[Federal Register Volume 73, Number 13 (Friday, January 18, 2008)]
[Notices]
[Pages 3470-3471]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-835]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2008N-0004]


Draft Guidance for Industry on Acute Bacterial Otitis Media: 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availability of a draft guidance for industry entitled ``Acute 
Bacterial Otitis Media: Developing Drugs for Treatment.'' The purpose 
of this draft guidance is to assist clinical trial sponsors and 
investigators in the development of antimicrobial drug products for the 
treatment of acute bacterial otitis media (ABOM). The agency's thinking 
in this area has evolved in recent years, and this draft guidance, when 
finalized, will inform sponsors of the changes in our recommendations. 
In addition, it will fulfill a statutory requirement to publish such a 
guidance enacted in the Food and Drug Administration Amendments Act of 
2007 (FDAAA).

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this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by April 17, 2008.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857. Send one self-addressed adhesive label to 
assist that office in processing your requests. Submit written comments 
on the draft guidance to the Division of Dockets Management (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. Submit electronic comments to either http://www.fda.gov/dockets/ecomments or http://www.regulations.gov. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document.

FOR FURTHER INFORMATION CONTACT: John Alexander, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 6134, Silver Spring, MD 20993-0002, 301-
796-1400.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Acute Bacterial Otitis Media: Developing Drugs for 
Treatment.'' The purpose of this draft guidance is to assist clinical 
trial sponsors and investigators in the development of antimicrobial 
drug products for the treatment of ABOM. This guidance revises the 
draft guidance regarding ABOM published in 1998. Section 911 of FDAAA 
(Public Law 110-85) adds section 511 to the Federal Food, Drug, and 
Cosmetic Act that directs the Secretary of Health and Human Services to 
``issue guidance for the conduct of clinical trials with respect to 
antibiotic drugs, including antimicrobials to treat * * * acute 
bacterial otitis media * * *.'' This draft guidance will fulfill this 
statutory requirement.
    The design of clinical trials for ABOM was the subject of an Anti-
Infective Drugs Advisory Committee meeting on July 11, 2002. In 
addition, other advisory committee meetings have focused on the 
development of specific drug products for this indication. As a result 
of these public discussions, as well as review of pending applications 
at FDA, the agency's thinking in this area has evolved in recent years, 
and this guidance informs sponsors of the changes in our 
recommendations. Specifically, this draft guidance recommends that ABOM 
clinical trials be designed as superiority rather than noninferiority 
trials, and discusses some possible study designs that might be 
employed in an ABOM trial designed to show superiority. This draft 
guidance

[[Page 3471]]

also recommends that microbiological information be obtained in at 
least one of the controlled studies. This draft guidance discusses 
patient-reported outcome instruments for assessing clinical response, 
and the use of time to resolution as a possible approach to assessing 
the primary endpoint in clinical studies.
    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 acute bacterial otitis media. 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 draft 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 0910-0014; the collections of information in 21 CFR part 314 have 
been approved under 0910-0001; and the collections of information 
referred to in the guidance Establishment and Operation of Clinical 
Trial Data Monitoring Committees have been approved under 0910-0581.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified 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.
    Please note that in January 2008, the FDA Web site is expected to 
transition to the Federal Dockets Management System (FDMS). FDMS is a 
Government-wide, electronic docket management system. After the 
transition date, electronic submissions will be accepted by FDA through 
the FDMS only. When the exact date of the transition to FDMS is known, 
FDA will publish a Federal Register notice announcing that date.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: January 11, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-835 Filed 1-17-08; 8:45 am]
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