[Federal Register Volume 76, Number 168 (Tuesday, August 30, 2011)]
[Rules and Regulations]
[Pages 53816-53817]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-22105]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 14

[Docket No. FDA-2011-N-0002]


Advisory Committee; Change of Name and Function; Technical 
Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the 
standing advisory committees' regulations to change the name and 
function of the Anesthetic and Life Support Drugs Advisory Committee. 
This action is being taken to reflect changes made to the charter for 
this advisory committee.

DATES: Effective September 6, 2011.

FOR FURTHER INFORMATION CONTACT: Philip Bautista, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001.

SUPPLEMENTARY INFORMATION: FDA is announcing that the name of the 
Anesthetic and Life Support Drugs Advisory Committee, which was 
established on May 1, 1978, has been changed. The Agency decided that 
the name ``Anesthetic and Analgesic Drug Products 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 analgesics, e.g., abuse-deterrent opioids, novel 
analgesics, and opioid abuse.
    The Committee reviews and evaluates available data concerning the 
safety and effectiveness of marketed and investigational human drug 
products including analgesics, e.g., abuse-deterrent opioids, novel 
analgesics, and issues related to opioid abuse, and those for use in 
anesthesiology.
    The Anesthetic and Life Support Drugs Advisory Committee name was 
changed and its functions expanded in the charter renewal dated June 9, 
2011. FDA is hereby revising 21 CFR 14.100 (c)(1) 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)(3)(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 the expanded function of the 
advisory committee to 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 and Drug, and Cosmetic Act and 
under

[[Page 53817]]

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 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; Pub. L. 107-109, Pub. L. 108-155.


0
2. Section 14.100 is amended by revising the heading of paragraph 
(c)(1) and paragraph (c)(1)(ii) to read as follows:


Sec.  14.100  List of standing advisory committees.

* * * * *
    (c) * * *
    (1) Anesthetic and Analgesic Drug Products Advisory Committee.
* * * * *
    (ii) Function: Reviews and evaluates data concerning the safety and 
effectiveness of marketed and investigational human drug products 
including analgesics, e.g., abuse-deterrent opioids, novel analgesics, 
and issues related to opioid abuse, and those for use in 
anesthesiology.
* * * * *

    Dated: August 25, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-22105 Filed 8-29-11; 8:45 am]
BILLING CODE 4160-01-P