Advisory Committee on Infant Mortality; Notice of Meeting, 61625-61626 [05-21245]
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61625
Federal Register / Vol. 70, No. 205 / Tuesday, October 25, 2005 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of Respondents
Annual Frequency per
Response
200
30 (maximum)
1 There
Dated: October 17, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–21240 Filed 10–24–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Clinical Pharmacology Subcommittee
of the Advisory Committee for
Pharmaceutical Science; Notice of
Meeting
AGENCY:
Hours per Response
6,000
Total Hours
0.5
3,000
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA projects 30 emergency risk
related surveys per year with a sample
of between 50 and 200 respondents per
survey. FDA also projects a response
time of 0.5 hours per response. These
estimates are based on the maximum
sample size per questionnaire that FDA
can analyze in a timely manner. The
annual frequency of response was
determined by the maximum number of
questionnaires that will be sent to any
individual respondent. Some
respondents may be contacted only one
time per year, while other respondents
may be contacted several times
annually, depending on the human
drug, biologic, or medical device under
evaluation. It is estimated that, given the
expected type of issues that will be
addressed by the surveys, it will take 0.5
hours for a respondent to gather the
requested information and fill in the
answers.
Food and Drug Administration,
HHS.
ACTION:
Total Annual Responses
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Clinical
Pharmacology Subcommittee of the
Advisory Committee for Pharmaceutical
Science.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on November 14, 2005, from 8:30
VerDate Aug<31>2005
15:53 Oct 24, 2005
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a.m. to 5:30 p.m. and on November 15,
2005, from 8:30 a.m. to 1:30 p.m.
Location: Food and Drug
Administration, Center for Drug
Evaluation and Research Advisory
Committee Conference Room, rm. 1066,
5630 Fishers Lane, Rockville, MD.
Contact Person: Mimi Phan, Center
for Drug Evaluation and Research (HFD–
21), Food and Drug Administration,
5600 Fishers Lane (for express delivery,
5630 Fishers Lane, rm. 1093) Rockville,
MD 20857, 301–827–7001, FAX: 301–
827–6776, e-mail: phanm@cder.fda.gov,
or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area), code 3014512539. Please call the
Information Line for up-to-date
information on this meeting.
Agenda: On November 14, 2005, the
subcommittee will: (1) Receive an
update on previous Clinical
Pharmacology Subcommittee meeting
recommendations and an introduction
to the topics of this meeting, (2) discuss
and provide comments on the evidence
and process for translation of
pharmacogenetic information (e.g.,
Cytochrome P 2C9 polymorphisms) into
label updates for approved products, (3)
discuss current evidence related to the
pharmacogenetics of warfarin as a
potential basis for label updates, and (4)
discuss and provide comments on the
critical path pilot project, the End-ofPhase 2A meetings which will include
a case study. On November 15, 2005, the
subcommittee will discuss and and
provide comments on: (1) An update on
the critical path biomarker-surrogate
endpoint project, (2) the use of
biomarker information in labels to
facilitate individualizing
pharmacotherapy, and (3) the analytical
and clinical validation criteria for
approving a clinical assay (‘‘diagnostic
test’’). The background material will
become available no later than the day
before the meeting and will be posted
on FDA’s Web site at https://
www.fda.gov/ohrms/dockets/ac/
acmenu.htm under the heading
‘‘Advisory Committee for
Pharmaceutical Science.’’ (Click on the
year 2005 and scroll down to the
Advisory Committee for Pharmaceutical
Science meetings.)
Procedure: Interested persons may
present data, information, or views,
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orally or in writing, on issues pending
before the subcommittee. Written
submissions may be made to the contact
person by November 4, 2005. Oral
presentations from the public will be
scheduled between approximately 11:15
a.m. and 11:30 a.m. and 3:35 p.m. and
3:50 p.m. on November 14, 2005, and
between approximately 11:20 a.m. and
11:50 a.m. on November 15, 2005. Time
allotted for each presentation may be
limited. Those desiring to make formal
oral presentations should notify the
contact person before November 4,
2005, and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Mimi Phan at
least 7 days in advance of the meeting.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: October 18, 2005.
Jason Brodsky,
Acting Associate Commissioner for External
Relations.
[FR Doc. 05–21241 Filed 10–24–05; 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).
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61626
Federal Register / Vol. 70, No. 205 / Tuesday, October 25, 2005 / Notices
Dates and Times: November 29, 2005, 9
a.m.–5 p.m., November 30, 2005, 8:30 a.m.–
3 p.m.
Place: Washington, DC area hotel yet to be
determined.
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:
Department programs that are directed at
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,
including outcomes following childbirth;
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 on infant
mortality; and the implementation of the
Healthy Start program and Healthy People
2010 infant mortality objectives.
Agenda: Topics that will be discussed
include the following: Health Disparities in
the Maternal and Child Health (MCH)
Population and A Life-course Perspective for
Perinatal Health and Preconception Care.
Substantial time will be spent in
Subcommittee and full Committee
discussions aimed at formulating the ACIM
issues agenda. Proposed agenda items are
subject to change as priorities indicate.
Time will be provided for public
comments limited to five minutes each;
comments are to be submitted no later than
November 14, 2005.
For Further Information Contact: Anyone
requiring information regarding the
Committee should 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.
Individuals who are submitting public
comments or who have questions regarding
the meeting and location should contact Ann
M. Koontz, C.N.M., Dr.P.H., HRSA, Maternal
and Child Health Bureau, telephone: (301)
443–6327, e-mail: ann.koontz@hrsa.hhs.gov.
Name: National Advisory Council on
Nurse Education and Practice (NACNEP).
Dates and Times: November 2, 2005, 8:30
a.m.–5 p.m., November 3, 2005, 8:30 a.m.–5
p.m., November 4, 2005, 8:30 a.m.–3 p.m.
Place: DoubleTree Hotel and Executive
Center, 1750 Rockville Pike, Rockville,
Maryland 20852.
Status: The meeting will be open to the
public.
Agenda: Agency and Bureau
administrative updates will be provided. The
purpose of the meeting will be to address
issues related to the status of the nursing
workforce. Two leading educators/
researchers will present on their findings
related to nursing workforce data, trends and
issues. In addition, representatives from four
nursing organizations representing nursing
education, practice and licensing will present
their data, trends, and workforce issues.
During this meeting and the subsequent April
2006 meeting, Council workgroups will
deliberate on content presented and
formulate recommendations to the Secretary
of Health and Human Services and the
Congress on nursing workforce issues based
on the latest data and trends. This meeting
will form the basis for NACNEP’s mandated
Sixth Annual Report.
For Further Information Contact: Anyone
interested in obtaining a roster of members,
minutes of the meeting, or other relevant
information should write or contact Ms.
Donna English, M.P.H., R.N., Executive
Secretary, National Advisory Council on
Nurse Education and Practice, Parklawn
Building, Room 9–35, 5600 Fishers Lane,
Rockville, Maryland 20857, telephone (301)
443–5688.
Dated: October 18, 2005.
Tina M. Cheatham,
Director, Division of Policy Review and
Coordination.
[FR Doc. 05–21245 Filed 10–24–05; 8:45 am]
Health Resources and Services
Administration
BILLING CODE 4165–15–P
AGENCY:
Health Resources and Services
Administration
National Advisory Council on Nurse
Education and Practice; 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:
15:53 Oct 24, 2005
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Advisory Committee on Organ
Transplantation; Notice of Meeting
Health Resources and Services
Administration, HHS.
ACTION: Notice; amendment.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
VerDate Aug<31>2005
Dated: October 19, 2005.
Tina M. Cheatham,
Director, Division of Policy Review and
Coordination.
[FR Doc. 05–21243 Filed 10–24–05; 8:45 am]
SUMMARY: The Health Resources and
Services Administration published a
notice in the Federal Register of
September 29, 2005 (70 FR 56926–
56927) announcing an Advisory
Committee on Organ Transplantation
meeting on November 3–4 2005. The
notice is being amended to change type
of meeting, place, dates, and time.
FOR FURTHER INFORMATION CONTACT: Ms.
Sherry Whipple at 301–443–2764 or email: swhipple@hrsa.gov.
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Correction
In the Federal Register of September
29, 2005, in FR Doc. 05–19431, on page
56927, 1ST column, under the heading
Summary, 8th line, change to read:
The meeting will be an Audio
Conference Call on November 1, 2005,
from 12 noon to 4 p.m. EST. To access
the conference call, call the USA Toll
Free Number 888–791–2132 and enter
the Passcode ‘‘ACOT.’’ The conference
call leader is Dr. James Burdick.
Dated: October 18, 2005.
Tina M. Cheatham,
Director, Division of Policy Review and
Coordination.
[FR Doc. 05–21244 Filed 10–24–05; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[USCG–2005–21722]
Collection of Information Under
Review by Office of Management and
Budget (OMB): 1625–0089
Coast Guard, DHS.
Request for comments.
AGENCY:
ACTION:
SUMMARY: In compliance with the
Paperwork Reduction Act of 1995, this
request for comments announces that
the Coast Guard has forwarded one
Information Collection Request (ICR)—
(1) 1625–0089, The National
Recreational Boating Survey—abstracted
below, to the Office of Information and
Regulatory Affairs (OIRA) of the Office
of Management and Budget (OMB) for
review and comment. Our ICR describes
the information we seek to collect from
the public. Review and comment by
OIRA ensures that we impose only
paperwork burdens commensurate with
our performance of duties.
DATES: Please submit comments on or
before November 25, 2005.
ADDRESSES: To make sure that your
comments and related material do not
reach the docket [USCG–2005–21722] or
OIRA more than once, please submit
them by only one of the following
means:
(1)(a) By mail to the Docket
Management Facility, U.S. Department
of Transportation (DOT), room PL–401,
400 Seventh Street, SW., Washington,
DC 20590–0001. (b) By mail to OIRA,
725 17th St. NW., Washington, DC
20503, to the attention of the Desk
Officer for the Coast Guard.
(2)(a) By delivery to room PL–401 at
the address given in paragraph (1)(a)
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Agencies
[Federal Register Volume 70, Number 205 (Tuesday, October 25, 2005)]
[Notices]
[Pages 61625-61626]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-21245]
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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).
[[Page 61626]]
Dates and Times: November 29, 2005, 9 a.m.-5 p.m., November 30,
2005, 8:30 a.m.-3 p.m.
Place: Washington, DC area hotel yet to be determined.
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:
Department programs that are directed at 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, including outcomes following childbirth;
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 on infant mortality; and the
implementation of the Healthy Start program and Healthy People 2010
infant mortality objectives.
Agenda: Topics that will be discussed include the following:
Health Disparities in the Maternal and Child Health (MCH) Population
and A Life-course Perspective for Perinatal Health and Preconception
Care. Substantial time will be spent in Subcommittee and full
Committee discussions aimed at formulating the ACIM issues agenda.
Proposed agenda items are subject to change as priorities indicate.
Time will be provided for public comments limited to five
minutes each; comments are to be submitted no later than November
14, 2005.
For Further Information Contact: Anyone requiring information
regarding the Committee should 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.
Individuals who are submitting public comments or who have
questions regarding the meeting and location should contact Ann M.
Koontz, C.N.M., Dr.P.H., HRSA, Maternal and Child Health Bureau,
telephone: (301) 443-6327, e-mail: ann.koontz@hrsa.hhs.gov.
Dated: October 18, 2005.
Tina M. Cheatham,
Director, Division of Policy Review and Coordination.
[FR Doc. 05-21245 Filed 10-24-05; 8:45 am]
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