[Federal Register Volume 88, Number 238 (Wednesday, December 13, 2023)]
[Notices]
[Pages 86337-86338]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27301]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Request for Nominations for Voting Members 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 
nominations for voting members excluding consumer and industry 
representatives, to serve on the Genetic Metabolic Diseases Advisory 
Committee (the Committee) in the Center for Drug Evaluation and 
Research. Nominations will be accepted for current vacancies effective 
with this notice. 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.

DATES: Nominations received on or before February 12, 2024 will be 
given first consideration for membership on the Committee. Nominations 
received after February 12, 2024 will be considered for nomination to 
the committee as later vacancies occur.

ADDRESSES: All nominations for membership should be sent electronically 
by logging into the FDA Advisory Committee Membership Nomination 
Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm and selecting Academician/Practitioner from the dropdown menu 
(regardless of whether Academician/Practitioner accurately describes 
the nominee), 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: 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: 
[email protected].

SUPPLEMENTARY INFORMATION: FDA is requesting nomination for voting 
members to fill current vacancies on the Genetic Metabolic Diseases 
Advisory Committee. This notice does not include consumer and industry 
representative nominations. The Agency will publish two separate 
notices announcing the vacancy of a representative of consumer 
interests and the vacancy of a representative of industry interests.

I. General Description of the Committee 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. Criteria for Voting Members

    The Committee consists of a core of nine voting members, including 
the Chair. Members and the Chair are selected by the Commissioner or 
designee from among authorities knowledgeable in the fields of medical 
genetics, manifestations of inborn errors of metabolism, small 
population trial design, translational science, pediatrics, 
epidemiology, or statistics and related specialties. Members will be 
invited to serve for overlapping terms of up to 4 years. Non-Federal 
members of this committee will serve either as Special Government 
Employees or non-voting representatives. Federal members will serve as 
Regular Government Employees. The core of voting members may include 
one technically qualified member, selected by the Commissioner or 
designee, who serves as an individual, but who is identified with 
consumer interests and is recommended by either a consortium of 
consumer-oriented organizations or other interested persons. In 
addition to the voting members, the Committee may include one non-
voting representative member who is identified with industry interests. 
There may also be an alternate industry representative.

III. Nomination Procedures

    Any interested person may nominate one or more qualified 
individuals for membership on the Committee with the exception of the 
following: individuals who are not U.S. citizens or nationals cannot be 
appointed as Advisory Committee Members (42 U.S.C. 217(a))

[[Page 86338]]

in FDA. Self-nominations are also accepted. Nominations must include a 
cover letter; 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 
Nomination Portal (see ADDRESSES). Nominations must 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 ask potential candidates to provide 
detailed information concerning such matters related to financial 
holdings, employment, and research grants and/or contracts to permit 
evaluation of possible sources of conflicts of interest.
    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. 2023-27301 Filed 12-12-23; 8:45 am]
BILLING CODE 4164-01-P