Draft Guidance for Industry on Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention; Availability, 37102-37103 [05-12764]

Download as PDF 37102 Federal Register / Vol. 70, No. 123 / Tuesday, June 28, 2005 / Notices pertaining to announcements of meetings and other committee management activities for both CDC and the Agency for Toxic Substances and Disease Registry. DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Dated: June 22, 2005. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 05–12689 Filed 6–27–05; 8:45 am] Board of Scientific Counselors Meeting, National Institute for Occupational Safety and Health (NIOSH) In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces the following committee meeting: Name: Board of Scientific Counselors (BSC), NIOSH. Time and Date: 10 a.m.–3:30 p.m., July 21, 2005. Place: National Institute for Occupational Safety and Health, Robert A. Taft Laboratories, 4676 Columbia Parkway, Cincinnati, Ohio 45226. Status: Open to the public, limited only by the space available. The meeting room accommodates approximately 50 people. Visiting members of the public must present valid identification (U.S. Federal ID, State Driver’s License, or other State-sanctioned ID) for entry to Taft Laboratories and must be escorted by facility staff at all times while inside the facility. Purpose: The Secretary, Department of Health and Human Services; the Assistant Secretary for Health; and by delegation the Director, Centers for Disease Control and Prevention, are authorized under Sections 301 and 308 of the Public Health Service Act to conduct directly or by grants or contracts, research, experiments, and demonstrations relating to occupational safety and health and to mine health. The Board of Scientific Counselors shall provide guidance to the Director, NIOSH, on research and preventions programs. Specifically, the Board shall provide guidance on the Institute’s research activities related to developing and evaluating hypotheses, systematically documenting findings and disseminating results. The Board shall evaluate the degree to which the activities of NIOSH: (1) Conform to appropriate scientific standards, (2) address current, relevant needs, and (3) produce intended results. Matters To be Discussed: Agenda items include a report from the Director of NIOSH; progress reports by BSC working groups on the National Occupational Research Agenda and the health hazard evaluation program, NIOSH emergency/terrorism preparedness, a tour of the Taft Laboratories, and closing remarks. Agenda items are subject to change as priorities dictate. Contact Person for More Information: Roger Rosa, Executive Secretary, BSC, NIOSH, CDC, 200 Independence Avenue, SW., Room 715H, Washington, DC 20201, telephone (202) 205–7856, fax (202) 260– 4464. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices VerDate jul<14>2003 16:46 Jun 27, 2005 Jkt 205001 BILLING CODE 4163–18–P Dated: June 20, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–12763 Filed 6–27–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005D–0240] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2001D–0262] (formerly Docket No. 01–0262) Draft ‘‘Guidance for Food and Drug Administration Reviewers: Premarket Notification Submissions for Automated Testing Instruments Used in Blood Establishments;’’ Withdrawal of Guidance AGENCY: Food and Drug Administration, HHS. ACTION: Notice; withdrawal. SUMMARY: The Food and Drug Administration (FDA) is announcing the withdrawal of a draft guidance that was issued on August 3, 2001. DATES: June 28, 2005. FOR FURTHER INFORMATION CONTACT: Paul E. Levine, Jr., Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–6210. SUPPLEMENTARY INFORMATION: In a notice published in the Federal Register of August 3, 2001 (66 FR 40708), FDA announced the availability of a draft document entitled ‘‘Guidance for FDA Reviewers: Premarket Notification Submissions for Automated Testing Instruments Used in Blood Establishments.’’ This draft guidance is being withdrawn because it no longer reflects the following: (1) All of the information FDA reviewers should expect to be included in a premarket notification submitted to the Center for Biologics Evaluation and Research for such devices and (2) the recommended approach FDA reviewers should take in reviewing premarket submissions for automated instruments testing used in blood establishments. In the future, FDA may issue for public comment draft special control guidances on instrumentation for blood borne pathogen donor screening and immunohematology testing. PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 Draft Guidance for Industry on Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention.’’ The draft guidance is intended to assist sponsors in developing 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. DATES: Submit written or electronic comments on the draft guidance by August 29, 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 selfaddressed 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 https:// 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. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled E:\FR\FM\28JNN1.SGM 28JNN1 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 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 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]
[Pages 37102-37103]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-12764]


-----------------------------------------------------------------------

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Gingivitis: 
Development and Evaluation of Drugs for Treatment or Prevention.'' The 
draft guidance is intended to assist sponsors in developing 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.

DATES: Submit written or electronic comments on the draft guidance by 
August 29, 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 https://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.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled

[[Page 37103]]

``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. 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.

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 https://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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