[Federal Register Volume 59, Number 152 (Tuesday, August 9, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-19358]


[[Page Unknown]]

[Federal Register: August 9, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
 

Request for Nominations for Members on Public Advisory Committees 
in the Center for Biologics Evaluation and Research

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is requesting 
nominations for members to serve on certain public advisory committees 
in the Center for Biologics Evaluation and Research. Nominations will 
be accepted for current vacancies and vacancies that will or may occur 
on the committees during the next 12 months.
    FDA has a special interest in ensuring that women, minority groups, 
and the physically handicapped are adequately represented on advisory 
committees and, therefore, extends particular encouragement to 
nominations for appropriately qualified female, minority, and 
physically handicapped candidates. Final selections from among 
qualified candidates for 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: Because scheduled vacancies occur on various dates throughout 
each year, no cutoff date is established for receipt of nominations. 
However, when possible, nominations should be received at least 6 
months before the date of scheduled vacancies for each year, as 
indicated in this notice.

ADDRESSES: All nominations for membership, except for consumer-
nominated members should be sent to Jack Gertzog (address below ). All 
nominations for consumer-nominated members should be sent to Susan K. 
Meadows (address below).

FOR FURTHER INFORMATION CONTACT:
     Regarding all nominations for membership, except consumer-
nominated membership: Jack Gertzog, Center for Biologics Evaluation and 
Research (HFM-21), Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852-1448, 301-594-1054.
    Regarding all nominations for consumer-nominated members: Susan K. 
Meadows, Office of Consumer Affairs (HFE-20), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-5006.

SUPPLEMENTARY INFORMATION: FDA is requesting nominations of members for 
the following four advisory committees for vacancies listed below. 
Individuals should have expertise in the activity of the committee.
    1. Allergenic Products Advisory Committee: Three vacancies 
occurring August 31, 1995.
    2. Biological Response Modifiers Advisory Committee: One vacancy 
occurring immediately.
    3. Blood Products Advisory Committee: Five vacancies occurring 
September 30, 1995.
    4. Vaccines and Related Biological Products Advisory Committee: 
Three vacancies occurring January 31, 1995.
    The functions of the four committees listed above are to review and 
evaluate scientific, technical, and medical data concerning the safety, 
effectiveness, and appropriate use of allergenic products, blood and 
products derived from blood and serum, vaccines, immunological 
products, biological response modifiers, and other biological products 
intended for use in the diagnosis, prevention, or treatment of human 
diseases, and to make appropriate recommendations to the Commissioner 
of Food and Drugs. These four committees also review and evaluate 
intramural research programs.

Criteria for Members

    Persons nominated for membership on the committees described above 
must have adequately diversified research and/or clinical experience 
appropriate to the work of each committee in such fields as allergenic 
products, internal medicines, cytokines, lymphokines, molecular 
biology, rDNA technology, infectious diseases, viral oncology, cellular 
kinetics, epidemiology, statistics, hematology, immunology, blood 
banking, virology, bacteriology, pediatrics, microbiology, nuclear 
biology, and biochemistry, or other appropriate areas of expertise.
    The specialized training and experience necessary to qualify the 
nominees as an expert suitable for appointment is subject to review, 
but may include experience in medical practice, teaching, research, 
and/or public service relevant to the field of activity of the 
committee. The term of office is 4 years.

Criteria for Consumer-Nominated Members

    FDA currently attempts to place on each of the committees described 
above one voting member who is nominated by consumer organizations. 
These members are recommended by a consortium of 12 consumer 
organizations which has the responsibility for screening, interviewing, 
and recommending consumer-nominated candidates with appropriate 
scientific credentials. Candidates are sought who are aware of the 
consumer impact of committee issues, but who also possess enough 
technical background to understand and contribute to the committee's 
work. This would involve, for example, an understanding of research 
design, benefit/risk, and the legal requirements for safety and 
efficacy of the products under review, and considerations regarding 
individual products. The agency notes, however, that for some advisory 
committees, it may require such nominees to meet the same technical 
qualifications and specialized training required of other expert 
members of the committee. The term of office for these members is 4 
years. Nominations for all committees listed above are invited for 
consideration for membership as openings become available.

Nomination Procedure

    Any interested person may nominate one or more qualified persons 
for membership on one or more of the advisory committees. Nominations 
shall specify the committee for which the nominee is recommended. 
Nominations shall state that the nominee is aware of the nomination, 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 in order 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) and 21 CFR part 14 relating to advisory committees.

    Dated: August 3, 1994.
 Linda A. Suydam,
 Interim Deputy Commissioner for Operaitions.
[FR Doc. 94-19358 Filed 8-8-94; 8:45 am]
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