
[Federal Register: February 27, 2008 (Volume 73, Number 39)]
[Notices]               
[Page 10454-10455]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27fe08-56]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
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 Representative on the Pediatric 
Advisory Committee

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 Pe[ntilde]a (see FOR FURTHER INFORMATION CONTACT).

FOR FURTHER INFORMATION CONTACT:  Carlos Pe[ntilde]a, 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.Pe[ntilde]a@fda.hhs.gov.

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

[[Page 10455]]

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.
[FR Doc. E8-3719 Filed 2-26-08; 8:45 am]

BILLING CODE 4160-01-S
