Notice2022-09071
Request for Nominations on the Pediatric Advisory Committee
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 28, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) 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.
Full Text
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<title>Federal Register, Volume 87 Issue 82 (Thursday, April 28, 2022)</title>
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[Federal Register Volume 87, Number 82 (Thursday, April 28, 2022)]
[Notices]
[Pages 25276-25277]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-09071]
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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 or Agency) 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 May 31,
2022. (See sections I and II of this document for further details.)
Concurrently, nomination materials for prospective candidates should be
sent to FDA by May 31, 2022.
ADDRESSES: All statements of interest from industry organizations
interested in participating in the selection process of nonvoting
industry representative nomination should be sent to Shivana Srivastava
(see FOR FURTHER INFORMATION CONTACT). All nominations for nonvoting
industry representatives may be submitted electronically by accessing
the FDA Advisory Committee Membership Nomination Portal: <a href="https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm">https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm</a> 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 of an FDA
advisory committee can also be obtained by visiting FDA's website at
<a href="https://www.fda.gov/AdvisoryCommittees/default.htm">https://www.fda.gov/AdvisoryCommittees/default.htm</a>.
FOR FURTHER INFORMATION CONTACT: Shivana Srivastava, Office of the
Commissioner, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 32, Rm. 5157, Silver Spring,
[[Page 25277]]
MD 20993, 301-796-8695, email: <a href="/cdn-cgi/l/email-protection#44172c2d32252a256a17362d32253730253225042220256a2c2c376a232b32"><span class="__cf_email__" data-cfemail="ce9da6a7b8afa0afe09dbca7b8afbdbaafb8af8ea8aaafe0a6a6bde0a9a1b8">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: The Agency intends to add a nonvoting
industry representative(s) to the Pediatric Advisory Committee:
I. General Description of the Committee Duties
The Committee reviews, 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
in 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 (the 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 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 resume, and the name of
the committee of interest should be sent to the FDA Advisory Committee
Membership Nomination Portal (see ADDRESSES) 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 individuals on its advisory
committees regardless of their gender identification, religious
affiliation, racial and ethnic identification, or disability status and
therefore encourages nominations of appropriately qualified candidates
from all 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: April 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09071 Filed 4-27-22; 8:45 am]
BILLING CODE 4164-01-P
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