[Federal Register: April 13, 2005 (Volume 70, Number 70)]
[Notices]
[Page 19488-19489]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13ap05-130]
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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: cerny@cder.fda.gov.
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