[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.
[[Page 50884]]
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]
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