83 FR 4209 - Proposed Information Collection Activity; Comment Request Title:

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families

Federal Register Volume 83, Issue 20 (January 30, 2018)

Page Range		4209-4210
FR Document		2018-01705

Federal Register, Volume 83 Issue 20 (Tuesday, January 30, 2018)

[Federal Register Volume 83, Number 20 (Tuesday, January 30, 2018)]
[Notices]
[Pages 4209-4210]
From the Federal Register Online  [www.thefederalregister.org]
[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

4210 Federal Register / Vol. 83, No. 20 / Tuesday, January 30, 2018 / Notices

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

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

Annual/Final Report to the Secretary (depending on re-
porting period) .................................................................. 25 1 1 50 1250

Estimated Total Annual Burden DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT:
Hours: 1,250. HUMAN SERVICES Dianne Paraoan, Center for Drug
In compliance with the requirements Evaluation and Research, Food and
Food and Drug Administration Drug Administration, 10903 New
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Hampshire Ave., Bldg. 51, Rm. 3326,
[Docket No. FDA–2018–N–0129]
Silver Spring, MD 20993, 301–796–
Administration for Children and
Evaluating Inclusion and Exclusion 2500, Dianne.Paraoan@fda.hhs.gov.
Families is soliciting public comment
on the specific aspects of the Criteria in Clinical Trials; Public SUPPLEMENTARY INFORMATION:
information collection described above. Meeting
I. Background
Copies of the proposed collection of AGENCY: Food and Drug Administration, This public meeting implements
information can be obtained and HHS. FDA’s mandate under section 610 of the
comments may be forwarded by writing ACTION: Notice of public meeting. FDA Reauthorization Act of 2017 to
to the Administration for Children and convene a public meeting to discuss
Families, Office of Administration, SUMMARY: The Food and Drug clinical trial inclusion and exclusion
Office Planning, Research and Administration (FDA, the Agency, or criteria that will ultimately inform an
Evaluation, 370 L’Enfant Promenade we) is announcing a public meeting FDA guidance on this subject. Among
SW, Washington, DC 20447, Attn: ACF entitled ‘‘Evaluating Inclusion and other things, the public meeting will
Reports Clearance Officer. Email Exclusion Criteria in Clinical Trials.’’ include discussion about various ways
address: infocollection@acf.hhs.gov. All Convened by the Duke-Robert J. in which participation in clinical trials
requests should be identified by the title Margolis, MD, Center for Health Policy can be improved, including through
of the information collection. at Duke University and supported by a alternative trial designs and expanded
cooperative agreement with FDA, the access trials (see Section II. Topics for
The Department specifically requests purpose of the public meeting is to bring
comments on: (a) Whether the proposed Discussion at the Public Meeting).
the stakeholder community together to Inclusion of relevant subpopulations
collection of information is necessary discuss a variety of topics related to
for the proper performance of the in drug development programs helps
eligibility criteria in clinical trials and ensure that approved products will be
functions of the agency, including their potential impact on patient access
whether the information shall have safe and effective for the population
to investigational drugs, and how to likely to be treated when the drug is
practical utility; (b) the accuracy of facilitate the enrollment of a diverse marketed. However, certain eligibility
theagency’s estimate of the burden of patient population. criteria in clinical trials can exclude
the proposed collection of information; DATES: The public meeting will be held patient subgroups, resulting in the
(c) the quality, utility, and clarity of the on April 16, 2018, from 8:30 a.m. to 5 enrollment of study populations that
information to be collected; and (d) p.m. See the SUPPLEMENTARY may not be fully representative of that
ways to minimize the burden of the INFORMATION section for registration date broader patient population. FDA has
collection of information on and information. and will continue its efforts to
respondents, including through the use ADDRESSES: The public meeting will be encourage greater diversity in clinical
of automated collection techniques or held at the National Press Club, 529 trial populations. For example, FDA
other forms of information technology. 14th St. NW, Washington, DC 20045. regulations require marketing
Consideration will be given to For additional travel and hotel applications to provide analyses of
comments and suggestions submitted information, please refer to the safety and effectiveness by demographic
daltland on DSKBBV9HB2PROD with NOTICES

within 60 days of this publication. following website: https:// and other relevant subgroups (see 21
healthpolicy.duke.edu/events/ CFR 314.50(d)(5)(v)). In addition, in
Robert Sargis,
evaluating-inclusion-and-exclusion- 2016, FDA published guidance on the
Reports Clearance Officer. criteria-clinical-trials. There will also be collection of race and ethnicity data in
[FR Doc. 2018–01705 Filed 1–29–18; 8:45 am] a live webcast for those unable to attend clinical trials (available on FDA’s
BILLING CODE 4184–01–P the meeting in person (see Streaming guidance web page at https://
Webcast of the Public Meeting). www.fda.gov/downloads/

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Document Created: 2018-10-26 10:12:19
Document Modified: 2018-10-26 10:12:19

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
FR Citation		83 FR 4209

83 FR 4209 - Proposed Information Collection Activity; Comment Request Title:

DEPARTMENT OF HEALTH AND HUMAN SERVICESAdministration for Children and Families

Federal Register Volume 83, Issue 20 (January 30, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families