81_FR_13419 81 FR 13370 - Submission for OMB Review; Comment Request

81 FR 13370 - Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families

Federal Register Volume 81, Issue 49 (March 14, 2016)

Page Range13370-13371
FR Document2016-05605

Federal Register, Volume 81 Issue 49 (Monday, March 14, 2016)
[Federal Register Volume 81, Number 49 (Monday, March 14, 2016)]
[Notices]
[Pages 13370-13371]
From the Federal Register Online  [www.thefederalregister.org]
[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: [email protected].
    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: [email protected], 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



                                                  13370                                  Federal Register / Vol. 81, No. 49 / Monday, March 14, 2016 / Notices

                                                  OMB Comment                                                            healthy marriage and relationship                     program applicants prior to random
                                                     OMB is required to make a decision                                  education (HMRE) services. The Office                 assignment and administer a follow-up
                                                  concerning the collection of information                               of Planning, Research, and Evaluation                 survey to all study participants 12
                                                  between 30 and 60 days after                                           (OPRE) within ACF proposes data                       months after random assignment.
                                                  publication of this document in the                                    collection activity in six HMRE grantees                2. Process study. The goal of the
                                                  Federal Register. Therefore, a comment                                 as part of the Strengthening                          process study is to support the
                                                  is best assured of having its full effect                              Relationship Education and Marriage
                                                                                                                                                                               interpretation of impact findings and
                                                  if OMB receives it within 30 days of                                   Services (STREAMS) evaluation. The
                                                                                                                                                                               document program operations to
                                                  publication. Written comments and                                      purpose of STREAMS is to measure the
                                                                                                                                                                               support future replication. STREAMS
                                                  recommendations for the proposed                                       effectiveness and quality of HMRE
                                                                                                                         programs designed to strengthen                       will conduct semi-structured interviews
                                                  information collection should be sent                                                                                        with program staff and selected
                                                  directly to the following: Office of                                   intimate relationships. In particular, the
                                                                                                                         evaluation will examine HMRE                          community stakeholders, conduct focus
                                                  Management and Budget, Paperwork                                                                                             groups with program participants,
                                                  Reduction Project, Email: OIRA_                                        programs for youth in high school, at-
                                                                                                                         risk youth, and adults. The study will                administer a paper-and-pencil survey to
                                                  SUBMISSION@OMB.EOP.GOV, Attn:                                                                                                program staff, and collect data on
                                                  Desk Officer for the Administration for                                fill knowledge gaps about the
                                                                                                                         effectiveness of HMRE programming for                 adherence to program curricula through
                                                  Children and Families.                                                                                                       an add on to an existing program MIS
                                                                                                                         youth and adults and strategies for
                                                  Robert Sargis,                                                         improving program delivery and                        (nFORM, OMB no. 0970–0460).
                                                  Reports Clearance Officer.                                             participant engagement in services. The                 This 30-Day Notice includes the
                                                  [FR Doc. 2016–05641 Filed 3–11–16; 8:45 am]                            STREAMS evaluation will include two                   following data collection activities: (1)
                                                  BILLING CODE 4184–01–P                                                 components, an impact study and a                     A topic guide for semi-structured
                                                                                                                         process study.                                        interviews with program staff and
                                                                                                                            1. Impact Study. The goal of the                   community stakeholders, (2) focus
                                                  DEPARTMENT OF HEALTH AND                                               impact study is to provide rigorous                   group guides for adult program
                                                  HUMAN SERVICES                                                         estimates of the effectiveness of program             participants, (3) focus group guides for
                                                                                                                         services and interventions to improve                 youth in schools, (4) a staff survey, (5)
                                                  Administration for Children and                                        program implementation. The impact
                                                  Families                                                                                                                     the MIS functions for collecting data on
                                                                                                                         study will use an experimental design.
                                                                                                                                                                               adherence to program curricula (6)
                                                                                                                         Eligible program applicants will be
                                                  Submission for OMB Review;                                                                                                   introductory script that program staff
                                                                                                                         randomly assigned to either a program
                                                  Comment Request                                                                                                              will use to introduce the study to
                                                                                                                         group that is offered program services or
                                                                                                                                                                               participants, (7) the MIS functions for
                                                    Title: Strengthening Relationship                                    a control group that is not. Grantee staff
                                                                                                                                                                               conducting random assignment, (8) a
                                                  Education and Marriage Services                                        will use an add-on to an existing
                                                                                                                         program MIS (the nFORM system, OMB                    baseline survey for youth, (9) a follow-
                                                  (STREAMS) Evaluation.                                                                                                        up survey for youth, (10) a baseline
                                                    OMB No.: New Collection.                                             no. 0970–0460) to conduct random
                                                    Description: The Office of Family                                    assignment in sites enrolling at-risk                 survey for adults, and (11) a follow-up
                                                  Assistance (OFA) within the                                            youth and adults. STREAMS will use                    survey for adults.
                                                  Administration for Children and                                        classroom-level or school-level random                  Respondents: Program applicants,
                                                  Familes (ACF) at the U.S. Department of                                assignment for programs serving youth                 study participants, grantee staff, and
                                                  Health and Human Services has issued                                   in high school. STREAMS will collect                  local stakeholders (such as staff at
                                                  grants to 46 organizations to provide                                  baseline information from eligible                    referral agencies).

                                                                                                                                  ANNUAL BURDEN ESTIMATES
                                                                                                                                             Total             Annual          Number of           Average
                                                                                                                                                                                                                    Annual
                                                                                    Instrument                                             number of         number of       responses per       burden hours    burden hours
                                                                                                                                          respondents       respondents        respondent        per response

                                                  1. Topic guide for staff and stakeholder interviews ............                                 150                  50                1                  1             50
                                                  2. Focus group guide for adults ..........................................                       120                  40                1               1.5              60
                                                  3. Focus group guide for youth in schools .........................                               60                  20                1               1.5              30
                                                  4. Staff survey .....................................................................            120                  40                1                 .5             20
                                                  5. Study MIS session adherence form ...............................                               48                  48              104               .08             399
                                                  6a. Introductory script, grantee staff ...................................                         8                  18              219               .08             140
                                                  6b. Introductory script, program applicants ........................                           5,250               1,750                1               .08             140
                                                  7. Study MIS to conduct random assignment ....................                                     8                  18              208               .08             133
                                                  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
jstallworth on DSK7TPTVN1PROD with NOTICES




                                                    Estimated Total Annual Burden                                        C Street SW., Washington, DC 20201,                     OMB Comment: OMB is required to
                                                  Hours: 3,579.                                                          Attn: OPRE Reports Clearance Officer.                 make a decision concerning the
                                                    Additional Information: Copies of the                                All requests should be identified by the              collection of information between 30
                                                  proposed collection may be obtained by                                 title of the information collection. Email            and 60 days after publication of this
                                                  writing to the Administration for                                      address: OPREinfocollection@                          document in the Federal Register.
                                                  Children and Families, Office of                                       acf.hhs.gov.                                          Therefore, a comment is best assured of
                                                  Planning, Research and Evaluation, 330                                                                                       having its full effect if OMB receives it


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                                                                                Federal Register / Vol. 81, No. 49 / Monday, March 14, 2016 / Notices                                             13371

                                                  within 30 days of publication. Written                  information, or other information that                information marked as ‘‘confidential’’
                                                  comments and recommendations for the                    identifies you in the body of your                    will not be disclosed except in
                                                  proposed information collection should                  comments, that information will be                    accordance with 21 CFR 10.20 and other
                                                  be sent directly to the following: Office               posted on http://www.regulations.gov.                 applicable disclosure law. For more
                                                  of Management and Budget, Paperwork                       • If you want to submit a comment                   information about FDA’s posting of
                                                  Reduction Project, Email: OIRA_                         with confidential information that you                comments to public dockets, see 80 FR
                                                  SUBMISSION@OMB.EOP.GOV, Attn:                           do not wish to be made available to the               56469, September 18, 2015, or access
                                                  Desk Officer for the Administration for                 public, submit the comment as a                       the information at: http://www.fda.gov/
                                                  Children and Families.                                  written/paper submission and in the                   regulatoryinformation/dockets/
                                                                                                          manner detailed (see ‘‘Written/Paper                  default.htm.
                                                  Robert Sargis,                                          Submissions’’ and ‘‘Instructions’’).                     Docket: For access to the docket to
                                                  ACF Certifying Officer.                                                                                       read background documents or the
                                                  [FR Doc. 2016–05605 Filed 3–11–16; 8:45 am]
                                                                                                          Written/Paper Submissions
                                                                                                                                                                electronic and written/paper comments
                                                  BILLING CODE 4184–73–P                                     Submit written/paper submissions as                received, go to http://
                                                                                                          follows:                                              www.regulations.gov and insert the
                                                                                                             • Mail/Hand delivery/Courier (for                  docket number, found in brackets in the
                                                  DEPARTMENT OF HEALTH AND                                written/paper submissions): Division of               heading of this document, into the
                                                  HUMAN SERVICES                                          Dockets Management (HFA–305), Food                    ‘‘Search’’ box and follow the prompts
                                                                                                          and Drug Administration, 5630 Fishers                 and/or go to the Division of Dockets
                                                  Food and Drug Administration                            Lane, Rm. 1061, Rockville, MD 20852.                  Management, 5630 Fishers Lane, Rm.
                                                                                                             • For written/paper comments
                                                  [Docket No. FDA–2014–N–2235]                                                                                  1061, Rockville, MD 20852.
                                                                                                          submitted to the Division of Dockets                     Submit written requests for single
                                                  Draft Environmental Assessment and                      Management, FDA will post your                        copies of the guidance to the Policy and
                                                  Preliminary Finding of No Significant                   comment, as well as any attachments,                  Regulations Staff (HFV–6), Center for
                                                  Impact Concerning Investigational Use                   except for information submitted,
                                                                                                                                                                Veterinary Medicine, Food and Drug
                                                  of Oxitec OX513A Mosquitoes;                            marked and identified, as confidential,
                                                                                                                                                                Administration, 7519 Standish Pl.,
                                                  Availability                                            if submitted as detailed in
                                                                                                                                                                Rockville, MD 20855. Send one self-
                                                                                                          ‘‘Instructions.’’
                                                  AGENCY:    Food and Drug Administration,                   Instructions: All submissions received             addressed adhesive label to assist that
                                                  HHS.                                                    must include the Docket No. FDA–                      office in processing your requests.
                                                                                                          2014–N–2235 for Draft Environmental                   Persons with access to the Internet may
                                                  ACTION:   Notice.
                                                                                                          Assessment and Preliminary Finding of                 obtain the draft EA at either http://
                                                  SUMMARY:   The Food and Drug                            No Significant Impact Concerning                      www.fda.gov/animalveterinary/
                                                  Administration (FDA, the Agency) is                     Investigational Use of Oxitec OX513A                  developmentapprovalprocess/
                                                  announcing the availability for public                  Mosquitoes. Received comments will be                 environmentalassessments/
                                                  comment of the draft environmental                      placed in the docket and, except for                  ucm300656.htm or http://
                                                  assessment (EA) submitted by Oxitec                     those submitted as ‘‘Confidential                     www.regulations.gov.
                                                  Ltd. and a preliminary finding of no                    Submissions,’’ publicly viewable at                   FOR FURTHER INFORMATION CONTACT:
                                                  significant impact (FONSI) in support of                http://www.regulations.gov or at the                  Brinda Dass, Center for Veterinary
                                                  the conduct of an investigational release               Division of Dockets Management                        Medicine (HFV–2), Food and Drug
                                                  of genetically engineered (GE)                          between 9 a.m. and 4 p.m., Monday                     Administration, 7500 Standish Pl.,
                                                  mosquitoes under an investigational                     through Friday.                                       Rockville, MD 20855, 240–276–8247,
                                                  new animal drug exemption.                                 • Confidential Submissions—To                      email: abig@fda.hhs.gov.
                                                  DATES: Submit either electronic or                      submit a comment with confidential                    SUPPLEMENTARY INFORMATION: FDA is
                                                  written comments on the draft EA by                     information that you do not wish to be                announcing that a draft EA and
                                                  April 13, 2016.                                         made publicly available, submit your                  preliminary FONSI, in support of a
                                                  ADDRESSES: You may submit comments                      comments only as a written/paper                      proposed investigational release (i.e.,
                                                  as follows:                                             submission. You should submit two                     field trial) of OX513A Aedes aegypti GE
                                                                                                          copies total. One copy will include the               mosquitoes (OX513A mosquitoes), as
                                                  Electronic Submissions                                  information you claim to be confidential              part of an existing mosquito control
                                                    Submit electronic comments in the                     with a heading or cover note that states              program in Key Haven, FL, are being
                                                  following way:                                          ‘‘THIS DOCUMENT CONTAINS                              made available for public comment. The
                                                    • Federal eRulemaking Portal: http://                 CONFIDENTIAL INFORMATION.’’ The                       OX513A is a strain of Ae. aegypti
                                                  www.regulations.gov. Follow the                         Agency will review this copy, including               mosquito whose recombinant DNA
                                                  instructions for submitting comments.                   the claimed confidential information, in              (rDNA) construct encodes a conditional
                                                  Comments submitted electronically,                      its consideration of comments. The                    lethality trait such that the offspring of
                                                  including attachments, to http://                       second copy, which will have the                      the matings of male OX513A
                                                  www.regulations.gov will be posted to                   claimed confidential information                      mosquitoes and wild type Ae. aegypti
                                                  the docket unchanged. Because your                      redacted/blacked out, will be available               do not survive to adulthood. The
                                                  comment will be made public, you are                    for public viewing and posted on                      intended result is a decrease in the
                                                  solely responsible for ensuring that your               http://www.regulations.gov. Submit                    overall population of Ae. aegypti in the
                                                  comment does not include any                            both copies to the Division of Dockets
jstallworth on DSK7TPTVN1PROD with NOTICES




                                                                                                                                                                environment. Only male OX513A
                                                  confidential information that you or a                  Management. If you do not wish your                   mosquitoes are intended to be released.
                                                  third party may not wish to be posted,                  name and contact information to be                       To encourage public transparency,
                                                  such as medical information, your or                    made publicly available, you can                      and in compliance with 21 CFR
                                                  anyone else’s Social Security number, or                provide this information on the cover                 25.51(b)(3), the Agency is placing Oxitec
                                                  confidential business information, such                 sheet and not in the body of your                     Ltd.’s draft EA and preliminary FONSI
                                                  as a manufacturing process. Please note                 comments and you must identify this                   that are the subject of this notice on
                                                  that if you include your name, contact                  information as ‘‘confidential.’’ Any                  public display at the Division of Dockets


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Document Created: 2016-03-12 01:00:40
Document Modified: 2016-03-12 01:00:40
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
FR Citation81 FR 13370 

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