2024-11811. Advisory Committee; Science Advisory Board to the National Center for Toxicological Research; Termination; Removal From List of Standing Committees

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is announcing the termination of the Science Advisory Board to the National Center for Toxicological Research (NCTR). This document announces the reasons for termination and removes the Science Advisory Board to the NCTR from the Agency's list of standing advisory committees.

DATES:

This rule is effective May 30, 2024.

FOR FURTHER INFORMATION CONTACT:

Ashley Groves, Designated Federal Officer, National Center for Toxicological Research, Food and Drug Administration, 3900 NCTR Rd., 50-719, Jefferson, AR 72079, 870-543-7956, [e-mail].

SUPPLEMENTARY INFORMATION:

The Science Advisory Board to the National Center for Toxicological Research (the Committee) was established on June 2, 1973 (38 FR 18478). The Committee advises the Commissioner of Food and Drugs 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 is no longer needed and will be terminated on June 2, 2024. Over the past several years, the Committee has met very infrequently, and the effort and expense of maintaining the Committee are no longer justified. The Science Board to FDA (Science Board) provides advice to the Commissioner and other appropriate officials on specific complex scientific and technical issues important to FDA and its mission, including emerging issues within the scientific community. Additionally, the Committee provides advice that supports the Agency in keeping pace with technical and scientific developments, including in regulatory science; and input into the Agency's research agenda; and on upgrading its scientific and research facilities and training opportunities. It also provides, where requested, expert review of Agency-sponsored intramural and extramural scientific research programs. In the future, any issues on which NCTR requires expert advice will be addressed by utilizing the Science Board with additional augmentation of expertise by appropriate subject matter experts serving as temporary members on that committee.

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 June 2, 2024, in accordance with 21 CFR 14.55. This final rule merely removes the name of the Science Advisory Board to the National Center for Toxicological Research from the list of standing advisory committees in § 14.100 (21 CFR 14.100).

Therefore, the Agency is amending § 14.100(e) as set forth in the regulatory text of the document.

List of Subjects in 21 CFR Part 14

• Administrative practice and procedure
• Advisory committee
• 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.

§ 14.100

[Amended]

2. Amend § 14.100 by removing paragraph (e).

Dated: May 23, 2024.

Lauren K. Roth,

Associate Commissioner for Policy.