[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: 94-19359]


[[Page Unknown]]

[Federal Register: August 9, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

 

Request for Nominations for Members on Public Advisory Committees 
in the Center for Drug 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 Drug Evaluation and Research. Nominations will be 
accepted for current vacancies and vacancies that will or may occur on 
the committees during the next 16 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 selection 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 Adele S. Seifried (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: Adele S. Seifried, Center for Drug Evaluation and Research 
(HFD-9), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-443-5455.
     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 17 advisory committees for vacancies listed below. 
Individuals should have expertise in the activity of the committee.
    1. Anesthetic and Life Support Drugs Advisory Committee: Five 
vacancies occurring March 31, 1995.
    2. Anti-Infective Drugs Advisory Committee: Two vacancies occurring 
November 30, 1994, and three vacancies occurring November 30, 1995.
    3. Antiviral Drugs Advisory Committee: Three vacancies occurring 
immediately, including that of the consumer-nominated member, two 
vacancies occurring October 31, 1994, and three vacancies occurring 
October 31, 1995.
    4. Arthritis Advisory Committee: Six vacancies occurring 
immediately and three vacancies occurring September 30, 1995.
     5. Cardiovascular and Renal Drugs Advisory Committee: Three 
vacancies occurring immediately and three vacancies occurring June 30, 
1995.
     6. Dermatologic Drugs Advisory Committee: Three vacancies 
occurring August 31, 1995.
    7. Endocrinologic and Metabolic Drugs Advisory Committee: One 
vacancy occurring immediately and two vacancies occurring June 30, 
1995.
     8. Fertility and Maternal Health Drugs Advisory Committee: Three 
vacancies occurring June 30, 1995.
    9. Gastrointestinal Drugs Advisory Committee: One vacancy occurring 
immediately and two vacancies occurring June 30, 1995, including that 
of the consumer-nominated member.
     10. Generic Drugs Advisory Committee: One vacancy occurring 
immediately, six vacancies occurring October 31, 1994, including that 
of the consumer-nominated member, and three vacancies occurring October 
31, 1995.
    11. Medical Imaging Drugs Advisory Committee: Six vacancies 
occurring immediately, including that of the consumer-nominated member, 
and four vacancies occurring June 30, 1995.
    12. Nonprescription Drugs Advisory Committee: Three vacancies 
occurring May 31, 1995.
    13. Oncologic Drugs Advisory Committee: Two vacancies occurring 
June 30, 1995.
    14. Peripheral and Central Nervous Systems Drugs Advisory 
Committee: Two vacancies occurring January 31, 1995, including that of 
the consumer-nominated member.
    15. Psychopharmacologic Drugs Advisory Committee: Two vacancies 
occurring June 30, 1995.
    16. Pulmonary-Allergy Drugs Advisory Committee: Three vacancies 
occurring immediately and four occurring May 31, 1995.
    The functions of the 16 committees listed above are to review and 
evaluate available scientific, technical, and medical data concerning 
the safety and effectiveness of marketed and investigational human 
drugs for use in the area of medical specialties, indicated by the 
title of the committee, and to make appropriate recommendations to the 
Commissioner of Food and Drugs.
    17. Drug Abuse Advisory Committee: One vacancy occurring 
immediately and two vacancies occurring May 31, 1995.
    The functions of the Drug Abuse Advisory Committee are to: (1) 
Advise the Commissioner regarding the scientific and medical evaluation 
of information gathered by the Department of Health and Human Services 
(DHHS) and the Department of Justice on the safety, efficacy, and abuse 
potential of drugs; and (2) recommend actions to be taken by DHHS 
regarding the marketing, investigation, and control of such drugs.

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 the committee in such fields as 
anesthesiology, surgery, internal medicine, infectious disease, asthma, 
rheumatology, microbiology, pediatrics, ophthalmology, cardiology, 
clinical/medical oncology, hematology, radiology, nuclear medicine, 
biostatistics, epidemiology, dermatopathology/immunodermatology, 
dermatology, psychopharmacology, neurochemistry, neuropharmacology, 
endocrinology, obstetrics and gynecology, reproductive endocrinology, 
gastroenterology, pharmacology, clinical pharmacology, hepatology, 
virology, pharmaceutical manufacturing, bioavailability and 
bioequivalence research, pharmacokinetics, neurology, psychiatry, 
psychology, neuropharmacology, neuropathology, pulmonary disease, 
allergy, immunology, clinical immunology, or other appropriate areas of 
expertise.
    The specialized training and experience necessary to qualify the 
nominee 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 Procedures

    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. 
FDA will ask potential candidates 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 2, 1994.
 Linda A. Suydam,
 Interim Deputy Commissioner for Operations.
[FR Doc. 94-19359 Filed 8-8-94; 8:45 am]
BILLING CODE 4160-01-F