06-6276. Request for Nominations for Voting Members on a Public Advisory Committee; Pediatric Advisory Committee

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Pediatric Advisory Committee in the Office of the Commissioner. Nominations will be accepted for vacancies that have occurred on or before June 30, 2006.

FDA has 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:

No cutoff date is established for the receipt of nominations. However, nominations received on or before July 28, 2006, will be given first consideration for membership on the Pediatric Advisory Committee.

ADDRESSES:

All nominations for membership should be sent to Jan Johannessen (see FOR FURTHER INFORMATION CONTACT).

FOR FURTHER INFORMATION CONTACT:

Jan N. Johannessen, Office of Science and Health Coordination (HF-33), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-6687, FAX [phone], e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

FDA is requesting nominations for voting members on the Pediatric Advisory Committee. There are currently six vacancies on this committee. These vacancies need to be filled as soon as possible.

I. Function of the Pediatric Advisory Committee

The committee advises the Commissioner of Food and Drugs on pediatric therapeutics, pediatric research, and other matters involving pediatrics for which FDA has regulatory responsibility. The Committee also advises and makes recommendations to the Secretary of Health and Human Services under 21 CFR 50.54 for products regulated by FDA and 45 CFR 46.407 on research involving children as subjects that is conducted or supported by the Department of Health and Human Services and involves a product regulated by FDA.

II. Qualifications

Persons nominated for membership on the committees shall have scientific expertise in one or more of the following areas: Pediatric research, pediatric subspecialties, pediatric therapeutics, statistics, and/or biomedical ethics. There is a particular need for clinical and/or scientific expertise in pediatric neurology, adolescent medicine or statistics. The term of office is up to 4 years, depending on the appointment date.

III. Nomination Procedures

Any interested person may nominate one or more qualified persons for membership on the Pediatric Advisory Committee. Self-nominations are also accepted. Nominations shall include the name of the committee, a complete curriculum vitae of each nominee, current business address and telephone number, and shall state that the nominee is aware of the nomination, is willing to serve as a member, and appears to have no conflict of interest that would preclude membership. 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.

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 10, 2006.

Randall W. Lutter,

Associate Commissioner for Policy and Planning.