Advisory Committee on Infant Mortality; Notice of Meeting, 68823-68824 [E6-20120]
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Federal Register / Vol. 71, No. 228 / Tuesday, November 28, 2006 / Notices
The CDRH Web site may be accessed at
https://www.fda.gov/cdrh. A search
capability for all CDRH guidance
documents is available at https://
www.fda.gov/cdrh/guidance.html.
Guidance documents are also available
on the Division of Dockets Management
Internet site at https://www.fda.gov/
ohrms/dockets.
Dated: November 20, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–20032 Filed 11–27–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0468]
Training Program for Regulatory
Project Managers; Information
Available to Industry
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
ycherry on PROD1PC61 with NOTICES
SUMMARY: The Food and Drug
Administration (FDA) Center for Drug
Evaluation and Research (CDER) is
announcing the continuation of the
Regulatory Project Management Site
Tours and Regulatory Interaction
Program (the Site Tours Program). The
purpose of this notice is to invite
pharmaceutical companies interested in
participating in this program to contact
CDER.
DATES: Pharmaceutical companies may
submit proposed agendas to the agency
by January 29, 2007.
ADDRESSES: Submit written proposed
agendas regarding the Site Tours
Program to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852, or to Beth
Duvall-Miller (see FOR FURTHER
INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT: Beth
Duvall-Miller, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6466,
Silver Spring, MD 20993–0002, 301–
796–0700.
SUPPLEMENTARY INFORMATION:
I. Background
An important part of CDER’s
commitment to make safe and effective
drugs available to all Americans is
optimizing the efficiency and quality of
the drug review process. To support this
primary goal, CDER has initiated
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15:42 Nov 27, 2006
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various training and development
programs to promote high performance
in its regulatory project management
staff. CDER seeks to enhance
significantly review efficiency and
review quality by providing the staff
with a better understanding of the
pharmaceutical industry and its
operations. To this end, CDER is
continuing its training program to give
regulatory project managers the
opportunity to tour pharmaceutical
facilities. The goals are to provide the
following: (1) Firsthand exposure to
industry’s drug development processes
and (2) a venue for sharing information
about project management procedures
(but not drug-specific information) with
industry representatives.
II. The Site Tours Program
In this program, over a 2- to 3-day
period, small groups (five or less) of
regulatory project managers, including a
senior level regulatory project manager,
can observe operations of
pharmaceutical manufacturing and/or
packaging facilities, pathology/
toxicology laboratories, and regulatory
affairs operations. Neither this tour nor
any part of the program is intended as
a mechanism to inspect, assess, judge,
or perform a regulatory function, but is
meant rather to improve mutual
understanding and to provide an avenue
for open dialogue. During the Site Tours
Program, regulatory project managers
will also participate in daily workshops
with their industry counterparts,
focusing on selective regulatory issues
important to both CDER staff and
industry. The primary objective of the
daily workshops is to learn about the
team approach to drug development,
including drug discovery, preclinical
evaluation, tracking mechanisms, and
regulatory submission operations. The
overall benefit to regulatory project
managers will be exposure to project
management, team techniques, and
processes employed by the
pharmaceutical industry. By
participating in this program, the
regulatory project manager will grow
professionally by gaining a better
understanding of industry processes and
procedures.
III. Site Selection
All travel expenses associated with
the site tours will be the responsibility
of CDER; therefore, selection will be
based on the availability of funds and
resources for each fiscal year. Firms
interested in offering a site tour or
learning more about this training
opportunity should respond by (see
DATES) by submitting a proposed agenda
to the Division of Dockets Management
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
68823
or to Beth Duvall-Miller (see
ADDRESSES).
Dated: November 20, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–20041 Filed 11–27–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Committee on Infant
Mortality; 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 Infant
Mortality (ACIM).
Dates and Times: November 29, 2006,
9 a.m.–5 p.m.; November 30, 2006,
8:30 a.m.–3 p.m.
Place: Washington Marriott Hotel, 1221
22nd Street, NW., Washington, DC 20037,
(202)–872–1500.
Status: The meeting is open to the public
with attendance limited to space availability.
Purpose: The Committee provides advice
and recommendations to the Secretary of
Health and Human Services on the following
issues: Department of Health and Human
Services’ programs that focus on reducing
infant mortality and improving the health
status of pregnant women and infants, factors
affecting the continuum of care with respect
to maternal and child health care, and
outcomes following childbirth. It also
includes strategies to coordinate the variety
of Federal, State, local and private programs
and efforts that are designed to deal with the
health and social problems impacting infant
mortality, and the implementation of the
Healthy Start program and Healthy People
2010 infant mortality objectives.
Agenda: The committee plans to discuss
the following topics: The Healthy Start
Program and its National Evaluation,
Breastfeeding Rates, Maternal and Child
Health Bureau’s Depression Activities, and
Centers for Medicare & Medicaid Services
Program update. The meeting allots
substantial time for subcommittee and full
committee discussions to formulate the
ACIM issues agenda. The items on the
agenda items are subject to change as the
Committee continues to discuss priorities.
The Committee provides a 5-minute time
limit for each public comment. Submit
comments no later than November 17, 2006.
For Further Information Contact: Anyone
requiring information regarding the
Committee can contact Peter C. van Dyck,
M.D., M.P.H., Executive Secretary, ACIM,
Health Resources and Services
Administration (HRSA), Room 18–05,
Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857, Telephone: (301) 443–
2170.
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68824
Federal Register / Vol. 71, No. 228 / Tuesday, November 28, 2006 / Notices
Individuals who submit public comments
or who have questions regarding the meeting
and location can contact David S. de la Cruz,
Ph.D., M.P.H., HRSA, Maternal and Child
Health Bureau, telephone: (301) 443–6332, email: David.delaCruz@hrsa.hhs.gov.
Dated: November 17, 2006.
Cheryl R. Dammons,
Director, Division of Policy Review and
Coordination.
[FR Doc. E6–20120 Filed 11–27–06; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HOMELAND
SECURITY
U.S. Citizenship and Immigration
Services
Agency Information Collection
Activities: Extension of a Currently
Approved Information Collection;
Comment Request.
30-day notice of information
collection under review: Notice of
Naturalization Oath Ceremony; Form N–
445, OMB Control No. 1615–0054.
ycherry on PROD1PC61 with NOTICES
ACTION:
The Department of Homeland
Security, U.S. Citizenship and
Immigration Service (USCIS) has
submitted the following information
collection request to the Office of
Management and Budget (OMB) for
review and clearance in accordance
with the Paperwork Reduction Act of
1995. The information collection was
previously published in the Federal
Register on September 12, 2006 at 71 FR
53703, allowing for a 60-day public
comment period. No public comments
were received on this information
collection.
The purpose of this notice is to allow
an additional 30 days for public
comments. Comments are encouraged
and will be accepted until December 28,
2006. This process is conducted in
accordance with 5 CFR 1320.10.
Written comments and/or suggestions
regarding the item(s) contained in this
notice, especially regarding the
estimated public burden and associated
response time, should be directed to the
Department of Homeland Security
(DHS), and to the Office of Management
and Budget (OMB) USCIS Desk Officer.
Comments may be submitted to: USCIS,
Director, Regulatory Management
Division, Clearance Office, 111
Massachusetts Avenue, Suite 3008,
Washington, DC 20529. Comments may
also be submitted to DHS via facsimile
to 202–272–8352 or via e-mail at
rfs.regs@dhs.gov, and to the OMB USCIS
Desk Officer via facsimile at 202–395–
6974 or via email at
kastrich@omb.eop.gov.
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15:42 Nov 27, 2006
Jkt 211001
When submitting comments by e-mail
please make sure to add OMB Control
Number 1615–0054 in the subject box.
Written comments and suggestions from
the public and affected agencies should
address one or more of the following
four points:
(1) Evaluate whether the collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information will have practical utility;
(2) Evaluate the accuracy of the
agency’s estimate of the burden of the
collection of information, including the
validity of the methodology and
assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses.
Overview of this information
collection:
(1) Type of Information Collection:
Extension of a currently approved
information collection.
(2) Title of the Form/Collection:
Notice of Naturalization Oath
Ceremony.
(3) Agency form number, if any, and
the applicable component of the
Department of Homeland Security
sponsoring the collection: Form N–445.
U.S. Citizenship and Immigration
Services.
(4) Affected public who will be asked
or required to respond, as well as a brief
abstract: Primary: Individual or
households. The information furnished
on this form refers to events that may
have occurred since the applicant’s
initial interview and prior to the
administration of the oath of allegiance.
Several months may elapse between
these dates and the information that is
provided assists the officer in rendering
an appropriate decision on the
application.
(5) An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
respond: 650,000 responses at 5 minutes
(.083) per response.
(6) An estimate of the total public
burden (in hours) associated with the
collection: 53,950 annual burden hours.
If you have additional comments,
suggestions, or need a copy of the
information collection instrument,
please contact Richard A. Sloan,
Director, Regulatory Management
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
Division, U.S. Citizenship and
Immigration Services, U.S. Department
of Homeland Security, 111
Massachusetts Avenue, NW., Suite
3008, Washington, DC, 20529.
Dated: November 21, 2006.
Stephen Tarragon,
Deputy Director, Regulatory Management
Division, U.S. Citizenship and Immigration
Services.
[FR Doc. E6–20047 Filed 11–27–06; 8:45 am]
BILLING CODE 4410–10–P
DEPARTMENT OF HOMELAND
SECURITY
U.S. Citizenship and Immigration
Services
Agency Information Collection
Activities; Revision of a Currently
Approved Information Collection;
Comment Request.
U.S. Citizenship and
Immigration Services, DHS.
ACTION: 30-Day Notice of information
collection under review: Petition for
Alien Fiance(e); Form I–129F. OMB
Control No. 1615–0001.
AGENCY:
The Department of Homeland
Security, U.S. Citizenship and
Immigration Service (USCIS) has
submitted the following information
collection request to the Office of
Management and Budget (OMB) for
review and clearance in accordance
with the Paperwork Reduction Act of
1995. The information collection was
previously published in the Federal
Register on May 26, 2006 at 71 FR
30434, allowing for a 60-day public
comment period. USCIS received
several comments from the public on
this information collection. These
comments are addressed in the
supporting statement that USCIS will
submit to OMB.
The purpose of this notice is to allow
an additional 30 days for public
comments. Comments are encouraged
and will be accepted until December 28,
2006. This process is conducted in
accordance with 5 CFR 1320.10.
Written comments and/or suggestions
regarding the item(s) contained in this
notice, especially regarding the
estimated public burden and associated
response time, should be directed to the
Department of Homeland Security
(DHS), and to the Office of Management
and Budget (OMB) USCIS Desk Officer.
Comments may be submitted to: USCIS,
Director, Regulatory Management
Division, Clearance Office, 111
Massachusetts Avenue, Suite 3008,
Washington, DC 20529. Comments may
E:\FR\FM\28NON1.SGM
28NON1
Agencies
[Federal Register Volume 71, Number 228 (Tuesday, November 28, 2006)]
[Notices]
[Pages 68823-68824]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-20120]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Advisory Committee on Infant Mortality; 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 Infant Mortality (ACIM).
Dates and Times: November 29, 2006, 9 a.m.-5 p.m.; November 30,
2006, 8:30 a.m.-3 p.m.
Place: Washington Marriott Hotel, 1221 22nd Street, NW.,
Washington, DC 20037, (202)-872-1500.
Status: The meeting is open to the public with attendance
limited to space availability.
Purpose: The Committee provides advice and recommendations to
the Secretary of Health and Human Services on the following issues:
Department of Health and Human Services' programs that focus on
reducing infant mortality and improving the health status of
pregnant women and infants, factors affecting the continuum of care
with respect to maternal and child health care, and outcomes
following childbirth. It also includes strategies to coordinate the
variety of Federal, State, local and private programs and efforts
that are designed to deal with the health and social problems
impacting infant mortality, and the implementation of the Healthy
Start program and Healthy People 2010 infant mortality objectives.
Agenda: The committee plans to discuss the following topics: The
Healthy Start Program and its National Evaluation, Breastfeeding
Rates, Maternal and Child Health Bureau's Depression Activities, and
Centers for Medicare & Medicaid Services Program update. The meeting
allots substantial time for subcommittee and full committee
discussions to formulate the ACIM issues agenda. The items on the
agenda items are subject to change as the Committee continues to
discuss priorities.
The Committee provides a 5-minute time limit for each public
comment. Submit comments no later than November 17, 2006.
For Further Information Contact: Anyone requiring information
regarding the Committee can contact Peter C. van Dyck, M.D., M.P.H.,
Executive Secretary, ACIM, Health Resources and Services
Administration (HRSA), Room 18-05, Parklawn Building, 5600 Fishers
Lane, Rockville, MD 20857, Telephone: (301) 443-2170.
[[Page 68824]]
Individuals who submit public comments or who have questions
regarding the meeting and location can contact David S. de la Cruz,
Ph.D., M.P.H., HRSA, Maternal and Child Health Bureau, telephone:
(301) 443-6332, e-mail: David.delaCruz@hrsa.hhs.gov.
Dated: November 17, 2006.
Cheryl R. Dammons,
Director, Division of Policy Review and Coordination.
[FR Doc. E6-20120 Filed 11-27-06; 8:45 am]
BILLING CODE 4165-15-P