[Federal Register Volume 82, Number 211 (Thursday, November 2, 2017)]
[Notices]
[Pages 50883-50884]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23903]



[[Page 50883]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6266]


Request for Nominations 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 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 December 
4, 2017 (see sections I and II of this document for further details). 
Concurrently, nomination materials for prospective candidates should be 
sent to FDA by December 4, 2017. Nominations received on or before 
December 4, 2017 will be given first consideration for membership on 
the Pediatric Advisory Committee. Nominations received after December 
4, 2017 will be considered for nomination to the committee as later 
vacancies occur.

ADDRESSES: All statements of interest from industry organizations 
interested in participating in the selection process of nonvoting 
industry representative nomination should be sent to Marieann Brill 
(see FOR FURTHER INFORMATION CONTACT). All nominations for nonvoting 
industry representatives should be sent electronically by logging into 
the FDA Advisory Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or by mail to Advisory Committee 
Oversight and Management Staff, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993-0002. 
Information about becoming a member on an FDA advisory committee can 
also be obtained by visiting FDA's Web site at https://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: Regarding all nomination questions for 
nonvoting industry representative the primary contact is: Marieann 
Brill, Office of the Commissioner, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 32, Rm. 5154, Silver Spring, MD 20993, 240-
402-3838, email: [email protected].

SUPPLEMENTARY INFORMATION: FDA is requesting nominations for nonvoting 
industry representative(s) on the Pediatric Advisory Committee:

I. General Description of the Committee Duties

    The Committee reviews and evaluates 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, 505B, 510(k), 515, and 520(m) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351, 352, 355, 355a, 355c, 360(k), 
360e, and 360j(m)); (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, Public Law 110-85, and Public Law 112-
144; (5) pediatric labeling changes as specified in Public Law 107-109, 
Public Law 110-85, and Public Law 112-144; (6) adverse event reports 
for drugs studied under Public Law 107-109, Public Law 110-85, and 
Public Law 112-144; (7) any safety issues that may occur as specified 
Public Law 107-109, Public Law 110-85, and Public Law 112-144; (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 of Health and Human Services (Secretary) (HHS) directly or to 
the Secretary through the Commissioner on research involving children 
as subjects that is conducted or supported by HHS 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 r[eacute]sum[eacute]s. 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. Nomination Procedures

    Any interested person may nominate one or more qualified 
individuals for membership on the advisory committee. Self-nominations 
are also accepted. Nominations must include a current, complete 
r[eacute]sum[eacute] or curriculum vitae for each nominee and a signed 
copy of the Acknowledgement and Consent form available at the FDA 
Advisory Nomination Portal (see ADDRESSES). Nominations must also 
specify the advisory committee for which the nominee is recommended. 
Nominations must also acknowledge that the nominee is aware of the 
nomination unless self-nominated. 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.
    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.


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    Dated: October 30, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-23903 Filed 11-1-17; 8:45 am]
 BILLING CODE 4164-01-P


