[Federal Register Volume 70, Number 70 (Wednesday, April 13, 2005)]
[Notices]
[Pages 19488-19489]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-7342]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Request for Nominations for Voting Consumer Representative 
Members on Public Advisory Committees

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is requesting 
nominations for voting consumer representatives to serve on its 
advisory committees that are under the purview of the Center for Drug 
Evaluation and Research (CDER).
    FDA has a special interest in ensuring that women, minority groups, 
and individuals with disabilities are adequately represented on its 
advisory committees and, therefore, encourages nominations of qualified 
candidates from these groups.

DATES: Nominations will be accepted for current vacancies and for those 
that will or may occur through December 31, 2005. Because vacancies 
occur on various dates throughout the year, there is no cutoff date for 
the receipt of nominations.

ADDRESSES: All nominations should be sent to the contact person listed 
in the FOR FURTHER INFORMATION CONTACT section of this document.

FOR FURTHER INFORMATION CONTACT: Igor Cerny, Center for Drug Evaluation 
and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, Maryland 20857, 301-827-7001, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting 
consumer representatives to all of its advisory committees identified 
in section I of this document.

I. Functions

    The functions of advisory committees under the purview of CDER are 
listed in the following paragraphs.

A. Arthritis Advisory Committee

    The committee reviews and evaluates data concerning the safety and 
effectiveness of marketed and investigational human drug products for 
use in the treatment of arthritis, rheumatism, and related diseases and 
makes appropriate recommendations to the Commissioner of Food and Drugs 
(the Commissioner).

B. Anti-Infective Drugs Advisory Committee

    The committee reviews and evaluates available data concerning the 
safety and effectiveness of marketed and investigational human drug 
products for use in the treatment of infectious diseases and disorders 
and makes appropriate recommendations to the Commissioner.

C. Cardiovascular and Renal Drugs Advisory Committee

    The committee reviews and evaluates available data concerning the 
safety and effectiveness of marketed and investigational human drug 
products for use in the treatment of cardiovascular and renal disorders 
and makes appropriate recommendations to the Commissioner.

D. Dermatologic and Ophthalmic Drugs Advisory Committee

    The committee reviews and evaluates available data concerning the 
safety and

[[Page 19489]]

effectiveness of marketed and investigational human drug products for 
use in the treatment of dermatologic and ophthalmic disorders and makes 
appropriate recommendations to the Commissioner.

E. Endocrinologic and Metabolic Drugs Advisory Committee

    The committee reviews and evaluates data concerning the safety and 
effectiveness of marketed and investigational human drug products for 
use in the treatment of endocrine and metabolic disorders and makes 
appropriate recommendations to the Commissioner.

F. Nonprescription Drugs Advisory Committee

    The committee reviews and evaluates available data concerning the 
safety and effectiveness of over-the-counter (nonprescription) human 
drug products, or any other FDA-regulated product, for use in the 
treatment of a broad spectrum of human symptoms and diseases and 
advises the Commissioner either on the issuance of monographs 
establishing conditions under which these drugs are generally 
recognized as safe and effective and not misbranded, or on the approval 
of new drug applications for such drugs. The committee serves as a 
forum for the exchange of views regarding the prescription and 
nonprescription status, including switches from one status to another, 
of these various drug products and combinations thereof. The committee 
may also conduct peer review of agency sponsored intramural and 
extramural scientific biomedical programs in support of FDA's mission 
and regulatory responsibilities.

G. Pulmonary-Allergy Drugs Advisory Committee

    The committee reviews and evaluates available data concerning the 
safety and effectiveness of marketed and investigational human drug 
products for use in the treatment of pulmonary disease and diseases 
with allergic and/or immunologic mechanisms and makes appropriate 
recommendations to the Commissioner.

II. Criteria for Members

    Persons who are nominated for membership on the committees as 
consumer representatives must meet the following criteria: (1) 
Demonstrate ties to consumer and community-based organizations, (2) be 
able to analyze technical data, (3) understand research design, (4) 
discuss benefits and risks, and (5) evaluate the safety and efficacy of 
products under review. The consumer representative must be able to 
represent the consumer perspective on issues and actions before the 
advisory committee; serve as a liaison between the committee and 
interested consumers, associations, coalitions, and consumer 
organizations; and facilitate dialogue with the advisory committees on 
scientific issues that affect consumers.

III. Selection Procedures

    The selection of members representing consumer interests is 
conducted through procedures that include the use of organizations 
representing the public interest and consumer advocacy groups. The 
organizations have the responsibility of recommending candidates of the 
agency's selection.

IV. Nomination Procedures

    All nominations must include a cover letter, a curriculum vitae or 
resume (that includes the nominee's office address, telephone number, 
and e-mail address), and a list of consumer or community-based 
organizations for which the candidate can demonstrate active 
participation.
    Any interested person or organization may nominate one or more 
qualified persons for membership on one or more of the advisory 
committees to represent consumer interests. Self-nominations are also 
accepted. FDA will ask the potential candidates to provide detailed 
information concerning such matters as financial holdings, employment, 
and research grants and/or contracts to permit evaluation of possible 
sources of a conflict of interest. The nomination should specify the 
committee(s) of interest. The term of office is up to 4 years, 
depending on the appointment date.
    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: April 1, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-7342 Filed 4-12-05; 8:45 am]
BILLING CODE 4160-01-S