[Federal Register Volume 63, Number 21 (Monday, February 2, 1998)]
[Notices]
[Pages 5387-5393]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-2498]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0009]
Medical Devices; Exemptions From Premarket Notification and
Reserved Devices; Class I
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
class I devices, subject to certain limitations, that will be exempt
from premarket notification requirements on February 19, 1998. FDA is
also publishing a list of those class I devices that FDA believes will
remain subject to premarket notification requirements because they meet
the new statutory criteria for premarket notification requirements.
These lists do not include class I devices that have been previously
exempted by regulation from the premarket notification requirements.
FDA is taking this action in order to meet a requirement of the Food
and Drug Administration Modernization Act of 1997 (the FDAMA). The
agency requests comments on whether the list of class I devices that
will remain subject to the premarket notification requirements should
be modified.
DATES: This notice is effective February 19, 1998. Submit written
comments by May 4, 1998.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Heather S. Rosecrans, Center for
Devices and Radiological Health (HFZ-404), Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-
1190.
SUPPLEMENTARY INFORMATION:
I. Statutory Background
Under section 513 of the act (21 U.S.C. 360c), FDA must classify
devices into one of three regulatory classes: Class I, class II, or
class III. FDA classification of a device is determined by the amount
of regulation necessary to provide a reasonable assurance of safety and
effectiveness. Under the Medical Device Amendments of 1976 (the 1976
amendments) (Pub. L. 94-295), as amended by the Safe Medical Devices
Act of 1990 (Pub. L. 101-629), devices are to be classified into class
I (general controls) if there is information showing that the general
controls of the act are sufficient to ensure safety and effectiveness;
into class II (special controls), if general controls, by themselves,
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls to provide such assurance; and into class III (premarket
approval), if there is insufficient information to support classifying
a device into class I or class II and the device is a life-sustaining
or life-supporting device, or is for a use which is of substantial
importance in preventing impairment of human health, or presents a
potential unreasonable risk of illness or injury. Most generic types of
devices that were on the market before the date of the 1976 amendments
(May 28, 1976) (generally referred to as preamendments devices) have
been classified by FDA under the procedures set forth in section 513(c)
and (d) of the act through the issuance of classification regulations
into one of these three regulatory classes. Devices introduced into
interstate commerce for the first time on or after May 28, 1976
(generally referred to as postamendments devices) are classified
through the premarket notification process under section
[[Page 5388]]
510(k) of the act (21 U.S.C. 360(k)). Section 510(k) of the act and the
implementing regulations, 21 CFR part 807, require persons who intend
to market a new device to submit a premarket notification report
containing information that allows FDA to determine whether the new
device is substantially equivalent within the meaning of section 513(i)
of the act to a legally marketed device that does not require premarket
approval. Unless exempted from premarket notification requirements,
persons may not market a new device under section 510(k) of the act,
unless they receive a substantial equivalence order from FDA or an
order reclassifying the device into class I or class II, section 513(i)
of the act. On November 21, 1997, the President signed into law the
FDAMA (Pub. L. 105-115). Section 206 of the FDAMA, in part, added a new
section 510(l) to the act. Under section 501 of the FDAMA, new section
510(l) of the act becomes effective on February 19, 1998. New section
510(l) of the act provides that a class I device is exempt from the
premarket notification requirements under section 510(k) of the act,
unless the device is intended for a use which is of substantial
importance in preventing impairment of human health or it presents a
potential unreasonable risk of illness or injury (hereafter ``reserved
criteria''). Based on these reserved criteria, FDA has evaluated all
class I devices to determine which device types should be subject to
premarket notification requirements.
In developing the list of reserved devices, the agency considered
its experience in reviewing premarket notifications for these device
types, focusing on the risk inherent with the device and/or the disease
being treated or diagnosed, e.g., devices with rapidly evolving
technology or expansions of intended uses. The agency considered the
history of adverse event reports under the medical device reporting
program for these devices, as well as their history of product recalls.
Given the inherent risks with the devices listed and/or the disease or
condition being treated or diagnosed, FDA believes that the devices
listed as reserved are intended for a use that is of substantial
importance in preventing impairment of human health or present a
potential unreasonable risk of illness or injury. In this notice, FDA
is publishing two lists of devices: (1) A list of the class I devices
that FDA believes will be exempt from the premarket notification
requirements on February 19, 1998, under section 510(l) of the act,
subject to certain limitations from the premarket notification
requirements described herein; and (2) a list of the devices that FDA
believes fit the reserved criteria under section 510(l) of the act and,
therefore, will continue to be subject to premarket notification
requirements. These lists do not include class I devices that have been
previously exempted by regulation from the premarket notification
requirements. FDA believes that class I devices that have previously
been exempted generally do not fall within the reserved criteria under
section 510(l) of the act. When FDA issues a proposed rule to amend the
regulations to codify class I devices that remain subject to the
premarket notification requirements, FDA, in limited cases, may propose
to revoke the exemption from the premarket notification requirements
based on the reserved criteria of section 510(l) of the act.
II. Limitations on Exemptions
As stated previously, FDA believes that the generic types of class
I devices listed herein, in addition to a vast majority of class I
devices previously exempted, should be exempt from the premarket
notification requirements under section 510(l) of the act. FDA further
believes, however, that these generic device categories should be
exempt only to the extent that they have existing or reasonably
foreseeable characteristics of commercially distributed devices within
that generic type or, in the case of in vitro diagnostic devices, for
which a misdiagnosis as a result of using the device, would not be
associated with high morbidity or mortality. FDA believes that certain
changes to devices within a generic type that is generally exempt may
make the device intended for a use that is of substantial importance in
preventing impairment of human health or may make the device present a
potential unreasonable risk of illness or injury. Accordingly, devices
changed in this manner would fall within the reserved criteria under
section 510(l) of the act and would require premarket notification.
FDA believes that devices that have different intended uses than
legally marketed devices in that generic type present a potential
unreasonable risk of illness or injury because their safety and
effectiveness characteristics are unknown. Moreover, FDA believes that
in vitro diagnostic devices that are intended for a use, for which a
misdiagnosis as a result of using the device, could result in high
morbidity or mortality, either are intended for a use that is of
substantial importance in preventing impairment of human health or
present a potential unreasonable risk of illness or injury.
Accordingly, because FDA believes that devices incorporating the
characteristics described above fit within the reserved criteria under
section 510(l) of the act, FDA considers any class I device to be
subject to premarket notification requirements if the device: (1) Has
an intended use that is different from the intended use of a legally
marketed device in that generic type; e.g., the device is intended for
a different medical purpose, or the device is intended for lay use
instead of use by health care professionals; or (2) operates using a
different fundamental scientific technology than that used by a legally
marketed device in that generic type, e.g., a surgical instrument cuts
tissue with a laser beam rather than with a sharpened metal blade, or
an in vitro diagnostic device detects or identifies infectious agents
by using a deoxyribonucleic acid (DNA) probe or nucleic acid
hybridization or amplification technology rather than culture or
immunoassay technology; or (3) is a in-vitro device that is intended:
(a) For use in the diagnosis, monitoring or screening of neoplastic
diseases with the exception of immunohistochemical devices; (b) for use
in screening or diagnosis of familial and acquired genetic disorders,
including inborn errors of metabolism; (c) for measuring an analyte
that serves as a surrogate marker for screening, diagnosis, or
monitoring life threatening diseases such as acquired immune deficiency
syndrome (AIDS), chronic or active hepatitis, tuberculosis, or
myocardial infarction or to monitor therapy; (d) to assess the risk of
cardiovascular diseases; (e) for use in diabetes management; (f) to
identify or infer the identity of a microorganism directly from
clinical material; (g) for detection of antibodies to microorganisms
other than immunoglobulin G (IgG) and IgG assays when the results are
not qualitative, or are used to determine immunity, or the assay is
intended for use in matrices other than serum or plasma; uses
noninvasive testing; and (h) for near patient testing (point of care).
Class I devices incorporating such changes or modifications are not
exempt from premarket notification because FDA believes they meet the
reserved criteria described above, under 510(l).
In addition to the general limitation on exemptions that FDA
considers applicable to all class I devices that is described above,
FDA also considers certain devices within a generic class to remain
subject to the premarket notification requirements because they
[[Page 5389]]
either are intended for a use that is of substantial importance in
preventing impairment of human health or they present a potential
unreasonable risk of illness or injury. For example, FDA, elsewhere in
this document, states that it considers liquid bandages generally to be
exempt from the premarket notification requirements, but considers a
subcategory of those devices, those intended for treatment of burns and
other open wounds, to remain subject to the premarket notification
requirements. FDA believes that liquid bandages intended for burns and
other open wounds should remain subject to this requirement because
they are of substantial importance in preventing impairment of human
health by helping to prevent infections.
FDA advises additionally that an exemption from the requirement of
premarket notification does not mean that the device is exempt from any
other statutory or regulatory requirements, unless such exemption is
explicitly provided by order or regulation.
III. Lists of Devices
The following devices are devices that FDA believes meet the
reserved criteria in section 206 of the FDAMA and, therefore, would
remain subject to premarket notification under new section 510(l) added
to the act:
Table 1.--Reserved Class I Devices
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21 CFR Section Name of Device
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862.1065.............. Ammonia test system
862.1113.............. Bilirubin (total and unbound) in the neonate test system
862.1410.............. Iron (non-heme) test system
862.1415.............. Iron-binding capacity test system
862.1495.............. Magnesium test system
862.1580.............. Phosphorous (inorganic) test system
862.1660.............. Quality control material (assayed and unassayed)\1\
862.1680.............. Testosterone test system
862.1775.............. Uric acid test system
862.3110.............. Antimony test system
862.3120.............. Arsenic test system
862.3220.............. Carbon monoxide test system
862.3240.............. Cholinesterase test system
862.3600.............. Mercury test system
864.7040.............. Adenosine triphosphate release assay
864.8950.............. Russell viper venom reagent
864.9050.............. Blood bank supplies
864.9125.............. Vacuum-assisted blood collection system
864.9195.............. Blood mixing devices and blood weighing devices\2\
866.2390.............. Transport culture medium
866.2560.............. Microbial growth monitor\3\
866.2850.............. Automated zone reader
866.2900.............. Microbiological specimen collection and transport device
866.3110.............. Campylobacter fetus serological reagents
866.3120.............. Chlamydia serological reagents
866.3235.............. Epstein-Barr virus serological reagents
866.3370.............. Mycobacterium tuberculosis immunofluorescent reagents
866.3870.............. Trypanosoma spp. serological reagents
872.4200.............. Dental handpiece and accessories
872.6250.............. Dental chair and accessories\4\
872.6640.............. Dental operative unit and accessories\5\
872.6710.............. Boiling water sterilizer
876.5160.............. Urological clamps for males\6\
878.4460.............. Surgeon's glove
880.5090.............. Liquid bandage\7\
880.5680.............. Pediatric position holder
880.6250.............. Patient examination glove
880.6375.............. Patient lubricant
880.6760.............. Protective restraint
882.1030.............. Ataxiagraph
882.1420.............. Electroencephalogram (EEG) signal spectrum analyzer
882.4060.............. Ventricular cannula\8\
882.4545.............. Shunt system implantation instrument\9\
884.2980(a)........... Telethermographic system\10\
884.2982(a)........... Liquid crystal thermographic system\11\
886.4070.............. Powered corneal burr\12\
886.4300.............. Intraocular lens guide\13\
886.4370.............. Keratome
888.1500.............. Goniometer
890.3850.............. Mechanical wheelchair
890.5710.............. Hot or cold disposable packs\14\
892.1100.............. Scintillation (gamma) camera
892.1110.............. Positron camera
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\1\ Meets reserved criteria when assayed and unassayed when used for donor screening.
\2\ Meets reserved criteria when automated.
\3\ Meets reserved criteria when automated blood culturing systems.
\4\ Meets reserved criteria when dental chair with the operative unit.
\5\ Meets reserved criteria when it is not the accessory tray to the unit.
[[Page 5390]]
\6\ Meets reserved criteria when devices are for internal use or are used for females.
\7\ Meets reserved criteria for uses other than as a skin protectant.
\8\ Meets reserved criteria if not made of surgical grade stainless steel.
\9\ Meets reserved criteria if not made of surgical stainless steel.
\10\ Meets reserved criteria if an adjunct use system.
\11\ Meets reserved criteria if nonelectrically powered and AC-powered adjunctive system.
\12\ Meets reserved criteria if for use other than for removing rust rings.
\13\ Meets reserved criteria if used as folders and injectors for soft or foldable IOL's.
\14\ Meets reserved criteria if indicated for use on infants.
The following devices are devices that FDA believes do not meet the
reserved criteria under section 206 of the FDAMA and, therefore, will
be exempt from premarket notification as of February 19, 1998, under
new section 510(l) added to the act:
Table 2.--Exempted Class I Devices
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21 CFR Section Name of Device
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862.1030.............. Alanine amino transferase (ALT/SGPT) test system
862.1040.............. Aldolase test system
862.1060.............. Delta-aminolevulinic acid test system
862.1075.............. Androstenedione test system
862.1080.............. Androsterone test system
862.1095.............. Ascorbic acid test system
862.1115.............. Urinary bilirubin and its conjugates (nonquantitative) test system
862.1130.............. Blood volume test system
862.1135.............. C-peptides of proinsulin test system
862.1165.............. Catecholamines (total) test system
862.1175.............. Cholesterol (total) test system
862.1180.............. Chymotrypsin test system
862.1185.............. Compound S (11-deoxycortisol) test system
862.1195.............. Corticoids test system
862.1200.............. Corticosterone test system
862.1240.............. Cystine test system
862.1245.............. Dehydroepiandrosterone (free and sulfate) test system
862.1250.............. Desoxycorticosterone test system
862.1260.............. Estradiol test system
862.1265.............. Estriol test system
862.1270.............. Estrogen (total, in pregnancy) test system
862.1275.............. Estrogens (total, nonpregnancy) test system
862.1280.............. Estrone test system
862.1285.............. Etiocholanolone test system
862.1300.............. Follicle-stimulating hormone test system
862.1310.............. Galactose test system
862.1325.............. Gastrin test system
862.1330.............. Globulin test system
862.1335.............. Glucagon test system
862.1360.............. Gamma-glutamyl transpeptidase and isoenzymes test system
862.1370.............. Human growth hormone test system
862.1375.............. Histidine test system
862.1385.............. 17-Hydroxycorticosteroids (17-ketogenic steroids) test system
862.1390.............. 5-Hydroxyindole acetic acid/serotonin test system
862.1395.............. 17-Hydroxyprogesterone test system
862.1400.............. Hydroxyproline test system
862.1405.............. Immunoreactive insulin test system
862.1430.............. 17-Ketosteroids test system
862.1435.............. Ketones (nonquantitative) test system
862.1450.............. Lactic acid test system
862.1460.............. Leucine aminopeptidase test system
862.1465.............. Lipase test system
862.1475.............. Lipoprotein test system
862.1485.............. Luteinizing hormone test system
862.1500.............. Malic dehydrogenase test system
862.1505.............. Mucopolysaccharides (nonquantitative) test sytem
862.1510.............. Nitrite (nonquantitative) test system
862.1520.............. 5'-Nucleotidase test system
862.1530.............. Plasma oncometry test system
862.1535.............. Ornithine carbamyl transferase test system
862.1540.............. Osmolality test system
862.1542.............. Oxalate test system
862.1550.............. Urinary pH (nonquantitative) test system
862.1560.............. Urinary phenylketones (nonquantitative) test system
862.1570.............. Phosphohexose isomerase test system
862.1590.............. Porphobilinogen test system
862.1595.............. Porphyrins test system
862.1605.............. Pregnanediol test system
[[Page 5391]]
862.1610.............. Prenanetriol test system
862.1615.............. Pregnenolone test system
862.1620.............. Progesterone test system
862.1625.............. Prolactin (lactogen) test system
862.1630.............. Protein (fractionation) test system
862.1645.............. Urinary protein or albumin (nonquantitative) test system
862.1650.............. Pyruvate kinase test system
862.1655.............. Pyruvic acid test system
862.1660.............. Quality control material (assayed and unassayed)\1\
862.1705.............. Triglyceride test system
862.1725.............. Trypsin test system
862.1730.............. Free tyrosine test system
862.1780.............. Urinary calculi (stones) test system
862.1785.............. Urinary urobilinogen (nonquantitative) test system
862.1790.............. Uroporphyrin test system
862.1795.............. Vanilmandelic acid test system
862.1805.............. Vitamin A test system
862.1820.............. Xylose test system
862.2140.............. Centrifugal chemistry analyzer for clinical use
862.2150.............. Continuous flow sequential multiple chemistry analyzer for clinical use
862.2160.............. Discrete photometric chemistry analyzer for clinical use
862.2170.............. Micro chemistry analyzer for clinical use
862.2250.............. Gas liquid chromatography system for clinical use
862.2260.............. High pressure liquid chromatography system for clinical use
862.2270.............. Thin-layer chromatography system for clinical use
862.2300.............. Colorimeter photometer, or spectrophotometer for clinical use
862.2400.............. Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical
use
862.2500.............. Enzyme analyzer for clinical use
862.2540.............. Flame emission photometer for clinical use
862.2560.............. Fluorometer for clinical use
862.2680.............. Microtitrator for clinical use
862.2700.............. Nephelometer for clinical use
862.2730.............. Osmometer for clinical use
862.2750.............. Pipetting and diluting system for clinical use
862.2850.............. Atomic absorption spectrophotometer for clinical use
862.2860.............. Mass spectrometer for clinical use
862.2900.............. Automated urinalysis system
862.3280.............. Clinical toxicology control material
864.2280.............. Cultured animal and human cells
864.5240.............. Automated blood cell diluting apparatus
864.9185.............. Blood grouping view box
864.9195.............. Blood mixing devices and blood weighing devices\2\
864.9225.............. Cell-freezing apparatus and reagents for in vitro diagnostic use
864.9275.............. Blood bank centrifuge for in vitro diagnostic use
864.9320.............. Copper sulphate solution for specific gravity determination
864.9750.............. Heat-sealing device
866.2660.............. Microorganism differentiation and identification device
866.3040.............. Aspergillus spp. serological reagents
866.3140.............. Corynebacterium spp. serological reagents
866.3145.............. Coxsackievirus serological reagents
866.3200.............. Echinococcus spp. serological reagents
866.3240.............. Equine encephalomyelitis virus serological reagents
866.3355.............. Listeria spp. serological reagents
866.3360.............. Lymphocytic choriomeningitis virus serological reagents
866.3375.............. Mycoplasma spp. serological reagents
866.3380.............. Mumps virus serological reagents
866.3405.............. Poliovirus serological reagents
866.3480.............. Respiratory syncytial virus serological reagents
866.3500.............. Rickettsia serological reagents
866.3600.............. Schistosoma spp. serological reagents
866.3680.............. Sporothrix scheneckii serological reagents
866.3740.............. Streptococcus spp. serological reagents
866.3850.............. Trichinella spiralis serological reagents
866.5060.............. Prealbumin immunological test system
866.5065.............. Human allotypic marker immunological test system
866.5160.............. Beta-globulin immunological test system
866.5200.............. Carbonic anhydrase B and C immunological test system
866.5330.............. Factor XIII, A, S, immunological test system\3\
866.5400.............. Alpha-globulin immunological test system
866.5420.............. Alpha-I-glycoproteins immunological test system
866.5425.............. Alpha-2-glycoproteins immunological test system
866.5430.............. Beta-2-glycoprotein I immunological test system
[[Page 5392]]
866.5440.............. Beta-2-glycoprotein III immunological test system
866.5560.............. Lactic dehydrogenase immunological test system
866.5570.............. Lactoferrin immunological test system
866.5590.............. Lipoprotein X immunological test system
866.5715.............. Plasminogen immunological test system
866.5735.............. Prothrombin immunological test system\4\
866.5765.............. Retinol-binding protein immunological test system
866.5890.............. Inter-alpha trypsin inhibitor immunological test system
868.1910.............. Esophageal stethoscope
868.5620.............. Breathing mouthpiece
868.5640.............. Medicinal nonventilatory nebulizer (atomizer)
868.5675.............. Rebreathing device
868.5700.............. Nonpowered oxygen tent
868.6810.............. Tracheobronchial suction catheter
872.3400(b)(1)........ Karaya and sodium borate with or without acacia denture adhesive
874.1070.............. Short increment sensitivity index (SISI) adapter
874.1500.............. Gustometer
874.1800.............. Air or water caloric stimulator
874.1925.............. Toynbee diagnostic tube
874.3300(b)(1)........ Hearing aid\5\
874.4100.............. Epistaxis balloon
874.5300.............. Ear, nose, and throat examination and treatment unit
874.5550.............. Powered nasal irrigator
874.5840.............. Antistammering device
876.5160.............. Urological clamps for males\6\
876.5210.............. Enema kit
876.5250(b)(2)........ Urine collector and accessories
878.4040.............. Surgical apparel\7\
878.4200.............. Introduction/drainage catheter and accessories
878.4320.............. Removable skin clip
878.4680.............. Nonpowered, single patient, portable suction apparatus
878.4760.............. Removable skin staple
878.4820.............. Surgical instrument motors and accessories/attachments
878.4960.............. Operating tables and accessories and operating chair and accessories
880.5090.............. Liquid bandage\8\
880.5270.............. Neonatal eye pad
880.5420.............. Pressure infusor for an I.V. bag
882.4060.............. Ventricular cannula\9\
882.4545.............. Shunt system implantation instrument\10\
882.4650.............. Neurosurgical suture needle
882.4750.............. Skull punch\11\
884.1040.............. Viscometer for cervical mucus
886.1350.............. Keratoscope\12\
886.1780.............. Retinoscope\13\
886.1940.............. Tonometer sterilizer
886.4070.............. Powered corneal burr\14\
886.4300.............. Intraocular lens guide\15\
886.5850.............. Sunglasses (nonprescription)
890.5180.............. Manual patient rotation bed
890.5710.............. Hot or cold disposable pack\16\
892.1300.............. Nuclear rectilinear scanner
892.1320.............. Nuclear uptake probe
892.1330.............. Nuclear whole body scanner
892.1410.............. Nuclear electrocardiograph synchronizer
892.1890.............. Radiographic film illuminator
892.1910.............. Radiographic grid
892.1960.............. Radiographic intensifying screen
892.1970.............. Radiographic ECG/respirator, synchronizer
892.5650.............. Manual radionuclide applicator system
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\1\ Exemption is limited to unassayed material, except when used in conjunction with donor screening tests.
\2\ Exemption is limited to manual devices.
\3\ This exemption should not be confused with Sec. 864.7290.
\4\ This exemption should not be confused with Secs. 864.5425 or 864.7750.
\5\ Exemption is limited to air-conduction hearing aids.
\6\ Exemption does not include devices for internal use or devices used for females.
\7\ Exemption is limited to class I category other than surgical gowns and surgical masks.
\8\ Exemption is limited to uses as a skin protectant.
\9\ Exemption is limited to surgical grade stainless steel.
\10\ Exemption is limited to devices made of surgical grade stainless steel.
\11\ Exemption should not be confused with Sec. 882.4305.
\12\ Exemption is extended to those with software.
\13\ Exemption is limited to class I battery-powered devices.
\14\ Exemption is limited to rust ring removal.
[[Page 5393]]
\15\ Exemption does not apply if used as folders and injectors for soft or foldable IOL's.
\16\ Exemption does not apply when indicated for infants.
IV. Comments
Interested persons may, on or before May 4, 1998, submit to the
Dockets Management Branch (address above) written comments regarding
the notice. Two copies of any comments are to be submitted, except that
individuals may submit one copy. Comments are to be identified with the
docket number found in brackets in the heading of this document.
Received comments may be seen in the office above between 9 a.m. and 4
p.m., Monday through Friday.
Dated: January 23, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-2498 Filed 1-30-98; 8:45 am]
BILLING CODE 4160-01-F