Proposed Information Collection Activity; Comment Request, 45618-45619 [2012-18702]
Download as PDF
<![CDATA[
45618
Federal Register / Vol. 77, No. 148 / Wednesday, August 1, 2012 / Notices
inclusion (i.e., nursing homes). A
contractor will conduct face-to-face
interviews with the chairs of the
Violence Prevention Committees at 20
nursing homes, who as stated in
regulations, are in charge of overseeing
compliance efforts. These individuals
will include nursing home
administrators. The purpose of the
interviews is to measure compliance to
the state regulations (Aim 1). The
interview form was pilot-tested by the
study team in the Fall 2010 and
includes the following components as
mandated in the regulations: violence
prevention policies, reporting systems
for violent events, violence prevention
committee, written violence prevention
plan, violence risk assessments, post
incident response and violence
prevention training. The nursing home’s
policy and procedures documents will
be obtained by the contractor to provide
details about their workplace violence
prevention program. Questions will also
be asked about barriers and facilitators
to developing the violence prevention
program. These data will be collected in
the post-regulation time period.
recruited from a mailing list of home
healthcare aides certified from the State
of New Jersey Division of Consumer
Affairs Board of Nursing. The mailing
list was selected as the population
source of workers due to the ability to
capture all home healthcare aides in
New Jersey. Therefore, a sampling frame
based on home healthcare aides will be
used to select workers to participate in
the study. A random sample of 4000
(1333 annually) home healthcare aides
will be recruited for study participation.
A third-party contractor will be
responsible for sending the survey to the
random sample of 4000 home healthcare
aides (1333 annually). The Health
Professionals and Allied Employees
union will promote the survey to their
members. To maintain the worker’s
anonymity, the home healthcare agency
in which he/she works will not be
identified. The survey will describe the
workplace violence prevention training
home healthcare aides receive following
enactment of the New Jersey regulations
(Aim 2). There are no costs to
respondents other than their time.
A contractor will also collect assault
injury data from nursing home violent
event reports 3 years pre-regulation
(2009–2011) and 3 years post-regulation
(2012–2014). This data will be collected
from existing OSHA logs. The purpose
of collecting these data is to evaluate
changes in assault injury rates before
and after enactment of the regulations
(Aim 3). The following information will
be abstracted from the OSHA logs: date,
time and location of the incident;
identity, job title and job task of the
victim; identity of the perpetrator;
description of the violent act, including
whether a weapon was used;
description of physical injuries; number
of employees in the vicinity when the
incident occurred, and their actions in
response to the incident;
recommendations of police advisors,
employees or consultants, and; actions
taken by the facility in response to the
incident. No employee or perpetrator
identifiable information will be
collected.
In addition to nursing homes, home
healthcare aides will also be recruited.
These home healthcare aides will be
ESTIMATED ANNUALIZED BURDEN HOURS
No. of
respondents
No. of
responses per
respondent
Average
burden per
response
(in hrs)
Total burden
(in hrs)
Respondents
Form
Hospital Administrator .......................
Nursing Administrator .......................
Nurse Survey ....................................
Home Healthcare Aides ....................
Interview ...........................................
Interview ...........................................
Survey ..............................................
Survey ..............................................
17
7
1333
1333
1
1
1
1
1
1
20/60
20/60
17
7
445
445
Total ...........................................
...........................................................
........................
........................
........................
914
Kimberly S. Lane,
Deputy Director, Office of Science Integrity,
Office of the Associate Director for Science,
Office of the Director, Centers for Disease
Control and Prevention.
[FR Doc. 2012–18742 Filed 7–31–12; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
tkelley on DSK3SPTVN1PROD with NOTICES
Proposed Information Collection
Activity; Comment Request
Title: Mother and Infant Home
Visiting Program Evaluation: Follow-up
data collection on family outcomes.
OMB No.: 0970–0402.
Description: In 2011, the
Administration for Children and
Families (ACF) and Health Resources
and Services Administration (HRSA)
VerDate Mar<15>2010
19:53 Jul 31, 2012
Jkt 226001
within the U.S. Department of Health
and Human Services (HHS) launched a
national evaluation called the Mother
and Infant Home Visiting Program
Evaluation (MIHOPE). This evaluation,
mandated by the Affordable Care Act,
will inform the federal government
about the effectiveness of the Maternal,
Infant, and Early Childhood Home
Visiting (MIECHV) program in its first
few years of operation, and provide
information to help states develop and
strengthen home visiting programs in
the future. MIHOPE has two phases.
Phase 1 includes baseline data
collection and implementation data;
Phase 2 includes follow up data
collection. OMB approved a data
collection package for Phase 1 in July
2012. The purpose of the current
document is to request approval of data
collection efforts for Phase 2.
Data collected during Phase 2 will
include the following: (1) A one-hour
interview with the parent, (2) 30-
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
minutes of observed interactions
between the parent and child, (3) a
direct assessment of child development,
and (4) collection of saliva from the
parent or child for purposes of
measuring cotinine, an indicator of
smoking behavior and exposure to
second-hand smoke, and other health
and stress indicators. Saliva analysis
would not include assessment for illegal
drug use or DNA.
Data collected during Phase 2 will be
used to estimate the effects of MIECHVfunded programs on seven domains
specified for the evaluation in the ACA:
(1) Prenatal, maternal, and newborn
health; (2) child health and
development, including maltreatment,
injuries, and development; (3)
parenting; (4) school readiness and
academic achievement; (5) crime or
domestic violence; (6) family economic
self-sufficiency; and (7) coordination of
referrals for and provision of other
community resources. Data collected
E:\FR\FM\01AUN1.SGM
01AUN1
45619
Federal Register / Vol. 77, No. 148 / Wednesday, August 1, 2012 / Notices
during Phase 2 will also be used to
assess the differences in services used
between families who receive home
visiting and a comparison group.
Respondents: Respondents in Phase 2
will include parents and children who
are enrolled in the study. Data
collection activities will take place over
a three-year period.
ANNUAL BURDEN ESTIMATES
Annual
number of
respondents
Instrument
Number of
responses per
respondent
Average
burden hours
per response
Total annual
burden hours
Survey of parents in the study ........................................................................
Observed parent-child interactions ..................................................................
Direct assessments of children .......................................................................
Collecting saliva to measure cotinine ..............................................................
1360
2720
2720
2720
1
1
1
1
1.0
0.5
0.7
0.1
1360
1360
1904
272
Estimated Total Annual Burden Hours .....................................................
........................
........................
........................
4896
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded 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.
Email address:
OPREinfocollection@acf.hhs.gov. All
requests should be identified by the title
of the information collection.
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.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
tkelley on DSK3SPTVN1PROD with NOTICES
Steven M. Hanmer,
Reports Clearance Officer.
[FR Doc. 2012–18702 Filed 7–31–12; 8:45 am]
BILLING CODE 4184–22–M
VerDate Mar<15>2010
19:53 Jul 31, 2012
Jkt 226001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0813]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Applications for
Food and Drug Administration
Approval To Market a New Drug;
Revision of Postmarketing Reporting
Requirements—Discontinuance
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information including each proposed
extension of an existing collection of
information and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the reporting requirements contained in
FDA’s regulations on postmarketing
reporting of information pertaining to
drug shortages.
DATES: Submit either electronic or
written comments on the collection of
information by October 1, 2012.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
SUMMARY:
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
FOR FURTHER INFORMATION CONTACT:
Juanmanuel Vilela, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–7651,
juanmanuel.vilela@fda.hhs.gov.
Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information
[,including each proposed [extension/
reinstatement] of an existing collection
of information,] before submitting the
collection to OMB for approval. To
comply with this requirement, FDA is
publishing notice of the proposed
collection of information set forth in
this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
SUPPLEMENTARY INFORMATION:
E:\FR\FM\01AUN1.SGM
01AUN1
]]>Agencies
[Federal Register Volume 77, Number 148 (Wednesday, August 1, 2012)]
[Notices]
[Pages 45618-45619]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18702]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Title: Mother and Infant Home Visiting Program Evaluation: Follow-
up data collection on family outcomes.
OMB No.: 0970-0402.
Description: In 2011, the Administration for Children and Families
(ACF) and Health Resources and Services Administration (HRSA) within
the U.S. Department of Health and Human Services (HHS) launched a
national evaluation called the Mother and Infant Home Visiting Program
Evaluation (MIHOPE). This evaluation, mandated by the Affordable Care
Act, will inform the federal government about the effectiveness of the
Maternal, Infant, and Early Childhood Home Visiting (MIECHV) program in
its first few years of operation, and provide information to help
states develop and strengthen home visiting programs in the future.
MIHOPE has two phases. Phase 1 includes baseline data collection and
implementation data; Phase 2 includes follow up data collection. OMB
approved a data collection package for Phase 1 in July 2012. The
purpose of the current document is to request approval of data
collection efforts for Phase 2.
Data collected during Phase 2 will include the following: (1) A
one-hour interview with the parent, (2) 30-minutes of observed
interactions between the parent and child, (3) a direct assessment of
child development, and (4) collection of saliva from the parent or
child for purposes of measuring cotinine, an indicator of smoking
behavior and exposure to second-hand smoke, and other health and stress
indicators. Saliva analysis would not include assessment for illegal
drug use or DNA.
Data collected during Phase 2 will be used to estimate the effects
of MIECHV-funded programs on seven domains specified for the evaluation
in the ACA: (1) Prenatal, maternal, and newborn health; (2) child
health and development, including maltreatment, injuries, and
development; (3) parenting; (4) school readiness and academic
achievement; (5) crime or domestic violence; (6) family economic self-
sufficiency; and (7) coordination of referrals for and provision of
other community resources. Data collected
[[Page 45619]]
during Phase 2 will also be used to assess the differences in services
used between families who receive home visiting and a comparison group.
Respondents: Respondents in Phase 2 will include parents and
children who are enrolled in the study. Data collection activities will
take place over a three-year period.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Annual number responses per hours per Total annual
of respondents respondent response burden hours
----------------------------------------------------------------------------------------------------------------
Survey of parents in the study.................. 1360 1 1.0 1360
Observed parent-child interactions.............. 2720 1 0.5 1360
Direct assessments of children.................. 2720 1 0.7 1904
Collecting saliva to measure cotinine........... 2720 1 0.1 272
---------------------------------------------------------------
Estimated Total Annual Burden Hours......... .............. .............. .............. 4896
----------------------------------------------------------------------------------------------------------------
In compliance with the requirements of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Administration for Children and
Families is soliciting public comment on the specific aspects of the
information collection described above. Copies of the proposed
collection of information can be obtained and comments may be forwarded
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. Email
address: OPREinfocollection@acf.hhs.gov. All requests should be
identified by the title of the information collection.
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.
Consideration will be given to comments and suggestions submitted
within 60 days of this publication.
Steven M. Hanmer,
Reports Clearance Officer.
[FR Doc. 2012-18702 Filed 7-31-12; 8:45 am]
BILLING CODE 4184-22-M
