Submission for OMB Review; Comment Request, 13370-13371 [2016-05605]
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13370
Federal Register / Vol. 81, No. 49 / Monday, March 14, 2016 / Notices
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. 2016–05641 Filed 3–11–16; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
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 30-Day Notice includes the
following data collection activities: (1)
A topic guide for semi-structured
interviews with program staff and
community stakeholders, (2) focus
group guides for adult program
participants, (3) focus group guides for
youth in schools, (4) a staff survey, (5)
the MIS functions for collecting data on
adherence to program curricula (6)
introductory script that program staff
will use to introduce the study to
participants, (7) the MIS functions for
conducting random assignment, (8) a
baseline survey for youth, (9) a followup survey for youth, (10) a baseline
survey for adults, and (11) a follow-up
survey for adults.
Respondents: Program applicants,
study participants, grantee staff, and
local stakeholders (such as staff at
referral agencies).
ANNUAL BURDEN ESTIMATES
Total
number of
respondents
Instrument
jstallworth on DSK7TPTVN1PROD with NOTICES
1. Topic guide for staff and stakeholder interviews ............
2. Focus group guide for adults ..........................................
3. Focus group guide for youth in schools .........................
4. Staff survey .....................................................................
5. Study MIS session adherence form ...............................
6a. Introductory script, grantee staff ...................................
6b. Introductory script, program applicants ........................
7. Study MIS to conduct random assignment ....................
8. Baseline survey for youth ...............................................
9. Follow-up survey for youth .............................................
10. Baseline survey for adults ............................................
11. Follow-up survey for adults ...........................................
Estimated Total Annual Burden
Hours: 3,579.
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
VerDate Sep<11>2014
14:27 Mar 11, 2016
Jkt 238001
Annual
number of
respondents
150
120
60
120
48
8
5,250
8
3,600
3,240
4,000
3,200
50
40
20
40
48
18
1,750
18
1,200
1,080
1,333
1,067
C Street SW., Washington, DC 20201,
Attn: OPRE Reports Clearance Officer.
All requests should be identified by the
title of the information collection. Email
address: OPREinfocollection@
acf.hhs.gov.
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
1
1
1
1
104
219
1
208
1
1
1
1
Average
burden hours
per response
1
1.5
1.5
.5
.08
.08
.08
.08
.5
.5
.5
.75
Annual
burden hours
50
60
30
20
399
140
140
133
600
540
667
800
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
E:\FR\FM\14MRN1.SGM
14MRN1
Federal Register / Vol. 81, No. 49 / Monday, March 14, 2016 / Notices
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,
ACF Certifying Officer.
[FR Doc. 2016–05605 Filed 3–11–16; 8:45 am]
BILLING CODE 4184–73–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–2235]
Draft Environmental Assessment and
Preliminary Finding of No Significant
Impact Concerning Investigational Use
of Oxitec OX513A Mosquitoes;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, the Agency) is
announcing the availability for public
comment of the draft environmental
assessment (EA) submitted by Oxitec
Ltd. and a preliminary finding of no
significant impact (FONSI) in support of
the conduct of an investigational release
of genetically engineered (GE)
mosquitoes under an investigational
new animal drug exemption.
DATES: Submit either electronic or
written comments on the draft EA by
April 13, 2016.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
jstallworth on DSK7TPTVN1PROD with NOTICES
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
VerDate Sep<11>2014
14:27 Mar 11, 2016
Jkt 238001
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): 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–
2014–N–2235 for Draft Environmental
Assessment and Preliminary Finding of
No Significant Impact Concerning
Investigational Use of Oxitec OX513A
Mosquitoes. 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
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. 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
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
13371
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of the guidance to the Policy and
Regulations Staff (HFV–6), Center for
Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests.
Persons with access to the Internet may
obtain the draft EA at either https://
www.fda.gov/animalveterinary/
developmentapprovalprocess/
environmentalassessments/
ucm300656.htm or https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Brinda Dass, Center for Veterinary
Medicine (HFV–2), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8247,
email: abig@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
announcing that a draft EA and
preliminary FONSI, in support of a
proposed investigational release (i.e.,
field trial) of OX513A Aedes aegypti GE
mosquitoes (OX513A mosquitoes), as
part of an existing mosquito control
program in Key Haven, FL, are being
made available for public comment. The
OX513A is a strain of Ae. aegypti
mosquito whose recombinant DNA
(rDNA) construct encodes a conditional
lethality trait such that the offspring of
the matings of male OX513A
mosquitoes and wild type Ae. aegypti
do not survive to adulthood. The
intended result is a decrease in the
overall population of Ae. aegypti in the
environment. Only male OX513A
mosquitoes are intended to be released.
To encourage public transparency,
and in compliance with 21 CFR
25.51(b)(3), the Agency is placing Oxitec
Ltd.’s draft EA and preliminary FONSI
that are the subject of this notice on
public display at the Division of Dockets
E:\FR\FM\14MRN1.SGM
14MRN1
]]>Agencies
[Federal Register Volume 81, Number 49 (Monday, March 14, 2016)]
[Notices]
[Pages 13370-13371]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05605]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; 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 30-Day Notice includes the following data collection
activities: (1) A topic guide for semi-structured interviews with
program staff and community stakeholders, (2) focus group guides for
adult program participants, (3) focus group guides for youth in
schools, (4) a staff survey, (5) the MIS functions for collecting data
on adherence to program curricula (6) introductory script that program
staff will use to introduce the study to participants, (7) the MIS
functions for conducting random assignment, (8) a baseline survey for
youth, (9) a follow-up survey for youth, (10) a baseline survey for
adults, and (11) a follow-up survey for adults.
Respondents: Program applicants, study participants, grantee staff,
and local stakeholders (such as staff at referral agencies).
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Total number Annual number Number of Average
Instrument of of responses per burden hours Annual burden
respondents respondents respondent per response hours
----------------------------------------------------------------------------------------------------------------
1. Topic guide for staff and 150 50 1 1 50
stakeholder interviews.........
2. Focus group guide for adults. 120 40 1 1.5 60
3. Focus group guide for youth 60 20 1 1.5 30
in schools.....................
4. Staff survey................. 120 40 1 .5 20
5. Study MIS session adherence 48 48 104 .08 399
form...........................
6a. Introductory script, grantee 8 \1\ 8 219 .08 140
staff..........................
6b. Introductory script, program 5,250 1,750 1 .08 140
applicants.....................
7. Study MIS to conduct random 8 \1\ 8 208 .08 133
assignment.....................
8. Baseline survey for youth.... 3,600 1,200 1 .5 600
9. Follow-up survey for youth... 3,240 1,080 1 .5 540
10. Baseline survey for adults.. 4,000 1,333 1 .5 667
11. Follow-up survey for adults. 3,200 1,067 1 .75 800
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 3,579.
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, 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
[[Page 13371]]
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,
ACF Certifying Officer.
[FR Doc. 2016-05605 Filed 3-11-16; 8:45 am]
BILLING CODE 4184-73-P
