[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 This guidance finalizes the draft guidance published in the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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