[Federal Register Volume 88, Number 238 (Wednesday, December 13, 2023)]
[Notices]
[Pages 86342-86343]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 [email protected] 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: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm 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 
https://www.fda.gov/AdvisoryCommittees/default.htm.

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, 
[email protected].
    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 protected].

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