04-10831. Request for Nominations for Voting and Nonvoting Consumer Representative Members on Public Advisory Committees and Panels

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is requesting nominations for voting and nonvoting consumer representatives to serve on its advisory committees and panels in the Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), and Center for Devices and Radiological Health (CDRH). Nominations will be accepted for current vacancies and for those that will or may occur through December 31, 2004.

FDA has a special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on advisory committees and, therefore, encourages nominations of qualified candidates from these groups.

DATES:

Scheduled vacancies occur on various dates throughout the year. As a result, no cutoff date is established 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:

Michael Ortwerth, Advisory Committee Oversight and Management Staff (HF-4), FDA Office of the Commissioner, 5600 Fishers Lane, Rockville, MD 20857, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

FDA is requesting nominations for voting and nonvoting consumer representatives of the following advisory committees and panels for vacancies:

CBER

1. Blood Products Advisory Committee

CDRH

1. Neurological Devices Panel of the Medical Devices Advisory Committee

CDER

1. Anti-Infective Drugs Advisory Committee

2. Arthritis Advisory Committee

3. Peripheral and Central Nervous System Drugs Advisory Committee

4. Pulmonary-Allergy Drugs Advisory Committee

I. Criteria for Members

Persons nominated for membership on the committees as a consumer representative 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.

II. Selection Procedures

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

III. Nomination Procedures

All nominations must include a cover letter, a curriculum vitae or resume (which should include 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 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: May 5, 2004.

Peter J. Pitts,

Associate Commissioner for External Relations.