Draft Guidance for Industry on Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval; Availability; Reopening of Comment Period, 868-869 [E7-25601]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 73, Number 3 (Friday, January 4, 2008)]
[Notices]
[Pages 868-869]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-25601]


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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Draft Guidance for Industry on Antibacterial Drug Products: Use 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; Reopening 
of Comment Period

AGENCY: Food and Drug Administration, HHS.

[[Page 869]]


ACTION: Notice; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening until 
February 8, 2008, the comment period for the draft guidance for 
industry entitled ``Antibacterial Drug Products: Use of Noninferiority 
Studies to Support Approval,'' published in the Federal Register of 
October 15, 2007 (72 FR 58312). The draft guidance informed industry of 
FDA's current thinking regarding appropriate clinical study designs to 
evaluate antibacterial drugs, and asked sponsors to amend ongoing or 
completed studies accordingly. FDA is taking this action in response to 
a request for an extension of the comment period to allow interested 
persons additional time to review the draft guidance and submit 
comments.

DATES: Submit written or electronic comments by February 8, 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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    Submit written comments on the draft guidance to the Division of 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 either https://www.fda.gov/dockets/ecomments or https://
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electronic access to the draft guidance document.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

    In the Federal Register of October 15, 2007 (72 FR 58312), FDA 
published a notice announcing the availability of a draft guidance for 
industry entitled ``Antibacterial Drug Products: Use of Noninferiority 
Studies to Support Approval.'' The purpose of the 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. The 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. 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.
    The 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. The initial comment period for this guidance 
closed on December 14, 2007.

II. Reopening of Comment Period

    On November 13, 2007, the Pharmaceutical Research and Manufacturers 
of America requested an extension beyond the December 14, 2007, 
deadline for the submission of comments. FDA recognizes the effect this 
guidance may have on the development of new antimicrobial products and 
that additional time may be needed for comment. Therefore, FDA has 
decided to reopen the comment period on the draft guidance until 
February 8, 2008, to allow the public more time to review and comment 
on its contents.

III. How to Submit 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 to 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.
    Please note that in January 2008, the FDA Web site is expected to 
transition to the Federal Dockets Management System (FDMS). FDMS is a 
Government-wide, electronic docket management system. After the 
transition date, electronic submissions will be accepted by FDA through 
the FDMS only. When the exact date of the transition to FDMS is known, 
FDA will publish a Federal Register notice announcing that date.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either https://www.fda.gov/cder/guidance/index.htmor https://www.fda.gov/
ohrms/dockets/default.htm.

    Dated: December 27, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-25601 Filed 1-3-08; 8:45 am]
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