[Federal Register Volume 89, Number 15 (Tuesday, January 23, 2024)]
[Notices]
[Pages 4316-4317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01154]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-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 Cellular, Tissue, and Gene Therapies 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 
Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) 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 CTGTAC. 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 February 
22, 2024 (see sections I and II of this document for further details). 
Concurrently, nomination materials for prospective candidates should be 
sent to FDA by February 22, 2024.

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 Cicely 
Reese or Marie DeGregorio (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: Cicely Reese or Marie DeGregorio, 
Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 1232, Silver 
Spring, MD 20993-0002, 240-620-9987, email: <a href="/cdn-cgi/l/email-protection#85c6c7c0d7c6d1c2d1c4c6c5e3e1e4abededf6abe2eaf3"><span class="__cf_email__" data-cfemail="a2e1e0e7f0e1f6e5f6e3e1e2c4c6c38ccacad18cc5cdd4">[email protected]</span></a>.

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

[[Page 4317]]

I. Cellular, Tissue, and Gene Therapies Advisory Committee

    The Committee reviews and evaluates available data relating to the 
safety, effectiveness, and appropriate use of human cells, human 
tissues, gene transfer therapies, and xenotransplantation products, 
which are intended for transplantation, implantation, infusion, and 
transfer in the prevention and treatment of a broad spectrum of human 
diseases and in the reconstruction, repair, or replacement of tissues 
for various conditions. 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.

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 
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. Nomination 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: January 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-01154 Filed 1-22-24; 8:45 am]
BILLING CODE 4164-01-P


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