Document ID: FDA-2007-D-0375-0003
Agency: fda
Document Type: Notice
Title: Guidance for Industry; Availability: Acute Bacterial Sinusitis; Developing Drugs for Treatment
Posted Date: 2012-10-09T04:00Z

[Federal Register Volume 77, Number 195 (Tuesday, October 9, 2012)]
[Notices]
[Pages 61417-61418]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-24748]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0375 (Formerly 2007D-0395)]

Guidance for Industry on Acute Bacterial Sinusitis: 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 
Sinusitis: Developing Drugs for Treatment.'' This guidance addresses 
FDA's current thinking regarding the overall development program and 
clinical trial designs for drugs to support an indication for the 
treatment of acute bacterial sinusitis (ABS). This guidance finalizes 
the revised draft guidance of the same name issued on October 30, 2007.

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 Sinusitis: Developing Drugs for Treatment.'' 
The purpose of this guidance is to assist sponsors in the overall 
clinical development program of drugs to support an indication for the 
treatment of ABS. This guidance finalizes the revised draft guidance 
published on October 30, 2007, which in turn revised the draft guidance 
for industry, entitled ``Acute Bacterial Sinusitis--Developing 
Antimicrobial Drugs for Treatment,'' published in 1998. Changes from 
the revised draft guidance are incorporated in the appropriate sections 
of the guidance and are based on comments submitted to the docket for 
the draft guidance. In addition, developments in scientific and medical 
information and technology in the treatment of ABS are reflected in 
this guidance. This guidance fulfills the requirement set forth in the 
Food and Drug Administration Amendments Act of 2007 that directed FDA 
to update the ABS guidance within 5 years.\1\ This guidance also 
responds to the requirement set forth in the Food and Drug 
Administration Safety and Innovation Act that FDA review guidances for 
the conduct of clinical trials with respect to antibacterial and 
antifungal drugs, and revise such guidances as appropriate.\2\
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    \1\ See Title IX, section 911, of the Food and Drug 
Administration Amendments Act of 2007 (Pub. L. 110-85).
    \2\ See Title VIII, section 804(a)(1), of the Food and Drug 
Administration Safety and Innovation Act (Pub. L. 112-144).
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    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on developing drugs for the treatment of ABS. 
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 parts 312 and 314 have been 
approved under 0910-0014 and 0910-0001, respectively.

III. Comments

    Interested persons may submit either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. 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 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/

[[Page 61418]]

Guidances/default.htm or http://www.regulations.gov.

    Dated: October 3, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-24748 Filed 10-5-12; 8:45 am]
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