[Federal Register Volume 72, Number 209 (Tuesday, October 30, 2007)]
[Notices]
[Pages 61358-61359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-21332]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0395]


Draft Guidance for Industry on Acute Bacterial Sinusitis: 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availability of a draft guidance for industry entitled ``Acute 
Bacterial Sinusitis: Developing Drugs for Treatment.'' The purpose of 
this guidance is to assist clinical trial sponsors and investigators in 
the development of antimicrobial drug products for the treatment of 
acute bacterial sinusitis (ABS). The agency's thinking in this area has 
evolved in recent years, and this draft guidance, when finalized, will 
inform sponsors of our current thinking in this area. 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draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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 January 28, 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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on the draft guidance to the Division of Dockets Management (HFA-305), 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 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INFORMATION section for electronic access to the draft guidance 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: Steve Gitterman, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 6134, Silver Spring, MD 20993-0002, 301-
796-1600.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Acute Bacterial Sinusitis: Developing Drugs for Treatment.'' 
The purpose of this guidance is to assist clinical trial sponsors and 
investigators in the development of antimicrobial drug products for the 
treatment of ABS. This guidance revises the draft guidance regarding 
ABS published in 1998. Section 911 of the FDAAA (Public Law 110-85) 
adds section 511 to the Federal Food, Drug, and Cosmetic Act that 
directs the Secretary for Health and Human Services to ``issue guidance 
for the conduct of clinical trials with respect to antibiotic drugs, 
including antimicrobials to treat acute bacterial sinusitis.'' This 
guidance will fulfill this statutory requirement.
    The design of clinical trials for ABS was the subject of an Anti-
Infective Drug Products Advisory Committee meeting on October 28, 2003. 
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 guidance recommends that ABS 
clinical trials be designed as superiority rather than noninferiority 
trials, and discusses some possible study designs that might be 
employed in an ABS trial designed to show superiority. This guidance 
also recommends that microbiological information be obtained in at 
least one of the controlled studies. This 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. As required by FDAAA, this guidance also addresses 
the use of animal models and surrogate markers in the development of 
drugs for the treatment of ABS.
    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 sinusitis. 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

[[Page 61359]]

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 part 312 have been 
approved under OMB control number 0910-0014; the collections of 
information in 21 CFR part 314 have been approved under OMB control 
number 0910-0001; and the collections of information referred to in the 
guidance entitled ``Establishment and Operation of Clinical Trial Data 
Monitoring Committees'' have been approved under OMB control number 
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.

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: October 24, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-21332 Filed 10-29-07; 8:45 am]
BILLING CODE 4160-01-S