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Draft Guidance for Industry on Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment; Availability

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment.” The purpose of this draft guidance is to assist clinical trial sponsors and investigators in the development of antimicrobial drugs for the treatment of acute bacterial skin and skin structure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 FDA's thinking in this area has evolved in recent years, and this draft guidance, when finalized, will inform sponsors of the changes in the definitions of ABSSSI and the recommendations for clinical drug development.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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by November 26, 2010.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Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201,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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

Submit electronic comments on the draft guidance to http://www.regulations.gov.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.

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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.

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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FDA is announcing the availability of a draft guidance for industry entitled “Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment.”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.

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Dated: August 23, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.

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[FR Doc. 2010-21328 Filed 8-26-10; 8:45 am]

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