Rule2024-04751
Advisory Committee; Genetic Metabolic Diseases Advisory Committee; Addition to List of Standing Committees
Primary source
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Published
March 6, 2024
Effective
March 6, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is amending the standing advisory committee regulations to add the establishment of the Genetic Metabolic Diseases Advisory Committee (GeMDAC or the Committee) to the list of standing committees.
Full Text
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<title>Federal Register, Volume 89 Issue 45 (Wednesday, March 6, 2024)</title>
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[Federal Register Volume 89, Number 45 (Wednesday, March 6, 2024)]
[Rules and Regulations]
[Page 15959]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-04751]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 14
[Docket No. FDA-2024-N-0826]
Advisory Committee; Genetic Metabolic Diseases Advisory
Committee; Addition to List of Standing Committees
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is amending
the standing advisory committee regulations to add the establishment of
the Genetic Metabolic Diseases Advisory Committee (GeMDAC or the
Committee) to the list of standing committees.
DATES: This rule is effective March 6, 2024.
FOR FURTHER INFORMATION CONTACT: Moon Choi, Center for Drugs Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 31, Rm. 2417, Silver Spring, MD 20993, 301-796-2894,
<a href="/cdn-cgi/l/email-protection#8dcae8c0c9cccecdebe9eca3e5e5fea3eae2fb"><span class="__cf_email__" data-cfemail="2c6b4961686d6f6c4a484d0244445f024b435a">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: The Committee was established on December
12, 2023, and notice of establishment was published in the Federal
Register on December 13, 2023 (88 FR 86344).
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
(the Commissioner).
The Committee shall consist 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 or ex 1652fficious.
The core of voting members may include one technically qualified
member, selected by the Commissioner or designee, 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.
The Committee name and function have been established with the
establishment of the Committee charter. The change became effective
December 12, 2023. Therefore, the Agency is amending Sec. 14.100 (21
CFR 14.100) to add the Committee name and function to its current list
as set forth in the regulatory text of this document.
Under 5 U.S.C. 553(b)(4)(B) and (d) and 21 CFR 10.40(d) and
(copyright), the Agency finds good cause to dispense with notice and
public comment procedures and to proceed to an immediate effective date
on this rule.
Notice and public comment and a delayed effective date are
unnecessary and are not in the public interest as this final rule is
merely codifying the addition of the name and function of the GeMDAC to
the list of standing FDA advisory committees. The establishment of the
Committee is already effective, and the name and function that will be
added to Sec. 14.100 reflect the Committee charter. The Agency is
amending Sec. 14.100(c)(18) as set forth in the regulatory text of
this document.
List of Subjects in 21 CFR Part 14
Administrative practice and procedure, Advisory committees, Color
additives, Drugs, Radiation protection.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
14 is amended as follows:
PART 14--PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE
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1. The authority citation for part 14 continues to read as follows:
Authority: 5 U.S.C. 1001 et seq.; 15 U.S.C. 1451-1461; 21
U.S.C. 41-50, 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C.
2112; 42 U.S.C. 201, 262, 263b, 264, 284m, 284m-1; Pub. L. 107-109,
115 Stat. 1419.
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2. Section 14.100 is amended by adding paragraph (c)(18) to read as
follows:
Sec. 14.100 List of standing advisory committees.
* * * * *
(c) * * *
(18) Genetic Metabolic Diseases Advisory Committee.
(i) Date Established: December 12, 2023.
(ii) Function: 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.
* * * * *
Dated: March 1, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-04751 Filed 3-5-24; 8:45 am]
BILLING CODE 4164-01-P
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