Submission for OMB Review; Comment Request, 24423-24425 [2013-09797]
Download as PDF
<![CDATA[
24423
Federal Register / Vol. 78, No. 80 / Thursday, April 25, 2013 / Notices
programmatic information on activities
and objectives will continue to be
collected twice per year.
The National Asthma Control Program
at CDC has access to and analyzes
national-level asthma surveillance data
(https://www.cdc.gov/asthma/
asthmadata.htm). With the exception of
data from the Behavioral Risk Factor
Surveillance System (BRFSS), state level
analyses cannot be performed.
Therefore, as part of AIRS, state asthma
control programs submit aggregate
surveillance data to allow calculation of
asthma surveillance indicators across all
funded states (where data are available)
in a standardized manner. Data requests
through this system regularly include:
Hospital discharges (with asthma as first
listed diagnosis), and emergency
department visits (with asthma as first
listed diagnosis). Under AIRS,
participating states annually submit this
information to the AIRS system in
conjunction with an end-of-year report
describing state activities that meet
project objectives described above.
National and state asthma
surveillance data provide information
useful to examine progress on long-term
outcomes of state asthma programs. To
identify appropriate indicators of
program implementation and short-term
outcomes for AIRS, CDC previously
convened and facilitated workgroups
comprised of state asthma control
program representatives to generated
specific questions to collect data on key
features of state asthma control
programs: Partnerships, surveillance,
interventions, and evaluation.
With technical assistance provided by
NCEH staff, AIRS has provided states
with uniform data reporting methods
and linkages to other states’ asthma
programs and data. Thus, AIRS has
saved state resources and staff time
when they embark on asthma activities
similar to those being done elsewhere.
Also, the AIRS system has been
similarly helpful in linking states
together on occasions when a given state
seeks to report their results at national
meetings or publish their findings and
program results in scholarly journals.
For example, with CDC staff, three state
programs co-presented on a panel
regarding evaluations of their asthma
partnerships at the November, 2012
American Evaluation Association’s
Evaluation 2012 conference.
In addition, CDC staff have regularly
made requests from AIRS to obtain
standardized summaries of state
programs regarding such activities as
the number of states meeting staffing
requirements, number and timeliness of
state strategic evaluation plans, topics
for individual evaluation selected by
states, types and targets of interventions,
and use of asthma surveillance data in
state programs.
Furthermore, access to standardized
AIRS surveillance and programmatic
data allows CDC to provide timely and
accurate responses to the public and
Congress regarding the NCEH asthma
program (e.g., how many states have
asthma interventions targeting schools,
how many children are treated in
emergency departments, etc.).
There will be no cost for respondents,
other than their time, to participate in
AIRS. Based on the program’s
evaluation of past performance, it was
noted that the hours for the interim
report should be increased from 2 to 4
hours and those of the end of year be
decreased from 6 to 4 hours; however,
total burden hours remain at 8 hours per
year per respondent. The total estimated
annual burden hours are 288.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
State Health Departments ......
State Health Departments ......
Interim report on activities and objectives .............................
End of year report on activities, objectives and aggregate
surveillance.
Ron A. Otten,
Director, Office of Scientific Integrity, Office
of the Associate Director for Science, Office
of the Director, Centers for Disease Control
and Prevention.
[FR Doc. 2013–09756 Filed 4–24–13; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
tkelley on DSK3SPTVN1PROD with NOTICES
Submission for OMB Review;
Comment Request
Title: Child Support Noncustodial
Parent Employment Demonstration
(CSPED).
OMB No.: 0970—NEW.
Description: The Office of Child
Support Enforcement (OCSE) within the
Administration for Children and
Families (ACF) is proposing data
VerDate Mar<15>2010
17:22 Apr 24, 2013
Jkt 229001
collection activity as part of the Child
Support Noncustodial Parent
Employment Demonstration (CSPED). In
October 2012, OCSE issued grants to
eight state child support agencies to
provide employment, parenting, and
child support services to noncustodial
parents who are having difficulty
meeting their child support obligation.
The overall objective of the CSPED
evaluation is to document and evaluate
the effectiveness of the approaches
taken by these eight CSPED grantees.
This evaluation will yield information
about effective strategies for improving
child support payments by providing
noncustodial parents employment and
other services through child support
programs. It will generate extensive
information on how these programs
operated, what they cost, the effects the
programs had, and whether the benefits
of the programs exceed their costs. The
information gathered will be critical to
informing decisions related to future
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
36
36
Number of
responses per
respondent
1
1
Average
burden per
response
(in hrs.)
4
4
investments in child support-led
employment-focused programs for
noncustodial parents who have
difficulty meeting their child support
obligations.
The CSPED evaluation will include
the following two interconnected
components or ‘‘studies’’:
1. Implementation and Cost Study.
The goal of the implementation and cost
study is to provide a detailed
description of the programs—how they
are implemented, their participants, the
contexts in which they are operated,
their promising practices, and their
costs. The detailed descriptions will
assist in interpreting program impacts,
identifying program features and
conditions necessary for effective
program replication or improvement,
and carefully documenting the costs of
delivering these services. Key activities
of the implementation and cost study
will include: (1) Conducting semistructured interviews with program staff
E:\FR\FM\25APN1.SGM
25APN1
24424
Federal Register / Vol. 78, No. 80 / Thursday, April 25, 2013 / Notices
and selected community partner
organizations to gather information on
program implementation and costs; (2)
conducting focus groups with program
participants to elicit participation
experiences; (3) administering a webbased survey to program staff and
community partners to capture broader
staff program experiences; and (4)
collecting data on study participant
service use, dosage, and duration of
enrollment throughout the
demonstration using a web-based
Management Information System (MIS).
2. Impact Study. The goal of the
impact study is to provide rigorous
estimates of the effectiveness of the
eight programs using an experimental
research design. Program applicants
who are eligible for CSPED services will
be randomly assigned to either a
program group that is offered program
services or a control group that is not.
The study MIS that will document
service use for the implementation
study will also be used by grantee staff
to conduct random assignment for the
impact study. The impact study will
rely on data from surveys of
participants, as well as administrative
records from state and county data
systems. Survey data will be collected
twice from program applicants. Baseline
information will be collected from all
noncustodial parents who apply for the
program prior to random assignment. A
follow-up survey will be collected from
sample members twelve months after
random assignment. A wide range of
measures will be collected through
surveys, including measures of
employment stability and quality,
barriers to employment, parenting and
co-parenting, and demographic and
socio-economic characteristics. In
addition, data on child support
obligations and payments, Temporary
Assistance for Needy Families (TANF)
and Supplemental Nutrition Assistance
Program (SNAP) benefits, Medicaid
receipt, involvement with the criminal
justice system, and earnings and benefit
data collected through the
Unemployment Insurance (UI) system
will be obtained from state and county
databases.
A 60-Day Federal Register Notice was
published for this study on January 11,
2013. This 30-Day Federal Register
Notice covers the following data
collection activities: (1) Topic guides for
semi-structured interviews with
program staff and community partners,
(2) focus group guides for program
participants, (3) the web-based survey to
document program staff and partner
experiences, (4) the Management
Information System (MIS) functions for
tracking participation in the program,
(5) an introductory script which
program staff will use to introduce the
study to participants, (6) the baseline
survey used to capture participant
characteristics prior to randomization,
(7) the MIS functions for conducting
random assignment, and (8) the
extraction of child support, benefit,
earnings, and criminal justice data
extracted from state and county
administrative data systems.
Respondents: Respondents include
program applicants, study participants,
grantee staff and community partners, as
well as state and county staff
responsible for extracting data from
government databases for the
evaluation. Specific respondents per
instrument are noted in the burden table
below.
Annual Burden Estimates
The following tables provide the
burden estimates for the
implementation and cost study and the
impact study components of the current
request.
IMPLEMENTATION AND COST STUDY
Number of
respondents
Instrument
Staff interview topic guide with program staff and community partners .........
Focus group guide with program participants .................................................
Web survey of program staff and community partners ...................................
Study MIS for grantee and partner staff to track program participation .........
Number of
responses per
respondent
120
240
200
200
2
1
2
1,500
Average
burden hours
per response
1
1.5
0.5
0.0333
Total burden
hours
240
360
200
10,000
IMPACT STUDY
Number of
respondents
Instrument
Introductory script:
Grantee staff .............................................................................................
Program applicants 1 .................................................................................
Baseline survey of study participants ..............................................................
Study MIS used by program staff to conduct random assignment .................
Protocol for collecting administrative records ..................................................
Number of
responses per
respondent
120
12,600
12,000
120
32
105
1
1
105
2
Average
burden hours
per response
0.1667
0.1667
0.5833
0.1667
8
Total burden
hours
2,100
2,100
7,000
2,100
512
tkelley on DSK3SPTVN1PROD with NOTICES
1 Five percent of program applicants are not expected to agree to participate in the study; thus there are 5% more program applicants than
study participants.
Estimated Total Annual Burden
Hours: 8,204.
Additional Information: In
compliance with the requirements of
Section 3506(c)(2)(A) of the Paper Work
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
VerDate Mar<15>2010
17:22 Apr 24, 2013
Jkt 229001
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: ACF Reports Clearance Officer. All
requests should be identified by the title
of the information collection. Email
address: infocollection@acf.hhs.gov.
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
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
E:\FR\FM\25APN1.SGM
25APN1
Federal Register / Vol. 78, No. 80 / Thursday, April 25, 2013 / Notices
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.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2013–09797 Filed 4–24–13; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0642]
Assay Migration Studies for In Vitro
Diagnostic Devices; Guidance for
Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of the guidance entitled
‘‘Assay Migration Studies for In Vitro
Diagnostic Devices.’’ This guidance
presents a least burdensome regulatory
approach to gain FDA approval of Class
III or certain licensed in vitro diagnostic
devices in cases when a previously
approved assay is migrating (i.e.,
transitioning) to a new system for which
the assay has not been previously
approved, licensed, or cleared.
DATES: Submit either electronic or
written comments on this guidance at
any time. General comments on Agency
guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for
single copies of the guidance document
entitled ‘‘Assay Migration Studies for In
Vitro Diagnostic Devices’’ to the
Division of Small Manufacturers,
International and Consumer Assistance,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
Rm. 4613, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your request, or fax your request to 301–
847–8149. Alternatively, you may
submit written requests for single copies
of the guidance to the Office of
Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), 1401 Rockville Pike, suite
200N, Rockville, MD 20852. See the
SUPPLEMENTARY INFORMATION section for
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:22 Apr 24, 2013
Jkt 229001
information on electronic access to the
guidance.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. Identify comments with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Sally Hojvat, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5524, Silver Spring,
MD 20993–002, 301–796–5455.
For further information concerning
the study designs in the guidance:
Marina V. Kondratovich, Center for
Devices and Radiological Health,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm.
5666, Silver Spring, MD 20993–002,
301–796–6036.
For further information concerning
the guidance as it relates to devices
regulated by CBER:
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 1401 Rockville
Pike, suite 200N, Rockville, MD
20852, 301–827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
The Food and Drug Administration
(FDA) is announcing the availability of
a guidance document for industry and
FDA staff entitled ‘‘Assay Migration
Studies for In Vitro Diagnostic Devices.’’
This guidance presents a least
burdensome regulatory approach to gain
FDA approval of Class III or certain
licensed in vitro diagnostic devices in
cases when a previously approved assay
is migrating (i.e., transitioning) to a new
system for which the assay has not been
previously approved or licensed. The
approach in this guidance is also
applicable for some 510(k) cleared
devices for which transition to a new
system presents specific concerns,
either because of the nature of the
analyte and indications, or because of
the specific technology used (e.g.,
nucleic acid amplification tests). The
focus of this guidance is on the study
designs and performance criteria that
should be fulfilled in order for a sponsor
to utilize the migration study approach
in support of the change. The FDA
believes that the assay migration study
paradigm discussed in this guidance
provides a least burdensome scientific
and regulatory pathway for
manufacturers to transfer a previously
approved or licensed assay with full
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
24425
clinical data from an old system to a
new system (previously not approved or
licensed). The paradigm is suitable in
cases when sufficient knowledge can be
derived from the documentation of
design controls, risk analyses, and prior
performance studies on an old system.
The draft of this guidance was issued
on January 5, 2009 (74 FR 302). The
comment period closed on April 6,
2009. Three sets of comments were
received and reviewed by FDA. The
guidance was updated to address
comments where appropriate. The
updated guidance contains additional
examples and explanations and
supersedes the draft guidance ‘‘Assay
Migration Studies for In Vitro
Diagnostic Devices’’ issued on January
5, 2009.
II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on ‘‘migration studies’’
for in vitro diagnostic device. It does not
create or confer any rights for or on any
person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by using the
Internet. A search capability for all
CDRH guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov. To
receive ‘‘Assay Migration Studies for In
Vitro Diagnostic Devices,’’ you may
either send an email request to
dsmica@fda.hhs.gov to receive an
electronic copy of the document or send
a fax request to 301–847–8149 to receive
a hard copy. Please use the document
number 1660 to identify the guidance
you are requesting. Guidance
documents are also available on the
CBER Internet site at https://www.fda.
gov/BiologicsBloodVaccines/Guidance
ComplianceRegulatoryInformation/
default.htm.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations and guidance
documents. These collections of
information are subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). The
E:\FR\FM\25APN1.SGM
25APN1
]]>Agencies
[Federal Register Volume 78, Number 80 (Thursday, April 25, 2013)]
[Notices]
[Pages 24423-24425]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-09797]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: Child Support Noncustodial Parent Employment Demonstration
(CSPED).
OMB No.: 0970--NEW.
Description: The Office of Child Support Enforcement (OCSE) within
the Administration for Children and Families (ACF) is proposing data
collection activity as part of the Child Support Noncustodial Parent
Employment Demonstration (CSPED). In October 2012, OCSE issued grants
to eight state child support agencies to provide employment, parenting,
and child support services to noncustodial parents who are having
difficulty meeting their child support obligation. The overall
objective of the CSPED evaluation is to document and evaluate the
effectiveness of the approaches taken by these eight CSPED grantees.
This evaluation will yield information about effective strategies for
improving child support payments by providing noncustodial parents
employment and other services through child support programs. It will
generate extensive information on how these programs operated, what
they cost, the effects the programs had, and whether the benefits of
the programs exceed their costs. The information gathered will be
critical to informing decisions related to future investments in child
support-led employment-focused programs for noncustodial parents who
have difficulty meeting their child support obligations.
The CSPED evaluation will include the following two interconnected
components or ``studies'':
1. Implementation and Cost Study. The goal of the implementation
and cost study is to provide a detailed description of the programs--
how they are implemented, their participants, the contexts in which
they are operated, their promising practices, and their costs. The
detailed descriptions will assist in interpreting program impacts,
identifying program features and conditions necessary for effective
program replication or improvement, and carefully documenting the costs
of delivering these services. Key activities of the implementation and
cost study will include: (1) Conducting semi-structured interviews with
program staff
[[Page 24424]]
and selected community partner organizations to gather information on
program implementation and costs; (2) conducting focus groups with
program participants to elicit participation experiences; (3)
administering a web-based survey to program staff and community
partners to capture broader staff program experiences; and (4)
collecting data on study participant service use, dosage, and duration
of enrollment throughout the demonstration using a web-based Management
Information System (MIS).
2. Impact Study. The goal of the impact study is to provide
rigorous estimates of the effectiveness of the eight programs using an
experimental research design. Program applicants who are eligible for
CSPED services will be randomly assigned to either a program group that
is offered program services or a control group that is not. The study
MIS that will document service use for the implementation study will
also be used by grantee staff to conduct random assignment for the
impact study. The impact study will rely on data from surveys of
participants, as well as administrative records from state and county
data systems. Survey data will be collected twice from program
applicants. Baseline information will be collected from all
noncustodial parents who apply for the program prior to random
assignment. A follow-up survey will be collected from sample members
twelve months after random assignment. A wide range of measures will be
collected through surveys, including measures of employment stability
and quality, barriers to employment, parenting and co-parenting, and
demographic and socio-economic characteristics. In addition, data on
child support obligations and payments, Temporary Assistance for Needy
Families (TANF) and Supplemental Nutrition Assistance Program (SNAP)
benefits, Medicaid receipt, involvement with the criminal justice
system, and earnings and benefit data collected through the
Unemployment Insurance (UI) system will be obtained from state and
county databases.
A 60-Day Federal Register Notice was published for this study on
January 11, 2013. This 30-Day Federal Register Notice covers the
following data collection activities: (1) Topic guides for semi-
structured interviews with program staff and community partners, (2)
focus group guides for program participants, (3) the web-based survey
to document program staff and partner experiences, (4) the Management
Information System (MIS) functions for tracking participation in the
program, (5) an introductory script which program staff will use to
introduce the study to participants, (6) the baseline survey used to
capture participant characteristics prior to randomization, (7) the MIS
functions for conducting random assignment, and (8) the extraction of
child support, benefit, earnings, and criminal justice data extracted
from state and county administrative data systems.
Respondents: Respondents include program applicants, study
participants, grantee staff and community partners, as well as state
and county staff responsible for extracting data from government
databases for the evaluation. Specific respondents per instrument are
noted in the burden table below.
Annual Burden Estimates
The following tables provide the burden estimates for the
implementation and cost study and the impact study components of the
current request.
Implementation and Cost Study
----------------------------------------------------------------------------------------------------------------
Number of Average
Instrument Number of responses per burden hours Total burden
respondents respondent per response hours
----------------------------------------------------------------------------------------------------------------
Staff interview topic guide with program staff 120 2 1 240
and community partners..........................
Focus group guide with program participants...... 240 1 1.5 360
Web survey of program staff and community 200 2 0.5 200
partners........................................
Study MIS for grantee and partner staff to track 200 1,500 0.0333 10,000
program participation...........................
----------------------------------------------------------------------------------------------------------------
Impact Study
----------------------------------------------------------------------------------------------------------------
Number of Average
Instrument Number of responses per burden hours Total burden
respondents respondent per response hours
----------------------------------------------------------------------------------------------------------------
Introductory script:
Grantee staff................................ 120 105 0.1667 2,100
Program applicants \1\....................... 12,600 1 0.1667 2,100
Baseline survey of study participants............ 12,000 1 0.5833 7,000
Study MIS used by program staff to conduct random 120 105 0.1667 2,100
assignment......................................
Protocol for collecting administrative records... 32 2 8 512
----------------------------------------------------------------------------------------------------------------
\1\ Five percent of program applicants are not expected to agree to participate in the study; thus there are 5%
more program applicants than study participants.
Estimated Total Annual Burden Hours: 8,204.
Additional Information: In compliance with the requirements of
Section 3506(c)(2)(A) of the Paper Work 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 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:
ACF Reports Clearance Officer. All requests should be identified by the
title of the information collection. Email address:
infocollection@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
[[Page 24425]]
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.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2013-09797 Filed 4-24-13; 8:45 am]
BILLING CODE 4184-01-P
