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67858 Federal Register / Vol. 67, No.

216 / Thursday, November 7, 2002 / Notices

By order of the Board of Governors of the Dated: November 4, 2002. http://www.ncvhs.hhs.gov/, where
Federal Reserve System, October 31, 2002. Becky Rhodes, further information including an agenda
Jennifer J. Johnson, Deputy Associate Administrator, Office of will be posted when available.
Secretary of the Board. Transportation and Personal Property. Dated: October 29, 2002.
[FR Doc. 02–28116 Filed 11–6–02; 8:45 am] [FR Doc. 02–28510 Filed 11–6–02; 8:45 am] James Scanlon,
BILLING CODE 6820–14–P
<FNP> Acting Director, Office of Science and Data
Policy, Office of the Assistant Secretary for
Planning and Evaluation.
DEPARTMENT OF HEALTH AND [FR Doc. 02–28293 Filed 11–6–02; 8:45 am]
GENERAL SERVICES HUMAN SERVICES BILLING CODE 4151–05–M
ADMINISTRATION
National Committee on Vital and Health
Governmentwide Per Diem Advisory Statistics: Meeting DEPARTMENT OF HEALTH AND
Board Pursuant to the Federal Advisory HUMAN SERVICES
Committee Act, the Department of
AGENCY: Office of Governmentwide Agency for Toxic Substances and
Health and Human Services (HHS)
Policy, GSA. Disease Registry
announces the following advisory
ACTION: Notice of meeting. committee meeting. Statement of Organization, Functions,
Name: National Committee on Vital and Delegations of Authority
SUMMARY: Notice is hereby given that
and Health Statistics (NCVHS).
Time and Date: November 19, 2002— Part T (Agency for Toxic Substances
the Governmentwide Per Diem Advisory
9 a.m.–6 p.m. November 20, 2002—9 and Diseases Registry) of the Statement
Board will hold an open meeting from
a.m.–4 p.m. of Organization, Functions, and
2:00 p.m. to 4:00 p.m. on Thursday, Place: Hubert H. Humphrey Building, Delegations of Authority of the
November 14, 2002. The meeting will be 200 Independence Avenue, SW., Room Department of Health and Human
held at The Crystal City Marriott, 1999 705A, Washington, DC 20201. Services (50 FR 25129–25130, dated
Jefferson Davis Highway, Arlington, VA Status: Open. June 17, 1985, as amended most
22202. This meeting is open to the Purpose: At this meeting the recently at 62 FR 1119–1120, dated
public. Members of the public who wish Committee will hear presentations and January 8, 1997) is amended to abolish
to file a written statement with the hold discussions on several health data the Office of Federal Programs, Office of
Board may do so in writing c/o Rob policy topics. On the first day the full the Assistant Administrator, Agency for
Miller, Designated Federal Officer Committee will hear updates and status Toxic Substances and Disease Registry.
(MTT), General Services reports from the Department on several Section T–B, Organization and
Administration, 1800 F St., NW, Room topics including the implementation of Functions, is hereby amended as
G–219, Washington, DC 20405, or via e- the administrative simplification follows:
mail at robl.miller@gsa.gov. Due to provisions of the Health Insurance Delete the title and functional
critical mission and schedule Portability and Accountability Act of statement for the Office of Federal
requirements, there is insufficient time 1996 (HIPAA). There will also be a Program (TBB) in their entirety.
to provide the full 15 calendar days’ discussion of the Committee’s proposed
notice in the Federal Register prior to Dated: October 29, 2002.
recommendations to the Department on
this meeting, pursuant to the final rule privacy and code sets for medical Julie Louise Gerberding,
on Federal Advisory Committee records. There will be Subcommittee Administrator.
management codified at 41 CFR 102– breakout sessions late in the afternoon [FR Doc. 02–28320 Filed 11–6–02; 8:45 am]
3.150. of the first day and prior to the full BILLING CODE 4160–70–M
Purpose: To review the current Committee meeting on the second day.
process and methodology that is used by Agendas for these breakout sessions
GSA’s Office of Governmentwide Policy may be found on the NCVHS website DEPARTMENT OF HEALTH AND
to determine the per diem rates for (URL below). On the second day the HUMAN SERVICES
destinations within the continental Committee will hear presentations on
data issues on minority health and Food and Drug Administration
United States (CONUS). The Board will
receive recommendations for population-based health. Each of the
NCVHS Subcommittees will report on [Docket No. 01P–0350]
improvements to the current process
and methodology used to establish the their breakout sessions and other Determination That Sodium Tetradecyl
federal per diem rates within CONUS, activities. Finally, the agendas for future Sulfate Injection Was Not Withdrawn
and receive best practice NCVHS meetings will be discussed. From Sale for Reasons of Safety or
recommendations for developing a Contact Person for More Information:
Effectiveness
Governmentwide lodging program. Substantive program information as
well as summaries of meetings and a AGENCY: Food and Drug Administration,
For security and building access: (1)
roster of committee members may be HHS.
ADA accessible facility; (2) Public
obtained from Marjorie S. Greenberg, ACTION: Notice.
seating may be limited.
Executive Secretary, NCVHS, National
FOR FURTHER INFORMATION CONTACT: Rob Center for Health Statistics, Centers for SUMMARY: The Food and Drug
Miller, Designated Federal Officer, on Disease Control and Prevention, Room Administration (FDA) has determined
(202) 501–4621, or Joddy Garner on 1100, Presidential Building, 6525 that sodium tetradecyl sulfate injection
(202) 501–4857, Per Diem Program Belcrest Road, Hyattsville, Maryland (Sotradecol) was not withdrawn from
Manager, General Services 20782, telephone (301) 458–4245. sale for reasons of safety or
Administration. Also, inquiries may be Information also is available on the effectiveness. This determination will
sent to robl.miller@gsa.gov. NCVHS home page of the HHS Web site: allow FDA to approve abbreviated new

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Federal Register / Vol. 67, No. 216 / Thursday, November 7, 2002 / Notices 67859

drug applications (ANDAs) for sodium requesting that the agency determine DATES: Submit written or electronic
tetradecyl sulfate injection. whether sodium tetradecyl sulfate comments on this guidance by February
FOR FURTHER INFORMATION CONTACT: J. injection was withdrawn from sale for 5, 2003.
Kenneth Borgerding, Center for Drug reasons of safety or effectiveness. In ADDRESSES: Submit written requests for
Evaluation and Research (HFD–7), Food addition, on December 6, 2001, Omega single copies on a 3.5″ diskette of the
and Drug Administration, 5600 Fishers Laboratories, Ltd., submitted a citizen guidance document entitled ‘‘Class II
Lane, Rockville, MD 20857, 301–594– petition (Docket No. 01P–0350/CP2) Special Controls Guidance Document:
2041. under § 10.30 to FDA making the same Transcutaneous Air Conduction Hearing
SUPPLEMENTARY INFORMATION: In 1984,
request. FDA has reviewed its records Aid System; Guidance for Industry and
Congress enacted the Drug Price and has found no information to FDA’’ to the Division of Small
Competition and Patent Term indicate that sodium tetradecyl sulfate Manufacturers, International, and
Restoration Act of 1984 (Public Law 98– injection was withdrawn from the Consumer Assistance (HFZ–220), Center
417) (the 1984 amendments), which market for safety or efficacy reasons. for Devices and Radiological Health,
authorized the approval of duplicate Therefore, FDA concludes that the Food and Drug Administration, 1350
versions of drug products approved decision to not manufacture and market Piccard Dr., Rockville, MD 20850. Send
under an ANDA procedure. ANDA the product was not due to safety or two self-addressed adhesive labels to
sponsors must, with certain exceptions, efficacy concerns. Accordingly, the assist that office in processing your
show that the drug for which they are agency will maintain sodium tetradecyl request, or fax your request to 301–443–
seeking approval contains the same sulfate injection in the ‘‘Discontinued 8818. See the SUPPLEMENTARY
active ingredient in the same strength Drug Product List’’ section of the Orange INFORMATION section for information on
and dosage form as the ‘‘listed drug,’’ Book. The ‘‘Discontinued Drug Product electronic access to the guidance.
which is a version of the drug that was List’’ delineates, among other items, Submit written comments concerning
previously approved under a new drug drug products that have been this guidance to the Dockets
application (NDA). Sponsors of ANDAs discontinued from marketing for reasons Management Branch (HFA–305), Food
do not have to repeat the extensive other than safety or effectiveness. and Drug Administration, 5630 Fishers
clinical testing otherwise necessary to ANDAs that refer to sodium tetradecyl Lane, rm. 1061, Rockville, MD 20852.
gain approval of an NDA. The only sulfate injection may be approved by the Comments should be identified with the
clinical data required in an ANDA are agency. docket number found in brackets in the
data to show that the drug that is the Dated: October 28, 2002. heading of this document. Submit
subject of the ANDA is bioequivalent to Margaret M. Dotzel,
electronic comments to http://
the listed drug. www.fda.gov/dockets/ecomments.
Associate Commissioner for Policy.
The 1984 amendments include what FOR FURTHER INFORMATION CONTACT: Eric
[FR Doc. 02–28400 Filed 11–6–02; 8:45 am]
is now section 505(j)(7) of the Federal M. Mann, Center for Devices and
BILLING CODE 4160–01–S
Food, Drug, and Cosmetic Act (21 U.S.C. Radiological Health (HFZ–460), Food
355(j)(7)), which requires FDA to and Drug Administration, 9200
publish a list of all approved drugs. Corporate Blvd., Rockville, MD 20850,
DEPARTMENT OF HEALTH AND
FDA publishes this list as part of the 301–594–2080.
HUMAN SERVICES
‘‘Approved Drug Products with SUPPLEMENTARY INFORMATION:
Therapeutic Equivalence Evaluations,’’ Food and Drug Administration I. Background
which is generally known as the
‘‘Orange Book.’’ Under FDA regulations, The TACHAS is intended to
[Docket No. 02D–0439]
drugs are withdrawn from the list if the compensate for impaired hearing
agency withdraws or suspends approval Medical Devices; Class II Special without occluding the ear canal. It
of the drug’s NDA or ANDA for reasons Controls Guidance Document: consists of an air conduction hearing aid
of safety or effectiveness or if FDA Transcutaneous Air Conduction attached to a surgically fitted tube
determines that the listed drug was Hearing Aid System; Guidance for system, which is placed through the soft
withdrawn from sale for reasons of Industry and FDA; Availability tissues between the post auricular
safety or effectiveness (21 CFR 314.162). region and the outer ear canal. This
Regulations also provide that the agency AGENCY: Food and Drug Administration, special control guidance document lists
must make a determination as to HHS. the risks to health identified by FDA
whether a listed drug was withdrawn and describes measures that, if followed
from sale for reasons of safety or ACTION: Notice. by manufacturers and combined with
effectiveness, before an ANDA that the general controls, will generally
refers to that listed drug may be SUMMARY: The Food and Drug address the risks associated with these
approved (21 CFR 314.161(a)(1)). FDA Administration (FDA) is announcing the devices.
may not approve an ANDA that does not availability of the guidance entitled Elsewhere in this issue of the Federal
refer to a listed drug. ‘‘Class II Special Controls Guidance Register, FDA is publishing a final rule
Sodium tetradecyl sulfate injection is Document: Transcutaneous Air classifying TACHAS into class II
the subject of NDA 5–970. On August Conduction Hearing Aid System; (special controls) under section 513(f)(2)
13, 1946, Elkins Sinn received approval Guidance for Industry and FDA.’’ This of the Federal Food, Drug, and Cosmetic
to market sodium tetradecyl sulfate document describes a means by which Act (the act) (21 U.S.C. 360c(f)(2)). This
injection. During 2000, Elkins Sinn transcutaneous air conduction hearing guidance document will serve as the
discontinued manufacture of this aid systems (TACHAS) may comply special control for the TACHAS device.
product. with the requirement of special controls Section 513(f)(2) of the act provides that
On August 13, 2001, Bennett and for class II devices. Elsewhere in this any person who submits a premarket
Company submitted a citizen petition issue of the Federal Register, FDA is notification under section 510(k) of the
(Docket No. 01P–0350/CP1) under publishing a final rule classifying act (21 U.S.C. 360(k)) for a device that
§ 10.30 (21 CFR 10.30) to FDA TACHAS into class II (special controls). has not previously been classified may,

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