2011-22105. 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 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; Pub. L. 107-109, Pub. L. 108-155.

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

§ 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.