[Federal Register Volume 67, Number 133 (Thursday, July 11, 2002)]
[Notices]
[Pages 45981-45982]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-17477]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Request for Nominations for Members on Public Advisory 
Committees; Drug Safety and Risk Management Advisory Committee 
(Formally Drug Abuse Advisory Committee)

AGENCY:  Food and Drug Administration.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is requesting 
nominations for four members to serve on the Drug Safety and Risk 
Management Advisory Committee in the Center for Drug Evaluation and 
Research.
    FDA has a 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 each vacancy will be 
determined by the expertise required to meet specific agency needs and 
in a manner to ensure appropriate balance on membership.

DATES:  Nominations should be received before September 1, 2002.

ADDRESSES:  All nominations for membership should be sent to Kimberly 
Topper, and all nominations for consumer-nominated members should be 
sent to Linda Sherman (see FOR FURTHER INFORMATION CONTACT).

FOR FURTHER INFORMATION CONTACT: Kimberly Topper, Center for Drug 
Evaluation and Research (HFD-21), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-7001, e-mail: 
[email protected]; or
    Linda Sherman, Advisory Committee Oversight and Management Staff 
(HF-4), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-827-1220, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: On June 1, 2002, the Drug Safety and Risk 
Management Advisory Committee (formerly Drug Abuse Advisory Committee) 
was rechartered with 9 of the proposed 13 members. Accordingly, FDA is 
requesting nominations for members to serve on the Drug Safety and Risk 
Management Advisory Committee (formerly Drug Abuse Advisory Committee).
Function: The committee advises the Commissioner of Food and Drugs 
regarding the scientific and medical evaluation of all information 
gathered

[[Page 45982]]

by the Department of Health and Human Services (DHHS) and the 
Department of Justice with regard to safety, abuse potential, risk 
management, risk communication, and quantitative evaluation of 
spontaneous reports, and recommends actions to be taken by DHHS with 
regard to marketing, investigation, and control of such drugs or other 
substances.

Criteria for Members

    Persons nominated for membership on the committees described 
previously in this document 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, safety, 
abuse potential, risk management, risk communication and quantitative 
evaluation of spontaneous reports 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 
previously in this document one voting member who is nominated by 
consumer organizations. These members are recommended by consumer 
organizations which have the responsibility for screening, 
interviewing, and recommending 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 previously in this document 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 on 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: July 5, 2002.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 02-17477 Filed 7-10-02; 8:45 am]
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