[Federal Register Volume 72, Number 198 (Monday, October 15, 2007)]
[Notices]
[Page 58312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-20282]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0367]


Draft Guidance for Industry on Antibacterial Drug Products: Use 
of Noninferiority Studies to Support Approval; 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availability of a draft guidance for industry entitled ``Antibacterial 
Drug Products: Use of Noninferiority Studies to Support Approval.'' The 
purpose of this guidance is to inform industry of FDA's current 
thinking regarding appropriate clinical study designs to evaluate 
antibacterial drugs, and to ask sponsors to amend ongoing or completed 
studies accordingly. This guidance is in response to a number of public 
discussions in recent years regarding the use of active-controlled 
studies designed to show noninferiority as a basis for approval of 
antibacterial drug products.

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this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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 December 14, 2007.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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on the draft guidance to the Division of Dockets Management (HFA-305), 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INFORMATION section for electronic access to the draft guidance 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: Edward Cox, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 22, Rm. 6412, Silver Spring, MD 20993-0002, 301-796-1300.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Antibacterial Drug Products: Use of Noninferiority Studies 
to Support Approval.'' Most antibacterial drugs have been approved 
based on active-controlled noninferiority trials. There have been a 
number of public discussions in recent years on the use of 
noninferiority studies to support regulatory approval of antibacterial 
drug products. Some of these discussions have focused on specific 
diseases such as acute bacterial sinusitis, acute bacterial otitis 
media, and acute bacterial exacerbation of chronic bronchitis. These 
public discussions have contributed to FDA's evolving understanding of 
the science of clinical trials and, in particular, the appropriate role 
of active-controlled studies designed to show noninferiority in the 
development of antibacterial drug products.
    This draft guidance recommends that sponsors provide justification 
for the treatment effect size and the proposed noninferiority margin 
for all antibacterial development programs for which approval will rely 
on noninferiority 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 the use of 
noninferiority studies to support approval of antibacterial drug 
products. 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 (OMB) 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 OMB control numbers 0910-0014 and 0910-0001, 
respectively, and the collection of information under the guidance for 
industry Special Protocol Assessment has been approved under OMB 
control number 0910-0470.

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 9, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-20282 Filed 10-12-07; 8:45 am]
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