[107th Congress Public Law 188]
[From the U.S. Government Printing Office]
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[DOCID: f:publ188.107]
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PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF
2002
[[Page 116 STAT. 594]]
Public Law 107-188
107th Congress
An Act
To improve the ability of the United States to prevent, prepare for, and
respond to bioterrorism and other public health
emergencies. <<NOTE: June 12, 2002 - [H.R. 3448]>>
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, <<NOTE: Public Health
Security and Bioterrorism Preparedness and Response Act of 2002.>>
SECTION 1. SHORT TITLE; TABLE <<NOTE: 42 USC 201 note.>> OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Public Health
Security and Bioterrorism Preparedness and Response Act of 2002''.
(b) Table of Contents.--The table of contents of the Act is as
follows:
Sec. 1. Short title; table of contents.
TITLE I--NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC HEALTH
EMERGENCIES
Subtitle A--National Preparedness and Response Planning, Coordinating,
and Reporting
Sec. 101. National preparedness and response.
Sec. 102. Assistant Secretary for Public Health Emergency Preparedness;
National Disaster Medical System.
Sec. 103. Improving ability of Centers for Disease Control and
Prevention.
Sec. 104. Advisory committees and communications; study regarding
communications abilities of public health agencies.
Sec. 105. Education of health care personnel; training regarding
pediatric issues.
Sec. 106. Grants regarding shortages of certain health professionals.
Sec. 107. Emergency system for advance registration of health
professions volunteers.
Sec. 108. Working group.
Sec. 109. Antimicrobial resistance.
Sec. 110. Supplies and services in lieu of award funds.
Sec. 111. Additional amendments.
Subtitle B--Strategic National Stockpile; Development of Priority
Countermeasures
Sec. 121. Strategic national stockpile.
Sec. 122. Accelerated approval of priority countermeasures.
Sec. 123. Issuance of rule on animal trials.
Sec. 124. Security for countermeasure development and production.
Sec. 125. Accelerated countermeasure research and development.
Sec. 126. Evaluation of new and emerging technologies regarding
bioterrorist
attack and other public health emergencies.
Sec. 127. Potassium iodide.
Subtitle C--Improving State, Local, and Hospital Preparedness for and
Response to Bioterrorism and Other Public Health Emergencies
Sec. 131. Grants to improve State, local, and hospital preparedness for
and
response to bioterrorism and other public health emergencies.
Subtitle D--Emergency Authorities; Additional Provisions
Sec. 141. Reporting deadlines.
Sec. 142. Streamlining and clarifying communicable disease quarantine
provisions.
[[Page 116 STAT. 595]]
Sec. 143. Emergency waiver of Medicare, Medicaid, and SCHIP
requirements.
Sec. 144. Provision for expiration of public health emergencies.
Subtitle E--Additional Provisions
Sec. 151. Designated State public emergency announcement plan.
Sec. 152. Expanded research by Secretary of Energy.
Sec. 153. Expanded research on worker health and safety.
Sec. 154. Enhancement of emergency preparedness of Department of
Veterans
Affairs.
Sec. 155. Reauthorization of existing program.
Sec. 156. Sense of Congress.
Sec. 157. General Accounting Office report.
Sec. 158. Certain awards.
Sec. 159. Public access defibrillation programs and public access
defibrillation
demonstration projects.
TITLE II--ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND TOXINS
Subtitle A--Department of Health and Human Services
Sec. 201. Regulation of certain biological agents and toxins.
Sec. 202. Implementation by Department of Health and Human Services.
Sec. 203. Effective dates.
Sec. 204. Conforming amendment.
Subtitle B--Department of Agriculture
Sec. 211. Short title.
Sec. 212. Regulation of certain biological agents and toxins.
Sec. 213. Implementation by Department of Agriculture.
Subtitle C--Interagency Coordination Regarding Overlap Agents and Toxins
Sec. 221. Interagency coordination.
Subtitle D--Criminal Penalties Regarding Certain Biological Agents and
Toxins
Sec. 231. Criminal penalties.
TITLE III--PROTECTING SAFETY AND SECURITY OF FOOD AND DRUG SUPPLY
Subtitle A--Protection of Food Supply
Sec. 301. Food safety and security strategy.
Sec. 302. Protection against adulteration of food.
Sec. 303. Administrative detention.
Sec. 304. Debarment for repeated or serious food import violations.
Sec. 305. Registration of food facilities.
Sec. 306. Maintenance and inspection of records for foods.
Sec. 307. Prior notice of imported food shipments.
Sec. 308. Authority to mark articles refused admission into United
States.
Sec. 309. Prohibition against port shopping.
Sec. 310. Notices to States regarding imported food.
Sec. 311. Grants to States for inspections.
Sec. 312. Surveillance and information grants and authorities.
Sec. 313. Surveillance of zoonotic diseases.
Sec. 314. Authority to commission other Federal officials to conduct
inspections.
Sec. 315. Rule of construction.
Subtitle B--Protection of Drug Supply
Sec. 321. Annual registration of foreign manufacturers; shipping
information; drug and device listing.
Sec. 322. Requirement of additional information regarding import
components
intended for use in export products.
Subtitle C--General Provisions Relating to Upgrade of Agricultural
Security
Sec. 331. Expansion of Animal and Plant Health Inspection Service
activities.
Sec. 332. Expansion of Food Safety Inspection Service activities.
Sec. 333. Biosecurity upgrades at the Department of Agriculture.
Sec. 334. Agricultural biosecurity.
Sec. 335. Agricultural bioterrorism research and development.
Sec. 336. Animal enterprise terrorism penalties.
TITLE IV--DRINKING WATER SECURITY AND SAFETY
Sec. 401. Terrorist and other intentional acts.
[[Page 116 STAT. 596]]
Sec. 402. Other Safe Drinking Water Act amendments.
Sec. 403. Miscellaneous and technical amendments.
TITLE V--ADDITIONAL PROVISIONS
Subtitle A--Prescription Drug User Fees
Sec. 501. Short title.
Sec. 502. Findings.
Sec. 503. Definitions.
Sec. 504. Authority to assess and use drug fees.
Sec. 505. Accountability and reports.
Sec. 506. Reports of postmarketing studies.
Sec. 507. Savings clause.
Sec. 508. Effective date.
Sec. 509. Sunset clause.
Subtitle B--Funding Provisions Regarding Food and Drug Administration
Sec. 521. Office of Drug Safety.
Sec. 522. Division of Drug Marketing, Advertising, and Communications.
Sec. 523. Office of Generic Drugs.
Subtitle C--Additional Provisions
Sec. 531. Transition to digital television.
Sec. 532. 3-year delay in lock in procedures for Medicare+Choice plans;
change in Medicare+Choice reporting deadlines and annual,
coordinated election period for 2003, 2004, and 2005.
TITLE I--NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC HEALTH
EMERGENCIES
Subtitle A--National Preparedness and Response Planning, Coordinating,
and Reporting
SEC. 101. NATIONAL PREPAREDNESS AND RESPONSE.
(a) In General.--The Public Health Service Act (42 U.S.C. 201 et
seq.) is amended by adding at the end the following title:
``TITLE XXVIII--NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC
HEALTH EMERGENCIES
``Subtitle A--National Preparedness and Response Planning, Coordinating,
and Reporting
``SEC. 2801. NATIONAL <<NOTE: 42 USC 300hh.>> PREPAREDNESS PLAN.
``(a) In General.--
``(1) Preparedness and response regarding public health
emergencies.--The Secretary shall further develop and implement
a coordinated strategy, building upon the core public health
capabilities established pursuant to section 319A,
[[Page 116 STAT. 597]]
for carrying out health-related activities to prepare for and
respond effectively to bioterrorism and other public health
emergencies, including the preparation of a plan under this
section. The Secretary shall periodically thereafter review and,
as appropriate, revise the plan.
``(2) National approach.--In carrying out paragraph (1), the
Secretary shall collaborate with the States toward the goal of
ensuring that the activities of the Secretary regarding
bioterrorism and other public health emergencies are coordinated
with activities of the States, including local governments.
``(3) Evaluation of progress.--The plan under paragraph (1)
shall provide for specific benchmarks and outcome measures for
evaluating the progress of the Secretary and the States,
including local governments, with respect to the plan under
paragraph (1), including progress toward achieving the goals
specified in subsection (b).
``(b) Preparedness Goals.--The plan under subsection (a) should
include provisions in furtherance of the following:
``(1) Providing effective assistance to State and local
governments in the event of bioterrorism or other public health
emergency.
``(2) Ensuring that State and local governments have
appropriate capacity to detect and respond effectively to such
emergencies, including capacities for the following:
``(A) Effective public health surveillance and
reporting mechanisms at the State and local levels.
``(B) Appropriate laboratory readiness.
``(C) Properly trained and equipped emergency
response, public health, and medical personnel.
``(D) Health and safety protection of workers
responding to such an emergency.
``(E) Public health agencies that are prepared to
coordinate health services (including mental health
services) during and after such emergencies.
``(F) Participation in communications networks that
can effectively disseminate relevant information in a
timely and secure manner to appropriate public and
private entities and to the public.
``(3) Developing and maintaining medical countermeasures
(such as drugs, vaccines and other biological products, medical
devices, and other supplies) against biological agents and
toxins that may be involved in such emergencies.
``(4) Ensuring coordination and minimizing duplication of
Federal, State, and local planning, preparedness, and response
activities, including during the investigation of a suspicious
disease outbreak or other potential public health emergency.
``(5) Enhancing the readiness of hospitals and other health
care facilities to respond effectively to such emergencies.
``(c) Reports to Congress.--
``(1) In general.--Not <<NOTE: Deadline.>> later than one
year after the date of the enactment of the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002,
and biennially thereafter, the Secretary shall submit to the
Committee on Energy and Commerce of the House of
Representatives, and the Committee on Health, Education, Labor,
and Pensions of the Senate, a report concerning progress with
respect to the plan under
[[Page 116 STAT. 598]]
subsection (a), including progress toward achieving the goals
specified in subsection (b).
``(2) Additional authority.--Reports submitted under
paragraph (1) by the Secretary (other than the first report)
shall make recommendations concerning--
``(A) any additional legislative authority that the
Secretary determines is necessary for fully implementing
the plan under subsection (a), including meeting the
goals under subsection (b); and
``(B) any additional legislative authority that the
Secretary determines is necessary under section 319 to
protect the public health in the event of an emergency
described in section 319(a).
``(d) Rule of Construction.--This section may not be construed as
expanding or limiting any of the authorities of the Secretary that, on
the day before the date of the enactment of the Public Health Security
and Bioterrorism Preparedness and Response Act of 2002, were in effect
with respect to preparing for and responding effectively to bioterrorism
and other public health emergencies.''.
(b) Other <<NOTE: 42 USC 247d-6 note.>> Reports.--
(1) In general.--Not <<NOTE: Deadline.>> later than one year
after the date of the enactment of this Act, the Secretary of
Health and Human Services (referred to in this subsection as the
``Secretary'') shall submit to the Committee on Energy and
Commerce of the House of Representatives, and the Committee on
Health, Education, Labor, and Pensions of the Senate, a report
concerning--
(A) the recommendations and findings of the National
Advisory Committee on Children and Terrorism under
section 319F(c)(2) of the Public Health Service Act;
(B) the recommendations and findings of the EPIC
Advisory Committee under section 319F(c)(3) of such Act;
(C) the characteristics that may render a rural
community uniquely vulnerable to a biological attack,
including distance, lack of emergency transport,
hospital or laboratory capacity, lack of integration of
Federal or State public health networks, workforce
deficits, or other relevant characteristics;
(D) the characteristics that may render areas or
populations designated as medically underserved
populations (as defined in section 330 of such Act)
uniquely vulnerable to a biological attack, including
significant numbers of low-income or uninsured
individuals, lack of affordable and accessible health
care services, insufficient public and primary health
care resources, lack of integration of Federal or State
public health networks, workforce deficits, or other
relevant characteristics;
(E) the recommendations of the Secretary with
respect to additional legislative authority that the
Secretary determines is necessary to effectively
strengthen rural communities, or medically underserved
populations (as defined in section 330 of such Act); and
(F) the need for and benefits of a National Disaster
Response Medical Volunteer Service that would be a
private-sector, community-based rapid response corps of
medical volunteers.
[[Page 116 STAT. 599]]
(2) Study regarding local emergency response methods.--The
Secretary shall conduct a study of effective methods for the
provision of emergency response services through local
governments (including through private response contractors and
volunteers of such governments) in a consistent manner in
response to acts of bioterrorism or other public health
emergencies. Not <<NOTE: Deadline. Reports.>> later than 180
days after the date of the enactment of this Act, the Secretary
shall submit to the Committee on Energy and Commerce of the
House of Representatives, and the Committee on Health,
Education, Labor, and Pensions of the Senate, a report
describing the findings of the study.
SEC. 102. ASSISTANT SECRETARY FOR PUBLIC HEALTH EMERGENCY PREPAREDNESS;
NATIONAL DISASTER MEDICAL SYSTEM.
(a) In General.--Title XXVIII of the Public Health Service Act, as
added by section 101 of this Act, is amended by adding at the end the
following subtitle:
``Subtitle B--Emergency Preparedness and Response
``SEC. 2811. COORDINATION <<NOTE: 42 USC 300hh-11.>> OF PREPAREDNESS FOR
AND RESPONSE TO BIOTERRORISM AND OTHER PUBLIC HEALTH
EMERGENCIES.
``(a) Assistant Secretary for Public Health Emergency
Preparedness.--
``(1) In general.--There
is <<NOTE: Establishment.>> established within the Department of
Health and Human Services the position of Assistant Secretary
for Public Health Emergency
Preparedness. <<NOTE: President.>> The President shall appoint
an individual to serve in such position. Such Assistant
Secretary shall report to the Secretary.
``(2) Duties.--Subject to the authority of the Secretary,
the Assistant Secretary for Public Health Emergency Preparedness
shall carry out the following duties with respect to
bioterrorism and other public health emergencies:
``(A) Coordinate on behalf of the Secretary--
``(i) interagency interfaces between the
Department of Health and Human Services (referred
to in this paragraph as the `Department') and
other departments, agencies, and offices of the
United States; and
``(ii) interfaces between the Department and
State and local entities with responsibility for
emergency preparedness.
``(B) Coordinate the operations of the National
Disaster Medical System and any other emergency response
activities within the Department of Health and Human
Services that are related to bioterrorism and other
public health emergencies.
``(C) Coordinate the efforts of the Department to
bolster State and local emergency preparedness for a
bioterrorist attack or other public health emergency,
and evaluate the progress of such entities in meeting
the benchmarks and other outcome measures contained in
the national plan and in meeting the core public health
capabilities established pursuant to 319A.
[[Page 116 STAT. 600]]
``(D) Any other duties determined appropriate by the
Secretary.
``(b) National Disaster Medical System.--
``(1) In general.--The Secretary shall provide for the
operation in accordance with this section of a system to be
known as the National Disaster Medical System. The Secretary
shall designate the Assistant Secretary for Public Health
Emergency Preparedness as the head of the National Disaster
Medical System, subject to the authority of the Secretary.
``(2) Federal and state collaborative system.--
``(A) In general.--The National Disaster Medical
System shall be a coordinated effort by the Federal
agencies specified in subparagraph (B), working in
collaboration with the States and other appropriate
public or private entities, to carry out the purposes
described in paragraph (3).
``(B) Participating federal agencies.--The Federal
agencies referred to in subparagraph (A) are the
Department of Health and Human Services, the Federal
Emergency Management Agency, the Department of Defense,
and the Department of Veterans Affairs.
``(3) Purpose of system.--
``(A) In general.--The Secretary may activate the
National Disaster Medical System to--
``(i) provide health services, health-related
social services, other appropriate human services,
and appropriate auxiliary services to respond to
the needs of victims of a public health emergency
(whether or not determined to be a public health
emergency under section 319); or
``(ii) be present at locations, and for
limited periods of time, specified by the
Secretary on the basis that the Secretary has
determined that a location is at risk of a public
health emergency during the time specified.
``(B) Ongoing activities.--The National Disaster
Medical System shall carry out such ongoing activities
as may be necessary to prepare for the provision of
services described in subparagraph (A) in the event that
the Secretary activates the National Disaster Medical
System for such purposes.
``(C) Test for mobilization of system.--During the
one-year period beginning on the date of the enactment
of the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002, the Secretary
shall conduct an exercise to test the capability and
timeliness of the National Disaster Medical System to
mobilize and otherwise respond effectively to a
bioterrorist attack or other public health emergency
that affects two or more geographic locations
concurrently. Thereafter, the Secretary may periodically
conduct such exercises regarding the National Disaster
Medical System as the Secretary determines to be
appropriate.
``(c) Criteria.--
``(1) In general.--The Secretary shall establish criteria
for the operation of the National Disaster Medical System.
[[Page 116 STAT. 601]]
``(2) Participation agreements for non-federal entities.--In
carrying out paragraph (1), the Secretary shall establish
criteria regarding the participation of States and private
entities in the National Disaster Medical System, including
criteria regarding agreements for such participation. The
criteria shall include the following:
``(A) Provisions relating to the custody and use of
Federal personal property by such entities, which may in
the discretion of the Secretary include authorizing the
custody and use of such property to respond to emergency
situations for which the National Disaster Medical
System has not been activated by the Secretary pursuant
to subsection (b)(3)(A). Any such custody and use of
Federal personal property shall be on a reimbursable
basis.
``(B) Provisions relating to circumstances in which
an individual or entity has agreements with both the
National Disaster Medical System and another entity
regarding the provision of emergency services by the
individual. Such provisions shall address the issue of
priorities among the agreements involved.
``(d) Intermittent Disaster-Response Personnel.--
``(1) In general.--For the purpose of assisting the National
Disaster Medical System in carrying out duties under this
section, the Secretary may appoint individuals to serve as
intermittent personnel of such System in accordance with
applicable civil service laws and regulations.
``(2) Liability.--For purposes of section 224(a) and the
remedies described in such section, an individual appointed
under paragraph (1) shall, while acting within the scope of such
appointment, be considered to be an employee of the Public
Health Service performing medical, surgical, dental, or related
functions. With respect to the participation of individuals
appointed under paragraph (1) in training programs authorized by
the Assistant Secretary for Public Health Emergency Preparedness
or a comparable official of any Federal agency specified in
subsection (b)(2)(B), acts of individuals so appointed that are
within the scope of such participation shall be considered
within the scope of the appointment under paragraph (1)
(regardless of whether the individuals receive compensation for
such participation).
``(e) Certain Employment Issues Regarding Intermittent
Appointments.--
``(1) Intermittent disaster-response appointee.--For
purposes of this subsection, the term `intermittent disaster-
response appointee' means an individual appointed by the
Secretary under subsection (d).
``(2) Compensation for work injuries.--An intermittent
disaster-response appointee shall, while acting in the scope of
such appointment, be considered to be an employee of the Public
Health Service performing medical, surgical, dental, or related
functions, and an injury sustained by such an individual shall
be deemed `in the performance of duty', for purposes of chapter
81 of title 5, United States Code, pertaining to compensation
for work injuries. With respect to the participation of
individuals appointed under subsection (d) in training programs
authorized by the Assistant Secretary for Public Health
Emergency Preparedness or a comparable official of
[[Page 116 STAT. 602]]
any Federal agency specified in subsection (b)(2)(B), injuries
sustained by such an individual, while acting within the scope
of such participation, also shall be deemed `in the performance
of duty' for purposes of chapter 81 of title 5, United States
Code (regardless of whether the individuals receive compensation
for such participation). In the event of an injury to such an
intermittent disaster-response appointee, the Secretary of Labor
shall be responsible for making determinations as to whether the
claimant is entitled to compensation or other benefits in
accordance with chapter 81 of title 5, United States Code.
``(3) Employment and reemployment rights.--
``(A) In general.--Service as an intermittent
disaster-response appointee when the Secretary activates
the National Disaster Medical System or when the
individual participates in a training program authorized
by the Assistant Secretary for Public Health Emergency
Preparedness or a comparable official of any Federal
agency specified in subsection (b)(2)(B) shall be deemed
`service in the uniformed services' for purposes of
chapter 43 of title 38, United States Code, pertaining
to employment and reemployment rights of individuals who
have performed service in the uniformed services
(regardless of whether the individual receives
compensation for such participation). All rights and
obligations of such persons and procedures for
assistance, enforcement, and investigation shall be as
provided for in chapter 43 of title 38, United States
Code.
``(B) Notice of absence from position of
employment.--Preclusion of giving notice of service by
necessity of Service as an intermittent disaster-
response appointee when the Secretary activates the
National Disaster Medical System shall be deemed
preclusion by `military necessity' for purposes of
section 4312(b) of title 38, United States Code,
pertaining to giving notice of absence from a position
of employment. A determination of such necessity shall
be made by the Secretary, in consultation with the
Secretary of Defense, and shall not be subject to
judicial review.
``(4) Limitation.--An intermittent disaster-response
appointee shall not be deemed an employee of the Department of
Health and Human Services for purposes other than those
specifically set forth in this section.
``(f) Rule of Construction Regarding Use of Commissioned Corps.--If
the Secretary assigns commissioned officers of the Regular or Reserve
Corps to serve with the National Disaster Medical System, such
assignments do not affect the terms and conditions of their appointments
as commissioned officers of the Regular or Reserve Corps, respectively
(including with respect to pay and allowances, retirement, benefits,
rights, privileges, and immunities).
``(g) Definition.--For purposes of this section, the term `auxiliary
services' includes mortuary services, veterinary services, and other
services that are determined by the Secretary to be appropriate with
respect to the needs referred to in subsection (b)(3)(A).
``(h) Authorization of Appropriations.--For the purpose of providing
for the Assistant Secretary for Public Health Emergency Preparedness and
the operations of the National Disaster Medical
[[Page 116 STAT. 603]]
System, other than purposes for which amounts in the Public Health
Emergency Fund under section 319 are available, there are authorized to
be appropriated such sums as may be necessary for each of the fiscal
years 2002 through 2006.''.
(b) Sense of Congress Regarding Resources of National Disaster
Medical System.--It is the sense of the Congress that the Secretary of
Health and Human Services should provide sufficient resources to
entities tasked to carry out the duties of the National Disaster Medical
System for reimbursement of expenses, operations, purchase and
maintenance of equipment, training, and other funds expended in
furtherance of the National Disaster Medical System.
SEC. 103. IMPROVING ABILITY OF CENTERS FOR DISEASE CONTROL AND
PREVENTION.
Section 319D of the Public Health Service Act (42 U.S.C. 247d-4) is
amended to read as follows:
``SEC. 319D. REVITALIZING THE CENTERS FOR DISEASE CONTROL AND
PREVENTION.
``(a) Facilities; Capacities.--
``(1) Findings.--Congress finds that the Centers for Disease
Control and Prevention has an essential role in defending
against and combatting public health threats and requires secure
and modern facilities, and expanded and improved capabilities
related to bioterrorism and other public health emergencies,
sufficient to enable such Centers to conduct this important
mission.
``(2) Facilities.--
``(A) In general.--The Director of the Centers for
Disease Control and Prevention may design, construct,
and equip new facilities, renovate existing facilities
(including laboratories, laboratory support buildings,
scientific communication facilities, transshipment
complexes, secured and isolated parking structures,
office buildings, and other facilities and
infrastructure), and upgrade security of such
facilities, in order to better conduct the capacities
described in section 319A, and for supporting public
health activities.
``(B) Multiyear contracting authority.--For any
project of designing, constructing, equipping, or
renovating any facility under subparagraph (A), the
Director of the Centers for Disease Control and
Prevention may enter into a single contract or related
contracts that collectively include the full scope of
the project, and the solicitation and contract shall
contain the clause `availability of funds' found at
section 52.232-18 of title 48, Code of Federal
Regulations.
``(3) Improving the capacities of the centers for disease
control and prevention.--The Secretary, taking into account
evaluations under section 319B(a), shall expand, enhance, and
improve the capabilities of the Centers for Disease Control and
Prevention relating to preparedness for and responding
effectively to bioterrorism and other public health emergencies.
Activities that may be carried out under the preceding sentence
include--
``(A) expanding or enhancing the training of
personnel;
``(B) improving communications facilities and
networks, including delivery of necessary information to
rural areas;
[[Page 116 STAT. 604]]
``(C) improving capabilities for public health
surveillance and reporting activities, taking into
account the integrated system or systems of public
health alert communications and surveillance networks
under subsection (b); and
``(D) improving laboratory facilities related to
bioterrorism and other public health emergencies,
including increasing the security of such facilities.
``(b) National Communications and Surveillance Networks.--
``(1) In general.--The Secretary, directly or through awards
of grants, contracts, or cooperative agreements, shall provide
for the establishment of an integrated system or systems of
public health alert communications and surveillance networks
between and among--
``(A) Federal, State, and local public health
officials;
``(B) public and private health-related
laboratories, hospitals, and other health care
facilities; and
``(C) any other entities determined appropriate by
the Secretary.
``(2) Requirements.--The Secretary shall ensure that
networks under paragraph (1) allow for the timely sharing and
discussion, in a secure manner, of essential information
concerning bioterrorism or another public health emergency, or
recommended methods for responding to such an attack or
emergency.
``(3) Standards.--Not <<NOTE: Deadline.>> later than one
year after the date of the enactment of the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002,
the Secretary, in cooperation with health care providers and
State and local public health officials, shall establish any
additional technical and reporting standards (including
standards for interoperability) for networks under paragraph
(1).
``(c) Authorization of Appropriations.--
``(1) Facilities; capacities.--
``(A) Facilities.--For the purpose of carrying out
subsection (a)(2), there are authorized to be
appropriated $300,000,000 for each of the fiscal years
2002 and 2003, and such sums as may be necessary for
each of the fiscal years 2004 through 2006.
``(B) Mission; Improving capacities.--For the
purposes of achieving the mission of the Centers for
Disease Control and Prevention described in subsection
(a)(1), for carrying out subsection (a)(3), for better
conducting the capacities described in section 319A, and
for supporting public health activities, there are
authorized to be appropriated such sums as may be
necessary for each of the fiscal years 2002 through
2006.
``(2) National communications and surveillance networks.--
For the purpose of carrying out subsection (b), there are
authorized to be appropriated such sums as may be necessary for
each of the fiscal years 2002 through 2006.''.
[[Page 116 STAT. 605]]
SEC. 104. ADVISORY COMMITTEES AND COMMUNICATIONS; STUDY REGARDING
COMMUNICATIONS ABILITIES OF PUBLIC HEALTH AGENCIES.
(a) In General.--Section 319F of the Public Health Service Act (42
U.S.C. 247d-6) is amended--
(1) by striking subsections (b) and (i);
(2) by redesignating subsections (c) through (h) as
subsections (e) through (j), respectively; and
(3) by inserting after subsection (a) the following
subsections:
``(b) Advice to the Federal Government.--
``(1) Required advisory committees.--
In <<NOTE: Establishment.>> coordination with the working group
under subsection (a), the Secretary shall establish advisory
committees in accordance with paragraphs (2) and (3) to provide
expert recommendations to assist such working groups in carrying
out their respective responsibilities under subsections (a) and
(b).
``(2) National advisory committee on children and
terrorism.--
``(A) In general.--
For <<NOTE: Establishment.>> purposes of paragraph (1),
the Secretary shall establish an advisory committee to
be known as the National Advisory Committee on Children
and Terrorism (referred to in this paragraph as the
`Advisory Committee').
``(B) Duties.--The Advisory Committee shall provide
recommendations regarding--
``(i) the preparedness of the health care
(including mental health care) system to respond
to bioterrorism as it relates to children;
``(ii) needed changes to the health care and
emergency medical service systems and emergency
medical services protocols to meet the special
needs of children; and
``(iii) changes, if necessary, to the national
stockpile under section 121 of the Public Health
Security and Bioterrorism Preparedness and
Response Act of 2002 to meet the emergency health
security of children.
``(C) Composition.--The Advisory Committee shall be
composed of such Federal officials as may be appropriate
to address the special needs of the diverse population
groups of children, and child health experts on
infectious disease, environmental health, toxicology,
and other relevant professional disciplines.
``(D) Termination.--The Advisory Committee
terminates one year after the date of the enactment of
the Public Health Security and Bioterrorism Preparedness
and Response Act of 2002.
``(3) Emergency public information and communications
advisory committee.--
``(A) In general.--For purposes of paragraph (1),
the Secretary shall establish an advisory committee to
be known as the Emergency Public Information and
Communications Advisory Committee (referred to in this
paragraph as the `EPIC Advisory Committee').
``(B) Duties.--The EPIC Advisory Committee shall
make recommendations to the Secretary and the working
group under subsection (a) and report on appropriate
ways
[[Page 116 STAT. 606]]
to communicate public health information regarding
bioterrorism and other public health emergencies to the
public.
``(C) Composition.--The EPIC Advisory Committee
shall be composed of individuals representing a diverse
group of experts in public health, medicine,
communications, behavioral psychology, and other areas
determined appropriate by the Secretary.
``(D) Dissemination.--The Secretary shall review the
recommendations of the EPIC Advisory Committee and
ensure that appropriate information is disseminated to
the public.
``(E) Termination.--The EPIC Advisory Committee
terminates one year after the date of the enactment of
Public Health Security and Bioterrorism Preparedness and
Response Act of 2002.
``(c) Strategy for Communication of Information Regarding
Bioterrorism and Other Public Health Emergencies.--In coordination with
working group under subsection (a), the Secretary shall develop a
strategy for effectively communicating information regarding
bioterrorism and other public health emergencies, and shall develop
means by which to communicate such information. The Secretary may carry
out the preceding sentence directly or through grants, contracts, or
cooperative agreements.
``(d) Recommendation of Congress Regarding Official Federal Internet
Site on Bioterrorism.--It is the recommendation of Congress that there
should be established an official Federal Internet site on bioterrorism,
either directly or through provision of a grant to an entity that has
expertise in bioterrorism and the development of websites, that should
include information relevant to diverse populations (including messages
directed at the general public and such relevant groups as medical
personnel, public safety workers, and agricultural workers) and links to
appropriate State and local government sites.''.
(b) Study <<NOTE: 42 USC 247d-6 note.>> Regarding Communications
Abilities of Public Health Agencies.--The Secretary of Health and Human
Services, in consultation with the Federal Communications Commission,
the National Telecommunications and Information Administration, and
other appropriate Federal agencies, shall conduct a study to determine
whether local public health entities have the ability to maintain
communications in the event of a bioterrorist attack or other public
health emergency. The study shall examine whether redundancies are
required in the telecommunications system, particularly with respect to
mobile communications, for public health entities to maintain systems
operability and connectivity during such emergencies. The study shall
also include recommendations to industry and public health entities
about how to implement such redundancies if necessary.
SEC. 105. EDUCATION OF HEALTH CARE PERSONNEL; TRAINING REGARDING
PEDIATRIC ISSUES.
Section 319F(g) of the Public Health Service Act, as redesignated by
section 104(a)(2) of this <<NOTE: 42 USC 247d-6.>> Act, is amended to
read as follows:
``(g) Education; Training Regarding Pediatric Issues.--
``(1) Materials; core curriculum.--The Secretary, in
collaboration with members of the working group described
[[Page 116 STAT. 607]]
in subsection (b), and professional organizations and societies,
shall--
``(A) develop materials for teaching the elements of
a core curriculum for the recognition and identification
of potential bioweapons and other agents that may create
a public health emergency, and for the care of victims
of such emergencies, recognizing the special needs of
children and other vulnerable populations, to public
health officials, medical professionals, emergency
physicians and other emergency department staff,
laboratory personnel, and other personnel working in
health care facilities (including poison control
centers);
``(B) develop a core curriculum and materials for
community-wide planning by State and local governments,
hospitals and other health care facilities, emergency
response units, and appropriate public and private
sector entities to respond to a bioterrorist attack or
other public health emergency;
``(C) develop materials for proficiency testing of
laboratory and other public health personnel for the
recognition and identification of potential bioweapons
and other agents that may create a public health
emergency; and
``(D) provide for dissemination and teaching of the
materials described in subparagraphs (A) through (C) by
appropriate means, which may include telemedicine, long-
distance learning, or other such means.
``(2) Certain entities.--The entities through which
education and training activities described in paragraph (1) may
be carried out include Public Health Preparedness Centers, the
Public Health Service's Noble Training Center, the Emerging
Infections Program, the Epidemic Intelligence Service, the
Public Health Leadership Institute, multi-State, multi-
institutional consortia, other appropriate educational entities,
professional organizations and societies, private accrediting
organizations, and other nonprofit institutions or entities
meeting criteria established by the Secretary.
``(3) Grants and contracts.--In carrying out paragraph (1),
the Secretary may carry out activities directly and through the
award of grants and contracts, and may enter into interagency
cooperative agreements with other Federal agencies.
``(4) Health-related assistance for emergency response
personnel training.--The Secretary, in consultation with the
Attorney General and the Director of the Federal Emergency
Management Agency, may provide technical assistance with respect
to health-related aspects of emergency response personnel
training carried out by the Department of Justice and the
Federal Emergency Management Agency.''.
SEC. 106. GRANTS REGARDING SHORTAGES OF CERTAIN HEALTH PROFESSIONALS.
Part B of title III of the Public Health Service Act (42 U.S.C. 243
et seq.) is amended by inserting after section 319G the following
section:
``SEC. 319H. GRANTS <<NOTE: 42 USC 247d-7a.>> REGARDING TRAINING AND
EDUCATION OF CERTAIN HEALTH PROFESSIONALS.
``(a) In General.--The Secretary may make awards of grants and
cooperative agreements to appropriate public and nonprofit
[[Page 116 STAT. 608]]
private health or educational entities, including health professions
schools and programs as defined in section 799B, for the purpose of
providing low-interest loans, partial scholarships, partial fellowships,
revolving loan funds, or other cost-sharing forms of assistance for the
education and training of individuals in any category of health
professions for which there is a shortage that the Secretary determines
should be alleviated in order to prepare for or respond effectively to
bioterrorism and other public health emergencies.
``(b) Authority Regarding Non-Federal Contributions.--The Secretary
may require as a condition of an award under subsection (a) that a
grantee under such subsection provide non-Federal contributions toward
the purpose described in such subsection.
``(c) Authorization of Appropriations.--For the purpose of carrying
out this section, there are authorized to be appropriated such sums as
may be necessary for each of the fiscal years 2002 through 2006.''.
SEC. 107. EMERGENCY SYSTEM FOR ADVANCE REGISTRATION OF HEALTH
PROFESSIONS VOLUNTEERS.
Part B of title III of the Public Health Service Act, as amended by
section 106 of this Act, is amended by inserting after section 319H the
following section:
``SEC. 319I. EMERGENCY <<NOTE: 42 USC 247d-7b.>> SYSTEM FOR ADVANCE
REGISTRATION OF HEALTH PROFESSIONS VOLUNTEERS.
``(a) In General.--The Secretary shall, directly or through an award
of a grant, contract, or cooperative agreement, establish and maintain a
system for the advance registration of health professionals for the
purpose of verifying the credentials, licenses, accreditations, and
hospital privileges of such professionals when, during public health
emergencies, the professionals volunteer to provide health services
(referred to in this section as the `verification system'). In carrying
out the preceding sentence, the Secretary shall provide for an
electronic database for the verification system.
``(b) Certain Criteria.--The Secretary shall establish provisions
regarding the promptness and efficiency of the system in collecting,
storing, updating, and disseminating information on the credentials,
licenses, accreditations, and hospital privileges of volunteers
described in subsection (a).
``(c) Other Assistance.--The Secretary may make grants and provide
technical assistance to States and other public or nonprofit private
entities for activities relating to the verification system developed
under subsection (a).
``(d) Coordination Among States.--The Secretary may encourage each
State to provide legal authority during a public health emergency for
health professionals authorized in another State to provide certain
health services to provide such health services in the State.
``(e) Rule of Construction.--This section may not be construed as
authorizing the Secretary to issue requirements regarding the provision
by the States of credentials, licenses, accreditations, or hospital
privileges.
``(f) Authorization of Appropriations.--For the purpose of carrying
out this section, there are authorized to be appropriated $2,000,000 for
fiscal year 2002, and such sums as may be necessary for each of the
fiscal years 2003 through 2006.''.
[[Page 116 STAT. 609]]
SEC. 108. WORKING GROUP.
Section 319F of the Public Health Service Act, as amended by section
104(a), <<NOTE: 42 USC 247d-6.>> is amended by striking subsection (a)
and inserting the following:
``(a) Working Group on Bioterrorism and Other Public Health
Emergencies.--
``(1) In general.--The Secretary, in coordination with the
Secretary of Agriculture, the Attorney General, the Director of
Central Intelligence, the Secretary of Defense, the Secretary of
Energy, the Administrator of the Environmental Protection
Agency, the Director of the Federal Emergency Management Agency,
the Secretary of Labor, the Secretary of Veterans Affairs, and
with other similar Federal officials as determined appropriate,
shall establish a working group on the prevention, preparedness,
and response to bioterrorism and other public health
emergencies. Such joint working group, or subcommittees thereof,
shall meet periodically for the purpose of consultation on,
assisting in, and making recommendations on--
``(A) responding to a bioterrorist attack, including
the provision of appropriate safety and health training
and protective measures for medical, emergency service,
and other personnel responding to such attacks;
``(B) prioritizing countermeasures required to
treat, prevent, or identify exposure to a biological
agent or toxin pursuant to section 351A;
``(C) facilitation of the awarding of grants,
contracts, or cooperative agreements for the
development, manufacture, distribution, supply-chain
management, and purchase of priority countermeasures;
``(D) research on pathogens likely to be used in a
biological threat or attack on the civilian population;
``(E) development of shared standards for equipment
to detect and to protect against biological agents and
toxins;
``(F) assessment of the priorities for and
enhancement of the preparedness of public health
institutions, providers of medical care, and other
emergency service personnel (including firefighters) to
detect, diagnose, and respond (including mental health
response) to a biological threat or attack;
``(G) in the recognition that medical and public
health professionals are likely to provide much of the
first response to such an attack, development and
enhancement of the quality of joint planning and
training programs that address the public health and
medical consequences of a biological threat or attack on
the civilian population between--
``(i) local firefighters, ambulance personnel,
police and public security officers, or other
emergency response personnel (including private
response contractors); and
``(ii) hospitals, primary care facilities, and
public health agencies;
``(H) development of strategies for Federal, State,
and local agencies to communicate information to the
public regarding biological threats or attacks;
[[Page 116 STAT. 610]]
``(I) ensuring that the activities under this
subsection address the health security needs of children
and other vulnerable populations;
``(J) strategies for decontaminating facilities
contaminated as a result of a biological attack,
including appropriate protections for the safety of
workers conducting such activities;
``(K) subject to compliance with other provisions of
Federal law, clarifying the responsibilities among
Federal officials for the investigation of suspicious
outbreaks of disease and other potential public health
emergencies, and for related revisions of the
interagency plan known as the Federal response plan; and
``(L) in consultation with the National Highway
Traffic Safety Administration and the U.S. Fire
Administration, ways to enhance coordination among
Federal agencies involved with State, local, and
community based emergency medical services, including
issuing a report that--
``(i) identifies needs of community-based
emergency medical services; and
``(ii) identifies ways to streamline and
enhance the process through which Federal agencies
support community-based emergency medical
services.
``(2) Consultation with experts.--In carrying out
subparagraphs (B) and (C) of paragraph (1), the working group
under such paragraph shall consult with the pharmaceutical,
biotechnology, and medical device industries, and other
appropriate experts.
``(3) Use of subcommittees regarding consultation
requirements.--With respect to a requirement under law that the
working group under paragraph (1) be consulted on a matter, the
working group may designate an appropriate subcommittee of the
working group to engage in the consultation.
``(4) Discretion in exercise of duties.--Determinations made
by the working group under paragraph (1) with respect to
carrying out duties under such paragraph are matters committed
to agency discretion for purposes of section 701(a) of title 5,
Unites States Code.
``(5) Rule of construction.--This subsection may not be
construed as establishing new regulatory authority for any of
the officials specified in paragraph (1), or as having any legal
effect on any other provision of law, including the
responsibilities and authorities of the Environmental Protection
Agency.''.
SEC. 109. ANTIMICROBIAL RESISTANCE.
Section 319E of the Public Health Service Act (42 U.S.C. 247d-5) is
amended--
(1) in subsection (b)--
(A) by striking ``shall conduct and support'' and
inserting ``shall directly or through awards of grants
or cooperative agreements to public or private entities
provide for the conduct of''; and
(B) by amending paragraph (4) to read as follows:
``(4) the sequencing of the genomes, or other DNA analysis,
or other comparative analysis, of priority pathogens (as
determined by the Director of the National Institutes of Health
[[Page 116 STAT. 611]]
in consultation with the task force established under subsection
(a)), in collaboration and coordination with the activities of
the Department of Defense and the Joint Genome Institute of the
Department of Energy; and'';
(2) in subsection (e)(2), by inserting after ``societies,''
the following: ``schools or programs that train medical
laboratory personnel,''; and
(3) in subsection (g), by striking ``and such sums'' and all
that follows and inserting the following: ``$25,000,000 for each
of the fiscal years 2002 and 2003, and such sums as may be
necessary for each of the fiscal years 2004 through 2006.''.
SEC. 110. SUPPLIES AND SERVICES IN LIEU OF AWARD FUNDS.
Part B of title III of the Public Health Service Act, as amended by
section 107 of this Act, is amended by inserting after section 319I the
following section:
``SEC. 319J. SUPPLIES <<NOTE: 42 USC 247d-7c.>> AND SERVICES IN LIEU OF
AWARD FUNDS.
``(a) In General.--Upon the request of a recipient of an award under
any of sections 319 through 319I or section 319K, the Secretary may,
subject to subsection (b), provide supplies, equipment, and services for
the purpose of aiding the recipient in carrying out the purposes for
which the award is made and, for such purposes, may detail to the
recipient any officer or employee of the Department of Health and Human
Services.
``(b) Corresponding Reduction in Payments.--With respect to a
request described in subsection (a), the Secretary shall reduce the
amount of payments under the award involved by an amount equal to the
costs of detailing personnel and the fair market value of any supplies,
equipment, or services provided by the Secretary. The Secretary shall,
for the payment of expenses incurred in complying with such request,
expend the amounts withheld.''.
SEC. 111. ADDITIONAL AMENDMENTS.
Part B of title III of the Public Health Service Act (42 U.S.C. 243
et seq.) is amended--
(1) in section 319A(a)(1), <<NOTE: 42 USC 247d-1.>> by
striking ``10 years'' and inserting ``five years'';
(2) in section 319B(a), in <<NOTE: 42 USC 247d-2.>> the
first sentence, by striking ``10 years'' and inserting ``five
years''; and
(3) in section 391F(e)(2), as <<NOTE: 42 USC 247d-
6.>> redesignated by section 104(a)(2) of this Act--
(A) by striking ``or'' after ``clinic,''; and
(B) by inserting before the period following: ``,
professional organization or society, school or program
that trains medical laboratory personnel, private
accrediting organization, or other nonprofit private
institution or entity meeting criteria established by
the Secretary''.
Subtitle B--Strategic National Stockpile; Development of Priority
Countermeasures
SEC. 121. STRATEGIC <<NOTE: 42 USC 300hh-12.>> NATIONAL STOCKPILE.
(a) Strategic National Stockpile.--
[[Page 116 STAT. 612]]
(1) In general.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary''), in
coordination with the Secretary of Veterans Affairs, shall
maintain a stockpile or stockpiles of drugs, vaccines and other
biological products, medical devices, and other supplies in such
numbers, types, and amounts as are determined by the Secretary
to be appropriate and practicable, taking into account other
available sources, to provide for the emergency health security
of the United States, including the emergency health security of
children and other vulnerable populations, in the event of a
bioterrorist attack or other public health emergency.
(2) Procedures.--The Secretary, in managing the stockpile
under paragraph (1), shall--
(A) consult with the working group under section
319F(a) of the Public Health Service Act;
(B) ensure that adequate procedures are followed
with respect to such stockpile for inventory management
and accounting, and for the physical security of the
stockpile;
(C) in consultation with Federal, State, and local
officials, take into consideration the timing and
location of special events;
(D) review and revise, as appropriate, the contents
of the stockpile on a regular basis to ensure that
emerging threats, advanced technologies, and new
countermeasures are adequately considered;
(E) devise plans for the effective and timely
supply-chain management of the stockpile, in
consultation with appropriate Federal, State and local
agencies, and the public and private health care
infrastructure; and
(F) ensure the adequate physical security of the
stockpile.
(b) Smallpox Vaccine Development.--
(1) In general.--The <<NOTE: Contracts.>> Secretary shall
award contracts, enter into cooperative agreements, or carry out
such other activities as may reasonably be required in order to
ensure that the stockpile under subsection (a) includes an
amount of vaccine against smallpox as determined by the
Secretary to be sufficient to meet the health security needs of
the United States.
(2) Rule of construction.--Nothing in this section shall be
construed to limit the private distribution, purchase, or sale
of vaccines from sources other than the stockpile described in
subsection (a).
(c) Disclosures.--No Federal agency shall disclose under section
552, United States Code, any information identifying the location at
which materials in the stockpile under subsection (a) are stored.
(d) Definition.--For purposes of subsection (a), the term
``stockpile'' includes--
(1) a physical accumulation (at one or more locations) of
the supplies described in subsection (a); or
(2) a contractual agreement between the Secretary and a
vendor or vendors under which such vendor or vendors agree to
provide to the Secretary supplies described in subsection (a).
(e) Authorization of Appropriations.--
[[Page 116 STAT. 613]]
(1) Strategic national stockpile.--For the purpose of
carrying out subsection (a), there are authorized to be
appropriated $640,000,000 for fiscal year 2002, and such sums as
may be necessary for each of fiscal years 2003 through 2006.
(2) Smallpox vaccine development.--For the purpose of
carrying out subsection (b), there are authorized to be
appropriated $509,000,000 for fiscal year 2002, and such sums as
may be necessary for each of fiscal years 2003 through 2006.
SEC. 122. ACCELERATED <<NOTE: 21 USC 356-1.>> APPROVAL OF PRIORITY
COUNTERMEASURES.
(a) In General.--The Secretary of Health and Human Services may
designate a priority countermeasure as a fast-track product pursuant to
section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356)
or as a device granted review priority pursuant to section 515(d)(5) of
such Act (21 U.S.C. 360e(d)(5)). Such a designation may be made prior to
the submission of--
(1) a request for designation by the sponsor or applicant;
or
(2) an application for the investigation of the drug under
section 505(i) of such Act or section 351(a)(3) of the Public
Health Service Act.
Nothing in this subsection shall be construed to prohibit a sponsor or
applicant from declining such a designation.
(b) Use of Animal Trials.--A drug for which approval is sought under
section 505(b) of the Federal Food, Drug, and Cosmetic Act or section
351 of the Public Health Service Act on the basis of evidence of
effectiveness that is derived from animal studies pursuant to section
123 may be designated as a fast track product for purposes of this
section.
(c) Priority Review of Drugs and Biological Products.--A priority
countermeasure that is a drug or biological product shall be considered
a priority drug or biological product for purposes of performance goals
for priority drugs or biological products agreed to by the Commissioner
of Food and Drugs.
(d) Definitions.--For purposes of this title:
(1) The term ``priority countermeasure'' has the meaning
given such term in section 319F(h)(4) of the Public Health
Service Act.
(2) The term ``priority drugs or biological products'' means
a drug or biological product that is the subject of a drug or
biologics application referred to in section 101(4) of the Food
and Drug Administration Modernization Act of 1997.
SEC. 123. ISSUANCE OF RULE ON ANIMAL TRIALS.
Not later <<NOTE: Deadline.>> than 90 days after the date of the
enactment of this Act, the Secretary of Health and Human Services shall
complete the process of rulemaking that was commenced under authority of
section 505 of the Federal Food, Drug, and Cosmetic Act and section 351
of the Public Health Service Act with the issuance of the proposed rule
entitled ``New Drug and Biological Drug Products; Evidence Needed to
Demonstrate Efficacy of New Drugs for Use Against Lethal or Permanently
Disabling Toxic Substances When Efficacy Studies in Humans Ethically
Cannot be Conducted'' published in the Federal Register on October 5,
1999 (64 Fed. Reg. 53960), and shall promulgate a final rule.
[[Page 116 STAT. 614]]
SEC. 124. SECURITY FOR COUNTERMEASURE DEVELOPMENT AND PRODUCTION.
Part B of title III of the Public Health Service Act, as amended by
section 110 of this Act, is amended by inserting after section 319J the
following section:
``SEC. 319K. SECURITY <<NOTE: 42 USC 247d-7d.>> FOR COUNTERMEASURE
DEVELOPMENT AND PRODUCTION.
``(a) In General.--The Secretary, in consultation with the Attorney
General and the Secretary of Defense, may provide technical or other
assistance to provide security to persons or facilities that conduct
development, production, distribution, or storage of priority
countermeasures (as defined in section 319F(h)(4)).
``(b) Guidelines.--The Secretary may develop guidelines to enable
entities eligible to receive assistance under subsection (a) to secure
their facilities against potential terrorist attack.''.
SEC. 125. ACCELERATED COUNTERMEASURE RESEARCH AND DEVELOPMENT.
Section 319F(h) of the Public Health Service Act, as redesignated by
section 104(a)(2) of this Act, <<NOTE: 42 USC 247d-6.>> is amended to
read as follows:
``(h) Accelerated Research and Development on Priority Pathogens and
Countermeasures.--
``(1) In general.--With respect to pathogens of potential
use in a bioterrorist attack, and other agents that may cause a
public health emergency, the Secretary, taking into
consideration any recommendations of the working group under
subsection (a), shall conduct, and award grants, contracts, or
cooperative agreements for, research, investigations,
experiments, demonstrations, and studies in the health sciences
relating to--
``(A) the epidemiology and pathogenesis of such
pathogens;
``(B) the sequencing of the genomes, or other DNA
analysis, or other comparative analysis, of priority
pathogens (as determined by the Director of the National
Institutes of Health in consultation with the working
group established in subsection (a)), in collaboration
and coordination with the activities of the Department
of Defense and the Joint Genome Institute of the
Department of Energy;
``(C) the development of priority countermeasures;
and
``(D) other relevant areas of research;
with consideration given to the needs of children and other
vulnerable populations.
``(2) Priority.--The Secretary shall give priority under
this section to the funding of research and other studies
related to priority countermeasures.
``(3) Role of department of veterans affairs.--In carrying
out paragraph (1), the Secretary shall consider using the
biomedical research and development capabilities of the
Department of Veterans Affairs, in conjunction with that
Department's affiliations with health-professions universities.
When advantageous to the Government in furtherance of the
purposes of such paragraph, the Secretary may enter into
cooperative agreements with the Secretary of Veterans Affairs to
achieve such purposes.
[[Page 116 STAT. 615]]
``(4) Priority countermeasures.--For purposes of this
section, the term `priority countermeasure' means a drug,
biological product, device, vaccine, vaccine adjuvant,
antiviral, or diagnostic test that the Secretary determines to
be--
``(A) a priority to treat, identify, or prevent
infection by a biological agent or toxin listed pursuant
to section 351A(a)(1), or harm from any other agent that
may cause a public health emergency; or
``(B) a priority to diagnose conditions that may
result in adverse health consequences or death and may
be caused by the administering of a drug, biological
product, device, vaccine, vaccine adjuvant, antiviral,
or diagnostic test that is a priority under subparagraph
(A).''.
SEC. 126. EVALUATION OF NEW <<NOTE: 42 USC 300hh-13.>> AND EMERGING
TECHNOLOGIES REGARDING BIOTERRORIST ATTACK AND OTHER PUBLIC
HEALTH EMERGENCIES.
(a) In General.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall promptly carry
out a program to periodically evaluate new and emerging technologies
that, in the determination of the Secretary, are designed to improve or
enhance the ability of public health or safety officials to conduct
public health surveillance activities relating to a bioterrorist attack
or other public health emergency.
(b) Certain Activities.--In carrying out this subsection, the
Secretary shall, to the extent practicable--
(1) survey existing technology programs funded by the
Federal Government for potentially useful technologies;
(2) promptly issue a request, as necessary, for information
from non-Federal public and private entities for ongoing
activities in this area; and
(3) evaluate technologies identified under paragraphs (1)
and (2) pursuant to subsection (c).
(c) Consultation and Evaluation.--In carrying out subsection (b)(3),
the Secretary shall consult with the working group under section 319F(a)
of the Public Health Service Act, as well as other appropriate public,
nonprofit, and private entities, to develop criteria for the evaluation
of such technologies and to conduct such evaluations.
(d) Report.--Not <<NOTE: Deadline.>> later than 180 days after the
date of the enactment of this Act, and periodically thereafter, the
Secretary shall submit to the Committee on Energy and Commerce of the
House of Representatives, and the Committee on Health, Education, Labor,
and Pensions of the Senate, a report on the activities under this
section.
SEC. 127. POTASSIUM <<NOTE: 42 USC 300hh-12 note.>> IODIDE.
(a) In General.--Through the national stockpile under section 121,
the President, subject to subsections (b) and (c), shall make available
to State and local governments potassium iodide tablets for stockpiling
and for distribution as appropriate to public facilities, such as
schools and hospitals, in quantities sufficient to provide adequate
protection for the population within 20 miles of a nuclear power plant.
(b) State and Local Plans.--
(1) In general.--Subsection (a) applies with respect to a
State or local government, subject to paragraph (2), if the
government involved meets the following conditions:
[[Page 116 STAT. 616]]
(A) Such government submits to the President a plan
for the stockpiling of potassium iodide tablets, and for
the distribution and utilization of potassium iodide
tablets in the event of a nuclear incident.
(B) The plan is accompanied by certifications by
such government that the government has not already
received sufficient quantities of potassium iodide
tablets from the Federal Government.
(2) Local governments.--Subsection (a) applies with respect
to a local government only if, in addition to the conditions
described in paragraph (1), the following conditions are met:
(A) The State in which the locality involved is
located--
(i) does not have a plan described in
paragraph (1)(A); or
(ii) has a plan described in such paragraph,
but the plan does not address populations at a
distance greater than 10 miles from the nuclear
power plant involved.
(B) The local government has petitioned the State to
modify the State plan to address such populations, not
exceeding 20 miles from such plant, and 60 days have
elapsed without the State modifying the State plan to
address populations at the full distance sought by the
local government through the petition.
(C) The local government has submitted its local
plan under paragraph (1)(A) to the State, and the State
has approved the plan and certified that the plan is not
inconsistent with the State emergency plan.
(c) Guidelines.--Not <<NOTE: Deadline.>> later than one year after
the date of the enactment of this Act, the President, in consultation
with individuals representing appropriate Federal, State, and local
agencies, shall establish guidelines for the stockpiling of potassium
iodide tablets, and for the distribution and utilization of potassium
iodide tablets in the event of a nuclear incident. Such tablets may not
be made available under subsection (a) until such guidelines have been
established.
(d) Information.--The President shall carry out activities to inform
State and local governments of the program under this section.
(e) Reports.--
(1) President.--Not later <<NOTE: Deadline.>> than six
months after the date on which the guidelines under subsection
(c) are issued, the President shall submit to the Congress a
report--
(A) on whether potassium iodide tablets have been
made available under subsection (a) or other Federal,
State, or local programs, and the extent to which State
and local governments have established stockpiles of
such tablets; and
(B) the measures taken by the President to implement
this section.
(2) National academy of sciences.--
(A) In general.--The
President <<NOTE: Contracts.>> shall request the
National Academy of Sciences to enter into an agreement
with the President under which the Academy conducts a
study to determine what is the most effective and safe
way to distribute and administer potassium iodide
tablets
[[Page 116 STAT. 617]]
on a mass scale. If the Academy declines to conduct the
study, the President shall enter into an agreement with
another appropriate public or nonprofit private entity
to conduct the study.
(B) Report.--The <<NOTE: Deadline.>> President shall
ensure that, not later than six months after the date of
the enactment of this Act, the study required in
subparagraph (A) is completed and a report describing
the findings made in the study is submitted to the
Congress.
(f) Applicability.--Subsections (a) and (d) cease to apply as
requirements if the President determines that there is an alternative
and more effective prophylaxis or preventive measures for adverse
thyroid conditions that may result from the release of radionuclides
from nuclear power plants.
Subtitle C--Improving State, Local, and Hospital Preparedness for and
Response to Bioterrorism and Other Public Health Emergencies
SEC. 131. GRANTS TO IMPROVE STATE, LOCAL, AND HOSPITAL PREPAREDNESS FOR
AND RESPONSE TO BIOTERRORISM AND OTHER PUBLIC HEALTH
EMERGENCIES.
(a) In General.--Part B of title III of the Public Health Service
Act (42 U.S.C. 243 et seq.) is amended by inserting after section 319C
the following sections:
``SEC. 319C-1. GRANTS <<NOTE: 42 USC 247d-3a.>> TO IMPROVE STATE, LOCAL,
AND HOSPITAL PREPAREDNESS FOR AND RESPONSE TO BIOTERRORISM
AND OTHER PUBLIC HEALTH EMERGENCIES.
``(a) In General.--To enhance the security of the United States with
respect to bioterrorism and other public health emergencies, the
Secretary shall make awards of grants or cooperative agreements to
eligible entities to enable such entities to conduct the activities
described in subsection (d).
``(b) Eligible Entities.--
``(1) In general.--To be eligible to receive an award under
subsection (a), an entity shall--
``(A)(i) be a State; and
``(ii) prepare and submit to the Secretary an
application at such time, and in such manner, and
containing such information as the Secretary may
require, including an assurance that the State--
``(I) has completed an evaluation under
section 319B(a), or an evaluation that is
substantially equivalent to an evaluation
described in such section (as determined by the
Secretary);
``(II) has prepared, or will (within 60 days
of receiving an award under this section) prepare,
a Bioterrorism and Other Public Health Emergency
Preparedness and Response Plan in accordance with
subsection (c);
``(III) has established a means by which to
obtain public comment and input on the plan
prepared under subclause (II), and on the
implementation of such plan,
[[Page 116 STAT. 618]]
that shall include an advisory committee or other
similar mechanism for obtaining comment from the
public at large as well as from other State and
local stakeholders;
``(IV) will use amounts received under the
award in accordance with the plan prepared under
subclause (II), including making expenditures to
carry out the strategy contained in the plan; and
``(V) with respect to the plan prepared under
subclause (II), will establish reasonable criteria
to evaluate the effective performance of entities
that receive funds under the award and include
relevant benchmarks in the plan; or
``(B)(i) be a political subdivision of a State or a
consortium of 2 or more such subdivisions; and
``(ii) prepare and submit to the Secretary an
application at such time, and in such manner, and
containing such information as the Secretary may
require.
``(2) Coordination with statewide plans.--An award under
subsection (a) to an eligible entity described in paragraph
(1)(B) may not be made unless the application of such entity is
in coordination with, and consistent with, applicable Statewide
plans described in subsection (d)(1).
``(c) Bioterrorism and Other Public Health Emergency Preparedness
and Response Plan.--Not later <<NOTE: Deadline.>> than 60 days after
receiving amounts under an award under subsection (a), an eligible
entity described in subsection (b)(1)(A) shall prepare and submit to the
Secretary a Bioterrorism and Other Public Health Emergency Preparedness
and Response Plan. Recognizing the assessment of public health needs
conducted under section 319B, such plan shall include a description of
activities to be carried out by the entity to address the needs
identified in such assessment (or an equivalent assessment).
``(d) Use of Funds.--An award under subsection (a) may be expended
for activities that may include the following and similar activities:
``(1) To develop Statewide plans (including the development
of the Bioterrorism and Other Public Health Emergency
Preparedness and Response Plan required under subsection (c)),
and community-wide plans for responding to bioterrorism and
other public health emergencies that are coordinated with the
capacities of applicable national, State, and local health
agencies and health care providers, including poison control
centers.
``(2) To address deficiencies identified in the assessment
conducted under section 319B.
``(3) To purchase or upgrade equipment (including stationary
or mobile communications equipment), supplies, pharmaceuticals
or other priority countermeasures to enhance preparedness for
and response to bioterrorism or other public health emergencies,
consistent with the plan described in subsection (c).
``(4) To conduct exercises to test the capability and
timeliness of public health emergency response activities.
``(5) To develop and implement the trauma care and burn
center care components of the State plans for the provision of
emergency medical services.
[[Page 116 STAT. 619]]
``(6) To improve training or workforce development to
enhance public health laboratories.
``(7) To train public health and health care personnel to
enhance the ability of such personnel--
``(A) to detect, provide accurate identification of,
and recognize the symptoms and epidemiological
characteristics of exposure to a biological agent that
may cause a public health emergency; and
``(B) to provide treatment to individuals who are
exposed to such an agent.
``(8) To develop, enhance, coordinate, or improve
participation in systems by which disease detection and
information about biological attacks and other public health
emergencies can be rapidly communicated among national, State,
and local health agencies, emergency response personnel, and
health care providers and facilities to detect and respond to a
bioterrorist attack or other public health emergency, including
activities to improve information technology and communications
equipment available to health care and public health officials
for use in responding to a biological threat or attack or other
public health emergency.
``(9) To enhance communication to the public of information
on bioterrorism and other public health emergencies, including
through the use of 2-1-1 call centers.
``(10) To address the health security needs of children and
other vulnerable populations with respect to bioterrorism and
other public health emergencies.
``(11) To provide training and develop, enhance, coordinate,
or improve methods to enhance the safety of workers and
workplaces in the event of bioterrorism.
``(12) To prepare and plan for contamination prevention
efforts related to public health that may be implemented in the
event of a bioterrorist attack, including training and planning
to protect the health and safety of workers conducting the
activities described in this paragraph.
``(13) To prepare a plan for triage and transport management
in the event of bioterrorism or other public health emergencies.
``(14) To enhance the training of health care professionals
to recognize and treat the mental health consequences of
bioterrorism or other public health emergencies.
``(15) To enhance the training of health care professionals
to assist in providing appropriate health care for large numbers
of individuals exposed to a bioweapon.
``(16) To enhance training and planning to protect the
health and safety of personnel, including health care
professionals, involved in responding to a biological attack.
``(17) To improve surveillance, detection, and response
activities to prepare for emergency response activities
including biological threats or attacks, including training
personnel in these and other necessary functions and including
early warning and surveillance networks that use advanced
information technology to provide early detection of biological
threats or attacks.
``(18) To develop, enhance, and coordinate or improve the
ability of existing telemedicine programs to provide health care
[[Page 116 STAT. 620]]
information and advice as part of the emergency public health
response to bioterrorism or other public health emergencies.
Nothing in this subsection may be construed as establishing new
regulatory authority or as modifying any existing regulatory authority.
``(e) Priorities in Use of Grants.--
``(1) In general.--
``(A) Priorities.--Except as provided in
subparagraph (B), the Secretary shall, in carrying out
the activities described in this section, address the
following hazards in the following priority:
``(i) Bioterrorism or acute outbreaks of
infectious diseases.
``(ii) Other public health threats and
emergencies.
``(B) Determination of the secretary.--In the case
of the hazard involved, the degree of priority that
would apply to the hazard based on the categories
specified in clauses (i) and (ii) of subparagraph (A)
may be modified by the Secretary if the following
conditions are met:
``(i) The Secretary determines that the
modification is appropriate on the basis of the
following factors:
``(I) The extent to which eligible
entities are adequately prepared for
responding to hazards within the
category specified in clause (i) of
subparagraph (A).
``(II) There has been a significant
change in the assessment of risks to the
public health posed by hazards within
the category specified in clause (ii) of
such subparagraph.
``(ii) Prior to modifying the priority, the
Secretary notifies the appropriate committees of
the Congress of the determination of the Secretary
under clause (i) of this subparagraph.
``(2) Areas of emphasis within categories.--The Secretary
shall determine areas of emphasis within the category of hazards
specified in clause (i) of paragraph (1)(A), and shall determine
areas of emphasis within the category of hazards specified in
clause (ii) of such paragraph, based on an assessment of the
risk and likely consequences of such hazards and on an
evaluation of Federal, State, and local needs, and may also take
into account the extent to which receiving an award under
subsection (a) will develop capacities that can be used for
public health emergencies of varying types.
``(f) Certain Activities.--In administering activities under section
319C(c)(4) or similar activities, the Secretary shall, where
appropriate, give priority to activities that include State or local
government financial commitments, that seek to incorporate multiple
public health and safety services or diagnostic databases into an
integrated public health entity, and that cover geographic areas lacking
advanced diagnostic and laboratory capabilities.
``(g) Coordination with Local Medical Response System.--An eligible
entity and local Metropolitan Medical Response Systems shall, to the
extent practicable, ensure that activities carried out under an award
under subsection (a) are coordinated with activities that are carried
out by local Metropolitan Medical Response Systems.
[[Page 116 STAT. 621]]
``(h) Coordination of Federal Activities.--In making awards under
subsection (a), the Secretary shall--
``(1) annually notify the Director of the Federal Emergency
Management Agency, the Director of the Office of Justice
Programs, and the Director of the National Domestic Preparedness
Office, as to the amount, activities covered under, and status
of such awards; and
``(2) coordinate such awards with other activities conducted
or supported by the Secretary to enhance preparedness for
bioterrorism and other public health emergencies.
``(i) Definition.--For purposes of this section, the term `eligible
entity' means an entity that meets the conditions described in
subparagraph (A) or (B) of subsection (b)(1).
``(j) Funding.--
``(1) Authorizations of appropriations.--
``(A) Fiscal year 2003.--
``(i) Authorizations.--For the purpose of
carrying out this section, there is authorized to
be appropriated $1,600,000,000 for fiscal year
2003, of which--
``(I) $1,080,000,000 is authorized
to be appropriated for awards pursuant
to paragraph (3) (subject to the
authority of the Secretary to make
awards pursuant to paragraphs (4) and
(5)); and
``(II) $520,000,000 is authorized to
be appropriated--
``(aa) for awards under
subsection (a) to States,
notwitstanding the eligibility
conditions under subsection (b),
for the purpose of enhancing the
preparedness of hospitals
(including children's
hospitals), clinics, health
centers, and primary care
facilities for bioterrorism and
other public health emergencies;
and
``(bb) for Federal, State,
and local planning and
administrative activities
related to such purpose.
``(ii) Contingent additional authorization.--
If a significant change in circumstances warrants
an increase in the amount authorized to be
appropriated under clause (i) for fiscal year
2003, there are authorized to be appropriated such
sums as may be necessary for such year for
carrying out this section, in addition to the
amount authorized in clause (i).
``(B) Other fiscal years.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of
the fiscal years 2004 through 2006.
``(2) Supplement not supplant.--Amounts appropriated under
paragraph (1) shall be used to supplement and not supplant other
State and local public funds provided for activities under this
section.
``(3) State bioterrorism and other public health emergency
preparedness and response block grant for fiscal year 2003.--
[[Page 116 STAT. 622]]
``(A) In general.--For fiscal year 2003, the
Secretary shall, in an amount determined in accordance
with subparagraphs (B) through (D), make an award under
subsection (a) to each State, notwithstanding the
eligibility conditions described in subsection (b), that
submits to the Secretary an application for the award
that meets the criteria of the Secretary for the receipt
of such an award and that meets other implementation
conditions established by the Secretary for such awards.
No other awards may be made under subsection (a) for
such fiscal year, except as provided in paragraph
(1)(A)(i)(II) and paragraphs (4) and (5).
``(B) Base amount.--In determining the amount of an
award pursuant to subparagraph (A) for a State, the
Secretary shall first determine an amount the Secretary
considers appropriate for the State (referred to in this
paragraph as the `base amount'), except that such amount
may not be greater than the minimum amount determined
under subparagraph (D).
``(C) Increase on basis of population.--After
determining the base amount for a State under
subparagraph (B), the Secretary shall increase the base
amount by an amount equal to the product of--
``(i) the amount appropriated under paragraph
(1)(A)(i)(I) for the fiscal year, less an amount
equal to the sum of all base amounts determined
for the States under subparagraph (B), and less
the amount, if any, reserved by the Secretary
under paragraphs (4) and (5); and
``(ii) subject to paragraph (4)(C), the
percentage constituted by the ratio of an amount
equal to the population of the State over an
amount equal to the total population of the States
(as indicated by the most recent data collected by
the Bureau of the Census).
``(D) Minimum amount.--Subject to the amount
appropriated under paragraph (1)(A)(i)(I), an award
pursuant to subparagraph (A) for a State shall be the
greater of the base amount as increased under
subparagraph (C), or the minimum amount under this
subparagraph. The minimum amount under this subparagraph
is--
``(i) in the case of each of the several
States, the District of Columbia, and the
Commonwealth of Puerto Rico, an amount equal to
the lesser of--
``(I) $5,000,000; or
``(II) if the amount appropriated
under paragraph (1)(A)(i)(I) is less
than $667,000,000, an amount equal to
0.75 percent of the amount appropriated
under such paragraph, less the amount,
if any, reserved by the Secretary under
paragraphs (4) and (5); or
``(ii) in the case of each of American Samoa,
Guam, the Commonwealth of the Northern Mariana
Islands, and the Virgin Islands, an amount
determined by the Secretary to be appropriate,
except that such amount may not exceed the amount
determined under clause (i).
[[Page 116 STAT. 623]]
``(4) Certain political subdivisions.--
``(A) In general.--For fiscal year 2003, the
Secretary may, before making awards pursuant to
paragraph (3) for such year, reserve from the amount
appropriated under paragraph (1)(A)(i)(I) for the year
an amount determined necessary by the Secretary to make
awards under subsection (a) to political subdivisions
that have a substantial number of residents, have a
substantial local infrastructure for responding to
public health emergencies, and face a high degree of
risk from bioterrorist attacks or other public health
emergencies. Not more than three political subdivisions
may receive awards pursuant to this subparagraph.
``(B) Coordination with statewide plans.--An award
pursuant to subparagraph (A) may not be made unless the
application of the political subdivision involved is in
coordination with, and consistent with, applicable
Statewide plans described in subsection (c).
``(C) Relationship to formula grants.--In the case
of a State that will receive an award pursuant to
paragraph (3), and in which there is located a political
subdivision that will receive an award pursuant to
subparagraph (A), the Secretary shall, in determining
the amount under paragraph (3)(C) for the State,
subtract from the population of the State an amount
equal to the population of such political subdivision.
``(D) Continuity of funding.--In determining whether
to make an award pursuant to subparagraph (A) to a
political subdivision, the Secretary may consider, as a
factor indicating that the award should be made, that
the political subdivision received public health funding
from the Secretary for fiscal year 2002.
``(5) Significant unmet needs; degree of risk.--
``(A) In general.--For fiscal year 2003, the
Secretary may, before making awards pursuant to
paragraph (3) for such year, reserve from the amount
appropriated under paragraph (1)(A)(i)(I) for the year
an amount determined necessary by the Secretary to make
awards under subsection (a) to eligible entities that--
``(i) have a significant need for funds to
build capacity to identify, detect, monitor, and
respond to a bioterrorist or other threat to the
public health, which need will not be met by
awards pursuant to paragraph (3); and
``(ii) face a particularly high degree of risk
of such a threat.
``(B) Recipients of grants.--Awards pursuant to
subparagraph (A) may be supplemental awards to States
that receive awards pursuant to paragraph (3), or may be
awards to eligible entities described in subsection
(b)(1)(B) within such States.
``(C) Finding with respect to district of
columbia.--The Secretary shall consider the District of
Columbia to have a significant unmet need for purposes
of subparagraph (A), and to face a particularly high
degree of risk for such purposes, on the basis of the
concentration of entities of national significance
located within the District.
[[Page 116 STAT. 624]]
``(6) Funding of local entities.--For fiscal year 2003, the
Secretary shall in making awards under this section ensure that
appropriate portions of such awards are made available to
political subdivisions, local departments of public health,
hospitals (including children's hospitals), clinics, health
centers, or primary care facilities, or consortia of such
entities.
``SEC. 319C-2. PARTNERSHIPS <<NOTE: 42 USC 247d-3b.>> FOR COMMUNITY AND
HOSPITAL PREPAREDNESS.
``(a) Grants.--The Secretary shall make awards of grants or
cooperative agreements to eligible entities to enable such entities to
improve community and hospital preparedness for bioterrorism and other
public health emergencies.
``(b) Eligibility.--To be eligible for an award under subsection
(a), an entity shall--
``(1) be a partnership consisting of--
``(A) one or more hospitals (including children's
hospitals), clinics, health centers, or primary care
facilities; and
``(B)(i) one or more political subdivisions of
States;
``(ii) one or more States; or
``(iii) one or more States and one or more political
subdivisions of States; and
``(2) prepare, in consultation with the Chief Executive
Officer of the State, District, or territory in which the
hospital, clinic, health center, or primary care facility
described in paragraph (1)(A) is located, and submit to the
Secretary, an application at such time, in such manner, and
containing such information as the Secretary may require.
``(c) Regional Coordination.--In making awards under subsection (a),
the Secretary shall give preference to eligible entities that submit
applications that, in the determination of the Secretary, will--
``(1) enhance coordination--
``(A) among the entities described in subsection
(b)(1)(A); and
``(B) between such entities and the entities
described in subsection (b)(1)(B); and
``(2) serve the needs of a defined geographic area.
``(d) Consistency of Planned Activities.--An entity described in
subsection (b)(1) shall utilize amounts received under an award under
subsection (a) in a manner that is coordinated and consistent, as
determined by the Secretary, with an applicable State Bioterrorism and
Other Public Health Emergency Preparedness and Response Plan.
``(e) Use of Funds.--An award under subsection (a) may be expended
for activities that may include the following and similar activities--
``(1) planning and administration for such award;
``(2) preparing a plan for triage and transport management
in the event of bioterrorism or other public health emergencies;
``(3) enhancing the training of health care professionals to
improve the ability of such professionals to recognize the
symptoms of exposure to a potential bioweapon, to make
appropriate diagnosis, and to provide treatment to those
individuals so exposed;
[[Page 116 STAT. 625]]
``(4) enhancing the training of health care professionals to
recognize and treat the mental health consequences of
bioterrorism or other public health emergencies;
``(5) enhancing the training of health care professionals to
assist in providing appropriate health care for large numbers of
individuals exposed to a bioweapon;
``(6) enhancing training and planning to protect the health
and safety of personnel involved in responding to a biological
attack;
``(7) developing and implementing the trauma care and burn
center care components of the State plans for the provision of
emergency medical services; or
``(8) conducting such activities as are described in section
319C-1(d) that are appropriate for hospitals (including
children's hospitals), clinics, health centers, or primary care
facilities.
``(f) Limitation on Awards.--A political subdivision of a State
shall not participate in more than one partnership described in
subsection (b)(1).
``(g) Priorities in Use of Grants.--
``(1) In general.--
``(A) Priorities.--Except as provided in
subparagraph (B), the Secretary shall, in carrying out
the activities described in this section, address the
following hazards in the following priority:
``(i) Bioterrorism or acute outbreaks of
infectious diseases.
``(ii) Other public health threats and
emergencies.
``(B) Determination of the secretary.--In the case
of the hazard involved, the degree of priority that
would apply to the hazard based on the categories
specified in clauses (i) and (ii) of subparagraph (A)
may be modified by the Secretary if the following
conditions are met:
``(i) The Secretary determines that the
modification is appropriate on the basis of the
following factors:
``(I) The extent to which eligible
entities are adequately prepared for
responding to hazards within the
category specified in clause (i) of
subparagraph (A).
``(II) There has been a significant
change in the assessment of risks to the
public health posed by hazards within
the category specified in clause (ii) of
such subparagraph.
``(ii) Prior to modifying the priority, the
Secretary notifies the appropriate committees of
the Congress of the determination of the Secretary
under clause (i) of this subparagraph.
``(2) Areas of emphasis within categories.--The Secretary
shall determine areas of emphasis within the category of hazards
specified in clause (i) of paragraph (1)(A), and shall determine
areas of emphasis within the category of hazards specified in
clause (ii) of such paragraph, based on an assessment of the
risk and likely consequences of such hazards and on an
evaluation of Federal, State, and local needs, and may also take
into account the extent to which receiving an award under
subsection (a) will develop capacities that can be used for
public health emergencies of varying types.
[[Page 116 STAT. 626]]
``(h) Coordination with Local Medical Response System.--An eligible
entity and local Metropolitan Medical Response Systems shall, to the
extent practicable, ensure that activities carried out under an award
under subsection (a) are coordinated with activities that are carried
out by local Metropolitan Medical Response Systems.
``(i) Authorization of Appropriations.--For the purpose of carrying
out this section, there are authorized to be appropriated such sums as
may be necessary for each of fiscal years 2004 through 2006.''.
(b) Certain Grants.--Section 319C of the Public Health Service Act
(42 U.S.C. 247d-3) is amended by striking subsection (f).
Subtitle D--Emergency Authorities; Additional Provisions
SEC. 141. REPORTING DEADLINES.
Section 319 of the Public Health Service Act (42 U.S.C. 247d) is
amended by adding at the end the following:
``(d) Data Submittal and Reporting Deadlines.--In any case in which
the Secretary determines that, wholly or partially as a result of a
public health emergency that has been determined pursuant to subsection
(a), individuals or public or private entities are unable to comply with
deadlines for the submission to the Secretary of data or reports
required under any law administered by the Secretary, the Secretary may,
notwithstanding any other provision of law, grant such extensions of
such deadlines as the circumstances reasonably require, and may waive,
wholly or partially, any sanctions otherwise applicable to such failure
to comply. Before <<NOTE: Federal Register, publication.>> or promptly
after granting such an extension or waiver, the Secretary shall notify
the Congress of such action and publish in the Federal Register a notice
of the extension or waiver.''.
SEC. 142. STREAMLINING AND CLARIFYING COMMUNICABLE DISEASE QUARANTINE
PROVISIONS.
(a) Elimination of Prerequisite for National Advisory Health Council
Recommendation Before Issuing Quarantine Rules.--
(1) Executive orders specifying diseases subject to
individual detentions.--Section 361(b) of the Public Health Act
(42 U.S.C. 264(b)) is amended by striking ``Executive orders of
the President upon the recommendation of the National Advisory
Health Council and the Surgeon General'' and inserting
``Executive orders of the President upon the recommendation of
the Secretary, in consultation with the Surgeon General,''.
(2) Regulations providing for apprehension of individuals.--
Section 361(d) of the Public Health Act (42 U.S.C. 264(d)) is
amended by striking ``On recommendation of the National Advisory
Health Council, regulations'' and inserting ``Regulations''.
(3) Regulations providing for apprehension of individuals in
wartime.--Section 363 of the Public Health Act (42 U.S.C. 266)
is amended by striking ``the Surgeon General, on recommendation
of the National Advisory Health Council,'' and
[[Page 116 STAT. 627]]
inserting ``the Secretary, in consultation with the Surgeon
General,''.
(b) Apprehension Authority To Apply in Cases of Exposure to
Disease.--
(1) Regulations providing for apprehension of individuals.--
Section 361(d) of the Public Health Act (42 U.S.C. 264(d)), as
amended by subsection (a)(2), is further amended--
(A) by striking ``(1)'' and ``(2)'' and inserting
``(A)'' and ``(B)'', respectively;
(B) by striking ``(d)'' and inserting ``(d)(1)'';
(C) in paragraph (1) (as designated by subparagraph
(B) of this paragraph), in the first sentence, by
striking ``in a communicable stage'' each place such
term appears and inserting ``in a qualifying stage'';
and
(D) by adding at the end the following paragraph:
``(2) For purposes of this subsection, the term `qualifying stage',
with respect to a communicable disease, means that such disease--
``(A) is in a communicable stage; or
``(B) is in a precommunicable stage, if the disease would be
likely to cause a public health emergency if transmitted to
other individuals.''.
(2) Regulations providing for apprehension of individuals in
wartime.--Section 363 of the Public Health Act (42 U.S.C. 266),
as amended by subsection (a)(3), is further amended by striking
``in a communicable stage''.
(c) State Authority.--Section 361 of the Public Health Act (42
U.S.C. 264) is amended by adding at the end the following:
``(e) Nothing in this section or section 363, or the regulations
promulgated under such sections, may be construed as superseding any
provision under State law (including regulations and including
provisions established by political subdivisions of States), except to
the extent that such a provision conflicts with an exercise of Federal
authority under this section or section 363.''.
SEC. 143. EMERGENCY WAIVER OF MEDICARE, MEDICAID, AND SCHIP
REQUIREMENTS.
(a) Waiver Authority.--Title XI of the Social Security Act (42
U.S.C. 1301 et seq.) is amended by inserting after section 1134 the
following new section:
``authority to waive requirements during national emergencies
``Sec. 1135. (a) Purpose.--The <<NOTE: 42 USC 1320b-5.>> purpose of
this section is to enable the Secretary to ensure to the maximum extent
feasible, in any emergency area and during an emergency period (as
defined in subsection (g)(1))--
``(1) that sufficient health care items and services are
available to meet the needs of individuals in such area enrolled
in the programs under titles XVIII, XIX, and XXI; and
``(2) that health care providers (as defined in subsection
(g)(2)) that furnish such items and services in good faith, but
that are unable to comply with one or more requirements
described in subsection (b), may be reimbursed for such items
and services and exempted from sanctions for such noncompliance,
absent any determination of fraud or abuse.
``(b) Secretarial Authority.--To the extent necessary to accomplish
the purpose specified in subsection (a), the Secretary
[[Page 116 STAT. 628]]
is authorized, subject to the provisions of this section, to temporarily
waive or modify the application of, with respect to health care items
and services furnished by a health care provider (or classes of health
care providers) in any emergency area (or portion of such an area)
during any portion of an emergency period, the requirements of titles
XVIII, XIX, or XXI, or any regulation thereunder (and the requirements
of this title other than this section, and regulations thereunder,
insofar as they relate to such titles), pertaining to--
``(1)(A) conditions of participation or other certification
requirements for an individual health care provider or types of
providers,
``(B) program participation and similar requirements for an
individual health care provider or types of providers, and
``(C) pre-approval requirements;
``(2) requirements that physicians and other health care
professionals be licensed in the State in which they provide
such services, if they have equivalent licensing in another
State and are not affirmatively excluded from practice in that
State or in any State a part of which is included in the
emergency area;
``(3) sanctions under section 1867 (relating to examination
and treatment for emergency medical conditions and women in
labor) for a transfer of an individual who has not been
stabilized in violation of subsection (c) of such section if the
transfer arises out of the circumstances of the emergency;
``(4) sanctions under section 1877(g) (relating to
limitations on physician referral);
``(5) deadlines and timetables for performance of required
activities, except that such deadlines and timetables may only
be modified, not waived; and
``(6) limitations on payments under section 1851(i) for
health care items and services furnished to individuals enrolled
in a Medicare+Choice plan by health care professionals or
facilities not included under such plan.
Insofar as the Secretary exercises authority under paragraph (6) with
respect to individuals enrolled in a Medicare+Choice plan, to the extent
possible given the circumstances, the Secretary shall reconcile payments
made on behalf of such enrollees to ensure that the enrollees do not pay
more than would be required had they received services from providers
within the network of the plan and may reconcile payments to the
organization offering the plan to ensure that such organization pays for
services for which payment is included in the capitation payment it
receives under part C of title XVIII.
``(c) Authority for Retroactive Waiver.--A waiver or modification of
requirements pursuant to this section may, at the Secretary's
discretion, be made retroactive to the beginning of the emergency period
or any subsequent date in such period specified by the Secretary.
``(d) Certification to Congress.--The Secretary shall provide a
certification and advance written notice to the Congress at least two
days before exercising the authority under this section with respect to
an emergency area. Such a certification and notice shall include--
``(1) a description of--
[[Page 116 STAT. 629]]
``(A) the specific provisions that will be waived or
modified;
``(B) the health care providers to whom the waiver
or modification will apply;
``(C) the geographic area in which the waiver or
modification will apply; and
``(D) the period of time for which the waiver or
modification will be in effect; and
``(2) a certification that the waiver or modification is
necessary to carry out the purpose specified in subsection (a).
``(e) Duration of Waiver.--
``(1) In general.--A waiver or modification of requirements
pursuant to this section terminates upon--
``(A) the termination of the applicable declaration
of emergency or disaster described in subsection
(g)(1)(A);
``(B) the termination of the applicable declaration
of public health emergency described in subsection
(g)(1)(B); or
``(C) subject to paragraph (2), the termination of a
period of 60 days from the date the waiver or
modification is first published (or, if applicable, the
date of extension of the waiver or modification under
paragraph (2)).
``(2) Extension of 60-day periods.--The Secretary may, by
notice, provide for an extension of a 60-day period described in
paragraph (1)(C) (or an additional period provided under this
paragraph) for additional period or periods (not to exceed,
except as subsequently provided under this paragraph, 60 days
each), but any such extension shall not affect or prevent the
termination of a waiver or modification under subparagraph (A)
or (B) of paragraph (1).
``(f) Report to Congress.--Within one year after the end of the
emergency period in an emergency area in which the Secretary exercised
the authority provided under this section, the Secretary shall report to
the Congress regarding the approaches used to accomplish the purposes
described in subsection (a), including an evaluation of such approaches
and recommendations for improved approaches should the need for such
emergency authority arise in the future.
``(g) Definitions.--For purposes of this section:
``(1) Emergency area; emergency period.--An `emergency area'
is a geographical area in which, and an `emergency period' is
the period during which, there exists--
``(A) an emergency or disaster declared by the
President pursuant to the National Emergencies Act or
the Robert T. Stafford Disaster Relief and Emergency
Assistance Act; and
``(B) a public health emergency declared by the
Secretary pursuant to section 319 of the Public Health
Service Act.
``(2) Health care provider.--The term `health care provider'
means any entity that furnishes health care items or services,
and includes a hospital or other provider of services, a
physician or other health care practitioner or professional, a
health care facility, or a supplier of health care items or
services.''.
(b) Effective Date.--The amendment <<NOTE: 42 USC 1320b-5
note.>> made by subsection (a) shall be effective on and after September
11, 2001.
[[Page 116 STAT. 630]]
SEC. 144. PROVISION FOR EXPIRATION OF PUBLIC HEALTH EMERGENCIES.
(a) In General.--Section 319(a) of the Public Health Service Act (42
U.S.C. 247d(a)), is amended by adding at the end the following new
sentence: ``Any such determination of a public health emergency
terminates upon the Secretary declaring that the emergency no longer
exists, or upon the expiration of the 90-day period beginning on the
date on which the determination is made by the Secretary, whichever
occurs first. Determinations that terminate under the preceding sentence
may be renewed by the Secretary (on the basis of the same or additional
facts), and the preceding sentence applies to each such renewal. Not
later than 48 hours after making a determination under this subsection
of a public health emergency (including a renewal), the Secretary shall
submit to the Congress written notification of the determination.''.
(b) Applicability.--The <<NOTE: 42 USC 247d note.>> amendment made
by subsection (a) applies to any public health emergency under section
319(a) of the Public Health Service Act, including any such emergency
that was in effect as of the day before the date of the enactment of
this Act. In the case of such an emergency that was in effect as of such
day, the 90-day period described in such section with respect to the
termination of the emergency is deemed to begin on such date of
enactment.
Subtitle E--Additional Provisions
SEC. 151. DESIGNATED STATE PUBLIC EMERGENCY ANNOUNCEMENT PLAN.
Section 613(b) of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act (42 U.S.C. 5196b(b)) is amended--
(1) in paragraph (5), by striking ``and'' at the end;
(2) in paragraph (6), by striking the period and inserting
``; and''; and
(3) by adding at the end the following:
``(7) include a plan for providing information to the public
in a coordinated manner.''.
SEC. 152. EXPANDED <<NOTE: 42 USC 7257d.>> RESEARCH BY SECRETARY OF
ENERGY.
(a) Detection and Identification Research.--
(1) In general.--In conjunction with the working group under
section 319F(a) of the Public Health Service Act, the Secretary
of Energy and the Administrator of the National Nuclear Security
Administration shall expand, enhance, and intensify research
relevant to the rapid detection and identification of pathogens
likely to be used in a bioterrorism attack or other agents that
may cause a public health emergency.
(2) Authorized activities.--Activities carried out under
paragraph (1) may include--
(A) the improvement of methods for detecting
biological agents or toxins of potential use in a
biological attack and the testing of such methods under
variable conditions;
(B) the improvement or pursuit of methods for
testing, verifying, and calibrating new detection and
surveillance tools and techniques; and
(C) carrying out other research activities in
relevant areas.
[[Page 116 STAT. 631]]
(3) Report.--Not <<NOTE: Deadline.>> later than 180 days
after the date of the enactment of this Act, the Administrator
of the National Nuclear Security Administration shall submit to
the Committee on Energy and Natural Resources and the Committee
on Armed Services of the Senate, and the Committee on Energy and
Commerce and the Committee on Armed Services of the House of
Representatives, a report setting forth the programs and
projects that will be funded prior to the obligation of funds
appropriated under subsection (b).
(b) Authorization.--For the purpose of carrying out this section,
there are authorized to be appropriated such sums as may be necessary in
each of fiscal years 2002 through 2006.
SEC. 153. EXPANDED <<NOTE: 29 USC 669a.>> RESEARCH ON WORKER HEALTH AND
SAFETY.
The Secretary of Health and Human Services (referred to in this
section as the ``Secretary''), acting through the Director of the
National Institute of Occupational Safety and Health, shall enhance and
expand research as deemed appropriate on the health and safety of
workers who are at risk for bioterrorist threats or attacks in the
workplace, including research on the health effects of measures taken to
treat or protect such workers for diseases or disorders resulting from a
bioterrorist threat or attack. Nothing in this section may be construed
as establishing new regulatory authority for the Secretary or the
Director to issue or modify any occupational safety and health rule or
regulation.
SEC. 154. ENHANCEMENT <<NOTE: 38 USC note prec. 8101.>> OF EMERGENCY
PREPAREDNESS OF DEPARTMENT OF VETERANS AFFAIRS.
(a) Readiness of Department Medical Center.--(1) The Secretary of
Veterans Affairs shall take appropriate actions to enhance the readiness
of Department of Veterans Affairs medical centers to protect the
patients and staff of such centers from chemical or biological attack or
otherwise to respond to such an attack and so as to enable such centers
to fulfil their obligations as part of the Federal response to public
health emegencies.
(2) Actions under paragraph (1) shall include--
(A) the provision of decontamination equipment and personal
protection equipment at Department medical centers; and
(B) the provision of training in the use of such equipment
to staff of such centers.
(b) Security at Department Medical and Research Facilities.--(1)
Not <<NOTE: Deadline.>> later than 180 days after the date of the
enactment of this Act, the Secretary shall carry out an evaluation of
the security needs at Department medical centers and research
facilities. The evaluation shall address the following needs:
(A) Needs for the protection of patients and medical staff
during emergencies, including a chemical or biological attack or
other terrorist attack.
(B) Needs, if any, for screening personnel engaged in
research relating to biological pathogens or agents, including
work associated with such research.
(C) Needs for securing laboratories or other facilities
engaged in research relating to biological pathogens or agents.
(D) Any other needs the Secretary considers appropriate.
(2) The Secretary shall take appropriate actions to enhance the
security of Department medical centers and research facilities,
including staff and patients at such centers and facilities. In taking
[[Page 116 STAT. 632]]
such actions, the Secretary shall take into account the results of the
evaluation required by paragraph (1).
(c) Tracking of Pharmaceuticals and Medical Supplies and
Equipment.--The Secretary shall develop and maintain a centralized
system for tracking the current location and availability of
pharmaceuticals, medical supplies, and medical equipment throughout the
Department health care system in order to permit the ready
identification and utilization of such pharmaceuticals, supplies, and
equipment for a variety of purposes, including response to a chemical or
biological attack or other terrorist attack.
(d) Training.--The Secretary shall ensure that the Department
medical centers, in consultation with the accredited medical school
affiliates of such medical centers, develop and implement curricula to
train resident physicians and health care personnel in medical matters
relating to biological, chemical, or radiological attacks.
(e) Participation in National Disaster Medical System.--(1) The
Secretary shall, in consultation with the Secretary of Defense, the
Secretary of Health and Human Services, and the Director of the Federal
Emergency Management Agency, establish and maintain a training program
to facilitate the participation of the staff of Department medical
centers, and of the community partners of such centers, in the National
Disaster Medical System.
(2) The Secretary shall establish and maintain the training program
under paragraph (1) in accordance with the recommendations of the
working group under section 319F(a) of the Public Health Service Act.
(f) Mental Health Counseling.--(1) With respect to activities
conducted by personnel serving at Department medical centers, the
Secretary shall, in consultation with the Secretary of Health and Human
Services, the American Red Cross, and the working group under section
319F(a) of the Public Health Service Act, develop and maintain various
strategies for providing mental health counseling and assistance,
including counseling and assistance for post-traumatic stress disorder,
to local and community emergency response providers, veterans, active
duty military personnel, and individuals seeking care at Department
medical centers following a bioterrorist attack or other public health
emergency.
(2) The strategies under paragraph (1) shall include the following:
(A) Training and certification of providers of mental health
counseling and assistance.
(B) Mechanisms for coordinating the provision of mental
health counseling and assistance to emergency response providers
referred to in that paragraph.
(g) Authorization of Appropriations.--There is hereby authorized to
be appropriated for the Department of Veterans Affairs amounts as
follows:
(1) To carry out activities required by subsection (a)--
(A) $100,000,000 for fiscal year 2002; and
(B) such sums as may be necessary for each of fiscal
years 2003 through 2006.
(2) To carry out activities required by subsections (b)
through (f)--
(A) $33,000,000 for fiscal year 2002; and
(B) such sums as may be necessary for each of fiscal
years 2003 through 2006.
[[Page 116 STAT. 633]]
SEC. 155. REAUTHORIZATION OF EXISTING PROGRAM.
Section 582(f) of the Public Health Service Act (42 U.S.C. 290hh-
1(f)) is amended by striking ``2002 and 2003'' and inserting ``2003
through 2006''.
SEC. 156. SENSE OF CONGRESS.
It is the sense of the Congress that--
(1) many excellent university-based programs are already
functioning and developing important biodefense products and
solutions throughout the United States;
(2) accelerating the crucial work done at university centers
and laboratories will contribute significantly to the United
States capacity to defend against any biological threat or
attack;
(3) maximizing the effectiveness of, and extending the
mission of, established university programs would be one
appropriate use of the additional resources provided for in this
Act and the amendments made by this Act; and
(4) the Secretary of Health and Human Services should, as
appropriate, recognize the importance of existing public and
private university-based research, training, public awareness,
and safety related biological defense programs when the
Secretary makes awards of grants and contracts in accordance
with this Act and the amendments made by this Act.
SEC. 157. GENERAL <<NOTE: 42 USC 300hh note.>> ACCOUNTING OFFICE REPORT.
(a) In General.--The Comptroller General shall submit to the
Committee on Health, Education, Labor, and Pensions and the Committee on
Appropriations of the Senate, and to the Committee on Energy and
Commerce and the Committee on Appropriations of the House of
Representatives, a report that describes--
(1) Federal activities primarily related to research on,
preparedness for, and the management of the public health and
medical consequences of a bioterrorist attack against the
civilian population;
(2) the coordination of the activities described in
paragraph (1);
(3) the effectiveness of such efforts in preparing national,
State, and local authorities to address the public health and
medical consequences of a potential bioterrorist attack against
the civilian population;
(4) the activities and costs of the Civil Support Teams of
the National Guard in responding to biological threats or
attacks against the civilian population;
(5) the activities of the working group under subsection (a)
and the efforts made by such group to carry out the activities
described in such subsection; and
(6) the ability of private sector contractors to enhance
governmental responses to biological threats or attacks.
SEC. 158. CERTAIN AWARDS.
Section 319(a) of the Public Health Service Act (42 U.S.C. 247d(a))
is amended in the matter after and below paragraph (2) by striking
``grants and'' and inserting ``grants, providing awards for expenses,
and''.
[[Page 116 STAT. 634]]
SEC. 159. PUBLIC <<NOTE: Community Access to Emergency Defibrillation
Act of 2002.>> ACCESS DEFIBRILLATION PROGRAMS AND PUBLIC
ACCESS DEFIBRILLATION DEMONSTRATION PROJECTS.
(a) Short Title.--This <<NOTE: 42 USC 201 note.>> section may be
cited as the ``Community Access to Emergency Defibrillation Act of
2002''.
(b) Findings.--Congress <<NOTE: 42 USC 244 note.>> makes the
following findings:
(1) Over 220,000 Americans die each year from cardiac
arrest. Every 2 minutes, an individual goes into cardiac arrest
in the United States.
(2) The chance of successfully returning to a normal heart
rhythm diminishes by 10 percent each minute following sudden
cardiac arrest.
(3) Eighty percent of cardiac arrests are caused by
ventricular fibrillation, for which defibrillation is the only
effective treatment.
(4) Sixty percent of all cardiac arrests occur outside the
hospital. The average national survival rate for out-of-hospital
cardiac arrest is only 5 percent.
(5) Communities that have established and implemented public
access defibrillation programs have achieved average survival
rates for out-of-hospital cardiac arrest as high as 50 percent.
(6) According to the American Heart Association, wide use of
defibrillators could save as many as 50,000 lives nationally
each year.
(7) Successful public access defibrillation programs ensure
that cardiac arrest victims have access to early 911
notification, early cardiopulmonary resuscitation, early
defibrillation, and early advanced care.
(c) Public Access Defibrillation Programs and Projects.--Part B of
title III of the Public Health Service Act (42 U.S.C. 243 et seq.), as
amended by Public Law 106-310, is amended by adding after section 311
the following:
``SEC. 312. PUBLIC <<NOTE: 42 USC 244.>> ACCESS DEFIBRILLATION PROGRAMS.
``(a) In General.--The <<NOTE: Grants.>> Secretary shall award
grants to States, political subdivisions of States, Indian tribes, and
tribal organizations to develop and implement public access
defibrillation programs--
``(1) by training and equipping local emergency medical
services personnel, including firefighters, police officers,
paramedics, emergency medical technicians, and other first
responders, to administer immediate care, including
cardiopulmonary resuscitation and automated external
defibrillation, to cardiac arrest victims;
``(2) by purchasing automated external defibrillators,
placing the defibrillators in public places where cardiac
arrests are likely to occur, and training personnel in such
places to administer cardiopulmonary resuscitation and automated
external defibrillation to cardiac arrest victims;
``(3) by setting procedures for proper maintenance and
testing of such devices, according to the guidelines of the
manufacturers of the devices;
``(4) by providing training to members of the public in
cardiopulmonary resuscitation and automated external
defibrillation;
``(5) by integrating the emergency medical services system
with the public access defibrillation programs so that emergency
[[Page 116 STAT. 635]]
medical services personnel, including dispatchers, are informed
about the location of automated external defibrillators in their
community; and
``(6) by encouraging private companies, including small
businesses, to purchase automated external defibrillators and
provide training for their employees to administer
cardiopulmonary resuscitation and external automated
defibrillation to cardiac arrest victims in their community.
``(b) Preference.--In awarding grants under subsection (a), the
Secretary shall give a preference to a State, political subdivision of a
State, Indian tribe, or tribal organization that--
``(1) has a particularly low local survival rate for cardiac
arrests, or a particularly low local response rate for cardiac
arrest victims; or
``(2) demonstrates in its application the greatest
commitment to establishing and maintaining a public access
defibrillation program.
``(c) Use of Funds.--A State, political subdivision of a State,
Indian tribe, or tribal organization that receives a grant under
subsection (a) may use funds received through such grant to--
``(1) purchase automated external defibrillators that have
been approved, or cleared for marketing, by the Food and Drug
Administration;
``(2) provide automated external defibrillation and basic
life support training in automated external defibrillator usage
through nationally recognized courses;
``(3) provide information to community members about the
public access defibrillation program to be funded with the
grant;
``(4) provide information to the local emergency medical
services system regarding the placement of automated external
defibrillators in public places;
``(5) produce materials to encourage private companies,
including small businesses, to purchase automated external
defibrillators; and
``(6) further develop strategies to improve access to
automated external defibrillators in public places.
``(d) Application.--
``(1) In general.--To be eligible to receive a grant under
subsection (a), a State, political subdivision of a State,
Indian tribe, or tribal organization shall prepare and submit an
application to the Secretary at such time, in such manner, and
containing such information as the Secretary may reasonably
require.
``(2) Contents.--An application submitted under paragraph
(1) shall--
``(A) describe the comprehensive public access
defibrillation program to be funded with the grant and
demonstrate how such program would make automated
external defibrillation accessible and available to
cardiac arrest victims in the community;
``(B) contain procedures for implementing
appropriate nationally recognized training courses in
performing cardiopulmonary resuscitation and the use of
automated external defibrillators;
``(C) contain procedures for ensuring direct
involvement of a licensed medical professional and
coordination with
[[Page 116 STAT. 636]]
the local emergency medical services system in the
oversight of training and notification of incidents of
the use of the automated external defibrillators;
``(D) contain procedures for proper maintenance and
testing of the automated external defibrillators,
according to the labeling of the manufacturer;
``(E) contain procedures for ensuring notification
of local emergency medical services system personnel,
including dispatchers, of the location and type of
devices used in the public access defibrillation
program; and
``(F) provide for the collection of data regarding
the effectiveness of the public access defibrillation
program to be funded with the grant in affecting the
out-of-hospital cardiac arrest survival rate.
``(e) Authorization of Appropriations.--For the purpose of carrying
out this section, there are authorized to be appropriated $25,000,000
for fiscal year 2003, and such sums as may be necessary for each of the
fiscal years 2004 through 2006. Not more than 10 percent of amounts
received under a grant awarded under this section may be used for
administrative expenses.
``SEC. 313. PUBLIC <<NOTE: 42 USC 245.>> ACCESS DEFIBRILLATION
DEMONSTRATION PROJECTS.
``(a) In General.--The Secretary shall award grants to political
subdivisions of States, Indian tribes, and tribal organizations to
develop and implement innovative, comprehensive, community-based public
access defibrillation demonstration projects that--
``(1) provide cardiopulmonary resuscitation and automated
external defibrillation to cardiac arrest victims in unique
settings;
``(2) provide training to community members in
cardiopulmonary resuscitation and automated external
defibrillation; and
``(3) maximize community access to automated external
defibrillators.
``(b) Use of Funds.--A recipient of a grant under subsection (a)
shall use the funds provided through the grant to--
``(1) purchase automated external defibrillators that have
been approved, or cleared for marketing, by the Food and Drug
Administration;
``(2) provide basic life training in automated external
defibrillator usage through nationally recognized courses;
``(3) provide information to community members about the
public access defibrillation demonstration project to be funded
with the grant;
``(4) provide information to the local emergency medical
services system regarding the placement of automated external
defibrillators in the unique settings; and
``(5) further develop strategies to improve access to
automated external defibrillators in public places.
``(c) Application.--
``(1) In general.--To be eligible to receive a grant under
subsection (a), a political subdivision of a State, Indian
tribe, or tribal organization shall prepare and submit an
application to the Secretary at such time, in such manner, and
containing such information as the Secretary may reasonably
require.
[[Page 116 STAT. 637]]
``(2) Contents.--An application submitted under paragraph
(1) may--
``(A) describe the innovative, comprehensive,
community-based public access defibrillation
demonstration project to be funded with the grant;
``(B) explain how such public access defibrillation
demonstration project represents innovation in providing
public access to automated external defibrillation; and
``(C) provide for the collection of data regarding
the effectiveness of the demonstration project to be
funded with the grant in--
``(i) providing emergency cardiopulmonary
resuscitation and automated external
defibrillation to cardiac arrest victims in the
setting served by the demonstration project; and
``(ii) affecting the cardiac arrest survival
rate in the setting served by the demonstration
project.
``(d) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section $5,000,000 for each of fiscal
years 2002 through 2006. Not more than 10 percent of amounts received
under a grant awarded under this section may be used for administrative
expenses.''.
TITLE II--ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND TOXINS
Subtitle A--Department of Health and Human Services
SEC. 201. REGULATION OF CERTAIN BIOLOGICAL AGENTS AND TOXINS.
(a) Biological Agents Provisions of the Antiterrorism and Effective
Death Penalty Act of 1996; Codification in the Public Health Service
Act, With Amendments.--Subpart 1 of part F of title III of the Public
Health Service Act (42 U.S.C. 262 et seq.) is amended by inserting after
section 351 the following:
``SEC. 351A. ENHANCED <<NOTE: 42 USC 262a.>> CONTROL OF DANGEROUS
BIOLOGICAL AGENTS AND TOXINS.
``(a) Regulatory Control of Certain Biological Agents and Toxins.--
``(1) List of biological agents and toxins.--
``(A) In general.--The Secretary shall by regulation
establish and maintain a list of each biological agent
and each toxin that has the potential to pose a severe
threat to public health and safety.
``(B) Criteria.--In determining whether to include
an agent or toxin on the list under subparagraph (A),
the Secretary shall--
``(i) consider--
``(I) the effect on human health of
exposure to the agent or toxin;
[[Page 116 STAT. 638]]
``(II) the degree of contagiousness
of the agent or toxin and the methods by
which the agent or toxin is transferred
to humans;
``(III) the availability and
effectiveness of pharmacotherapies and
immunizations to treat and prevent any
illness resulting from infection by the
agent or toxin; and
``(IV) any other criteria, including
the needs of children and other
vulnerable populations, that the
Secretary considers appropriate; and
``(ii) consult with appropriate Federal
departments and agencies and with scientific
experts representing appropriate professional
groups, including groups with pediatric expertise.
``(2) Biennial review.--The Secretary shall review and
republish the list under paragraph (1) biennially, or more often
as needed, and shall by regulation revise the list as necessary
in accordance with such paragraph.
``(b) Regulation of Transfers of Listed Agents and Toxins.--The
Secretary shall by regulation provide for--
``(1) the establishment and enforcement of safety procedures
for the transfer of listed agents and toxins, including measures
to ensure--
``(A) proper training and appropriate skills to
handle such agents and toxins; and
``(B) proper laboratory facilities to contain and
dispose of such agents and toxins;
``(2) the establishment and enforcement of safeguard and
security measures to prevent access to such agents and toxins
for use in domestic or international terrorism or for any other
criminal purpose;
``(3) the establishment of procedures to protect the public
safety in the event of a transfer or potential transfer of such
an agent or toxin in violation of the safety procedures
established under paragraph (1) or the safeguard and security
measures established under paragraph (2); and
``(4) appropriate availability of biological agents and
toxins for research, education, and other legitimate purposes.
``(c) Possession and Use of Listed Agents and Toxins.--The Secretary
shall by regulation provide for the establishment and enforcement of
standards and procedures governing the possession and use of listed
agents and toxins, including the provisions described in paragraphs (1)
through (4) of subsection (b), in order to protect the public health and
safety.
``(d) Registration; Identification; Database.--
``(1) Registration.--Regulations under subsections (b) and
(c) shall require registration with the Secretary of the
possession, use, and transfer of listed agents and toxins, and
shall include provisions to ensure that persons seeking to
register under such regulations have a lawful purpose to
possess, use, or transfer such agents and toxins, including
provisions in accordance with subsection (e)(6).
``(2) Identification; database.--Regulations under
subsections (b) and (c) shall require that registration include
(if available to the person registering) information regarding
the characterization of listed agents and toxins to facilitate
their
[[Page 116 STAT. 639]]
identification, including their source. The Secretary shall
maintain a national database that includes the names and
locations of registered persons, the listed agents and toxins
such persons are possessing, using, or transferring, and
information regarding the characterization of such agents and
toxins.
``(e) Safeguard and Security Requirements for Registered Persons.--
``(1) In general.--Regulations under subsections (b) and (c)
shall include appropriate safeguard and security requirements
for persons possessing, using, or transferring a listed agent or
toxin commensurate with the risk such agent or toxin poses to
public health and safety (including the risk of use in domestic
or international terrorism). The Secretary shall establish such
requirements in consultation with the Attorney General, and
shall ensure compliance with such requirements as part of the
registration system under such regulations.
``(2) Limiting access to listed agents and toxins.--
Requirements under paragraph (1) shall include provisions to
ensure that registered persons--
``(A) provide access to listed agents and toxins to
only those individuals whom the registered person
involved determines have a legitimate need to handle or
use such agents and toxins;
``(B) submit the names and other identifying
information for such individuals to the Secretary and
the Attorney General, promptly after first determining
that the individuals need access under subparagraph (A),
and periodically thereafter while the individuals have
such access, not less frequently than once every five
years;
``(C) deny access to such agents and toxins by
individuals whom the Attorney General has identified as
restricted persons; and
``(D) limit or deny access to such agents and toxins
by individuals whom the Attorney General has identified
as within any category under paragraph (3)(B)(ii), if
limiting or denying such access by the individuals
involved is determined appropriate by the Secretary, in
consultation with the Attorney General.
``(3) Submitted names; use of databases by attorney
general.--
``(A) In general.--Upon the receipt of names and
other identifying information under paragraph (2)(B),
the Attorney General shall, for the sole purpose of
identifying whether the individuals involved are within
any of the categories specified in subparagraph (B),
promptly use criminal, immigration, national security,
and other electronic databases that are available to the
Federal Government and are appropriate for such purpose.
``(B) Certain individuals.--For purposes of
subparagraph (A), the categories specified in this
subparagraph regarding an individual are that--
``(i) the individual is a restricted person;
or
``(ii) the individual is reasonably suspected
by any Federal law enforcement or intelligence
agency of--
``(I) committing a crime set forth
in section 2332b(g)(5) of title 18,
United States Code;
[[Page 116 STAT. 640]]
``(II) knowing involvement with an
organization that engages in domestic or
international terrorism (as defined in
section 2331 of such title 18) or with
any other organization that engages in
intentional crimes of violence; or
``(III) being an agent of a foreign
power (as defined in section 1801 of
title 50, United States Code).
``(C) Notification by attorney general regarding
submitted names.--After the receipt of a name and other
identifying information under paragraph (2)(B), the
Attorney General shall promptly notify the Secretary
whether the individual is within any of the categories
specified in subparagraph (B).
``(4) Notifications by secretary.--The Secretary, after
receiving notice under paragraph (3) regarding an individual,
shall promptly notify the registered person involved of whether
the individual is granted or denied access under paragraph (2).
If the individual is denied such access, the Secretary shall
promptly notify the individual of the denial.
``(5) Expedited review.--Regulations under subsections (b)
and (c) shall provide for a procedure through which, upon
request to the Secretary by a registered person who submits
names and other identifying information under paragraph (2)(B)
and who demonstrates good cause, the Secretary may, as
determined appropriate by the Secretary--
``(A) request the Attorney General to expedite the
process of identification under paragraph (3)(A) and
notification of the Secretary under paragraph (3)(C);
and
``(B) expedite the notification of the registered
person by the Secretary under paragraph (4).
``(6) Process regarding persons seeking to register.--
``(A) Individuals.--Regulations under subsections
(b) and (c) shall provide that an individual who seeks
to register under either of such subsections is subject
to the same processes described in paragraphs (2)
through (4) as apply to names and other identifying
information submitted to the Attorney General under
paragraph (2)(B). Paragraph (5) does not apply for
purposes of this subparagraph.
``(B) Other persons.--Regulations under subsections
(b) and (c) shall provide that, in determining whether
to deny or revoke registration by a person other than an
individual, the Secretary shall submit the name of such
person to the Attorney General, who shall use criminal,
immigration, national security, and other electronic
databases available to the Federal Government, as
appropriate for the purpose of promptly notifying the
Secretary whether the person, or, where relevant, the
individual who owns or controls such person, is a
restricted person or is reasonably suspected by any
Federal law enforcement or intelligence agency of being
within any category specified in paragraph (3)(B)(ii)
(as applied to persons, including individuals). Such
regulations shall provide that a person who seeks to
register under either of such subsections is subject to
the same processes described in paragraphs
[[Page 116 STAT. 641]]
(2) and (4) as apply to names and other identifying
information submitted to the Attorney General under
paragraph (2)(B). Paragraph (5) does not apply for
purposes of this subparagraph. The Secretary may exempt
Federal, State, or local governmental agencies from the
requirements of this subparagraph.
``(7) Review.--
``(A) Administrative review.--
``(i) In general.--Regulations under
subsections (b) and (c) shall provide for an
opportunity for a review by the Secretary--
``(I) when requested by the
individual involved, of a determination
under paragraph (2) to deny the
individual access to listed agents and
toxins; and
``(II) when requested by the person
involved, of a determination under
paragraph (6) to deny or revoke
registration for such person.
``(ii) Ex parte review.--During a review under
clause (i), the Secretary may consider information
relevant to the review ex parte to the extent that
disclosure of the information could compromise
national security or an investigation by any law
enforcement agency.
``(iii) Final agency action.--The decision of
the Secretary in a review under clause (i)
constitutes final agency action for purposes of
section 702 of title 5, United States Code.
``(B) Certain procedures.--
``(i) Submission of ex parte materials in
judicial proceedings.--When reviewing a decision
of the Secretary under subparagraph (A), and upon
request made ex parte and in writing by the United
States, a court, upon a sufficient showing, may
review and consider ex parte documents containing
information the disclosure of which could
compromise national security or an investigation
by any law enforcement agency. If the court
determines that portions of the documents
considered ex parte should be disclosed to the
person involved to allow a response, the court
shall authorize the United States to delete from
such documents specified items of information the
disclosure of which could compromise national
security or an investigation by any law
enforcement agency, or to substitute a summary of
the information to which the person may respond.
Any order by the court authorizing the disclosure
of information that the United States believes
could compromise national security or an
investigation by any law enforcement agency shall
be subject to the processes set forth in
subparagraphs (A) and (B)(i) of section
2339B(f)(5) of title 18, United States Code
(relating to interlocutory appeal and expedited
consideration).
``(ii) Disclosure of information.--In a review
under subparagraph (A), and in any judical
proceeding conducted pursuant to such review,
neither the Secretary nor the Attorney General may
be required to
[[Page 116 STAT. 642]]
disclose to the public any information that under
subsection (h) shall not be disclosed under
section 552 of title 5, United States Code.
``(8) Notifications regarding theft or loss of agents.--
Requirements under paragraph (1) shall include the prompt
notification of the Secretary, and appropriate Federal, State,
and local law enforcement agencies, of the theft or loss of
listed agents and toxins.
``(9) Technical assistance for registered persons.--The
Secretary, in consultation with the Attorney General, may
provide technical assistance to registered persons to improve
security of the facilities of such persons.
``(f) Inspections.--The Secretary shall have the authority to
inspect persons subject to regulations under subsection (b) or (c) to
ensure their compliance with such regulations, including prohibitions on
restricted persons and other provisions of subsection (e).
``(g) Exemptions.--
``(1) Clinical or diagnostic laboratories.--Regulations
under subsections (b) and (c) shall exempt clinical or
diagnostic laboratories and other persons who possess, use, or
transfer listed agents or toxins that are contained in specimens
presented for diagnosis, verification, or proficiency testing,
provided that--
``(A) the identification of such agents or toxins is
reported to the Secretary, and when required under
Federal, State, or local law, to other appropriate
authorities; and
``(B) such agents or toxins are transferred or
destroyed in a manner set forth by the Secretary by
regulation.
``(2) Products.--
``(A) In general.--Regulations under subsections (b)
and (c) shall exempt products that are, bear, or contain
listed agents or toxins and are cleared, approved,
licensed, or registered under any of the Acts specified
in subparagraph (B), unless the Secretary by order
determines that applying additional regulation under
subsection (b) or (c) to a specific product is necessary
to protect public health and safety.
``(B) Relevant laws.--For purposes of subparagraph
(A), the Acts specified in this subparagraph are the
following:
``(i) The Federal Food, Drug, and Cosmetic
Act.
``(ii) Section 351 of this Act.
``(iii) The Act commonly known as the Virus-
Serum-Toxin Act (the eighth paragraph under the
heading `Bureau of Animal Industry' in the Act of
March 4, 1913; 21 U.S.C. 151-159).
``(iv) The Federal Insecticide, Fungicide, and
Rodenticide Act.
``(C) Investigational use.--
``(i) In general.--The Secretary may exempt an
investigational product that is, bears, or
contains a listed agent or toxin from the
applicability of provisions of regulations under
subsection (b) or (c) when such product is being
used in an investigation authorized under any
Federal Act and the Secretary determines that
applying additional regulation under subsection
[[Page 116 STAT. 643]]
(b) or (c) to such product is not necessary to
protect public health and safety.
``(ii) Certain processes.--Regulations under
subsections (b) and (c) shall set forth the
procedures for applying for an exemption under
clause (i). In <<NOTE: Deadline.>> the case of
investigational products authorized under any of
the Acts specified in subparagraph (B), the
Secretary shall make a determination regarding a
request for an exemption not later than 14 days
after the first date on which both of the
following conditions have been met by the person
requesting the exemption:
``(I) The person has submitted to
the Secretary an application for the
exemption meeting the requirements
established by the Secretary.
``(II) The person has notified the
Secretary that the investigation has
been authorized under such an Act.
``(3) Public health emergencies.--The Secretary may
temporarily exempt a person from the applicability of the
requirements of this section, in whole or in part, if the
Secretary determines that such exemption is necessary to provide
for the timely participation of the person in a response to a
domestic or foreign public health emergency (whether determined
under section 319(a) or otherwise) that involves a listed agent
or toxin. With respect to the emergency involved, such exemption
for a person may not exceed 30 days, except that the Secretary,
after review of whether such exemption remains necessary, may
provide one extension of an additional 30 days.
``(4) Agricultural emergencies.--Upon request of the
Secretary of Agriculture, after the granting by such Secretary
of an exemption under section 212(g)(1)(D) of the Agricultural
Bioterrorism Protection Act of 2002 pursuant to a finding that
there is an agricultural emergency, the Secretary of Health and
Human Services may temporarily exempt a person from the
applicability of the requirements of this section, in whole or
in part, to provide for the timely participation of the person
in a response to the agricultural emergency. With respect to the
emergency involved, the exemption under this paragraph for a
person may not exceed 30 days, except that upon request of the
Secretary of Agriculture, the Secretary of Health and Human
Services may, after review of whether such exemption remains
necessary, provide one extension of an additional 30 days.
``(h) Disclosure of Information.--
``(1) Nondisclosure of certain information.--No Federal
agency specified in paragraph (2) shall disclose under section
552 of title 5, United States Code, any of the following:
``(A) Any registration or transfer documentation
submitted under subsections (b) and (c) for the
possession, use, or transfer of a listed agent or toxin;
or information derived therefrom to the extent that it
identifies the listed agent or toxin possessed, used, or
transferred by a specific registered person or discloses
the identity or location of a specific registered
person.
``(B) The national database developed pursuant to
subsection (d), or any other compilation of the
registration or transfer information submitted under
subsections (b)
[[Page 116 STAT. 644]]
and (c) to the extent that such compilation discloses
site-specific registration or transfer information.
``(C) Any portion of a record that discloses the
site-specific or transfer-specific safeguard and
security measures used by a registered person to prevent
unauthorized access to listed agents and toxins.
``(D) Any notification of a release of a listed
agent or toxin submitted under subsections (b) and (c),
or any notification of theft or loss submitted under
such subsections.
``(E) Any portion of an evaluation or report of an
inspection of a specific registered person conducted
under subsection (f) that identifies the listed agent or
toxin possessed by a specific registered person or that
discloses the identity or location of a specific
registered person if the agency determines that public
disclosure of the information would endanger public
health or safety.
``(2) Covered agencies.--For purposes of paragraph (1) only,
the Federal agencies specified in this paragraph are the
following:
``(A) The Department of Health and Human Services,
the Department of Justice, the Department of
Agriculture, and the Department of Transportation.
``(B) Any Federal agency to which information
specified in paragraph (1) is transferred by any agency
specified in subparagraph (A) of this paragraph.
``(C) Any Federal agency that is a registered
person, or has a sub-agency component that is a
registered person.
``(D) Any Federal agency that awards grants or
enters into contracts or cooperative agreements
involving listed agents and toxins to or with a
registered person, and to which information specified in
paragraph (1) is transferred by any such registered
person.
``(3) Other exemptions.--This subsection may not be
construed as altering the application of any exemptions to
public disclosure under section 552 of title 5, United States
Code, except as to subsection 552(b)(3) of such title, to any of
the information specified in paragraph (1).
``(4) Rule of construction.--Except as specifically provided
in paragraph (1), this subsection may not be construed as
altering the authority of any Federal agency to withhold under
section 552 of title 5, United States Code, or the obligation of
any Federal agency to disclose under section 552 of title 5,
United States Code, any information, including information
relating to--
``(A) listed agents and toxins, or individuals
seeking access to such agents and toxins;
``(B) registered persons, or persons seeking to
register their possession, use, or transfer of such
agents and toxins;
``(C) general safeguard and security policies and
requirements under regulations under subsections (b) and
(c); or
``(D) summary or statistical information concerning
registrations, registrants, denials or revocations of
registrations, listed agents and toxins, inspection
evaluations and reports, or individuals seeking access
to such agents and toxins.
[[Page 116 STAT. 645]]
``(5) Disclosures to congress; other disclosures.--This
subsection may not be construed as providing any authority--
``(A) to withhold information from the Congress or
any committee or subcommittee thereof; or
``(B) to withhold information from any person under
any other Federal law or treaty.
``(i) Civil Money Penalty.--
``(1) In general.--In addition to any other penalties that
may apply under law, any person who violates any provision of
regulations under subsection (b) or (c) shall be subject to the
United States for a civil money penalty in an amount not
exceeding $250,000 in the case of an individual and $500,000 in
the case of any other person.
``(2) Applicability of certain provisions.--The provisions
of section 1128A of the Social Security Act (other than
subsections (a), (b), (h), and (i), the first sentence of
subsection (c), and paragraphs (1) and (2) of subsection (f))
shall apply to a civil money penalty under paragraph (1) in the
same manner as such provisions apply to a penalty or proceeding
under section 1128A(a) of such Act. The Secretary may delegate
authority under this subsection in the same manner as provided
in section 1128A(j)(2) of the Social Security Act, and such
authority shall include all powers as contained in section 6 of
the Inspector General Act of 1978 (5 U.S.C. App.).
``(j) Notification in Event of Release.--Regulations under
subsections (b) and (c) shall require the prompt notification of the
Secretary by a registered person whenever a release, meeting criteria
established by the Secretary, of a listed agent or toxin has occurred
outside of the biocontainment area of a facility of the registered
person. Upon receipt of such notification and a finding by the Secretary
that the release poses a threat to public health or safety, the
Secretary shall take appropriate action to notify relevant State and
local public health authorities, other relevant Federal authorities,
and, if necessary, other appropriate persons (including the public). If
the released listed agent or toxin is an overlap agent or toxin (as
defined in subsection (l)), the Secretary shall promptly notify the
Secretary of Agriculture upon notification by the registered person.
``(k) Reports.--The Secretary shall report to the Congress annually
on the number and nature of notifications received under subsection
(e)(8) (relating to theft or loss) and subsection (j) (relating to
releases).
``(l) Definitions.--For purposes of this section:
``(1) The terms `biological agent' and `toxin' have the
meanings given such terms in section 178 of title 18, United
States Code.
``(2) The term `listed agents and toxins' means biological
agents and toxins listed pursuant to subsection (a)(1).
``(3) The term `listed agents or toxins' means biological
agents or toxins listed pursuant to subsection (a)(1).
``(4) The term `overlap agents and toxins' means biological
agents and toxins that--
``(A) are listed pursuant to subsection (a)(1); and
``(B) are listed pursuant to section 212(a)(1) of
the Agricultural Bioterrorism Protection Act of 2002.
``(5) The term `overlap agent or toxin' means a biological
agent or toxin that--
[[Page 116 STAT. 646]]
``(A) is listed pursuant to subsection (a)(1); and
``(B) is listed pursuant to section 212(a)(1) of the
Agricultural Bioterrorism Protection Act of 2002.
``(6) The term `person' includes Federal, State, and local
governmental entities.
``(7) The term `registered person' means a person registered
under regulations under subsection (b) or (c).
``(8) The term `restricted person' has the meaning given
such term in section 175b of title 18, United States Code.
``(m) Authorization of Appropriations.--For the purpose of carrying
out this section, there are authorized to be appropriated such sums as
may be necessary for each of the fiscal years 2002 through 2007.''.
(b) Report to Congress.--Not <<NOTE: Deadline. 42 USC 262a
note.>> later than one year after the date of the enactment of this Act,
the Secretary of Health and Human Services, after consultation with
other appropriate Federal agencies, shall submit to the Congress a
report that--
(1) describes the extent to which there has been compliance
by governmental and private entities with applicable regulations
under section 351A of the Public Health Service Act (as added by
subsection (a) of this section), including the extent of
compliance before the date of the enactment of this Act, and
including the extent of compliance with regulations promulgated
after such date of enactment;
(2) describes the actions to date and future plans of the
Secretary for updating the list of biological agents and toxins
under such section 351A;
(3) describes the actions to date and future plans of the
Secretary for determining compliance with regulations under such
section 351A and for taking appropriate enforcement actions;
(4) evaluates the impact of such section 351A on research on
biological agents and toxins listed pursuant to such section;
and
(5) provides any recommendations of the Secretary for
administrative or legislative initiatives regarding such section
351A.
SEC. 202. IMPLEMENTATION <<NOTE: Deadlines. 42 USC 262a note.>> BY
DEPARTMENT OF HEALTH AND HUMAN SERVICES.
(a) Date Certain for Notice of Possession.--Not later than 90 days
after the date of the enactment of this Act, all persons (unless exempt
under subsection (g) of section 351A of the Public Health Service Act,
as added by section 201 of this Act) in possession of biological agents
or toxins listed under such section 351A of the Public Health Service
Act shall notify the Secretary of Health and Human Services of such
possession. Not later <<NOTE: Guidelines.>> than 30 days after such date
of enactment, the Secretary shall provide written guidance on how such
notice is to be provided to the Secretary.
(b) Date Certain for Promulgation; Effective Date Regarding Criminal
and Civil Penalties.--Not <<NOTE: Rules.>> later than 180 days after the
date of the enactment of this Act, the Secretary of Health and Human
Services shall promulgate an interim final rule for carrying out section
351A of the Public Health Service Act, subject to subsection (c). Such
interim final rule shall take effect 60 days after the date on which
such rule is promulgated, including for purposes of--
[[Page 116 STAT. 647]]
(1) section 175b(c) of title 18, United States Code
(relating to criminal penalties), as added by section 231(a)(5)
of this Act; and
(2) section 351A(i) of the Public Health Service Act
(relating to civil penalties).
(c) Transitional Provision Regarding Current Research and
Education.--The interim final rule under subsection (b) shall include
time frames for the applicability of the rule that minimize disruption
of research or educational projects that involve biological agents and
toxins listed pursuant to section 351A(a)(1) of the Public Health
Service Act and that were underway as of the effective date of such
rule.
SEC. 203. EFFECTIVE <<NOTE: 42 USC 262a note.>> DATES.
(a) In General.--Regulations promulgated by the Secretary of Health
and Human Services under section 511 of the Antiterrorism and Effective
Death Penalty Act of 1996 are deemed to have been promulgated under
section 351A of the Public Health Service Act, as added by section 201
of this Act. Such regulations, including the list under subsection
(d)(1) of such section 511, that were in effect on the day before the
date of the enactment of this Act remain in effect until modified by the
Secretary in accordance with such section 351A and with section 202 of
this Act.
(b) Effective Date Regarding Disclosure of Information.--Subsection
(h) of section 351A of the Public Health Service Act, as added by
section 201 of this Act, is deemed to have taken effect on the effective
date of the Antiterrorism and Effective Death Penalty Act of 1996.
SEC. 204. CONFORMING AMENDMENT.
Subsections (d), (e), (f), and (g) of section 511 of the
Antiterrorism and Effective Death Penalty Act of 1996 (42 U.S.C. 262
note) are repealed.
Subtitle B--Department <<NOTE: Agricultural Bioterrorism Protection Act
of 2002.>> of Agriculture
SEC. 211. <<NOTE: 7 USC 8401 note.>> SHORT TITLE.
This subtitle may be cited as the ``Agricultural Bioterrorism
Protection Act of 2002''.
SEC. 212. REGULATION <<NOTE: 7 USC 8401.>> OF CERTAIN BIOLOGICAL AGENTS
AND TOXINS.
(a) Regulatory Control of Certain Biological Agents and Toxins.--
(1) List of biological agents and toxins.--
(A) In general.--The Secretary of Agriculture shall
by regulation establish and maintain a list of each
biological agent and each toxin that the Secretary
determines has the potential to pose a severe threat to
animal or plant health, or to animal or plant products.
(B) Criteria.--In determining whether to include an
agent or toxin on the list under subparagraph (A), the
Secretary shall--
(i) consider--
(I) the effect of exposure to the
agent or toxin on animal or plant
health, and on the production and
marketability of animal or plant
products;
[[Page 116 STAT. 648]]
(II) the pathogenicity of the agent
or the toxicity of the toxin and the
methods by which the agent or toxin is
transferred to animals or plants;
(III) the availability and
effectiveness of pharmacotherapies and
prophylaxis to treat and prevent any
illness caused by the agent or toxin;
and
(IV) any other criteria that the
Secretary considers appropriate to
protect animal or plant health, or
animal or plant products; and
(ii) consult with appropriate Federal
departments and agencies and with scientific
experts representing appropriate professional
groups.
(2) Biennial <<NOTE: Publication.>> review.--The Secretary
shall review and republish the list under paragraph (1)
biennially, or more often as needed, and shall by regulation
revise the list as necessary in accordance with such paragraph.
(b) Regulation of Transfers <<NOTE: Safety.>> of Listed Agents and
Toxins.--The Secretary shall by regulation provide for--
(1) the establishment and enforcement of safety procedures
for the transfer of listed agents and toxins, including measures
to ensure--
(A) proper training and appropriate skills to handle
such agents and toxins; and
(B) proper laboratory facilities to contain and
dispose of such agents and toxins;
(2) the establishment and enforcement of safeguard and
security measures to prevent access to such agents and toxins
for use in domestic or international terrorism or for any other
criminal purpose;
(3) the establishment of procedures to protect animal and
plant health, and animal and plant products, in the event of a
transfer or potential transfer of such an agent or toxin in
violation of the safety procedures established under paragraph
(1) or the safeguard and security measures established under
paragraph (2); and
(4) appropriate availability of biological agents and toxins
for research, education, and other legitimate purposes.
(c) Possession and Use of Listed Agents and Toxins.--The Secretary
shall by regulation provide for the establishment and enforcement of
standards and procedures governing the possession and use of listed
agents and toxins, including the provisions described in paragraphs (1)
through (4) of subsection (b), in order to protect animal and plant
health, and animal and plant products.
(d) Registration; Identification; Database.--
(1) Registration.--Regulations under subsections (b) and (c)
shall require registration with the Secretary of the possession,
use, and transfer of listed agents and toxins, and shall include
provisions to ensure that persons seeking to register under such
regulations have a lawful purpose to possess, use, or transfer
such agents and toxins, including provisions in accordance with
subsection (e)(6).
(2) Identification; database.--Regulations under subsections
(b) and (c) shall require that registration include (if
available to the person registering) information regarding the
characterization of listed agents and toxins to facilitate their
[[Page 116 STAT. 649]]
identification, including their source.
The <<NOTE: Records.>> Secretary shall maintain a national
database that includes the names and locations of registered
persons, the listed agents and toxins such persons are
possessing, using, or transferring, and information regarding
the characterization of such agents and toxins.
(e) Safeguard and Security Requirements for Registered Persons.--
(1) In general.--Regulations under subsections (b) and (c)
shall include appropriate safeguard and security requirements
for persons possessing, using, or transferring a listed agent or
toxin commensurate with the risk such agent or toxin poses to
animal and plant health, and animal and plant products
(including the risk of use in domestic or international
terrorism). The Secretary shall establish such requirements in
consultation with the Attorney General, and shall ensure
compliance with such requirements as part of the registration
system under such regulations.
(2) Limiting access to listed agents and toxins.--
Requirements under paragraph (1) shall include provisions to
ensure that registered persons--
(A) provide access to listed agents and toxins to
only those individuals whom the registered person
involved determines have a legitimate need to handle or
use such agents and toxins;
(B) submit the names and other identifying
information for such individuals to the Secretary and
the Attorney General, promptly after first determining
that the individuals need access under subparagraph (A),
and periodically thereafter while the individuals have
such access, not less frequently than once every five
years; and
(C)(i) in the case of listed agents and toxins that
are not overlap agents and toxins (as defined in
subsection (g)(1)(A)(ii)), limit or deny access to such
agents and toxins by individuals whom the Attorney
General has identified as within any category under
paragraph (3)(B), if limiting or denying such access by
the individuals involved is determined appropriate by
the Secretary, in consultation with the Attorney
General; and
(ii) in the case of listed agents and toxins that
are overlap agents--
(I) deny access to such agents and
toxins by individuals whom the Attorney
General has identified as within any
category referred to in paragraph
(3)(B)(i); and
(II) limit or deny access to such
agents and toxins by individuals whom
the Attorney General has identified as
within any category under paragraph
(3)(B)(ii), if limiting or denying such
access by the individuals involved is
determined appropriate by the Secretary,
in consultation with the Attorney
General.
(3) Submitted names; use of databases by attorney general.--
(A) In general.--Upon the receipt of names and other
identifying information under paragraph (2)(B), the
Attorney General shall, for the sole purpose of
identifying whether the individuals involved are within
any of the
[[Page 116 STAT. 650]]
categories specified in subparagraph (B), promptly use
criminal, immigration, national security, and other
electronic databases that are available to the Federal
Government and are appropriate for such purpose.
(B) Certain individuals.--For purposes of
subparagraph (A), the categories specified in this
subparagraph regarding an individual are that--
(i) the individual is within any of the
categories described in section 175b(d)(1) of
title 18, United States Code (relating to
restricted persons); or
(ii) the individual is reasonably suspected by
any Federal law enforcement or intelligence agency
of--
(I) committing a crime set forth in
section 2332b(g)(5) of title 18, United
States Code;
(II) knowing involvement with an
organization that engages in domestic or
international terrorism (as defined in
section 2331 of such title 18) or with
any other organization that engages in
intentional crimes of violence; or
(III) being an agent of a foreign
power (as defined in section 1801 of
title 50, United States Code).
(C) Notification by attorney general regarding
submitted names.--After the receipt of a name and other
identifying information under paragraph (2)(B), the
Attorney General shall promptly notify the Secretary
whether the individual is within any of the categories
specified in subparagraph (B).
(4) Notifications by secretary.--The Secretary, after
receiving notice under paragraph (3) regarding an individual,
shall promptly notify the registered person involved of whether
the individual is granted or denied access under paragraph (2).
If the individual is denied such access, the Secretary shall
promptly notify the individual of the denial.
(5) Expedited review.--Regulations under subsections (b) and
(c) shall provide for a procedure through which, upon request to
the Secretary by a registered person who submits names and other
identifying information under paragraph (2)(B) and who
demonstrates good cause, the Secretary may, as determined
appropriate by the Secretary--
(A) request the Attorney General to expedite the
process of identification under paragraph (3)(A) and
notification of the Secretary under paragraph (3)(C);
and
(B) expedite the notification of the registered
person by the Secretary under paragraph (4).
(6) Process regarding persons seeking to register.--
(A) Individuals.--Regulations under subsections (b)
and (c) shall provide that an individual who seeks to
register under either of such subsections is subject to
the same processes described in paragraphs (2) through
(4) as apply to names and other identifying information
submitted to the Attorney General under paragraph
(2)(B). Paragraph (5) does not apply for purposes of
this subparagraph.
(B) Other persons.--Regulations under subsections
(b) and (c) shall provide that, in determining whether
to deny or revoke registration by a person other than an
[[Page 116 STAT. 651]]
individual, the Secretary shall submit the name of such
person to the Attorney General, who shall use criminal,
immigration, national security, and other electronic
databases available to the Federal Government, as
appropriate for the purpose of promptly notifying the
Secretary whether the person, or, where relevant, the
individual who owns or controls such person, is within
any of the categories described in section 175b(d)(1) of
title 18, United States Code (relating to restricted
persons), or is reasonably suspected by any Federal law
enforcement or intelligence agency of being within any
category specified in paragraph (3)(B)(ii) (as applied
to persons, including individuals). Such regulations
shall provide that a person who seeks to register under
either of such subsections is subject to the same
processes described in paragraphs (2) and (4) as apply
to names and other identifying information submitted to
the Attorney General under paragraph (2)(B). Paragraph
(5) does not apply for purposes of this subparagraph.
The Secretary may exempt Federal, State, or local
governmental agencies from the requirements of this
subparagraph.
(7) Review.--
(A) Administrative review.--
(i) In general.--Regulations under subsections
(b) and (c) shall provide for an opportunity for a
review by the Secretary--
(I) when requested by the individual
involved, of a determination under
paragraph (2) to deny the individual
access to listed agents and toxins; and
(II) when requested by the person
involved, of a determination under under
paragraph (6) to deny or revoke
registration for such person.
(ii) Ex parte review.--During a review under
clause (i), the Secretary may consider information
relevant to the review ex parte to the extent that
disclosure of the information could compromise
national security or an investigation by any law
enforcement agency.
(iii) Final agency action.--The decision of
the Secretary in a review under clause (i)
constitutes final agency action for purposes of
section 702 of title 5, United States Code.
(B) Certain procedures.--
(i) Submission of ex parte materials in
judicial proceedings.--When reviewing a decision
of the Secretary under subparagraph (A), and upon
request made ex parte and in writing by the United
States, a court, upon a sufficient showing, may
review and consider ex parte documents containing
information the disclosure of which could
compromise national security or an investigation
by any law enforcement agency. If the court
determines that portions of the documents
considered ex parte should be disclosed to the
person involved to allow a response, the court
shall authorize the United States to delete from
such documents specified items of information the
disclosure of which could compromise national
security or an investigation by
[[Page 116 STAT. 652]]
any law enforcement agency, or to substitute a
summary of the information to which the person may
respond. Any order by the court authorizing the
disclosure of information that the United States
believes could compromise national security or an
investigation by any law enforcement agency shall
be subject to the processes set forth in
subparagraphs (A) and (B)(i) of section
2339B(f)(5) of title 18, United States Code
(relating to interlocutory appeal and expedited
consideration).
(ii) Disclosure of information.--In a review
under subparagraph (A), and in any judical
proceeding conducted pursuant to such review,
neither the Secretary nor the Attorney General may
be required to disclose to the public any
information that under subsection (h) shall not be
disclosed under section 552 of title 5, United
States Code.
(8) Notifications regarding theft or loss of agents.--
Requirements under paragraph (1) shall include the prompt
notification of the Secretary, and appropriate Federal, State,
and local law enforcement agencies, of the theft or loss of
listed agents and toxins.
(9) Technical assistance for registered persons.--The
Secretary, in consultation with the Attorney General, may
provide technical assistance to registered persons to improve
security of the facilities of such persons.
(f) Inspections.--The Secretary shall have the authority to inspect
persons subject to regulations under subsection (b) or (c) to ensure
their compliance with such regulations, including prohibitions on
restricted persons and other provisions of subsection (e).
(g) Exemptions.--
(1) Overlap agents and toxins.--
(A) In general.--
(i) Limitation.--In the case of overlap agents
and toxins, exemptions from the applicability of
provisions of regulations under subsection (b) or
(c) may be granted only to the extent provided in
this paragraph.
(ii) Definitions.--For purposes of this
section:
(I) The term ``overlap agents and
toxins'' means biological agents and
toxins that--
(aa) are listed pursuant to
subsection (a)(1); and
(bb) are listed pursuant to
section 315A(a)(1) of the Public
Health Service Act.
(II) The term ``overlap agent or
toxin'' means a biological agent or
toxin that--
(aa) is listed pursuant to
subsection (a)(1); and
(bb) is listed pursuant to
section 315A(a)(1) of the Public
Health Service Act.
(B) Clinical or diagnostic laboratories.--
Regulations under subsections (b) and (c) shall exempt
clinical or diagnostic laboratories and other persons
who possess, use, or transfer overlap agents or toxins
that are contained in specimens presented for diagnosis,
verification, or proficiency testing, provided that--
[[Page 116 STAT. 653]]
(i) the identification of such agents or
toxins is reported to the Secretary, and when
required under Federal, State, or local law, to
other appropriate authorities; and
(ii) such agents or toxins are transferred or
destroyed in a manner set forth by the Secretary
by regulation.
(C) Products.--
(i) In general.--Regulations under subsections
(b) and (c) shall exempt products that are, bear,
or contain overlap agents or toxins and are
cleared, approved, licensed, or registered under
any of the Acts specified in clause (ii), unless
the Secretary by order determines that applying
additional regulation under subsection (b) or (c)
to a specific product is necessary to protect
animal or plant health, or animal or plant
products.
(ii) Relevant laws.--For purposes of clause
(i), the Acts specified in this clause are the
following:
(I) The Federal Food, Drug, and
Cosmetic Act.
(II) Section 351 of the Public
Health Service Act.
(III) The Act commonly known as the
Virus-Serum-Toxin Act (the eighth
paragraph under the heading ``Bureau of
Animal Industry'' in the Act of March 4,
1913; 21 U.S.C. 151-159).
(IV) The Federal Insecticide,
Fungicide, and Rodenticide Act.
(iii) Investigational use.--
(I) In general.--The Secretary may
exempt an investigational product that
is, bears, or contains an overlap agent
or toxin from the applicability of
provisions of regulations under
subsection (b) or (c) when such product
is being used in an investigation
authorized under any Federal Act and the
Secretary determines that applying
additional regulation under subsection
(b) or (c) to such product is not
necessary to protect animal and plant
health, and animal and plant products.
(II) Certain processes.--Regulations
under subsections (b) and (c) shall set
forth the procedures for applying for an
exemption under subclause (I). In the
case of investigational products
authorized under any of the Acts
specified in clause (ii), the Secretary
shall make a determination regarding a
request for an exemption not later than
14 days after the first date on which
both of the following conditions have
been met by the person requesting the
exemption:
(aa) The person has
submitted to the Secretary an
application for the exemption
meeting the requirements
established by the Secretary.
(bb) The person has notified
the Secretary that the
investigation has been
authorized under such an Act.
(D) Agricultural emergencies.--The Secretary may
temporarily exempt a person from the applicability of
the
[[Page 116 STAT. 654]]
requirements of this section with respect to an overlap
agent or toxin, in whole or in part, if the Secretary
determines that such exemption is necessary to provide
for the timely participation of the person in a response
to a domestic or foreign agricultural emergency that
involves such an agent or toxin. With respect to the
emergency involved, the exemption under this
subparagraph for a person may not exceed 30 days, except
that the Secretary, after review of whether such
exemption remains necessary, may provide one extension
of an additional 30 days.
(E) Public health emergencies.--Upon request of the
Secretary of Health and Human Services, after the
granting by such Secretary of an exemption under
351A(g)(3) of the Public Health Service Act pursuant to
a finding that there is a public health emergency, the
Secretary of Agriculture may temporarily exempt a person
from the applicability of the requirements of this
section with respect to an overlap agent or toxin, in
whole or in part, to provide for the timely
participation of the person in a response to the public
health emergency. With respect to the emergency
involved, such exemption for a person may not exceed 30
days, except that upon request of the Secretary of
Health and Human Services, the Secretary of Agriculture
may, after review of whether such exemption remains
necessary, provide one extension of an additional 30
days.
(2) General authority for exemptions not involving overlap
agents or toxins.--In the case of listed agents or toxins that
are not overlap agents or toxins, the Secretary may grant
exemptions from the applicability of provisions of regulations
under subsection (b) or (c) if the Secretary determines that
such exemptions are consistent with protecting animal and plant
health, and animal and plant products.
(h) Disclosure of Information.--
(1) Nondisclosure of certain information.--No Federal agency
specified in paragraph (2) shall disclose under section 552 of
title 5, United States Code, any of the following:
(A) Any registration or transfer documentation
submitted under subsections (b) and (c), or permits
issued prior to the date of the enactment of this Act,
for the possession, use or transfer of a listed agent or
toxin; or information derived therefrom to the extent
that it identifies the listed agent or toxin possessed,
used or transferred by a specific person or discloses
the identity or location of a specific person.
(B) The national database developed pursuant to
subsection (d), or any other compilation of the
registration or transfer information submitted under
subsections (b) and (c) to the extent that such
compilation discloses site-specific registration or
transfer information.
(C) Any portion of a record that discloses the site-
specific or transfer-specific safeguard and security
measures used by a registered person to prevent
unauthorized access to listed agents and toxins.
(D) Any notification of a release of a listed agent
or toxin submitted under subsections (b) and (c), or any
[[Page 116 STAT. 655]]
notification of theft or loss submitted under such
subsections.
(E) Any portion of an evaluation or report of an
inspection of a specific registered person conducted
under subsection (f) that identifies the listed agent or
toxin possessed by a specific registered person or that
discloses the identity or location of a specific
registered person if the agency determines that public
disclosure of the information would endanger animal or
plant health, or animal or plant products.
(2) Covered agencies.--For purposes of paragraph (1) only,
the Federal agencies specified in this paragraph are the
following:
(A) The Department of Health and Human Services, the
Department of Justice, the Department of Agriculture,
and the Department of Transportation.
(B) Any Federal agency to which information
specified in paragraph (1) is transferred by any agency
specified in subparagraph (A) of this paragraph.
(C) Any Federal agency that is a registered person,
or has a sub-agency component that is a registered
person.
(D) Any Federal agency that awards grants or enters
into contracts or cooperative agreements involving
listed agents and toxins to or with a registered person,
and to which information specified in paragraph (1) is
transferred by any such registered person.
(3) Other exemptions.--This subsection may not be construed
as altering the application of any exemptions to public
disclosure under section 552 of title 5, United States Code,
except as to subsection 552(b)(3) of such title, to any of the
information specified in paragraph (1).
(4) Rule of construction.--Except as specifically provided
in paragraph (1), this subsection may not be construed as
altering the authority of any Federal agency to withhold under
section 552 of title 5, United States Code, or the obligation of
any Federal agency to disclose under section 552 of title 5,
United States Code, any information, including information
relating to--
(A) listed agents and toxins, or individuals seeking
access to such agents and toxins;
(B) registered persons, or persons seeking to
register their possession, use, or transfer of such
agents and toxins;
(C) general safeguard and security policies and
requirements under regulations under subsections (b) and
(c); or
(D) summary or statistical information concerning
registrations, registrants, denials or revocations of
registrations, listed agents and toxins, inspection
evaluations and reports, or individuals seeking access
to such agents and toxins.
(5) Disclosures to congress; other disclosures.--This
subsection may not be construed as providing any authority--
(A) to withhold information from the Congress or any
committee or subcommittee thereof; or
(B) to withhold information from any person under
any other Federal law or treaty.
(i) Civil Money Penalty.--
[[Page 116 STAT. 656]]
(1) In general.--In addition to any other penalties that may
apply under law, any person who violates any provision of
regulations under subsection (b) or (c) shall be subject to the
United States for a civil money penalty in an amount not
exceeding $250,000 in the case of an individual and $500,000 in
the case of any other person.
(2) Applicability of certain provisions.--The provisions of
sections 423 and 425(2) of the Plant Protection Act (7 U.S.C.
7733 and 7735(2)) shall apply to a civil money penalty or
activity under paragraph (1) in the same manner as such
provisions apply to a penalty or activity under the Plant
Protection Act.
(j) Notification in Event of Release.--Regulations under subsections
(b) and (c) shall require the prompt notification of the Secretary by a
registered person whenever a release, meeting criteria established by
the Secretary, of a listed agent or toxin has occurred outside of the
biocontainment area of a facility of the registered person. Upon receipt
of such notification and a finding by the Secretary that the release
poses a threat to animal or plant health, or animal or plant products,
the Secretary shall take appropriate action to notify relevant Federal,
State, and local authorities, and, if necessary, other appropriate
persons (including the public). If the released listed agent or toxin is
an overlap agent or toxin, the Secretary shall promptly notify the
Secretary of Health and Human Services upon notification by the
registered person.
(k) Reports.--The Secretary shall report to the Congress annually on
the number and nature of notifications received under subsection (e)(8)
(relating to theft or loss) and subsection (j) (relating to releases).
(l) Definitions.--For purposes of this section:
(1) The terms ``biological agent'' and ``toxin'' have the
meanings given such terms in section 178 of title 18, United
States Code.
(2) The term ``listed agents and toxins'' means biological
agents and toxins listed pursuant to subsection (a)(1).
(3) The term ``listed agents or toxins'' means biological
agents or toxins listed pursuant to subsection (a)(1).
(4) The terms ``overlap agents and toxins'' and ``overlap
agent or toxin'' have the meaning given such terms in subsection
(g)(1)(A)(ii).
(5) The term ``person'' includes Federal, State, and local
governmental entities.
(6) The term ``registered person'' means a person registered
under regulations under subsection (b) or (c).
(7) The term ``Secretary'' means the Secretary of
Agriculture.
(m) Authorization of Appropriations.--For the purpose of carrying
out this section, there are authorized to be appropriated such sums as
may be necessary for each of the fiscal years 2002 through 2007, in
addition to other funds that may be available.
SEC. 213. <<NOTE: Deadlines.>> IMPLEMENTATION BY DEPARTMENT OF
AGRICULTURE.
(a) <<NOTE: Rules. 7 USC 8401 note.>> Date Certain for Promulgation
of List.--Not later than 60 days after the date of the enactment of this
Act, the Secretary of Agriculture (referred to in this section as the
``Secretary'') shall promulgate an interim final rule that establishes
the initial list
[[Page 116 STAT. 657]]
under section 212(a)(1). <<NOTE: Guidelines.>> In promulgating such
rule, the Secretary shall provide written guidance on the manner in
which the notice required in subsection (b) is to be provided to the
Secretary.
(b) Date Certain for Notice of Possession.--Not later than 60 days
after the date on which the Secretary promulgates the interim final rule
under subsection (a), all persons (unless exempt under section 212(g))
in possession of biological agents or toxins included on the list
referred to in subsection (a) shall notify the Secretary of such
possession.
(c) Date Certain for Promulgation; Effective Date Regarding Criminal
and Civil Penalties.-- <<NOTE: Rules.>> Not later than 180 days after
the date of the enactment of this Act, the Secretary shall promulgate an
interim final rule for carrying out section 212, other than for the list
referred to in subsection (a) of this section (but such rule may
incorporate by reference provisions promulgated pursuant to subsection
(a)). Such interim final rule shall take effect 60 days after the date
on which such rule is promulgated, including for purposes of--
(1) section 175b(c) of title 18, United States Code
(relating to criminal penalties), as added by section 231(a)(5)
of this Act; and
(2) section 212(i) of this Act (relating to civil
penalties).
(d) Transitional Provision Regarding Current Research and
Education.--The interim final rule under subsection (c) shall include
time frames for the applicability of the rule that minimize disruption
of research or educational projects that involve biological agents and
toxins listed pursuant to section 212(a)(1) and that were underway as of
the effective date of such rule.
Subtitle C--Interagency Coordination Regarding Overlap Agents and Toxins
SEC. 221. <<NOTE: 7 USC 8411.>> INTERAGENCY COORDINATION.
(a) In General.--
(1) Coordination.--The Secretary of Agriculture and the
Secretary of Health and Human Services shall in accordance with
this section coordinate activities regarding overlap agents and
toxins.
(2) Overlap agents and toxins; other terms.--For purposes of
this section:
(A) The term ``overlap agent or toxin'' means a
biological agent or toxin that--
(i) is listed pursuant to section 315A(a)(1)
of the Public Health Service Act, as added by
section 201 of this Act; and
(ii) is listed pursuant to section 212(a)(1)
of this Act.
(B) The term ``section 351A program'' means the
program under section 351A of the Public Health Service
Act.
(C) The term ``section 212 program'' means the
program under section 212 of this Act.
(b) Certain Matters.--In carrying out the section 351A program and
the section 212 program, the Secretary of Health and Human Services and
the Secretary of Agriculture shall, to the
[[Page 116 STAT. 658]]
greatest extent practicable, coordinate activities to achieve the
following purposes:
(1) To minimize any conflicts between the regulations issued
under, and activities carried out under, such programs.
(2) To minimize the administrative burden on persons subject
to regulation under both of such programs.
(3) To ensure the appropriate availability of biological
agents and toxins for legitimate biomedical, agricultural or
veterinary research, education, or other such purposes.
(4) To ensure that registration information for overlap
agents and toxins under the section 351A and section 212
programs is contained in both the national database under the
section 351A program and the national database under the section
212 program.
(c) Memorandum of Understanding.--
(1) In general.--Promptly after the date of the enactment of
this Act, the Secretary of Agriculture and the Secretary of
Health and Human Services shall enter into a memorandum of
understanding regarding overlap agents and toxins that is in
accordance with paragraphs (2) through (4) and contains such
additional provisions as the Secretary of Agriculture and the
Secretary of Health and Human Services determine to be
appropriate.
(2) Single registration system regarding registered
persons.--The memorandum of understanding under paragraph (1)
shall provide for the development and implementation of a single
system of registration for persons who possess, use, or transfer
overlap agents or toxins and are required to register under both
the section 351A program and the section 212 program. For
purposes of such system, the memorandum shall provide for the
development and implementation of the following:
(A) A single registration form through which the
person submitting the form provides all information that
is required for registration under the section 351A
program and all information that is required for
registration under the section 212 program.
(B) A procedure through which a person may choose to
submit the single registration form to the agency
administering the section 351A program (in the manner
provided under such program), or to the agency
administering the section 212 program (in the manner
provided under such program).
(C) A procedure through which a copy of a single
registration form received pursuant to subparagraph (B)
by the agency administering one of such programs is
promptly provided to the agency administering the other
program.
(D) A procedure through which the agency receiving
the single registration form under one of such programs
obtains the concurrence of the agency administering the
other program that the requirements for registration
under the other program have been met.
(E) A procedure through which--
[[Page 116 STAT. 659]]
(i) the agency receiving the single
registration form under one of such programs
informs the agency administering the other program
whether the receiving agency has denied the
registration; and
(ii) each of such agencies ensures that
registrations are entered into the national
database of registered persons that is maintained
by each such agency.
(3) Process of identification.--With respect to the process
of identification under the section 351A program and the section
212 program for names and other identifying information
submitted to the Attorney General (relating to certain
categories of individuals and entities), the memorandum of
understanding under paragraph (1) shall provide for the
development and implementation of the following:
(A) A procedure through which a person who is
required to submit information pursuant to such process
makes (in addition to the submission to the Attorney
General) a submission, at the option of the person, to
either the agency administering the section 351A program
or the agency administering the section 212 program, but
not both, which submission satisfies the requirement of
submission for both of such programs.
(B) A procedure for the sharing by both of such
agencies of information received from the Attorney
General by one of such agencies pursuant to the
submission under subparagraph (A).
(C) A procedure through which the agencies
administering such programs concur in determinations
that access to overlap agents and toxins will be
granted.
(4) Coordination of inspections and enforcement.--The
memorandum of understanding under paragraph (1) shall provide
for the development and implementation of procedures under which
Federal personnel under the section 351A program and the section
212 program may share responsibilities for inspections and
enforcement activities under such programs regarding overlap
agents and toxins. Activities carried out under such procedures
by one of such programs on behalf of the other may be carried
out with or without reimbursement by the agency that administers
the other program.
(5) <<NOTE: Deadline.>> Date certain for implementation.--
The memorandum of understanding under paragraph (1) shall be
implemented not later than 180 days after the date of the
enactment of this Act. Until the single system of registration
under paragraph (2) is implemented, persons who possess, use, or
transfer overlap agents or toxins shall register under both the
section 351A program and the section 212 program.
(d) <<NOTE: Deadline.>> Joint Regulations.--Not later than 18
months after the date on which the single system of registration under
subsection (c)(2) is implemented, the Secretary of Health and Human
Services and the Secretary of Agriculture shall jointly issue
regulations for the possession, use, and transfer of overlap agents and
toxins that meet the requirements of both the section 351A program and
the section 212 program.
[[Page 116 STAT. 660]]
Subtitle D--Criminal Penalties Regarding Certain Biological Agents and
Toxins
SEC. 231. CRIMINAL PENALTIES.
(a) In General.--Section 175b of title 18, United States Code, as
added by section 817 of Public Law 107-56, is amended--
(1) by striking ``(a)'' and inserting ``(a)(1)'';
(2) by transferring subsection (c) from the current
placement of the subsection and inserting the subsection before
subsection (b);
(3) by striking ``(c)'' and inserting ``(2);
(4) by redesignating subsection (b) as subsection (d); and
(5) by inserting before subsection (d) (as so redesignated)
the following subsections:
``(b) Transfer to Unregistered Person.--
``(1) Select agents.--Whoever transfers a select agent to a
person who the transferor knows or has reasonable cause to
believe is not registered as required by regulations under
subsection (b) or (c) of section 351A of the Public Health
Service Act shall be fined under this title, or imprisoned for
not more than 5 years, or both.
``(2) Certain other biological agents and toxins.--Whoever
transfers a biological agent or toxin listed pursuant to section
212(a)(1) of the Agricultural Bioterrorism Protection Act of
2002 to a person who the transferor knows or has reasonable
cause to believe is not registered as required by regulations
under subsection (b) or (c) of section 212 of such Act shall be
fined under this title, or imprisoned for not more than 5 years,
or both.
``(c) Unregistered for Possession.--
``(1) Select agents.--Whoever knowingly possesses a
biological agent or toxin where such agent or toxin is a select
agent for which such person has not obtained a registration
required by regulations under section 351A(c) of the Public
Health Service Act shall be fined under this title, or
imprisoned for not more than 5 years, or both.
``(2) Certain other biological agents and toxins.--Whoever
knowingly possesses a biological agent or toxin where such agent
or toxin is a biological agent or toxin listed pursuant to
section 212(a)(1) of the Agricultural Bioterrorism Protection
Act of 2002 for which such person has not obtained a
registration required by regulations under section 212(c) of
such Act shall be fined under this title, or imprisoned for not
more than 5 years, or both.''.
(b) Conforming Amendments.--Chapter 10 of title 18, United States
Code, is amended--
(1) in section 175b (as added by section 817 of Public Law
107-56 and amended by subsection (a) of this section)--
(A) in subsection (d)(1), by striking ``The term''
and all that follows through ``does not include'' and
inserting the following: ``The term `select agent' means
a biological agent or toxin to which subsection (a)
applies. Such term (including for purposes of subsection
(a)) does not include''; and
[[Page 116 STAT. 661]]
(B) in the heading for the section, by striking
``Possession by restricted persons'' and inserting
``Select agents; certain other agents''; and
(2) in the chapter analysis, in the item relating to section
175b, by striking ``Possession by restricted persons.'' and
inserting ``Select agents; certain other agents.''.
(c) Technical Corrections.--Chapter 10 of title 18, United States
Code, as amended by section 817 of Public Law 107-56 and subsections (a)
and (b) of this section, is amended--
(1) in section 175(c), by striking ``protective'' and all
that follows and inserting ``protective, bona fide research, or
other peaceful purposes.'';
(2) in section 175b--
(A) in subsection (a)(1), by striking ``described in
subsection (b)'' and all that follows and inserting the
following: ``shall ship or transport in or affecting
interstate or foreign commerce, or possess in or
affecting interstate or foreign commerce, any biological
agent or toxin, or receive any biological agent or toxin
that has been shipped or transported in interstate or
foreign commerce, if the biological agent or toxin is
listed as a select agent in Appendix A of part 72 of
title 42, Code of Federal Regulations, pursuant to
section 351A of the Public Health Service Act, and is
not exempted under subsection (h) of section 72.6, or
Appendix A of part 72, of title 42, Code of Federal
Regulations.''; and
(B) in subsection (d)(3), by striking ``section
1010(a)(3)'' and inserting ``section 101(a)(3)'';
(3) in section 176(a)(1)(A), by striking ``exists by reason
of'' and inserting ``pertains to''; and
(4) in section 178--
(A) in paragraph (1), by striking ``means any micro-
organism'' and all that follows through ``product,
capable of'' and inserting the following: ``means any
microorganism (including, but not limited to, bacteria,
viruses, fungi, rickettsiae or protozoa), or infectious
substance, or any naturally occurring, bioengineered or
synthesized component of any such microorganism or
infectious substance, capable of'';
(B) in paragraph (2), by striking ``means the
toxic'' and all that follows through ``including--'' and
inserting the following: ``means the toxic material or
product of plants, animals, microorganisms (including,
but not limited to, bacteria, viruses, fungi,
rickettsiae or protozoa), or infectious substances, or a
recombinant or synthesized molecule, whatever their
origin and method of production, and includes--''; and
(C) in paragraph (4), by striking ``recombinant
molecule,'' and all that follows through
``biotechnology,'' and inserting ``recombinant or
synthesized molecule,''.
(d) Additional Technical Correction.--Section 2332a of title 18,
United States Code, is amended--
(1) in subsection (a), in the matter preceding paragraph
(1), by striking ``section 229F)'' and all that follows through
``section 178)--'' and inserting ``section 229F)--''; and
[[Page 116 STAT. 662]]
(2) in subsection (c)(2)(C), by striking ``a disease
organism'' and inserting ``a biological agent, toxin, or vector
(as those terms are defined in section 178 of this title)''.
TITLE III--PROTECTING SAFETY AND SECURITY OF FOOD AND DRUG SUPPLY
Subtitle A--Protection of Food Supply
SEC. 301. <<NOTE: 21 USC 341 note.>> FOOD SAFETY AND SECURITY STRATEGY.
(a) In General.--The President's Council on Food Safety (as
established by Executive Order No. 13100) shall, in consultation with
the Secretary of Transportation, the Secretary of the Treasury, other
relevant Federal agencies, the food industry, consumer and producer
groups, scientific organizations, and the States, develop a crisis
communications and education strategy with respect to bioterrorist
threats to the food supply. Such strategy shall address threat
assessments; technologies and procedures for securing food processing
and manufacturing facilities and modes of transportation; response and
notification procedures; and risk communications to the public.
(b) Authorization of Appropriations.--For the purpose of
implementing the strategy developed under subsection (a), there are
authorized to be appropriated $750,000 for fiscal year 2002, and such
sums as may be necessary for each subsequent fiscal year.
SEC. 302. PROTECTION AGAINST ADULTERATION OF FOOD.
(a) Increasing Inspections for Detection of Adulteration of Food.--
Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381)
is amended by adding at the end the following subsection:
``(h)(1) The Secretary shall give high priority to increasing the
number of inspections under this section for the purpose of enabling the
Secretary to inspect food offered for import at ports of entry into the
United States, with the greatest priority given to inspections to detect
the intentional adulteration of food.''.
(b) Improvements to Information Management Systems.--Section 801(h)
of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a)
of this section, is amended by adding at the end the following
paragraph:
``(2) The Secretary shall give high priority to making necessary
improvements to the information management systems of the Food and Drug
Administration that contain information related to foods imported or
offered for import into the United States for purposes of improving the
ability of the Secretary to allocate resources, detect the intentional
adulteration of food, and facilitate the importation of food that is in
compliance with this Act.''.
(c) Linkages With Appropriate Public Entities.--Section 801(h) of
the Federal Food, Drug, and Cosmetic Act, as amended by subsection (b)
of this section, is amended by adding at the end the following
paragraph:
``(3) The Secretary shall improve linkages with other regulatory
agencies of the Federal Government that share responsibility for food
safety, and shall with respect to such safety improve linkages
[[Page 116 STAT. 663]]
with the States and Indian tribes (as defined in section 4(e) of the
Indian Self-Determination and Education Assistance Act (25 U.S.C.
450b(e))).''.
(d) Testing for Rapid Detection of Adulteration of Food.--Section
801 of the Federal Food, Drug, and Cosmetic Act, as amended by
subsection (a) of this section, is amended by adding at the end the
following:
``(i)(1) For use in inspections of food under this section, the
Secretary shall provide for research on the development of tests and
sampling methodologies--
``(A) whose purpose is to test food in order to rapidly
detect the adulteration of the food, with the greatest priority
given to detect the intentional adulteration of food; and
``(B) whose results offer significant improvements over the
available technology in terms of accuracy, timing, or costs.
``(2) In providing for research under paragraph (1), the Secretary
shall give priority to conducting research on the development of tests
that are suitable for inspections of food at ports of entry into the
United States.
``(3) In providing for research under paragraph (1), the Secretary
shall as appropriate coordinate with the Director of the Centers for
Disease Control and Prevention, the Director of the National Institutes
of Health, the Administrator of the Environmental Protection Agency, and
the Secretary of Agriculture.
``(4) <<NOTE: Reports.>> The Secretary shall annually submit to the
Committee on Energy and Commerce of the House of Representatives, and
the Committee on Health, Education, Labor, and Pensions of the Senate, a
report describing the progress made in research under paragraph (1),
including progress regarding paragraph (2).''.
(e) <<NOTE: Deadline.>> Assessment of Threat of Intentional
Adulteration of Food.--The Secretary of Health and Human Services,
acting through the Commissioner of Food and Drugs, shall ensure that,
not later than six months after the date of the enactment of this Act--
(1) the assessment that (as of such date of enactment) is
being conducted on the threat of the intentional adulteration of
food is completed; and
(2) <<NOTE: Reports.>> a report describing the findings of
the assessment is submitted to the Committee on Energy and
Commerce of the House of Representatives and to the Committee on
Health, Education, Labor, and Pensions of the Senate.
(f) Authorization of Appropriations.--For the purpose of carrying
out this section and the amendments made by this section, there are
authorized to be appropriated $100,000,000 for fiscal year 2002, and
such sums as may be necessary for each of the fiscal years 2003 through
2006, in addition to other authorizations of appropriations that are
available for such purpose.
SEC. 303. ADMINISTRATIVE DETENTION.
(a) Expanded Authority.--Section 304 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 334) is amended by adding at the end the
following subsection:
``(h) Administrative Detention of Foods.--
``(1) Detention authority.--
``(A) In general.--An officer or qualified employee
of the Food and Drug Administration may order the
detention, in accordance with this subsection, of any
article of food
[[Page 116 STAT. 664]]
that is found during an inspection, examination, or
investigation under this Act conducted by such officer
or qualified employee, if the officer or qualified
employee has credible evidence or information indicating
that such article presents a threat of serious adverse
health consequences or death to humans or animals.
``(B) Secretary's approval.--An article of food may
be ordered detained under subparagraph (A) only if the
Secretary or an official designated by the Secretary
approves the order. An official may not be so designated
unless the official is the director of the district
under this Act in which the article involved is located,
or is an official senior to such director.
``(2) Period of detention.--An article of food may be
detained under paragraph (1) for a reasonable period, not to
exceed 20 days, unless a greater period, not to exceed 30 days,
is necessary, to enable the Secretary to institute an action
under subsection (a) or section 302. <<NOTE: Regulation.>> The
Secretary shall by regulation provide for procedures for
instituting such action on an expedited basis with respect to
perishable foods.
``(3) Security of detained article.--An order under
paragraph (1) with respect to an article of food may require
that such article be labeled or marked as detained, and shall
require that the article be removed to a secure facility, as
appropriate. An article subject to such an order shall not be
transferred by any person from the place at which the article is
ordered detained, or from the place to which the article is so
removed, as the case may be, until released by the Secretary or
until the expiration of the detention period applicable under
such order, whichever occurs first. This subsection may not be
construed as authorizing the delivery of the article pursuant to
the execution of a bond while the article is subject to the
order, and section 801(b) does not authorize the delivery of the
article pursuant to the execution of a bond while the article is
subject to the order.
``(4) Appeal of detention order.--
``(A) In general.--With respect to an article of
food ordered detained under paragraph (1), any person
who would be entitled to be a claimant for such article
if the article were seized under subsection (a) may
appeal the order to the Secretary. Within five days
after such an appeal is filed, the Secretary, after
providing opportunity for an informal hearing, shall
confirm or terminate the order involved, and such
confirmation by the Secretary shall be considered a
final agency action for purposes of section 702 of title
5, United States Code. If during such five-day period
the Secretary fails to provide such an opportunity, or
to confirm or terminate such order, the order is deemed
to be terminated.
``(B) Effect of instituting court action.--The
process under subparagraph (A) for the appeal of an
order under paragraph (1) terminates if the Secretary
institutes an action under subsection (a) or section 302
regarding the article of food involved.''.
(b) Prohibited Act.--Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the
following:
[[Page 116 STAT. 665]]
``(bb) The transfer of an article of food in violation of an order
under section 304(h), or the removal or alteration of any mark or label
required by the order to identify the article as detained.''.
(c) Temporary Holds at Ports of Entry.--Section 801 of the Federal
Food, Drug, and Cosmetic Act, as amended by section 302(d)of this
Act, <<NOTE: 21 USC 381.>> is amended by adding at the end the
following:
``(j)(1) If an officer or qualified employee of the Food and Drug
Administration has credible evidence or information indicating that an
article of food presents a threat of serious adverse health consequences
or death to humans or animals, and such officer or qualified employee is
unable to inspect, examine, or investigate such article upon the article
being offered for import at a port of entry into the United States, the
officer or qualified employee shall request the Secretary of Treasury to
hold the food at the port of entry for a reasonable period of time, not
to exceed 24 hours, for the purpose of enabling the Secretary to
inspect, examine, or investigate the article as appropriate.
``(2) The Secretary shall request the Secretary of Treasury to
remove an article held pursuant to paragraph (1) to a secure facility,
as appropriate. During the period of time that such article is so held,
the article shall not be transferred by any person from the port of
entry into the United States for the article, or from the secure
facility to which the article has been removed, as the case may be.
Subsection (b) does not authorize the delivery of the article pursuant
to the execution of a bond while the article is so held.
``(3) An officer or qualified employee of the Food and Drug
Administration may make a request under paragraph (1) only if the
Secretary or an official designated by the Secretary approves the
request. An official may not be so designated unless the official is the
director of the district under this Act in which the article involved is
located, or is an official senior to such director.
``(4) With respect to an article of food for which a request under
paragraph (1) is made, the Secretary, promptly after the request is
made, shall notify the State in which the port of entry involved is
located that the request has been made, and as applicable, that such
article is being held under this subsection.''.
SEC. 304. DEBARMENT FOR REPEATED OR SERIOUS FOOD IMPORT VIOLATIONS.
(a) Debarment Authority.--
(1) Permissive debarment.--Section 306(b)(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 335a(b)(1)) is amended--
(A) in subparagraph (A), by striking ``or'' after
the comma at the end;
(B) in subparagraph (B), by striking the period at
the end and inserting ``, or''; and
(C) by adding at the end the following subparagraph:
``(C) a person from importing an article of food or
offering such an article for import into the United
States.''.
(2) Amendment regarding debarment grounds.--Section 306(b))
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335a(b))
is amended--
(A) in paragraph (2), in the matter preceding
subparagraph (A), by inserting ``subparagraph (A) or (B)
of'' before ``paragraph (1)'';
[[Page 116 STAT. 666]]
(B) by redesignating paragraph (3) as paragraph (4);
and
(C) by inserting after paragraph (2) the following
paragraph:
``(3) Persons subject to permissive debarment; food
importation.--A person is subject to debarment under paragraph
(1)(C) if--
``(A) the person has been convicted of a felony for
conduct relating to the importation into the United
States of any food; or
``(B) the person has engaged in a pattern of
importing or offering for import adulterated food that
presents a threat of serious adverse health consequences
or death to humans or animals.''.
(b) Conforming Amendments.--Section 306 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 335a) is amended--
(1) in subsection (a), in the heading for the subsection, by
striking ``Mandatory Debarment.--'' and inserting ``Mandatory
Debarment; Certain Drug Applications.--'';
(2) in subsection (b)--
(A) in the heading for the subsection, by striking
``Permissive Debarment.--'' and inserting ``Permissive
Debarment; Certain Drug Applications; Food Imports.--'';
and
(B) in paragraph (2), in the heading for the
paragraph, by striking ``permissive debarment.--'' and
inserting ``permissive debarment; certain drug
applications.--'';
(3) in subsection (c)(2)(A)(iii), by striking ``subsection
(b)(2)'' and inserting ``paragraph (2) or (3) of subsection
(b)'';
(4) in subsection (d)(3)--
(A) in subparagraph (A)(i), by striking ``or
(b)(2)(A)'' and inserting `` or paragraph (2)(A) or (3)
of subsection (b)'';
(B) in subparagraph (A)(ii)(II), by inserting ``in
applicable cases,'' before ``sufficient audits'';
(C) in subparagraph (B), in each of clauses (i) and
(ii), by inserting ``or subsection (b)(3)'' after
``subsection (b)(2)(B)''; and
(D) in subparagraph (B)(ii), by inserting before the
period the following: ``or the food importation process,
as the case may be''.
(c) Effective Dates.--Section 306(l)(2) of the Federal Food, Drug,
and Cosmetic Act <<NOTE: 21 USC 335a.>> (21 U.S.C. 335a(l)(2)) is
amended--
(1) in the first sentence--
(A) by striking ``and'' after ``subsection
(b)(2),''; and
(B) by inserting ``, and subsection (b)(3)(A)''
after ``subsection (b)(2)(B)''; and
(2) in the second sentence, by inserting ``, subsection
(b)(3)(B),'' after ``subsection (b)(2)(B)''.
(d) Prohibited Act.--Section 301 of the Federal Food, Drug, and
Cosmetic Act, as amended by section 303(b) of this Act, is amended by
adding at the end the following:
``(cc) The importing or offering for import into the United States
of an article of food by, with the assistance of, or at the direction
of, a person debarred under section 306(b)(3).''.
[[Page 116 STAT. 667]]
(e) Importation by Debarred Persons.--Section 801 of the Federal
Food, Drug, and Cosmetic Act, as amended by section 303(c) of this
Act, <<NOTE: 21 USC 381.>> is amended by adding at the end the
following subsection:
``(k)(1) If an article of food is being imported or offered for
import into the United States, and the importer, owner, or consignee of
the article is a person who has been debarred under section 306(b)(3),
such article shall be held at the port of entry for the article, and may
not be delivered to such person. Subsection (b) does not authorize the
delivery of the article pursuant to the execution of a bond while the
article is so held. The article shall be removed to a secure facility,
as appropriate. During the period of time that such article is so held,
the article shall not be transferred by any person from the port of
entry into the United States for the article, or from the secure
facility to which the article has been removed, as the case may be.
``(2) An article of food held under paragraph (1) may be delivered
to a person who is not a debarred person under section 306(b)(3) if such
person affirmatively establishes, at the expense of the person, that the
article complies with the requirements of this Act, as determined by the
Secretary.''.
SEC. 305. REGISTRATION OF FOOD FACILITIES.
(a) In General.--Chapter IV of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 341 et seq.) is amended by adding at the end the
following:
``SEC. 415. <<NOTE: 21 USC 350d.>> REGISTRATION OF FOOD FACILITIES.
``(a) Registration.--
``(1) <<NOTE: Regulations.>> In general.--The Secretary
shall by regulation require that any facility engaged in
manufacturing, processing, packing, or holding food for
consumption in the United States be registered with the
Secretary. To be registered--
``(A) for a domestic facility, the owner, operator,
or agent in charge of the facility shall submit a
registration to the Secretary; and
``(B) for a foreign facility, the owner, operator,
or agent in charge of the facility shall submit a
registration to the Secretary and shall include with the
registration the name of the United States agent for the
facility.
``(2) Registration.--An entity (referred to in this section
as the `registrant') shall submit a registration under paragraph
(1) to the Secretary containing information necessary to notify
the Secretary of the name and address of each facility at which,
and all trade names under which, the registrant conducts
business and, when determined necessary by the Secretary through
guidance, the general food category (as identified under section
170.3 of title 21, Code of Federal Regulations) of any food
manufactured, processed, packed, or held at such
facility. <<NOTE: Notification.>> The registrant shall notify
the Secretary in a timely manner of changes to such information.
``(3) <<NOTE: Notification.>> Procedure.--Upon receipt of a
completed registration described in paragraph (1), the Secretary
shall notify the registrant of the receipt of such registration
and assign a registration number to each registered facility.
``(4) <<NOTE: Records.>> List.--The Secretary shall compile
and maintain an up-to-date list of facilities that are
registered under this section. Such list and any registration
documents submitted pursuant
[[Page 116 STAT. 668]]
to this subsection shall not be subject to disclosure under
section 552 of title 5, United States Code. Information derived
from such list or registration documents shall not be subject to
disclosure under section 552 of title 5, United States Code, to
the extent that it discloses the identity or location of a
specific registered person.
``(b) Facility.--For purposes of this section:
``(1) The term `facility' includes any factory, warehouse,
or establishment (including a factory, warehouse, or
establishment of an importer) that manufactures, processes,
packs, or holds food. Such term does not include farms;
restaurants; other retail food establishments; nonprofit food
establishments in which food is prepared for or served directly
to the consumer; or fishing vessels (except such vessels engaged
in processing as defined in section 123.3(k) of title 21, Code
of Federal Regulations).
``(2) The term `domestic facility' means a facility located
in any of the States or Territories.
``(3)(A) The term `foreign facility' means a facility that
manufacturers, processes, packs, or holds food, but only if food
from such facility is exported to the United States without
further processing or packaging outside the United States.
``(B) A food may not be considered to have undergone further
processing or packaging for purposes of subparagraph (A) solely
on the basis that labeling was added or that any similar
activity of a de minimis nature was carried out with respect to
the food.
``(c) Rule of Construction.--Nothing in this section shall be
construed to authorize the Secretary to require an application, review,
or licensing process.''.
(b) Prohibited Acts.--Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331), as amended by section 304(d) of this Act,
is amended by adding at the end the following:
``(dd) The failure to register in accordance with section 415.''.
(c) Importation; Failure to Register.--Section 801 of the Federal
Food, Drug, and Cosmetic Act, as amended by section 304(e) of this
Act, <<NOTE: 21 USC 381.>> is amended by adding at the end the
following subsection:
``(l)(1) If an article of food is being imported or offered for
import into the United States, and such article is from a foreign
facility for which a registration has not been submitted to the
Secretary under section 415, such article shall be held at the port of
entry for the article, and may not be delivered to the importer, owner,
or consignee of the article, until the foreign facility is so
registered. Subsection (b) does not authorize the delivery of the
article pursuant to the execution of a bond while the article is so
held. The article shall be removed to a secure facility, as appropriate.
During the period of time that such article is so held, the article
shall not be transferred by any person from the port of entry into the
United States for the article, or from the secure facility to which the
article has been removed, as the case may be.''.
(d) <<NOTE: 21 USC 350d note.>> Electronic Filing.--For the purpose
of reducing paperwork and reporting burdens, the Secretary of Health and
Human Services may provide for, and encourage the use of, electronic
methods of submitting to the Secretary registrations required pursuant
to this section. In providing for the electronic submission of
[[Page 116 STAT. 669]]
such registrations, the Secretary shall ensure adequate authentication
protocols are used to enable identification of the registrant and
validation of the data as appropriate.
(e) <<NOTE: Deadline.>> Rulemaking; Effective Date.--Not later than
18 months after the date of the enactment of this Act, the Secretary of
Health and Human Services shall promulgate proposed and final
regulations for the requirement of registration under section 415 of the
Federal Food, Drug, and Cosmetic Act (as added by subsection (a) of this
section). Such requirement of registration takes effect--
(1) upon the effective date of such final regulations; or
(2) upon the expiration of such 18-month period if the final
regulations have not been made effective as of the expiration of
such period, subject to compliance with the final regulations
when the final regulations are made effective.
SEC. 306. MAINTENANCE AND INSPECTION OF RECORDS FOR FOODS.
(a) In General.--Chapter IV of the Federal Food, Drug, and Cosmetic
Act, as amended by section 305 of this Act, is amended by inserting
before section 415 the following section:
``SEC. 414. <<NOTE: 21 USC 350c.>> MAINTENANCE AND INSPECTION OF
RECORDS.
``(a) Records Inspection.--If the Secretary has a reasonable belief
that an article of food is adulterated and presents a threat of serious
adverse health consequences or death to humans or animals, each person
(excluding farms and restaurants) who manufactures, processes, packs,
distributes, receives, holds, or imports such article shall, at the
request of an officer or employee duly designated by the Secretary,
permit such officer or employee, upon presentation of appropriate
credentials and a written notice to such person, at reasonable times and
within reasonable limits and in a reasonable manner, to have access to
and copy all records relating to such article that are needed to assist
the Secretary in determining whether the food is adulterated and
presents a threat of serious adverse health consequences or death to
humans or animals. <<NOTE: Applicability.>> The requirement under the
preceding sentence applies to all records relating to the manufacture,
processing, packing, distribution, receipt, holding, or importation of
such article maintained by or on behalf of such person in any format
(including paper and electronic formats) and at any location.
``(b) Regulations Concerning Recordkeeping.--The Secretary, in
consultation and coordination, as appropriate, with other Federal
departments and agencies with responsibilities for regulating food
safety, may by regulation establish requirements regarding the
establishment and maintenance, for not longer than two years, of records
by persons (excluding farms and restaurants) who manufacture, process,
pack, transport, distribute, receive, hold, or import food, which
records are needed by the Secretary for inspection to allow the
Secretary to identify the immediate previous sources and the immediate
subsequent recipients of food, including its packaging, in order to
address credible threats of serious adverse health consequences or death
to humans or animals. The Secretary shall take into account the size of
a business in promulgating regulations under this section.
``(c) Protection of Sensitive Information.--The Secretary shall take
appropriate measures to ensure that there are in effect effective
procedures to prevent the unauthorized disclosure of any trade secret or
confidential information that is obtained by the Secretary pursuant to
this section.
[[Page 116 STAT. 670]]
``(d) Limitations.--This section shall not be construed--
``(1) to limit the authority of the Secretary to inspect
records or to require establishment and maintenance of records
under any other provision of this Act;
``(2) to authorize the Secretary to impose any requirements
with respect to a food to the extent that it is within the
exclusive jurisdiction of the Secretary of Agriculture pursuant
to the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the
Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the
Egg Products Inspection Act (21 U.S.C. 1031 et seq.);
``(3) to have any legal effect on section 552 of title 5,
United States Code, or section 1905 of title 18, United States
Code; or
``(4) to extend to recipes for food, financial data, pricing
data, personnel data, research data, or sales data (other than
shipment data regarding sales).''.
(b) Factory Inspection.--Section 704(a) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 374(a)) is amended--
(1) in paragraph (1), by inserting after the first sentence
the following new sentence: ``In the case of any person
(excluding farms and restaurants) who manufactures, processes,
packs, transports, distributes, holds, or imports foods, the
inspection shall extend to all records and other information
described in section 414 when the Secretary has a reasonable
belief that an article of food is adulterated and presents a
threat of serious adverse health consequences or death to humans
or animals, subject to the limitations established in section
414(d).''; and
(2) in paragraph (2), in the matter preceding subparagraph
(A), by striking ``second sentence'' and inserting ``third
sentence''.
(c) Prohibited Act.--Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331) is amended--
(1) in paragraph (e)--
(A) by striking ``by section 412, 504, or 703'' and
inserting ``by section 412, 414, 504, 703, or 704(a)'';
and
(B) by striking ``under section 412'' and inserting
``under section 412, 414(b)''; and
(2) in paragraph (j), by inserting ``414,'' after ``412,''.
(d) <<NOTE: Deadline. 21 USC 350c note.>> Expedited Rulemaking.--
Not later than 18 months after the date of the enactment of this Act,
the Secretary shall promulgate proposed and final regulations
establishing recordkeeping requirements under subsection 414(b) of the
Federal Food, Drug, and Cosmetic Act (as added by subsection (a)).
SEC. 307. PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS.
(a) In General.--Section 801 of the Federal Food, Drug, and Cosmetic
Act, as amended by section 305(c) of this Act, is amended by adding at
the end the following subsection:
``(m)(1) <<NOTE: Regulations.>> In the case of an article of food
that is being imported or offered for import into the United States, the
Secretary, after consultation with the Secretary of the Treasury, shall
by regulation require, for the purpose of enabling such article to be
inspected at ports of entry into the United States, the submission to
the Secretary of a notice providing the identity of each of the
following: The article; the manufacturer and shipper of the article; if
known within the specified period of time that notice is required to be
[[Page 116 STAT. 671]]
provided, the grower of the article; the country from which the article
originates; the country from which the article is shipped; and the
anticipated port of entry for the article. An article of food imported
or offered for import without submission of such notice in accordance
with the requirements under this paragraph shall be refused admission
into the United States. Nothing in this section may be construed as a
limitation on the port of entry for an article of food.
``(2)(A) Regulations under paragraph (1) shall require that a notice
under such paragraph be provided by a specified period of time in
advance of the time of the importation of the article of food involved
or the offering of the food for import, which period shall be no less
than the minimum amount of time necessary for the Secretary to receive,
review, and appropriately respond to such notification, but may not
exceed five days. In determining the specified period of time required
under this subparagraph, the Secretary may consider, but is not limited
to consideration of, the effect on commerce of such period of time, the
locations of the various ports of entry into the United States, the
various modes of transportation, the types of food imported into the
United States, and any other such consideration. Nothing in the
preceding sentence may be construed as a limitation on the obligation of
the Secretary to receive, review, and appropriately respond to any
notice under paragraph (1).
``(B)(i) If an article of food is being imported or offered for
import into the United States and a notice under paragraph (1) is not
provided in advance in accordance with the requirements under paragraph
(1), such article shall be held at the port of entry for the article,
and may not be delivered to the importer, owner, or consignee of the
article, until such notice is submitted to the Secretary, and the
Secretary examines the notice and determines that the notice is in
accordance with the requirements under paragraph (1). Subsection (b)
does not authorize the delivery of the article pursuant to the execution
of a bond while the article is so held. The article shall be removed to
a secure facility, as appropriate. During the period of time that such
article is so held, the article shall not be transferred by any person
from the port of entry into the United States for the article, or from
the secure facility to which the article has been removed, as the case
may be.
``(ii) In carrying out clause (i) with respect to an article of
food, the Secretary shall determine whether there is in the possession
of the Secretary any credible evidence or information indicating that
such article presents a threat of serious adverse health consequences or
death to humans or animals.
``(3)(A) This subsection may not be construed as limiting the
authority of the Secretary to obtain information under any other
provision of this Act.
``(B) This subsection may not be construed as authorizing the
Secretary to impose any requirements with respect to a food to the
extent that it is within the exclusive jurisdiction of the Secretary of
Agriculture pursuant to the Federal Meat Inspection Act (21 U.S.C. 601
et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.),
or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.).''.
[[Page 116 STAT. 672]]
(b) Prohibited Act.--Section 301 of the Federal Food, Drug, and
Cosmetic Act, as amended by section 305(b) of this Act, <<NOTE: 21 USC
331.>> is amended by adding at the end the following:
``(ee) The importing or offering for import into the United States
of an article of food in violation of the requirements under section
801(m).''.
(c) <<NOTE: 21 USC 351 note.>> Rulemaking; Effective Date.--
(1) <<NOTE: Deadline.>> In general.--Not later than 18
months after the date of the enactment of this Act, the
Secretary of Health and Human Services shall promulgate proposed
and final regulations for the requirement of providing notice in
accordance with section 801(m) of the Federal Food, Drug, and
Cosmetic Act (as added by subsection (a) of this section). Such
requirement of notification takes effect--
(A) upon the effective date of such final
regulations; or
(B) upon the expiration of such 18-month period if
the final regulations have not been made effective as of
the expiration of such period, subject to compliance
with the final regulations when the final regulations
are made effective.
(2) Default; minimum period of advance notice.--If under
paragraph (1) the requirement for providing notice in accordance
with section 801(m) of the Federal Food, Drug, and Cosmetic Act
takes effect without final regulations having been made
effective, then for purposes of such requirement, the specified
period of time that the notice is required to be made in advance
of the time of the importation of the article of food involved
or the offering of the food for import shall be not fewer than
eight hours and not more than five days, which shall remain in
effect until the final regulations are made effective.
SEC. 308. AUTHORITY TO MARK ARTICLES REFUSED ADMISSION INTO UNITED
STATES.
(a) In General.--Section 801 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 381(a)), as amended by section 307(a) of this Act, is
amended by adding at the end the following:
``(n)(1) If a food has been refused admission under subsection (a),
other than such a food that is required to be destroyed, the Secretary
may require the owner or consignee of the food to affix to the container
of the food a label that clearly and conspicuously bears the statement:
`UNITED STATES: REFUSED ENTRY'.
``(2) All expenses in connection with affixing a label under
paragraph (1) shall be paid by the owner or consignee of the food
involved, and in default of such payment, shall constitute a lien
against future importations made by such owner or consignee.
``(3) A requirement under paragraph (1) remains in effect until the
Secretary determines that the food involved has been brought into
compliance with this Act.''.
(b) Misbranded Foods.--Section 403 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 343) is amended by adding at the end the
following:
``(v) If--
``(1) it fails to bear a label required by the Secretary
under section 801(n)(1) (relating to food refused admission into
the United States);
[[Page 116 STAT. 673]]
``(2) the Secretary finds that the food presents a threat of
serious adverse health consequences or death to humans or
animals; and
``(3) upon or after notifying the owner or consignee
involved that the label is required under section 801, the
Secretary informs the owner or consignee that the food presents
such a threat.''.
(c) <<NOTE: 21 USC 381 note.>> Rule of Construction.--With respect
to articles of food that are imported or offered for import into the
United States, nothing in this section shall be construed to limit the
authority of the Secretary of Health and Human Services or the Secretary
of the Treasury to require the marking of refused articles of food under
any other provision of law.
SEC. 309. PROHIBITION AGAINST PORT SHOPPING.
Section 402 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
342) is amended by adding at the end the following:
``(h) If it is an article of food imported or offered for import
into the United States and the article of food has previously been
refused admission under section 801(a), unless the person reoffering the
article affirmatively establishes, at the expense of the owner or
consignee of the article, that the article complies with the applicable
requirements of this Act, as determined by the Secretary.''.
SEC. 310. NOTICES TO STATES REGARDING IMPORTED FOOD.
Chapter IX of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
391 et seq.) is amended by adding at the end the following section:
``SEC. 908. <<NOTE: 21 USC 398.>> NOTICES TO STATES REGARDING IMPORTED
FOOD.
``(a) In General.--If the Secretary has credible evidence or
information indicating that a shipment of imported food or portion
thereof presents a threat of serious adverse health consequences or
death to humans or animals, the Secretary shall provide notice regarding
such threat to the States in which the food is held or will be held, and
to the States in which the manufacturer, packer, or distributor of the
food is located, to the extent that the Secretary has knowledge of which
States are so involved. In providing notice to a State, the Secretary
shall request the State to take such action as the State considers
appropriate, if any, to protect the public health regarding the food
involved.
``(b) Rule of Construction.--Subsection (a) may not be construed as
limiting the authority of the Secretary with respect to food under any
other provision of this Act.''.
SEC. 311. GRANTS TO STATES FOR INSPECTIONS.
Chapter IX of the Federal Food, Drug, and Cosmetic Act, as amended
by section 310 of this Act, is amended by adding at the end the
following section:
``SEC. 909. <<NOTE: 21 USC 399.>> GRANTS TO STATES FOR INSPECTIONS.
``(a) In General.--The Secretary is authorized to make grants to
States, territories, and Indian tribes (as defined in section 4(e) of
the Indian Self-Determination and Education Assistance Act (25 U.S.C.
450b(e))) that undertake examinations, inspections, and investigations,
and related activities under section 702. The funds provided under such
grants shall only be available for the costs
[[Page 116 STAT. 674]]
of conducting such examinations, inspections, investigations, and
related activities.
``(b) Notices Regarding Adulterated Imported Food.--The Secretary
may make grants to the States for the purpose of assisting the States
with the costs of taking appropriate action to protect the public health
in response to notification under section 908, including planning and
otherwise preparing to take such action.
``(c) Authorization of Appropriations.--For the purpose of carrying
out this section, there are authorized to be appropriated $10,000,000
for fiscal year 2002, and such sums as may be necessary for each of the
fiscal years 2003 through 2006.''.
SEC. 312. SURVEILLANCE AND INFORMATION GRANTS AND AUTHORITIES.
Part B of title III of the Public Health Service Act (42 U.S.C. 243
et seq.) is amended by inserting after section 317P the following:
``SEC. 317R. <<NOTE: 42 USC 247b-20.>> FOOD SAFETY GRANTS.
``(a) In General.--The Secretary may award grants to States and
Indian tribes (as defined in section 4(e) of the Indian Self-
Determination and Education Assistance Act (25 U.S.C. 450b(e))) to
expand participation in networks to enhance Federal, State, and local
food safety efforts, including meeting the costs of establishing and
maintaining the food safety surveillance, technical, and laboratory
capacity needed for such participation.
``(b) Authorization of Appropriations.--For the purpose of carrying
out this section, there are authorized to be appropriated $19,500,000
for fiscal year 2002, and such sums as may be necessary for each of the
fiscal years 2003 through 2006.''.
SEC. 313. <<NOTE: 7 USC 8319.>> SURVEILLANCE OF ZOONOTIC DISEASES.
The Secretary of Health and Human Services, through the Commissioner
of Food and Drugs and the Director of the Centers for Disease Control
and Prevention, and the Secretary of Agriculture shall coordinate the
surveillance of zoonotic diseases.
SEC. 314. AUTHORITY TO COMMISSION OTHER FEDERAL OFFICIALS TO CONDUCT
INSPECTIONS.
Section 702(a) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 372(a)) is amended--
(1) by striking ``(a)'' and inserting ``(a)(1)'';
(2) by striking ``In the case of food packed'' and inserting
the following:
``(3) In the case of food packed'';
(3) by striking ``For the purposes of this subsection'' and
inserting the following:
``(4) For the purposes of this subsection,''; and
(4) by inserting after paragraph (1) (as designated by
paragraph (1) of this section) the following paragraph:
``(2)(A) In addition to the authority established in paragraph (1),
the Secretary, pursuant to a memorandum of understanding between the
Secretary and the head of another Federal department or agency, is
authorized to conduct examinations and investigations for the purposes
of this Act through the officers and employees of such other department
or agency, subject to subparagraph (B). Such a memorandum shall include
provisions to ensure adequate training of such officers and employees to
conduct the examinations
[[Page 116 STAT. 675]]
and investigations. The memorandum of understanding shall contain
provisions regarding reimbursement. Such provisions may, at the sole
discretion of the head of the other department or agency, require
reimbursement, in whole or in part, from the Secretary for the
examinations or investigations performed under this section by the
officers or employees of the other department or agency.
``(B) A memorandum of understanding under subparagraph (A) between
the Secretary and another Federal department or agency is effective only
in the case of examinations or inspections at facilities or other
locations that are jointly regulated by the Secretary and such
department or agency.
``(C) <<NOTE: Reports.>> For any fiscal year in which the Secretary
and the head of another Federal department or agency carries out one or
more examinations or inspections under a memorandum of understanding
under subparagraph (A), the Secretary and the head of such department or
agency shall with respect to their respective departments or agencies
submit to the committees of jurisdiction (authorizing and appropriating)
in the House of Representatives and the Senate a report that provides,
for such year--
``(i) the number of officers or employees that carried out
one or more programs, projects, or activities under such
memorandum;
``(ii) the number of additional articles that were inspected
or examined as a result of such memorandum; and
``(iii) the number of additional examinations or
investigations that were carried out pursuant to such
memorandum.''.
SEC. 315. <<NOTE: 21 USC 331 note.>> RULE OF CONSTRUCTION.
Nothing in this title, or an amendment made by this title, shall be
construed to alter the jurisdiction between the Secretaries of
Agriculture and of Health and Human Services, under applicable statutes
and regulations.
Subtitle B--Protection of Drug Supply
SEC. 321. ANNUAL REGISTRATION OF FOREIGN MANUFACTURERS; SHIPPING
INFORMATION; DRUG AND DEVICE LISTING.
(a) Annual Registration; Listing.--Section 510 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360) is amended--
(1) in subsection (i)(1)--
(A) by striking ``Any establishment'' and inserting
``On or before December 31 of each year, any
establishment''; and
(B) by striking ``shall register'' and all that
follows and inserting the following: ``shall, through
electronic means in accordance with the criteria of the
Secretary, register with the Secretary the name and
place of business of the establishment, the name of the
United States agent for the establishment, the name of
each importer of such drug or device in the United
States that is known to the establishment, and the name
of each person who imports or offers for import such
drug or device to the United States for purposes of
importation.''; and
(2) in subsection (j)(1), in the first sentence, by striking
``or (d)'' and inserting ``(d), or (i)''.
[[Page 116 STAT. 676]]
(b) Importation; Statement Regarding Registration of Manufacturer.--
(1) In general.--Section 801 of the Federal Food, Drug, and
Cosmetic Act, as amended by section 308(a) of this Act, is
amended by adding at the end the following subsection:
``(o) If an article that is a drug or device is being imported or
offered for import into the United States, and the importer, owner, or
consignee of such article does not, at the time of offering the article
for import, submit to the Secretary a statement that identifies the
registration under section 510(i) of each establishment that with
respect to such article is required under such section to register with
the Secretary, the article may be refused admission. If the article is
refused admission for failure to submit such a statement, the article
shall be held at the port of entry for the article, and may not be
delivered to the importer, owner, or consignee of the article, until
such a statement is submitted to the Secretary. Subsection (b) does not
authorize the delivery of the article pursuant to the execution of a
bond while the article is so held. The article shall be removed to a
secure facility, as appropriate. During the period of time that such
article is so held, the article shall not be transferred by any person
from the port of entry into the United States for the article, or from
the secure facility to which the article has been removed, as the case
may be.''.
(2) Prohibited act.--Section 301 of the Federal Food, Drug,
and Cosmetic Act, as amended by section 307(b) of this Act, is
amended by adding at the end the following:
``(ff) The importing or offering for import into the United States
of a drug or device with respect to which there is a failure to comply
with a request of the Secretary to submit to the Secretary a statement
under section 801(o).''.
(c) <<NOTE: 21 USC 331 note.>> Effective Date.--The amendments made
by this section take effect upon the expiration of the 180-day period
beginning on the date of the enactment of this Act.
SEC. 322. REQUIREMENT OF ADDITIONAL INFORMATION REGARDING IMPORT
COMPONENTS INTENDED FOR USE IN EXPORT PRODUCTS.
(a) In General.--Section 801(d)(3) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381(d)(3)) is amended to read as follows:
``(3)(A) Subject to subparagraph (B), no component of a drug, no
component part or accessory of a device, or other article of device
requiring further processing, which is ready or suitable for use for
health-related purposes, and no article of a food additive, color
additive, or dietary supplement, including a product in bulk form, shall
be excluded from importation into the United States under subsection (a)
if each of the following conditions is met:
``(i) The importer of such article of a drug or device or
importer of such article of a food additive, color additive, or
dietary supplement submits to the Secretary, at the time of
initial importation, a statement in accordance with the
following:
``(I) Such statement provides that such article is
intended to be further processed by the initial owner or
consignee, or incorporated by the initial owner or
consignee, into a drug, biological product, device,
food, food additive,
[[Page 116 STAT. 677]]
color additive, or dietary supplement that will be
exported by the initial owner or consignee from the
United States in accordance with subsection (e) or
section 802, or with section 351(h) of the Public Health
Service Act.
``(II) The statement identifies the manufacturer of
such article and each processor, packer, distributor, or
other entity that had possession of the article in the
chain of possession of the article from the manufacturer
to such importer of the article.
``(III) The statement is accompanied by such
certificates of analysis as are necessary to identify
such article, unless the article is a device or is an
article described in paragraph (4).
``(ii) At the time of initial importation and before the
delivery of such article to the importer or the initial owner or
consignee, such owner or consignee executes a good and
sufficient bond providing for the payment of such liquidated
damages in the event of default as may be required pursuant to
regulations of the Secretary of the Treasury.
``(iii) Such article is used and exported by the initial
owner or consignee in accordance with the intent described under
clause (i)(I), except for any portions of the article that are
destroyed.
``(iv) <<NOTE: Records.>> The initial owner or consignee
maintains records on the use or destruction of such article or
portions thereof, as the case may be, and submits to the
Secretary any such records requested by the Secretary.
``(v) <<NOTE: Reports.>> Upon request of the Secretary, the
initial owner or consignee submits a report that provides an
accounting of the exportation or destruction of such article or
portions thereof, and the manner in which such owner or
consignee complied with the requirements of this subparagraph.
``(B) Notwithstanding subparagraph (A), the Secretary may refuse
admission to an article that otherwise would be imported into the United
States under such subparagraph if the Secretary determines that there is
credible evidence or information indicating that such article is not
intended to be further processed by the initial owner or consignee, or
incorporated by the initial owner or consignee, into a drug, biological
product, device, food, food additive, color additive, or dietary
supplement that will be exported by the initial owner or consignee from
the United States in accordance with subsection (e) or section 802, or
with section 351(h) of the Public Health Service Act.
``(C) This section may not be construed as affecting the
responsibility of the Secretary to ensure that articles imported into
the United States under authority of subparagraph (A) meet each of the
conditions established in such subparagraph for importation.''.
(b) Prohibited Act.--Section 301(w) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(w)) is amended to read as follows:
``(w) The making of a knowingly false statement in any statement,
certificate of analysis, record, or report required or requested under
section 801(d)(3); the failure to submit a certificate of analysis as
required under such section; the failure to maintain records or to
submit records or reports as required by such section; the release into
interstate commerce of any article or portion thereof imported into the
United States under such section or any finished product made from such
article or portion, except for export in
[[Page 116 STAT. 678]]
accordance with section 801(e) or 802, or with section 351(h) of the
Public Health Service Act; or the failure to so export or to destroy
such an article or portions thereof, or such a finished product.''.
(c) <<NOTE: 21 USC 331 note.>> Effective Date.--The amendments made
by this section take effect upon the expiration of the 90-day period
beginning on the date of the enactment of this Act.
Subtitle C--General Provisions Relating to Upgrade of Agricultural
Security
SEC. 331. <<NOTE: 7 USC 8320.>> EXPANSION OF ANIMAL AND PLANT HEALTH
INSPECTION SERVICE ACTIVITIES.
(a) In General.--The Secretary of Agriculture (referred to in this
section as the ``Secretary'') may utilize existing authorities to give
high priority to enhancing and expanding the capacity of the Animal and
Plant Health Inspection Service to conduct activities to--
(1) increase the inspection capacity of the Service at
international points of origin;
(2) improve surveillance at ports of entry and customs;
(3) enhance methods of protecting against the introduction
of plant and animal disease organisms by terrorists;
(4) develop new and improve existing strategies and
technologies for dealing with intentional outbreaks of plant and
animal disease arising from acts of terrorism or from
unintentional introduction, including--
(A) establishing cooperative agreements among
Veterinary Services of the Animal and Plant Health
Inspection Service, State animal health commissions and
regulatory agencies for livestock and poultry health,
and private veterinary practitioners to enhance the
preparedness and ability of Veterinary Services and the
commissions and agencies to respond to outbreaks of such
animal diseases; and
(B) strengthening planning and coordination with
State and local agencies, including--
(i) State animal health commissions and
regulatory agencies for livestock and poultry
health; and
(ii) State agriculture departments; and
(5) otherwise improve the capacity of the Service to protect
against the threat of bioterrorism.
(b) Automated Recordkeeping System.--The Administrator of the Animal
and Plant Health Inspection Service may implement a central automated
recordkeeping system to provide for the reliable tracking of the status
of animal and plant shipments, including those shipments on hold at
ports of entry and customs. The Secretary shall ensure that such a
system shall be fully accessible to or fully integrated with the Food
Safety Inspection Service.
(c) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section, $30,000,000 for fiscal year
2002, and such sums as may be necessary for each subsequent fiscal year.
[[Page 116 STAT. 679]]
SEC. 332. <<NOTE: 21 USC 679c.>> EXPANSION OF FOOD SAFETY INSPECTION
SERVICE ACTIVITIES.
(a) In General.--The Secretary of Agriculture may utilize existing
authorities to give high priority to enhancing and expanding the
capacity of the Food Safety Inspection Service to conduct activities
to--
(1) enhance the ability of the Service to inspect and ensure
the safety and wholesomeness of meat and poultry products;
(2) improve the capacity of the Service to inspect
international meat and meat products, poultry and poultry
products, and egg products at points of origin and at ports of
entry;
(3) strengthen the ability of the Service to collaborate
with relevant agencies within the Department of Agriculture and
with other entities in the Federal Government, the States, and
Indian tribes (as defined in section 4(e) of the Indian Self-
Determination and Education Assistance Act (25 U.S.C. 450b(e)))
through the sharing of information and technology; and
(4) otherwise expand the capacity of the Service to protect
against the threat of bioterrorism.
(b) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section, $15,000,000 for fiscal year
2002, and such sums as may be necessary for each subsequent fiscal year.
SEC. 333. <<NOTE: Appropriation authorization. State listing.>>
BIOSECURITY UPGRADES AT THE DEPARTMENT OF AGRICULTURE.
There is authorized to be appropriated for fiscal year 2002,
$180,000,000 for the purpose of enabling the Agricultural Research
Service to conduct building upgrades to modernize existing facilities,
of which (1) $100,000,000 shall be allocated for renovation, updating,
and expansion of the Biosafety Level 3 laboratory and animal research
facilities at the Plum Island Animal Disease Center (Greenport, New
York), and of which (2) $80,000,000 shall be allocated for the
Agricultural Research Service/Animal and Plant Health Inspection Service
facility in Ames, Iowa. There are authorized to be appropriated such
sums as may be necessary for fiscal years 2003 through 2006 for the
purpose described in the preceding sentence, for the planning and design
of an Agricultural Research Service biocontainment laboratory for
poultry research in Athens, Georgia, and for the planning, updating, and
renovation of the Arthropod-Borne Animal Disease Laboratory in Laramie,
Wyoming.
SEC. 334. <<NOTE: 7 USC 3353.>> AGRICULTURAL BIOSECURITY.
(a) Security at Colleges and Universities.--
(1) Grants.--The Secretary of Agriculture (referred to in
this section as the ``Secretary'') may award grants to covered
entities to review security standards and practices at their
facilities in order to protect against bioterrorist attacks.
(2) Covered entities.--Covered entities under this
subsection are colleges or universities that--
(A) are colleges or universities as defined in
section 1404 of the National Agricultural Research,
Extension, and Teaching Policy Act of 1977 (7 U.S.C.
3103); and
(B) have programs in food and agricultural sciences,
as defined in such section.
[[Page 116 STAT. 680]]
(3) Limitation.--Each individual covered entity may be
awarded one grant under paragraph (1), the amount of which shall
not exceed $50,000.
(4) Contract authority.--Colleges and universities receiving
grants under paragraph (1) may use such grants to enter into
contracts with independent private organizations with
established and demonstrated security expertise to conduct the
security reviews specified in such paragraph.
(b) Guidelines for Agricultural Biosecurity.--
(1) In general.--The Secretary may award grants to
associations of food producers or consortia of such associations
for the development and implementation of educational programs
to improve biosecurity on farms in order to ensure the security
of farm facilities against potential bioterrorist attacks.
(2) Limitation.--Each individual association eligible under
paragraph (1) may be awarded one grant under such paragraph, the
amount of which shall not exceed $100,000. Each consortium
eligible under paragraph (1) may be awarded one grant under such
paragraph, the amount of which shall not exceed $100,000 per
association participating in the consortium.
(3) Contract authority.--Associations of food producers
receiving grants under paragraph (1) may use such grants to
enter into contracts with independent private organizations with
established and demonstrated expertise in biosecurity to assist
in the development and implementation of educational programs to
improve biosecurity specified in such paragraph.
(c) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section such sums as may be necessary for
each fiscal year.
SEC. 335. <<NOTE: 7 USC 3354.>> AGRICULTURAL BIOTERRORISM RESEARCH AND
DEVELOPMENT.
(a) In General.--The Secretary of Agriculture (referred to in this
section as the ``Secretary'') may utilize existing research authorities
and research programs to protect the food supply of the United States by
conducting and supporting research activities to--
(1) enhance the capability of the Secretary to respond in a
timely manner to emerging or existing bioterrorist threats to
the food and agricultural system of the United States;
(2) develop new and continue partnerships with institutions
of higher education and other institutions to help form stable,
long-term programs to enhance the biosecurity and food safety of
the United States, including the coordination of the
development, implementation, and enhancement of diverse
capabilities for addressing threats to the nation's agricultural
economy and food supply, with special emphasis on planning,
training, outreach, and research activities related to
vulnerability analyses, incident response, detection, and
prevention technologies;
(3) strengthen coordination with the intelligence community
to better identify research needs and evaluate materials or
information acquired by the intelligence community relating to
potential threats to United States agriculture;
(4) expand the involvement of the Secretary with
international organizations dealing with plant and animal
disease control;
[[Page 116 STAT. 681]]
(5) continue research to develop rapid detection field test
kits to detect biological threats to plants and animals and to
provide such test kits to State and local agencies preparing for
or responding to bioterrorism;
(6) develop an agricultural bioterrorism early warning
surveillance system through enhancing the capacity of and
coordination between State veterinary diagnostic laboratories,
Federal and State agricultural research facilities, and public
health agencies; and
(7) otherwise improve the capacity of the Secretary to
protect against the threat of bioterrorism.
(b) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section, $190,000,000 for fiscal year
2002, and such sums as may be necessary for each subsequent fiscal year.
SEC. 336. ANIMAL ENTERPRISE TERRORISM PENALTIES.
(a) In General.--Section 43(a) of title 18, United States Code, is
amended to read as follows:
``(a) Offense.--Whoever--
``(1) travels in interstate or foreign commerce, or uses or
causes to be used the mail or any facility in interstate or
foreign commerce for the purpose of causing physical disruption
to the functioning of an animal enterprise; and
``(2) intentionally damages or causes the loss of any
property (including animals or records) used by the animal
enterprise, or conspires to do so,
shall be punished as provided for in subsection (b).''.
(b) Penalties.--Section 43(b) of title 18, United States Code, is
amended to read as follows:
``(b) Penalties.--
``(1) Economic damage.--Any person who, in the course of a
violation of subsection (a), causes economic damage not
exceeding $10,000 to an animal enterprise shall be fined under
this title or imprisoned not more than 6 months, or both.
``(2) Major economic damage.--Any person who, in the course
of a violation of subsection (a), causes economic damage
exceeding $10,000 to an animal enterprise shall be fined under
this title or imprisoned not more than 3 years, or both.
``(3) Serious bodily injury.--Any person who, in the course
of a violation of subsection (a), causes serious bodily injury
to another individual shall be fined under this title or
imprisoned not more than 20 years, or both.
``(4) Death.--Any person who, in the course of a violation
of subsection (a), causes the death of an individual shall be
fined under this title and imprisoned for life or for any term
of years.''.
(c) Restitution.--Section 43(c) of title 18, United States Code, is
amended--
(1) in paragraph (1), by striking ``and'' at the end;
(2) in paragraph (2), by striking the period at the end and
inserting ``; and''; and
(3) by adding at the end the following:
``(3) for any other economic damage resulting from the
offense.''.
[[Page 116 STAT. 682]]
TITLE IV--DRINKING WATER SECURITY AND SAFETY
SEC. 401. TERRORIST AND OTHER INTENTIONAL ACTS.
The Safe Drinking Water Act (title XIV of the Public Health Service
Act) is amended by inserting the following new section after section
1432:
``SEC. 1433. <<NOTE: 42 USC 300i-2.>> TERRORIST AND OTHER INTENTIONAL
ACTS.
``(a) Vulnerability Assessments.--(1) Each community water system
serving a population of greater than 3,300 persons shall conduct an
assessment of the vulnerability of its system to a terrorist attack or
other intentional acts intended to substantially disrupt the ability of
the system to provide a safe and reliable supply of drinking water. The
vulnerability assessment shall include, but not be limited to, a review
of pipes and constructed conveyances, physical barriers, water
collection, pretreatment, treatment, storage and distribution
facilities, electronic, computer or other automated systems which are
utilized by the public water system, the use, storage, or handling of
various chemicals, and the operation and maintenance of such
system. <<NOTE: Deadline.>> The Administrator, not later than August 1,
2002, after consultation with appropriate departments and agencies of
the Federal Government and with State and local governments, shall
provide baseline information to community water systems required to
conduct vulnerability assessments regarding which kinds of terrorist
attacks or other intentional acts are the probable threats to--
``(A) substantially disrupt the ability of the system to
provide a safe and reliable supply of drinking water; or
``(B) otherwise present significant public health concerns.
``(2) <<NOTE: Certification. Deadlines.>> Each community water
system referred to in paragraph (1) shall certify to the Administrator
that the system has conducted an assessment complying with paragraph (1)
and shall submit to the Administrator a written copy of the assessment.
Such certification and submission shall be made prior to:
``(A) March 31, 2003, in the case of systems serving a
population of 100,000 or more.
``(B) December 31, 2003, in the case of systems serving a
population of 50,000 or more but less than 100,000.
``(C) June 30, 2004, in the case of systems serving a
population greater than 3,300 but less than 50,000.
``(3) Except for information contained in a certification under this
subsection identifying the system submitting the certification and the
date of the certification, all information provided to the Administrator
under this subsection and all information derived therefrom shall be
exempt from disclosure under section 552 of title 5 of the United States
Code.
``(4) No community water system shall be required under State or
local law to provide an assessment described in this section to any
State, regional, or local governmental entity solely by reason of the
requirement set forth in paragraph (2) that the system submit such
assessment to the Administrator.
``(5) <<NOTE: Deadlines. Protocols.>> Not later than November 30,
2002, the Administrator, in consultation with appropriate Federal law
enforcement and intelligence officials, shall develop such protocols as
may be necessary to protect the copies of the assessments required to be
submitted
[[Page 116 STAT. 683]]
under this subsection (and the information contained therein) from
unauthorized disclosure. Such protocols shall ensure that--
``(A) each copy of such assessment, and all information
contained in or derived from the assessment, is kept in a secure
location;
``(B) only individuals designated by the Administrator may
have access to the copies of the assessments; and
``(C) no copy of an assessment, or part of an assessment, or
information contained in or derived from an assessment shall be
available to anyone other than an individual designated by the
Administrator.
At the earliest possible time prior to November 30, 2002, the
Administrator shall complete the development of such protocols for the
purpose of having them in place prior to receiving any vulnerability
assessments from community water systems under this subsection.
``(6)(A) Except as provided in subparagraph (B), any individual
referred to in paragraph (5)(B) who acquires the assessment submitted
under paragraph (2), or any reproduction of such assessment, or any
information derived from such assessment, and who knowingly or
recklessly reveals such assessment, reproduction, or information other
than--
``(i) to an individual designated by the Administrator under
paragraph (5),
``(ii) for purposes of section 1445 or for actions under
section 1431, or
``(iii) for use in any administrative or judicial proceeding
to impose a penalty for failure to comply with this section,
shall upon conviction be imprisoned for not more than one year or fined
in accordance with the provisions of chapter 227 of title 18, United
States Code, applicable to class A misdemeanors, or both, and shall be
removed from Federal office or employment.
``(B) Notwithstanding subparagraph (A), an individual referred to in
paragraph (5)(B) who is an officer or employee of the United States may
discuss the contents of a vulnerability assessment submitted under this
section with a State or local official.
``(7) Nothing in this section authorizes any person to withhold any
information from Congress or from any committee or subcommittee of
Congress.
``(b) Emergency Response Plan.--Each community water system serving
a population greater than 3,300 shall prepare or revise, where
necessary, an emergency response plan that incorporates the results of
vulnerability assessments that have been
completed. <<NOTE: Certification. Deadline.>> Each such community water
system shall certify to the Administrator, as soon as reasonably
possible after the enactment of this section, but not later than 6
months after the completion of the vulnerability assessment under
subsection (a), that the system has completed such plan. The emergency
response plan shall include, but not be limited to, plans, procedures,
and identification of equipment that can be implemented or utilized in
the event of a terrorist or other intentional attack on the public water
system. The emergency response plan shall also include actions,
procedures, and identification of equipment which can obviate or
significantly lessen the impact of terrorist attacks or other
intentional actions on the public health and the safety and supply of
drinking water provided to communities and individuals. Community water
systems
[[Page 116 STAT. 684]]
shall, to the extent possible, coordinate with existing Local Emergency
Planning Committees established under the Emergency Planning and
Community Right-to-Know Act (42 U.S.C. 11001 et seq.) when preparing or
revising an emergency response plan under this subsection.
``(c) Record Maintenance.--Each community water system shall
maintain a copy of the emergency response plan completed pursuant to
subsection (b) for 5 years after such plan has been certified to the
Administrator under this section.
``(d) Guidance to Small Public Water Systems.--The Administrator
shall provide guidance to community water systems serving a population
of less than 3,300 persons on how to conduct vulnerability assessments,
prepare emergency response plans, and address threats from terrorist
attacks or other intentional actions designed to disrupt the provision
of safe drinking water or significantly affect the public health or
significantly affect the safety or supply of drinking water provided to
communities and individuals.
``(e) Funding.--(1) There are authorized to be appropriated to carry
out this section not more than $160,000,000 for the fiscal year 2002 and
such sums as may be necessary for the fiscal years 2003 through 2005.
``(2) The Administrator, in coordination with State and local
governments, may use funds made available under paragraph (1) to provide
financial assistance to community water systems for purposes of
compliance with the requirements of subsections (a) and (b) and to
community water systems for expenses and contracts designed to address
basic security enhancements of critical importance and significant
threats to public health and the supply of drinking water as determined
by a vulnerability assessment conducted under subsection (a). Such basic
security enhancements may include, but shall not be limited to the
following:
``(A) the purchase and installation of equipment for
detection of intruders;
``(B) the purchase and installation of fencing, gating,
lighting, or security cameras;
``(C) the tamper-proofing of manhole covers, fire hydrants,
and valve boxes;
``(D) the rekeying of doors and locks;
``(E) improvements to electronic, computer, or other
automated systems and remote security systems;
``(F) participation in training programs, and the purchase
of training manuals and guidance materials, relating to security
against terrorist attacks;
``(G) improvements in the use, storage, or handling of
various chemicals; and
``(H) security screening of employees or contractor support
services.
Funding under this subsection for basic security enhancements shall not
include expenditures for personnel costs, or monitoring, operation, or
maintenance of facilities, equipment, or systems.
``(3) The Administrator may use not more than $5,000,000 from the
funds made available under paragraph (1) to make grants to community
water systems to assist in responding to and alleviating any
vulnerability to a terrorist attack or other intentional acts intended
to substantially disrupt the ability of the system to provide a safe and
reliable supply of drinking water (including
[[Page 116 STAT. 685]]
sources of water for such systems) which the Administrator determines to
present an immediate and urgent security need.
``(4) The Administrator may use not more than $5,000,000 from the
funds made available under paragraph (1) to make grants to community
water systems serving a population of less than 3,300 persons for
activities and projects undertaken in accordance with the guidance
provided to such systems under subsection (d).
SEC. 402. OTHER SAFE DRINKING WATER ACT AMENDMENTS.
The Safe Drinking Water Act (title XIV of the Public Health Service
Act) is amended by inserting the following new sections after section
1433 (as added by section 401 of this Act):
``SEC. 1434. <<NOTE: 42 USC 300i-3.>> CONTAMINANT PREVENTION, DETECTION
AND RESPONSE.
``(a) <<NOTE: Contracts.>> In General.--The Administrator, in
consultation with the Centers for Disease Control and, after
consultation with appropriate departments and agencies of the Federal
Government and with State and local governments, shall review (or enter
into contracts or cooperative agreements to provide for a review of)
current and future methods to prevent, detect and respond to the
intentional introduction of chemical, biological or radiological
contaminants into community water systems and source water for community
water systems, including each of the following:
``(1) Methods, means and equipment, including real time
monitoring systems, designed to monitor and detect various
levels of chemical, biological, and radiological contaminants or
indicators of contaminants and reduce the likelihood that such
contaminants can be successfully introduced into public water
systems and source water intended to be used for drinking water.
``(2) Methods and means to provide sufficient notice to
operators of public water systems, and individuals served by
such systems, of the introduction of chemical, biological or
radiological contaminants and the possible effect of such
introduction on public health and the safety and supply of
drinking water.
``(3) Methods and means for developing educational and
awareness programs for community water systems.
``(4) Procedures and equipment necessary to prevent the flow
of contaminated drinking water to individuals served by public
water systems.
``(5) Methods, means, and equipment which could negate or
mitigate deleterious effects on public health and the safety and
supply caused by the introduction of contaminants into water
intended to be used for drinking water, including an examination
of the effectiveness of various drinking water technologies in
removing, inactivating, or neutralizing biological, chemical,
and radiological contaminants.
``(6) Biomedical research into the short-term and long-term
impact on public health of various chemical, biological and
radiological contaminants that may be introduced into public
water systems through terrorist or other intentional acts.
``(b) Funding.--For the authorization of appropriations to carry out
this section, see section 1435(e).
[[Page 116 STAT. 686]]
``SEC. 1435. <<NOTE: 42 USC 300i-4.>> SUPPLY DISRUPTION PREVENTION,
DETECTION AND RESPONSE.
``(a) <<NOTE: Contracts.>> Disruption of Supply or Safety.--The
Administrator, in coordination with the appropriate departments and
agencies of the Federal Government, shall review (or enter into
contracts or cooperative agreements to provide for a review of) methods
and means by which terrorists or other individuals or groups could
disrupt the supply of safe drinking water or take other actions against
water collection, pretreatment, treatment, storage and distribution
facilities which could render such water significantly less safe for
human consumption, including each of the following:
``(1) Methods and means by which pipes and other constructed
conveyances utilized in public water systems could be destroyed
or otherwise prevented from providing adequate supplies of
drinking water meeting applicable public health standards.
``(2) Methods and means by which collection, pretreatment,
treatment, storage and distribution facilities utilized or used
in connection with public water systems and collection and
pretreatment storage facilities used in connection with public
water systems could be destroyed or otherwise prevented from
providing adequate supplies of drinking water meeting applicable
public health standards.
``(3) Methods and means by which pipes, constructed
conveyances, collection, pretreatment, treatment, storage and
distribution systems that are utilized in connection with public
water systems could be altered or affected so as to be subject
to cross-contamination of drinking water supplies.
``(4) Methods and means by which pipes, constructed
conveyances, collection, pretreatment, treatment, storage and
distribution systems that are utilized in connection with public
water systems could be reasonably protected from terrorist
attacks or other acts intended to disrupt the supply or affect
the safety of drinking water.
``(5) Methods and means by which information systems,
including process controls and supervisory control and data
acquisition and cyber systems at community water systems could
be disrupted by terrorists or other groups.
``(b) Alternative Sources.--The review under this section shall also
include a review of the methods and means by which alternative supplies
of drinking water could be provided in the event of the destruction,
impairment or contamination of public water systems.
``(c) Requirements and Considerations.--In carrying out this section
and section 1434--
``(1) the Administrator shall ensure that reviews carried
out under this section reflect the needs of community water
systems of various sizes and various geographic areas of the
United States; and
``(2) the Administrator may consider the vulnerability of,
or potential for forced interruption of service for, a region or
service area, including community water systems that provide
service to the National Capital area.
``(d) Information Sharing.--As soon as practicable after reviews
carried out under this section or section 1434 have been evaluated, the
Administrator shall disseminate, as appropriate as determined by the
Administrator, to community water systems
[[Page 116 STAT. 687]]
information on the results of the project through the Information
Sharing and Analysis Center, or other appropriate means.
``(e) Funding.--There are authorized to be appropriated to carry out
this section and section 1434 not more than $15,000,000 for the fiscal
year 2002 and such sums as may be necessary for the fiscal years 2003
through 2005.''.
SEC. 403. MISCELLANEOUS AND TECHNICAL AMENDMENTS.
The Safe Drinking Water Act is amended as follows:
(1) Section 1414(i)(1) <<NOTE: 42 USC 300g-3.>> is amended
by inserting ``1433'' after ``1417''.
(2) Section 1431 <<NOTE: 42 USC 300i.>> is amended by
inserting in the first sentence after ``drinking water'' the
following: ``, or that there is a threatened or potential
terrorist attack (or other intentional act designed to disrupt
the provision of safe drinking water or to impact adversely the
safety of drinking water supplied to communities and
individuals), which''.
(3) Section 1432 <<NOTE: 42 USC 300i-1.>> is amended as
follows:
(A) By striking ``5 years'' in subsection (a) and
inserting ``20 years''.
(B) By striking ``3 years'' in subsection (b) and
inserting ``10 years''.
(C) By striking ``$50,000'' in subsection (c) and
inserting ``$1,000,000''.
(D) By striking ``$20,000'' in subsection (c) and
inserting ``$100,000''.
(4) Section 1442 <<NOTE: 42 USC 300j-1.>> is amended as
follows:
(A) By striking ``this subparagraph'' in subsection
(b) and inserting ``this subsection''.
(B) By amending subsection (d) to read as follows:
``(d) <<NOTE: Appropriation authorization.>> There are authorized
to be appropriated to carry out subsection (b) not more than $35,000,000
for the fiscal year 2002 and such sums as may be necessary for each
fiscal year thereafter.''.
TITLE V--ADDITIONAL PROVISIONS
Subtitle <<NOTE: Prescription Drug User Fee Amendments of 2002.>> A--
Prescription Drug User Fees
SEC. 501. <<NOTE: 21 USC 301 note.>> SHORT TITLE.
This subtitle may be cited as the ``Prescription Drug User Fee
Amendments of 2002''.
SEC. 502. <<NOTE: 21 USC 379g note.>> FINDINGS.
The Congress finds that--
(1) prompt approval of safe and effective new drugs and
other therapies is critical to the improvement of the public
health so that patients may enjoy the benefits provided by these
therapies to treat and prevent illness and disease;
(2) the public health will be served by making additional
funds available for the purpose of augmenting the resources of
the Food and Drug Administration that are devoted to the process
for the review of human drug applications and the assurance of
drug safety;
(3) the provisions added by the Prescription Drug User Fee
Act of 1992, as amended by the Food and Drug Administration
Modernization Act of 1997, have been successful in
[[Page 116 STAT. 688]]
substantially reducing review times for human drug applications
and should be--
(A) reauthorized for an additional 5 years, with
certain technical improvements; and
(B) carried out by the Food and Drug Administration
with new commitments to implement more ambitious and
comprehensive improvements in regulatory processes of
the Food and Drug Administration, including--
(i) strengthening and improving the review and
monitoring of drug safety;
(ii) considering greater interaction between
the agency and sponsors during the review of drugs
and biologics intended to treat serious diseases
and life-threatening diseases; and
(iii) developing principles for improving
first-cycle reviews; and
(4) the fees authorized by amendments made in this subtitle
will be dedicated towards expediting the drug development
process and the process for the review of human drug
applications as set forth in the goals identified for purposes
of part 2 of subchapter C of chapter VII of the Federal Food,
Drug, and Cosmetic Act, in the letters from the Secretary of
Health and Human Services to the chairman of the Committee on
Energy and Commerce of the House of Representatives and the
chairman of the Committee on Health, Education, Labor and
Pensions of the Senate, as set forth in the Congressional
Record.
SEC. 503. DEFINITIONS.
Section 735 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379g) is amended--
(1) in paragraph (1), in the matter after and below
subparagraph (C), by striking ``licensure, as described in
subparagraph (D)'' and inserting ``licensure, as described in
subparagraph (C)'';
(2) in paragraph (3)--
(A) in subparagraph (A), by striking ``and'' at the
end;
(B) in subparagraph (B), by striking the period and
inserting ``, and'';
(C) by inserting after subparagraph (B) the
following subparagraph:
``(C) which is on the list of products described in
section 505(j)(7)(A) or is on a list created and
maintained by the Secretary of products approved under
human drug applications under section 351 of the Public
Health Service Act.''; and
(D) in the matter after and below subparagraph (C)
(as added by subparagraph (C) of this paragraph), by
striking ``Service Act,'' and all that follows through
``biological product'' and inserting the following:
``Service Act. Such term does not include a biological
product'';
(3) in paragraph (6), by adding at the end the following
subparagraph:
``(F) In the case of drugs approved after October 1,
2002, under human drug applications or supplements:
collecting, developing, and reviewing safety information
on the drugs, including adverse event reports, during a
period
[[Page 116 STAT. 689]]
of time after approval of such applications or
supplements, not to exceed three years.''; and
(4) in paragraph (8)--
(A) by striking the matter after and below
subparagraph (B);
(B) by striking subparagraph (B);
(C) by striking ``is the lower of'' and all that
follows through ``Consumer Price Index'' and inserting
``is the Consumer Price Index''; and
(D) by striking ``1997, or'' and inserting
``1997.''.
SEC. 504. AUTHORITY TO ASSESS AND USE DRUG FEES.
(a) Types of Fees.--Section 736(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379h(a)) is amended--
(1) in the matter preceding paragraph (1), by striking
``fiscal year 1998'' and inserting ``fiscal year 2003'';
(2) in paragraph (1)(A)--
(A) in each of clauses (i) and (ii), by striking
``in subsection (b)'' and inserting ``under subsection
(c)(4)''; and
(B) in clause (ii), by adding at the end the
following sentence: ``Such fee shall be half of the
amount of the fee established under clause (i).'';
(3) in paragraph (2)(A), in the matter after and below
clause (ii)--
(A) by striking ``in subsection (b)'' and inserting
``under subsection (c)(4)''; and
(B) by striking ``payable on or before January 31''
and inserting ``payable on or before October 1''; and
(4) in paragraph (3)--
(A) by amending subparagraph (A) to read as follows:
``(A) In general.--Except as provided in
subparagraph (B), each person who is named as the
applicant in a human drug application, and who, after
September 1, 1992, had pending before the Secretary a
human drug application or supplement, shall pay for each
such prescription drug product the annual fee
established under subsection (c)(4). Such fee shall be
payable on or before October 1 of each year. Such fee
shall be paid only once for each product for a fiscal
year in which the fee is payable.''; and
(B) in subparagraph (B), by striking ``The listing''
and all that follows through ``filed under section
505(b)(2)'' and inserting the following: ``A
prescription drug product shall not be assessed a fee
under subparagraph (A) if such product is identified on
the list compiled under section 505(j)(7)(A) with a
potency described in terms of per 100 mL, or if such
product is the same product as another product approved
under an application filed under section 505(b)''.
(b) Fee Amounts.--Section 736(b) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379h(b)) is amended to read as follows:
``(b) Fee Revenue Amounts.--Except as provided in subsections (c),
(d), (f), and (g), fees under subsection (a) shall be established to
generate the following revenue amounts:
[[Page 116 STAT. 690]]
----------------------------------------------------------------------------------------------------------------
Fiscal Year Fiscal Year Fiscal Year Fiscal Year Fiscal Year
``Type of Fee Revenue 2003 2004 2005 2006 2007
----------------------------------------------------------------------------------------------------------------
Application/Supplement.................... $74,300,000 $77,000,000 $84,000,000 $86,434,000 $86,434,000
Establishment............................. $74,300,000 $77,000,000 $84,000,000 $86,433,000 $86,433,000
Product................................... $74,300,000 $77,000,000 $84,000,000 $86,433,000 $86,433,000
Total Fee Revenue......................... $222,900,000 $231,000,000 $252,000,000 $259,300,000 $259,300,000
----------------------------------------------------------------------------------------------------------------
If, after the date of the enactment of the Prescription Drug User Fee
Amendments of 2002, legislation is enacted requiring the Secretary to
fund additional costs of the retirement of Federal personnel, fee
revenue amounts shall be increased in each year by the amount necessary
to fully fund the portion of such additional costs that are attributable
to the process for the review of human drug applications.''.
(c) Adjustments.--Section 736(c) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379h(c)) is amended--
(1) in paragraph (1)--
(A) in the matter preceding subparagraph (A), by
striking ``fees and total fee revenues'' and inserting
``revenues'';
(B) in subparagraph (A)--
(i) by striking ``during the preceding fiscal
year''; and
(ii) by striking ``, or'' and inserting the
following: ``for the 12 month period ending June
30 preceding the fiscal year for which fees are
being established, or'';
(C) in subparagraph (B), by striking ``for such
fiscal year'' and inserting ``for the previous fiscal
year''; and
(D) in the matter after and below subparagraph (B),
by striking ``fiscal year 1997''; and inserting ``fiscal
year 2003'';
(2) by redesignating paragraphs (2) and (3) as paragraphs
(4) and (5), respectively;
(3) by inserting after paragraph (1) the following
paragraphs:
``(2) <<NOTE: Effective date.>> Workload adjustment.--
Beginning with fiscal year 2004, after the fee revenues
established in subsection (b) are adjusted for a fiscal year for
inflation in accordance with paragraph (1), the fee revenues
shall be adjusted further for such fiscal year to reflect
changes in the workload of the Secretary for the process for the
review of human drug applications. With respect to such
adjustment:
``(A) The adjustment shall be determined by the
Secretary based on a weighted average of the change in
the total number of human drug applications, commercial
investigational new drug applications, efficacy
supplements, and manufacturing supplements submitted to
the Secretary. <<NOTE: Federal Register, publication.>>
The Secretary shall publish in the Federal Register the
fee revenues and fees resulting from the adjustment and
the supporting methodologies.
``(B) Under no circumstances shall the adjustment
result in fee revenues for a fiscal year that are less
than the fee revenues for the fiscal year established in
subsection (b), as adjusted for inflation under
paragraph (1).
[[Page 116 STAT. 691]]
``(3) Final year adjustment.--For fiscal year 2007, the
Secretary may, in addition to adjustments under paragraphs (1)
and (2), further increase the fee revenues and fees established
in subsection (b) if such an adjustment is necessary to provide
for not more than three months of operating reserves of
carryover user fees for the process for the review of human drug
applications for the first three months of fiscal year 2008. If
such an adjustment is necessary, the rationale for the amount of
the increase shall be contained in the annual notice
establishing fee revenues and fees for fiscal year 2007. If the
Secretary has carryover balances for such process in excess of
three months of such operating reserves, the adjustment under
this paragraph shall not be made.''; and
(4) in paragraph (4) (as redesignated by paragraph (2) of
this subsection), by amending such paragraph to read as follows:
``(4) <<NOTE: Effective date.>> Annual fee setting.--The
Secretary shall, 60 days before the start of each fiscal year
that begins after September 30, 2002, establish, for the next
fiscal year, application, product, and establishment fees under
subsection (a), based on the revenue amounts established under
subsection (b) and the adjustments provided under this
subsection.''.
(d) Fee Waiver or Reduction.--Section 736(d)) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379h(d)) is amended--
(1) in paragraph (1)--
(A) in subparagraph (C), by inserting ``or'' after
the comma at the end;
(B) by striking subparagraph (D); and
(C) by redesignating subparagraph (E) as
subparagraph (D); and
(2) in paragraph (3), in each of subparagraphs (A) and (B),
by striking ``paragraph (1)(E)'' each place such term appears
and inserting ``paragraph (1)(D)''.
(e) Assessment of Fees.--Section 736(f) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379h(f)) is amended--
(1) in the heading for the subsection, by striking
``Assessment of Fees.--'' and inserting ``Limitations.--''; and
(2) in paragraph (1), by striking the heading for the
paragraph and all that follows through ``fiscal year beginning''
and inserting the following: ``In general.--Fees under
subsection (a) shall be refunded for a fiscal year beginning''.
(f) Crediting and Availability of Fees.--
(1) In general.--Section 736(g)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379h(g)(1)) is amended by
striking ``Fees collected for a fiscal year'' and all that
follows through ``fiscal year limitation.'' and inserting the
following: ``Fees authorized under subsection (a) shall be
collected and available for obligation only to the extent and in
the amount provided in advance in appropriations Acts. Such fees
are authorized to remain available until expended.''.
(2) Collections and appropriation acts.--Section 736(g)(2)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379h(g)(2)) is amended--
(A) by redesignating subparagraphs (A) and (B) as
clauses (i) and (ii), respectively;
[[Page 116 STAT. 692]]
(B) by striking ``(2) Collections'' and all that
follows through ``the amount specified'' in clause (i)
(as so redesignated) and inserting the following:
``(2) Collections and appropriation acts.--
``(A) In general.--The fees authorized by this
section--
``(i) shall be retained in each fiscal year in
an amount not to exceed the amount specified'';
(C) by moving clause (ii) (as so redesignated) two
ems to the right; and
(D) by adding at the end the following subparagraph:
``(B) Compliance.--The Secretary shall be considered
to have met the requirements of subparagraph (A)(ii) in
any fiscal year if the costs funded by appropriations
and allocated for the process for the review of human
drug applications--
``(i) are not more than 3 percent below the
level specified in subparagraph (A)(ii); or
``(ii)(I) are more than 3 percent below the
level specified in subparagraph (A)(ii), and fees
assessed for the fiscal year following the
subsequent fiscal year are decreased by the amount
in excess of 3 percent by which such costs fell
below the level specified in such subparagraph;
and
``(II) such costs are not more than 5 percent
below the level specified in such subparagraph.''.
(3) Authorization of appropriations.--Section 736(g)(3) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)(3))
is amended by striking subparagraphs (A) through (E) and
inserting the following:
``(A) $222,900,000 for fiscal year 2003;
``(B) $231,000,000 for fiscal year 2004;
``(C) $252,000,000 for fiscal year 2005;
``(D) $259,300,000 for fiscal year 2006; and
``(E) $259,300,000 for fiscal year 2007;''.
SEC. 505. <<NOTE: Effective dates. Deadlines. 21 USC 379g note.>>
ACCOUNTABILITY AND REPORTS.
(a) Public Accountability.--
(1) Consultation.--In developing recommendations to the
Congress for the goals and plans for meeting the goals for the
process for the review of human drug applications for the fiscal
years after fiscal year 2007, and for the reauthorization of
sections 735 and 736 of the Federal Food, Drug, and Cosmetic
Act, the Secretary of Health and Human Services (referred to in
this section as the ``Secretary'') shall consult with the
Committee on Energy and Commerce of the House of
Representatives, the Committee on Health, Education, Labor, and
Pensions of the Senate, appropriate scientific and academic
experts, health care professionals, representatives of patient
and consumer advocacy groups, and the regulated industry.
(2) <<NOTE: Federal Register, publication.>>
Recommendations.--The Secretary shall publish in the Federal
Register recommendations under paragraph (1), after negotiations
with the regulated industry; shall present such recommendations
to the congressional committees specified in such paragraph;
shall hold a meeting at which the public may present its views
on such recommendations; and shall provide
[[Page 116 STAT. 693]]
for a period of 30 days for the public to provide written
comments on such recommendations.
(b) Performance Report.--Beginning with fiscal year 2003, not later
than 60 days after the end of each fiscal year during which fees are
collected under part 2 of subchapter C of chapter VII of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.), the Secretary of
Health and Human Services shall prepare and submit to the President, the
Committee on Energy and Commerce of the House of Representatives, and
the Committee on Health, Education, Labor, and Pensions of the Senate a
report concerning the progress of the Food and Drug Administration in
achieving the goals identified in the letters described in section
502(4) during such fiscal year and the future plans of the Food and Drug
Administration for meeting the goals.
(c) Fiscal Report.--Beginning with fiscal year 2003, not later than
120 days after the end of each fiscal year during which fees are
collected under the part described in subsection (b), the Secretary of
Health and Human Services shall prepare and submit to the Committee on
Energy and Commerce of the House of Representatives, and the Committee
on Health, Education, Labor, and Pensions of the Senate, a report on the
implementation of the authority for such fees during such fiscal year
and the use, by the Food and Drug Administration, of the fees collected
during such fiscal year for which the report is made.
SEC. 506. REPORTS OF POSTMARKETING STUDIES.
Section 506B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
356b) is amended by adding at the end the following subsections:
``(d) Disclosure.--If a sponsor fails to complete an agreed upon
study required by this section by its original or otherwise negotiated
deadline, the Secretary shall publish a statement on the Internet site
of the Food and Drug Administration stating that the study was not
completed and, if the reasons for such failure to complete the study
were not satisfactory to the Secretary, a statement that such reasons
were not satisfactory to the Secretary.
``(e) Notification.--With respect to studies of the type required
under section 506(b)(2)(A) or under section 314.510 or 601.41 of title
21, Code of Federal Regulations, as each of such sections was in effect
on the day before the effective date of this subsection, the Secretary
may require that a sponsor who, for reasons not satisfactory to the
Secretary, fails to complete by its deadline a study under any of such
sections of such type for a drug or biological product (including such a
study conducted after such effective date) notify practitioners who
prescribe such drug or biological product of the failure to complete
such study and the questions of clinical benefit, and, where
appropriate, questions of safety, that remain unanswered as a result of
the failure to complete such study. Nothing in this subsection shall be
construed as altering the requirements of the types of studies required
under section 506(b)(2)(A) or under section 314.510 or 601.41 of title
21, Code of Federal Regulations, as so in effect, or as prohibiting the
Secretary from modifying such sections of title 21 of such Code to
provide for studies in addition to those of such type.''.
[[Page 116 STAT. 694]]
SEC. 507. <<NOTE: 21 USC 379g note.>> SAVINGS CLAUSE.
Notwithstanding section 107 of the Food and Drug Administration
Modernization Act of 1997, and notwithstanding the amendments made by
this subtitle, part 2 of subchapter C of chapter VII of the Federal
Food, Drug, and Cosmetic Act, as in effect on the day before the date of
the enactment of this Act, continues to be in effect with respect to
human drug applications and supplements (as defined in such part as of
such day) that, on or after October 1, 1997, but before October 1, 2002,
were accepted by the Food and Drug Administration for filing and with
respect to assessing and collecting any fee required by such Act for a
fiscal year prior to fiscal year 2003.
SEC. 508. <<NOTE: 21 USC 356b note.>> EFFECTIVE DATE.
The amendments made by this subtitle shall take effect October 1,
2002.
SEC. 509. <<NOTE: 21 USC 379g note.>> SUNSET CLAUSE.
The amendments made by sections 503 and 504 cease to be effective
October 1, 2007, and section 505 ceases to be effective 120 days after
such date.
Subtitle B--Funding Provisions Regarding Food and Drug Administration
SEC. 521. OFFICE OF DRUG SAFETY.
Of the amounts appropriated for the Food and Drug Administration for
a fiscal year, the Secretary of Health and Human Services shall reserve
for the Office of Drug Safety (within such Administration), the
following amounts:
(1) For fiscal year 2003, an amount equal to the sum of
$5,000,000 and the amount made available under appropriations
Acts for such Office for fiscal year 2002.
(2) For fiscal year 2004, an amount equal to the sum of
$10,000,000 and the amount made available under appropriations
Acts for such Office for fiscal year 2002.
(3) For each subsequent fiscal year, an amount equal to the
sum of the amount made available under appropriations Acts for
such Office for fiscal year 2004 and an amount sufficient to
offset the effects of inflation occurring after the beginning of
fiscal year 2004.
SEC. 522. <<NOTE: Appropriation authorization.>> DIVISION OF DRUG
MARKETING, ADVERTISING, AND COMMUNICATIONS.
For the Division of Drug Marketing, Advertising, and Communications
(within the Office of Medical Policy, Food and Drug Administration),
there are authorized to be appropriated the following amounts, stated as
increases above the amount made available under appropriations Acts for
such Division for fiscal year 2002:
(1) For fiscal year 2003, an increase of $2,500,000.
(2) For fiscal year 2004, an increase of $4,000,000.
(3) For fiscal year 2005, an increase of $5,500,000.
(4) For fiscal year 2006, an increase of $7,500,000.
(5) For fiscal year 2007, an increase of $7,500,000.
[[Page 116 STAT. 695]]
SEC. 523. <<NOTE: Appropriation authorization.>> OFFICE OF GENERIC
DRUGS.
For the Office of Generic Drugs (within the Food and Drug
Administration), there are authorized to be appropriated the following
amounts, stated as increases above the amount made available under
appropriations Acts for such Office for fiscal year 2002:
(1) For fiscal year 2003, an increase of $3,000,000.
(2) For fiscal year 2004, an increase of $6,000,000.
(3) For fiscal year 2005, an increase of $9,000,000.
(4) For fiscal year 2006, an increase of $12,000,000.
(5) For fiscal year 2007, an increase of $15,000,000.
Subtitle C--Additional Provisions
SEC. 531. <<NOTE: 47 USC 336 note.>> TRANSITION TO DIGITAL TELEVISION.
(a) <<NOTE: Deadline.>> Pair Assignment Required.--In order to
further promote the orderly transition to digital television, and to
promote the equitable allocation and use of digital channels by
television broadcast permittees and licensees, the Federal
Communications Commission, at the request of an eligible licensee or
permittee, shall, within 90 days after the date of enactment of this
Act, allot, if necessary, and assign a paired digital television channel
to that licensee or permittee, provided that--
(1) such channel can be allotted and assigned without
further modification of the tables of allotments as set forth in
sections 73.606 and 73.622 of the Commission's regulations (47
CFR 73.606, 73.622); and
(2) such allotment and assignment is otherwise consistent
with the Commission's rules (47 CFR part 73).
(b) Eligible Transition Licensee or Permittee.--For purposes of
subsection (a), the term ``eligible licensee or permittee'' means only a
full power television broadcast licensee or permittee (or its successor
in interest) that--
(1) had an application pending for an analog television
station construction permit as of October 24, 1991, which
application was granted after April 3, 1997; and
(2) as of the date of enactment of this Act, is the
permittee or licensee of that station.
(c) Requirements on Licensee or Permittee.--
(1) Construction deadline.--Any licensee or permittee
receiving a paired digital channel pursuant to this section--
(A) shall be required to construct the digital
television broadcast facility within 18 months of the
date on which the Federal Communications Commission
issues a construction permit therefore, and
(B) shall be prohibited from obtaining or receiving
an extension of time from the Commission beyond the
construction deadline established by paragraph (1).
(2) Prohibition of analog operation using digital pair.--Any
licensee or permittee receiving a paired digital channel
pursuant to this section shall be prohibited from giving up its
current paired analog assignment and becoming a single-channel
broadcaster and operating in analog on such paired digital
channel.
(d) Relief Restricted.--Any paired digital allotment and assignment
made under this section shall not be available to any
[[Page 116 STAT. 696]]
other applicant unless such applicant is an eligible licensee or
permittee within the meaning of subsection (b).
SEC. 532. 3-YEAR DELAY IN LOCK IN PROCEDURES FOR MEDICARE+CHOICE PLANS;
CHANGE IN CERTAIN MEDICARE+CHOICE DEADLINES AND ANNUAL,
COORDINATED ELECTION PERIOD FOR 2003, 2004, AND 2005.
(a) Lock-In Delay.--Section 1851(e) of the Social Security Act (42
U.S.C. 1395w-21(e)) is amended--
(1) in paragraph (2)(A), by striking ``through 2001'' and
``during 1998, 1999, 2000, and 2001'' and inserting ``through
2004'' and ``during the period beginning January 1, 1998, and
ending on December 31, 2004'', respectively;
(2) in the heading to paragraph (2)(B), by striking ``during
2002'' and inserting ``during 2005'';
(3) in paragraphs (2)(B)(i) and (2)(C)(i), by striking
``2002'' and inserting ``2005'' each place it appears;
(4) in paragraph (2)(D), by striking ``2001'' and inserting
``2004''; and
(5) in paragraph (4), by striking ``2002'' and inserting
``2005'' each place it appears.
(b) Change in Reporting Deadline.--
(1) In general.--Section 1854(a)(1) of such Act (42 U.S.C.
1395w-24(a)(1)) is amended by striking ``Not later than July 1
of each year'' and inserting ``Not later than the second Monday
in September of 2002, 2003, and 2004 (or July 1 of each other
year)''.
(2) <<NOTE: Applicability. 42 USC 1395w-24 note.>>
Effective date.--The amendment made by paragraph (1) shall apply
to information submitted for years beginning with 2003.
(c) Delay in Annual, Coordinated Election Period.--
(1) In general.--Section 1851(e) of such Act (42 U.S.C.
1395w-21(e)) is amended--
(A) in paragraph (3)(B), by striking ``means'' and
all that follows and inserting the following: ``means,
with respect to a year before 2003 and after 2005, the
month of November before such year and with respect to
2003, 2004, and 2005, the period beginning on November
15 and ending on December 31 of the year before such
year.''; and
(B) in paragraph (6)(A), by striking ``each
subsequent year (as provided in paragraph (3))'' and
inserting ``during the annual, coordinated election
period under paragraph (3) for each subsequent year''.
(2) <<NOTE: Applicability. 42 USC 1395w-21 note.>>
Effective date.--The amendment made by paragraph (1) shall apply
to the annual, coordinated election period for years beginning
with 2003.
(d) Change to Annual Announcement of Payment Rates.--
(1) In general.--Section 1853(b)(1) of such Act (42 U.S.C.
1395w-23(b)(1)) is amended by striking ``not later than March 1
before the calendar year concerned'' and inserting ``for years
before 2004 and after 2005 not later than March 1 before the
calendar year concerned and for 2004 and 2005 not later than the
second Monday in May before the respective calendar year''.
[[Page 116 STAT. 697]]
(2) <<NOTE: Applicability. 42 USC 1395w-23 note.>>
Effective date.--The amendment made by paragraph (1) shall first
apply to announcements for years after 2003.
Approved June 12, 2002.
LEGISLATIVE HISTORY--H.R. 3448:
---------------------------------------------------------------------------
HOUSE REPORTS: No. 107-481 (Comm. of Conference).
CONGRESSIONAL RECORD:
Vol. 147 (2001):
Dec. 11, 12, considered and passed
House.
Dec. 20, considered and passed
Senate, amended.
Vol. 148 (2002):
May 22, House agreed to conference
report.
May 23, Senate agreed to conference
report.
WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 38 (2002):
June 12, Presidential remarks.
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