[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