[Federal Register: October 30, 2007 (Volume 72, Number 209)]
[Notices]
[Page 61358-61359]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30oc07-42]
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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Draft Guidance for Industry on Acute Bacterial Sinusitis: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availability of a draft guidance for industry entitled ``Acute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evolved in recent years, and this draft guidance, when finalized, will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draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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on the draft guidance to the Division of Dockets Management (HFA-305),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INFORMATION section for electronic access to the draft guidance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