[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]
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