[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draft guidance of the same name issued on August 27, 2010.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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