Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Notices 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draft guidance for industry entitled 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-thecounter 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comments on the draft guidance.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 The draft guidance and 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may obtain the draft guidance at either 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

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Advisory Commission on Childhood 

Vaccines; Request for Nominations for 

Voting Members

AGENCY: Health Resources and Services 

Administration, HHS.

ACTION: Notice; amendment.

SUMMARY: The Health Resources and 

Services Administration is amending a 

notice that appeared in the Federal 

Register of July 8, 2005, FR Doc. 13422, 

pages 39517–38518, requesting 

nominations for voting members to fill 

three vacancies on the Advisory 

Commission on Childhood Vaccines. 

The deadline date for receiving 

nominations was on or before August 8, 

2005. This document amends the notice 

by extending the deadline date for 

receiving nominations.

DATES: The agency must receive 

nominations on or before September 16, 

2005.

FOR FURTHER INFORMATION CONTACT: Ms. 

Cheryl Lee at 301–443–2124 or e-mail 

clee@hrsa.gov.

Dated: August 18, 2005. 

Tina M. Cheatham, 

Director, Division of Policy Review and 

Coordination.

[FR Doc. 05–16789 Filed 8–23–05; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Advisory Council on the 

National Health Service Corps; Notice 

of Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), notice is hereby given 

of the following meeting:

Name: National Advisory Council on the 

National Health Service Corps. 

Dates and Times: September 8, 2005, 1 

p.m.–7:30 p.m.; September 9, 2005, 8:30 

a.m.–6 p.m.; and September 10, 2005, 9 a.m.–

5:30 p.m. 

Place: Hamilton Crowne Plaza, 1001 14th 

Street NW., Washington, DC 20005, 202–

682–0111. 

Status: The meeting will be open to the 

public. 

Agenda: The Council will continue its 

discussion on the National Health Service 

Corps legislation in preparation for the 

upcoming reauthorization. Program staff and 

Agency management will provide guidance 

on program operations possible implications 

of legislative changes. 

For Further Information Contact: Tira 

Robinson-Patterson, Division of National 

Health Service Corps, Bureau of Health 

Professions, Health Resources and Services 

Administration, Parklawn Building, Room 

8A–55, 5600 Fishers Lane, Rockville, MD 

20857; telephone: (301) 594–4140.

Dated: August 17, 2005. 

Tina M. Cheatham, 

Director, Division of Policy Review and 

Coordination.

[FR Doc. 05–16791 Filed 8–23–05; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Advisory Committee on Training in 

Primary Care Medicine and Dentistry; 

Notice of Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), notice is hereby given 

of the following meeting:

Name: Advisory Committee on Training in 

Primary Care Medicine and Dentistry. 

Date and Time: September 29, 2005, 8:30 

a.m.–4:30 p.m. and September 30, 2005, 8 

a.m.–2 p.m. 

Place: The Holiday Inn Select, 8120 

Wisconsin Avenue, Bethesda, Maryland 

20814. 

Status: The meeting will be open to the 

public. 

Purpose: The Advisory Committee 

provides advice and recommendations on a 

broad range of issues dealing with programs 

and activities authorized under section 747 

of the Public Health Service Act as amended 

by The Health Professions Education 

Partnership Act of 1998, Public Law 105–

392. At this meeting the Advisory Committee 

will begin work on its sixth report which will 

be submitted to Congress and to the Secretary 

of the Department of Health and Human 

Services in November 2006. The report will 

focus on the role of Title VII, section 747 

grant programs in preparing primary care 

practitioners to care for underserved highrisk groups and vulnerable populations. 

Agenda: The meeting on Thursday, 

September 29, will begin with opening 

comments from the Chair of the Advisory 

Committee who will welcome new members. 

Introductory remarks will be given by the 

49662 Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Notices 

Division of Medicine and Dentistry, Health 

Resources and Services Administration, and 

remarks have been invited from the Bureau 

of Health Professions and the Agency. A 

plenary session will follow in which 

speakers will address the Advisory 

Committee on the topic of health-outcomes 

disparities in at-risk populations and the 

interface of Title VII, section 747 training 

programs with community groups to enhance 

care for vulnerable populations. In plenary 

session and in small workgroups, the 

Advisory Committee will make plans for the 

report. There also will be annual elections for 

a new chair and two vice chairs. An 

opportunity will be provided for public 

comment. 

On Friday, September 30, the Advisory 

Committee will open its meeting with an 

address on the topic of a theoretical 

framework for understanding vulnerability as 

it relates to individual patients and patient 

populations. The Advisory Committee will 

continue work on the sixth report and select 

members to serve on a Writing Group whose 

members will guide the report preparation 

process. An opportunity will be provided for 

public comment. 

For Further Information Contact: Anyone 

interested in obtaining a roster of members or 

other relevant information should write or 

contact Jerilyn K. Glass, M.D., Ph.D., Division 

of Medicine and Dentistry, Bureau of Health 

Professions, Health Resources and Services 

Administration, Room 9A–27, Parklawn 

Building, 5600 Fishers Lane, Rockville, 

Maryland 20857, Telephone (301) 443–6785. 

The Web address for information on the 

Advisory Committee is http://bhpr.hrsa.gov/

medicine-dentistry/actpcmd.

Dated: August 17, 2005. 

Tina M. Cheatham, 

Director, Division of Policy Review and 

Coordination.

[FR Doc. 05–16788 Filed 8–23–05; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Clinical Center; Notice of Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of a meeting of the NIH 

Advisory Board for Clinical Research. 

The meeting will be open to the 

public, with attendance limited to space 

available. Individuals who plan to 

attend and need special assistance, such 

as sign language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting.

Name of Committee: NIH Advisory Board 

for Clinical Research. 

Date: September 23, 2005. 

Time: 10 a.m. to 2 p.m. 

Agenda: To discuss progress of activities 

related to research opportunities, training, 

planning and funding in the NIH intramural 

clinical research program. 

Place: National Institutes of Health, 

Building 10, 10 Center Drive, CRC Medical 

Board Room 4–2551, Bethesda, MD 20892. 

Contact Person: Maureen E. Gormley, 

Executive Secretary, Mark O. Hatfield 

Clinical Research Center, National Institutes 

of Health, Building 10, Room 6–1610, 

Bethesda, MD 20892, 301/496–2897. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

into the building by non-government 

employees. Persons without a government 

I.D. will need to show a photo I.D. and signin at the security desk upon entering the 

building.

Dated: August 17, 2005. 

Anthony M. Coelho, Jr., 

Acting Director, Office of Federal Advisory 

Committee Policy.

[FR Doc. 05–16757 Filed 8–23–05; 8:45 am] 

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Neurological 

Disorders and Stroke; Notice of 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of meetings of the 

National Advisory Neurological 

Disorders and Stroke Council. 

The meetings will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy.

Name of Committee: National Advisory 

Neurological Disorders and Stroke Council, 

Training, Career Development, and Special 

Programs Subcommittee. 

Date: September 14, 2005. 

Open: 8 p.m. to 9:30 p.m. 

Agenda: To discuss the training programs 

of the Institute. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD 20814.

Closed: 9:30 p.m. to 10 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD 20814. 

Contact Person: Margaret Jacobs, Acting 

Training and Special Programs Officer, 

National Institute of Neurological Disorders 

and Stroke, National Institutes of Health, 

6001 Executive Blvd., Suite 2154 MSC 9527, 

Bethesda, MD 20892–9527, 301–496–4188, 

mj22o@nih.gov.

Name of Committee: National Advisory 

Neurological Disorders and Stroke Council, 

Clinical Trials Subcommittee. 

Date: September 15, 2005. 

Open: 8 a.m. to 9 a.m. 

Agenda: To discuss clinical trials policy. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, C Wing, 

Conference Room 6, Bethesda, MD 20892.

Closed: 9 a.m. to 10 a.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, C Wing, 

Conference Room 6, Bethesda, MD 20892. 

Contact Person: John Marler, MD, 

Associate Director for Clinical Trials, 

National Institute of Neurological Disorders 

and Stroke, National Institutes of Health, 

6001 Executive Blvd., Suite 2216, Bethesda, 

MD 20892, (301) 496–9135, 

jm137f@niah.gov.

Name of Committee: National Advisory 

Neurological Disorders and Stroke Council, 

Basic and Preclinical Programs 

Subcommittee. 

Date: September 15, 2005. 

Open: 8 a.m. to 10 a.m. 

Agenda: To discuss basic and preclinical 

programs policy. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, A Wing, 

Conference Room 8A–28, Bethesda, MD 

20892. 

Contact Person: Robert Baughman, MD, 

Associate Director for Technology 

Development, National Institute of 

Neurological Disorders and Stroke, National 

Institutes of Health, 6001 Executive Blvd., 

Suite 2137, MSC 9527, Bethesda, MD 20892–

9527, (301) 496–1779. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

into the building by non-government 

employees. Persons without a government 

I.D. will need to show a photo I.D. and signin at the security desk upon entering the 

building. 

Information is also available on the 

Institute’s/Center’s home page: http://

www.ninds.nih.gov, where an agenda and 

any additional information for the meeting 

will be posted when available.