Request for Nominations of Individuals and Consumer Organizations for the Genetic Metabolic Diseases Advisory Committee

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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 nominations for a voting consumer representative to serve on the Genetic Metabolic Diseases Advisory Committee. FDA is also requesting that any consumer organizations interested in participating in the selection of a voting consumer representative to serve on the Genetic Metabolic Diseases Advisory Committee notify FDA in writing. Nominees recommended to serve as a voting consumer representative may either be self-nominated or may be nominated by a consumer organization. Nominations will be accepted for the current vacancy 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.

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 86342-86343]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-27302]

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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 Consumer 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
nominations for a voting consumer representative to serve on the
Genetic Metabolic Diseases Advisory Committee. FDA is also requesting
that any consumer organizations interested in participating in the
selection of a voting consumer representative to serve on the Genetic
Metabolic Diseases Advisory Committee notify FDA in writing. Nominees
recommended to serve as a voting consumer representative may either be
self-nominated or may be nominated by a consumer organization.
Nominations will be accepted for the current vacancy 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: Any consumer organization interested in participating in the
selection of an appropriate voting member to represent consumer
interests on the Genetic Metabolic Diseases Advisory Committee may send
a letter or email stating that interest to FDA (see ADDRESSES) by
February 12, 2024 for vacancy listed in this notice. Concurrently,
nomination materials for prospective candidates should be sent to FDA
(see ADDRESSES) by February 12, 2024. Nominations will be accepted for
current vacancy.

ADDRESSES: All statements of interest from consumer organizations
interested in participating in the selection process should be
submitted electronically to <a href="/cdn-cgi/l/email-protection#2465676b6977775146494d57574d4b4a57644240450a4c4c570a434b52"><span class="__cf_email__" data-cfemail="80c1c3cfcdd3d3f5e2ede9f3f3e9efeef3c0e6e4e1aee8e8f3aee7eff6">[email&#160;protected]</span></a> or by mail to
Advisory Committee and Management Staff, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver Spring, MD 20993-
0002.
Consumer representative nominations should be submitted
electronically by logging into the FDA Advisory Committee Membership
Nomination

[[Page 86343]]

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, 10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver Spring, MD
20993-0002. Additional information about becoming a member of 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:
For questions relating to participation in the selection process:
Kimberly Hamilton, Advisory Committee Oversight and Management Staff,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm.
5122, Silver Spring, MD 20993-0002, 301-796-8220,
<a href="/cdn-cgi/l/email-protection#751e1c18171007190c5b1d14181c19011a1b351311145b1d1d065b121a03"><span class="__cf_email__" data-cfemail="d8b3b1b5babdaab4a1f6b0b9b5b1b4acb7b698bebcb9f6b0b0abf6bfb7ae">[email&#160;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, <a href="/cdn-cgi/l/email-protection#1d5a5850595c5e5d7b797c3375756e337a726b"><span class="__cf_email__" data-cfemail="f9bebcb4bdb8bab99f9d98d791918ad79e968f">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION: FDA is requesting nominations for a voting
consumer representative on the Genetic Metabolic Diseases Advisory
Committee. Elsewhere in this Federal Register, FDA is publishing
separate documents regarding:

1. Genetic Metabolic Diseases Advisory Committee; Notice of
Establishment
2. Request for Nominations for Voting Members on a Public Advisory
Committee: Genetic Metabolic Diseases Advisory Committee
3. Request for Nominations of Individuals and Industry Organizations
for the Genetic Metabolic Diseases Advisory Committee

I. Function and General Description of the Committee Duties

Genetic Metabolic Diseases Advisory Committee

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 Members

Persons nominated for membership as a consumer representative on
this committee should meet the following criteria: (1) demonstrate an
affiliation with and/or active participation in consumer or community-
based organizations, (2) be able to analyze technical data, (3)
understand research design, (4) discuss benefits and risks, and (5)
evaluate the safety and efficacy of products under review. The consumer
representative should be able to represent the consumer perspective on
issues and actions before the advisory committee; serve as a liaison
between the committee and interested consumers, associations,
coalitions, and consumer organizations; and facilitate dialogue with
the advisory committees on scientific issues that affect consumers.

III. Selection Procedures

Selection of members representing consumer interests is conducted
through procedures that include the use of organizations representing
the public interest and public advocacy groups. These organizations
recommend nominees for the Agency's selection. Representatives from the
consumer health branches of Federal, State, and local governments also
may participate in the selection process. Any consumer organization
interested in participating in the selection of an appropriate voting
member to represent consumer interests should send a letter stating
that interest to FDA (see ADDRESSES) within 30 days of publication of
this document.
Within the subsequent 60 days, FDA will compile a list of consumer
organizations that will participate in the selection process and will
forward to each such organization a ballot listing at least two
qualified nominees selected by the Agency based on the nominations
received, together with each nominee's current curriculum vitae or
r[eacute]sum[eacute]. Ballots are to be filled out and returned to FDA
within 30 days. The nominee receiving the highest number of votes
ordinarily will be selected to serve as the member representing
consumer interests for that particular advisory committee.

IV. Nomination Procedures

Any interested person or organization may nominate one or more
qualified persons to represent consumer interests on the Genetic
Metabolic Diseases Advisory 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)) in FDA.
Self-nominations are also accepted. Nominations must include 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; a signed copy of the Acknowledgment and
Consent form available at the FDA Advisory Nomination Portal (see
ADDRESSES); and a list of consumer or community-based organizations for
which the candidate can demonstrate active participation.
Nominations should also specify the advisory committee for which
the nominee is recommended. In addition, 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. Members will be invited
to serve for terms up to 4 years.
FDA will review all nominations received within the specified
timeframes and prepare a ballot containing the names of qualified
nominees. Names not selected will remain on a list of eligible nominees
and be reviewed periodically by FDA to determine continued interest.
After selecting qualified nominees for the ballot, FDA will provide
those consumer organizations that are participating in the selection
process with the opportunity to vote on the listed nominees. Only
organizations vote in the selection process. Persons who nominate
themselves to serve as voting consumer representatives will not
participate in the selection process.
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. 2023-27302 Filed 12-12-23; 8:45 am]
BILLING CODE 4164-01-P

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