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.

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, Prabhakara.Atreya@fda.hhs.gov.

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 § 14.100 (21 CFR 14.100).

Therefore, the Agency is amending § 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

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.

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