Proposed Information Collection Activity; Comment Request, 76499-76500 [2015-30994]
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Federal Register / Vol. 80, No. 236 / Wednesday, December 9, 2015 / Notices
analytical approaches integrating
multiple sources of data and in using
the results for impact monitoring,
planning, and HIV/AIDS policy-making;
(7) supports and strengthens global and
country capacity to monitor and
evaluate HIV/AIDS prevention, care,
treatment programs, health system
strengthening, other related global
health programs, and health systems
through the development of standards,
guidelines, curricula, and other tools;
(8) coordinates, oversees, or assists in
the formulation of M&E funding/budgets
and in the execution of extramural
awards; and (9) collaborates with other
DGHT branches, other CDC and HHS
programs and offices, other USG
agencies, and other national and
international organizations.
James Seligman,
Acting Chief Operating Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2015–30968 Filed 12–8–15; 8:45 am]
BILLING CODE 4160–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Title: Strengthening Relationship
Education and Marriage Services
(STREAMS) Evaluation
OMB No.: New Collection
Description: The Office of Family
Assistance (OFA) within the
Administration for Children and
Familes (ACF) at the U.S. Department of
Health and Human Services has issued
grants to 46 organizations to provide
healthy marriage and relationship
education (HMRE) services. The Office
of Planning, Research, and Evaluation
(OPRE) within ACF proposes data
collection activity in six HMRE grantees
as part of the Strengthening
Relationship Education and Marriage
Services (STREAMS) evaluation. The
purpose of STREAMS is to measure the
effectiveness and quality of HMRE
programs designed to strengthen
intimate relationships. In particular, the
evaluation will examine HMRE
programs for youth in high school, atrisk youth, and adults. The study will
fill knowledge gaps about the
effectiveness of HMRE programming for
youth and adults and strategies for
improving program delivery and
participant engagement in services. The
STREAMS evaluation will include two
components, an impact study and a
process study.
1. Impact Study. The goal of the
impact study is to provide rigorous
estimates of the effectiveness of program
services and interventions to improve
program implementation. The impact
study will use an experimental design.
Eligible program applicants will be
randomly assigned to either a program
group that is offered program services or
a control group that is not. Grantee staff
will use an add-on to an existing
program MIS (the nFORM system, OMB
no. 0970–0460) to conduct random
assignment in sites enrolling at-risk
youth and adults. STREAMS will use
classroom-level or school-level random
assignment for programs serving youth
in high school. STREAMS will collect
baseline information from eligible
program applicants prior to random
assignment and administer a follow-up
survey to all study participants 12
months after random assignment.
2. Process study. The goal of the
process study is to support the
interpretation of impact findings and
document program operations to
support future replication. STREAMS
will conduct semi-structured interviews
with program staff and selected
community stakeholders, conduct focus
groups with program participants,
administer a paper-and-pencil survey to
program staff, and collect data on
adherence to program curricula through
an add on to an existing program MIS
(nForm, OMB no. 0970–0460).
This 60-Day Notice includes the
following data collection activities: (1)
Introductory script that program staff
will use to introduce the study to
participants, (2) the MIS functions for
conducting random assignment, (3) a
baseline survey for youth, (4) a baseline
survey for adults, (5) a follow-up survey
for youth, (6) a follow-up survey for
adults, (7) a topic guide for semistructured interviews with program staff
and community stakeholders, (8) focus
group guides for program participants,
(9) a staff survey, and (10) the MIS
functions for collecting data on
adherence to program curricula.
Respondents: Program applicants,
study participants, grantee staff, and
local stakeholders (such as staff at
referral agencies).
ANNUAL BURDEN ESTIMATES
Total number
of respondents
Instrument
Annual
number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Annual burden
hours
Impact Study, Introductory Script and Random Assignment
1. Grantee staff ....................................................................
2. Program applicants ..........................................................
3. Study MIS for grantee to conduct random assignment ..
24
7,500
16
12
3,750
8
313
1
313
.08
.08
.08
301
300
200
1,550
2,000
1,395
1,600
1
1
1
1
.5
.5
.5
.75
775
1,000
698
1,200
75
45
30
15
60
1
1
1
1
1
1
1.5
1.5
1.5
.5
75
68
45
23
30
Impact Study, Baseline Surveys
mstockstill on DSK4VPTVN1PROD with NOTICES
4.
5.
6.
7.
Baseline Survey for Youth ...............................................
Baseline Survey for Adults ..............................................
Follow-up Survey for Youth .............................................
Follow-up Survey for Adults ............................................
3,100
4,000
2,790
3,200
Process Study
8. Topic guide for process study staff and stakeholder
interviews ..........................................................................
9. Focus group guide for adults ...........................................
10. Focus group guide for youth in schools ........................
11. Focus group guide for youth out of schools ..................
12. Staff survey ....................................................................
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Federal Register / Vol. 80, No. 236 / Wednesday, December 9, 2015 / Notices
ANNUAL BURDEN ESTIMATES—Continued
Total number
of respondents
Instrument
13. Study MIS nFORM for grantees to report session adherence to curriculum .......................................................
Estimated Total Annual Burden
Hours: 5,314
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.
Robert Sargis,
ACF Certifying Officer.
[FR Doc. 2015–30994 Filed 12–8–15; 8:45 am]
mstockstill on DSK4VPTVN1PROD with NOTICES
BILLING CODE 4184–73–P
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Jkt 238001
Annual
number of
respondents
48
24
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–2881]
Standards-Based Approach to
Analytical Performance Evaluation of
Next Generation Sequencing in Vitro
Diagnostic Tests; Public Workshop;
Reopening of Comment Period
AGENCY:
Number of
responses per
respondent
Food and Drug Administration,
312
Average
burden hours
per response
.08
Annual burden
hours
599
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’’).
HHS.
Written/Paper Submissions
Notice of public workshop;
reopening of comment period.
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–N–2881 for ‘‘Standards-Based
Approach to Analytical Performance
Evaluation of Next-Generation
Sequencing In Vitro Diagnostic Tests.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
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
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
ACTION:
The Food and Drug
Administration (FDA) is reopening the
comment period for the notice of a
public workshop that appeared in the
Federal Register of September 9, 2015.
In the notice of the public workshop,
FDA requested comments on the
workshop topics about the proposed
standards-based regulatory strategy for
next-generation sequencing (NGS) tests
that produce results on variation in the
human genome. The Agency is taking
this action in response to requests to
allow interested persons additional time
to submit comments.
DATES: FDA is reopening the comment
period for the notice of the public
workshop published September 9, 2015.
Submit either electronic or written
comments by December 24, 2015.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
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
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Agencies
[Federal Register Volume 80, Number 236 (Wednesday, December 9, 2015)]
[Notices]
[Pages 76499-76500]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-30994]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Title: Strengthening Relationship Education and Marriage Services
(STREAMS) Evaluation
OMB No.: New Collection
Description: The Office of Family Assistance (OFA) within the
Administration for Children and Familes (ACF) at the U.S. Department of
Health and Human Services has issued grants to 46 organizations to
provide healthy marriage and relationship education (HMRE) services.
The Office of Planning, Research, and Evaluation (OPRE) within ACF
proposes data collection activity in six HMRE grantees as part of the
Strengthening Relationship Education and Marriage Services (STREAMS)
evaluation. The purpose of STREAMS is to measure the effectiveness and
quality of HMRE programs designed to strengthen intimate relationships.
In particular, the evaluation will examine HMRE programs for youth in
high school, at-risk youth, and adults. The study will fill knowledge
gaps about the effectiveness of HMRE programming for youth and adults
and strategies for improving program delivery and participant
engagement in services. The STREAMS evaluation will include two
components, an impact study and a process study.
1. Impact Study. The goal of the impact study is to provide
rigorous estimates of the effectiveness of program services and
interventions to improve program implementation. The impact study will
use an experimental design. Eligible program applicants will be
randomly assigned to either a program group that is offered program
services or a control group that is not. Grantee staff will use an add-
on to an existing program MIS (the nFORM system, OMB no. 0970-0460) to
conduct random assignment in sites enrolling at-risk youth and adults.
STREAMS will use classroom-level or school-level random assignment for
programs serving youth in high school. STREAMS will collect baseline
information from eligible program applicants prior to random assignment
and administer a follow-up survey to all study participants 12 months
after random assignment.
2. Process study. The goal of the process study is to support the
interpretation of impact findings and document program operations to
support future replication. STREAMS will conduct semi-structured
interviews with program staff and selected community stakeholders,
conduct focus groups with program participants, administer a paper-and-
pencil survey to program staff, and collect data on adherence to
program curricula through an add on to an existing program MIS (nForm,
OMB no. 0970-0460).
This 60-Day Notice includes the following data collection
activities: (1) Introductory script that program staff will use to
introduce the study to participants, (2) the MIS functions for
conducting random assignment, (3) a baseline survey for youth, (4) a
baseline survey for adults, (5) a follow-up survey for youth, (6) a
follow-up survey for adults, (7) a topic guide for semi-structured
interviews with program staff and community stakeholders, (8) focus
group guides for program participants, (9) a staff survey, and (10) the
MIS functions for collecting data on adherence to program curricula.
Respondents: Program applicants, study participants, grantee staff,
and local stakeholders (such as staff at referral agencies).
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Annual number Number of Average
Instrument Total number of responses per burden hours Annual burden
of respondents respondents respondent per response hours
----------------------------------------------------------------------------------------------------------------
Impact Study, Introductory Script and Random Assignment
----------------------------------------------------------------------------------------------------------------
1. Grantee staff................ 24 12 313 .08 301
2. Program applicants........... 7,500 3,750 1 .08 300
3. Study MIS for grantee to 16 8 313 .08 200
conduct random assignment......
----------------------------------------------------------------------------------------------------------------
Impact Study, Baseline Surveys
----------------------------------------------------------------------------------------------------------------
4. Baseline Survey for Youth.... 3,100 1,550 1 .5 775
5. Baseline Survey for Adults... 4,000 2,000 1 .5 1,000
6. Follow-up Survey for Youth... 2,790 1,395 1 .5 698
7. Follow-up Survey for Adults.. 3,200 1,600 1 .75 1,200
----------------------------------------------------------------------------------------------------------------
Process Study
----------------------------------------------------------------------------------------------------------------
8. Topic guide for process study 150 75 1 1 75
staff and stakeholder
interviews.....................
9. Focus group guide for adults. 90 45 1 1.5 68
10. Focus group guide for youth 60 30 1 1.5 45
in schools.....................
11. Focus group guide for youth 30 15 1 1.5 23
out of schools.................
12. Staff survey................ 120 60 1 .5 30
[[Page 76500]]
13. Study MIS nFORM for grantees 48 24 312 .08 599
to report session adherence to
curriculum.....................
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 5,314
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.
Robert Sargis,
ACF Certifying Officer.
[FR Doc. 2015-30994 Filed 12-8-15; 8:45 am]
BILLING CODE 4184-73-P