Submission for OMB Review; Comment Request, 3432-3433 [2013-00592]
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3432
Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Notices
ANNUAL BURDEN ESTIMATES
Total
number of
respondents
Instrument
Telephone Interview ...........................................................
Key Leaders Interview .......................................................
Other Leaders Interview ....................................................
Front-line Staff Interview ....................................................
Governing Body/Policy Council Interview ..........................
Local Education Agency Interview .....................................
Parent Focus Group ..........................................................
Estimated Total Annual Burden
Hours: 552.
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
Number of
responses per
respondent
Average burden
hours per
response
1
1
1
1
1
1
1
0.75
1.5
1
1
1
1
1.5
120
24
30
96
72
12
144
comments and suggestions submitted
within 60 days of this publication.
Steven M. Hanmer,
Reports Clearance, Officer.
[FR Doc. 2013–00593 Filed 1–15–13; 8:45 am]
BILLING CODE 4184–22–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
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
Total burden
hours
90
36
30
96
72
12
216
Annual burden
hours
90
36
30
96
72
12
216
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
family follow-up survey, (2) 30-minutes
of observed interactions between the
parent and child, (3) a direct assessment
of child development, (4) measurement
of mother’s weight and child’s height
and weight, (5) collection of saliva from
the mother and child for purposes
measuring cotinine, an indicator of
smoking behavior and exposure to
second-hand smoke, and cortisol, an
indicator stress exposure and regulation,
and (6) extend collection of weekly
home visitor logs on home visiting
services until a family is no longer
receiving services.
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) use of other
community resources. Data collected
during Phase 2 will also be used to
assess the differences in services used
between families who receive home
visiting and a comparison group, and to
assess the quantity of home visiting
services received by families.
Respondents: The respondents in
Phase 2 will include 4335 parents who
are enrolled in the study. Data
collection activities will take place over
a three-year period.
ANNUAL BURDEN ESTIMATES
Annual
number of
respondents
mstockstill on DSK4VPTVN1PROD with
Instrument
Home visitor logs ...........................................................................................
Family follow-up survey .................................................................................
Direct parent-child interactions ......................................................................
Direct child assessments ...............................................................................
VerDate Mar<15>2010
17:01 Jan 15, 2013
Jkt 229001
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
Average burden
hours per
response
50
1
1
1
0.09
1.0
0.5
0.7
170
1445
2890
1445
E:\FR\FM\16JAN1.SGM
16JAN1
Total annual
burden hours
765
1445
1445
1012
3433
Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Notices
ANNUAL BURDEN ESTIMATES—Continued
Annual
number of
respondents
Instrument
Collecting saliva to measure cotinine and cortisol, and measuring height
and weight ..................................................................................................
Estimated Total Annual Burden
Hours: 5,334
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. Email
address:
OPREinfocollection@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, Email:
OIRA_SUBMISSION@OMB.EOP.GOV,
Attn: Desk Officer for the
Administration, for Children and
Families.
Steven M. Hanmer,
Reports Clearance, Officer.
[FR Doc. 2013–00592 Filed 1–15–13; 8:45 am]
BILLING CODE 4184–22–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0921]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Electronic
Submission of Food and Drug
Administration Adverse Event Reports
and Other Safety Information Using the
Electronic Submission Gateway and
the Safety Reporting Portal
mstockstill on DSK4VPTVN1PROD with
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
SUMMARY:
VerDate Mar<15>2010
17:01 Jan 15, 2013
Jkt 229001
Number of
responses per
respondent
2890
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995
(the PRA).
DATES: Fax written comments on the
collection of information by February
15, 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 0910–0645. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400T, Rockville, MD 20850,
domini.bean@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.
Electronic Submission of Food and
Drug Administration Adverse Event
Reports and Other Safety Information
Using the Electronic Submission
Gateway and the Safety Reporting
Portal—21 CFR 310.305, 314.80, 314.98,
314.540, 514.80, 600.80, 1271.350 and
Part 803 (OMB Control Number 0910–
0645)—Revision
The FDA Safety Reporting Portal (the
SRP) (formerly referred to as the
MedWatchPlus Portal and Rational
Questionnaire) and the Electronic
Submission Gateway (ESG) are the
Agency’s electronic systems for
collecting, submitting, and processing
adverse event reports and other safety
information for FDA-regulated products.
To ensure the safety and identify any
risks, harms, or other dangers to health
for all FDA-regulated human and animal
products, the Agency needs to be
informed whenever an adverse event,
product quality problem, or product use
error occurs. This risk identification
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
1
Average burden
hours per
response
Total annual
burden hours
0.3
867
process is the first necessary step that
allows the Agency to gather the
information necessary to be able to
evaluate the risk associated with the
product and take whatever action is
necessary to mitigate or eliminate the
public’s exposure to the risk.
Some adverse event reports are
required to be submitted to FDA
(mandatory reporting) and some adverse
event reports are submitted voluntarily
(voluntary reporting). Requirements
regarding mandatory reporting of
adverse events or product problems
have been codified in 21 CFR parts 310,
314, 514, 600, 803 and 1271, specifically
§§ 310.305, 314.80, 314.98, 314.540,
514.80, 600.80, 803.30, 803.40, 803.50,
803.53, 803.56 and 1271.350(a) (21 CFR
310.305, 314.80, 314.98, 314.540,
514.80, 600.80, 803.30, 803.40, 803.50,
803.53, 803.56 and 1271.350(a)). Many
of the adverse event reports submitted
to FDA are currently filed in paper
format using FDA Forms FDA 3500,
3500A, 1932, and 1932a, approved
under OMB control numbers 0910–0284
and 0910–0291. This notice solicits
comments on adverse event reports filed
electronically via the SRP and the ESG,
approved under OMB control number
0910–0645.
I. The FDA Safety Reporting Portal
Rational Questionnaires
FDA currently has OMB approval to
receive three types of adverse event
reports electronically via the SRP using
rational questionnaires. FDA sought
comments on the extension of OMB
approval for the existing three rational
questionnaires, as well as comments on
a proposed fourth rational questionnaire
that will be used for a new safety
reporting program being launched by
the Center for Tobacco Products (CTP).
A. Reportable Food Registry Reports
The Food and Drug Administration
Amendments Act of 2007 (Pub. L. 110–
85) (FDAAA) amended the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) by creating a new section
417 (21 U.S.C. 350f), Reportable Food
Registry (RFR or the Registry). Section
417 of the FD&C Act defines ‘‘reportable
food’’ as an ‘‘article of food (other than
infant formula or dietary supplements)
for which there is a reasonable
E:\FR\FM\16JAN1.SGM
16JAN1
]]>Agencies
[Federal Register Volume 78, Number 11 (Wednesday, January 16, 2013)]
[Notices]
[Pages 3432-3433]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-00592]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; 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 family follow-up survey, (2) 30-minutes of observed
interactions between the parent and child, (3) a direct assessment of
child development, (4) measurement of mother's weight and child's
height and weight, (5) collection of saliva from the mother and child
for purposes measuring cotinine, an indicator of smoking behavior and
exposure to second-hand smoke, and cortisol, an indicator stress
exposure and regulation, and (6) extend collection of weekly home
visitor logs on home visiting services until a family is no longer
receiving services.
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) use of other community resources. Data collected
during Phase 2 will also be used to assess the differences in services
used between families who receive home visiting and a comparison group,
and to assess the quantity of home visiting services received by
families.
Respondents: The respondents in Phase 2 will include 4335 parents
who are enrolled in the study. Data collection activities will take
place over a three-year period.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Annual number Number of Average burden
Instrument of responses per hours per Total annual
respondents respondent response burden hours
----------------------------------------------------------------------------------------------------------------
Home visitor logs............................... 170 50 0.09 765
Family follow-up survey......................... 1445 1 1.0 1445
Direct parent-child interactions................ 2890 1 0.5 1445
Direct child assessments........................ 1445 1 0.7 1012
[[Page 3433]]
Collecting saliva to measure cotinine and 2890 1 0.3 867
cortisol, and measuring height and weight......
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 5,334
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. Email address:
OPREinfocollection@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, Email: OIRA_SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the Administration, for
Children and Families.
Steven M. Hanmer,
Reports Clearance, Officer.
[FR Doc. 2013-00592 Filed 1-15-13; 8:45 am]
BILLING CODE 4184-22-M
