Proposed Information Collection Activity; Comment Request, 66008-66009 [2015-27416]

Download as PDF 66008 Federal Register / Vol. 80, No. 208 / Wednesday, October 28, 2015 / Notices activities to adapt them to current needs. The information collected will be used to advise programs and provide capacity-building assistance tailored to the identified needs. Overall, these development activities are intended to provide information that will increase the success of the surveillance or research projects through increasing response rates and decreasing response error, thereby decreasing future data collection burden to the public. The studies that will be covered under this request will include one or more of the following investigational modalities: (1) Structured and qualitative interviewing for surveillance, research, interventions and material development, (2) cognitive interviewing for development of specific data collection instruments, (3) methodological research (4) usability testing of technology-based instruments and materials, (5) field testing of new methodologies and materials, (6) investigation of mental models for health decision-making, to inform health communication messages, and (7) organizational needs assessments to support development of capacity. Respondents who will participate in individual and group interviews (qualitative, cognitive, and computer assisted development activities) are selected purposively from those who respond to recruitment advertisements. In addition to utilizing advertisements for recruitment, respondents who will participate in research on survey methods may be selected purposively or systematically from within an ongoing surveillance or research project. Participation of respondents is voluntary. The total burden hours are 55,820. There is no cost to participants other than their time. ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Type of respondent Form name General public ................................................. Healthcare providers ....................................... General public ................................................. Healthcare providers ....................................... General public ................................................. Healthcare providers ....................................... General Public ................................................ Healthcare providers ....................................... General public ................................................. Healthcare providers ....................................... Screener Att6 ................................................. Screener Att6 ................................................. Consent Forms Att9 ....................................... Consent Forms Att9 ....................................... Individual interview Att4 ................................. Individual Interview Att4 ................................. Focus Group Interview Att7 ........................... Focus Group Interview Att7 ........................... Survey of Individual Att5 ................................ Survey of Individual Att5 ................................ Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2015–27431 Filed 10–27–15; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families mstockstill on DSK4VPTVN1PROD with NOTICES Proposed Information Collection Activity; Comment Request Proposed Project: Implementation Plan Guidance for the Tribal Maternal, Infant, and Early Childhood Home Visiting Grant Program. Title: Tribal Maternal, Infant, and Early Childhood Home Visiting Program Needs Assessment and Implementation Plan. OMB No.: 0970–0389. Description: Social Security Act, Title V, Section 511 (42 U.S.C. 711), as added by § 2951 of the Patient Protection and Affordable Care Act (Pub. L. 111–148), VerDate Sep<11>2014 19:16 Oct 27, 2015 Jkt 238001 created the Maternal, Infant, and Early Childhood Home Visiting Program (MIECHV) and authorized the Secretary of HHS (in Section 511(h)(2)(A)) to award grants to Indian tribes (or a consortium of Indian tribes), tribal organizations, or urban Indian organizations to conduct an early childhood home visiting program. The legislation set aside 3 percent of the total MIECHV program appropriation (authorized in Section 511(j)) for grants to tribal entities. Tribal MIECHV grants, to the greatest extent practicable, are to be consistent with the requirements of the MIECHV grants to states and jurisdictions (authorized in Section 511(c)), and include conducting a needs assessment and establishing quantifiable, measurable benchmarks. The Administration for Children and Families, Office of Child Care and Office of the Deputy Assistant Secretary for Early Childhood Development, in collaboration with the Health Resources and Services Administration, Maternal and Child Health Bureau, plans to awarded grants for the Tribal Maternal, Infant, and Early Childhood Home Visiting Program (Tribal Home Visiting). The Tribal Home Visiting grant awards PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 68,208 29,232 34,104 14,616 5,544 2,376 3,360 1,440 25,200 10,800 Number of responses per respondent Average hours per response 1 1 1 1 1 1 1 1 1 1 10/60 10/60 5/60 5/60 1 1 2 2 30/60 30/60 will support 5-year cooperative agreements to conduct community needs assessments, plan for and implement high-quality, culturallyrelevant, evidence-based home visiting programs in at-risk Tribal communities, and participate in research and evaluation activities to build the knowledge base on home visiting among Native populations. In Year 1 of the cooperative agreement, grantees must (1) conduct a comprehensive community needs and readiness assessment and (2) develop a plan to respond to identified needs. Specifically, grantees will be required to conduct or update a needs and readiness assessment, and develop an implementation plan to respond to those needs, including a plan for performance measurement and CQI and participating in or conducting rigorous evaluation activities. Grantees will be expected to submit the needs assessment and implementation plan within 10 months of the Year 1 award date. Respondents: Tribal Maternal, Infant, and Early Childhood Home Visiting Program Year 1 Grantees. E:\FR\FM\28OCN1.SGM 28OCN1 66009 Federal Register / Vol. 80, No. 208 / Wednesday, October 28, 2015 / Notices ANNUAL BURDEN ESTIMATES Number of responses per respondent Number of respondents Instrument Average burden hours per response Total burden hours Tribal Maternal, Infant, and Early Childhood Home Visiting Program Needs Assessment and Plan for Responding to Identified Needs ......................... 25 1 100 2,500 Estimated Total Annual Burden Hours ..................................................... ........................ ........................ ........................ 2,500 In compliance with the requirements of Section 506(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: ACF Reports Clearance Officer. Email address: infocollection@ 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, Reports Clearance Officer. [FR Doc. 2015–27416 Filed 10–27–15; 8:45 am] mstockstill on DSK4VPTVN1PROD with NOTICES BILLING CODE 4184–01–P VerDate Sep<11>2014 19:16 Oct 27, 2015 Jkt 238001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0477] Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational Device Exemptions Reports and Records AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on investigational device exemptions reports and records. DATES: Submit either electronic or written comments on the collection of information by December 28, 2015. ADDRESSES: You may submit comments as follows: SUMMARY: 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 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 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 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– 2012–N–0477 for Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational Device Exemptions Reports and Records. 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 E:\FR\FM\28OCN1.SGM 28OCN1

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[Federal Register Volume 80, Number 208 (Wednesday, October 28, 2015)]
[Notices]
[Pages 66008-66009]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27416]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Proposed Information Collection Activity; Comment Request

    Proposed Project: Implementation Plan Guidance for the Tribal 
Maternal, Infant, and Early Childhood Home Visiting Grant Program.
    Title: Tribal Maternal, Infant, and Early Childhood Home Visiting 
Program Needs Assessment and Implementation Plan.
    OMB No.: 0970-0389.
    Description: Social Security Act, Title V, Section 511 (42 U.S.C. 
711), as added by Sec.  2951 of the Patient Protection and Affordable 
Care Act (Pub. L. 111-148), created the Maternal, Infant, and Early 
Childhood Home Visiting Program (MIECHV) and authorized the Secretary 
of HHS (in Section 511(h)(2)(A)) to award grants to Indian tribes (or a 
consortium of Indian tribes), tribal organizations, or urban Indian 
organizations to conduct an early childhood home visiting program. The 
legislation set aside 3 percent of the total MIECHV program 
appropriation (authorized in Section 511(j)) for grants to tribal 
entities. Tribal MIECHV grants, to the greatest extent practicable, are 
to be consistent with the requirements of the MIECHV grants to states 
and jurisdictions (authorized in Section 511(c)), and include 
conducting a needs assessment and establishing quantifiable, measurable 
benchmarks.
    The Administration for Children and Families, Office of Child Care 
and Office of the Deputy Assistant Secretary for Early Childhood 
Development, in collaboration with the Health Resources and Services 
Administration, Maternal and Child Health Bureau, plans to awarded 
grants for the Tribal Maternal, Infant, and Early Childhood Home 
Visiting Program (Tribal Home Visiting). The Tribal Home Visiting grant 
awards will support 5-year cooperative agreements to conduct community 
needs assessments, plan for and implement high-quality, culturally-
relevant, evidence-based home visiting programs in at-risk Tribal 
communities, and participate in research and evaluation activities to 
build the knowledge base on home visiting among Native populations.
    In Year 1 of the cooperative agreement, grantees must (1) conduct a 
comprehensive community needs and readiness assessment and (2) develop 
a plan to respond to identified needs. Specifically, grantees will be 
required to conduct or update a needs and readiness assessment, and 
develop an implementation plan to respond to those needs, including a 
plan for performance measurement and CQI and participating in or 
conducting rigorous evaluation activities. Grantees will be expected to 
submit the needs assessment and implementation plan within 10 months of 
the Year 1 award date.
    Respondents: Tribal Maternal, Infant, and Early Childhood Home 
Visiting Program Year 1 Grantees.

[[Page 66009]]



                                             Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                                     Number of        Average
                   Instrument                        Number of     responses per   burden hours    Total burden
                                                    respondents     respondent     per response        hours
----------------------------------------------------------------------------------------------------------------
Tribal Maternal, Infant, and Early Childhood                  25               1             100           2,500
 Home Visiting Program Needs Assessment and Plan
 for Responding to Identified Needs.............
                                                 ---------------------------------------------------------------
    Estimated Total Annual Burden Hours.........  ..............  ..............  ..............           2,500
----------------------------------------------------------------------------------------------------------------

    In compliance with the requirements of Section 506(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: ACF Reports Clearance Officer. Email 
address: infocollection@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,
Reports Clearance Officer.
[FR Doc. 2015-27416 Filed 10-27-15; 8:45 am]
 BILLING CODE 4184-01-P