[Federal Register Volume 73, Number 3 (Friday, January 4, 2008)]
[Notices]
[Pages 868-869]
From the Federal Register Online via the Government Publishing 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Draft Guidance for Industry on Antibacterial Drug Products: Use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February 8, 2008, the comment period for the draft guidance for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 The draft guidance informed industry of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persons additional time to review the draft guidance and submit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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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Submit written comments on the draft guidance to the Division of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 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electronic access to the draft guidance document.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
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published a notice announcing the availability of a draft guidance for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 http://www.fda.gov/cder/guidance/index.htmor http://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]
BILLING CODE 4160-01-S