[Federal Register Volume 63, Number 46 (Tuesday, March 10, 1998)]
[Notices]
[Pages 11684-11685]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-6152]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Request for Nominations for Members on Public Advisory
Committees; Pharmacy Compounding Advisory Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is requesting
nominations for 15 members to serve on the Pharmacy Compounding
Advisory Committee in the Center for Drug Evaluation and Research.
Elsewhere in this issue of the Federal Register, FDA is publishing a
final rule announcing the establishment of this committee.
FDA has special interest in ensuring that women, minority groups,
and the physically challenged are adequately represented on advisory
committees and, therefore, extends particular encouragement to
nominations for appropriately qualified female, minority, or physically
challenged candidates.
DATES: Nominations should be received on or before April 9, 1998.
ADDRESSES: All nominations for membership, except for the
representative of a consumer organization, should be sent to Kimberly
L. Topper (address below). All nominations for the representative of a
consumer organization should be sent to Annette J. Funn (address
below).
FOR FURTHER INFORMATION CONTACT:
Regarding all nominations for membership, except for the
representative of a consumer organization: Kimberly L. Topper, Center
for Drug Evaluation and Research (HFD-21), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-5455.
Regarding all nominations for the representative of a consumer
organization: Annette J. Funn, Office of Consumer Affairs (HFE-88),
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,
301-827-5006.
SUPPLEMENTARY INFORMATION: On November 21, 1997, the President signed
the Food and Drug Administration Modernization Act of 1997 (Pub. L.
105-115) (the Modernization Act). Section 127 of the Modernization Act
added section 503A to the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 353a). Section 503A directs FDA to issue regulations relating to
the application of Federal law to the practice of pharmacy compounding.
To assist the agency in preparing these regulations, Congress directed
FDA to convene and consult an advisory committee that will include
representatives of the National Association of Boards of Pharmacy
(NABP), the United States Pharmacopoeia (U.S.P.), pharmacy, physician,
and consumer organizations, as well as other experts selected by the
agency. Accordingly, FDA is requesting nominations for 15 members to
serve on the Pharmacy Compounding Advisory Committee.
Function
The function of the committee is to provide advice on scientific,
technical, and medical issues concerning drug compounding by licensed
practitioners and to make appropriate recommendations to the
Commissioner of Food and Drugs.
Criteria for Members
Persons nominated for membership should have expertise in one or
more of the following fields: Pharmaceutical compounding, the practices
of pharmacies specializing in compounding, the practices of general
retail pharmacies, the practices of hospital pharmacies, fields of
medicine in which compounding drugs or the use of compounded drugs is
relatively common, pharmaceutical manufacturing, clinical toxicology,
clinical pharmacology, chemistry, and related specialties. The
committee will include one representative of the NABP, one
representative of the U.S.P., one representative of a pharmacy
organization, one representative of a
[[Page 11685]]
physician organization, one representative of a consumer organization,
and one representative of the pharmaceutical manufacturing industry.
The term of office is 4 years, except that initial appointments will be
staggered to permit an orderly rotation of membership.
Nomination Procedures
Interested persons may nominate one or more qualified persons for
membership on the advisory committee. Nominations shall state that the
nominee is willing to serve as a member of the advisory committee and
appears to have no conflict of interest that would preclude committee
membership. Potential candidates will be asked by FDA to provide
detailed information concerning such matters as financial holdings,
consultancies, and research grants or contracts to permit evaluation of
possible sources of conflict of interest.
Selection of a representative of a consumer organization is
conducted through procedures which include use of a consortium of
consumer organizations which has the responsibility for screening,
interviewing, and recommending candidates for the agency's selection.
Representatives of a consumer organization must possess appropriate
qualifications to understand and contribute to the committee's work.
Selection of the member representing pharmaceutical manufacturing
industry interests will be made in accordance with the advisory
committee member selection process (21 CFR 14.80).
The NABP and the U.S.P. will be sent letters requesting nominations
for their representatives on the advisory committee.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. App. 2), section 503A of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 353a), section 904 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 394) as amended by the Food and Drug
Administration Revitalization Act (Pub. L. 101-635), and 21 CFR part
14, relating to advisory committees.
Dated: March 3, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-6152 Filed 3-9-98; 8:45 am]
BILLING CODE 4160-01-F
