[Federal Register Volume 88, Number 238 (Wednesday, December 13, 2023)]
[Notices]
[Pages 86345-86346]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27303]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Request for Nominations of Individuals and Industry Organizations 
for the Genetic Metabolic Diseases 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 industry organizations interested in participating in the 
selection of a nonvoting industry representative to serve on the 
Genetic Metabolic Diseases Advisory Committee (the Committee) in the 
Center for Drug Evaluation and Research notify FDA in writing. FDA is 
also requesting nominations for a nonvoting industry representative to 
serve on the Committee. Nominees recommended to serve as a nonvoting 
industry representative may either be self-nominated or nominated by an 
industry organization. Nominations will be accepted for the current 
vacancy effective with this notice.

DATES: Any industry organization interested in participating in the 
selection of an appropriate nonvoting member to represent industry 
interest, must send a letter stating that interest to the FDA by 
February 12, 2024, (see sections I and II of this document for 
details). Concurrently, nomination materials for prospective candidates 
should be sent to FDA by February 12, 2024.

ADDRESSES: All statements of interest from interested industry 
organizations interested in participating in the selection process of a 
nonvoting industry representative should be sent electronically to 
Nicholas Marsh (see FOR FURTHER INFORMATION CONTACT). All nominations 
for the nonvoting industry representative 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 on 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: Nicolas Marsh, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 31, Rm. 2418, Silver Spring, MD 20993-0002, 240-
402-5357, email: <a href="/cdn-cgi/l/email-protection#8fe1e6ece7e0e3eefca1e2eefdfce7cfe9ebeea1e7e7fca1e8e0f9"><span class="__cf_email__" data-cfemail="3856515b505754594b1655594a4b50785e5c591650504b165f574e">[email protected]</span></a>.
    For questions relating to the Genetic Metabolic Diseases Advisory 
Committee: Moon Choi, Center for Drug Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, 
Silver Spring, MD 20993-0002, 301-796-2894, email: <a href="/cdn-cgi/l/email-protection#a7e0e2eae3e6e4e7c1c3c689cfcfd489c0c8d1"><span class="__cf_email__" data-cfemail="b8fffdf5fcf9fbf8dedcd996d0d0cb96dfd7ce">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: FDA is requesting nominations for a 
nonvoting industry representative for the Genetic Metabolic Diseases 
Advisory Committee.
    Elsewhere in this issue of the Federal Register, FDA is publishing 
separate documents regarding:

1. Genetic Metabolic Diseases Advisory Committee; Notice of 
Establishment
2. Request for Nominations for Voting Members for the Genetic Metabolic 
Diseases Advisory Committee
3. Request for Nominations of Individuals and Consumer Organizations 
for the Genetic Metabolic Diseases Advisory Committee

[[Page 86346]]

I. General Description of the Genetic Metabolic Diseases Advisory 
Committee's Duties

    The Committee reviews and evaluates data on the safety and 
effectiveness of marketed and investigational human drug and biologic 
products for use in the treatment of genetic metabolic diseases and 
makes appropriate recommendations to the Commissioner of Food and 
Drugs.

II. Qualifications

    Persons nominated for the Committee should be full-time employees 
of firms that develop human drug and biologic products, or consulting 
firms that represent human drug and biologic product developers or have 
similar appropriate ties to industry.

III. Selection Procedure

    Any industry organization interested in participating in the 
selection of an appropriate nonvoting member to represent industry 
interest must 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 60 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 or curriculum vitae. The 
letter will also state that it is the responsibility of the interested 
organizations to confer with one another and to select a candidate, to 
represent industry interest for the committee, within 60 days after the 
receipt of the FDA letter. 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 
temporary nonvoting members to represent industry interests.

IV. Nomination Procedure

    Individuals may self-nominate and/or an organization may nominate 
one or more individuals to serve as a temporary nonvoting industry 
representative. Nominations must include a cover letter and a current, 
complete r[eacute]sum[eacute] or curriculum vitae for each nominee, 
including current business and/or home address, telephone number, and 
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). Nominations should specify the 
advisory committee for which the nominee is recommended within 60 days 
of publication of this document (see DATES). Nominations should 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. Only interested industry organizations participate in the 
selection process. Persons who nominate themselves as nonvoting 
industry representatives will not participate in the selection process.
    FDA seeks to include the views of members of all gender groups, 
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: December 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-27303 Filed 12-12-23; 8:45 am]
BILLING CODE 4164-01-P


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