Submission for OMB Review; Comment Request, 49382-49383 [E9-23242]
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49382
Federal Register / Vol. 74, No. 186 / Monday, September 28, 2009 / Notices
exposure as a condition of new drug
approval. However, registries such as
these monitor only a small number of
medications, and many suffer from
methodologic limitations including high
loss to follow-up rates and incomplete
or nonspecific outcome information.
Teratology Information Services (TIS)
utilize trained specialists to provide free
phone consultation, risk assessment,
and counseling about exposures during
pregnancy and breastfeeding—including
medications—to women and healthcare
providers. Altogether, they respond to
approximately 70,000–100,000 inquiries
each year in the United States and
Canada. Because they have direct
contact with pregnant and breastfeeding
women, TIS are in a unique position to
monitor the effects of medication
exposures during pregnancy and
lactation. The objective of this project is
to assess the quality of information on
(1) pregnancy outcomes (e.g., live birth,
stillbirth, premature birth, low birth
weight, etc.) and (2) maternal and infant
health following medication use during
pregnancy and lactation that can be
obtained from maternal interviews
conducted by TIS in the U.S. The
project will assess the willingness of
pregnant and breastfeeding women who
contact a TIS about medication
exposure to participate in and complete
a follow-up study; whether these
women are similar in demographic
characteristics to the U.S. population of
child-bearing age women; the specificity
and completeness of the information
obtained from such a study about
pregnancy outcomes, and maternal and
infant health; and the amount of time
required to conduct the follow-up.
Within a continuous six-month
period, three individual TIS will recruit
all women who contact their service (up
to a maximum of 250 enrollees per TIS)
who have used any prescription or overthe-counter medication, vitamin, herbal,
or other dietary supplement during
pregnancy or while breastfeeding to
participate in a follow-up study.
Informed consent to participate will be
obtained from each woman by
telephone. For each pregnant woman
who agrees to participate, the TIS will
then conduct 4 telephone interviews: (1)
At enrollment; (2) during the third
trimester of pregnancy; (3)
approximately one month after delivery;
and (4) when the infant is about 3
months old. For each breastfeeding
woman who agrees to participate, the
TIS will then conduct 3 telephone
interviews: (1) At enrollment; (2)
approximately one month after
enrollment; and (3) 3 months after
enrollment, if the woman is still taking
medication and still breastfeeding. The
interviews will assess maternal and fetal
health throughout pregnancy, and
maternal and infant health at delivery,
during the newborn and early infancy
period, and while breastfeeding, and
correlate these outcomes with
medication exposure during pregnancy
and while breastfeeding. There is no
cost to respondents other than their
time. The total estimated annualized
burden is 516 hours.
ESTIMATE OF ANNUALIZED BURDEN HOURS
Number of
respondents
Responses
per
respondent
Avg. burden
per response
(in hours)
Type of respondent
Form name
All Respondents ..............................................
Screened Eligible Respondents- ....................
Pregnancy Exposure (Group 1)/Lactation Exposure (Group 2)/Pregnancy and Lactation
Exposure (Group 3).
Groups 1, 2 and 3 ...........................................
Group 1 and 3 .................................................
Telephone script .............................................
Tracking ..........................................................
Consent ..........................................................
294
250
250
1
1
1
3/60
5/60
20/60
Enrollment ......................................................
Initial Pregnancy .............................................
Follow-up Pregnancy .....................................
Initial Infant .....................................................
Follow-up Infant ..............................................
Initial breastfeeding ........................................
Follow-up breastfeeding .................................
250
200
200
200
200
100
100
1
1
1
1
1
1
1.5
10/60
30/60
20/60
20/60
15/60
20/60
15/60
Groups 2 and 3 ...............................................
Dated: September 18, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E9–23309 Filed 9–25–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
srobinson on DSKHWCL6B1PROD with NOTICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Proposed Projects:
Title: Project LAUNCH Cross-Site
Evaluation.
OMB No.: New Collection.
Description: The Administration for
Children and Families (ACF), U.S.
VerDate Nov<24>2008
16:33 Sep 25, 2009
Jkt 217001
Department of Health and Human
Services, is planning to collect data as
part of a cross-site evaluation of a new
initiative called Project LAUNCH
(Linking Actions for Unmet Needs in
Children’s Health): Project LAUNCH is
intended to promote the healthy
development and wellness of children
ages birth to eight years. A total of 18
Project LAUNCH grantees will be
funded to improve coordination among
child-serving systems, build
infrastructure, and improve methods for
providing services. Grantees will also
implement a range of public health
strategies to support young child
wellness in a designated locality.
Data for the cross-site evaluation of
Project LAUNCH will be collected
through: (1) Interviews conducted
during annual site visits to Project
LAUNCH grantees, and (2) semi-annual
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reports that will be submitted
electronically on a Web-based dataentry system. Information will be
collected from all Project LAUNCH
grantees.
During annual site visits, researchers
will conduct interviews with Project
LAUNCH service providers and
collaborators in States/Tribes and local
communities of focus. Site visitors will
ask program administrators questions
about all Project LAUNCH activities,
including: infrastructure development;
collaboration and coordination among
partner agencies, organizations, and
service providers; and development,
implementation, and refinement of
service strategies.
As part of the proposed data
collection, Project LAUNCH staff will be
asked to submit semi-annual electronic
reports on State/Tribal and local
E:\FR\FM\28SEN1.SGM
28SEN1
49383
Federal Register / Vol. 74, No. 186 / Monday, September 28, 2009 / Notices
systems development and on services
that children and families receive. The
electronic data reports also will collect
data about other Project LAUNCHfunded service enhancements, such as
trainings, Project LAUNCH systems
change activities, and changes in
provider settings. Information provided
in these reports will be aggregated on a
quarterly basis, and reported semiannually.
Respondents: State/Tribal Child
Wellness Coordinator, State/Tribal
Wellness Council Members, State ECCS
Project Director, Local Child Wellness
Coordinator, Local Wellness Council
Members, Local Evaluator, and Local
Service Providers.
ANNUAL BURDEN ESTIMATES’>
Annual
number of
respondents
Instrument
Site Visit Interview Guide ................................................................................
Electronic Data Reporting: Systems Measures ...............................................
Electronic Data Reporting: Services Measures ...............................................
Estimated Annual Burden Hours: 702
hours.
Additional Information
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade, SW., Washington, DC
20447, Attn: OPRE Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. E-mail address:
OPREinfocol1ection@acf.hhs.gov.
OMB Comment
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Fax: 202–395–6974.
Attn: Desk Officer for the
Administration for Children and
Families.
Dated: September 17, 2009.
Seth F. Chamberlain,
OPRE Reports Clearance Officer.
[FR Doc. E9–23242 Filed 9–25–09; 8:45 am]
srobinson on DSKHWCL6B1PROD with NOTICES
BILLING CODE M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
VerDate Nov<24>2008
16:33 Sep 25, 2009
Jkt 217001
216
18
18
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting 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
Institute of Mental Health Special
Emphasis Panel. K99.
Date: October 29, 2009.
Time: 1 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852.
(Telephone Conference Call).
Contact Person: Megan Libbey, PhD,
Scientific Review Officer, Division of
Extramural Activities, National Institute
of Mental Health, NIH, Neuroscience
Center, 6001 Executive Blvd., Room
6148, MSC 9609, Rockville, MD 20852–
9609. 301–402–6807.
libbeym@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.242, Mental Health Research
Grants; 93.281, Scientist Development
Award, Scientist Development Award for
Clinicians, and Research Scientist Award;
93.282, Mental Health National Research
Service Awards for Research Training,
National Institutes of Health, HHS)
Dated: September 21, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–23337 Filed 9–25–09; 8:45 am]
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Number of
responses per
respondent
1
2
2
Average
burden hours
per response
Estimated
annual burden
hours
1.25
4
8
270
144
288
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
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/or contract proposals 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 and/or contract proposals,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel.
Pharmacodynamic Assays for Cancer
Therapeutics.
Date: October 6, 2009.
Time: 11 a.m. to 1:30 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 6116
Executive Boulevard, Room # 210, Rockville,
MD 20852. (Telephone Conference Call).
Contact Person: Thomas M Vollberg, PhD,
Scientific Review Officer, Special Review
and Logistics Branch, Division of Extramural
Activities, National Cancer Institute, 6116
Executive Boulevard, Room 7142, Bethesda,
MD 20892. 301–594–9582.
vollbert@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to scheduling
conflicts.
Name of Committee: National Cancer
Institute Special Emphasis Panel. R13
Conference Grants Review.
Date: October 29, 2009.
Time: 1 p.m. to 5 p.m.
E:\FR\FM\28SEN1.SGM
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]]>Agencies
[Federal Register Volume 74, Number 186 (Monday, September 28, 2009)]
[Notices]
[Pages 49382-49383]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-23242]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Proposed Projects:
Title: Project LAUNCH Cross-Site Evaluation.
OMB No.: New Collection.
Description: The Administration for Children and Families (ACF),
U.S. Department of Health and Human Services, is planning to collect
data as part of a cross-site evaluation of a new initiative called
Project LAUNCH (Linking Actions for Unmet Needs in Children's Health):
Project LAUNCH is intended to promote the healthy development and
wellness of children ages birth to eight years. A total of 18 Project
LAUNCH grantees will be funded to improve coordination among child-
serving systems, build infrastructure, and improve methods for
providing services. Grantees will also implement a range of public
health strategies to support young child wellness in a designated
locality.
Data for the cross-site evaluation of Project LAUNCH will be
collected through: (1) Interviews conducted during annual site visits
to Project LAUNCH grantees, and (2) semi-annual reports that will be
submitted electronically on a Web-based data-entry system. Information
will be collected from all Project LAUNCH grantees.
During annual site visits, researchers will conduct interviews with
Project LAUNCH service providers and collaborators in States/Tribes and
local communities of focus. Site visitors will ask program
administrators questions about all Project LAUNCH activities,
including: infrastructure development; collaboration and coordination
among partner agencies, organizations, and service providers; and
development, implementation, and refinement of service strategies.
As part of the proposed data collection, Project LAUNCH staff will
be asked to submit semi-annual electronic reports on State/Tribal and
local
[[Page 49383]]
systems development and on services that children and families receive.
The electronic data reports also will collect data about other Project
LAUNCH-funded service enhancements, such as trainings, Project LAUNCH
systems change activities, and changes in provider settings.
Information provided in these reports will be aggregated on a quarterly
basis, and reported semi-annually.
Respondents: State/Tribal Child Wellness Coordinator, State/Tribal
Wellness Council Members, State ECCS Project Director, Local Child
Wellness Coordinator, Local Wellness Council Members, Local Evaluator,
and Local Service Providers.
Annual Burden Estimates'>
----------------------------------------------------------------------------------------------------------------
Number of Average burden Estimated
Instrument Annual number responses per hours per annual burden
of respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Site Visit Interview Guide...................... 216 1 1.25 270
Electronic Data Reporting: Systems Measures..... 18 2 4 144
Electronic Data Reporting: Services Measures.... 18 2 8 288
----------------------------------------------------------------------------------------------------------------
Estimated Annual Burden Hours: 702 hours.
Additional Information
Copies of the proposed collection may be obtained by writing to the
Administration for Children and Families, Office of Planning, Research
and Evaluation, 370 L'Enfant Promenade, SW., Washington, DC 20447,
Attn: OPRE Reports Clearance Officer. All requests should be identified
by the title of the information collection. E-mail address:
OPREinfocol1ection@acf.hhs.gov.
OMB Comment
OMB is required to make a decision concerning the collection of
information between 30 and 60 days after publication of this document
in the Federal Register. Therefore, a comment is best assured of having
its full effect if OMB receives it within 30 days of publication.
Written comments and recommendations for the proposed information
collection should be sent directly to the following: Office of
Management and Budget, Paperwork Reduction Project, Fax: 202-395-6974.
Attn: Desk Officer for the Administration for Children and Families.
Dated: September 17, 2009.
Seth F. Chamberlain,
OPRE Reports Clearance Officer.
[FR Doc. E9-23242 Filed 9-25-09; 8:45 am]
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