Document ID: FDA-2012-N-0781-0001
Agency: fda
Document Type: Notice
Title: Requests for Nonvoting Industry Representatives, Industry Involvement in Selection Processes: Pediatric Advisory Committee
Posted Date: 2012-08-10T04:00Z

[Federal Register Volume 77, Number 155 (Friday, August 10, 2012)]
[Notices]
[Pages 47853-47854]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-19639]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0781]

Request for Notification From Industry Organizations Interested 
in Participating in Selection Process for Nonvoting Industry 
Representative on the Pediatric Advisory Committee and Request for 
Nominations for Nonvoting Industry Representatives on the Pediatric 
Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 the Pediatric Advisory 
Committee for the Office of the Commissioner (OC) notify FDA in 
writing. FDA is also requesting nominations for a nonvoting industry 
representative(s) to serve on the Pediatric Advisory Committee. A 
nominee may either be self-nominated or nominated by an organization to 
serve as a nonvoting industry representative. Nominations will be 
accepted for current vacancies 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 that interest to FDA by September 
10, 2012, for the vacancy listed in this notice. Concurrently, 
nomination materials for prospective candidates should be sent to FDA 
by September 10, 2012.

ADDRESSES: All letters of interest and nominations should be submitted 
in writing to Walter Ellenberg (see FOR FURTHER INFORMATION CONTACT).

FOR FURTHER INFORMATION CONTACT: Walter Ellenberg, Office of the 
Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 32, Rm. 5154, Silver Spring, MD 20993, 301-796-0885, FAX: 301-
847-8640, walter.ellenberg@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: The Agency intends to add a nonvoting 
industry representative(s) to the following advisory committee:

I. OC Advisory Committee

Pediatric Advisory Committee

    The Committee reviews and evaluates and makes recommendations to 
the Commissioner of Food and Drugs

[[Page 47854]]

regarding: (1) Pediatric research conducted under sections 351, 409I, 
and 499 of the Public Health Service Act and sections 501, 502, 505, 
505A, and 505B, 510K, 515, and 520m of the Federal Food, Drug, and 
Cosmetic Act; (2) identification of research priorities related to 
pediatric therapeutics (including drugs and biological products) and 
medical devices for pediatric populations and the need for additional 
diagnostics and treatments of specific pediatric diseases or 
conditions, (3) the ethics, design, and analysis of clinical trials 
related to pediatric therapeutics (including drugs and biological 
products) and medical devices, (4) pediatric labeling disputes as 
specified in Public Law 107-109 and Public Law 110-85, (5) pediatric 
labeling changes as specified in Public Law 107-109 and Public Law 110-
85, (6) adverse event reports for drugs studied under Public Law 107-
109 and 110-85 and labeled, (7) any safety issues that may occur as 
specified Public Law 107-109 and Public Law 110-85, (8) any other 
pediatric issue or pediatric labeling dispute involving FDA-regulated 
products, (9) pediatric ethical issues including research involving 
children as subjects as specified in 21 CFR 50.54; and (10) any other 
matter involving pediatrics for which FDA has regulatory 
responsibility.
    The Committee also advises and makes recommendations to 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 industry organization interested in participating 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 a candidate, within 60 days after the receipt of 
the FDA letter, to serve as the nonvoting member to represent industry 
interests for the 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. Contact information, 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 of 
publication of this document (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 seeks to include the views of women and men, members of all 
racial and ethnic groups, and individuals with and without disabilities 
on its advisory committees and, therefore, encourages nominations of 
appropriately qualified candidates from these groups. Specifically, in 
this document, nominations for nonvoting representatives of industry 
interests are encouraged from the pediatric pharmaceutical research and 
biotechnology manufacturing industry.

    Authority: 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 7, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-19639 Filed 8-9-12; 8:45 am]
BILLING CODE 4160-01-P