[Federal Register Volume 77, Number 191 (Tuesday, October 2, 2012)]
[Notices]
[Pages 60126-60127]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-24211]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0971; Formerly Docket FDA-2008-N-0041; Formerly 
2008N-0004]


Guidance for Industry on Acute Bacterial Otitis Media: 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 
Otitis Media: 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 otitis media (ABOM). This guidance 
finalizes the revised draft guidance of the same name issued on January 
18, 2008.

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

[[Page 60127]]

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 Otitis Media: Developing Drugs for 
Treatment.'' The purpose of this guidance is to assist sponsors in the 
overall clinical development of drugs to support an indication for the 
treatment of ABOM, defined in the guidance as ``the recent or acute 
onset of inflammation of the middle ear caused by a bacterial 
pathogen.'' This guidance finalizes the revised draft guidance issued 
on January 18, 2008, which in turn revised the draft guidance for 
industry entitled ``Acute Otitis Media--Developing Antimicrobial Drugs 
for Treatment'' issued in 1998. Changes from the revised draft guidance 
are incorporated in the appropriate sections of the guidance and are 
based on comments received to the docket for the draft guidance. In 
addition, developments in scientific and medical information and 
technology in the treatment of ABOM are included in this guidance. This 
guidance fulfills the statutory requirement described in the Food and 
Drug Administration Amendments Act of 2007 that directed FDA to update 
the guidance within 5 years.\1\ This guidance also responds to the 
requirement set forth in the Food and Drug Administration Safety and 
Innovation Act of 2012 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 of 2012 (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 
ABOM. 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. The collections 
of information referred to in the guidance for clinical trial sponsors 
entitled ``Establishment and Operation of Clinical Trial Data 
Monitoring Committees'' have been approved under 0910-0581.

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

    Dated: September 26, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-24211 Filed 10-1-12; 8:45 am]
BILLING CODE 4160-01-P