[Federal Register Volume 65, Number 212 (Wednesday, November 1, 2000)]
[Notices]
[Pages 65320-65321]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-27966]


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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 four members to serve on the Pharmacy Compounding 
Advisory Committee in the Center for Drug Evaluation and Research.
    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. Final selection from among each vacancy will be 
determined by the expertise required to meet specific agency needs and 
in a manner to ensure appropriate balance of membership.

DATES: Nominations should be received on or before December 1, 2000.

ADDRESSES: All nominations for membership should be sent to Jayne E. 
Peterson (address below).

FOR FURTHER INFORMATION CONTACT:
    Regarding all nominations for membership: Jayne E. Peterson, Center 
for Drug Evaluation and Research (HFD-21), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7001.

SUPPLEMENTARY INFORMATION: On November 21, 1997, the President signed 
the Food and Drug Administration Modernization Act of 1997 (Public Law 
105-115) (the Modernization Act). Section 127 of the Modernization Act 
added section 503A to the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 353a)). Section 503A of the act 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 Pharmacopeia (USP), 
pharmacy, physician and consumer organizations, as well as other 
experts selected by the agency. The Pharmacy Compounding Advisory 
Committee was formed on March 10, 1998, and 15 members were appointed 
to the committee. The terms of four members have expired or the 
positions have otherwise become vacant. Accordingly, FDA is requesting 
nominations for four 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

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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 current committee includes one representative of the 
NABP, one representative of the USP, one representative of a consumer 
organization, and one representative of the pharmaceutical 
manufacturing industry whose terms have not yet expired. The term of 
office is up to 4 years.

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.
    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 (Public Law 101-635), and 21 CFR part 
14, relating to advisory committees.

    Dated: October 25, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-27966 Filed 10-31-00; 8:45 am]
BILLING CODE 4160-01-F