Proposed Information Collection Activity; Comment Request; Healthy Marriage and Responsible Fatherhood Performance Measures and Additional Data Collection (Part of the Fatherhood and Marriage Local Evaluation and Cross-Site (FaMLE Cross-Site) Project)-Extension, 5631-5633 [2018-02494]
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Federal Register / Vol. 83, No. 27 / Thursday, February 8, 2018 / Notices
(OFA) achieve its goals to foster
economically secure households and
communities for the well-being and
long-term success of children and
families. The purpose of the PAIVED
study is to better understand the
prevalence of intimate partner violence
(IPV) experienced by the population of
fathers served by Responsible
Fatherhood (RF) programs, and the
services that federally-funded RF
programs are providing to address and
contribute to the prevention of IPV
among its participants. The proposed
data collection will include whether IPV
content is included in RF programs, the
types of activities they are using to
address IPV, and related successes and
challenges. Other collected data will
include barriers to addressing IPV in RF
programs, the relevance of addressing
IPV with fathers, fathers’ reactions to
this programming, and what types of
partnerships RF programs have with
other agencies to address IPV. This
information will be collected through
interviews conducted over the phone
and in-person with RF grantee program
staff and community partners. This
information will be critical to inform
future efforts to address and contribute
to the prevention of IPV through RF
programming.
Respondents: Responsible Fatherhood
grantee program staff (e.g., program
directors and facilitators) and
community partners.
ANNUAL BURDEN ESTIMATES
Total/annual
number of
respondents
Instrument
daltland on DSKBBV9HB2PROD with NOTICES
RF grantee/community partner screening and participant recruitment ...........
RF grantee program staff semi-structured interview .......................................
Community partner semi-structured interview .................................................
Estimated Total Annual Burden
Hours: 87.
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, 330 C Street SW,
Washington, DC 20201, 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
VerDate Sep<11>2014
17:18 Feb 07, 2018
Jkt 244001
37
23
10
comments and suggestions submitted
within 60 days of this publication.
Mary Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2018–02476 Filed 2–7–18; 8:45 am]
BILLING CODE 4184–73–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
[OMB NO.: 0970–0460]
Proposed Information Collection
Activity; Comment Request; Healthy
Marriage and Responsible Fatherhood
Performance Measures and Additional
Data Collection (Part of the Fatherhood
and Marriage Local Evaluation and
Cross-Site (FaMLE Cross-Site)
Project)—Extension
Description
Background
For decades various organizations and
agencies have been developing and
operating programs to strengthen
families through healthy marriage and
relationship education and responsible
fatherhood programming. The
Administration for Children and
Families (ACF), Office of Family
Assistance (OFA), has had
administrative responsibility for federal
funding of such programs since 2006
through the Healthy Marriage (HM) and
Responsible Fatherhood (RF) Grant
Programs. The authorizing legislation
for the programs may be found in
Section 403(a)(2) of the Social Security
Act [1].
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
1
1
1
Average
burden hours
per response
Annual
burden hours
1
1.5
1.5
37
35
15
Extension of Current Approval
The Offices of Family Assistance
(OFA) and Planning, Research and
Evaluation (OPRE) in the
Administration for Children and
Families (ACF), U.S. Department of
Health and Human Services (HHS) are
proposing to extend performance
measure and other data collection
activities, in service to the HM and RF
programs. This data collection is part of
the Fatherhood and Marriage Local
Evaluation and Cross-site (FaMLE Crosssite) project, whose purpose is to
support high quality data collection,
strengthen local evaluations, and
conduct cross-site analysis for the
Responsible Fatherhood and Healthy
Marriage grantees. ACF is requesting
comment on the following data
collection, which has been ongoing
under OMB #0970–0460 since 2016.
There are no changes proposed to the
information collection, we are only
requesting an extension to continue data
collection with the current grantees
through 2020.
Performance measures. ACF is
proposing to extend collection of a set
of performance measures that are
collected by all grantees. These
measures collect standardized
information in the following areas:
• Applicant characteristics;
• Program operations (including
program characteristics and service
delivery); and
• Participant outcomes:
Æ Entrance survey, with four
versions: (1) Healthy Marriage Program
Pre-Program Survey for Adult-Focused
Programs; (2) Healthy Marriage Program
Pre-Program Survey for Youth-Focused
Programs; (3) Responsible Fatherhood
E:\FR\FM\08FEN1.SGM
08FEN1
5632
Federal Register / Vol. 83, No. 27 / Thursday, February 8, 2018 / Notices
Program Pre-Program Survey for
Community-Based-Fathers; and (4)
Responsible Fatherhood Program PreProgram Survey for Incarcerated
Fathers.
Æ Exit survey, with four versions: (1)
Healthy Marriage Program Post-Program
Survey for Adult-Focused Programs; (2)
Healthy Marriage Program Post-Program
Survey for Youth-Focused Programs; (3)
Responsible Fatherhood Program PostProgram Survey for Community-BasedFathers; and (4) Responsible Fatherhood
Program Post-Program Survey for
Incarcerated Fathers.
These measures were developed per
extensive review of the research
literature and grantees’ past measures.
Grantees are required to submit data
on these standardized measures on a
regular basis (e.g., quarterly). In addition
to the performance measures mention
above, ACF proposes to extend
collection for these data submissions:
• Semi-annual Performance Progress
Report (PPR), with two versions: (1)
Performance Progress Report for Healthy
Marriage Programs, and (2) Performance
Progress Report for Responsible
Fatherhood Programs; and
• Quarterly Performance Report
(QPR), with two versions: (1) Quarterly
Performance Progress Report for Healthy
Marriage Programs, and (2) Quarterly
Performance Progress Report for
Responsible Fatherhood Programs.
A management information system
has been implemented which improves
efficiency and the quality of data, and
makes reporting easier.
Additional data collection. We also
seek to extend the approval to collect
information from a sub-set of grantees
on how they designed and implemented
their programs (information on
outcomes associated with programs will
also be assessed), per the following
protocols:
• Staff interview protocol on program
design (will be collected from about half
of all grantees);
• Staff interview protocols on
program implementation (will be
collected from about 10 grantees); and
• Program participant focus group
protocol (will be conducted with about
10 grantees).
Respondents: Responsible Fatherhood
and Healthy Marriage Program grantees
(e.g., grantee staff) and program
applicants and participants—
participants are called ‘‘clients.’’
ANNUAL BURDEN ESTIMATES
Instrument
Total
number of
respondents
Respondent
Annual
number of
respondents
Number of
responses per
respondent
Average
burden
hours per
response
Annual
burden
hours
Data Collection by Grantees (DCS, or Data Collected by Sites)
Instrument DCS–1: Applicant characteristics.
Instrument DCS–2: Grantee
program operations.
Instrument DCS–3: Service
receipt in MIS.
Instrument DCS–4: Entrance and Exit Surveys.
Instrument DCS–5: Semiannual report.
Instrument DCS–6: Quarterly performance report.
Program applicants ............
Program staff ......................
Program staff ......................
265,838
360
120
87,504
360
120
1
243
1
0.25
0.10
0.75
21,876
8,750
90
Program staff ......................
1,540
1,540
156
0.50
39,916
Program clients (Entrance
Survey; 4 versions).
Program clients (Exit Survey; 4 versions).
Program staff (Entrance
and Exit surveys on
paper).
Program staff (2 versions) ..
239,493
79,831
1
0.42
33,529
132,087
44,029
1
0.42
18,492
60
20
1,285
0.30
7,712
120
120
2
3
720
120
120
2
1
240
Program staff (2 versions) ..
Data Collection by the Contractor (DCI, or Data collected by the Contractor Itself)
daltland on DSKBBV9HB2PROD with NOTICES
Instrument DCI–1: Topic
guide on program design.
Instrument DCI–2: Topic
guide on program implementation.
Instrument DCI–3: Focus
group protocol.
Program staff ......................
60
20
1
1
20
Program staff ......................
300
100
1
1
100
Program clients ..................
801
267
1
1.50
401
Estimated Total Annual Burden
Hours: 131,846.
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
VerDate Sep<11>2014
17:18 Feb 07, 2018
Jkt 244001
to the Administration for Children and
Families, Office of Planning, Research,
and Evaluation, 330 C Street SW,
Washington, DC 20201, 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
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
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
E:\FR\FM\08FEN1.SGM
08FEN1
Federal Register / Vol. 83, No. 27 / Thursday, February 8, 2018 / Notices
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Reference
[1] https://www.ssa.gov/OP_Home/ssact/
title04/0403.htm.
Mary Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2018–02494 Filed 2–7–18; 8:45 am]
BILLING CODE 4184–35–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–E–1664]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; JUBLIA
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for JUBLIA and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of an
application to the Director of the U.S.
Patent and Trademark Office (USPTO),
Department of Commerce, for the
extension of a patent which claims that
human drug product.
DATES: Anyone with knowledge that any
of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by April 9, 2018.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
August 7, 2018. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before April 9, 2018.
The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of April 9, 2018. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:18 Feb 07, 2018
Jkt 244001
acceptance receipt is on or before that
date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2015–E–1664 for ’’Determination of
Regulatory Review Period for Purposes
of Patent Extension; JUBLIA.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
PO 00000
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Fmt 4703
Sfmt 4703
5633
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with § 10.20 (21
CFR 10.20) and other applicable
disclosure law. For more information
about FDA’s posting of comments to
public dockets, see 80 FR 56469,
September 18, 2015, or access the
information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6250, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION:
I. Background
The Drug Price Competition and
Patent Term Restoration Act of 1984
(Pub. L. 98–417) and the Generic
Animal Drug and Patent Term
Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
E:\FR\FM\08FEN1.SGM
08FEN1
]]>Agencies
[Federal Register Volume 83, Number 27 (Thursday, February 8, 2018)]
[Notices]
[Pages 5631-5633]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02494]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
[OMB NO.: 0970-0460]
Proposed Information Collection Activity; Comment Request;
Healthy Marriage and Responsible Fatherhood Performance Measures and
Additional Data Collection (Part of the Fatherhood and Marriage Local
Evaluation and Cross-Site (FaMLE Cross-Site) Project)--Extension
Description
Background
For decades various organizations and agencies have been developing
and operating programs to strengthen families through healthy marriage
and relationship education and responsible fatherhood programming. The
Administration for Children and Families (ACF), Office of Family
Assistance (OFA), has had administrative responsibility for federal
funding of such programs since 2006 through the Healthy Marriage (HM)
and Responsible Fatherhood (RF) Grant Programs. The authorizing
legislation for the programs may be found in Section 403(a)(2) of the
Social Security Act [1].
Extension of Current Approval
The Offices of Family Assistance (OFA) and Planning, Research and
Evaluation (OPRE) in the Administration for Children and Families
(ACF), U.S. Department of Health and Human Services (HHS) are proposing
to extend performance measure and other data collection activities, in
service to the HM and RF programs. This data collection is part of the
Fatherhood and Marriage Local Evaluation and Cross-site (FaMLE Cross-
site) project, whose purpose is to support high quality data
collection, strengthen local evaluations, and conduct cross-site
analysis for the Responsible Fatherhood and Healthy Marriage grantees.
ACF is requesting comment on the following data collection, which has
been ongoing under OMB #0970-0460 since 2016. There are no changes
proposed to the information collection, we are only requesting an
extension to continue data collection with the current grantees through
2020.
Performance measures. ACF is proposing to extend collection of a
set of performance measures that are collected by all grantees. These
measures collect standardized information in the following areas:
Applicant characteristics;
Program operations (including program characteristics and
service delivery); and
Participant outcomes:
[cir] Entrance survey, with four versions: (1) Healthy Marriage
Program Pre-Program Survey for Adult-Focused Programs; (2) Healthy
Marriage Program Pre-Program Survey for Youth-Focused Programs; (3)
Responsible Fatherhood
[[Page 5632]]
Program Pre-Program Survey for Community-Based-Fathers; and (4)
Responsible Fatherhood Program Pre-Program Survey for Incarcerated
Fathers.
[cir] Exit survey, with four versions: (1) Healthy Marriage Program
Post-Program Survey for Adult-Focused Programs; (2) Healthy Marriage
Program Post-Program Survey for Youth-Focused Programs; (3) Responsible
Fatherhood Program Post-Program Survey for Community-Based-Fathers; and
(4) Responsible Fatherhood Program Post-Program Survey for Incarcerated
Fathers.
These measures were developed per extensive review of the research
literature and grantees' past measures.
Grantees are required to submit data on these standardized measures
on a regular basis (e.g., quarterly). In addition to the performance
measures mention above, ACF proposes to extend collection for these
data submissions:
Semi-annual Performance Progress Report (PPR), with two
versions: (1) Performance Progress Report for Healthy Marriage
Programs, and (2) Performance Progress Report for Responsible
Fatherhood Programs; and
Quarterly Performance Report (QPR), with two versions: (1)
Quarterly Performance Progress Report for Healthy Marriage Programs,
and (2) Quarterly Performance Progress Report for Responsible
Fatherhood Programs.
A management information system has been implemented which improves
efficiency and the quality of data, and makes reporting easier.
Additional data collection. We also seek to extend the approval to
collect information from a sub-set of grantees on how they designed and
implemented their programs (information on outcomes associated with
programs will also be assessed), per the following protocols:
Staff interview protocol on program design (will be
collected from about half of all grantees);
Staff interview protocols on program implementation (will
be collected from about 10 grantees); and
Program participant focus group protocol (will be
conducted with about 10 grantees).
Respondents: Responsible Fatherhood and Healthy Marriage Program
grantees (e.g., grantee staff) and program applicants and
participants--participants are called ``clients.''
Annual Burden Estimates
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Respondent Total number Annual number responses per hours per Annual burden
of respondents of respondents respondent response hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Data Collection by Grantees (DCS, or Data Collected by Sites)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Instrument DCS-1: Applicant Program applicants.......... 265,838 87,504 1 0.25 21,876
characteristics. Program staff............... 360 360 243 0.10 8,750
Instrument DCS-2: Grantee program Program staff............... 120 120 1 0.75 90
operations.
Instrument DCS-3: Service receipt in MIS.. Program staff............... 1,540 1,540 156 0.50 39,916
Instrument DCS-4: Entrance and Exit Program clients (Entrance 239,493 79,831 1 0.42 33,529
Surveys. Survey; 4 versions).
Program clients (Exit 132,087 44,029 1 0.42 18,492
Survey; 4 versions).
Program staff (Entrance and 60 20 1,285 0.30 7,712
Exit surveys on paper).
Instrument DCS-5: Semi-annual report...... Program staff (2 versions).. 120 120 2 3 720
Instrument DCS-6: Quarterly performance Program staff (2 versions).. 120 120 2 1 240
report.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Data Collection by the Contractor (DCI, or Data collected by the Contractor Itself)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Instrument DCI-1: Topic guide on program Program staff............... 60 20 1 1 20
design.
Instrument DCI-2: Topic guide on program Program staff............... 300 100 1 1 100
implementation.
Instrument DCI-3: Focus group protocol.... Program clients............. 801 267 1 1.50 401
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 131,846.
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, 330 C Street SW, Washington, DC
20201, Attn: OPRE Reports Clearance Officer. Email address:
[email protected]. 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
[[Page 5633]]
other forms of information technology. Consideration will be given to
comments and suggestions submitted within 60 days of this publication.
Reference
[1] https://www.ssa.gov/OP_Home/ssact/title04/0403.htm.
Mary Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2018-02494 Filed 2-7-18; 8:45 am]
BILLING CODE 4184-35-P
