[Federal Register: September 19, 2005 (Volume 70, Number 180)]
[Notices]
[Page 54945-54946]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19se05-87]
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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Draft Guidance for Industry on Acne Vulgaris: Developing Drugs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availability of a draft guidance for industry entitled ``Acne Vulgaris: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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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on the draft guidance to the Division of Dockets Management (HFA-305),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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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access to the draft guidance document.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FDA is announcing the availability of a draft guidance for industry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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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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