[Federal Register Volume 70, Number 180 (Monday, September 19, 2005)]
[Notices]
[Pages 54945-54946]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-18512]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0340]


Draft Guidance for Industry on Acne Vulgaris: Developing Drugs 
for Treatment; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Acne Vulgaris: 
Developing Drugs for Treatment.'' This document has been developed to 
provide guidance on the development of drug products for the treatment 
of acne vulgaris other than nodulocystic acne.

DATES: Submit written or electronic comments on the draft guidance by 
December 19, 2005. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857. Send one self-addressed adhesive label to 
assist that office in processing your requests. Submit written comments 
on the draft guidance to the Division of Dockets Management (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Frank Cross, Center for Drug 
Evaluation and Research (HFD-540), Food and Drug Administration, 9201 
Corporate Blvd., Rockville, MD 20850, 301-827-2020.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Acne Vulgaris: Developing Drugs for Treatment.'' This 
document has been developed to provide guidance on the development of 
drug products for the treatment of acne vulgaris other than 
nodulocystic acne. The information presented may help applicants plan 
clinical studies, design clinical protocols, implement and 
appropriately monitor the conduct of clinical trials, collect relevant 
data for analysis, and perform appropriate types of analyses of study 
data.
    The recommendations in the draft guidance are based on careful 
assessment of important issues raised in the review of clinical trials 
for acne vulgaris. These recommendations represent the agency's current 
thinking regarding design of clinical trials intended to support the 
approval of drug products for the treatment of acne vulgaris. 
Applicants are encouraged to discuss development plans with the agency 
review division before embarking on a study, to ensure that the

[[Page 54946]]

clinical trial design and analysis plan meet defined objectives.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on this topic. 
It does not create or confer any rights for or on any person and does 
not operate to bind FDA or the public. An alternative approach may be 
used if such approach satisfies the requirements of the applicable 
statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collection of information in this guidance has been approved under OMB 
control number 0910-0001 (expires May 31, 2008).

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. The draft guidance and received 
comments may be seen in the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: September 8, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-18512 Filed 9-16-05; 8:45 am]
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