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Request for Nominations for Voting Members for the Genetic Metabolic Diseases Advisory Committee

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 ...

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Department of Health and Human Services

Food and Drug Administration

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

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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: GEMDAC@fda.hhs.gov.

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)) ( printed page 86338) in FDA. Self-nominations are also accepted. Nominations must include a cover letter; a current, complete résumé 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

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Federal Register Citation

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88 FR 86337

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“Request for Nominations for Voting Members for the Genetic Metabolic Diseases Advisory Committee,” thefederalregister.org (December 13, 2023), https://thefederalregister.org/documents/2023-27301/request-for-nominations-for-voting-members-for-the-genetic-metabolic-diseases-advisory-committee.