[Federal Register Volume 78, Number 205 (Wednesday, October 23, 2013)]
[Notices]
[Pages 63220-63221]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-24787]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1181]


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 guidance for industry entitled ``Acute Bacterial Skin 
and Skin Structure Infections: Developing Drugs for Treatment.'' The 
purpose of this guidance is to assist sponsors in the development of 
new antibacterial drugs to treat acute bacterial skin and skin 
structure infections (ABSSSI). This guidance finalizes the revised 
draft guidance of the same name issued on August 27, 2010.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of this 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 
guidance document.
    Submit electronic comments on the 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 guidance for industry 
entitled ``Acute Bacterial Skin and Skin Structure Infections: 
Developing Drugs for Treatment.'' The purpose of this guidance is to 
assist sponsors in the development of new antibacterial drugs for the 
treatment of ABSSSI.
    This guidance describes approaches for entry criteria and trial 
designs for the evaluation of new drugs for the treatment of ABSSSI. 
The guidance focuses on the noninferiority trial design and describes 
an endpoint for which there is a well-defined treatment effect. The 
guidance also provides the justification for the noninferiority margin. 
After careful consideration of comments received in response to the 
draft guidance issued on August 27, 2010, important clarifications 
about trial populations, designs, and endpoints for ABSSSI were 
included in this guidance. In addition, this guidance reflects recent 
developments in scientific information that pertain to drugs being 
developed for the treatment of ABSSSI.
    Issuance of this guidance fulfills a portion of the requirements of 
Title VIII, section 804, of the Food and Drug Administration Safety and 
Innovation Act (Pub. L. 112-144), which requires FDA to ``. . . review 
and, as appropriate, revise not fewer than 3 guidance documents per 
year . . . for the conduct of clinical trials with respect to 
antibacterial and antifungal drugs . . . .''
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). This guidance represents 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 refers to previously approved collections of 
information 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 collections of information in 21 CFR parts 312 and 314 have 
been approved under OMB control numbers 0910-0014 and 0910-0001, 
respectively.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of 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, and

[[Page 63221]]

will be posted to the docket at http://www.regulations.gov.

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.

    Dated: October 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-24787 Filed 10-22-13; 8:45 am]
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