[Federal Register Volume 75, Number 166 (Friday, August 27, 2010)]
[Notices]
[Pages 52755-52756]
From the Federal Register Online via the Government Printing 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Draft Guidance for Industry on Acute Bacterial Skin and Skin 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availability of a draft guidance for industry entitled ``Acute 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 The purpose of this draft guidance is to assist clinical 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thinking in this area has evolved in recent years, and this draft 
guidance, when finalized, will inform sponsors of the changes in the 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by November 26, 2010.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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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