[Federal Register Volume 69, Number 174 (Thursday, September 9, 2004)]
[Notices]
[Pages 54686-54687]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-20348]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Request for Nominations for Nonvoting Members Representing 
Industry Interests on Public Advisory Panels or Committees

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is requesting 
nominations for nonvoting industry representatives to serve on public 
advisory committees under the purview of the Center for Biologics 
Evaluation and Research (CBER).

DATES: Industry organizations interested in participating in the 
selection of a nonvoting member to represent industry for vacancies 
listed in this notice must send a letter to FDA by October 12, 2004, 
stating their interest in one or more committees.
    Concurrently, nomination materials for prospective candidates 
should be sent to FDA by October 12, 2004. A nominee may either be 
self-nominated or nominated by an organization to serve as a nonvoting 
industry representative.

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

FOR FURTHER INFORMATION CONTACT: Gail Dapolito, Center for Biologics 
Evaluation and Research (HFM-71), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20857-1448, 301-827-0314, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Section 120 of the FDA Modernization Act of 
(FDAMA) of 1997 (21 U.S.C. 355) requires that FDA advisory committees 
include representatives from the biologics manufacturing industries. 
The agency intends to add nonvoting industry representatives to all its 
advisory committees identified in section I of this document.

I. Functions

Advisory Committees Under the Purview of CBER

A. Allergenic Products Advisory Committee

    The committee reviews and evaluates available data concerning the 
safety, effectiveness, and adequacy of labeling of marketed and 
investigational allergenic biological products or materials that are 
administered to humans for the diagnosis, prevention, or treatment of 
allergies and allergic diseases.

B. Blood Products Advisory Committee

    The committee reviews and evaluates available data concerning the 
safety, effectiveness, and appropriate use of blood and products 
derived from blood and serum or biotechnology which are intended for 
use in the diagnosis,

[[Page 54687]]

prevention, or treatment of human diseases.

C. Transmissible Spongiform Encephalopathies Advisory Committee

    The committee reviews and evaluates available scientific data 
concerning the safety of products which may be at risk for transmission 
of spongiform encephalopathies having an impact on the public health.

D. Vaccines and Related Biological Products Advisory Committee

    The committee reviews and evaluates data concerning the safety, 
effectiveness, and appropriate use of vaccines and related biological 
products which are intended for use in the prevention, treatment, or 
diagnosis of human diseases.

II. Selection Procedure

    Any organization in the biologics manufacturing industry wishing to 
participate in the selection of a nonvoting member to represent 
industry on a particular advisory committee should send a letter 
stating that interest to the FDA contact (see FOR FURTHER INFORMATION 
CONTACT) within 30 days of publication of this notice. Persons who 
nominate themselves as industry representatives for a certain advisory 
committee will not participate in the selection process. It is, 
therefore, recommended that nominations be made by someone within an 
organization, trade association, or firm who is willing to participate 
in the selection process. Within the subsequent 30 days, FDA will send 
a letter to each organization and a list of all nominees along with 
their resumes. The letter will state that the interested organizations 
are responsible for conferring with one another to select a candidate, 
within 60 days after receiving the letter, to serve as the nonvoting 
member representing on a particular advisory committee. If no 
individual is selected within that 60 days, the Commissioner of Food 
and Drugs may select the nonvoting member to represent industry 
interests.

III. Application Procedure

    Individuals may nominate themselves or an organization representing 
the biologics manufacturing industry may nominate one or more 
individuals to serve as nonvoting industry representatives. A current 
curriculum vitae (which includes the nominee's business address, 
telephone number, and e-mail address) and the name of the committee of 
interest should be sent to the FDA contact person. FDA will forward all 
nominations to the organizations that have expressed interest in 
participating in the selection process for that committee.
    FDA has a special interest in ensuring that women, minority groups, 
individuals with physical disabilities, and small businesses are 
adequately represented on its advisory committees. Therefore, the 
agency encourages nominations for appropriately qualified candidates 
from these groups.
    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 31, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 04-20348 Filed 9-8-04; 8:45 am]
BILLING CODE 4160-01-S