[Federal Register Volume 88, Number 174 (Monday, September 11, 2023)]
[Notices]
[Pages 62380-62381]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-19496]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0008]


Request for Nominations From Industry Organizations Interested in 
Participating in the Selection Process for Nonvoting Industry 
Representatives and Request for Nominations for Nonvoting Industry 
Representatives on the Vaccines and Related Biological Products 
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 nonvoting industry representatives to serve on the 
Vaccines and Related Biological Products Advisory Committee (VRBPAC) 
for the Center for Biologics Evaluation and Research notify FDA in 
writing. FDA is also requesting nominations for a nonvoting industry 
representative(s) to serve on the VRBPAC. 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 October 
11, 2023 (see sections I and II of this document for further details). 
Concurrently, nomination materials for prospective candidates should be 
sent to FDA by October 11, 2023.

ADDRESSES: All statements of interest from industry organizations 
interested in participating in the selection process of nonvoting 
industry representative nominations should be sent via email to Sussan 
Paydar (see FOR FURTHER INFORMATION CONTACT). All nominations for 
nonvoting industry representatives must be submitted electronically by 
accessing the FDA Advisory Committee Membership Nomination Portal at: 
https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm. 
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: Sussan Paydar or Valerie Vashio, 
Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 1333, Silver 
Spring, MD 20993-0002, 202-657-8533, email: <a href="/cdn-cgi/l/email-protection#b1f2f3f4e3e7e3f3e1f0f2f1d7d5d09fd9d9c29fd6dec7"><span class="__cf_email__" data-cfemail="ffbcbdbaada9adbdafbebcbf999b9ed197978cd1989089">[email protected]</span></a>.

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

I. Vaccines and Related Biological Products Advisory Committee

    The Committee reviews and evaluates data concerning the safety, 
effectiveness, and appropriate use of vaccines and related biological 
products that are intended for use in the prevention, treatment, or 
diagnosis of human diseases, and as required, any other products for 
which the Food and Drug Administration has regulatory responsibility. 
The Committee also considers the quality and relevance of FDA's 
research program which provides scientific support for the regulation 
of these products and makes appropriate recommendations to the 
Commissioner of Food and Drugs (the Commissioner).

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 via email 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 notification 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

[[Page 62381]]

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. Nominations must include a current, complete 
r[eacute]sum[eacute] or curriculum vitae for each nominee, including 
current business address and telephone number, email address if 
available, and a signed copy of the Acknowledgement and Consent form 
available at the FDA Advisory Committee Membership Nomination Portal 
(see ADDRESSES) within 30 days of publication of this document (see 
DATES). 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. 1001 et seq.) and 21 CFR part 14, relating to advisory 
committees.

    Dated: September 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-19496 Filed 9-8-23; 8:45 am]
BILLING CODE 4164-01-P


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