02-17401. Advisory Committee: Change of Name and Function; Technical Amendment

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendment.

SUMMARY:

The Food and Drug Administration (FDA) is amending the standing advisory committees’ regulations to change the name and function of the Drug Abuse Advisory Committee. This action is being taken to reflect changes made to the charter for this advisory committee.

DATES:

This rule is effective July 11, 2002.

FOR FURTHER INFORMATION CONTACT:

Theresa Green, Committee Management Officer (HF-4), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1220.

SUPPLEMENTARY INFORMATION:

FDA is announcing that the name of the Drug Abuse Advisory Committee, which was established on May 31, 1978, has been changed. The agency decided that the name “Drug Safety and Risk Management Advisory Committee” would more accurately describe the subject areas for which the committee is responsible. The mandate of the committee is being expanded to include drug specific risk management and medication errors, educational campaigns and risk communication messages, and advice on potential drug name changes to reduce potential medication errors. The committee reviews and evaluates data on risk management plans, provides active surveillance methodologies, trademark studies, methodologies for risk management communication, and related issues.

The Drug Abuse Advisory Committee name was changed and its functions expanded in the charter renewal dated May 31, 2002. FDA is revising 21 CFR 14.100(c)(7) to reflect these changes.

Publication of this final rule constitutes a final action on this change under the Administrative Procedure Act. Under 5 U.S.C. 553(b)(B) and (d) and 21 CFR 10.40(d) and (e), the agency finds good cause to dispense with notice and public procedure and to proceed to an immediately effective regulation. Such notice and procedures are unnecessary and are not in the public interest, because the final rule is merely codifying the new name and expanded function of the advisory committee reflect the current committee charter.

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 21 CFR part 14 continues to read as follows:

Authority: 5 U.S.C. App. 2; 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.

2. Section 14.100 is amended by revising the heading of paragraph (c)(7) and paragraph (c)(7)(ii) to read as follows:

§ 14.100

List of standing advisory committees.

* * * * *

(c) * * *

(7) Drug Safety and Risk Management Advisory Committee.

* * * * *

(ii) Function: Reviews and evaluates data on risk management plans, provides active surveillance methodologies, trademark studies, methodologies for risk management communication, and related issues.

* * * * *

Dated: July 5, 2002.

William K. Hubbard,

Senior Associate Commissioner for Policy, Planning, and Legislation.