[Federal Register Volume 89, Number 132 (Wednesday, July 10, 2024)]
[Rules and Regulations]
[Pages 56662-56663]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-15136]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 14

[Docket No. FDA-2024-N-3008]


Advisory Committee; Allergenic Products Advisory Committee; 
Termination; Removal From List of Standing Committees

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (HHS).

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the termination of the Allergenic Products Advisory Committee, Center 
for Biologics Evaluation and Research. This document announces the 
reasons for termination and removes the Allergenic Products Advisory 
Committee from the Agency's list of standing advisory committees.

DATES: This rule is effective July 10, 2024.

FOR FURTHER INFORMATION CONTACT: Prabhakara Atreya, Division of 
Scientific Advisors and Consultants, Center for Biologics Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 71, Silver Spring, MD 20993-0002, 240-506-4946, 
[email protected].

SUPPLEMENTARY INFORMATION: The Allergenic Products Advisory Committee 
(the Committee) was established on July 9, 1984 (49 FR 30688). The 
Committee advises the Commissioner of Food and Drugs (Commissioner) or 
designee in discharging responsibilities as they relate to helping to 
ensure safe and effective drugs for human use and as required, any 
other product for which FDA has regulatory responsibility.
    The Committee reviews and evaluates data concerning the safety, 
effectiveness, and adequacy of labeling of marketed and investigational 
allergenic biological products or materials that are administered to 
humans for the diagnosis, prevention, or treatment of allergies and 
allergic disease, and makes appropriate recommendations to the 
Commissioner of its findings regarding the affirmation or revocation of 
biological product licenses, on the safety, effectiveness, and labeling 
of the products, on clinical and laboratory studies of such products, 
on amendments or revisions to regulations governing the manufacture, 
testing, and licensing of allergenic biological products, and on the 
quality and relevance of FDA's research programs that provide the 
scientific support for regulating these agents.
    Over the past several years, the Committee has met infrequently. As 
such, the effort and expense of maintaining the Committee can no longer 
be justified. The Committee will be terminated on July 9, 2024. The 
responsibilities of this Committee will be integrated into the Vaccines 
and Related Biological Products Advisory Committee (VRBPAC) charter 
ensuring that FDA has a mechanism to seek independent expert input on 
allergenic biological products. Specifically, the VRBPAC charter will 
be revised such that VRBPAC will be available to provide advice and 
recommendations to the Commissioner on allergenic biological products 
or materials for humans for the diagnosis, prevention, or treatment of 
allergies and allergic disease, as appropriate.
    Under 5 U.S.C. 553(b)(3)(B) and (d) and 21 CFR 10.40(d) and (e), 
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 because the Committee is not being adequately used, and 
termination of the committee is effective on July 9, 2024, in 
accordance with 21 CFR 14.55. This final rule merely removes the name 
of the Allergenic Products Advisory Committee from the list of standing 
advisory committees in Sec.  14.100 (21 CFR 14.100).
    Therefore, the Agency is amending Sec.  14.100(b) as set forth in 
the regulatory text of the 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.

[[Page 56663]]

Sec.  14.100  [Amended]

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2. Amend Sec.  14.100 by removing paragraph (b)(1) and redesignating 
paragraphs (b)(2) through (4) as paragraphs (b)(1) through (3).

    Dated: July 5, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-15136 Filed 7-9-24; 8:45 am]
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