[Federal Register Volume 66, Number 90 (Wednesday, May 9, 2001)]
[Notices]
[Pages 23718-23719]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-11619]


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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 the 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.

ADDRESSES: All nominations and curricula vitae should be sent to the 
addresses below.

FOR FURTHER INFORMATION CONTACT:
    Regarding nominations, except for consumer representatives: John 
Treacy, Center for Drug Evaluation and Research (HFD-21), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7001, 
e-mail: <a href="/cdn-cgi/l/email-protection#2256504743415b62414647500c4446430c454d54"><span class="__cf_email__" data-cfemail="6317110602001a23000706114d0507024d040c15">[email protected]</span></a>.
    Regarding nominations for consumer representatives: Maureen Hess, 
Office of Consumer Affairs (HFE-50), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-5006, e-mail: 
<a href="/cdn-cgi/l/email-protection#0964616c7a7a49666a276f6d68276e667f"><span class="__cf_email__" data-cfemail="533e3b362020133c307d3537327d343c25">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: FDA is requesting nominations of members for 
the following 16 advisory committees for vacancies listed below. 
Individuals should have expertise in the activity of the committee.
    1. Advisory Committee for Pharmaceutical Science: Two vacancies 
occurring immediately, two vacancies occurring October 31, 2001, and 
six vacancies occurring October 31, 2002, including that of the 
consumer-nominated member.
    2. Advisory Committee for Reproductive Health Drugs: Four vacancies 
occurring immediately, four vacancies occurring June 30, 2001, and 
three vacancies occurring June 30, 2002.
    3. Anesthetic and Life Support Drugs Advisory Committee: Five 
vacancies occurring immediately, and four vacancies occurring March 31, 
2002, including that of the consumer-nominated member.
    4. Anti-Infective Drugs Advisory Committee: Five vacancies 
occurring November 30, 2001, and three vacancies occurring November 30, 
2002.
    5. Antiviral Drugs Advisory Committee: Three vacancies occurring 
immediately, three vacancies occurring October 31, 2001, and two 
vacancies occurring October 31, 2002.
    6. Arthritis Advisory Committee: Two vacancies occurring September 
30, 2001, and four vacancies occurring September 30, 2002.
    7. Cardiovascular and Renal Drugs Advisory Committee: Three 
vacancies occurring June 30, 2001, including that of the consumer-
nominated member, and four vacancies occurring June 30, 2003.
    8. Dermatologic Drugs Advisory Committee: Seven vacancies occurring 
immediately, four vacancies occurring August 31, 2001, and four 
vacancies occurring August 31, 2002, including that of the consumer-
nominated member.
    9. Endocrinologic and Metabolic Drugs Advisory Committee: One 
vacancy occurring immediately, one vacancy occurring June 30, 2001, and 
four vacancies occurring June 30, 2002.
    10. Gastrointestinal Drugs Advisory Committee: Three vacancies 
occurring June 30, 2001, and two vacancies occurring June 30, 2002.
    11. Medical Imaging Drugs Advisory Committee: Ten vacancies 
occurring immediately, three vacancies occurring June 30, 2001, and two 
vacancies occurring June 30, 2002, including that of the consumer-
nominated member.
    12. Nonprescription Drugs Advisory Committee: Four vacancies 
occurring immediately, including that of the consumer-nominated member, 
one vacancy occurring on May 30, 2001, and four vacancies occurring May 
31, 2002.
    13. Oncologic Drugs Advisory Committee: Two vacancies occurring 
June 30, 2001, and three vacancies occurring June 30, 2002.
    14. Peripheral and Central Nervous Systems Drugs Advisory 
Committee: Seven vacancies occurring immediately.
    15. Psychopharmacologic Drugs Advisory Committee: Two vacancies 
occurring June 30, 2001, and four vacancies occurring June 30, 2002, 
including that of the consumer-nominated member.
    16. Pulmonary-Allergy Drugs Advisory Committee: Two vacancies 
occurring immediately, two vacancies occurring May 31, 2001, including 
that of the consumer-nominated member, and five vacancies occurring May 
31, 2002.
Function
    The functions of the 16 committees listed above are to review and 
evaluate available scientific, technical, and

[[Page 23719]]

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.
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 up to 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 up to 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: May 2, 2001.
Bonnie H. Malkin,
Special Assistant to the Senior Associate Commissioner.
[FR Doc. 01-11619 Filed 5-8-01; 8:45 am]
BILLING CODE 4160-01-S


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