Agency Information Collection Activities: Submission for OMB Review; Comment Request, 22056 [05-8509]
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Federal Register / Vol. 70, No. 81 / Thursday, April 28, 2005 / Notices
30040, June 4, 1999; final: 67 FR 59528,
September 23, 2002), (2) that it focused
too much on general epidemiologic
issues, and (3) that it overemphasized
the utility of pregnancy registries
without a balanced review of the
strengths of other data sources for
evaluating pregnancy outcome data.
Based on these comments and
discussions with FDA’s Pregnancy
Labeling Subcommittee of the Advisory
Committee for Reproductive Health
Drugs on June 3, 1999 (64 FR 23340,
April 30, 1999), and March 28 and 29,
2000 (65 FR 10811, February 29, 2000),
and with other interested parties, the
draft guidance has been revised and
finalized. The name has been changed
from ‘‘Evaluating Pregnancy Outcome
Data’’ to ‘‘Evaluating the Risks of Drug
Exposure in Human Pregnancies’’ to
reflect more accurately the information
contained in the guidance.
This guidance is being issued
consistent with FDA’s good guidance
practice regulation (21 CFR 10.115). The
guidance represents the agency’s current
thinking with regard to evaluating data
on the effects of drug exposure during
pregnancy. 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. 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,
https://www.fda.gov/cber/
guidelines.htm, or https://www.fda.gov/
ohrms/dockets/default.htm.
Dated: April 19, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–8466 Filed 4–27–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources
and Services Administration (HRSA)
publishes abstracts of information
collection requests under review by the
Office of Management and Budget
(OMB), in compliance with the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35). To request a copy of
the clearance requests submitted to
OMB for review, call the HRSA Reports
Clearance Office on (301) 443–1129.
The following request has been
submitted to the Office of Management
and Budget for review under the
Paperwork Reduction Act of 1995:
Proposed Project: The National Health
Service Corps (NHSC) Recruitment and
Retention Assistance Application (OMB
No. 0915–0230)—Revision
The National Health Service Corps
(NHSC) of the Bureau of Health
Professions (BHPr), HRSA, is committed
to improving the health of the Nation’s
underserved by uniting communities in
need with caring health professionals
and by supporting communities’ efforts
to build better systems of care.
The Application for NHSC
Recruitment and Retention Assistance
submitted by sites or clinicians, requests
information on the practice site,
sponsoring agency, recruitment contact,
staffing levels, service users, charges for
services, employment policies, and
fiscal management capabilities.
Assistance in completing the
application may be obtained through the
appropriate State Primary Care Offices,
State Primary Care Associations and
NHSC Contractors. The information on
the application is used for determining
eligibility of sites and to verify the need
for NHSC providers. Sites must apply
once every three years.
Estimates of annualized reporting
burden are as follows:
Type of report
Number of
respondents
Response per
respondents
Hours per
response
Total burden
hours
Application .......................................................................................................
2900
1
.5
1450
Written comments and
recommendations concerning the
proposed information collection should
be sent within 30 days of this notice to:
John Kraemer, Desk Officer, Human
Resources and Housing Branch, Office
of Management and Budget, New
Executive Office Building, Room 10235,
Washington, DC 20503.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: April 22, 2005.
Tina M. Cheatham,
Director, Division of Policy Review and
Coordination.
[FR Doc. 05–8509 Filed 4–27–05; 8:45 am]
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:
BILLING CODE 4165–15–P
VerDate jul<14>2003
16:00 Apr 27, 2005
Jkt 205001
Health Resources and Services
Administration
Advisory Committee on Training in
Primary Care Medicine and Dentistry;
Notice of Meeting
Name: Advisory Committee on Training in
Primary Care Medicine and Dentistry.
Date and Time: May 19, 2005, 8:30 a.m.–
4:30 p.m. and May 20, 2005, 8 a.m.–2 p.m.
Place: The Bethesda Marriott, 5151 Pooks
Hill Road, Bethesda, Maryland 20814.
PO 00000
Frm 00065
Fmt 4703
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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 continue to work on its fifth report
which will be submitted to Congress and to
the Secretary of the Department of Health
and Human Services in November 2005 and
which focuses on measuring outcomes of
Title VII, section 747 grant programs.
Agenda: The meeting on Thursday, May
19, will begin with opening comments from
the Chair of the Advisory Committee. A
plenary session will follow in which
Advisory Committee members will discuss
various sections of the fifth report. The
Advisory Committee will divide into
E:\FR\FM\28APN1.SGM
28APN1
]]>Agencies
[Federal Register Volume 70, Number 81 (Thursday, April 28, 2005)]
[Notices]
[Page 22056]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-8509]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources and Services Administration
(HRSA) publishes abstracts of information collection requests under
review by the Office of Management and Budget (OMB), in compliance with
the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request
a copy of the clearance requests submitted to OMB for review, call the
HRSA Reports Clearance Office on (301) 443-1129.
The following request has been submitted to the Office of
Management and Budget for review under the Paperwork Reduction Act of
1995:
Proposed Project: The National Health Service Corps (NHSC) Recruitment
and Retention Assistance Application (OMB No. 0915-0230)--Revision
The National Health Service Corps (NHSC) of the Bureau of Health
Professions (BHPr), HRSA, is committed to improving the health of the
Nation's underserved by uniting communities in need with caring health
professionals and by supporting communities' efforts to build better
systems of care.
The Application for NHSC Recruitment and Retention Assistance
submitted by sites or clinicians, requests information on the practice
site, sponsoring agency, recruitment contact, staffing levels, service
users, charges for services, employment policies, and fiscal management
capabilities. Assistance in completing the application may be obtained
through the appropriate State Primary Care Offices, State Primary Care
Associations and NHSC Contractors. The information on the application
is used for determining eligibility of sites and to verify the need for
NHSC providers. Sites must apply once every three years.
Estimates of annualized reporting burden are as follows:
----------------------------------------------------------------------------------------------------------------
Number of Response per Hours per Total burden
Type of report respondents respondents response hours
----------------------------------------------------------------------------------------------------------------
Application................................. 2900 1 .5 1450
----------------------------------------------------------------------------------------------------------------
Written comments and recommendations concerning the proposed
information collection should be sent within 30 days of this notice to:
John Kraemer, Desk Officer, Human Resources and Housing Branch, Office
of Management and Budget, New Executive Office Building, Room 10235,
Washington, DC 20503.
Dated: April 22, 2005.
Tina M. Cheatham,
Director, Division of Policy Review and Coordination.
[FR Doc. 05-8509 Filed 4-27-05; 8:45 am]
BILLING CODE 4165-15-P
