[Federal Register Volume 75, Number 166 (Friday, August 27, 2010)]
[Notices]
[Pages 52755-52756]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-21328]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0433]
Draft Guidance for Industry on Acute Bacterial Skin and Skin
Structure Infections: 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availability of a draft guidance for industry entitled ``Acute
Bacterial Skin and Skin Structure Infections: Developing Drugs for
Treatment.'' The purpose of this draft guidance is to assist clinical
trial sponsors and investigators in the development of antimicrobial
drugs for the treatment of acute bacterial skin and skin structure
infections (ABSSSI), impetigo, and minor cutaneous abscesses. FDA's
thinking in this area has evolved in recent years, and this draft
guidance, when finalized, will inform sponsors of the changes in the
definitions of ABSSSI and the recommendations for clinical drug
development.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by November 26, 2010.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Joseph G. Toerner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6244, Silver Spring, MD 20993-0002, 301-
796-1300.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Acute Bacterial Skin and Skin Structure Infections:
Developing Drugs for Treatment.'' The purpose of this draft guidance is
to assist clinical trial sponsors and investigators in the development
of antimicrobial drugs for the treatment of ABSSSI, impetigo, and minor
cutaneous abscesses. This guidance revises the draft guidance regarding
uncomplicated and complicated skin and skin structure infections
published in 1998. The guidance also addresses the clinical development
of new drugs to treat drug-resistant bacterial pathogens implicated in
ABSSSI, such as methicillin-resistant Staphylococcus aureus.
The definitions of ABSSSI and the designs of ABSSSI clinical trials
were discussed at a meeting of the Anti-Infective Drugs Advisory
Committee on November 18, 2008. In addition, other advisory committee
meetings have focused on the development of specific drugs for this
indication. As a result of these public discussions, as well as review
of applications at FDA, the agency's thinking in this area has evolved
in recent years and this draft guidance informs sponsors of the changes
in our recommendations. Specifically, the guidance defines the clinical
disease entities and provides a justification for a noninferiority
margin for the design of active-controlled clinical trials that can be
used to provide evidence of efficacy for the treatment of ABSSSI. The
guidance describes a new responder efficacy endpoint for noninferiority
trials that is based on the historical studies used to justify the
noninferiority margin. Currently, there are ongoing efforts in the
scientific community to develop and evaluate new efficacy endpoints for
ABSSSI. The guidance also defines the clinical disease entities of skin
infections for which a superiority trial is recommended.
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 developing
drugs for the treatment of ABSSSI. 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 refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
The collections of information in 21 CFR part 312 have been approved
under OMB control number 0910-0014 and the collections of information
in 21 CFR part 314 have been approved under OMB control number 0910-
0001.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. 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/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.
[[Page 52756]]
Dated: August 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-21328 Filed 8-26-10; 8:45 am]
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