Advisory Committee on Training in Primary Care Medicine and Dentistry; Notice of Meeting, 49661-49662 [05-16788]
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Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Notices
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draft guidance for industry entitled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comments on the draft guidance.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 The draft guidance and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may obtain the draft guidance at either
https://www.fda.gov/cder/guidance/
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index.htm or https://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
PO 00000
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49661
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
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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 https://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,
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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,
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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: https://
www.ninds.nih.gov, where an agenda and
any additional information for the meeting
will be posted when available.
E:\FR\FM\24AUN1.SGM
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]]>Agencies
[Federal Register Volume 70, Number 163 (Wednesday, August 24, 2005)]
[Notices]
[Pages 49661-49662]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-16788]
-----------------------------------------------------------------------
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 high-risk 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
[[Page 49662]]
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 https://
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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