Office of the Under Secretary for Management; Notice of Availability of Alternative Fuel Vehicle Report for Fiscal Year 2004, 37103 [05-12748]
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Federal Register / Vol. 70, No. 123 / Tuesday, June 28, 2005 / Notices
‘‘Gingivitis: Development and
Evaluation of Drugs for Treatment or
Prevention.’’ This guidance is intended
to assist sponsors in developing clinical
trials for drug products that treat or
prevent gingivitis.
Gingivitis, an inflammation of the soft
tissues that surround the teeth, is a part
of the wider classification of periodontal
diseases, which include gingivitis at the
milder end and periodontitis at the
more severe end. In 1986, FDA
approved Peridex (0.12% chlorhexidine
gluconate rinse), the first prescription
product for gingivitis. In 1997, Colgate’s
Total toothpaste (0.30% triclosan,
0.24% sodium fluoride) was approved
through the new drug application (NDA)
process as an over-the-counter (OTC)
dentifrice that also has a gingivitis
indication. During the past several
decades, many products have also
entered the marketplace as OTC
products that were purported to treat or
prevent gingivitis. As a result of the
proliferation and promotion of those
products, the agency convened a
subcommittee of the Dental Products
Panel (the Subcommittee) in 1993 to
evaluate OTC products that make
gingivitis and related claims and that
were in the marketplace without an
NDA. The Subcommittee’s charge was
to review the submitted data and to
report its findings on the safety and
effectiveness of OTC ingredients for the
reduction or prevention of gingivitis. On
May 29, 2003, a final subcommittee
report was published in the Federal
Register (68 FR 32232) as an advance
notice of proposed rulemaking, the first
step in establishing an OTC monograph
for these drug products.
Unlike the NDA process that consists
of a review of the entire drug product,
the monograph process reviews only
active ingredients in the class of drug
products for safety and efficacy. Until
the monograph is finalized, only
gingivitis products containing active
ingredients that were marketed in the
United States before 1975 can continue
to be marketed. Any manufacturer
attempting to enter the marketplace
with a gingivitis product containing an
active ingredient that has no prior
marketing history in the United States
should either petition the developing
monograph to consider its inclusion or
submit a new NDA for approval before
marketing. Sponsors of OTC
antigingivitis drugs with active
ingredients that the Subcommittee
classified as needing further information
to make a decision are encouraged to
submit further data for review. As a
result of these actions, FDA is
publishing this guidance document on
the development of antigingivitis drugs.
VerDate jul<14>2003
16:46 Jun 27, 2005
Jkt 205001
The guidance is intended to aid drug
sponsors in developing clinical trials
either for submitting additional
information to the antigingivitis
rulemaking, or for gaining approval for
a new antigingivitis drug through the
NDA process.
This 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, OTC 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).
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on the development and evaluation of
drugs for treatment or prevention of
gingivitis. 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.
37103
DEPARTMENT OF HOMELAND
SECURITY
Office of the Under Secretary for
Management; Notice of Availability of
Alternative Fuel Vehicle Report for
Fiscal Year 2004
Office of the Under Secretary
for Management, Department of
Homeland Security.
ACTION: Notice.
AGENCY:
SUMMARY: The Department of Homeland
Security, Office of the Under Secretary
for Management, is issuing this notice in
order to comply with the Energy Policy
Act of 1992 and 42 U.S.C. 13218(b). The
purpose of this notice is to announce
the public availability of the Department
of Homeland Security’s Alternative Fuel
Vehicle (AFV) Report for Fiscal Year
2004 at the following Web site: https://
www.dhs.gov/dhspublic/interapp/
editorial/editorial_0620.xml.
FOR FURTHER INFORMATION CONTACT:
Questions regarding AFV reports on the
Department of Homeland Security Web
site should be addressed to the
Department of Homeland Security, Fleet
and Transportation Program Manager
(Attn: Steven Sosson), Washington, DC
20528, telephone 202–692–4226.
Janet Hale,
Under Secretary for Management,
Department of Homeland Security.
[FR Doc. 05–12748 Filed 6–27–05; 8:45 am]
BILLING CODE 4110–10–P
II. 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 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. The draft
guidance and received comments may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either http:/
/www.fda.gov/cder/guidance/index.htm
or https://www.fda.gov/ohrms/dockets/
default.htm.
Dated: June 22, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–12764 Filed 6–27–05; 8:45 am]
BILLING CODE 4160–01–S
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DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[CGD17–05–009]
Application for Recertification of Cook
Inlet Regional Citizens’ Advisory
Council
Coast Guard, DHS.
Notice of availability; request
for comments.
AGENCY:
ACTION:
SUMMARY: The Coast Guard announces
the availability of and seeks comments
on the application for recertification
submitted by the Cook Inlet Regional
Citizen’s Advisory Council (CIRCAC) for
September 1, 2005, through August 31,
2006. Under the Oil Terminal and
Tanker Environmental Oversight Act of
1990, the Coast Guard may certify on an
annual basis, an alternative voluntary
advisory group in lieu of a Regional
Citizens’ Advisory Council for Cook
Inlet, Alaska. The current certification
for CIRCAC will expire August 31, 2005.
E:\FR\FM\28JNN1.SGM
28JNN1
]]>Agencies
[Federal Register Volume 70, Number 123 (Tuesday, June 28, 2005)]
[Notices]
[Page 37103]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-12748]
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DEPARTMENT OF HOMELAND SECURITY
Office of the Under Secretary for Management; Notice of
Availability of Alternative Fuel Vehicle Report for Fiscal Year 2004
AGENCY: Office of the Under Secretary for Management, Department of
Homeland Security.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Department of Homeland Security, Office of the Under
Secretary for Management, is issuing this notice in order to comply
with the Energy Policy Act of 1992 and 42 U.S.C. 13218(b). The purpose
of this notice is to announce the public availability of the Department
of Homeland Security's Alternative Fuel Vehicle (AFV) Report for Fiscal
Year 2004 at the following Web site: https://www.dhs.gov/dhspublic/
interapp/editorial/editorial_0620.xml.
FOR FURTHER INFORMATION CONTACT: Questions regarding AFV reports on the
Department of Homeland Security Web site should be addressed to the
Department of Homeland Security, Fleet and Transportation Program
Manager (Attn: Steven Sosson), Washington, DC 20528, telephone 202-692-
4226.
Janet Hale,
Under Secretary for Management, Department of Homeland Security.
[FR Doc. 05-12748 Filed 6-27-05; 8:45 am]
BILLING CODE 4110-10-P
