[Federal Register Volume 70, Number 163 (Wednesday, August 24, 2005)]
[Notices]
[Pages 49660-49661]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-16754]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0240]


Draft Guidance for Industry on Gingivitis: Development and 
Evaluation of Drugs for Treatment or Prevention; Availability; 
Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending to October 
28, 2005, the comment period for the draft guidance for industry 
entitled ``Gingivitis: Development and Evaluation of Drugs for 
Treatment or Prevention.'' The draft guidance is intended to assist 
sponsors in conducting clinical trials for drug products that treat or 
prevent gingivitis. It addresses specific protocol design elements as 
well as general concerns about drugs for this indication. FDA published 
a notice of availability of the draft guidance, with a comment period 
that closes on August 29, 2005. FDA is taking this action in response 
to a request for 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persons additional time to review the draft guidance and submit 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DATES: Submit written or electronic comments on the draft guidance by 
October 28, 2005. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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on the draft guidance to the Division of Dockets Management (HFA-305), 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. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Frederick Hyman, Center for Drug 
Evaluation and Research (HFD-540), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-2020.

[[Page 49661]]


SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 28, 2005 (70 FR 37102), FDA 
published a notice announcing the availability of a draft guidance for 
industry entitled ``Gingivitis: Development and Evaluation of Drugs for 
Treatment or Prevention.'' This guidance is intended to assist sponsors 
in conducting clinical trials for drug products that treat or prevent 
gingivitis. The guidance document provides assistance in several ways. 
It addresses specific design elements such as choosing inclusionary and 
exclusionary criteria, selecting relevant endpoints, assessing 
gingivitis, determining the clinical significance of the effect, and 
collecting meaningful safety data. It also provides comments on general 
concerns (e.g., prevention versus treatment claims, over-the-counter 
versus prescription status, special population enrollment, and 
nonclinical development issues related to products that are intended 
for administration within the oral cavity for the treatment or 
prevention of gingivitis). The initial comment period closes on August 
29, 2005.

II. Extension of Time

    On July 15, 2005, the Consumer Healthcare Products Association 
requested a 60-day extension beyond the August 29, 2005, deadline for 
the submission of comments. The request stated that additional time is 
needed to assemble a comprehensive submission that requires 
coordinating extensive input from representatives of their member 
companies. FDA considers an extension of time for submission of 
comments to be in the public interest. Accordingly, FDA is extending 
the comment period for 60 days to October 28, 2005, as requested.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the draft guidance. 
Two copies of mailed comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. The 
draft guidance and received comments are available for public 
examination 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 draft guidance 
at either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: August 17, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-16754 Filed 8-23-05; 8:45 am]
BILLING CODE 4160-01-S