[Federal Register: July 11, 2002 (Volume 67, Number 133)]
[Rules and Regulations]               
[Page 45900]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11jy02-5]                         


[[Page 45900]]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 14

 
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:


Sec. 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.
[FR Doc. 02-17401 Filed 7-10-02; 8:45 am]
BILLING CODE 4160-01-S