Advisory Commission on Childhood Vaccines; Request for Nominations for Voting Members, 49661 [05-16789]
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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draft guidance for industry entitled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comments on the draft guidance.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 The draft guidance and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may obtain the draft guidance at either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/
VerDate jul<14>2003
15:23 Aug 23, 2005
Jkt 205001
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]
BILLING CODE 4165–15–P
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]
BILLING CODE 4165–15–P
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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[Federal Register Volume 70, Number 163 (Wednesday, August 24, 2005)]
[Notices]
[Page 49661]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-16789]
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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]
BILLING CODE 4165-15-P
