Proposed Information Collection Activity; Comment Request Title:, 4209-4210 [2018-01705]

Download as PDF 4209 Federal Register / Vol. 83, No. 20 / Tuesday, January 30, 2018 / Notices the child’s primary caregiver (who will be the mother if she is available), (2) direct assessments of child development, (3) a semi-structured interview with the caregiver, (4) surveys with the child’s teacher, (5) a direct assessment of the caregiver, and (6) 15 minutes of videotaped interactions between the caregiver and child. In addition to collecting these data, the MIHOPE–LT project will also maintain up-to-date consent forms for the collection of administrative data. Future information collection requests and related Federal Register Notices will describe future data collection efforts for this project. Data collected during the kindergarten follow-up study will be used to estimate the effects of MIECHVfunded programs on seven domains: (1) Maternal health; (2) child health; (3) child development and school performance; (4) child maltreatment; (5) parenting; (6) crime or domestic violence; and (7) family economic selfsufficiency. Respondents: The respondents in this follow-up study will include 4,115 families who participated in MIHOPE and 4,115 teachers of the focal children from those families. ANNUAL BURDEN ESTIMATES Total number of respondents Instrument daltland on DSKBBV9HB2PROD with NOTICES Survey of caregivers ............................................................ Direct assessments of children ............................................ Semi-structured interview with caregivers ........................... Survey of the focal children’s teachers ............................... Direct assessments of caregivers ........................................ Videotaped caregiver-child interactions ............................... Estimated Total Annual Burden Hours: 5,211. In compliance with the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research, and Evaluation, 330 C Street SW, Washington, DC 20201, Attn: OPRE Reports Clearance Officer. Email address: OPREinfocollection@ acf.hhs.gov. All requests should be identified by the title of the information collection. 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 VerDate Sep<11>2014 18:18 Jan 29, 2018 Jkt 244001 Annual number of respondents 4115 4115 100 4115 4115 8230 1372 1372 33 1372 1372 2743 comments and suggestions submitted within 60 days of this publication. Mary Jones, ACF/OPRE Certifying Officer. [FR Doc. 2018–01683 Filed 1–29–18; 8:45 am] BILLING CODE 4184–77–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request Title: Tribal Maternal, Infant, and Early Childhood Home Visiting Program: Guidance for Submitting an Annual or Final Report to the Secretary OMB No.: 0970–0409. Description: Section 511(e)(8)(A) of Title V of the Social Security Act requires that grantees under the Maternal, Infant, and Early Childhood Home Visiting (MIECHV) program for states and jurisdictions submit an annual report to the Secretary of Health and Human Services regarding the program and activities carried out under the program, including such data and information as the Secretary shall require. Section 511(h)(2)(A) further states that the requirements for the MIECHV grants to tribes, tribal organizations, and urban Indian organizations are to be consistent, to the greatest extent practicable, with the requirements for grantees under the MIECHV program for states and jurisdictions. The Administration for Children and Families, Office of Child Care, in PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 Number of responses per respondent 1 1 1 1 1 1 Average burden hours per response 1 1.5 2 0.5 0.25 0.25 Annual burden hours 1372 2058 66 686 343 686 collaboration with the Health Resources and Services Administration, Maternal and Child Health Bureau, has awarded grants for the Tribal Maternal, Infant, and Early Childhood Home Visiting Program (Tribal Home Visiting). The Tribal Home Visiting discretionary grants support 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; establish, measure, and report on progress toward meeting performance measures in six legislatively-mandated benchmark areas; and conduct rigorous evaluation activities to build the knowledge base on home visiting among Native populations. Tribal Home Visiting grantees have been notified that in every year of their grant, after the first year, they must comply with the requirement for submitting an Annual Report to the Secretary that should feature activities carried out under the program during the past reporting period and a final report to the Secretary during the final year of their grant. In order to assist grantees with meeting the requirements of the Annual and Final Report to the Secretary, ACF created guidance for grantees to use when writing their reports. The existing guidance (OMB Control No. 0970–0409, Expiration Date 10/31/18) provides sections where grantees must address the following: • Update on Home Visiting Program Goals and Objectives • Update on the Implementation of Home Visiting Program in Targeted Community(ies) E:\FR\FM\30JAN1.SGM 30JAN1 4210 Federal Register / Vol. 83, No. 20 / Tuesday, January 30, 2018 / Notices • Progress toward Meeting Legislatively Mandated Benchmark Requirements • Update on Rigorous Evaluation Activities • Home Visiting Program Continuous Quality Improvement (CQI) Efforts • Administration of Home Visiting Program • Technical Assistance Needs The proposed data collection form is as follows: ACF is requesting approval to renew and update the existing Tribal Home Visiting Guidance for Submitting an Annual or Final Report to the Secretary (OMB Control No. 0970–0409) that will include instructions for grantees to submit either an annual or final report on the progress of their program to the Secretary, depending on the reporting period. Respondents: Tribal Maternal, Infant, and Early Childhood Home Visiting Program Managers (The information collection does not include direct interaction with individuals or families that receive the services). ANNUAL BURDEN ESTIMATES Annual number of respondents Instrument daltland on DSKBBV9HB2PROD with NOTICES Annual/Final Report to the Secretary (depending on reporting period) .................................................................. Estimated Total Annual Burden Hours: 1,250. In compliance with the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. 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 Administration, Office 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 theagency’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. 2018–01705 Filed 1–29–18; 8:45 am] BILLING CODE 4184–01–P VerDate Sep<11>2014 18:18 Jan 29, 2018 Jkt 244001 Number of responses per respondent 25 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–0129] Evaluating Inclusion and Exclusion Criteria in Clinical Trials; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting. The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting entitled ‘‘Evaluating Inclusion and Exclusion Criteria in Clinical Trials.’’ Convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, the purpose of the public meeting is to bring the stakeholder community together to discuss a variety of topics related to eligibility criteria in clinical trials and their potential impact on patient access to investigational drugs, and how to facilitate the enrollment of a diverse patient population. DATES: The public meeting will be held on April 16, 2018, from 8:30 a.m. to 5 p.m. See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: The public meeting will be held at the National Press Club, 529 14th St. NW, Washington, DC 20045. For additional travel and hotel information, please refer to the following website: https:// healthpolicy.duke.edu/events/ evaluating-inclusion-and-exclusioncriteria-clinical-trials. There will also be a live webcast for those unable to attend the meeting in person (see Streaming Webcast of the Public Meeting). SUMMARY: PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 Average burden hours per response Total responses 1 Total annual burden hours 50 1250 FOR FURTHER INFORMATION CONTACT: Dianne Paraoan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3326, Silver Spring, MD 20993, 301–796– 2500, Dianne.Paraoan@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background This public meeting implements FDA’s mandate under section 610 of the FDA Reauthorization Act of 2017 to convene a public meeting to discuss clinical trial inclusion and exclusion criteria that will ultimately inform an FDA guidance on this subject. Among other things, the public meeting will include discussion about various ways in which participation in clinical trials can be improved, including through alternative trial designs and expanded access trials (see Section II. Topics for Discussion at the Public Meeting). Inclusion of relevant subpopulations in drug development programs helps ensure that approved products will be safe and effective for the population likely to be treated when the drug is marketed. However, certain eligibility criteria in clinical trials can exclude patient subgroups, resulting in the enrollment of study populations that may not be fully representative of that broader patient population. FDA has and will continue its efforts to encourage greater diversity in clinical trial populations. For example, FDA regulations require marketing applications to provide analyses of safety and effectiveness by demographic and other relevant subgroups (see 21 CFR 314.50(d)(5)(v)). In addition, in 2016, FDA published guidance on the collection of race and ethnicity data in clinical trials (available on FDA’s guidance web page at https:// www.fda.gov/downloads/ E:\FR\FM\30JAN1.SGM 30JAN1

Agencies

[Federal Register Volume 83, Number 20 (Tuesday, January 30, 2018)]
[Notices]
[Pages 4209-4210]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01705]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Proposed Information Collection Activity; Comment Request Title: 
Tribal Maternal, Infant, and Early Childhood Home Visiting Program: 
Guidance for Submitting an Annual or Final Report to the Secretary

    OMB No.: 0970-0409.
    Description: Section 511(e)(8)(A) of Title V of the Social Security 
Act requires that grantees under the Maternal, Infant, and Early 
Childhood Home Visiting (MIECHV) program for states and jurisdictions 
submit an annual report to the Secretary of Health and Human Services 
regarding the program and activities carried out under the program, 
including such data and information as the Secretary shall require. 
Section 511(h)(2)(A) further states that the requirements for the 
MIECHV grants to tribes, tribal organizations, and urban Indian 
organizations are to be consistent, to the greatest extent practicable, 
with the requirements for grantees under the MIECHV program for states 
and jurisdictions.
    The Administration for Children and Families, Office of Child Care, 
in collaboration with the Health Resources and Services Administration, 
Maternal and Child Health Bureau, has awarded grants for the Tribal 
Maternal, Infant, and Early Childhood Home Visiting Program (Tribal 
Home Visiting). The Tribal Home Visiting discretionary grants support 
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; establish, measure, 
and report on progress toward meeting performance measures in six 
legislatively-mandated benchmark areas; and conduct rigorous evaluation 
activities to build the knowledge base on home visiting among Native 
populations.
    Tribal Home Visiting grantees have been notified that in every year 
of their grant, after the first year, they must comply with the 
requirement for submitting an Annual Report to the Secretary that 
should feature activities carried out under the program during the past 
reporting period and a final report to the Secretary during the final 
year of their grant. In order to assist grantees with meeting the 
requirements of the Annual and Final Report to the Secretary, ACF 
created guidance for grantees to use when writing their reports. The 
existing guidance (OMB Control No. 0970-0409, Expiration Date 10/31/18) 
provides sections where grantees must address the following:
 Update on Home Visiting Program Goals and Objectives
 Update on the Implementation of Home Visiting Program in 
Targeted Community(ies)

[[Page 4210]]

 Progress toward Meeting Legislatively Mandated Benchmark 
Requirements
 Update on Rigorous Evaluation Activities
 Home Visiting Program Continuous Quality Improvement (CQI) 
Efforts
 Administration of Home Visiting Program
 Technical Assistance Needs
    The proposed data collection form is as follows:
    ACF is requesting approval to renew and update the existing Tribal 
Home Visiting Guidance for Submitting an Annual or Final Report to the 
Secretary (OMB Control No. 0970-0409) that will include instructions 
for grantees to submit either an annual or final report on the progress 
of their program to the Secretary, depending on the reporting period.
    Respondents: Tribal Maternal, Infant, and Early Childhood Home 
Visiting Program Managers (The information collection does not include 
direct interaction with individuals or families that receive the 
services).

                                             Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                  Annual  number     Number of                        Average
           Instrument                   of        responses  per       Total       burden hours    Total annual
                                    respondents      respondent      responses     per response    burden hours
----------------------------------------------------------------------------------------------------------------
Annual/Final Report to the                    25               1               1              50            1250
 Secretary (depending on
 reporting period)..............
----------------------------------------------------------------------------------------------------------------

    Estimated Total Annual Burden Hours: 1,250.
    In compliance with the requirements of Section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995, the Administration for Children and 
Families is soliciting public comment on the specific aspects of the 
information collection described above. 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 
Administration, Office Planning, Research and Evaluation, 370 L'Enfant 
Promenade SW, Washington, DC 20447, Attn: ACF Reports Clearance 
Officer. Email address: [email protected]. 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 
theagency'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. 2018-01705 Filed 1-29-18; 8:45 am]
 BILLING CODE 4184-01-P