Document ID: FDA-2016-N-0001-0025
Agency: fda
Document Type: Rule
Title: Pharmaceutical Science and Clinical Pharmacology Advisory Committee
Posted Date: 2016-03-07T05:00Z

[Federal Register Volume 81, Number 44 (Monday, March 7, 2016)]
[Rules and Regulations]
[Page 11663]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04940]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 14

[Docket No. FDA-2016-N-0001]

Pharmaceutical Science and Clinical Pharmacology Advisory 
Committee

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 of the 
Advisory Committee for Pharmaceutical Science and Clinical 
Pharmacology. This action is being taken to reflect the change made to 
the charter for this advisory committee.

DATES: This rule is effective March 7, 2016. The name change became 
applicable January 22, 2016.

FOR FURTHER INFORMATION CONTACT: Teresa Hays, Committee Management 
Officer, Food and Drug Administration, 10903 New Hampshire Ave., Silver 
Spring, MD 20993, 301-796-8220.

SUPPLEMENTARY INFORMATION: FDA is announcing that the name of the 
Advisory Committee for Pharmaceutical Science and Clinical 
Pharmacology, which was established on January 22, 1990, has been 
changed. The Agency decided that the name ``Pharmaceutical Science and 
Clinical Pharmacology Advisory Committee'' more accurately describes 
the subject areas for which the committee is responsible. The committee 
reviews and evaluates scientific, clinical, and technical issues 
related to the safety and effectiveness of drug products for use in the 
treatment of a broad spectrum of human diseases; the quality 
characteristics that such drugs purport or are represented to have and, 
as required, any other product for which the Food and Drug 
Administration has regulatory responsibility; and makes appropriate 
recommendations to the Commissioner of Food and Drugs. The committee 
may also review Agency sponsored intramural and extramural biomedical 
research programs in support of FDA's drug regulatory responsibilities 
and its critical path initiatives related to improving the efficacy and 
safety of drugs and improving the efficiency of drug development.
    The Pharmaceutical Science and Clinical Pharmacology Advisory 
Committee name was changed in the charter renewal dated January 22, 
2016. In this final rule, FDA is revising 21 CFR 14.100(c)(15) to 
reflect the change.
    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 procedures 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 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, Drug, and Cosmetic Act and under 
the 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 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; Pub. 
L. 113-54.

0
2. Section 14.100 is amended by revising the heading of paragraph 
(c)(15) to read as follows:

Sec.  14.100  List of standing advisory committees.

* * * * *
    (c) * * *
    (15) Pharmaceutical Science and Clinical Pharmacology Advisory 
Committee. * * *
* * * * *

    Dated: March 1, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-04940 Filed 3-4-16; 8:45 am]
 BILLING CODE 4164-01-P