[Federal Register Volume 80, Number 65 (Monday, April 6, 2015)]
[Rules and Regulations]
[Page 18307]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-07789]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 14
[Docket No. FDA-2009-N-0443]
Advisory Committee; Anti-Infective Drugs Advisory Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending the
standing advisory committees' regulations to change the name of the
Anti-Infective Drugs Advisory Committee. This action is being taken to
change the name of this committee on the Agency's list of standing
advisory committees.
DATES: This rule is effective April 6, 2015. The name change became
applicable March 4, 2015.
FOR FURTHER INFORMATION CONTACT: Michael Ortwerth, Advisory Committee
Oversight and Management Staff, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002, FAX:
301-847-8640, or [email protected].
SUPPLEMENTARY INFORMATION: The Anti-Infective Drugs Advisory Committee
(the Committee) was established on October 7, 1980 (45 FR 79025). The
Committee reviews and evaluates available data concerning the safety
and effectiveness of marketed and investigational human drug products
for use in the treatment of infectious diseases and disorders.
The Committee name has been changed to the following: Antimicrobial
Drugs Advisory Committee. The Agency changed the name to better reflect
the products and issues that will be brought to the committee. The
change became effective March 4, 2015.
Therefore, the Agency is amending 21 CFR 14.100(c) as set forth in
the regulatory text of this document.
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 comment
procedures and to proceed to an immediate effective date on this rule.
Notice and public comment and a delayed effective date are unnecessary
and are not in the public interest as this final rule merely removes
the name of the Anti-Infective Drugs Advisory Committee from the list
of standing advisory committees in 21 CFR 14.100 and replaces it with
the Antimicrobial Drugs Advisory Committee.
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
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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; Pub.
L. 113-54.
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2. Amend Sec. 14.100 by revising paragraph (c)(2) introductory text to
read as follows:
Sec. 14.100 List of standing advisory committees.
* * * * *
(c) * * *
(2) Antimicrobial Drugs Advisory Committee.
* * * * *
Dated: March 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07789 Filed 4-3-15; 8:45 am]
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