Notice2023-27303
Request for Nominations of Individuals and Industry Organizations for the Genetic Metabolic Diseases Advisory Committee
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 13, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 238 (Wednesday, December 13, 2023)</title>
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[Federal Register Volume 88, Number 238 (Wednesday, December 13, 2023)]
[Notices]
[Pages 86345-86346]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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: <a href="https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm">https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm</a> 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 <a href="https://www.fda.gov/AdvisoryCommittees/default.htm">https://www.fda.gov/AdvisoryCommittees/default.htm</a>.
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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