[Federal Register Volume 77, Number 195 (Tuesday, October 9, 2012)]
[Notices]
[Pages 61417-61418]
From the Federal Register Online via the Government Publishing 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the revised draft guidance of the same name issued on October 30, 2007.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 This guidance finalizes the revised draft guidance
published on October 30, 2007, which in turn revised the draft guidance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]
BILLING CODE 4160-01-P