CFR Citation: 42 CFR 59
Legal Deadline: None
Abstract: This rule would return the Family Planning Service Program,
funded under Title X of the Public Health Service Act, to the
compliance standards operative prior to February 2, l988, with regard
to the statutory provision prohibiting abortion as a method of family
planning in projects funded under that title.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 02/05/93 58 FR 7464
NPRM Comment Period End 08/09/93 58 FR 34024
Final Action 10/00/94
Small Entities Affected: None
Government Levels Affected: State
Agency Contact: Gerald Bennett, Acting Deputy Assistant Secretary for
Population Affairs, Department of Health and Human Services, Public
Health Service, P.O.Box 23783, Washington, DC 20026-3783, 202 690-8335
RIN: 0905-AE03
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Substance Abuse and Mental Health Services
Administration (SAMHSA)
_______________________________________________________________________
1211. CONFIDENTIALITY OF SUBSTANCE ABUSE PATIENT RECORDS
Significance:
Subject to OMB review: Undetermined
Regulatory Plan entry: Undetermined
Legal Authority: 42 USC 290dd-2, as amended by PL 102-321; 42 USC
290dd-3, as amended by PL 102-321
CFR Citation: 42 CFR 2
Legal Deadline: None
Abstract: This action modifies rules at 42 CFR part 2 to clarify
coverage of general medical facilities in light of U.S. v. Eide, 875
F.2d 1429, 1438 (9th Cir. 1989).
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/00/94
NPRM Comment Period End 08/00/94
Final Action 11/00/94
Small Entities Affected: Businesses, Governmental Jurisdictions,
Organizations
Government Levels Affected: State, Local, Tribal, Federal
Additional Information: Alternate Contact: Sue Martone, DLEA, SAMHSA,
PHS, Room 12C-15, 5600 Fishers Lane, Rockville, MD 20857; 301-443-4640
Agency Contact: Joseph D. Faha, Director, DLEA, SAMHSA, Department of
Health and Human Services, Public Health Service, 5600 Fishers Lane,
Room 12C-15, Rockville, MD 20857, 301 443-4640
RIN: 0905-AD97
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Substance Abuse and Mental Health Services
Administration (SAMHSA)
_______________________________________________________________________
1212. PROTECTION AND ADVOCACY FOR INDIVIDUALS WITH MENTAL ILLNESS
Significance:
Subject to OMB review: Undetermined
Regulatory Plan entry: Undetermined
Legal Authority: 42 USC 10801 et seq, as amended by PL 102-173
CFR Citation: 45 CFR subchapter H
Legal Deadline: Final, Statutory, May 27, 1992.
Section 9 of P.L. 102-173, enacted on 11/27/91, sets this deadline.
Abstract: Sets requirements for funding State and State-designated
systems for protecting and advocating for individuals with mental
illness. By law, these requirements must be set out in regulations.
These requirements are intended to be published with revisions to 45
CFR 1385 et seq. These rules govern formula grants from the
Administration on Developmental Disabilities for protecting and
advocating for individuals with developmental disabilities.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/00/94
NPRM Comment Period End 08/00/94
Final Action 10/00/94
Small Entities Affected: Governmental Jurisdictions, Organizations
Government Levels Affected: State, Local
Additional Information: Alternate Contact: Sue Martone, DLEA, SAMHSA,
PHS; Room 12C-15, 5600 Fishers Lane, Rockville, MD 20857; 301-443-4640
Agency Contact: Joseph D. Faha, Director, DLEA, SAMHSA, Department of
Health and Human Services, Public Health Service, 5600 Fishers Lane,
Room 12C-15, Rockville, MD 20857, 301 443-4640
RIN: 0905-AD99
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Substance Abuse and Mental Health Services
Administration (SAMHSA)
_______________________________________________________________________
1213. COMMUNITY MENTAL HEALTH SERVICES BLOCK GRANTS
Significance:
Subject to OMB review: Undetermined
Regulatory Plan entry: Undetermined
Legal Authority: 42 USC 300X-1, P.L. 102-321, ADAMHA Reorganization
Act
CFR Citation: 45 CFR 96
Legal Deadline: None
Abstract: States and territories must submit annual applications which
include State plans and implementation reports for services delivery to
adults with serious mental illness and children with serious emotional
disturbance under the Community Mental Health Services Block Grant
statute. Regulatory action is necessary to establish uniform
application format and to institute requirements with regard to
addressing and reporting on the statutory criteria the Secretary must
use to determine if applications comply with legislative mandates
(sections 1911, 1920 and 1941-1954 of the Public Health Service Act, as
amended by P.L. 102-321), thus meeting approval for grant award.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 09/00/94
NPRM Comment Period End 11/00/94
Small Entities Affected: Governmental Jurisdictions, Organizations
Government Levels Affected: State, Tribal
Agency Contact: Joseph Faha, Director, Div. of Legislation and External
Affairs, Department of Health and Human Services, Public Health
Service, Room 12C-15, Parklawn Building, 5600 Fishers Lane, Rockville,
MD 20857, 301 443-4640
RIN: 0905-AE24
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--Substance Abuse and Mental Health Services
Administration (SAMHSA)
_______________________________________________________________________
1214. BLOCK GRANTS FOR PREVENTION AND TREATMENT OF SUBSTANCE ABUSE
Significance:
Subject to OMB review: Yes
Regulatory Plan entry: Undetermined
Legal Authority: 42 USC 300-x et seq, as amended by PL 102-321
CFR Citation: 45 CFR 96
Legal Deadline: Final, Statutory, August 25, 1992.
Awards to States after January 1, 1993 cannot be made until
implementing regulations are published.
Abstract: Sets requirements for block grants for prevention and
treatment of substance abuse. The requirements include criteria for
approval of State plans which must by statute be prescribed in
regulations. These provisions are effective immediately. However,
States have 90 days from the effective date to bring previously
submitted FY 1993 applications into substantial compliance and need to
submit applications in the prescribed format beginning only with 1994
applications.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Interim Final Rule 03/31/93 58 FR 17062
Interim Final Rule Comment
Period End 06/01/93
Final Action 06/00/94
Small Entities Affected: Governmental Jurisdictions, Organizations
Government Levels Affected: State, Tribal
Additional Information: Alternate Contact: Sue Martone, DLEA, SAMHSA,
PHS, 5600 Fishers Lane, Room 12C-15, Rockville, MD 20852; 301-443-4640
Agency Contact: Joseph D. Faha, Director, DLEA, SAMHSA, Department of
Health and Human Services, Public Health Service, 5600 Fishers Lane,
Room 12C-15, Rockville, MD 20857, 301 443-4640
RIN: 0905-AD98
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--Substance Abuse and Mental Health Services
Administration (SAMHSA)
_______________________________________________________________________
1215. BLOCK GRANTS FOR PREVENTION AND TREATMENT OF SUBSTANCE ABUSE
(TOBACCO PROVISIONS)
Significance:
Subject to OMB review: Yes
Economically significant: Yes
Regulatory Plan entry: Undetermined
Legal Authority: 42 USC 300x-21
CFR Citation: 45 CFR 96; 45 CFR 130
Legal Deadline: None
Abstract: Sets standards and procedures for enforcement of State law
against sale of tobacco products to minors as a condition of full
funding of Federal block grants to States for prevention and treatment
of substance abuse. These requirements apply beginning in fiscal year
1994 except, under certain conditions, in fiscal year 1995.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 08/26/93 58 FR 45156
NPRM Comment Period End 10/25/93 58 FR 45156
Final Action 07/00/94
Small Entities Affected: Businesses, Governmental Jurisdictions
Government Levels Affected: State, Tribal
Additional Information: Alternate Contact: Sue Martone, DLEA, SAMHSA,
PHS, Room 12C-15, 5600 Fishers Lane, Rockville, MD 20852; 301-443-4640
Agency Contact: Joseph D. Faha, Director, DLEA, SAMHSA, Department of
Health and Human Services, Substance Abuse and Mental Health Services
Administration, 5600 Fishers Lane, 12-C-15, Rockville, MD 20857, 301
443-4640
RIN: 0905-AE05
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Centers for Disease Control and Prevention
(CDC)
_______________________________________________________________________
1216. RESPIRATORY PROTECTIVE DEVICES
Significance:
Subject to OMB review: Yes
Regulatory Plan entry: Yes
Legal Authority: 30 USC 842(h); 30 USC 844; 30 USC 957
CFR Citation: 30 CFR 11; 42 CFR 84
Legal Deadline: None
Abstract: The proposed rule is the first in a series of regulatory
modules which will upgrade current respirator certification
requirements. This first module will update testing requirements for
air-purifying respirators with particulate filters. The existing
requirements allow potentially excessive filter leakage. The proposed
rule would also benefit health care settings implementing CDC
recommendations for preventing the transmission of tuberculosis. These
recommendations include performance criteria for respiratory devices.
The proposed rule will enable the certification of a broader range of
respirators that meet the CDC performance criteria.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 08/27/87 52 FR 32402
First Public Hearing 01/20/88 52 FR 37639
Second Public Hearing 01/27/88 52 FR 37639
NPRM Public Comment Period End 03/28/88 53 FR 5595
Second NPRM 04/00/94
Second NPRM Comment Period End 05/00/94
Final Action 00/00/00
Final Action Effective 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Richard Metzler, Chief, Cert. & Quality Assurance Br.,
Division of Safety Research, NIOSH, Department of Health and Human
Services, Public Health Service, Centers for Disease Control and
Prevention, 944 Chestnut Ridge Road, Morgantown, WV 26505, 304 284-5713
RIN: 0905-AB58
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--Centers for Disease Control and Prevention
(CDC)
_______________________________________________________________________
1217. INTERSTATE SHIPMENT OF BIOLOGICAL MATERIAL THAT CONTAINS OR MAY
CONTAIN ETIOLOGIC AGENTS
Legal Authority: 42 USC 216; 42 USC 264; 42 USC 271
CFR Citation: 42 CFR 72
Legal Deadline: None
Abstract: The revised regulation will clarify and expand the
requirements for proper packaging and handling of etiologic agents
during interstate shipment. The revised regulation will ensure that all
biological material that could contain etiologic agents is packaged in
a manner for interstate shipment that minimizes the potential for
leakage and possible contamination of the environment and minimizes
direct physical contact with the contents by package handlers. The
revised regulation is not expected to have a major impact on the cost
of shipping these materials.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 03/02/90 55 FR 7678
NPRM Comment Period End 05/09/90 55 FR 7678
Final Action 06/00/94
Final Action Effective 09/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Jonathan Y. Richmond, Ph.D., Director, Office of Health
and Safety, Centers for Disease Control and Prevention, Department of
Health and Human Services, Public Health Service, 1600 Clifton Road
NE., Atlanta, GA 30333, 404 639-3883
RIN: 0905-AC89
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--Centers for Disease Control and Prevention
(CDC)
_______________________________________________________________________
1218. MEDICAL EXAMINATION OF ALIENS
Legal Authority: 8 USC 1182; 8 USC 1224; 8 USC 1225; 42 USC 216; 42
USC 249; 42 USC 252; PL 101-649
CFR Citation: 42 CFR 34
Legal Deadline: None
Abstract: This is a proposed revision in the regulations for the
medical examination of aliens. The regulations were developed to
provide for the physical and mental examination of aliens within the
United States or in other countries as required by the Immigration and
Nationality Act. This revision would update the regulations in
accordance with current epidemiologic concepts and medical diagnostic
standards.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Interim Final Rule 05/31/91 56 FR 25000
Interim Final Comment Period End08/02/91 56 FR 25000
Final Action 00/00/00
Final Action Effective 00/00/00
Small Entities Affected: None
Government Levels Affected: State, Federal
Agency Contact: Charles R. McCance, Director, Division of Quarantine,
Department of Health and Human Services, Public Health Service, Centers
for Disease Control and Prevention, 1600 Clifton Road, Mailstop E-104,
Atlanta, GA 30333, 404 639-8100
RIN: 0905-AD29
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Prerule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1219. MEDICAL FOODS
Significance:
Subject to OMB review: Yes
Economically significant: Undetermined
Regulatory Plan entry: Undetermined
Legal Authority: 21 USC 321; 21 USC 341; 21 USC 342; 21 USC 343; 21
USC 348; 21 USC 350; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 360ee;
21 USC 371
CFR Citation: Not yet determined
Legal Deadline: None
Abstract: The Food and Drug Administration is considering development
of regulations for medical foods, as defined by the Orphan Drug Act
Amendments of 1988 (21 USC 360ee(b)(3)) to assure, among other things,
the safety and effectiveness of these products, proper labeling of the
nutrient content and purported uses, including adequate and appropriate
directions for use, and quality control and good manufacturing
practices.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
ANPRM 09/00/94
ANPRM Comment Period End 11/00/94
Small Entities Affected: Businesses
Government Levels Affected: State, Federal
Agency Contact: Carol Lang, Regulatory Branch, Division of Programs and
Enforcement Policy, Office of Spec Nut., Department of Health and Human
Services, Public Health Service, Food and Drug Administration, Center
for Food Safey and Applied Nutrition, 200 C St. SW Washington, DC
20204, 202 205-5372
RIN: 0905-AD91
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Prerule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1220. SPECIFIC REQUIREMENTS ON CONTENT AND FORMAT OF LABELING
FOR HUMAN PRESCRIPTION DRUGS; ADDITION OF ``GERIATRIC USE'' SUBSECTION IN
THE LABELING
Significance:
Subject to OMB review: Undetermined
Legal Authority: 21 USC 352; 21 USC 355; 42 USC 262
CFR Citation: 21 CFR 201
Legal Deadline: None
Abstract: On November 1, 1990 (55 FR 46134), the agency proposed to
amend its regulations governing the content and format of labeling for
human prescription drug products to require a subsection in the
labeling that would include information on the use of a drug in the
elderly. This proposal reflects growing recognition by FDA and others
of the special concerns associated with prescription drug use in this
age group. FDA believes that providing access to this information is
necessary for the safe and effective use of prescription drugs in older
populations. The agency is reviewing the public comments submitted in
response to the proposed rule and preparing a final rule.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 11/01/90 55 FR 46134
NPRM Comment Period End 12/31/90 55 FR 46134
ANPRM 10/00/94
Small Entities Affected: Undetermined
Government Levels Affected: None
Agency Contact: Thomas C. Kuchenberg, Regulatory Counsel, Department of
Health and Human Services, Public Health Service, Division Regulatory
Affairs, Food and Drug, Administration, Center for Drug Evaluation, and
Research (HFD-362), 301 594-1046
RIN: 0905-AE26
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Prerule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1221. CERTIFICATION OF DRUGS COMPOSED WHOLLY OR PARTLY OF
INSULIN; FEES FOR CERTIFICATION OF DRUGS COMPOSED WHOLLY OF PARTLY OF
INSULIN
Significance:
Subject to OMB review: Undetermined
Legal Authority: 21 USC 352; 21 USC 356; 21 USC 371
CFR Citation: 21 CFR 429.40; 21 CFR 429.55
Legal Deadline: None
Abstract: The Food and Drug Administration intends to issue an interim
rule, with opportunity for public comment, to announce that it will no
longer routinely perform tests and assays on insulin samples prior to
certification where there is a testing and marketing history sufficient
to establish that precertification testing is no longer necessary. The
interim rule will also revise the fee schedule for insulin
certification services to reflect the change in FDA's certification
policy.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
ANPRM 06/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Wayne H. Mitchell, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Division of
Regulatory Affairs, Center for Drug Evaluation and Research (HFD-362),
301 594-1049
RIN: 0905-AE28
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Prerule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1222. SUNGLASS LABELING
Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined
Regulatory Plan entry: Undetermined
Legal Authority: 21 USC 352
CFR Citation: 21 CFR 801
Legal Deadline: None
Abstract: The failure of sunglasses to block the transmittance of a
sufficient amount of UV rays may result in macular degeneration, a
condition affecting vision significantly. Not all sunglasses provide
adequate protection for those at high risk. FDA believes that consumers
should be aware of the degree of protection provided. FDA is publishing
the ANPRM to gather additional information on the extent of the problem
and to seek potential solutions.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
ANPRM 06/00/94
Small Entities Affected: Undetermined
Government Levels Affected: None
Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department
of Health and Human Services, Food and Drug Administration, CDRH (HFZ-
84), 2098 Gaither Road, Rockville, MD 20850, 301 594-4765
RIN: 0905-AE35
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Prerule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1223. INVESTIGATIONAL DEVICE EXEMPTION: COST RECOVERY
Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined
Regulatory Plan entry: Undetermined
Legal Authority: 21 USC 360j (g)
CFR Citation: 21 CFR 812.7
Legal Deadline: None
Abstract: FDA is considering revising its regulation concerning
recovering costs from patients for devices being investigated for
safety and effectiveness information before commercial marketing.
Presently, 21 CFR 812.7(b) prohibits investigators from charging
subjects a price larger than that necessary to recover costs of
manufacture, research, development and handling. FDA believes that this
may encourage more widespread use of investigational devices than is
appropriate. FDA is publishing this ANPRM to gather information on the
nature and extent of the problem.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
ANPRM 06/00/94
Small Entities Affected: Undetermined
Government Levels Affected: None
Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department
of Health and Human Services, Food and Drug Administration, CDRH (HFZ-
84), 2098 Gaither Road, Rockville, MD 20850, 301 594-4765
RIN: 0905-AE36
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1224. NEW ANIMAL DRUG APPROVAL PROCESS
Significance:
Subject to OMB review: Undetermined
Legal Authority: 21 USC 360b; 21 USC 371
CFR Citation: 21 CFR 514.1; 21 CFR 514.8
Legal Deadline: None
Abstract: On December 17, 1991, the agency published a proposed
revision of the existing regulations that is consistent with the
current procedural regulations for human drugs where appropriate. The
New Animal Drug Application (NADA) revisions articulate general
requirements in regulations containing performance standards and would
complement them through detailed guidelines on, among other matters,
appropriate ways of meeting requirements for submission of chemistry,
pharmacology, and statistical data that would better address the
intricate scientific issues involved. A separate proposed rule for
reporting requirements for marketed animal drugs also published on that
date. The agency intends to repropose NADA proposed rule to incorporate
some recent changes in procedure.
Timetable:
New Animal Drug Approval Process NPRM 12/17/91 (56 FR 65544) NPRM 10/
00/94
Reporting Requirements for Marketed Animal Drugs NPRM 12/17/91 (56 FR
65581) Final Action 10/00/94
Small Entities Affected: Undetermined
Government Levels Affected: None
Additional Information: For information concerning reporting
requirements for marketed animal drugs, contact William C. Keller,
Director, Division of Surveillance, Center for Veterinary Medicine,
Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855,
(301) 594-1722.
Agency Contact: Andrew J. Beaulieu, Deputy Director, Office of New
Animal Drug Evaluation, Department of Health and Human Services, Public
Health Service, Center for Veterinary Medicine (HFV-101), 7500 Standish
Place, Rockville, MD 20855, 301 594-1623
RIN: 0905-AA96
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1225. POLICIES CONCERNING USES OF SULFITING AGENTS
Significance:
Subject to OMB review: Yes
Economically significant: Undetermined
Regulatory Plan entry: Yes
Legal Authority: 21 USC 321; 21 USC 336; 21 USC 341; 21 USC 342; 21
USC 343; 21 USC 348; 21 USC 371
CFR Citation: 21 CFR 182.3616; 21 CFR 182.3637; 21 CFR 182.3739; 21
CFR 182.3766; 21 CFR 182.3798; 21 CFR 182.3862; 21 CFR 100; 21 CFR
130.9
Legal Deadline: None
Abstract: Acceptable evidence and information exist to show that a
subgroup of asthmatics is at moderate to severe risk for a severe
reaction upon exposure to sulfites. The agency's primary tool for
handling a situation where population subgroups may be at increased
risk from a food ingredient that is safe for most people is to use
labeling to inform those persons who need or want to avoid the
ingredient. The agency issued a final rule, effective January 7, 1987,
that requires that when a sulfiting agent is present in a finished food
at 10 parts per million or greater, the sulfiting agent must be
declared on the label. In addition, FDA issued a final rule, effective
August 8, 1986, prohibiting the use of sulfiting agents on raw fruits
and vegetables intended to be served or sold raw to consumers (e.g., in
salad bars). On December 10, 1987, FDA announced its tentative
conclusion that there is no longer a basis to find that the use of
sulfiting agents on ``fresh'' potatoes served or sold unpackaged to
consumers is GRAS. On December 19, 1988, FDA proposed to affirm, with
specific limitations, that certain other uses of sulfiting agents are
GRAS (cont)
Timetable:
Food Labeling; Declaration of Sulfiting Agents NPRM 04/03/85 (50 FR
13306) Final Action 07/09/86 (51 FR 25012) Effective Date 01/09/87
(51 FR 25012)
GRAS Status of the Use of Sulfiting Agents on Fresh Potatoes NPRM-To
be Merged w/Frozen Potatoes 12/10/87 (52 FR 46968) Final Action 03/15/
90 (55 FR 9826)
GRAS Status of Certain Other Food Uses of Sulfiting Agents, Etc. NPRM
12/19/88 (53 FR 51065) Final Action 10/00/94
Revoking Use of Sulfiting Agents on Fruits & Vegetables, Etc. NPRM 08/
14/85 (50 FR 32836) Final Action 07/09/86 (51 FR 25021) Final Action
Effective 08/09/86 (51 FR 25021)
Status of the Use of Sulfiting Agents on Shrimp NPRM 12/19/88 (53 FR
51065) Tentative Final Rule 09/00/94
Status of Use of Sulfit Agents on Minimally Procd & Froz Potatoes NPRM
09/00/94
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Additional Information: ABSTRACT CONT: and to establish labeling
requirements for sulfiting agents in standardized foods.
On March 15, 1990 (55 FR 9826), FDA issued a final rule prohibiting the
use of sulfiting agents on ``fresh'' potatoes (55 FR 9826) and
requested data and information concerning the use of sulfiting agents
on frozen potatoes (55 FR 9834).
On August 3, 1990, the United States District Court for the Middle
District of Pennsylvania declared the final rule concerning fresh
potatoes to be ``null and void'' based on perceived procedural defects
in the rulemaking proceeding. The Government appealed the district
court's decision. On May 22, 1991, the U.S. Court of Appeals for the
Third Circuit en banc affirmed, by an equally divided vote and without
opinion, the decision of the district court invalidating on procedural
grounds FDA's final rule revoking the GRAS status of the use of
sulfiting agents on fresh potatoes.
FDA's reproposed rule will include the GRAS status of sulfiting agents
on both minimally processed (formerly fresh) and frozen potatoes.
Agency Contact: JoAnn Ziyad, Consumer Safety Officer, Department of
Health and Human Services, Food and Drug Administration, Center for
Food Safety and Applied Nutrition (HFS-207), 200 C Street SW.,
Washington, DC 20204, 202 254-9528
RIN: 0905-AB52
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1226. INFANT FORMULA ACT
Significance:
Subject to OMB review: Yes
Regulatory Plan entry: Yes
Legal Authority: 21 USC 350a
CFR Citation: 21 CFR 107; 21 CFR 106
Legal Deadline: None
Abstract: The agency published on December 24, 1991, a final rule
implementing the Infant Formula Act of 1986. The rule establishes
infant formula record and record retention requirements. The agency is
also preparing a proposed rule that will establish current good
manufacturing practice regulations, quality control procedures, quality
factors, notification requirements and reports for the production of
infant formulas.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Final Action 12/24/91 56 FR 66566
NPRM 09/00/94
NPRM Comment Period End 11/00/94
Current Good Mfg. Practices; Qual Control Proc NPRM 05/00/94
Infant Form Cons Comp, Micro Test & Recd Retention Req NPRM 01/26/89
(54 FR 3783) NPRM (Comment Period End) 03/27/89 (54 FR 3783)
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Carolyn W. Miles, Nutritionist, Regulatory Branch,
Department of Health and Human Services, Food and Drug Administration,
Center for Food Safety and Applied Nutrition (HFS-456) 200 C Street
SW., Washington, DC 20204, 202 205-5372
RIN: 0905-AC46
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1227. IMPLEMENTATION OF TITLE I OF THE GENERIC ANIMAL DRUG AND PATENT
TERM RESTORATION ACT
Significance:
Subject to OMB review: Undetermined
Regulatory Plan entry: Yes
Legal Authority: 21 USC 360b
CFR Citation: 21 CFR 514
Legal Deadline: Final, Statutory, November 15, 1989.
Abstract: The agency proposes to amend its regulations to implement
title I of the Generic Animal Drug and Patent Term Restoration Act
which established new standards for marketing approval of generic
copies of animal drug products approved after 1962.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 10/00/94
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Lonnie W. Luther, Chief, Generic Animal Drug and
Quality Control Staff, Department of Health and Human Services, Public
Health Service, Center for Veterinary Medicine (HFV-102), 7500 Standish
Place, Rockville, MD 20855, 301 594-1623
RIN: 0905-AD15
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1228. PRESCRIPTION DRUG MARKETING ACT OF 1987; POLICY INFORMATION,
GUIDANCE, AND CLARIFICATIONS
Legal Authority: PL 100-293 Prescription Drug Marketing Act of 1987
CFR Citation: 21 CFR 203
Legal Deadline: None
Abstract: The Prescription Drug Marketing Act of 1987 (PDMA) amended
the Federal Food, Drug, and Cosmetic Act to: (1) require State
licensing of wholesale distributors of prescription human drugs under
Federal guidelines including minimum standards for storage, handling,
and recordkeeping; (2) ban the reimportation of prescription human
drugs produced in the United States, except when reimported by the
manufacturer for emergency use; (3) ban the sale, trade, or purchase of
drug samples; (4) ban trafficking in or counterfeiting of drug coupons;
(5) mandate storage, handling, and recordkeeping requirements for drug
samples; (6) require licensed practitioners to request drug samples in
writing; (7) prohibit, with certain exceptions, the resale of
prescription human drugs purchased by hospitals or health care
facilities; and (8) set forth criminal and civil penalties for
violations of these provisions. In the Federal Register of September
14, 1990 (55 FR 38012), FDA issued a final rule setting forth Federal
guidelines for State licensing of wholesale drug distributors. This
proposed rule would provide (cont)
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 04/00/94
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Additional Information: ABSTRACT CONT: information, guidance, and
clarification of those sections of PDMA that are not related to State
licensing of wholesale distributors.
Agency Contact: Philip L. Chao, Regulatory Counsel, Division of
Regulatory Affairs, Department of Health and Human Services, Food and
Drug Administration, Center for Drug Evaluation and Research, 7500
Standish Place, Rockville, MD 20855, 301 594-1049
RIN: 0905-AD44
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1229. IMPLEMENTATION OF THE SAFE MEDICAL DEVICES ACT OF 1990
Significance:
Subject to OMB review: Yes
Regulatory Plan entry: Yes
Legal Authority: PL 101-629 Safe Medical Devices Act of 1990
CFR Citation: 21 CFR 860; 21 CFR 820; 21 CFR 807; 21 CFR 803; 21 CFR
17; 21 CFR 812; 21 CFR 7; 21 CFR 814; 21 CFR 821; 21 CFR 861; 21 CFR
895
Legal Deadline:
NPRM, Statutory, August 28, 1991, for Medical Device Tracking.
Final, Statutory, November 28, 1991, for Exemption of Humanitarian
Devices, etc.
Other, Statutory, December 1, 1991, for Classification of Transitional
Devices Notice.
Final, Statutory, November 28, 1992, for Medical Device Tracking.
Abstract: The Safe Medical Devices Act of 1990 (SMDA), enacted November
28, 1990, was intended to assure marketed devices are safe and
effective, FDA learns quickly of device problems, and has authority to
remove defective devices from the market. The act directs or authorizes
FDA to develop these regulations: Medical Device Reporting--This rule
will require healthcare facilities and distributors to report deaths
and serious injuries/illnesses related to medical devices. Medical
Device Tracking--This regulation requires manufacturers to track
certain devices to the user. Classification of Transitional Devices--
FDA issued a notice to require submission of adverse safety and
effectiveness data on transitional devices. FDA will now propose to
keep each device in class III, or reclassify it in class I or II. Good
Manufacturing Practices for Medical Devices--FDA proposed to add
preproduction design validation in existing CGMP regulations. Exemption
of Humanitarian Devices--The proposed rule gives procedures for
applications for certain premarket review exemptions for humanitarian
devices. (cont)
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Final Action 00/00/00
Assignment of Agency Component for Review of Premarket Applctns Notice
(Public Hearing) 07/12/91 (56 FR 31951) Final Action 11/21/91 (56 FR
31951)
Civil Money Penalties NPRM 05/26/93 (58 FR 30680) Final Action 06/00/
94
Classification of Transitional Devices Notice 11/14/91 (56 FR
57960) Notice(Extension of Comment Period) 03/10/92 (57 FR
8462) Notice (Extension of Deadline) 11/30/92 (57 FR 56586) Notice
(Extension of Deadline) 11/30/92 (57 FR 56586) Final Rule (Contact
Lenses) 03/04/94 (59 FR 10283)
CGMPs for Medical Devices ANPRM (Revisions;Request for Cmnts) 06/15/90
(55 FR 24544) ANPRM (Suggested Changes;Availblty) 11/30/90 (55 FR
49644) ANPRM (Extension of Comment Period) 02/14/91 (56 FR
5965) Notice (Open Public Advsy Cmte Mtg) 04/17/91 (56 FR
15626) Final Action 11/23/93 (58 FR 61952)
Exemption of Humanitarian Devices NPRM 12/21/92 (57 FR 60491) Final
Action 07/00/94
Medical Device Reporting Notice (Public Conf.;Rqst for Info) 03/28/91
(56 FR 12934) NPRM 11/26/91 (56 FR 60024) Final Rule (Distributor
Reporting) 09/01/93 (58 FR 46514) Final Action 05/00/94
Medical Device Tracking NPRM 03/27/92 (57 FR 10702) NPRM 05/29/92 (57
FR 22971) Final Action 05/29/92 (57 FR 22966) Final Action (Not.
Stat. Eff. Date 08/16/93 (58 FR 43442)
Miscellaneous Procedural Changes in Medical Device Regulations Final
Action 12/10/92 (57 FR 58400)
Pre-Amendment Class III Devices Notice 04/00/94
Recall of Medical Devices NPRM 04/00/94
Reports of Removals and Corrections of Medical Devices NPRM 03/23/94
(59 FR 13828)
Safe Medical Devices Act of 1990; Implementation Plans Notice 04/05/91
(56 FR 14111)
Summaries of Safety & Effectiveness for Premarket Notification Final
Action 04/28/92 (57 FR 18062) Notice (Stay of Effective Date) 06/01/92
(57 FR 23059) Final Action 04/00/94
Temporary Suspension of a Premarket Approval Application NPRM 10/12/93
(58 FR 52729) Final Action 00/00/00
Small Entities Affected: Businesses
Government Levels Affected: Undetermined
Additional Information: ABSTRACT CONT: Summaries of Safety and
Effectiveness for Premarket Notification--A final rule will set forth
information to be included in data summaries on which substantial
equivalence determinations are made. Recall of Medical Devices--FDA
will propose procedures for using its authority to order device recalls
and notifications. Reports of Removal and Corrections--FDA will propose
procedures for manufacturers to report to FDA health-related market
removals and corrections of devices. Civil Penalties--FDA proposed
regulations to establish procedures for a hearing to which persons are
entitled before the imposition of civil penalties. Procedural Changes
in Medical Device Regulations--This final rule made revisions in
regulations necessary because of procedural changes made by the SMDA.
Premarket Review of Combination Products--FDA published a final rule
establishing procedures for determining which FDA center will review
premarket approval applications for products that are a combination of
a device and a drug or biologic.
Agency Contact: Joseph M. Sheehan, Department of Health and Human
Services, Food and Drug Administration, Center for Devices and
Radiological Health, 2098 Gaither Road, Rockville, MD 20850, 301 594-
4765
RIN: 0905-AD59
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1230. REPORTING OF ERRORS AND ACCIDENTS RELATING TO BLOOD SAFETY AND
WITHDRAWAL OF PREVIOUSLY PROPOSED RULE
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC
355; 21 USC 360; 21 USC 360i; 21 USC 371; 21 USC 374; 42 USC 216; 42
USC 262 to 264
CFR Citation: 21 CFR 600; 21 CFR 606
Legal Deadline: None
Abstract: All licensed blood establishments are required to notify FDA
promptly of errors or accidents in the manufacture of products that may
effect the safety, purity, or potency of any biological product (21 CFR
600.14). The reporting of certain errors or accidents occurring in the
manufacture of blood and blood components is necessary so that FDA can
respond where the public health may be endangered and provide added
assurance as to the continued safety, identity, quality, purported
quality, and purity of blood and blood components. FDA has determined
that errors and accidents that are detected and corrected before a
finished unit is removed from the unprocessed inventory and made
available for release and distribution do not affect the safety of the
blood supply and need not be reported to the agency. The proposed rule
would require licensed establishments, unlicensed establishments, and
transfusion services to report and keep records. The cost to licensed
establishments would be minimal. (cont)
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 02/00/95
NPRM Comment Period End 06/00/95
Small Entities Affected: Businesses, Organizations
Government Levels Affected: None
Procurement: This is a procurement-related action for which there is no
statutory requirement. There is a paperwork burden associated with this
action.
Additional Information: ABSTRACT CONT: Since they already are required
to report, licensed establishments would only have to make some changes
in standard operating procedures. Unlicensed establishments are already
required to keep records and conduct investigations. Under the proposed
rule they would have to establish reporting procedures and report to
FDA. The transfusion services would have to assure their recordkeeping
and investigation procedures are sufficient and establish reporting
procedures. Reporting by transfusions services is expected to be
minimal.
Agency Contact: Jean M. Olson, Regulatory Counsel, Department of Health
and Human Services, Food and Drug Administration, Center for Biologics
Evaluation and Research (HFM-635), 1401 Rockville Pike, Suite 200N,
Rockville, MD 20852-1448, 301 594-3074
RIN: 0905-AD67
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1231. PROPOSED LABELING FOR DRUG PRODUCTS BASED ON FALSE OR FRAUDULENT
DATA
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355
to 358; 21 USC 360 to 360b; 21 USC 371; 21 USC 374; 21 USC 376; 42 USC
216; 42 USC 241; 42 USC 262; 42 USC 263b to 263n; 42 USC 264
CFR Citation: 21 CFR 201
Legal Deadline: None
Abstract: The agency proposes to revise its regulations pertaining to
human drug product labeling. The proposed revisions would subject drug
products whose labeling was based in whole or in part on false or
fraudulent data or information to the statutory requirements in
sections 502(f) (1) of the Federal Food, Drug, and Cosmetic Act. The
proposal would also interpret the term ``false or fraudulent
labeling.''
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 04/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Philip L. Chao, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Division of
Regulatory Affairs, Center for Drug Evaluation and Research (HFD-362),
301 594-1049
RIN: 0905-AD71
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1232. REVIEW OF WARNINGS, USE INSTRUCTIONS, AND PRECAUTIONARY INFORMATION
UNDER SECTION 314 OF THE NATIONAL CHILDHOOD VACCINE INJURY ACT OF 1986
Legal Authority: PL 99-660, sec 314
CFR Citation: Not applicable
Legal Deadline: Final, Statutory, June 22, 1989.
Abstract: Section 314 of the National Childhood Vaccine Injury Act of
1986 mandated that the warnings, use instructions, and precautionary
information of specified childhood vaccines be reviewed and that their
adequacy in warning health care professionals of the nature and extent
of dangers posed by such vaccines be determined. This precautionary
information is contained in the package insert of each vaccine licensed
by the agency. FDA held a public meeting to receive public comment on
the adequacy of these package inserts.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Notice of Public Meeting; Public
Comment on Package Inserts 07/31/92 57 FR 33915
NPRM 11/00/94
Small Entities Affected: None
Government Levels Affected: State
Additional Information: A public meeting was held on 9/18/92 on Section
314 Labeling Review. Presentations were made by FDA, CDC,
manufacturers, parents groups, and the public on the adequacy of the
current labeling.
Agency Contact: Tracey Forfa, Regulatory Counsel, Department of Health
and Human Services, Food and Drug Administration, Center for Biologics
Evaluation and Research, 1401 Rockville Pike, Suite 200N (HFM-635),
Rockville, MD 20852-1448, 301 594-3074
RIN: 0905-AD72
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1233. MEDICAL DEVICES; INFANT APNEA MONITOR; DEVELOPMENT OF MANDATORY
STANDARD
Legal Authority: 21 USC 360d
CFR Citation: 21 CFR 800
Legal Deadline: None
Abstract: FDA is proposing a mandatory standard for infant apnea
monitors which are intended for use on infants to detect cessation of
breathing. The standard includes requirements for infant apnea monitors
in four areas: Patient monitoring, electrical, mechanical and
environmental, and labeling. FDA considered reliance upon voluntary
standards to address risks presented by these devices but determined
that a mandatory standard is necessary.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
ANPRM 07/08/83 48 FR 31392
NPRM 04/00/94
Small Entities Affected: Businesses
Government Levels Affected: Undetermined
Agency Contact: James J. McCue, Jr., Chief, Operations Staff,
Department of Health and Human Services, Food and Drug Administration,
Center for Devices and Radiological Health, (HFZ-84), 2098 Gaither Rd.
Rockville, MD 20850, 301 594-4765
RIN: 0905-AD83
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1234. MAMMOGRAPHY QUALITY STANDARDS ACT OF 1992
Significance:
Subject to OMB review: Undetermined
Legal Authority: PL 102-539 Mammography Quality Standards Act of 1992
CFR Citation: 21 CFR 900
Legal Deadline: Final, Statutory, July 27, 1993.
Standards for accreditation bodies are required by July 27, 1993.
Abstract: The purpose of the Mammography Quality Standards Act of 1992,
enacted October 27, 1992, is to assure quality in all aspects of the
practice of mammography. The primary mechanism for this is oversight of
all mammography facilities through a certification and inspection
program. Only facilities certified by the Secretary will be permitted
to produce, process, or interpret mammographic images. The statute also
requires the establishment of an advisory committee to set regulatory
quality standards and also provides for the establishment of
surveillance systems to evaluate breast cancer screening programs.
Regulations are required in several areas: Issuance and denial of
certificates; standards for accreditation bodies; approval or
withdrawal of approval of accreditation bodies; quality standards for
facilities; certification of personnel, an inspection program, a user
fee program, and an enforcement program. The statute mandates other
activities for which regulations may also be necessary, although not
specifically required.
Timetable:
Accrediting Bodies and Quality Standards Reproposal 01/00/95
Approval of Accrediting Bodies Interim Final 12/21/93 (58 FR 67558)
Quality Standards for Mammography Facilities Interim Final 12/21/93
(58 FR 67565)
Small Entities Affected: Businesses, Governmental Jurisdictions
Government Levels Affected: State, Federal
Agency Contact: Richard E. Gross, Office of Health and Industry
Programs, Department of Health and Human Services, Food and Drug
Administration, HFZ-200, 1901 Chapman Ave., Rockville, MD 20857, 301
443-4600
RIN: 0905-AE19
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1235. ADVERSE EXPERIENCE REPORTING REQUIREMENTS FOR HUMAN DRUG
AND LICENSED BIOLOGICAL PRODUCTS
Significance:
Subject to OMB review: Yes
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21
USC 353; 21 USC 355; 21 USC 356; 21 USC 357; 21 USC 371; 21 USC 374; 21
USC 216; 21 USC 262; 21 USC 263; 21 USC 263a; 21 USC 264
CFR Citation: 21 CFR 20; 21 CFR 310; 21 CFR 312; 21 CFR 314; 21 CFR
600
Legal Deadline: None
Abstract: The agency proposes to amend its adverse experience reporting
regulations for human drug products and licensed biological products to
make the requirements consistent with a new single unified form (FDA
Form 3500A) and require the use of this new reporting form. The new
form was announced as part of FDA's MedWatch program. The proposed
regulations would also revise certain definitions and reporting periods
and formats as recommended by the International Conference on
Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH) and the World Health Organization's
Council for International Organizations of Medical Sciences (CIOMS). In
addition, the proposal would amend the regulations governing the design
of, and the analysis and reporting of data from, clinical studies.
These proposed amendments are intended to provide more complete and
accurate information that would enable sponsors, investigators, and FDA
to determine early on the toxicity of investigational drugs during
clinical studies.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 05/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Howard P. Muller, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Division of
Regulatory Affairs, Center for Drug Evaluation and Research (HFD-362),
301 594-1049
RIN: 0905-AE29
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1236. ELECTRONIC SIGNATURES
Significance:
Subject to OMB review: Undetermined
Legal Authority: 21 USC 301 et seq; 21 USC 201 et seq
CFR Citation: 21 CFR 11
Legal Deadline: None
Abstract: FDA is proposing regulations to set forth criteria for agency
acceptance of electronic records and electronic signatures in lieu of
paper records and handwritten signatures. The new rules would apply to
any records requirements in Chapter I of Title 21 (all program areas
and industries), unless specifically exempted by future regulations.
For documents required to be maintained, but not submitted to FDA,
persons could use electronic records and signatures upon the effective
date of a final rule. For documents submitted to FDA, persons could use
electronic records and signatures if FDA has stated, in a public docket
to be maintained for that purpose, that the intended receiving
organization is prepared to accept the submission in electronic form.
(The proposed rule does not require use of electronic records and
signatures, but permits their use under certain circumstances.) This
action is being taken as a follow-up to the agency's 7/21/92 advance
notice of proposed rulemaking. The intended effect is to permit and
foster use of new technologies in a manner that is consistent with
FDA's overall mission and that preserves the integrity of the agency's
enforcement
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
ANPRM 07/21/92 57 FR 32185
ANPRM Comment Period End 10/19/92 57 FR 32185
NPRM 06/00/94
Small Entities Affected: Businesses, Governmental Jurisdictions
Government Levels Affected: Federal
Additional Information: activities.
Agency Contact: Paul J. Motise, Department of Health and Human
Services, Food and Drug Administration, Center for Drug Evaluation and
Research, 7500 Standish Place (HFD-323), Rockville, MD 20855, 301 594-
1089
RIN: 0905-AE31
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1237. FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
Significance:
Subject to OMB review: Yes
Economically significant: Undetermined
Regulatory Plan entry: Undetermined
Legal Authority: 42 USC 262; 21 USC 321; 21 USC 331; 21 USC 351; 21
USC 352; 21 USC 353; 21 USC 355; 21 USC 356; 21 USC 357; 21 USC 360; 21
USC 371; 21 USC 372; 21 USC 373; 21 USC 374; 21 USC 375
CFR Citation: 21 CFR 54; 21 CFR 312.53; 21 CFR 312.57; 21 CFR 312.64;
21 CFR 314.50; 21 CFR 314.60; 21 CFR 314.94; 21 CFR 314.200; 21 CFR
314.300; 21 CFR 320.36; 21 CFR 330.10; 21 CFR 601.2; 21 CFR 807.31; 21
CFR 807.87; 21 CFR 807.100
Legal Deadline: None
Abstract: This proposed regulation addresses the problem of certain
financial arrangements and interests of clinical investigators that
have the potential to bias the outcome of clinical trials. The problem
is significant because clinical research data provide the basis for
FDA's evaluation of drugs, biologics and devices for marketing. The
regulation requires the sponsor of a product that is the subject of a
marketing application to submit either a statement certifying that the
clinical investigator is not a party to any problematic financial
interests and arrangements or a statement disclosing problematic
interests and arrangements to which the investigator is a party. This
information would enable FDA to subject the relevant clinical research
data to an appropriate level of scrutiny to test its reliability.
Alternatives are to prohibit investigators from holding certain
financial interests altogether or to require divestiture by the
investigator of a prohibited interest. The estimated costs to industry
associated with preparation, submission, and retention of the
information required by this proposed rule are well below the $100
million threshold that defines a significant (cont)
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 04/00/94
NPRM Comment Period End 07/00/94
Final Action 10/00/95
Small Entities Affected: None
Government Levels Affected: None
Additional Information: ABSTRACT CONT: regulatory action. The proposed
rule is not expected to impose a significant resource burden on FDA
because the submission of statements is limited to clinical data
submitted in support of marketing applications, ruling out data from
the large number of studies that do not lead to applications, and FDA
estimates that sponsors will be able to certify for the majority of
their clinical investigators, so that most submitted data will not
require intensified scrutiny. The proposed rule will strengthen the FDA
review process.
Agency Contact: John S. Ensign, Office of Health Affairs (HFY-20),
Department of Health and Human Services, Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20857, 301 443-1382
RIN: 0905-AE32
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1238. EFFECTIVE DATE OF REQUIREMENT FOR SUBMISSION OF PREMARKET
APPROVAL APPLICATIONS
Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined
Regulatory Plan entry: Undetermined
Legal Authority: 21 USC 360e
CFR Citation: 21 CFR 868; 21 CFR 870; 21 CFR 872; 21 CFR 878; 21 CFR
882; 21 CFR 888
Legal Deadline: Final, Statutory, December 1, 1995.
Abstract: Class III devices which were on the market before 1976 were
exempt from premarket approval until FDA issues a rule requiring the
submission of premarket approval applications. The Safe Medical Devices
Act of 1990 directed FDA to Review the classification of pre-1976 Class
III devices and require premarket approval for those devices remaining
in Class III. There are approximately 125 pre-1976 Class III devices
not yet addressed. The devices covered by this proposal are devices
which FDA believes may no longer be commercially viable. FDA is
providing an opportunity for manufacturers to petition for
reclassification before premarket approval is required.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/00/94
Small Entities Affected: Undetermined
Government Levels Affected: None
Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department
of Health and Human Services, Food and Drug Administration, CDRH (HFZ-
84), 2098 Gaither Road, Rockville, MD 20857, 301 594-4765
RIN: 0905-AE34
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1239. LATEX CONDOMS/GLOVES: EXPIRATION DATE LABELING
Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined
Regulatory Plan entry: Undetermined
Legal Authority: 21 USC 351; 21 USC 352
CFR Citation: 21 CFR 801
Legal Deadline: None
Abstract: Latex patient examination and surgeon gloves and latex
condoms are used as a barrier to transmission of diseases through
bodily fluids, including AIDS. Latex deteriorates over time, reducing
its utility as a barrier. The proposed rule would require manufacturers
of these products to perform testing to establish an appropriate
expiration date for their product and to place that date on their
labeling.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 04/00/94
Small Entities Affected: Undetermined
Government Levels Affected: None
Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department
of Health and Human Services, Food and Drug Administration, CDRH (HFZ-
84), 2098 Gaither Road, Rockville, MD 20850, 301 594-4765
RIN: 0905-AE37
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1240. AMALGAM INGREDIENT LABELING
Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined
Regulatory Plan entry: Undetermined
Legal Authority: 21 USC 352
CFR Citation: 21 CFR 801
Legal Deadline: None
Abstract: Certain dental amalgams may contain ingredients which may
cause some persons severe adverse reactions. Therefore, FDA would
propose that labeling for dental amalgams must include the ingredients
so that health professionals may choose the appropriate amalgam for the
patient.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 07/00/94
Small Entities Affected: Undetermined
Government Levels Affected: None
Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department
of Health and Human Services, Food and Drug Administration, CDRH (HFZ-
84), 2098 Gaither Road, Rockville, MD 20850, 301 594-4765
RIN: 0905-AE39
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1241. LATEX WARNING
Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined
Regulatory Plan entry: Undetermined
Legal Authority: 21 USC 352
CFR Citation: 21 CFR 801
Legal Deadline: None
Abstract: Certain persons may be subject to severe adverse reaction
upon contact with latex. Therefore, FDA would propose to require that
devices containing latex have a warning in the labeling concerning the
presence of latex and the potential risk. This will enable health
professionals and consumers to make an informed choice concerning the
use of a device.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/00/94
Small Entities Affected: Undetermined
Government Levels Affected: None
Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department
of Health and Human Services, Food and Drug Administration, (HFZ-84),
2098 Gaither Road, Rockville, MD 20850, 301 594-4765
RIN: 0905-AE40
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1242. PREMARKET APPROVAL APPLICATIONS: SUPPLEMENTS
Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined
Regulatory Plan entry: Undetermined
Legal Authority: 21 USC 360e
CFR Citation: 21 CFR 814.39
Legal Deadline: None
Abstract: FDA has become aware of several situations in which a
supplement to an approved premarket for a change in a device approval
application (PMA) was not submitted even though FDA believed that a
supplement. Therefore, FDA would propose to revise its regulation to
clarify when a supplement is required. This would result in fewer
unapproved changes in devices.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/00/94
Small Entities Affected: Undetermined
Government Levels Affected: None
Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department
of Health and Human Services, Food and Drug Administration, CDRH (HFZ-
84), 2098 Gaither Road, Rockville, MD 20850, 301 594-4765
RIN: 0905-AE41
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1243. RESTRICTED DEVICES
Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined
Regulatory Plan entry: Undetermined
Legal Authority: 21 USC 351; 21 USC 360j(e)
CFR Citation: 21 CFR 801; 21 CFR 899
Legal Deadline: None
Abstract: The proposal would designate certain categories of devices as
``restricted devices.'' Restricted devices are defined by the statute
as devices that must be restricted in their sale, distribution or use
because of their potential for harmful effect or collateral measures
necessary to their use. FDA would propose to include in this category
devices such as those that pierce or penetrate the skin, implantable
devices, devices that introduce medicinal gas or energy into the body
and devices that are used for diagnosis that must be interpreted or
analyzed by a qualified health professional. Restricted devices are
subject to certain limitations on distribution and to special labeling
requirements. FDA also may regulate the advertising of restricted
devices.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 05/00/94
Small Entities Affected: Undetermined
Government Levels Affected: None
Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department
of Health and Human Services, Food and Drug Administration, CDRH (HFZ-
84), 2098 Gaither Road, Rockville, MD 20850, 301 594-4765
RIN: 0905-AE42
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1244. PRESCRIPTION DRUG PRODUCT LABELING; MEDICATION GUIDE
Significance:
Subject to OMB review: Yes
Economically significant: Yes
Regulatory Plan entry: Undetermined
Legal Authority: 21 USC 321; 21 USC 352; 21 USC 371; 21 USC 355; 42
USC 262
CFR Citation: 21 CFR 201; 21 CFR 208; 21 CFR 314; 21 CFR 600
Legal Deadline: None
Abstract: This proposed rule would require that labeling, written in
nontechnical language and directed at patients, be dispensed with
prescription drug and biological products that are primarily used on an
out-patient basis without the direct supervision of a health care
professional. The patient labeling would inform the patient about the
product and would include such information as the product's approved
uses, contraindications, proper administration, adverse drug reactions
and cautions for specific populations. The proposed rule would require
manufacturers and/or distributors of these products to prepare patient
labeling, and would require dispensers to provide the patient labeling
to each patient or agent of the patient receiving a covered product.
FDA is proposing this rule to promote the safe and effective use of
prescription drug products by patients and to ensure that patients have
the opportunity to be informed of a drug product's risks and benefits.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: Businesses
Government Levels Affected: State, Federal
Agency Contact: Louis A. Morris, Chief, Marketing Practices &
Communication Branch, (HFD-240), Department of Health and Human
Services, Public Health Service, 5600 Fishers Lane, Rockville, MD
20857, 301 594-6818
RIN: 0905-AE43
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1245. SUBSTANCES PROHIBITED FOR USE IN RUMINANT FEED
Significance:
Regulatory Plan entry: Undetermined
Legal Authority: 21 USC 321; 21 USC 342; 21 USC 348; 21 USC 371
CFR Citation: 21 CFR 589.2000
Legal Deadline: None
Abstract: The Food and Drug Administration is considering a proposal to
ban the feeding of certain materials to ruminants. Epidemiological
evidence developed in the United Kingdom suggests increased vigilance
and precautionary practices are necessary to assure that Bovine
Spongiform Encephalopathy (BSE) is not introduced among cattle herds in
the United States. This same evidence has suggested that the feeding of
certain animal derived materials caused the BSE epidemic in the United
Kingdom.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 04/00/94
NPRM Comment Period End 07/00/94
Final Action 12/00/94
Small Entities Affected: Undetermined
Government Levels Affected: None
Agency Contact: John P. Honstead, Veterinary Medical Officer,
Department of Health and Human Services, Food and Drug Administration,
Center for Veterinary Medicine, (HFV-222), 7500 Standish Place,
Rockville, MD 20855, 301 594-1728
RIN: 0905-AE45
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1246. HEARING AIDS; PROFESSIONAL AND PATIENT LABELING;
CONDITIONS FOR SALE
Significance:
Subject to OMB review: Yes
Economically significant: Undetermined
Regulatory Plan entry: Undetermined
Legal Authority: 21 USC 351; 21 USC 352; 21 USC 360d; 21 USC 371; 21
USC 360j(e)
CFR Citation: 21 CFR 801.420; 21 CFR 801.421
Legal Deadline: None
Abstract: FDA is considering revising its present regulation governing
the labeling and conditions for sale of hearing aids. The present rule
requires an examination by a physician before purchase of a hearing
aid, but permits an informed adult to waive that requirement. There is
some evidence that this waiver provision is being misused. FDA is
reconsidering which types of health professionals are competent to
perform hearing evaluations. FDA is also considering revisions to its
professional and patient labeling to require updated information.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
ANPRM 11/10/93 58 FR 59695
ANPRM Comment Period End 01/10/94 58 FR 59695
NPRM 06/00/94
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department
of Health and Human Services, Public Health Service, CDRH (HFZ-84),
2098 Gaither Road, Rockville, MD 20850, 301 594-4765
RIN: 0905-AE46
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1247. OVER-THE-COUNTER (OTC) DRUG REVIEW
Significance:
Subject to OMB review: Undetermined
Legal Authority: 21 USC 321p; 21 USC 351; 21 USC 352; 21 USC 353; 21
USC 355; 21 USC 360a; 21 USC 371a
CFR Citation: 21 CFR 310; 21 CFR 330; 21 CFR 333; 21 CFR 334; 21 CFR
335; 21 CFR 336; 21 CFR 337; 21 CFR 338; 21 CFR 339; 21 CFR 340; 21 CFR
341; 21 CFR 342; 21 CFR 343; 21 CFR 344; 21 CFR 345; ...
Legal Deadline: None
Abstract: The OTC drug review establishes conditions under which OTC
drugs are considered generally recognized as safe and effective and not
misbranded. After a final monograph (i.e., final rule) is issued, only
OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. NOTE: NPRM for
``Antidotes, Toxic Ingestion Products'' was combined with NPRM for
``Emetic Products'' and reproposed as ``Poison Treatment Products.''
NPRM for ``Astringent (Wet Dressings) Products'' was included in the
NPRM for ``Skin Protectant Products.'' NPRM for ``Diaper Rash
Products'' was included in NPRMs for ``Antifungal,'' ``Antimicrobial,''
``External Analgesic'' and ``Skin Protectant Products.'' NPRM for
``Fever Blister/Cold Sore Products (External)'' was included in NPRMs
for ``External Analgesic'' and ``Skin Protectant Products.'' NPRM for
``Insect Bites and Stings (Relief) Products'' was included in NPRMs for
``External Analgesic'' and ``Skin Protectant Products.'' ``Poison Ivy/
Oak/Sumac Prevention'' was included in NPRMs for ``External Analgesic''
and ``Skin Protectant Products.'' NPRM for ``Mercurial (Topical)
Products'' to be included in revised NPRM (cont)
Timetable:
Acne (Topical) Products ANPRM 03/23/82 (47 FR 12430) NPRM 01/15/85
(50 FR 2172) NPRM (Amendment) 08/07/91 (56 FR 37622) Final Action 08/
16/91 (56 FR 41008)
Alcohol (Oral) in OTC Drug Products NPRM 10/21/93 (58 FR 54466)
Alcohol (Topical) Products (To be merged w/other rulemkg) ANPRM 05/21/
82 (47 FR 22324)
Anorectal Products ANPRM 05/27/80 (45 FR 35576) NPRM 08/15/88 (53 FR
30756) Final Action 08/03/90 (55 FR 31776) Final Action (LYCD) 09/02/
93 (58 FR 46746) Final Action (Witch Hazel) 07/00/94
Antacid Drug Products ANPRM 04/05/73 (38 FR 8714) NPRM 11/12/73 (38
FR 31260) Final Action 06/04/74 (39 FR 9862) NPRM (Amendment)
(Overindulgence) 12/24/91 (56 FR 66754) Final Action (Amendment)
(Warning) 08/26/93 (58 FR 45204) NPRM (Amendment) (Testing) 09/23/93
(58 FR 49826) NPRM (Amendment)(Sodium Bicarb.) 02/02/94 (59 FR 5060)
Anthelmintic Products ANPRM 09/09/80 (45 FR 59541) NPRM 08/24/82 (47
FR 37062) Final Action 08/01/86 (51 FR 27756)
Antibiotic First Aid Products ANPRM 04/01/77 (42 FR 17642) NPRM 07/
09/82 (47 FR 29986) Final Action 12/11/87 (52 FR 47312) NPRM
(Amendment) 08/18/89 (54 FR 34188) Final Action 03/15/90 (55 FR
9721) NPRM (Amendment) 05/11/90 (55 FR 19868) NPRM (Amendment) 06/08/
90 (55 FR 23450) Final Action (Amendment) 10/03/90 (55 FR
40379) Final Action (Amendment) 12/05/90 (55 FR 50171)
Anticaries Products ANPRM 03/28/80 (45 FR 20666) NPRM 09/30/85 (50 FR
39854) NPRM 06/15/88 (53 FR 22430) Final Action 09/00/94
Antidiarrheal Products ANPRM 03/21/75 (40 FR 12924) NPRM 04/30/86 (51
FR 16138) Final Action 09/00/94
Antidotes, Toxic Ingestion Prdts (Now Poison Treatment Prdts) ANPRM
01/05/82 (47 FR 444)
Antiemetic Products ANPRM 03/21/75 (40 FR 12934) NPRM 07/13/79 (44 FR
41064) Final Action 04/30/87 (52 FR 15886) NPRM (Amendment) 08/26/93
(58 FR 45216) Final Action 04/00/94
Antiflatulent Drug Products NPRM 11/12/73 (38 FR 31260) Final Action
06/04/74 (39 FR 19877) NPRM (Amendment) 01/29/88 (53 FR 2716)
Antifungal (Topical) Products ANPRM 03/23/82 (47 FR 12480) NPRM 12/
12/89 (54 FR 51136) NPRM (Amendment) (Diaper Rash) 06/20/90 (55 FR
25240) Final Action (Amdt.)(Diaper Rash) 12/18/92 (57 FR 60430) Final
Action (Partial) 09/02/93 (58 FR 46744) Final Action 09/23/93 (58 FR
49890)
Antimicrobial Products ANPRM 09/13/74 (39 FR 33103) NPRM 01/06/78 (43
FR 1210) NPRM (Amendment) (Diaper Rash) 06/20/90 (55 FR 25246)
Antiperspirant Products ANPRM 10/10/78 (43 FR 46694) NPRM 08/20/82
(47 FR 36492) Final Action 00/00/00
Antiseptic First Aid ANPRM 09/13/74 (39 FR 33103) NPRM 01/06/78 (43
FR 1210) NPRM (Revised) 07/22/91 (56 FR 33644) Final Action 00/00/00
Antiseptic Products (Professional Use) ANPRM 09/13/74 (39 FR
33103) NPRM 01/06/78 (43 FR 1210) NPRM (Revised) 09/00/94
Aphrodisiac Products ANPRM 10/01/82 (47 FR 43572) NPRM 01/15/85 (50
FR 2168) Final Action 07/07/89 (54 FR 28780)
Aspirin (Heart Labeling) NPRM 10/20/93 (58 FR 54224)
Aspirin (Reye Syndrome) NPRM 10/20/93 (58 FR 54228)
Astringent (Wet Dressings) Prdts (Merged w/other rulemkg) ANPRM 09/07/
82 (47 FR 39436)
Benign Prostatic Hypertrophy Products ANPRM 10/01/82 (47 FR
43566) NPRM 02/20/87 (52 FR 5406) Final Action 02/27/90 (55 FR 6926)
Boil Ointments ANPRM 06/29/82 (47 FR 28306) NPRM 01/26/88 (53 FR
2198) Published 11/15/93 (58 FR 60332)
Camphorated Oil Drug Products ANPRM 09/26/80 (45 FR 63869) Final
Action 09/21/82 (47 FR 41716)
Cholecystokinetic Products ANPRM 02/12/80 (45 FR 9286) NPRM 08/24/82
(47 FR 37068) Final Action 06/10/83 (48 FR 27004) NPRM (Amendment)
08/15/88 (53 FR 30786) Final Action (Amendment) 02/28/89 (54 FR 8320)
Corn and Callus Remover Products ANPRM 01/05/82 (47 FR 522) NPRM 02/
20/87 (52 FR 5412) Final Action 08/14/90 (55 FR 33258)
Cough/Cold (Anticholinergic) Products ANPRM 09/09/76 (41 FR
38312) NPRM 07/09/82 (47 FR 30002) Final Action 11/08/85 (50 FR
46582)
Cough/Cold (Antihistamine) Products ANPRM 09/09/76 (41 FR 38312) NPRM
01/15/85 (50 FR 2200) NPRM (Amendment) 08/24/87 (52 FR 31892) Final
Action 12/09/92 (57 FR 58356) Final Action (Amendment)(Warning) 01/28/
94 (59 FR 4216)
Cough/Cold (Antitussive) Products ANPRM 09/09/76 (41 FR 38312) NPRM
10/19/83 (48 FR 48576) Final Action 08/12/87 (52 FR 30042) NPRM
(Amendment) 07/06/89 (54 FR 28442) NPRM (Amendment) 10/02/89 (54 FR
40412) Final Action (Amendment) 07/06/90 (55 FR 27806) Final Action
(Amendment) 10/03/90 (55 FR 40381) NPRM (Amendment)(Warning) 06/19/92
(57 FR 27666) NPRM (Amendment)(Ingredients) 12/09/92 (57 FR
58378) Final Action (Amendment)(Warning) 10/20/93 (58 FR 54232) Final
Action (Amdt.)(Ingredients) 08/00/94
Cough/Cold (Bronchodilator) Products ANPRM 09/09/76 (41 FR
38312) NPRM 10/26/82 (47 FR 47520) Final Action 10/02/86 (51 FR
35326) NPRM (Amendment)(Warning) 06/19/92 (57 FR 27662) Final Action
(Amendment)(Warning) 10/20/93 (58 FR 54238)
Cough/Cold (Combination) Products ANPRM 09/09/76 (41 FR 38312) NPRM
08/12/88 (53 FR 30522) Final Action 00/00/00
Cough/Cold (Expectorant) Products ANPRM 09/09/76 (41 FR 38312) NPRM
07/09/82 (47 FR 30002) Final Action 02/28/89 (54 FR 8494) Final
Action (Technical Changes) 06/30/92 (57 FR 29176)
Cough/Cold (Expectorant/Ipecac) Products Final Action 09/14/92 (57 FR
41857)
Cough/Cold (Nasal Decongestant) Products ANPRM 09/09/76 (41 FR
38312) NPRM 01/15/85 (50 FR 2220) NPRM (Amendment) 06/19/92 (57 FR
27658) Final Action 09/00/94
Dandruff, Seborrheic Dermatitis and Psoriasis Control Products ANPRM
12/03/82 (47 FR 54646) NPRM 07/30/86 (51 FR 27346) Final Action 12/
04/91 (56 FR 63554) NPRM (Amendment) 04/05/93 (58 FR 17554) Final
Action 01/28/94 (59 FR 4000)
Daytime Sedatives ANPRM 12/08/75 (40 FR 57292) NPRM 06/13/78 (43 FR
25544) Final Action 06/22/79 (44 FR 36378)
Diaper Rash Products (Merged w/other rulemkg) ANPRM 09/07/82 (47 FR
39406)
Digestive Aid Products ANPRM 01/05/82 (47 FR 454) NPRM 01/29/88 (53
FR 2706) Final Action 10/21/93 (58 FR 54450)
Emetic Products ANPRM 03/21/75 (40 FR 12939) NPRM 09/05/78 (43 FR
39544)
Exocrine Pancreatic Insufficiency Products ANPRM 12/21/79 (44 FR
75666) NPRM 11/08/85 (50 FR 46594) NPRM (Reproposed) 07/15/91 (56 FR
32282) Final Action 00/00/00
External Analgesic Products ANPRM 12/04/79 (44 FR 69768) NPRM 02/08/
83 (48 FR 5852) NPRM (Amendment) (Dandruff) 07/30/86 (51 FR
27360) NPRM (Amendment) (Anorectal) 08/25/88 (53 FR 32592) NPRM
(Amendment) (Poison Ivy) 10/03/89 (54 FR 40818) NPRM (Amendment) (Fvr
Blister/Ext) 01/31/90 (55 FR 3370) NPRM (Amendment) (1%Hydrocortisone)
02/27/90 (55 FR 6932) NPRM (Amendment) (Diaper Rash) 06/20/90 (55 FR
25234) Final Action (Diaper Rash) 12/18/92 (57 FR 60426) Final Action
00/00/00
Fever Blister Products (Internal) ANPRM 01/05/82 (47 FR 502) NPRM 06/
17/85 (50 FR 25156) Final Action 06/30/92 (57 FR 29166)
Fvr Blister/Cold Sore Prdts (Ext.) (To be merged w/other
rulemkg) ANPRM 09/07/82 (47 FR 39436)
Hair Grower and Hair Loss Prevention Products ANPRM 11/07/80 (45 FR
73955) NPRM 01/15/85 (50 FR 2190) Final Action 07/07/89 (54 FR 28772)
Hormone (Topical) Products ANPRM 01/05/82 (47 FR 430) NPRM 10/02/89
(54 FR 40618) Final Action 09/09/93 (58 FR 57608)
Hypo/Hyperphosphatemia Products ANPRM 12/09/80 (45 FR 81154) NPRM 01/
15/85 (50 FR 2160) Final Action 05/11/90 (55 FR 19852)
Ingrown Toenail Relief Products ANPRM 10/17/80 (45 FR 69128) NPRM 09/
03/82 (47 FR 39120) Final Action 09/09/93 (58 FR 47602)
Insect Bite & Sting (Relief) Prdts (Merged w/other rulemkg) ANPRM 09/
07/82 (47 FR 39412)
Insect Repellent Drug Products (Internal) ANPRM 01/05/82 (47 FR
424) NPRM 06/10/83 (48 FR 26986) Final Action 06/17/85 (50 FR 25170)
Internal Analgesic Products ANPRM 07/08/77 (42 FR 35346) NPRM 11/16/
88 (53 FR 46204) NPRM (Amendment) (Overindulgence) 12/24/91 (56 FR
66762) NPRM (Amdt.)(Sodium Bicarbonate) 02/02/94 (59 FR 5068)
Internal Analgesic Products (Overindulgence) Final Action 00/00/00
Internal Deodorant Products ANPRM 01/05/82 (47 FR 512) NPRM 06/17/85
(50 FR 25162) Final Action 05/11/90 (55 FR 19862)
Labeling of Drug Products for OTC Use NPRM 04/05/93 (58 FR
17553) Final Action 01/28/94 (59 FR 3998)
Laxative Products ANPRM 03/21/75 (40 FR 12902) NPRM 01/15/85 (50 FR
2124) NPRM (Amendment) 10/01/86 (51 FR 35136) NPRM (Amendment) 09/02/
93 (58 FR 46589) Final Action 00/00/00
Leg Muscle Cramps (Nocturnal Relief) Products ANPRM 10/01/82 (47 FR
43562) NPRM 11/08/85 (50 FR 46588) Final Action 09/00/94
Male Genital Desensitizer Products ANPRM 09/07/82 (47 FR 39412) NPRM
10/02/85 (50 FR 40260) Final Action 06/19/92 (57 FR 27654)
Menstrual Products ANPRM 12/07/82 (47 FR 55075) NPRM 11/16/88 (53 FR
46194)
Mercurial (Topical) Products (To be merged w/other rulemkg) ANPRM 01/
05/82 (47 FR 436)
Nailbiting/Thumbsucking Deterrent Products ANPRM 10/17/80 (45 FR
69122) NPRM 09/03/82 (47 FR 39096) Final Action 09/02/93 (58 FR
46749)
Nighttime Sleep Aid Products ANPRM 12/08/75 (40 FR 57292) NPRM 06/13/
78 (43 FR 25544) Final Action 02/14/89 (54 FR 6814) NPRM (Amendment)
08/26/93 (58 FR 45217) Final Action (Amendment) 04/00/94
NDA Labeling Exclusivity NPRM 11/09/93 (58 FR 59622)
Ophthalmic Products ANPRM 05/06/80 (45 FR 30002) NPRM 06/28/83 (48 FR
29788) Final Action 03/04/88 (53 FR 7076) Final Action (Anti-
infective) 12/18/92 (57 FR 60416)
Oral Discomfort (Relief) Products ANPRM 05/25/82 (47 FR 22712) NPRM
09/24/91 (56 FR 48302)
Oral Health Care Products ANPRM 05/25/82 (47 FR 22760) NPRM 01/27/88
(53 FR 2436) NPRM (Amendment) (Antimicrobials) 02/09/94 (59 FR
6084) Final Action 00/00/00
Oral Mucosal Injury Products (Merged w/Oral Health Care) ANPRM 11/02/
79 (44 FR 63270) NPRM 07/26/83 (48 FR 33984)
Oral Wound Healing Products ANPRM 11/02/79 (44 FR 63270) NPRM 07/26/
83 (48 FR 33984) Final Action 07/18/86 (51 FR 26112)
Otic Products (Earwax) NPRM 07/09/82 (47 FR 30012) Final Action 08/
08/86 (51 FR 28656)
Otic Products (Swimmers Ear) NPRM 07/30/86 (51 FR 27366) Final Action
09/00/94
Overindulgence Remedies ANPRM 10/01/82 (47 FR 43540) NPRM 12/24/91
(56 FR 66742) NPRM (Amendment)(Warning) 05/05/93 (58 FR 26886)
Overindulgence Remedies/Prevention of Inebriation ANPRM 10/01/82 (47
FR 43540) Final Action 07/19/83 (48 FR 32872)
Pediculicide Products ANPRM 06/29/82 (47 FR 28312) NPRM 04/03/89 (54
FR 13480) Final Action 12/14/93 (58 FR 65452)
Poison Ivy/Oak/Sumac Prevention (Merged w/other rulemkg) ANPRM 09/07/
82 (47 FR 39412)
Poison Treatment Products NPRM 01/15/85 (50 FR 2244) Final Action 09/
00/94
Reporting of Adverse Reactions NPRM 06/00/94
Skin Bleaching Products ANPRM 11/03/78 (43 FR 51546) NPRM 09/03/82
(47 FR 39108) NPRM (Reproposed) 09/00/94
Skin Protectant Products ANPRM 08/04/78 (43 FR 34628) NPRM 02/15/83
(48 FR 6820) NPRM (Amendment) (Astringent) 04/03/89 (54 FR
13490) NPRM (Amendment) (Poison Ivy) 10/03/89 (54 FR 40808) NPRM
(Amendment) (Fvr Blister/Ext) 01/31/90 (55 FR 3362) NPRM (Amendment)
(Diaper Rash) 06/20/90 (55 FR 25204) Final Action (Astringent) 10/21/
93 (58 FR 54466) Final Action (Witch Hazel) 07/00/94 Final Action 00/
00/00
Smoking Deterrent Products ANPRM 01/05/82 (47 FR 490) NPRM 07/03/85
(50 FR 27552) Final Action 06/01/93 (58 FR 31236)
Sodium Labeling NPRM 04/25/91 (56 FR 19222) Final Action 00/00/00
Status of Certain Category II and III Ingredients NPRM 05/16/90 (55 FR
20434) Final Action 11/07/90 (55 FR 46914) NPRM 08/25/92 (57 FR
38568) Final Action 05/10/93 (58 FR 27636)
Stimulant (Overindulgence) Products NPRM (Amendment) 12/24/91 (56 FR
66758)
Stimulant Products ANPRM 12/08/75 (40 FR 57292) NPRM 06/13/78 (43 FR
25544) Final Action 02/29/88 (53 FR 6100)
Stomach Acidifier Products ANPRM 10/19/79 (44 FR 60316) NPRM 01/15/85
(50 FR 2184) Final Action 08/17/88 (53 FR 31270)
Sunscreen Products ANPRM 08/25/78 (43 FR 38206) NPRM 05/12/93 (58 FR
28194)
Sweet Spirits of Nitre ANPRM 02/22/80 (45 FR 11846) Final Action 06/
27/80 (45 FR 43400)
Topical Drug Products Containing Benzoyl Peroxide (Labeling) NPRM 07/
00/94
Vaginal Contraceptive Products ANPRM 12/12/80 (45 FR 82014) NPRM 07/
00/94
Vaginal Drug Products ANPRM 10/13/83 (48 FR 46694) Withdrawal
Published 02/03/94 (59 FR 5226)
Vitamin/Mineral Products ANPRM 03/16/79 (44 FR 16126) Withdrawal 11/
27/81 (46 FR 57914)
Wart Remover Products ANPRM 10/03/80 (45 FR 65609) NPRM 09/03/82 (47
FR 39102) NPRM (Amendment) 03/27/87 (52 FR 9992) Final Action 08/14/
90 (55 FR 33246) NPRM (Amendment)(Directions) 01/28/94 (59 FR 4015)
Water Soluble Gums NPRM 10/30/90 (55 FR 45782) Final Action 08/26/93
(58 FR 45194)
Weight Control Products ANPRM 02/26/82 (47 FR 8466) NPRM 10/30/90 (55
FR 45788) Final Action 08/08/91 (56 FR 37792) NPRM (Amendment) 09/00/
94
Small Entities Affected: None
Government Levels Affected: None
Additional Information: ABSTRACT CONT: for ``Antimicrobial Products.''
NPRM for ``Alcohol (Topical) Products'' to be included in revised NPRM
for ``Antimicrobial Products.'' The NPRM for ``Antimicrobial Products''
is being revised because it is being updated and split into two
sections: first aid products and health care products.
SMALL ENTITIES AFFECTED: The effects, if any, vary depending on the
individual rulemaking. However, the agency anticipates that the rules
would not have a significant economic impact on a substantial number of
small entities as defined by the Regulatory Flexibility Act.
Agency Contact: William E. Gilbertson, Director, Monograph Review
Staff, Office of OTC Drug Evaluation, Department of Health and Human
Services, Food and Drug Administration, Center for Drug Evaluation and
Research (HFD-210), 5600 Fishers Lane, Rockville, MD 20857, 301 295-
8000
RIN: 0905-AA06
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1248. ABBREVIATED NEW DRUG APPLICATION REGULATIONS (TITLE I OF THE ``DRUG
PRICE COMPETITION AND PATENT TERM RESTORATION ACT OF 1984'')
Significance:
Subject to OMB review: Undetermined
Legal Authority: 21 USC 355 title I
CFR Citation: 21 CFR 10; 21 CFR 310; 21 CFR 314; 21 CFR 320
Legal Deadline: None
Abstract: Until the passage of title I of the Drug Price Competition
and Patent Term Restoration Act of 1984, abbreviated new drug
application (ANDA) procedures were only available for generic products
equivalent to pioneer drugs approved before 1962. Title I opened up the
ANDA policy to generic copies of products approved after 1962. On July
10, 1989 (54 FR 28872), FDA proposed regulations to implement Title I.
The proposal provides for the submission of abbreviated new drug
applications for generic versions of drug products first approved after
1962. These new provisions will benefit consumers by making generic
drug products available more quickly.
The agency is preparing the final rule in two segments. The final rule
for the first segment, which establishes requirements for the format
and content of an ANDA, suitability petitions, and certain
administrative actions, published in the Federal Register of April 28,
1992 (57 FR 17950). The agency is reviewing the public comments
submitted in response to the proposed requirements for patent
certification and exclusivity and preparing a final rule on the
segment.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 07/10/89 54 FR 28872
NPRM Comment Period End 10/10/89 54 FR 28872
NPRM Extension of Comment Period10/11/89 54 FR 41629
NPRM Public Comment Period End 01/09/90 54 FR 41629
NPRM Extension of Comment Period01/16/90 55 FR 1471
NPRM Public Comment Period End 04/09/90 55 FR 1471
Content and Format, Suitability Petitions Final Action 04/28/92 (57 FR
17950)
Patent Certification and Exclusivity Final Action 06/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Philip L. Chao, Regulatory Counsel, Division of
Regulatory Affairs, Department of Health and Human Services, Food and
Drug Administration, Center for Drug Evaluation and Research (HFD-362),
7500 Standish Place, Rockville, MD 20855, 301 594-1049
RIN: 0905-AB63
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1249. CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS;
NOTIFICATION OF CONSIGNEES RECEIVING BLOOD AND BLOOD COMPONENTS AT
INCREASED RISK FOR TRANSMITTING HIV INFECTION
Legal Authority: 21 USC 351 to 360k; 21 USC 374; 42 USC 262 to 264
CFR Citation: 21 CFR 606; 21 CFR 610
Legal Deadline: None
Abstract: The agency currently requires that all blood and blood
components intended for the manufacture of any product be tested for
antibody to human immunodeficiency virus (HIV). In instances when the
blood of a donor is found to contain antibodies to HIV, some blood
centers have initiated a program of voluntary ``look-back'' to notify
consignees of blood and blood components obtained from the donor's
prior donations. Consignees may withdraw or destroy such blood and
blood products, and may trace and notify recipients. A well-conducted
look-back program can provide an effective mechanism for identifying,
testing, and counseling transfusion recipients who are at increased
risk of HIV infection--those who receive blood from a donor later found
to be infected with HIV. The agency is publishing a final rule to
establish a mandatory look-back program. The final rule will require
blood collection facilities to develop a procedure to notify consignees
promptly whenever a blood donor who has previously donated blood or
source plasma is found to be positive for the antibody to HIV; and to
keep appropriate records when such notification has been made. In
addition, the final (cont)
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/30/93 58 FR 34962
Final Action 00/00/00
Small Entities Affected: Businesses, Organizations
Government Levels Affected: Undetermined
Additional Information: ABSTRACT CONT: rule will require hospital
transfusion services to notify recipients of blood products of
increased risk for transmitting HIV and to keep appropriate records of
the notification process. The purpose of the rulemaking is to ensure
the notification of consignees and blood transfusion recipients and
that prompt and appropriate action is taken.
Agency Contact: Sharon Carayiannis, Consumer Safety Officer, Department
of Health and Human Services, Food and Drug Administration, Center for
Biologics Evaluation and Research (HFM-635), 1401 Rockville Pike, Suite
200N, Rockville, MD 20852-1448, 301 594-3074
RIN: 0905-AC90
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1250. LEAD IN FOODS
Significance:
Regulatory Plan entry: Undetermined
Legal Authority: 21 USC 321; 21 USC 336; 21 USC 342(a); 21 USC 346; 21
USC 346a; 21 USC 348; 21 USC 371
CFR Citation: 21 CFR 109; 21 CFR 182; 21 CFR 189
Legal Deadline: None
Abstract: In light of the public health concerns raised by continuing
findings concerning the effects of low levels of exposure to lead,
particularly exposure by pregnant women, infants, and children, the
agency is undertaking a comprehensive effort to further reduce lead
levels in food where controllable or avoidable sources of lead addition
to food can be identified. The goal of FDA is to reduce consumers'
exposure to lead in the diet to the lowest level that can be
practicably obtained. FDA has identified several potential sources of
dietary lead exposure that it intends to address in proposed rules in
its initiatives to reduce exposure to lead in the diet.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/01/89 54 FR 23485
NPRM Comment Period End 07/31/89 54 FR 23485
Prohibit Use of Lead-Soldered Food Cans NPRM 06/21/93 (58 FR
33860) Final Action 08/00/94
Prohibit Use of Tin-Coated Lead Foil Capsules on Wine Bottles NPRM 11/
25/92 (57 FR 55485) Final Action 08/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Michael E. Kashtock, Supervisory Consumer Safety
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Food Safety and Applied Nutrition (HFS-306),
200 C Street SW., Washington, DC 20204, 202 205-4681
RIN: 0905-AC91
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1251. EXPEDITING APPROVAL FOR DRUGS INTENDED TO TREAT LIFE-THREATENING
AND SEVERELY DEBILITATING ILLNESSES
Significance:
Subject to OMB review: Undetermined
Legal Authority: 21 USC 351 to 357; 21 USC 371; 42 USC 262
CFR Citation: 21 CFR 312
Legal Deadline: None
Abstract: In the Federal Register of October 21, 1988 (53 FR 41561),
FDA issued an interim rule, effective upon date of publication, with
opportunity for public comment, that set forth procedures designed to
speed the availability of new therapies to desperately ill patients,
while preserving appropriate guarantees for safety and effectiveness.
These procedures are intended to facilitate the development,
evaluation, and marketing of such products, especially where no
satisfactory alternative therapies exist. These procedures reflect the
recognition that physicians and patients are generally willing to
accept greater risks or side effects from products that treat life-
threatening and severely debilitating illnesses. These procedures also
reflect the recognition that the benefits of the drug need to be
evaluated in light of the severity of the disease being treated. The
procedures apply to life-threatening or severely debilitating
illnesses. The agency is reviewing the public comments submitted in
response to the interim rule and preparing a Federal Register document
that will respond to these comments. The (cont)
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Interim Final Rule 10/21/88 53 FR 41561
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Additional Information: ABSTRACT CONT: agency is also considering the
recommendations contained in the report of the ``National Committee to
Review Current Procedures for Approval of New Drugs for Cancer and
AIDS.''
Agency Contact: Philip L. Chao, Regulatory Counsel, Division of
Regulatory Affairs, Department of Health and Human Services, Food and
Drug Administration, Center for Drug Evaluation and Research (HFD-362),
7500 Standish Place, Rockville, MD 20855, 301 594-1049
RIN: 0905-AC94
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1252. FEES FOR CERTIFICATION SERVICES; INSULIN AND COLOR ADDITIVE
CERTIFICATION PROGRAMS
Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined
Regulatory Plan entry: Undetermined
Legal Authority: 21 USC 502; 21 USC 506; 21 USC 701; 21 USC 706
CFR Citation: 21 CFR 80.10; 21 CFR 429.55
Legal Deadline: None
Abstract: In the Federal Register of October 4, 1991 (56 FR 50248), FDA
issued an interim rule effective on November 4, 1991 with opportunity
for public comment, revising the fee schedule for insulin certification
services. The fees are intended to recover the full costs of operation
of FDA's insulin certification program, including the unfunded
liability of the Civil Service Retirement Fund and appropriate overhead
costs of the Public Health Service and Department of Health and Human
Services. FDA is also considering similar amendments to the regulations
governing fees for the color additive certification program.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Interim Final Rule (Insulin) 10/04/91 56 FR 50248
Final Action (Color Additives) 12/00/94
Small Entities Affected: Undetermined
Government Levels Affected: None
Agency Contact: David R. Petak, Chief, Accounting Branch, Office of
Management, Department of Health and Human Services, Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301 443-1766
RIN: 0905-AD34
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1253. MANDATORY HACCP SEAFOOD INSPECTION PROGRAM
Significance:
Subject to OMB review: Yes
Economically significant: Yes
Regulatory Plan entry: Yes
Legal Authority: 21 USC 342 Federal Food, Drug, and Cosmetic Act; 21
USC 371 Federal Food, Drug, and Cosmetic Act; 21 USC 374 Federal Food,
Drug, and Cosmetic Act; 42 USC 264 Public Health Service Act; 21 USC
321; 21 USC 343; 21 USC 346; 21 USC 348; 21 USC 379e; 21 USC 381; 42
USC 241; 42 USC 242l; 42 USC 300U-l; 42 USC 216; 42 USC 243
CFR Citation: 21 CFR 123; 21 CFR 1240
Legal Deadline: None
Abstract: The Food and Drug Administration intends to issue
requirements for the safe processing and importing of fish and fishery
products in keeping with Hazard Analysis Critical Control Point (HACCP)
principles. HACCP involves the identification and monitoring of
``critical control points'' in a processing or other operation the
failure of which can render a product adulterated. HACCP has been
strongly endorsed by the National Academy of Sciences for use by the
seafood industry.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 01/28/94 59 FR 4142
NPRM Comment Period End 03/29/94 50 FR 4142
Final Action 02/00/95
Small Entities Affected: Businesses
Government Levels Affected: Federal
Additional Information: 42 USC 264 42 USC 271
Agency Contact: Philip Spiller, Deputy Director, Office of Seafood,
Department of Health and Human Services, Food and Drug Administration,
Center for Food Safety and Applied Nutrition (HFS-401), 200 C Street
SW., Washington, DC 20204, 202 254-3885
RIN: 0905-AD60
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1254. BOTTLED WATER
Significance:
Regulatory Plan entry: Undetermined
Legal Authority: 21 USC 341; 21 USC 343(h); 21 USC 349; 21 USC 371(a)
CFR Citation: 21 CFR 103
Legal Deadline: Other, Statutory.
Other deadline is for publication of NPRM or Notice within 180 days of
EPA final action.
Abstract: In fulfillment of its mandate under the Safe Drinking Water
Act, EPA is currently in the midst of reviewing and establishing
standards for contaminants in public drinking water such as pathogenic
bacteria, pesticides and organic chemicals. When EPA establishes such
standards for public drinking water, FDA is required to take
appropriate action to amend its regulations for bottled drinking water
or state its reasons for not doing so. FDA also establishes identity
standards for a food when it has determined that the standard will
promote honesty and fair dealing in the interest of consumers.
Timetable:
Beverages; Bottled Water NPRM 01/05/93 (58 FR 393) Final Action 07/
00/94
Microbiological Quality Standard NPRM 10/06/93 (58 FR 25042) Final
Action 11/00/94
Quality Standard for Lead and Copper NPRM 01/05/93 (58 FR 389) Final
Action 05/00/94
Quality Standards for 24 Contaminants NPRM 08/04/93 (58 FR 41612)
Quality Standards for 35 Contaminants Final Action 09/00/94
Quality Standards for 39 Contaminants NPRM 01/05/93 (58 FR 382) Final
Action 05/00/94
Small Entities Affected: Undetermined
Government Levels Affected: None
Agency Contact: Michael E. Kashtock, Supervisory Consumer Safety
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Food Safety and Applied Nutrition (HFS-306),
200 C Street SW., Washington, DC 20204, 202 205-4681
RIN: 0905-AD65
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1255. SPECIFIC REQUIREMENTS ON CONTENT AND FORMAT OF LABELING FOR HUMAN
PRESCRIPTION DRUGS; REVISION OF ``PEDIATRIC USE'' SUBSECTION IN THE
LABELING
Significance:
Subject to OMB review: Undetermined
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355
to 358; 21 USC 360 to 360b; 21 USC 371; 21 USC 374; 21 USC 376; 42 USC
216; 42 USC 241; 42 USC 262; 42 USC 263b to 263n; 42 USC 264
CFR Citation: 21 CFR 201
Legal Deadline: None
Abstract: In the Federal Register of October 16, 1992 (57 FR 47423),
the agency proposed to amend its regulations pertaining to the specific
content and format of prescription drug labeling by revising the
current ``Pediatric Use'' subsection of professional labeling to
provide for the inclusion of more complete information about use of a
drug in children and about hazards associated with this use. This
regulatory action is intended to respond to concerns in FDA and
elsewhere that current prescription drug labeling does not contain
adequate information about the use of drugs in children. The agency is
reviewing the public comments submitted in response to the proposed
rule and preparing a final rule.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 10/16/92 57 FR 47423
NPRM Comment Period End 12/15/92 57 FR 47423
Final Action 06/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Erica L. Keys, Regulatory Counsel, Department of Health
and Human Services, Food and Drug Administration, Center for Drug
Evaluation and Research, (HFD-362), 301 594-1049
RIN: 0905-AD76
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1256. RECORDKEEPING AND REPORTING: ELECTRONIC PRODUCTS
Legal Authority: 21 USC 360hh; 21 USC 360ii; 21 USC 360jj; 21 USC
360kk; 21 USC 360ll; 21 USC 360mm; 21 USC 360nn; 21 USC 360oo; 21 USC
360oo
CFR Citation: 21 CFR 1000; 21 CFR 1002
Legal Deadline: None
Abstract: The Final Rule would amend FDA regulations on Recordkeeping
and Reporting of adverse events and other information relating to
radiation emitting electronic products. The timing and content of
certain reports will be revised to enhance the usefulness of the
information. This action will result in improved protection of the
public health while reducing the regulatory burden on manufacturers and
distributors.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
ANPRM 07/02/82 47 FR 29004
ANPRM 11/16/82 47 FR 51706
ANPRM 07/01/85 50 FR 27024
NPRM 10/25/90 55 FR 43066
NPRM Comment Period End 01/22/91 55 FR 43066
Final Action 06/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department
of Health and Human Services, Public Health Service, Food and Drug
Administration, Center for Devices and Radiological Health (HFZ-84),
2098 Gaither Rd., Rockville, MD 20850, 301 594-4765
RIN: 0905-AD78
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1257. GENERAL BIOLOGICAL PRODUCT STANDARDS; ALTERNATIVE PROCEDURES AND
EXCEPTIONS
Legal Authority: 42 USC 262
CFR Citation: 21 CFR 610; 21 CFR 640; 21 CFR 630
Legal Deadline: None
Abstract: The Food and Drug Administration is amending its regulations
governing biological products. This amendment would authorize the
Director, Center for Biologics Evaluation and Research, to approve an
exception or alternative to any regulation in 21 CFR governing
biological products. The regulation will provide flexibility needed to
accommodate rapid changes in biotechnology and to assure the continued
availability of biological products.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Final Action 12/00/94
Small Entities Affected: None
Government Levels Affected: Undetermined
Agency Contact: Stephen Ripley, Consumer Safety Officer, Department of
Health and Human Services, Food and Drug Administration, Center for
Biologics Evaluation and Research, 1401 Rockville Pike, Suite 200N
(HFM-635), Rockville, MD 20852-1448, 301 594-3074
RIN: 0905-AD82
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1258. MEDICAL DEVICES; PROTECTIVE RESTRAINTS; REVOCATION OF EXEMPTIONS
FROM 510(K) PREMARKET NOTIFICATION PROCEDURES AND CURRENT GOOD
MANUFACTURING PRACTICES REGULATIONS
Legal Authority: 21 USC 351; 21 USC 360; 21 USC 360c; 21 USC 360e; 21
USC 360y; 21 USC 371
CFR Citation: 21 CFR 880.6760; 21 CFR 890.3910
Legal Deadline: None
Abstract: FDA has become aware through various sources of numerous
reports of complications including permanent physical injuries, severe
psychological disabilities, other serious injuries and deaths that have
been attributed to incorrect supervision, handling or application of
protective restraint devices by medical or paramedical personnel.
Complications associated with protective restraint devices frequently
result from misuse of the devices. To address potential misuse,
manufacturers should include specific directions for use, to the extent
that such directions are not currently available or not attached to or
kept with the garment. Revocation of the premarket notification
exemptions will allow FDA to collect information about the current
availability and actual employment of directions for use and to monitor
the introduction into commerce of new and changed protective
restraints. Revocation of the exempting Current Good Manufacturing
Practice regulation will allow FDA to require the necessary controls
over labeling. FDA is also considering educational programs to address
this problem. FDA anticipates total first year costs of $930,000 for
this regulation. (cont)
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/19/92 57 FR 27397
NPRM Comment Period End 08/18/92 57 FR 27397
Final Action 06/00/94
Small Entities Affected: Businesses
Government Levels Affected: Undetermined
Additional Information: ABSTRACT CONT: These costs will be offset by
the saving of lives and reduced product liability exposure.
Agency Contact: Patricia Dubill, Department of Health and Human
Services, Food and Drug Administration, Center for Devices and
Radiological Health, (HFZ-84), 2098 Gaither Rd., Rockville, MD 20850,
301 594-4765
RIN: 0905-AD84
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1259. THRESHOLD OF REGULATION POLICY FOR COMPONENTS OF FOOD CONTACT
ARTICLES
Significance:
Regulatory Plan entry: Undetermined
Legal Authority: 21 USC 321; 21 USC 341; 21 USC 342; 21 USC 346a; 21
USC 348; 21 USC 371
CFR Citation: 21 CFR 170; 21 CFR 171; 21 CFR 174
Legal Deadline: None
Abstract: FDA is proposing a policy for determining when the
likelihood/extent of migration of a component of a food contact article
is so trivial as not to require regulation as a food additive. A
substance considered under this Threshold of Regulation Policy would
undergo an abbreviated review by FDA, as opposed to the extensive
review and formal issuance of a regulation required for other food
additives. This proposal lists the criteria which must be met for a
food-contact material to be reviewed under this policy and identifies
the types of data that FDA will need for its review. This policy will
reduce regulatory cost and delays and thereby bring important and
innovative products to market faster.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 10/12/93 58 FR 52719
Final Action 12/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Edward J. Machuga, Consumer Safety Officer, Department
of Health and Human Services, Food and Drug Administration, Center for
Food Safety and Applied Nutrition (HFS-216), 200 C Street, SW.,
Washington, DC 20204, 202 254-9528
RIN: 0905-AD86
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1260. FOOD LABELING REVIEW
Significance:
Subject to OMB review: Yes
Economically significant: Undetermined
Regulatory Plan entry: Undetermined
Legal Authority: 15 USC 1453; 15 USC 1454; 15 USC 1455; 21 USC 321; 21
USC 331; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 371
CFR Citation: 21 CFR 100; 21 CFR 101; 21 CFR 102; 21 CFR 161
Legal Deadline: None
Abstract: The Nutrition Labeling and Education Act of 1990 (NLEA)
requires that most foods bear nutrition labeling. In developing the
final rules that were published on January 6, 1993, the agency
identified three areas that should be the subject of additional
rulemaking: a definition for the nutrient content claim ``healthy''; a
definition for ``nonfunctional slack-fill''; and requirements for the
identification of certain ingredients on food labels. Proposed
regulations addressing these issues were published on January 6, 1993.
On May 12, 1993, FDA announced that, in accordance with the NLEA, the
regulation it proposed on January 6, 1993, on nonfunctional slack-fill
was considered a final rule. Subsequently, on December 6, 1993, FDA
issued a final rule responding to the comments received to the January
6, 1993, proposal. FDA also proposed on June 15, 1993, to amend its
January 6, 1993, final rules on nutrient content and health claims to
have the provisions that exempted restaurant menus from the
requirements for how nutrient content claims and health claims are to
be made. FDA also proposed to modify the provisions that delay the
effective date of these regulations for (cont)
Timetable:
Misleading Containers; Nonfunctional Slack Fill NPRM 01/06/93 (58 FR
2957) Final Action 12/06/93 (58 FR 64123)
Nutrient Content Claims and Health Claims; Restaurant Foods NPRM 06/
15/93 (58 FR 33055) Final Action 05/00/94
Nutrient Content, Definition of the Term, Healthy NPRM 01/06/93 (58 FR
2944) Final Action 09/00/94
Protein Hydrolysates; Broth in Tuna; and/or Labeling NPRM (Declaration
of Ingredients) 01/06/93 (58 FR 2950) Final Action (Dec. of
Ingredients) 12/00/94
Reference Daily Intakes NPRM 01/04/94 (59 FR 427) Final Action 08/00/
94
Small Entities Affected: Businesses
Government Levels Affected: State, Federal
Additional Information: ABSTRACT CONT: small restaurant firms for one
year. Finally, the agency proposed January 4, 1994, to establish
reference daily intakes based on the 9th and 10th editions of the
National Research Council's Recommended Dietary Allowances. These
actions were proposed following reconsideration of the provisions in
question.
Agency Contact: F. Edward Scarbrough, Director, Office of Food
Labeling, Department of Health and Human Services, Public Health
Service, Center for Food Safety and Applied Nutrition, (HFS-150) 200 C
St. SW Washington, DC 20204, 202 205-4561
RIN: 0905-AD89
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1261. LEVO-ALPHA-METHADOL (LAAM) IN MAINTENANCE; JOINT PROPOSED REVISION
OF CONDITIONS FOR USE
Significance:
Subject to OMB review: Undetermined
Legal Authority: 21 USC 355; 21 USC 371; 21 USC 823; 42 USC 241(d); 42
USC 290ee-3; 42 USC 257a
CFR Citation: 21 CFR 291
Legal Deadline: None
Abstract: The Food and Drug Administration and the National Institute
on Drug Abuse are issuing an interim rule, to be effective upon date of
publication with opportunity for public comment, that revises the
conditions for the treatment of narcotic addiction to provide for the
use of LAAM, when approved, in the maintenance treatment of narcotic
addicts. This action will allow narcotic treatment programs to provide
an additional treatment drug for use in the maintenance treatment of
narcotic addicts. The only narcotic drug currently approved for use in
the treatment of narcotic addiction is methadone.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Interim Final Rule 07/20/93 58 FR 38704
Interim Final Rule Comment
Period End 09/20/93 58 FR 38704
Final Action 11/00/94
Small Entities Affected: None
Government Levels Affected: State, Local
Agency Contact: Thomas C. Kuchenberg, Regulatory Counsel, Department of
Health and Human Services, Public Health Service, Division of
Regulatory Affairs, Food and Drug Administration, Center for Drug
Evaluation and Research, 301 594-1046
RIN: 0905-AD92
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1262. TEMPOROMANDIBULAR JOINT IMPLANT CLASSIFICATION
Legal Authority: 21 USC 360c; 21 USC 360e
CFR Citation: 21 CFR 872.3940; 21 CFR 872.3950; 21 CFR 872.3960; 21
CFR 872.3970
Legal Deadline: None
Abstract: The final rule would classify into class III (Premarket
approval) certain temporomandibular joint (TMJ) prostheses including
the interarticular disc prosthesis (the interpositional implant), the
mandibular condyle prosthesis, and the glenoid fossa prosthesis. This
action would allow FDA to require manufacturers of these devices to
submit premarket approval applications demonstrating the safety and
effectiveness of these devices. The devices present a risk of implant
loosening or displacement; foreign body reaction; degenerative changes
to the natural articulating surfaces; infection; and loss of implant
integrity.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 09/18/92 57 FR 43165
NPRM Comment Period End 12/08/92 57 FR 56876
Reproposal 02/14/94 59 FR 6935
Final Action 08/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department
of Health and Human Services, Public Health Service, FDA, CDRH (HFZ-
84), 2098 Gaither Rd., Rockville, MD 20850, 301 594-4765
RIN: 0905-AD93
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1263. CLINICAL INVESTIGATOR DISQUALIFICATION
Significance:
Subject to OMB review: Undetermined
Legal Authority: 21 USC 360j(g)
CFR Citation: 21 CFR 812
Legal Deadline: None
Abstract: The rule would amend the investigational device exemption
(IDE) regulations to provide for a procedure for disqualification of
clinical investigators in cases of fraud or other serious violations of
the regulations. Persons whose disqualification is proposed would be
entitled to an opportunity for hearing.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 10/06/93 58 FR 52144
Final Action 09/00/94
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department
of Health and Human Services, Public Health Service, FDA, CDRH (HFZ-
84), 2098 Gaither Rd., Rockville, MD 20850, 301 594-4765
RIN: 0905-AD94
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1264. REVOCATION OF INTRAOCULAR LENS INVESTIGATION DEVICE EXEMPTION
Significance:
Subject to OMB review: Undetermined
Legal Authority: 21 USC 360j(g)
CFR Citation: 21 CFR 813; 21 CFR 812
Legal Deadline: None
Abstract: The rule would revoke the separate investigational device
exemption regulation for intraocular lenses (IOLs). IOLs would then be
subject to the same IDE regulation (21 CFR Part 812) as all other
devices. The IOL-IDE regulation was originally created as an interim
measure.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 10/06/93 58 FR 52142
Final Action 09/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department
of Health and Human Services, Public Health Service, FDA, CDRH (HFZ-
84), 2098 Gaither Rd., Rockville, MD 20850, 301 594-4765
RIN: 0905-AD95
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1265. DIETARY SUPPLEMENT LABEL REVIEW
Significance:
Subject to OMB review: Yes
Economically significant: Undetermined
Regulatory Plan entry: Undetermined
Legal Authority: 15 USC 1453; 15 USC 1454; 15 USC 1455; 21 USC 321; 21
USC 342; 21 USC 343; 21 USC 348; 21 USC 371
CFR Citation: 21 CFR 101
Legal Deadline: NPRM, Statutory, June 15, 1993. Final, Statutory,
December 31, 1993.
If final regulations on labeling of Dietary Supplements are not
published by 12/31/93, the proposed regulations shall be considered the
final regulations.
Abstract: With the publication of various final rules on January 6,
1993, the agency completed action on its food labeling initiative under
the Nutrition Labeling and Education Act of 1990. Rulemaking on
nutrition labeling of dietary supplements was delayed due to
requirements of the Dietary Supplement Act of 1992 (DSA), which amended
the law to provide that the agency would issue proposed regulations for
dietary supplements by June 15, 1993, and final regulations by December
31, 1993. Three proposed regulations were developed and published on
June 18, 1993; Health Claims for Dietary Supplements, Nutrient Content
Claims for Dietary Supplements, and Mandatory Nutrition Labeling for
Dietary Supplements. On October 14, 1993, FDA published a proposal to
not authorize health claims on the labels of dietary supplements of 5
nutrient/disease relationships: (1) Dietary fiber and cancer (2)
Dietary Fiber and CVD, (3) Antioxidants and Cancer, (4) Omega-3 fatty
acids and CHD, (5) Zinc and immune function in the elderly. In
addition, FDA also published a proposed rule to authorize the use of
health claims about the relationship of folates and neural tube
defects. On January 4, 1994, FDA published notices (cont)
Timetable:
Health Claims and Label Statements; Dietary Supplements NPRM Folic
Acid and Neural Tube Def 10/14/93 (58 FR 53254) Final Action 09/00/94
Health Claims; Diet. Fiber/Cancer, CHD; Antioxidant/CVD; Omega-3 NPRM
10/14/93 (58 FR 53296)
Health Claims; Dietary Supplements NPRM 06/18/93 (58 FR 33700) Final
Action 01/04/94 (59 FR 395)
Nutrient Content Claims; Dietary Supplements NPRM 06/18/93 (58 FR
33731) Final Action 01/04/94 (59 FR 378)
Nutrition Labeling; Dietary Supplements NPRM 06/18/93 (58 FR
33715) Final Action 01/04/94 (59 FR 354)
Small Entities Affected: Businesses
Government Levels Affected: State, Federal
Additional Information: ABSTRACT CONT: stating that it considered the
proposals to be final regulations by operational statute. However, the
notices also stated that FDA considers the October 14, 1993,
rulemakings to be ongoing. The agency intends to continue rulemaking
with respect to folates and to issue a final rule as quickly as
possible. FDA is also considering new scientific information that may
support health claims for some of the nutrient-disease relationships
given above. If this information is sufficient to support claims, the
agency will repropose to allow those claims.
Agency Contact: John Hathcock, Director, Divisions of Science and
Applied Technology, Office of Special Nutrionals, Department of Health
and Human Services, Food and Drug Administration, Center for Food
Safety and Applied Nutrition, 200 C St. SW., Washington, DC 20204, 202
594-6006
RIN: 0905-AD96
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1266. ADVERSE EXPERIENCE REPORTING REQUIRED FOR LICENSED BIOLOGICAL
PRODUCTS
Significance:
Subject to OMB review: Yes
Legal Authority: 21 USC 321; 21 USC 351; 21 USC 352; 21 USC 353; 21
USC 355; 21 USC 360; 21 USC 371; 21 USC 374; 42 USC 216; 42 USC 262; 42
USC 263; 42 USC 263a; 42 USC 264; 42 USC 300AA 25
CFR Citation: 21 CFR 600
Legal Deadline: None
Abstract: FDA is amending the regulations to require manufacturers,
packers, and distributors (hereafter referred to as LICENSED
MANUFACTURERS of licensed biological products to report to FDA within
15 working days all adverse experiences associated with the use of a
biological product that are both serious and unexpected; any
significant increase in the frequency of a serious, but expected
adverse experience; periodically all other adverse experiences; and
product distribution and disposition data. FDA is taking this action to
provide a mechanism under which LICENSED MANUFACTURERS would inform the
agency, on a timely basis, of any unanticipated safety problems with
marketed biological products.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 03/29/90 55 FR 11611
NPRM Comment Period End 05/29/90 55 FR 11611
Final Action 05/00/94
Small Entities Affected: Businesses, Organizations
Government Levels Affected: State
Agency Contact: Paula McKeever, Consumer Safety Officer, Department of
Health and Human Services, Public Health Service, 1401 Rockville Pike,
Suite 200N, Rockville, MD 20852-1448, 301 594-3074
RIN: 0905-AE18
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1267. TAMPER-EVIDENT PACKAGING REQUIREMENTS FOR OVER-THE-COUNTER
HUMAN DRUG PRODUCTS
Significance:
Subject to OMB review: Undetermined
Legal Authority: 21 USC 321; 21 USC 351; 21 USC 352; 21 USC 371
CFR Citation: 21 CFR 211
Legal Deadline: None
Abstract: On January 18, 1994 (59 FR 2542), the agency proposed to
amend its tamper-resistant packaging requirements to require that all
over-the-counter (OTC) human drug products marketed in two-piece, hard
gelatin capsules be sealed. The proposal also solicited public comments
on whether additional regulatory changes, such as packaging performance
standards, may be necessary. FDA has required tamper-resistant
packaging features for OTC drug products since 1982. The tamper-
resistant packaging regulations were revised in 1989 in response to
continuing tamper incidents. Despite the regulatory protection provided
by the regulations, two-piece, hard gelatin capsules remain vulnerable
to malicious tampering and were implicated in tampering incidents in
1991. This proposed regulatory action is in response to the 1991
tampering incidents.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 01/18/94 59 FR 2542
NPRM Comment Period End 03/21/94 59 FR 2542
Final Action 04/00/95
Small Entities Affected: Undetermined
Government Levels Affected: None
Agency Contact: Howard P. Muller, Regulatory Counsel, Department of
Health and Human Services, Public Health Service, Division of
Regulatory Affairs, Food and, Drug Administration, Center for Drug E,
Evaluation and Research (HFD-362), 301 594-1049
RIN: 0905-AE27
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1268. VOLUNTARY, FEE-FOR-SERVICE SEAFOOD INSPECTION PROGRAM
CFR Citation: 21 CFR 197
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Withdrawn - replaced by the
Seafood HACCP Program (RIN 0905-
AD60) 01/28/94 59 FR 4142
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Mary Snyder, 202 254-3888
RIN: 0905-AD23
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1269. PART 1260; HUMAN SEMEN FOR ARTIFICIAL INSEMINATION
CFR Citation: 21 CFR 1260
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
No action planned in the next 12
months 03/15/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Ann Reed Gaines, 301 594-3074
RIN: 0905-AD80
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1270. INVESTIGATIONAL NEW DRUG APPLICATIONS
CFR Citation: 21 CFR 312
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
No action planned in the next 12
months 04/01/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Ilisa B. Bernstein, 301 443-1382
RIN: 0905-AD85
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1271. DIETARY SUPPLEMENTS
CFR Citation: Not yet determined
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
No action planned in the next 12
months 03/15/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Judith Kraus, 202 205-5372
RIN: 0905-AD90
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1272. PROPOSAL TO ESTABLISH PROCEDURES FOR THE SAFE PROCESSING,
PACKAGING, STORAGE, AND DISTRIBUTION OF SMOKED FISH, SMOKE-FLAVORED FISH,
AND SALTED FISH
CFR Citation: 21 CFR 122
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Withdrawn - merged into Seafood
HACCP Program (RIN 0905-AD60) 01/28/94 59 FR 4142
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Mary I. Snyder, 202 254-3888
RIN: 0905-AE21
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Health Resources and Services
Administration (HRSA)
_______________________________________________________________________
1273. NATIONAL HEALTH SERVICE CORPS LOAN REPAYMENT PROGRAM; GRANTS FOR
STATE LOAN REPAYMENT PROGRAMS
Significance:
Subject to OMB review: Yes
Regulatory Plan entry: Undetermined
Legal Authority: PL 100-177; PL 101-597
CFR Citation: 42 CFR 62.21 to 62.30; 42 CFR 62.51 to 62.58
Legal Deadline: None
Abstract: The National Health Service Corps (NHSC) Revitalization
Amendments of 1990, PL 101-597, amends Section 338B of the PHS Act
which authorizes the NHSC Loan Repayment Program. These Amendments also
revise the State Loan Repayment Program at Section 338I of the PHS Act.
The interim rule relating to both these programs as published April 3,
1989, will be revised to reflect the 1990 amendments. Regulations
governing the Special Repayment Program established under PL 100-177
were published on 11/6/91 in final form under RIN 0905-AD58, separate
from this NPRM (RIN 0905-AC65). The amended NHSC Loan Repayment Program
(RIN 0905-AD57) removes the provision which limits the Secretary's loan
repayment to one month in advance of services.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Interim Final Rule 04/03/89 56 FR 13458
NPRM 10/00/94
Small Entities Affected: None
Government Levels Affected: State
Agency Contact: Rhoda Abrams, Director, Office of Program and Policy
Development, Bureau of Primary Health Care, Department of Health and
Human Services, Public Health Service, East-West Tower Bldg., 4350
East-West Highway, 7th Floor, Bethesda, MD 20814, 301 594-4060
RIN: 0905-AC65
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Health Resources and Services
Administration (HRSA)
_______________________________________________________________________
1274. ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK RULES
Significance:
Subject to OMB review: Yes
Legal Authority: 42 USC 1320b-8 section 1138 of the Social Security
Act; 42 USC 274 Section 372 of the Public Health Service Act
CFR Citation: 42 CFR 121
Legal Deadline: None
Abstract: Section 1138 of the Social Security Act requires Medicare and
Medicaid participating hospitals that perform organ transplants to be
members of and abide by the rules and requirements of the Organ
Procurement and Transplantation Network (OPTN) as established by
section 372 of the Public Health Service Act. Section 1138 also
requires that for organ procurement costs attributable to payments to
an Organ Procurement Organization (OPO) to be paid by Medicare or
Medicaid, the OPO must be a member of and abide by the rules and
requirements of the OPTN. No other entity (for example, a
histocompatibility laboratory) is required to be a member of or abide
by the rules of the OPTN under the provisions of the statute. It is the
Department's position that no rule, requirement, policy, or other
issuance of the OPTN will be considered to be a ``rule or requirement''
of the Network within the meaning of section 1138 unless the Secretary
has formally approved that rule. The OPTN is currently in operation and
these rules will impose no further cost or provide any benefit other
than that which now exists.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
NPRM Comment Period End 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Judy Braslow, Director, Division of Organ
Transplantation, Bureau of Health Resources Development, Department of
Health and Human Services, Public Health Service, Room 11A-22, Parklawn
Building, 5600 Fishers Lane, Rockville, MD 20857, 301 443-7577
RIN: 0905-AD26
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Health Resources and Services
Administration (HRSA)
_______________________________________________________________________
1275. HEALTH EDUCATION ASSISTANCE LOAN (HEAL) PROGRAM: LENDERS'
PERFORMANCE STANDARDS
Significance:
Subject to OMB review: Yes
Legal Authority: 42 USC 216; 42 USC 292 to 292o
CFR Citation: 42 CFR 60
Legal Deadline: NPRM, Statutory, October 13, 1993.
Abstract: This Notice of Proposed Rulemaking proposes to amend the
existing regulations governing the HEAL Program to establish standards
for lenders and holders as required by the Health Professions Education
Extension Amendments of 1992 (Pub. L. 102-408). These standards would
provide lenders and holders a greater incentive to work to maintain low
HEAL default rates and, thus, improve the long-term solvency of the
Student Loan Insurance Fund.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 04/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Michael Heningburg, Director, Division of Student
Assistance, Bureau of Health Professions, Department of Health and
Human Services, Health Resources and Services Administration, 5600
Fishers Lane, Parklawn Building, Room 8-48, Rockville, Maryland 20857,
301 443-1173
RIN: 0905-AD87
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Health Resources and Services
Administration (HRSA)
_______________________________________________________________________
1276. GRANTS FOR NURSE PRACTITIONER AND NURSE-MIDWIFERY PROGRAMS
Significance:
Subject to OMB review: Yes
Legal Authority: 42 USC 216; 42 USC 296m
CFR Citation: 42 CFR 57, subpart Y
Legal Deadline: None
Abstract: This Notice of Proposed Rulemaking amends the Grants for
Nurse Practitioner and Nurse Midwifery Programs regulations to bring
the existing regulations into conformity with amendments made by the
Health Professions Extension Amendments of 1992 (Pub. L. 102-408) and
to include other changes to bring the regulations into line with
current national nursing standards for education and practice.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 07/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Marla E. Salmon, ScD. RN, Director, Division of
Nursing, Bureau of Health Professions, Department of Health and Human
Services, Health Resources and Services Administration, 9-35, Parklawn
Building, 5600 Fishers Lane, Rockville, MD 20857, 301 443-5786
RIN: 0905-AE11
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Health Resources and Services
Administration (HRSA)
_______________________________________________________________________
1277. GRANTS FOR FACULTY TRAINING PROJECTS IN GERIATRIC MEDICINE AND
DENTISTRY
Significance:
Subject to OMB review: Yes
Legal Authority: 42 USC 216; 42 USC 294o
CFR Citation: 42 CFR 57, subpart PP
Legal Deadline: None
Abstract: This Notice of Proposed Rulemaking amends the Grants for
Faculty Training Projects in Geriatric Medicine and Dentistry
regulations to bring the existing regulations into conformity with
technical amendments made by the Health Professions Extension
Amendments of 1992 (Pub. L. 102-408); to propose two new definitions
for ``relevant advanced training or experience'' and ``geriatric
psychiatry''; and to remove a section regarding the period of time for
fellowship appointments for more flexibility in implementing the
program.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 03/03/94 59 FR 10104
NPRM Comment Period End 04/04/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Neil H. Sampson, Director, Division of Associated,
Dental & Public Health Professions, BHPr, Department of Health and
Human Services, Health Resources and Services Administration, Room 8-
101, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857, 301
443-6853
RIN: 0905-AE13
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Health Resources and Services
Administration (HRSA)
_______________________________________________________________________
1278. MEDICAL FACILITY CONSTRUCTION AND MODERNIZATION
REQUIREMENTS FOR PROVISION OF SERVICES TO PERSONS UNABLE TO PAY
Significance:
Subject to OMB review: Yes
Legal Authority: 42 USC 291 et seq; 42 USC 300q et seq
CFR Citation: 42 CFR 124 subpart F
Legal Deadline: None
Abstract: The current regulations stipulate that an indigent is
ineligible for Hill-Burton uncompensated services if the individual is
covered under a third-party insurance or governmental program. This
requirement has created major compliance problems for many Hill-Burton
obligated nursing homes. In most of these nursing homes, the only
individuals who meet the income eligibility requirements for receipt of
Hill-Burton uncompensated services (Category A and B eligibility) are
also covered by their State's Medicaid program; hence, they are by
definition ineligible for Hill-Burton uncompensated services. The
proposed regulations would address this problem by establishing a third
income- eligibility level (Category C) for nursing homes, which would
allow individuals whose annual incomes are greater than those under
Category A and B to be eligible for nursing home services. This would
result in a limit substantially above the Medicaid income eligibility
limit, thus allowing more individuals to be eligible for services in
Hill-Burton nursing homes.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 04/04/94 59 FR 15693
NPRM Comment Period End 06/03/94 59 FR 15693
Small Entities Affected: Organizations
Government Levels Affected: None
Agency Contact: Charlotte G. Pascoe, Director, Division of Facilities
Compliance, Bureau of Health Resources Development, Department of
Health and Human Services, Public Health Service, 5600 Fishers Lane,
Room 11-19, Parklawn Building, Rockville, Maryland 20857, 301 443-5656
RIN: 0905-AE33
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--Health Resources and Services
Administration (HRSA)
_______________________________________________________________________
1279. NATIONAL VACCINE INJURY COMPENSATION (NVIC) PROGRAM: REVISIONS TO
THE VACCINE INJURY TABLE
Significance:
Subject to OMB review: Yes
Legal Authority: 42 USC 216; 42 USC 300aa-14; 42 USC 300aa-1 note.
CFR Citation: 42 CFR 100
Legal Deadline: NPRM, Statutory, December 22, 1990.
Section 312 of PL 99-660 requires the Secretary to propose regulations
to amend the Vaccine Injury Table, based on the findings of the
Institute of Medicine (IOM) study, (cont)
Abstract: The National Vaccine Injury Compensation (NVIC) Program,
administered by the Secretary, and governed by subtitle 2 of title XXI
of the Public Health Service Act, as enacted by the National Childhood
Vaccine Injury Act of 1986 (the Act), provides a system of no-fault
compensation for certain individuals who have been injured by specific
childhood vaccines. The nature of the injuries, disabilities,
illnesses, conditions, and deaths which will be presumed to result from
the administration of specific vaccines, and the time period in which
the first symptom or manifestation of onset must occur for this
presumption to apply, are outlined in section 2114 of the Act in what
is known as the Vaccine Injury Table. This Final Rule makes refinements
to the Vaccine Injury Table to more accurately reflect current
scientific knowledge about the conditions that result from vaccines
which will result in appropriate compensation for injuries related to
vaccines.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 08/14/92 57 FR 36878
Public Hearing 10/29/92 57 FR 49055
NPRM Comment Period End 02/11/93
Final Action 04/00/94
Small Entities Affected: None
Government Levels Affected: None
Additional Information: LEGAL DEADLINE CONT: within 3 years of the
effective date of title III (12/22/87). Since the IOM study was not
completed until August 1991, it was not possible to meet this legal
deadline. This section also requires the Final regulation to be
published 6 months after the NPRM. Given the 180-day comment period,
the 6-month requirement is an impossibility.
Agency Contact: Thomas E. Balbier, Jr., Director, Division of Vaccine
Injury Compensation Program, BHPr, Department of Health and Human
Services, Health Resources and Services Administration, 5600 Fishers
Lane, Parklawn Building, Room 8A35, Rockville, Maryland 20857, 301 443-
6593
RIN: 0905-AD64
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--Health Resources and Services
Administration (HRSA)
_______________________________________________________________________
1280. MATERNAL AND CHILD HEALTH (MCH) PROJECT GRANTS
Significance:
Subject to OMB review: Yes
Regulatory Plan entry: Undetermined
Legal Authority: 42 USC 702(a)
CFR Citation: 42 CFR 51a
Legal Deadline: None
Abstract: This proposed rule revises existing regulations governing the
Maternal and Child Health (MCH) Federal Set-Aside programs to
accommodate changing policy concerns, implement data collection
requirements established under the Omnibus Budget Reconciliation Act
(OBRA) of 1989 (Pub. L. 101-239), and make other technical or
clarifying changes. This proposed rule will bring the existing
regulations up-to-date with current Department policy and statutory
amendments to these programs.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 07/21/93 58 FR 38995
NPRM Comment Period End 09/20/93 58 FR 38995
Final Action 04/00/94
Small Entities Affected: Businesses, Governmental Jurisdictions,
Organizations
Government Levels Affected: State, Local, Federal
Agency Contact: Lynn Squire, Reports Clearance Officer/Office of
Program Development, Maternal & Child Health Bureau, Department of
Health and Human Services, Health Services Administration, 5600 Fishers
Lane, Parklawn Building, Room 18-20, Rockville, Maryland 20857, 301
443-2778
RIN: 0905-AD88
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--Health Resources and Services
Administration (HRSA)
_______________________________________________________________________
1281. MEDICAL FACILITY CONSTRUCTION AND MODERNIZATION; REQUIREMENTS FOR
PROVISION OF SERVICES TO PERSONS UNABLE TO PAY
Significance:
Subject to OMB review: Yes
Legal Authority: 42 USC 291 et seq; 42 USC 300q et seq
CFR Citation: 42 CFR 124 subpart F
Legal Deadline: None
Abstract: The proposed rule would revise the rules currently governing
how certain health care facilities, assisted under titles VI and XVI of
the Public Health Service Act, fulfill the assurance given in their
applications for assistance that they would provide a reasonable volume
of services to persons unable to pay. Public comment on the current
rules and operational experience with them has indicated the need to
revise the current requirements with respect to nonprofit facilities
that provide substantial amounts of free or below-cost care under their
own programs but are unable, under current requirements, to credit such
care toward fulfillment of their assurance. The intended effect of
these proposed rules is to allow qualified facilities to satisfy their
uncompensated services assurance through their continued provision of
free or below-cost health services.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 11/04/93 58 FR 58828
NPRM Comment Period End 01/03/94
Final Action 08/00/94
Small Entities Affected: Organizations
Government Levels Affected: None
Agency Contact: Charlotte G. Pascoe, Director, Div. of Facilities and
Compliance, Bureau of Health Resources Development, Department of
Health and Human Services, Health Resources and Services
Administration, Room 11-19 Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857, 301 443-5656
RIN: 0905-AE06
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--Health Resources and Services
Administration (HRSA)
_______________________________________________________________________
1282. GRANTS FOR THE ESTABLISHMENT OF DEPARTMENTS OF FAMILY MEDICINE
Significance:
Subject to OMB review: Yes
Legal Authority: 42 USC 216; 42 USC 293k
CFR Citation: 42 CFR 57, subpart R
Legal Deadline: None
Abstract: This Notice of Proposed Rulemaking amends the Grants for the
Establishment of Departments of Family Medicine regulations to expand
the definition of ``academic administrative unit'' to clarify which
academic administrative units are eligible for support under the
authority of section 747 of the Public Health Service Act.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Final Action 05/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Marc L. Rivo, M.D., Director, Division of Medicine,
Bureau of Health Professions, Department of Health and Human Services,
Health Resources and Services Administration, Room 4C-25, Parklawn
Building, 5600 Fishers Lane, Rockville, MD 20857, 301 443-6190
RIN: 0905-AE17
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--Health Resources and Services
Administration (HRSA)
_______________________________________________________________________
1283. NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON
PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS: AMENDMENT TO DATA BANK
REGULATIONS TO COMPLY WITH COURT ORDER
Significance:
Subject to OMB review: Yes
Legal Authority: 42 USC 11101 et seq
CFR Citation: 45 CFR 60
Legal Deadline: None
Abstract: These regulations amend the current regulations under section
60.7(a) and (c) to require reporting of medical malpractice payments
only by entities which make these payments on behalf of physicians and
other health care practitioners, deleting the requirement of reporting
by persons who make such payments.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Final Action 06/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Thomas C. Croft, Director, Division of Quality
Assurance, Bureau of Health Professions, Department of Health and Human
Services, Health Resources and Services Administration, Room 8-67,
Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857, 301
443-2300
RIN: 0905-AE38
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Public Health Service (PHS)--Health Resources and Services
Administration (HRSA)
_______________________________________________________________________
1284. HEALTH EDUCATION ASSISTANCE LOAN (HEAL) PROGRAM: SCHOOL COLLECTION
ASSISTANCE
Significance:
Subject to OMB review: Yes
CFR Citation: 42 CFR 60
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 12/21/93 58 FR 67346
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: James W. Farrington, D.M.D., 301 443-1173
RIN: 0905-AC87
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Public Health Service (PHS)--Health Resources and Services
Administration (HRSA)
_______________________________________________________________________
1285. HEALTH EDUCATION ASSISTANCE LOAN (HEAL) PROGRAM: POSTJUDGMENT
COLLECTIONS
CFR Citation: 42 CFR 60
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Withdrawn - Recent program
development obviates need for
regulation. 02/04/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Michael Heningburg, 301 443-1173
RIN: 0905-AD11
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Public Health Service (PHS)--Health Resources and Services
Administration (HRSA)
_______________________________________________________________________
1286. NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON
PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS: AUTHORIZED AGENTS
CFR Citation: 45 CFR 60
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Withdrawn - Recent program
development obviates need for
regulation. 02/07/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Thomas C. Croft, 301 443-2300
RIN: 0905-AE10
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Public Health Service (PHS)--Health Resources and Services
Administration (HRSA)
_______________________________________________________________________
1287. NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON
PHYSICIANS AND OTHER HEALTH PRACTITIONERS: AMENDMENTS TO COLLECTION OF
USER FEES
CFR Citation: 45 CFR 60
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Withdrawn -Action to be
incorporated into more
comprehensive package. 02/04/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Thomas C. Croft, 301 443-2300
RIN: 0905-AE15
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Public Health Service (PHS)--Health Resources and Services
Administration (HRSA)
_______________________________________________________________________
1288. GRANTS FOR HEALTH PROFESSIONS PROJECTS IN GERIATRICS
Significance:
Subject to OMB review: Yes
CFR Citation: 42 CFR 57, subpart OO
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 12/20/93 58 FR 66297
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Neil H. Sampson, 301 443-6853
RIN: 0905-AE16
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Indian Health Service (IHS)
_______________________________________________________________________
1289. INDIAN HEALTH SERVICE LOAN REPAYMENT PROGRAM REGULATIONS
Significance:
Subject to OMB review: Undetermined
Legal Authority: PL 100-713
CFR Citation: 42 CFR 36
Legal Deadline: None
Abstract: Public Law 100-713, enacted November 23, 1988, authorized a
program in which health professionals would have their health
professions education loans repayed in amounts up to a maximum of
$25,000 per year in exchange for service in an Indian health program.
The Secretary is directed to implement some provisions by regulations,
i.e., waiver provision. P. L. 102-573 raised the maximum to $35,000 for
repayment of educational loans.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 04/00/94
NPRM Comment Period End 06/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Linus Everling, Chief, Scholarship Branch, Indian
Health Service, Department of Health and Human Services, Public Health
Service, 12300 Twinbrook Parkway, Suite 100, Rockville, MD 20852, 301
443-6197
RIN: 0905-AC96
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Indian Health Service (IHS)
_______________________________________________________________________
1290. INDIAN HEALTH SERVICE CATASTROPHIC HEALTH EMERGENCY FUND PROGRAM
Significance:
Subject to OMB review: Undetermined
Legal Authority: PL 100-713
CFR Citation: 42 CFR 36
Legal Deadline: None
Abstract: Public Law 100-713, enacted November 23, 1988, authorized a
new program establishing a catastrophic health emergency fund. The
Secretary is directed to establish the program by regulations
consistent with provisions of the Law including a definition of a
catastrophic disease.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/00/94
NPRM Comment Period End 08/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Richard J. McCloskey, Dir., Div. of Legislation and
Regulations, Indian Health Service, Department of Health and Human
Services, Public Health Service, 12300 Twinbrook Parkway., Suite 450,
Rockville, MD 20852, 301 443-1116
RIN: 0905-AC97
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Indian Health Service (IHS)
_______________________________________________________________________
1291. REVISION OF INDIAN SELF-DETERMINATION REGULATIONS
Significance:
Subject to OMB review: Undetermined
Legal Authority: PL 93-638; PL 100-202; PL 100-446; PL 100-472; PL
100-581; PL 101-301; 25 USC 450
CFR Citation: 42 CFR 36; 48 CFR 380.4; 48 CFR 352.280-4
Legal Deadline: NPRM, Statutory, May 5, 1989. Final, Statutory, August
5, 1989.
Abstract: Public Law 93-638 passed in 1975, requires the IHS to turn
over administrative responsibility for services delivery programs to
tribes so requesting, using the mechanism of contracting. Public Law
93-638 also authorizes the IHS to make grants to tribe(s) for the
planning, development, and or operations of health programs. Public Law
100-472, enacted October 5, 1988, made significant changes to the
statute and required that regulations implementing the amendments be
promulgated in final within ten months of enactment. The law provides
for tribal consultation and participation in the development of the
regulations.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 01/20/94 59 FR 3166
NPRM Comment Period End 05/20/94
Final Action 11/00/94
Small Entities Affected: None
Government Levels Affected: Tribal
Procurement: This is a procurement-related action for which there is a
statutory requirement. There is a paperwork burden associated with this
action.
Additional Information: The Act (P.L. 100-472) provides that except for
construction contracts, the Office of Federal Procurement Policy Act
and Federal Acquisition Regulations shall not apply to self-
determination contracts. Therefore, implementing regulations for the
Indian Self-Determination Act amendments will include a subpart on
construction contracts which, unlike other self-determination awards,
will be made subject to certain procurement rules (e.g., FARS, HSARS,
FSARS).
Agency Contact: Richard J. McCloskey, Dir., Div. of Legislation and
Regulations, Indian Health Service, Department of Health and Human
Services, Public Health Service, 12300 Twinbrook Parkway, Suite 450,
Rockville, MD 20852, 301 443-1116
RIN: 0905-AC98
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Indian Health Service (IHS)
_______________________________________________________________________
1292. REVISION OF URBAN INDIAN HEALTH REGULATIONS
Significance:
Subject to OMB review: Undetermined
Legal Authority: PL 100-713
CFR Citation: 42 CFR 36
Legal Deadline: None
Abstract: P.L. 100-713, enacted November 23, 1988, requires the
Secretary to prescribe, by regulation, the criteria for selecting urban
Indian organizations to enter into contracts.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/00/94
NPRM Comment Period End 08/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Richard J. McCloskey, Dir., Div. of Legislation and
Regulations, Indian Health Service, OPEL, Department of Health and
Human Services, Public Health Service, 12300 Twinbrook Parkway, Suite
450, Rockville, MD 20852, 301 443-1116
RIN: 0905-AD20
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Indian Health Service (IHS)
_______________________________________________________________________
1293. ACQUISITION UNDER THE BUY INDIAN ACT
Significance:
Subject to OMB review: Undetermined
Legal Authority: 25 USC 47
CFR Citation: 48 CFR ch 3, app A
Legal Deadline: None
Abstract: This regulation will update and standardize existing
regulations for the Buy Indian Act to coincide with the Department of
Interior regulations at 48 CFR Chapter 14. There are no costs
associated with these revised regulations. These revisions will
increase competition among Indian economic enterprises and facilitate
economic development of Indian reservations by increasing opportunities
for Indian businesses.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
NPRM Comment Period End 00/00/00
Small Entities Affected: None
Government Levels Affected: Tribal
Procurement: This is a procurement-related action for which there is a
statutory requirement. The agency has not yet determined whether there
is a paperwork burden associated with this action.
Agency Contact: Myrna Mooney, Small and Disadvantaged Business
Utilization, Specialist, Department of Health and Human Services,
Public Health Service, 12300 Twinbrook Parkway - Suite 450, Rockville,
MD 20852, 301 443-1480
RIN: 0905-AE09
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--Indian Health Service (IHS)
_______________________________________________________________________
1294. REVIEW OF THE DETERMINATION OF AN INDIAN TRIBE'S RESOURCE
DEFICIENCY LEVEL
Significance:
Subject to OMB review: Undetermined
Legal Authority: PL 100-713
CFR Citation: 42 CFR 36
Legal Deadline: None
Abstract: P.L. 100-713, enacted November 23, 1988, requires the
Secretary to establish, by regulation, procedures which would allow any
Indian tribe to petition the Secretary for a review of any
determination of the health resources deficiency level of such tribe.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 10/10/91 56 FR 51189
NPRM Comment Period End 12/09/91 56 FR 51189
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Richard J. McCloskey, Dir., Div. of Legislation and
Regulations, Indian Health Service, OPEL, Department of Health and
Human Services, Public Health Service, 12300 Twinbrook Parkway, Suite
450, Rockville, MD 20852, 301 443-1116
RIN: 0905-AD21
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--National Institutes of Health (NIH)
_______________________________________________________________________
1295. GRANTS FOR RESEARCH PROJECTS
Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined
Legal Authority: 42 USC 216
CFR Citation: 42 CFR 52
Legal Deadline: None
Abstract: Regulations covering grants for research projects will be
amended to show changes necessitated by enactment of Public Laws 99-
158, 99-660, 100-607, 101-549, 101-613, 102-222, 102-321, and 102-588,
and to show their applicability to various programs administered by the
Centers for Disease Control and the Food and Drug Administration
previously omitted from the regulations.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/00/94
Small Entities Affected: Undetermined
Government Levels Affected: None
Agency Contact: John J. Migliore, NIH Regulations Officer, Department
of Health and Human Services, National Institutes of Health, 9000
Rockville Pike, 31/3B07, Bethesda, MD 20892, 301 496-4606
RIN: 0905-AC02
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--National Institutes of Health (NIH)
_______________________________________________________________________
1296. NATIONAL INSTITUTES OF HEALTH AIDS RESEARCH LOAN REPAYMENT PROGRAM
Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined
Legal Authority: 42 USC 216; 42 USC 288-1
CFR Citation: 42 CFR 68
Legal Deadline: None
Abstract: Section 634 of PL 100-607 creates a new program through which
health professionals can obtain federally funded repayment of
educational loans by conducting AIDS research as NIH employees. The new
regulations will cover this program.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/00/94
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Marc Horowitz, Director, NIH AIDS Research Loan
Repayment Program, Department of Health and Human Services, Public
Health Service, Office of AIDS Research, National Institutes of Health,
9000 Rockville Pike, Bethesda, MD 20892, 301 496-0357
RIN: 0905-AD18
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--National Institutes of Health (NIH)
_______________________________________________________________________
1297. HAZARDOUS SUBSTANCES BASIC RESEARCH AND TRAINING GRANTS
Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined
Legal Authority: 42 USC 9660; 42 USC 216
CFR Citation: 42 CFR 65a
Legal Deadline: None
Abstract: Regulations will be promulgated concerning grants for
research and training made for the purpose of understanding, assessing,
and reducing the adverse effect on human health of exposure to
hazardous substances. The grants are authorized by section 311(a) of
the Comprehensive Environmental Response, Compensation, and Liability
Act (CERCLA) of 1980, as added by section 209 of the Superfund
Amendments and Reauthorization Act (SARA) of 1986, P.L. 99-499.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Dr. William A. Suk, Program Administrator, Division of
Extramural Research and Training, Department of Health and Human
Services, Public Health Service, NIEHS, P.O. Box 12233, Research
Triangle Park, NC 27709, 919 541-0797
RIN: 0905-AD46
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--National Institutes of Health (NIH)
_______________________________________________________________________
1298. NATIONAL INSTITUTES OF HEALTH CONSTRUCTION GRANTS
Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined
Legal Authority: 42 USC 216; 42 USC 285a-2; 42 USC 285a-3; 42 USC
285a-4; 42 USC 285b-3; 42 USC 285b-4; 42 USC 285d-6; 42 USC 285i; 42
USC 285m-3; 42 USC 287a-2; 42 USC 287a-3; 42 USC 300cc-41
CFR Citation: 42 CFR 52b
Legal Deadline: None
Abstract: Regulations concerning NCI construction grants will be
amended to more clearly show their general applicability to all NIH
extramural programs with construction grant authority. Additionally,
the regulations will be amended to show new administrative and
technical requirements, add new procedures for the recovery of grant
funds for facilities no longer used for biomedical research, show new
PHS Act section numbers, and update the listing of other HHS
regulations relevant to construction grants.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: John J. Migliore, NIH Regulations Officer, Department
of Health and Human Services, Public Health Service, National
Institutes of Health, 9000 Rockville Pike, Bldg. 31, Rm 3B11, Bethesda,
Maryland 20892, 301 496-4606
RIN: 0905-AD49
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--National Institutes of Health (NIH)
_______________________________________________________________________
1299. TRAINING GRANTS
Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined
Legal Authority: 42 USC 216; 42 USC 285a-2(b)(3); 42 USC 285b; 42 USC
285c; 42 USC 285c-2; 42 USC 285c-8; 42 USC 285d; 42 USC 285d-2; 42 USC
285e,; 42 USC 285e-1; 42 USC 285f to 285g; 42 USC 285g-4(b)(1); 42 USC
285h to 285i; 42 USC 285j-1; 42 USC 285i; ...
CFR Citation: 42 CFR 63a
Legal Deadline: None
Abstract: New regulations concerning non-NRSA training grants
authorized by various PHS Act sections and training activities
authorized by section 103(h)(2) of the Clean Air Act, as amended by
section 901 of the Clean Air Act Amendments of 1990, P.L. 101-549. The
regulations are intended to serve as a standing set of regulations that
could be adapted for future training grant programs.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 07/00/94
Small Entities Affected: None
Government Levels Affected: None
Additional Information: 42 USC 285m 42 USC 287c 42 USC 287c-1 42 USC
300cc-15(b)(1) 42 USC 300cc-41(a)(5)(C) 42 USC 740(h)(2)
Agency Contact: John J. Migliore, NIH Regulations Officer, Department
of Health and Human Services, Public Health Service, National
Institutes of Health, 9000 Rockville Pike, Bldg. 31, Rm 3B-11,
Bethesda, MD 20892, 301 496-4606
RIN: 0905-AD56
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--National Institutes of Health (NIH)
_______________________________________________________________________
1300. NATIONAL INSTITUTES OF HEALTH CENTER GRANTS
Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined
Legal Authority: 42 USC 216; 42 USC 285a-3; 42 USC 285b-4; 42 USC
285c-5; 42 USC 285d-6; 42 USC 285e-2; 42 USC 285e-3; 42 USC 285f-1; 42
USC 285g-5; 42 USC 285g-7; 42 USC 285m-3; 42 USC 285o-2; 42 USC 300cc-
16
CFR Citation: 42 CFR 52a
Legal Deadline: None
Abstract: NIH Center Grants regulations will be amended to show their
applicability to the Drug Abuse Research Centers Program authorized by
PHS Act, section 464N, as added by section 123 of the ADAMHA
Reorganization Act, P.L. 102-321, and several new centers authorized
under the NIH Revitalization Act of 1993.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 07/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: John J. Migliore, NIH Regulations Officer, Department
of Health and Human Services, Public Health Service, Building 31, Room
3B-11, 9000 Rockville Pike, Bethesda, MD 20892, 301 496-4606
RIN: 0905-AE00
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--National Institutes of Health (NIH)
_______________________________________________________________________
1301. RESPONSIBILITIES OF PUBLIC HEALTH SERVICE FUNDED INSTITUTIONS FOR
PROMOTING OBJECTIVITY IN RESEARCH
Significance:
Subject to OMB review: Yes
Regulatory Plan entry: Yes
Legal Authority: 42 USC 216; 42 USC 289b-1
CFR Citation: 42 CFR 50, subpart F; 42 CFR 309
Legal Deadline: Final, Statutory, December 8, 1993.
Final rules implementing 42 U.S.C. 289b-1 must be issued not later than
180 days after June 10, l993
Abstract: PHS proposes to issue regulations requiring the institutions
that apply for or receive funding for biomedical, behavioral, and
certain other health-related research under the PHS Act to assume full
responsibility for ensuring that the financial interests of the
respective institution and the employees of the institution do not
compromise the objectivity with which PHS-funded research is conducted
or reported.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 04/00/94
Small Entities Affected: Businesses, Organizations
Government Levels Affected: None
Agency Contact: Dr. George J. Galasso, Associate Director for
Extramural Affairs, Department of Health and Human Services, Public
Health Service, NIH, Shannon Building, Room 152, Bethesda, MD 20892,
301 496-5356
RIN: 0905-AE01
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--National Institutes of Health (NIH)
_______________________________________________________________________
1302. GRANTS FOR NATIONAL ALCOHOL RESEARCH CENTERS
Significance:
Subject to OMB review: Undetermined
Legal Authority: 42 USC 216, 285n-2
CFR Citation: 42 CFR 54a
Legal Deadline: None
Abstract: Regulations governing grants for alcohol abuse and alcoholism
prevention, treatment, and rehabilitation services, and National
Alcohol Research Centers will be amended to set forth changes
necessitated by enactment of the Alcohol, Drug Abuse, and Mental Health
Administration (ADAMHA) Reorganization Act, Public Law 102-321, and
other changes necessary to update the regulations.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 04/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: John J. Migliore, NIH Regulations Officer, Department
of Health and Human Services, Public Health Service, National
Institutes of Health, Bldg. 31, Rm. 3B-11, 9000 Rockville Pike,
Bethesda, MD 20892, 301 496-2832
RIN: 0905-AE08
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--National Institutes of Health (NIH)
_______________________________________________________________________
1303. TRAINEESHIPS
Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined
Legal Authority: 42 USC 216; 42 USC 284(b)(1)(C); 42 USC 285c-8; 42
USC 286b-3; 42 USC 287c; 42 USC 287c-1
CFR Citation: 42 CFR 63
Legal Deadline: None
Abstract: Regulations concerning National Institutes of Health, and
National Library Medicine traineeships will be revised in their
entirety to cover traineeships awarded under the authority provided in
PHS Act sections 405(b)(1)(C), 421, 434, 474, 484, and 485B.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 08/06/93 58 FR 42039
NPRM Comment Period End 10/05/93
Final Action 07/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: John Migliore, NIH Regulations Officer, Department of
Health and Human Services, Public Health Service, National Institutes
of Health, 9000 Rockville Pike, Bldg. 31, Rm. 3B11, Bethesda, MD 20892,
301 496-4606
RIN: 0905-AD28
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--National Institutes of Health (NIH)
_______________________________________________________________________
1304. STANDARDS FOR BONE MARROW REGISTRIES AND CENTERS
Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined
Legal Authority: 42 USC 216; 42 USC 274k
CFR Citation: 42 CFR 122
Legal Deadline: Final, Statutory, May 14, 1991.
Abstract: Regulations will be promulgated to implement title I of PL
101-616, Transplant Amendments Act of 1990, which added section 379 to
the Public Health Service Act. Section 379 authorizes the Secretary to
establish and maintain a National Bone Marrow Donor Registry, and
further provides that the Secretary shall establish and enforce
criteria, standards, and procedures for entities participating in the
National Bone Marrow Donor Program, including the National Registry.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Interim Final Rule 06/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Paul R. McCurdy, MD, Special Assistant for Clinical
Hematology, Div. of Blood Diseases and Resources, NHLBI, Department of
Health and Human Services, Public Health Service, Federal Building,
Room 516, 7550 Wisconsin Avenue, Bethesda, MD 20892, 301 496-8387
RIN: 0905-AD51
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--National Institutes of Health (NIH)
_______________________________________________________________________
1305. NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES HAZARDOUS WASTE
WORKER TRAINING
Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined
Legal Authority: 42 USC 9660a; 42 USC 1816
CFR Citation: 42 CFR 65
Legal Deadline: None
Abstract: Regulations concerning the NIEHS Hazardous Waste Worker
Training Program will be amended to make them applicable to grants
administered under the Hazardous Materials Employee Training Grant
Program. The grants are authorized under section 118 of the Hazardous
Materials Transportation Act (HMTA), 49 USC App. 1816, as amended by
the Hazardous Materials Transportation Uniform Safety Act (HMTUSA) of
1990, P.L. 101-615.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 09/29/93 58 FR 50897
NPRM Comment Period End 11/29/93
Final Action 07/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: John J. Migliore, NIH Regulations Officer, Department
of Health and Human Services, Public Health Service, National
Institutes of Health, 9000 Rockville Pike, Bldg. 31, Rm. 3B11,
Bethesda, MD 20892, 301 496-4606
RIN: 0905-AD69
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--National Institutes of Health (NIH)
_______________________________________________________________________
1306. NATIONAL HEART, LUNG, AND BLOOD INSTITUTE GRANTS FOR
PREVENTION AND CONTROL PROJECTS
Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined
Legal Authority: 42 USC 216; 42 USC 285b-1
CFR Citation: 42 CFR 52e
Legal Deadline: None
Abstract: Regulations governing NHLBI grants for prevention and control
projects will be amended to conform them to changes in PHS Act section
419 made by the NIH Revitalization Act of 1993.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Final Action 07/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: John J. Migliore, NIH Regulations Officer, Department
of Health and Human Services, Public Health Service, NIH, Building 31,
Room 3B11, 9000 Rockville Pike, Bethesda, MD 20892, 301 496-2832
RIN: 0905-AE25
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Public Health Service (PHS)--National Institutes of Health (NIH)
_______________________________________________________________________
1307. SPECIAL VOLUNTEER SERVICES AT THE NATIONAL INSTITUTES OF HEALTH
Significance:
Subject to OMB review: Yes
CFR Citation: 45 CFR 57a
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Withdrawn - No compelling public
need under E.O. 12866. 04/01/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Stephen C. Benowitz, 301 496-3592
RIN: 0905-AC95
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Public Health Service (PHS)--National Institutes of Health (NIH)
_______________________________________________________________________
1308. MINORITY BIOMEDICAL RESEARCH SUPPORT PROGRAM
Significance:
Subject to OMB review: Yes
CFR Citation: 42 CFR 52c
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 11/19/93 58 FR 61029
Final Action Effective 12/20/93 58 FR 61029
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: John J. Migliore, 301 496-4606
RIN: 0905-AD47
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Public Health Service (PHS)--National Institutes of Health (NIH)
_______________________________________________________________________
1309. NATIONAL HEART, LUNG, AND BLOOD INSTITUTE GRANTS FOR PREVENTION AND
CONTROL PROJECTS
Significance:
Subject to OMB review: Yes
Economically significant: Undetermined
CFR Citation: 42 CFR 52e
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 10/21/93 58 FR 54297
Final Action Effective 11/22/93 58 FR 54297
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: John J. Migliore, 301 496-4606
RIN: 0905-AD48
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--Agency for Health Care Policy and Research
(AHCPR)
_______________________________________________________________________
1310. HEALTH SERVICES RESEARCH, EVALUATION, DEMONSTRATION, AND
DISSEMINATION PROJECTS; PEER REVIEW OF GRANTS AND CONTRACTS
Significance:
Subject to OMB review: Undetermined
Legal Authority: 42 USC 299c-1(e)
CFR Citation: 42 CFR 67
Legal Deadline: None
Abstract: This final rule revises the regulations under 42 CFR part 67
governing grants for health services research and grants for health
services research centers made by the former National Center for Health
Services Research and Health Care Technology Assessment (NCHSR). Public
Law 101-239, enacted on December 19, 1989, established the Agency for
Health Care Policy and Research to replace the NCHSR, and in title IX
of the PHS Act and section 1142 of the Social Security Act provided the
new agency with a much expanded role in health services research. The
final rule will reflect applicable provisions of these statutes, as
amended by P.L. 102-410.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 11/16/93 58 FR 60510
NPRM Comment Period End 01/18/94
Final Action 08/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Linda K. Demlo, Ph.D., Director, Office of Program
Development, Agency for Health Care Policy and Research, Department of
Health and Human Services, Public Health Service, Suite 603, 2101 East
Jefferson Street, Rockville, MD 20852, 301 594-2453
RIN: 0905-AD30
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Health Care Financing Administration (HCFA)
_______________________________________________________________________
1311. HOSPICE SERVICES (MB-7-P)
Significance:
Subject to OMB review: Undetermined
Legal Authority: 42 USC 1396d(a)(18); 42 USC 1396d(o); 42 USC
1396a(a)(13)(D); 42 USC 1396o(a)(2)(E)
CFR Citation: 42 CFR 418.32; 42 CFR 435.218; 42 CFR 435.231; 42 CFR
440.185; 42 CFR 447.53; 42 CFR 447.327; 42 CFR 447.381 to 447.384; 42
CFR 435.726; 42 CFR 435.735; 42 CFR 436.231
Legal Deadline: None
Abstract: This regulation would implement section 9505 of PL 99-272 by
establishing eligibility and coverage requirements, payment procedures
and conditions of participation for optional Medicaid coverage of
hospice care. It would also implement section 9435(b) of PL 99-509
regarding payment for hospice care for individuals residing in a
nursing facility or intermediate care facility in a State that has not
elected to cover hospice services. It also would implement sections
4705 and 4717 of PL 101-508 which further clarifies conditions for
payment and the scope of benefits.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 08/00/94
Small Entities Affected: Organizations
Government Levels Affected: State
Agency Contact: Robert Wardwell, Director, Division of Coverage Policy,
Department of Health and Human Services, Health Care Financing
Administration, Room 400 EHR, 6325 Security Blvd., Baltimore, MD 21207,
410 966-5659
RIN: 0938-AC52
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Health Care Financing Administration (HCFA)
_______________________________________________________________________
1312. OPTIONAL PAYMENT SYSTEM FOR LOW MEDICARE VOLUME SKILLED NURSING
FACILITIES (BPD-409-P)
Significance:
Subject to OMB review: Yes
Legal Authority: 42 USC 1395yy(d)
CFR Citation: 42 CFR 413.200; 42 CFR 413.202; 42 CFR 413.204; 42 CFR
413.208; 42 CFR 413.210; 42 CFR 413.212; 42 CFR 413.214; 42 CFR
413.216; 42 CFR 413.220; 42 CFR 413.221; 42 CFR 413.1; 42 CFR 413.24
Legal Deadline: None
Abstract: This rule proposes to allow skilled nursing facilities (SNFs)
that provide fewer than 1,500 days of care to Medicare beneficiaries in
a cost reporting period to have the option of receiving prospective
payments in the following cost reporting period. The prospective
payments would be based on components of SNF costs such as routine
operating costs, capital-related costs, and a return on equity for
proprietary facilities for routine services furnished before October 1,
1993. This rule would also specify that the return on equity provision
for proprietary SNFs is eliminated effective October 1, 1993.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 04/00/94
Small Entities Affected: None
Government Levels Affected: Undetermined
Agency Contact: William Goeller, Director, Division of Payment and
Reporting Policy, Department of Health and Human Services, Health Care
Financing Administration, Room 1-F-5 ELR, 6325 Security Blvd.,
Baltimore, MD 21207, 410 966-4513
RIN: 0938-AD02
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Health Care Financing Administration (HCFA)
_______________________________________________________________________
1313. MEDICAID ELIGIBILITY OF POVERTY LEVEL GROUPS AND EXTENDED COVERAGE
OF SERVICES (MB-13-F)
Significance:
Subject to OMB review: Yes
Legal Authority: 42 USC 1396a(a)(10); 42 USC 1396a(l); 42 USC
1396a(f); 42 USC 1396a(m); 42 USC 1396b(f); 42 USC 1396r-1; 42 USC
1396a(a)(47); 42 USC 1396a(e)(6); 42 USC 1396a(e)(7); 42 USC
1396a(a)(17)
CFR Citation: 42 CFR 431; 42 CFR 435; 42 CFR 436; 42 CFR 440; 42 CFR
447
Legal Deadline: None
Abstract: This rule amends the Medicaid regulations to incorporate
changes relating to Medicaid eligibility groups and coverage of
services made by the Medicare Catastrophic Coverage Act of 1988 (PL
100-360), the Omnibus Budget Reconciliation Acts of 1990, 1989, 1987,
and 1986, (PL 101-508, PL 101-239, PL 100-203 and PL 99-509), and the
Homeless Eligibility Clarification Act of the Anti-Drug Abuse Act of
1986 (PL 99-570). This rule adds eligibility groups of pregnant women,
infants and children, and aged and disabled individuals with incomes up
to specified percentage of the Federal poverty line; clarify
eligibility of homeless individuals; and add provisions for the
presumptive eligibility period for pregnant women who, based on
preliminary information, appear to meet income requirements under
Medicaid.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 03/23/94 59 FR 13666
NPRM Comment Period End 05/23/94
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: State, Local
Agency Contact: Marinos Svolos, Director, Division of Eligibility
Policy, Medicaid Bureau, Department of Health and Human Services,
Health Care Financing Administration, Room 323 East High Rise, 6325
Security Blvd., Baltimore, MD 21207, 410 966-4451
RIN: 0938-AD17
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Health Care Financing Administration (HCFA)
_______________________________________________________________________
1314. TRANSFER OF RESOURCES FOR LESS THAN FAIR MARKET VALUE (MB-10-P)
Significance:
Subject to OMB review: Undetermined
Legal Authority: 42 USC 1396p(c)
CFR Citation: 42 CFR 435; 42 CFR 436
Legal Deadline: None
Abstract: These regulations would conform the Medicaid regulations to
section 1917(c) of the Social Security Act, which was extensively
revised by section 303(b) of MCCA '88 (PL 100-360) as amended by
section 608(d)(16)(B) of FSA '88 (PL 100-485) and section 6411(e)(1) of
based services with no time limit on the penalty if these individuals
or their spouses made transfers of assets (including establishing
trusts under certain conditions) for less than fair market value during
a prohibited period. The period of ineligibility applies if the
individual or spouse made a transfer of assets for less than fair
market value at any time during or after the 36-month period
immediately before a date established according to a formula
established in the law.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/00/94
Small Entities Affected: None
Government Levels Affected: State, Local
Additional Information: ABSTRACT CONT: This rule will also reflect
statutory revisions mandated by OBRA '93.
Agency Contact: Marinos Svolos, Director, Division of Eligibility
Policy, Department of Health and Human Services, Health Care Financing
Administration, Room 323 EHR, 6325 Security Blvd., Baltimore, MD 21207,
410 966-4451
RIN: 0938-AD18
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Health Care Financing Administration (HCFA)
_______________________________________________________________________
1315. MEDICARE COVERAGE OF OUTPATIENT OCCUPATIONAL THERAPY SERVICES (BPD-
425-P)
Significance:
Subject to OMB review: Undetermined
Legal Authority: 42 USC 1395x(g); 42 USC 1395x(p); 42 USC 1395x(w)(1)
CFR Citation: 42 CFR 400.202; 42 CFR 410; 42 CFR 424; 42 CFR 484; 42
CFR 485; 42 CFR 489
Legal Deadline: None
Abstract: This rule would implement section 9337 of PL 99-509 which
provides Medicare coverage for outpatient occupational therapy services
furnished by providers and independent practitioners, identical to the
coverage for outpatient physical therapy. It also would implement
section 6133(a) of PL 101-239 which increased the payment limit for
outpatient occupational therapy services provided by independent
practitioners. This proposed rule would also redesignate current
subpart Q of part 405 of the Medicare rules as new part 485.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Marsha Klamner, Program Analyst, Alternative Delivery
Organizations Branch, Department of Health and Human Services, Health
Care Financing Administration, Rm. 401, EHR, 6325 Security Blvd.,
Baltimore, MD 21207, 410 966-4632
RIN: 0938-AD32
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Health Care Financing Administration (HCFA)
_______________________________________________________________________
1316. REVISIONS TO THE FREEDOM OF INFORMATION REGULATIONS (OPA-1-P)
Significance:
Subject to OMB review: Yes
Legal Authority: 5 USC 552; EO 12600
CFR Citation: 42 CFR 401.101 to 401.104; 42 CFR 401.110 to 401.112; 42
CFR 401.120 to 401.125; 42 CFR 401.130 to 401.138; 42 CFR 401.140 to
401.145; 42 CFR 401.150 to 401.154
Legal Deadline: None
Abstract: This rule proposes changes to the regulations implementing
the Freedom of Information Act (FOIA). The regulations are being
revised based on HCFA's experience with the FOIA in administering the
Medicare and Medicaid programs. This rule would also conform HCFA's
FOIA regulations to regulations published by the Department of Health
and Human Services, as well as to guidance issued by the Office of
Management and Budget, the Department of Justice, Presidential
Executive Order 12600, and to the Freedom of Information Reform Act of
1986.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/00/94
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Martha DiSario, Acting Director, Office of Public
Affairs, Department of Health and Human Services, Health Care Financing
Administration, Room 435-H HHH Building, 200 Independence Avenue SW.,
Washington, DC 20201, 202 690-6113
RIN: 0938-AD60
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Health Care Financing Administration (HCFA)
_______________________________________________________________________
1317. NEW MINIMUM STANDARDS FOR MEDICARE SUPPLEMENTAL (MEDIGAP) POLICIES
(BPD-491-P)
Significance:
Subject to OMB review: Undetermined
Legal Authority: 42 USC 1395u; 42 USC 1395ss
CFR Citation: 42 CFR 403.200; 42 CFR 403.201; 42 CFR 403.205; 42 CFR
403.206; 42 CFR 403.210; 42 CFR 403.211 to 403.220; 42 CFR 403.222; 42
CFR 403.224; 42 CFR 403.226; 42 CFR 403.228; 42 CFR 403.229; 42 CFR
403.231; 42 CFR 403.332; 42 CFR 403.239; 42 CFR 403.250 to 403.258
Legal Deadline: None
Abstract: This rule would organize and codify in regulations the
statutory changes to Medigap provisions made in 1987, 1988, 1989, and
1990. It will contain specific procedures for review of State
regulatory plans (and individual policies) as required in OBRA '90. The
new standards were enacted by OBRA '87, and '90, the Medicare
Catastrophic Coverage Act of 1988 and the Medicare Catastrophic
Coverage Repeal Act of 1989.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Additional Information:
TIMETABLE: Under development.
Agency Contact: Thomas E. Hoyer, Director, Div. of Provider Services
Coverage Policy, Department of Health and Human Services, Health Care
Financing Administration, Room 401, EHR, 6325 Security Boulevard,
Baltimore, Maryland 21207, 410 966-4607
RIN: 0938-AD82
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Health Care Financing Administration (HCFA)
_______________________________________________________________________
1318. CLARIFICATION OF ``WITHOUT FAULT'' AS IT APPLIES TO PHYSICIAN
PROVIDER AND SUPPLIER LIABILITY (BPD-719-P)
Significance:
Subject to OMB review: Undetermined
Legal Authority: 42 USC 1395gg
CFR Citation: 42 CFR 405.350 to 405.355; 42 CFR 405.356 to 405.361; 20
CFR 404.506 to 510
Legal Deadline: None
Abstract: This rule would amend the Medicare regulations to clarify our
interpretation of ``without fault'' as it applies to physician,
provider, supplier and beneficiary liability for overpayments. This
definition would result in greater uniformity of determinations by
carriers and intermediaries. Additionally, this proposed rule would
incorporate in HCFA regulations pertinent portions of Social Security
Administration regulations dealing with ``without fault.''
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 07/00/94
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Paul Olenick, Director, Division of Medicare
Eligibility Policy, Department of Health and Human Services, Health
Care Financing Administration, Room 401, EHR, 6325 Security Boulevard,
Baltimore, Maryland 21207, 410 966-4472
RIN: 0938-AD95
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Health Care Financing Administration (HCFA)
_______________________________________________________________________
1319. PROTECTION OF INCOME AND RESOURCES FOR COMMUNITY SPOUSE (MB-23-P)
Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined
Legal Authority: 42 USC 1396r-5
CFR Citation: 42 CFR 435.630; 42 CFR 435.632; 42 CFR 435.634; 42 CFR
435.636; 42 CFR 435.638; 42 CFR 435.640; 42 CFR 435.642; 42 CFR
435.644; 42 CFR 435.646; 42 CFR 435.648
Legal Deadline: None
Abstract: These regulations would interpret section 303(a) of MCCA '88,
as amended by section 608(d)(16)(A) of the FSA (PL 100-485), section
6411(e)(3) of OBRA '89 (PL 101-239) and section 4714 of OBRA '90 (PL
101-508). Section 303(a) allocates income and resources between a
spouse who is institutionalized and the spouse remaining in the
community. It also provides special post- eligibility rules for
institutionalized individuals who have spouses in the community. The
revision would allow the community spouse to retain more income to meet
living expenses.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 07/00/94
Small Entities Affected: Undetermined
Government Levels Affected: State, Local
Agency Contact: Marinos Svolos, Director, Division of Eligibility
Policy, Department of Health and Human Services, Health Care Financing
Administration, Room 323, EHR, 6325 Security Boulevard, Baltimore,
Maryland 21207, 410 966-4451
RIN: 0938-AE12
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Health Care Financing Administration (HCFA)
_______________________________________________________________________
1320. PHYSICIAN CERTIFICATION AND PLAN OF CARE REQUIREMENTS AND
INSPECTION OF CARE REVIEWS (HSQ-178-P)
Significance:
Subject to OMB review: Undetermined
Legal Authority: 42 USC 1396b(g); 42 USC 1396a(a)(30); 42 USC
1396a(a)(44)
CFR Citation: 42 CFR 400; 42 CFR 440; 42 CFR 441; 42 CFR 456; 42 CFR
483
Legal Deadline: None
Abstract: This proposed rule would make the requirements for physician
certification and development of a plan of care general State plan
requirements. States would no longer be required to make quarterly
showings that they had determined compliance with those requirements or
with utilization review. A quarterly demonstration to the Secretary of
an effective program of medical review as demonstrated by a
satisfactory utilization control program would be limited to
Inspections of Care (IOCs) in participating Intermediate Care
Facilities/Mentally Retarded (ICFs/MR) and psychiatric hospitals. This
rule will establish review criteria specifically for ICFs/MRs that
ensure essential client protections and focus on the provision of
active treatment. This rule will also clarify utilization control
requirements included in 42 CFR part 456, Subpart S.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 09/00/94
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Helene Fredeking, Director, Division of Long Term Care
Services, Department of Health and Human Services, Health Care
Financing Administration, 2-D-2, ME, 6325 Security Boulevard,
Baltimore, Maryland 21207, 410 966-6807
RIN: 0938-AE17
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Health Care Financing Administration (HCFA)
_______________________________________________________________________
1321. MEDICAID PAYMENT OF MEDICARE COST SHARING FOR QUALIFIED MEDICARE
BENEFICIARIES AND QUALIFIED DISABLED AND WORKING INDIVIDUALS AND
SPECIFIED LOW-INCOME MEDICARE BENEFICIARIES (MB-031-P)
Significance:
Subject to OMB review: Yes
Legal Authority: 42 USC 1396a(a)(10)(E); Clause VIII of the matter
following 42 USC 1396a(a)(10)(F); 42 USC 1396a(e)(8); 42 USC
1396a(m)(4); 42 USC 1396a(n); 42 USC 1396b(f)(4); 42 USC 1396d(a); 42
USC 1396d(p); 42 USC 1302
CFR Citation: 42 CFR 431.625; 42 CFR 435; 42 CFR 436; 42 CFR 441.256;
42 CFR 447.600 to 447.620; 42 CFR 447.51; 42 CFR 447.53
Legal Deadline: None
Abstract: These rules would propose to require States to include in
their State plans payment of Medicare cost-sharing for specified low-
income Medicare beneficiaries (SLMBS), Qualified Medicare Beneficiaries
(QMB) and Qualified Disabled and Working Individuals (QDWI). The
territories have the option to do the same. We would define cost-
sharing, specify criteria for determining QMB status, propose
requirements and options for payment amounts and limitations, and
provide for Federal financial participation in State payments for
Medicare cost-sharing on behalf of QMBs. For QDWIs Federal financial
participation would be limited to Medicare, Part A premium. The changes
would implement provisions of MCCA '88 as modified by the FSA '88, TMRA
'88, OBRA '89, and OBRA '90. Many of these provisions went into effect
January 1, 1989.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/00/94
Small Entities Affected: None
Government Levels Affected: State, Local
Agency Contact: Marinos Svolos, Director, Division of Eligibility
Policy, Department of Health and Human Services, Health Care Financing
Administration, Room 323, EHR, 6325 Security Blvd., Baltimore, MD
21207, 410 966-4451
RIN: 0938-AE38
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Health Care Financing Administration (HCFA)
_______________________________________________________________________
1322. POST-CONTRACT BENEFICIARY PROTECTIONS AND OTHER PROVISIONS (OCC-
011-F)
Legal Authority: 42 USC 1395mm
CFR Citation: 42 CFR 417
Legal Deadline: None
Abstract: This rule will provide Medicare beneficiaries with certain
coverage for pre-existing conditions under supplemental insurance after
non-renewal or termination of a Medicare HMO or CMP contract; provide a
30-day open enrollment period for individuals who would otherwise lose
prepaid Medicare coverage as a result of termination, non-renewal or
reduction in service area of a risk contract; accelerate the deadline
for risk contracting HMOs and CMPs to submit adjusted community rate
proposals, require all HMOs and CMPs to furnish a copy of an executed
enrollment application form to Medicare applicants, and require HCPPs
to comply with HMO/CMP beneficiary application procedures.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 03/11/94 59 FR 11230
NPRM Comment Period End 05/09/94
Final Action 00/00/00
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Tracy Jensen, Office of Coordinated Care Policy and
Planning, Department of Health and Human Services, Health Care
Financing Administration, Room 4360 Cohen Building, 330 Independence
Ave. SW., Washington, DC 20201, 202 619-2158
RIN: 0938-AE63
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Health Care Financing Administration (HCFA)
_______________________________________________________________________
1323. COVERAGE OF PHYSICIAN ASSISTANT, NURSE PRACTITIONER, AND CLINICAL
NURSE SPECIALIST SERVICES (BPD-708-P)
Significance:
Subject to OMB review: Undetermined
Legal Authority: 42 USC 1395x(s)(2)(K); 42 USC 1395u(b)(12); 42 USC
1395x(aa)
CFR Citation: 42 CFR 405; 42 CFR 410
Legal Deadline: None
Abstract: This proposed rule would conform Medicare regulations to the
provisions in sections 9338 of OBRA '86, 4076(a) of OBRA '87, 6114 of
OBRA '89, and 4155 of OBRA '90. These sections amended portions of the
Social Security Act (the Act) concerning the coverage of and payment
for certain services described in section 1861(s)(2)(K) of the Act that
are performed by physician assistants, nurse practitioners, and
clinical nurse specialists.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: Businesses
Government Levels Affected: None
Additional Information: TIMETABLE: Pending publication of 0938-AF01
(BPD-709-F).
Agency Contact: William Larson, Program Analyst, Office of Coverage &
Eligibility Policy, Department of Health and Human Services, Health
Care Financing Administration, Room 401, EHR, 6325 Security Blvd.,
Baltimore, MD 21207, 410 966-4639
RIN: 0938-AF00
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Health Care Financing Administration (HCFA)
_______________________________________________________________________
1324. UTILIZATION AND QUALITY CONTROL PEER REVIEW ORGANIZATIONS (PRO):
CONFIDENTIAL INFORMATION (HSQ-190-P)
Significance:
Subject to OMB review: Undetermined
Legal Authority: 42 USC 1320c-9
CFR Citation: 42 CFR 476
Legal Deadline: None
Abstract: This rule would revise existing regulations to clarify which
PRO information is considered confidential, to whom confidential
information may be disclosed, and the conditions for disclosure.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 01/00/95
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Harvey Brook, Office of Peer Review, Department of
Health and Human Services, Health Care Financing Administration, Room
2-D-2, ME Bldg., 6325 Security Blvd., Baltimore, MD 21207, 410 966-6853
RIN: 0938-AF03
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Health Care Financing Administration (HCFA)
_______________________________________________________________________
1325. DAY HABILITATION AND RELATED SERVICES (MB-37-P)
Significance:
Subject to OMB review: Undetermined
Legal Authority: PL 101-239, Sec 6411(g)
CFR Citation: 42 CFR 440
Legal Deadline: None
Abstract: Section 6411(g) of OBRA '89 prohibits disallowance on day
habilitation services included in State plans which were approved on or
before June 30, 1989. This prohibition will continue until clarifying
regulations are promulgated. This rule would specify the types of day
habilitation and related services that a State may cover under
paragraph (9) or (13) of section 1905(a) of the Social Security Act on
behalf of persons with mental retardation or with related conditions.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Robert Wardwell, Director, Division of Coverage Policy,
Department of Health and Human Services, Health Care Financing
Administration, Room 400, EHR, 6325 Security Blvd., Baltimore, MD
21207, 410 966-5659
RIN: 0938-AF10
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Health Care Financing Administration (HCFA)
_______________________________________________________________________
1326. MEDICAID THIRD PARTY LIABILITY: COST EFFECTIVENESS WAIVERS (MB-39-
F)
Significance:
Subject to OMB review: Yes
Legal Authority: 42 USC 1396a(a)(25)
CFR Citation: 42 CFR 433.138; 42 CFR 433.139
Legal Deadline: None
Abstract: This rule would provide States with the opportunity to
request waivers of certain third party liability requirements if the
State has more cost effective methods than those required to be used
under current regulations. These requirements relate to methods and
procedures for determining liability of third parties to pay for
services furnished under Medicaid and for paying claims. The waivers
would apply to administratively imposed requirements, not statutory
requirements.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 02/02/94 59 FR 4880
NPRM Comment Period End 04/03/94 59 FR 4880
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: State
Agency Contact: Richard Friedman, Director, Division of Payment
Systems, Department of Health and Human Services, Health Care Financing
Administration, 273, EHR, 6325 Security Blvd., Baltimore, MD 21207, 410
966-3292
RIN: 0938-AF11
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Health Care Financing Administration (HCFA)
_______________________________________________________________________
1327. OBRA '90 AND MISCELLANEOUS MANAGED CARE TECHNICAL AMENDMENTS (MB-
044-P)
Significance:
Subject to OMB review: Yes
Legal Authority: 42 USC 1396b(m); 42 USC 1396a(e)(2)(A)
CFR Citation: 42 CFR 434.21 to 44; 42 CFR 447.361; 42 CFR 447.362
Legal Deadline: None
Abstract: This rule would require certain health insuring organizations
to be subject to the regulations governing prepaid health plans. This
proposed rule would also allow State-only funds to be paid to Medicaid
contracting entities. These funds would not be considered when
computing the rate at which Federal financial participation is made.
This rule would also incorporate several technical amendments from
section 4732 of OBRA '90.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 04/00/94
Small Entities Affected: Businesses, Organizations
Government Levels Affected: State, Local
Agency Contact: Mike Fiore, Deputy Director, Medicaid Coordinated Care
Office, Department of Health and Human Services, Health Care Financing
Administration, Room 233, ELR, 6325 Security Blvd., Baltimore, MD
21207, 410 966-4460
RIN: 0938-AF15
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Health Care Financing Administration (HCFA)
_______________________________________________________________________
1328. CRITERIA FOR THE DETERMINATION OF REASONABLE COSTS FOR MEDICARE --
CONTRACTING PREPAID HEALTH PLANS (OCC-018-F)
Significance:
Subject to OMB review: Yes
Economically significant: Undetermined
Legal Authority: 42 USC 1395mm(h); 42 USC 1395x(v)(1)(A)
CFR Citation: 42 CFR 417.532(a)(3); 42 CFR 417.802; 42 CFR 417.800(c)
Legal Deadline: None
Abstract: This rule will remove the absolute payment limit that is to
be applied to Prepaid Health Organizations' cost contracts under
section 1876 of the Social Security Act. This regulation will also set
forth the revised criteria that HCFA will use in determining claimed
costs that are reasonable and therefore reimbursable for prepaid health
organizations with cost contracts under section 1876 and agreements
under section 1833.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 02/22/94 59 FR 8435
NPRM Comment Period End 04/25/94 59 FR 8435
Final Action 00/00/00
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Jennifer Messersmith, Program Analyst, Office of
Coordinated Care Policy and Planning, Department of Health and Human
Services, Health Care Financing Administration, 4360 Cohen Bldg., 330
Independence Ave. SW., Washington, DC 20201, 202 401-2325
RIN: 0938-AF16
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Health Care Financing Administration (HCFA)
_______________________________________________________________________
1329. PROVIDER REIMBURSEMENT DETERMINATIONS AND APPEALS REVISIONS (BPD-
727-P)
Significance:
Subject to OMB review: Undetermined
Legal Authority: 42 USC 1395oo
CFR Citation: 42 CFR 405
Legal Deadline: None
Abstract: This regulation would update and clarify regulations
governing the Provider Reimbursement Review Board and would deal with
such issues as the parties to a Board hearing, jurisdiction of the
Board, time periods for filing appeals, and the definition of ``good
cause'' for late filings. The Board has authority to adjudicate
disputes between providers and intermediaries under section 1878 of the
Social Security Act.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 08/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Paul Olenick, Director, Division of Medicare &
Eligibility Policy, Department of Health and Human Services, Health
Care Financing Administration, Room 401, EHR, 6325 Security Boulevard,
Baltimore, Maryland 21207, 410 966-4472
RIN: 0938-AF28
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Health Care Financing Administration (HCFA)
_______________________________________________________________________
1330. ALTERNATIVE SANCTIONS FOR PSYCHIATRIC HOSPITALS (HSQ-191-P)
Significance:
Subject to OMB review: Undetermined
Legal Authority: 42 USC 1395cc; 42 USC 1396a
CFR Citation: 42 CFR 488
Legal Deadline: None
Abstract: These regulations would provide an alternative to terminating
a psychiatric hospital's participation in the Medicare and Medicaid
programs for facilities found to be out of compliance with
participation requirements. These alternative sanctions could be
imposed instead of terminating a psychiatric hospital's participation
in the Medicare and Medicaid programs where deficiencies do not present
immediate jeopardy to the health and safety of psychiatric hospital
patients.
These amendments are necessary to conform HCFA regulations to changes
made by section 6020 of OBRA '89 (PL 101-239) and section 4755 of OBRA
'90 (PL 101-508).
The purpose of the legislation is to encourage correction of
deficiencies that do not jeopardize patient health and safety before
termination becomes necessary.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 12/00/94
Small Entities Affected: Undetermined
Government Levels Affected: State, Federal
Agency Contact: Pam Vocke, Director, Division of Program Operations,
Department of Health and Human Services, Health Care Financing
Administration, Room 2-D-2, ME, 6325 Security Boulevard, Baltimore,
Maryland 21207, 410 966-7089
RIN: 0938-AF32
_______________________________________________________________________
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Health Care Financing Administration (HCFA)
_______________________________________________________________________
1331. MEDICARE, MEDICAID, AND CLIA PROGRAMS: INSPECTION AND CERTIFICATION
PROCEDURES FOR LABORATORIES (HSQ-193-P)
Significance:
Subject to OMB review: Undetermined
Legal Authority: 42 USC 1395w-2; 42 USC 263a
CFR Citation: 42 CFR 493
Legal Deadline: None
Abstract: This rule would implement procedures for States to follow in
inspecting and certifying laboratories under CLIA '88 (PL 100-578).
This rule is needed to carry out the authority of the Department of
Health and Human Services to inspect laboratories, as mandated by
section 353(g) of the Public Health Service Act, and to take
enforcement actions as authorized by section 353(h) and (i) of the
Public Health Services Act and section 1846 of the Social Security Act.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 08/00/94
Small Entities Affected: Businesses, Governmental Jurisdictions
Government Levels Affected: State, Federal
Agency Contact: Pam Vocke, Director, Division of Program Operations,
Department of Health and Human Services, Health Care Financing
Administration, Room 2-D-2 ME, 6325 Security Boulevard, Baltimore,
Maryland 21207, 410 966-7089
RIN: 0938-AF33
_______________________________________________________________________