[Federal Register Volume 87, Number 82 (Thursday, April 28, 2022)]
[Notices]
[Pages 25276-25277]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: 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 of an FDA 
advisory committee can also be obtained by visiting FDA's website at 
https://www.fda.gov/AdvisoryCommittees/default.htm.

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: [email protected].

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