Comment Request, 75171 [2012-30367]
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Federal Register / Vol. 77, No. 244 / Wednesday, December 19, 2012 / Notices
10.3109/17435390.2011.648223.
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Jeong J, Han BS, Han JH, Chung YH, Kim
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IJ [2008]. Lung function changes in
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20:567–574.
Sung JH, Ji, JH, Park JD, Yoon, JU, Kim DS,
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MH, Kelman BJ, Yu IJ [2009]. Subchronic
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Dated: December 12, 2012.
John Howard,
Director, National Institute for Occupational
Safety and Health, Centers for Disease Control
and Prevention.
[FR Doc. 2012–30515 Filed 12–18–12; 8:45 am]
BILLING CODE 4163–19–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
sroberts on DSK5SPTVN1PROD with
Comment Request
Title: Mother and Infant Home
Visiting Program Evaluation—Strong
Start: Data collection.
Description: In September 2012, the
Administration for Children and
Families (ACF), the Centers for
Medicare and Medicaid Services (CMS),
and the Health Resources and Services
Administration (HRSA) within the U.S.
Department of Health and Human
Services (HHS) launched an evaluation
called the Mother and Infant Home
Visiting Program Evaluation—Strong
Start (MIHOPE—Strong Start). The
study will evaluate the effectiveness of
two evidence-based home visiting
models—Healthy Families America and
Nurse Family Partnership—at
improving birth outcomes for women
who are enrolled in Medicaid. The
evaluation is part of the Strong Start for
Mothers and Newborns initiative, which
is informing the federal government
about the effects of prenatal
interventions that may provide better
care, improved health, and reduced
medical costs by improving birth
outcomes.
Data collected for MIHOPE-Strong
Start will include the following: (1) A
20-minute baseline family survey, (2)
two-hour semi-structured interviews
with state administrators of the
Maternal, Infant, and Early Childhood
Home Visiting program, (3) web-based
surveys with program managers of local
home visiting programs, and (4) webbased surveys with home visitors in
those programs. In addition, the study
VerDate Mar<15>2010
16:35 Dec 18, 2012
Jkt 229001
will collect information on dosage and
referrals from home visiting programs’
management information systems, and
will collect information on family
outcomes from state and vital records
systems.
These data will be combined with
administrative data to estimate the
effects of the home visiting programs on
birth outcomes and infant health and
health care in the first year, both overall
and for groups of families and programs.
Data on program implementation will
provide information on how local
programs operate and the dosage of
home visiting services that families
receive.
Respondents: The respondents will
include 20,000 women who are no more
than seven months pregnant when they
enter the study, 8 state administrators,
68 program managers, and 782 home
visitors. Data collection activities will
take place over a three-year period. The
annual burden on the public for these
activities is estimated to be 2,435 hours
over a three year period (approximately
21 minutes per person over three years).
Copies of the proposed instruments
and brief project description 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. Email
address:
OPREinfocollection@acf.hhs.gov.
The Department specifically requests
comments on (a) whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
A comment is best assured of having
its full effect if it is received within 30
days of this publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to Administration for
Children and Families, Office of
Planning, Research and Evaluation, 370
L’Enfant Promenade SW., Washington,
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
75171
DC 20447, Attn: OPRE Reports
Clearance Officer.
Steven M. Hanmer,
Reports Clearance Officer.
[FR Doc. 2012–30367 Filed 12–18–12; 8:45 am]
BILLING CODE 4184–22–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0976]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance:
Emergency Use Authorization of
Medical Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by January 18,
2013.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0595. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
Ila
S. Mizrachi, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
7726, Ila.Mizrachi@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
FOR FURTHER INFORMATION CONTACT:
Reporting and Recordkeeping for
Emergency Use Authorization of
Medical Products (OMB Control
Number 0910–0595)—Extension
The guidance describes the Agency’s
general recommendations and
procedures for issuance of emergency
E:\FR\FM\19DEN1.SGM
19DEN1
Agencies
[Federal Register Volume 77, Number 244 (Wednesday, December 19, 2012)]
[Notices]
[Page 75171]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-30367]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Comment Request
Title: Mother and Infant Home Visiting Program Evaluation--Strong
Start: Data collection.
Description: In September 2012, the Administration for Children and
Families (ACF), the Centers for Medicare and Medicaid Services (CMS),
and the Health Resources and Services Administration (HRSA) within the
U.S. Department of Health and Human Services (HHS) launched an
evaluation called the Mother and Infant Home Visiting Program
Evaluation--Strong Start (MIHOPE--Strong Start). The study will
evaluate the effectiveness of two evidence-based home visiting models--
Healthy Families America and Nurse Family Partnership--at improving
birth outcomes for women who are enrolled in Medicaid. The evaluation
is part of the Strong Start for Mothers and Newborns initiative, which
is informing the federal government about the effects of prenatal
interventions that may provide better care, improved health, and
reduced medical costs by improving birth outcomes.
Data collected for MIHOPE-Strong Start will include the following:
(1) A 20-minute baseline family survey, (2) two-hour semi-structured
interviews with state administrators of the Maternal, Infant, and Early
Childhood Home Visiting program, (3) web-based surveys with program
managers of local home visiting programs, and (4) web-based surveys
with home visitors in those programs. In addition, the study will
collect information on dosage and referrals from home visiting
programs' management information systems, and will collect information
on family outcomes from state and vital records systems.
These data will be combined with administrative data to estimate
the effects of the home visiting programs on birth outcomes and infant
health and health care in the first year, both overall and for groups
of families and programs. Data on program implementation will provide
information on how local programs operate and the dosage of home
visiting services that families receive.
Respondents: The respondents will include 20,000 women who are no
more than seven months pregnant when they enter the study, 8 state
administrators, 68 program managers, and 782 home visitors. Data
collection activities will take place over a three-year period. The
annual burden on the public for these activities is estimated to be
2,435 hours over a three year period (approximately 21 minutes per
person over three years).
Copies of the proposed instruments and brief project description
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. Email address: OPREinfocollection@acf.hhs.gov.
The Department specifically requests comments on (a) whether the
proposed collection of information is necessary for the proper
performance of the functions of the agency, including whether the
information shall have practical utility; (b) the accuracy of the
agency's estimate of the burden of the proposed collection of
information; (c) the quality, utility, and clarity of the information
to be collected; and (d) ways to minimize the burden of the collection
of information on respondents, including through the use of automated
collection techniques or other forms of information technology.
A comment is best assured of having its full effect if it is
received within 30 days of this publication. Written comments and
recommendations for the proposed information collection should be sent
directly to Administration for Children and Families, Office of
Planning, Research and Evaluation, 370 L'Enfant Promenade SW.,
Washington, DC 20447, Attn: OPRE Reports Clearance Officer.
Steven M. Hanmer,
Reports Clearance Officer.
[FR Doc. 2012-30367 Filed 12-18-12; 8:45 am]
BILLING CODE 4184-22-M