81 FR 11663 - Pharmaceutical Science and Clinical Pharmacology Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 44 (March 7, 2016)

Page Range		11663-11663
FR Document		2016-04940

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.

Federal Register, Volume 81 Issue 44 (Monday, March 7, 2016)

[Federal Register Volume 81, Number 44 (Monday, March 7, 2016)]
[Rules and Regulations]
[Page 11663]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-04940]


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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

Federal Register / Vol. 81, No. 44 / Monday, March 7, 2016 / Rules and Regulations 11663

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[FR Doc. 2016–04855 Filed 3–4–16; 8:45 am] committee is responsible. The List of Subjects in 21 CFR Part 14
BILLING CODE 4910–13–P committee reviews and evaluates
scientific, clinical, and technical issues Administrative practice and
related to the safety and effectiveness of procedure, Advisory committees, Color
DEPARTMENT OF HEALTH AND drug products for use in the treatment additives, Drugs, Radiation protection.
HUMAN SERVICES of a broad spectrum of human diseases; Therefore, under the Federal Food,
the quality characteristics that such Drug, and Cosmetic Act and under the
Food and Drug Administration drugs purport or are represented to have authority delegated to the Commissioner
and, as required, any other product for of Food and Drugs, 21 CFR part 14 is
21 CFR Part 14 which the Food and Drug amended as follows:
[Docket No. FDA–2016–N–0001] Administration has regulatory
responsibility; and makes appropriate PART 14—PUBLIC HEARING BEFORE
Pharmaceutical Science and Clinical recommendations to the Commissioner A PUBLIC ADVISORY COMMITTEE
Pharmacology Advisory Committee of Food and Drugs. The committee may
AGENCY: Food and Drug Administration, also review Agency sponsored ■ 1. The authority citation for 21 CFR
HHS. intramural and extramural biomedical part 14 continues to read follows:
ACTION: Final rule. research programs in support of FDA’s Authority: 5 U.S.C. App. 2; 15 U.S.C.
drug regulatory responsibilities and its 1451–1461, 21 U.S.C. 41–50, 141–149, 321–
SUMMARY: The Food and Drug critical path initiatives related to 394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42
Administration (FDA) is amending the improving the efficacy and safety of U.S.C. 201, 262, 263b, 264, Pub. L. 107–109;
standing advisory committees’ drugs and improving the efficiency of Pub. L. 108–155; Pub. L. 113–54.
regulations to change the name of the drug development.
Advisory Committee for Pharmaceutical ■ 2. Section 14.100 is amended by
Science and Clinical Pharmacology. The Pharmaceutical Science and
revising the heading of paragraph (c)(15)
This action is being taken to reflect the Clinical Pharmacology Advisory
to read as follows:
change made to the charter for this Committee name was changed in the
advisory committee. charter renewal dated January 22, 2016. § 14.100 List of standing advisory
DATES: This rule is effective March 7, In this final rule, FDA is revising 21 committees.
2016. The name change became CFR 14.100(c)(15) to reflect the change. * * * * *
applicable January 22, 2016. Publication of this final rule (c) * * *
FOR FURTHER INFORMATION CONTACT: constitutes a final action on this change
(15) Pharmaceutical Science and
Teresa Hays, Committee Management under the Administrative Procedure
Officer, Food and Drug Administration, Clinical Pharmacology Advisory
Act. Under 5 U.S.C. 553(b)(3)(B) and (d)
10903 New Hampshire Ave., Silver Committee. * * *
and 21 CFR 10.40(d) and (e), the Agency
Spring, MD 20993, 301–796–8220. finds good cause to dispense with notice * * * * *
SUPPLEMENTARY INFORMATION: FDA is and public procedures and to proceed to Dated: March 1, 2016.
announcing that the name of the an immediately effective regulation. Jill Hartzler Warner,
Advisory Committee for Pharmaceutical Such notice and procedures are
mstockstill on DSK4VPTVN1PROD with RULES

Associate Commissioner for Special Medical
Science and Clinical Pharmacology, unnecessary and are not in the public Programs.
which was established on January 22, interest because the final rule is merely [FR Doc. 2016–04940 Filed 3–4–16; 8:45 am]
1990, has been changed. The Agency codifying the new name of the advisory
decided that the name ‘‘Pharmaceutical BILLING CODE 4164–01–P
committee to reflect the current
Science and Clinical Pharmacology committee charter.
Advisory Committee’’ more accurately
describes the subject areas for which the

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Document Created: 2018-02-02 15:08:18
Document Modified: 2018-02-02 15:08:18

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
Dates		This rule is effective March 7, 2016. The name change became applicable January 22, 2016.
Contact		Teresa Hays, Committee Management Officer, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-8220.
FR Citation		81 FR 11663
CFR Associated		Administrative Practice and Procedure; Advisory Committees; Color Additives; Drugs and Radiation Protection

81 FR 11663 - Pharmaceutical Science and Clinical Pharmacology Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 44 (March 7, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration