Attachment J - STREAMS 60 Day FRN

Federal Register / Vol. 83, No. 234 / Thursday, December 6, 2018 / Notices

62871

ANNUAL BURDEN ESTIMATES
Instrument

Number of
respondents

Number of
responses per
respondent

Average
burden hours
per
response

Total burden
hours

OCSE–157 .......................................................................................................

54

1

7

378

Estimated Total Annual Burden
Hours: 378.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 330
C Street SW, Washington, DC 20201.
Attention 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
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. 2018–26508 Filed 12–4–18; 8:45 am]
BILLING CODE 4184–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Strengthening Relationship
Education and Marriage Services
(STREAMS) Evaluation (OMB#0970–
0481)
Office of Planning, Research,
and Evaluation, Administration for
Children and Families, HHS.

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AGENCY:

ACTION:

Request for Public Comment.

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The Office of Family
Assistance (OFA) within the
Administration for Children and
Families (ACF) at the U.S. Department
of Health and Human Services has
issued grants to organizations to provide
healthy marriage and relationship
education (HMRE) services. Under a
previously approved data collection
activity (OMB#0970–0481), the Office of
Planning, Research, and Evaluation
(OPRE) within ACF is conducting the
Strengthening Relationship Education
and Marriage Services (STREAMS)
evaluation with five HMRE grantees.
The purpose of STREAMS is to measure
the effectiveness and quality of HMRE
programs designed to strengthen
intimate relationships. This data
collection request is for an extension of
previously approved data collection
instruments and for two additional data
collection instruments.
DATES: Comments due within 60 days of
publication. 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.
ADDRESSES: 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.
SUPPLEMENTARY INFORMATION:
Description: The STREAMS
evaluation includes two components, an
impact study and a process study. The
evaluation will examine HMRE
programs for youth in high school, adult
couples, and adult individuals.
SUMMARY:

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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 uses an experimental design.
Eligible program applicants are
randomly assigned to either a program
group that is offered program services or
a control group that is not. STREAMS
collects baseline information from
eligible program applicants prior to
random assignment and administers a
follow-up survey to 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
conducts semi-structured interviews
with program staff and selected
community stakeholders, conducts
focus groups with program participants,
administers a survey to program staff,
and collects data on adherence to
program curricula through an add on to
an existing program MIS (nFORM, OMB
no. 0970–0460).
This data collection request is for an
extension of previously approved data
collection instruments for the impact
study and for two additional data
collection instruments associated with
the impact study. The two additional
instruments will allow for longer-term
follow-up in two of the five evaluation
sites. (1) The second follow-up survey
for youth will be administered
approximately 24 to 36 months after
random assignment to study
participants in the STREAMS site
serving youth. (2) The second follow-up
survey for adults will be administered
approximately 30 months after random
assignment to study participants in one
of the STREAMS evaluation sites
serving adults.
Respondents: Study participants.

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62872

Federal Register / Vol. 83, No. 234 / Thursday, December 6, 2018 / Notices
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

Previously Approved Burden that Remains
Introductory script, grantee staff ..........................................
Introductory script, program applicants ...............................
Add-on to nFORM to conduct random assignment .............
Follow-up survey for youth ..................................................
Baseline survey for adults ...................................................
Follow-up survey for adults ..................................................

8
600
8
690
600
2,300

8
200
8
230
200
767

25
1
25
1
1
1

0.08
0.08
0.08
0.5
0.5
0.75

16
16
16
115
100
575

500
267

1
1

0.5
0.75

250
200

Estimated Total Annual Burden Hours: ........................................................................................................................................

1,288

Current Request for Approval
Second follow-up survey for youth ......................................
Second follow-up survey for adults .....................................

Comments: 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.
Authority: 42 U.S.C. 603; Sec. 811 (b)
Healthy Marriage Promotion and Promoting
Responsible Fatherhood Grants of the Claims
Resolution Act of 2010, Pub. L. No. 111–291,
124 Stat. 3064
Mary B. Jones,
ACF/OPRE Certifying Officer.
BILLING CODE 4184–73–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration

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[Docket No. FDA–2014–D–1814]

Bacterial Risk Control Strategies for
Blood Collection Establishments and
Transfusion Services To Enhance the
Safety and Availability of Platelets for
Transfusion; Draft Guidance for
Industry; Availability
Food and Drug Administration,

HHS.
ACTION:

Notice of availability.

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The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
document entitled ‘‘Bacterial Risk
Control Strategies for Blood Collection
Establishments and Transfusion
Services to Enhance the Safety and
Availability of Platelets for Transfusion;
Draft Guidance for Industry.’’ The draft
guidance document provides blood
collection establishments and
transfusion services with
recommendations to control the risk of
bacterial contamination of room
temperature stored platelets intended
for transfusion. The guidance provides
recommendations for all platelet
products, including platelets
manufactured by automated methods
(apheresis platelets), whole blood
derived (WBD) platelets, pooled
platelets (pre-storage and post-storage)
and platelets stored in additive
solutions. The draft guidance replaces
the draft guidance of the same title
dated March 2016.

SUMMARY:

Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by February 4,
2019. Submit either electronic or
written comments on the draft guidance
by February 4, 2019 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.

DATES:

[FR Doc. 2018–26450 Filed 12–4–18; 8:45 am]

AGENCY:

1,500
800

You may submit comments
on any guidance at any time as follows:

ADDRESSES:

Electronic Submissions
Submit electronic comments in the
following way:

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• 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–
2014–D–1814 for ‘‘Bacterial Risk
Control Strategies for Blood Collection

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