Submission for OMB Review; Comment Request, 13370-13371 [2016-05605]

Download as PDF 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: http:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http:// 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 http://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 http://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 http://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: http://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 http:// 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 http:// www.fda.gov/animalveterinary/ developmentapprovalprocess/ environmentalassessments/ ucm300656.htm or http:// 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