[Federal Register Volume 75, Number 228 (Monday, November 29, 2010)]
[Notices]
[Pages 73109-73110]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-29796]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0150; Formerly Docket No. 2007D-0367]


Guidance for Industry on Antibacterial Drug Products: Use of 
Noninferiority Trials 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 guidance for industry entitled ``Antibacterial Drug 
Products: Use of Noninferiority Trials to Support Approval.'' The 
purpose of this guidance is to provide information on FDA's current 
thinking regarding appropriate use of noninferiority (NI) clinical 
trial designs to evaluate antibacterial drug products. The Agency's 
thinking in this area has evolved in recent years in response to a 
number of public discussions on the use of active-controlled trials 
designed to show NI as the basis for approval of antibacterial drug 
products. This guidance finalizes the draft guidance published in the 
Federal Register of October 15, 2007.

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 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 ``Antibacterial Drug Products: Use of Noninferiority Trials to 
Support Approval.'' The purpose of this guidance is to inform industry, 
sponsors, applicants, researchers, and the public on the appropriate 
uses of NI clinical trial designs to evaluate antibacterial drug 
products and to amend ongoing or completed trials accordingly. In the 
Federal Register of October 15, 2007 (72 FR 58312), FDA announced a 
notice of availability of the draft guidance for industry entitled 
``Antibacterial Drug Products: Use of Noninferiority Studies to Support 
Approval'' in response to numerous public discussions that focused 
primarily on the following indications: Acute bacterial sinusitis, 
acute bacterial exacerbation of chronic bronchitis, and acute bacterial 
otitis media. Since FDA issued the draft guidance, there have been 
public discussions on consistent and reliable estimates of the efficacy 
of active treatment to placebo for other infectious disease indications 
for the NI trial design. The public comments received on the draft 
guidance have been considered and the guidance has been revised as 
appropriate. The guidance emphasizes that adequate scientific evidence 
should be provided to support the proposed NI margin for any indication 
being studied in any proposed, ongoing, or completed active-controlled 
trial designed to show NI.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115).

[[Page 73110]]

The guidance represents the Agency's current thinking on this topic. 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) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed 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.

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: November 22, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-29796 Filed 11-26-10; 8:45 am]
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