E8-3719. Request for Notification From Industry Organizations Interested in Participating in the Selection Process for a Nonvoting Industry Representative on the Pediatric Advisory Committee and Request for Nominations for a Nonvoting Industry ...

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on its Pediatric Advisory Committee notify FDA in writing. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for an upcoming vacancy on June 30, 2008, effective with this notice.

DATES:

Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests must send a letter stating the interest to FDA by March 28, 2008, for vacancies listed in this notice. Concurrently, nomination material for prospective candidates should be sent to FDA by March 28, 2008.

ADDRESSES:

All letters of interest and nominations should be submitted in writing to Carlos Peña (see FOR FURTHER INFORMATION CONTACT).

FOR FURTHER INFORMATION CONTACT:

Carlos Peña, Office of Science and Health Coordination, Office of the Commissioner (HF-33), Food and Drug Administration, 5600 Fishers Lane (for express delivery, rm. 14B-08), Rockville, MD 20857, 301-827-3340, or by e-mail: Carlos.Peñ[e-mail].

SUPPLEMENTARY INFORMATION:

The agency requests nominations for a nonvoting industry representative on the Pediatric Advisory Committee.

I. Function

The committee advises and makes recommendations to the Commissioner of Food and Drugs (the Commissioner) regarding: (1) Pediatric research conducted under sections 351, 409I, and 499 of the Public Health Service Act (42 U.S.C. 262, 284m, and 290b) and sections 501, 502, 505, 505A, and 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351, 352, 355, 355a, and 355c); (2) identification of research priorities related to pediatric therapeutics and the need for additional treatments of specific pediatric diseases or conditions; (3) the ethics, design, and analysis of clinical trials related to pediatric therapeutics; (4) pediatric labeling disputes as specified in section 3 of the Best Pharmaceuticals for Children Act (Public Law 107-109); (5) pediatric labeling changes as specified in section 5 of the Best Pharmaceuticals for Children Act; (6) adverse event reports for drugs granted pediatric exclusivity and any safety issues that may occur as specified in section 17 of the Best Pharmaceuticals for Children Act; (7) any other pediatric issue or pediatric labeling dispute involving FDA-regulated products; (8) research involving children as subjects as specified in 21 CFR 50.54; and (9) any other matter involving pediatrics for which FDA has regulatory responsibility. The committee also advises and makes recommendations to the Secretary of Health and Human Services (the Secretary) directly or to the Secretary through the Commissioner on research involving children as subjects that is conducted or supported by the Department of Health and Human Services as specified in 45 CFR 46.407.

II. Selection Procedure

Any pediatric products industry, association, or organization interested in the selection of an appropriate nonvoting member to represent industry interests should send a letter stating that interest to the FDA contact (see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of this document (see DATES). Within the subsequent 30 days, FDA will send a letter to each organization that has expressed an interest, attaching a complete list of all such organizations, and a list of all nominees along with their current resumes. The letter will also state that it is the responsibility of the interested organizations to confer with one another and to select an industry representative, within 60 days after the receipt of the FDA letter, and the industry representative will serve as the nonvoting member to represent industry interests for the Pediatric Advisory Committee. The interested organizations are not bound by the list of nominees in selecting a candidate. However, if no individual is selected within 60 days, the Commissioner will select the nonvoting member to represent industry interests.

III. Application Procedure

Individuals may self nominate and/or an organization may nominate one or more individuals to serve as a nonvoting industry representative. A current curriculum vitae and the name of the committee of interest should be sent to the FDA contact person (see FOR FURTHER INFORMATION CONTACT) within 30 days (see DATES). FDA will forward all nominations to the organizations expressing interest in participating in the selection process for the committee (persons who nominate themselves as nonvoting industry representatives will not participate in the selection process).

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, and therefore, 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: February 19, 2008.

Randall W. Lutter,

Deputy Commissioner for Policy.