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