[Federal Register Volume 60, Number 33 (Friday, February 17, 1995)]
[Rules and Regulations]
[Pages 9296-9297]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-4196]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 14

Advisory Committees; Amendments
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 function of the 
Anti-Infective Drugs Advisory Committee and to change the name and the 
function of the Dermatologic Drugs Advisory Committee. This action is 
being taken due to an administrative transfer of functions for the 
committees in the review of human drug products for use in the 
treatment of ophthalmic disorders.

EFFECTIVE DATE: February 17, 1995.

FOR FURTHER INFORMATION CONTACT: Donna M. Combs, Committee Management 
Office (HFA-306), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-443-2765.

SUPPLEMENTARY INFORMATION:
    FDA is revising Sec. 14.100(c)(2) (21 CFR 14.100(c)(2)) to remove 
the review of human drug products for use in the treatment of 
ophthalmic disorders from the function of the Anti-Infective Drugs 
Advisory Committee. The review of human drug products for use in the 
treatment of ophthalmic disorders has been transferred to the 
Dermatologic and Ophthalmic Drugs Advisory Committee (formerly the 
Dermatologic Drugs Advisory Committee). The function of the Anti-
Infective Drugs Advisory Committee was revised in the charter renewal 
dated October 3, 1994. In this document, FDA is formally changing the 
function of the committee.
    FDA is also revising Sec. 14.100(c)(6) to change the name and the 
function of the Dermatologic Drugs Advisory Committee. The function of 
the committee has been amended to include the review of human drug 
products for use in the treatment of ophthalmic disorders. The name was 
changed to reflect the committee's revised function. In the Federal 
Register of December 6, 1994 (59 FR 62734), FDA published a notice of 
charter renewals dated October 3, 1994, for the Anti-Infective Drugs 
Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory 
Committee. In that notice, the [[Page 9297]] agency stated that the 
name of the Dermatologic Drugs Advisory Committee had been changed to 
the Dermatologic and Ophthalmic Drugs Advisory Committee. In this 
document, FDA is formally changing the name and the function of the 
committee.
    Under the Administrative Procedure Act (5 U.S.C. 553(b)(3) and (d)) 
and under 21 CFR 10.40(c)(4), (d), and (e), notice and public procedure 
and delayed effective date on this regulation are unnecessary and not 
in the public interest. The regulation relates to agency organization 
and procedure. Furthermore, the agency finds good cause to proceed to 
an immediately effective rule. It would be contrary to the public 
interest to delay notice to the public and embodiment in the 
regulations of the administrative change regarding review of 
information on ophthalmic disorders by the appropriately constituted 
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

    1. The authority citation for 21 CFR part 14 continues to read as 
follows:

    Authority: Secs. 201-903 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 321-394; 21 U.S.C. 41-50, 141-149, 467f, 679, 821, 
1034; secs. 2, 351, 354, 361 of the Public Health Service Act (42 
U.S.C. 201, 262, 263b, 264); secs. 2-12 of the Fair Packaging and 
Labeling Act (15 U.S.C. 1451-1461); 5 U.S.C. App. 2; 28 U.S.C. 2112.

    2. Section 14.100 is amended by revising paragraph (c)(2)(ii), the 
heading of paragraph (c)(6), and paragraph (c)(6)(ii) to read as 
follows:


Sec. 14.100  List of standing advisory committees.

* * * * *
    (c) * * *
    (2) * * *
    (ii) Function: 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.
* * * * *
    (6) Dermatologic and Ophthalmic Drugs Advisory Committee.
* * * * *
    (ii) Function: Reviews and evaluates available data concerning the 
safety and effectiveness of marketed and investigational human drug 
products for use in the treatment of dermatologic and ophthalmic 
disorders.
* * * * *
    Dated: February 14, 1995.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 95-4196 Filed 2-16-95; 8:45 am]
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