[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 [www.gpo.gov]
[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, 
[email protected].

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

0
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.


0
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]
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