Attachment E - 60 Day FRN

82490

Federal Register / Vol. 85, No. 244 / Friday, December 18, 2020 / Notices

interested persons to develop and
submit data, information, and/or
comments for this notice. We have
concluded that it is reasonable to extend
the comment period for 60 days. FDA
believes that this extension allows
adequate time for any interested persons
to submit data, information, and/or
comments.
Dated: December 11, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–27749 Filed 12–17–20; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: The Maternal,
Infant, and Early Childhood Home
Visiting Program Performance
Measurement Information System,
OMB No. 0906–0017, Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:

In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than February 16,
2021.
SUMMARY:

Submit your comments to
[email protected] or mail the HRSA
Information Collection Clearance
Officer, 14N136B, 5600 Fishers Lane,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email [email protected]
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.

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ADDRESSES:

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SUPPLEMENTARY INFORMATION:

Information Collection Request Title:
The Maternal, Infant, and Early
Childhood Home Visiting Program
Performance Measurement Information
System, OMB No. 0906–0017, Revision.
Abstract: This clearance request is for
continued approval of the Maternal,
Infant, and Early Childhood Home
Visiting (MIECHV) Program
Performance Measurement Information
System.
The MIECHV Program, administered
by HRSA in partnership with the
Administration for Children and
Families, supports voluntary, evidencebased home visiting services to pregnant
women and to parents with young
children up to kindergarten entry.
States, certain non-profit organizations,
and Tribal entities are eligible to receive
funding from the MIECHV program and
have the flexibility to tailor the program
to serve the specific needs of their
communities. HRSA is revising the data
collection forms for the MIECHV
program by making the following
changes:
• Form 1, Table 1: Update table to
include reporting for gender nonconforming participants and unknown/
did not report participant gender.
• Form 1, Tables 3, 4, 6, 7, 8, 9, 10,
11, and 18: Update tables to include
reporting for gender non-conforming
participants and unknown/did not
report adult participant gender.
• Form 1, Tables 3, 5, 6, 7, 18, 19, and
20: Update tables to remove index child
gender reporting.
• Form 1, Table 15: Change table title
to ‘‘Home Visits’’.
• Form 1, Table 15: Update table to
collect the number of home visits
completed virtually.
• Form 1, Tables 4, 9, 10, and 18:
Update tables to include reporting for
new and continuing adult participants.
• Form 1, Tables 5, 19, and 20:
Update tables to include reporting for
new and continuing index children.
• Form 1, Table 16: Add new table to
include reporting on father and
additional caregiver engagement.
• Form 1, Tables 16, 17, 18, 19, 20,
and 21: Update table numbers to reflect
the addition of Table 16.
• Form 2, Measure 13: Change
measure name to ‘‘Behavioral Concern
Inquiries’’
• Form 2, Measure 16: Update
measure to reflect caregiver health
insurance coverage status.
• Form 2: Add two measures to
collect information on substance use
screening and referrals.

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Need and Proposed Use of the
Information: HRSA uses performance
information to demonstrate program
accountability and continuously
monitor and provide oversight to
MIECHV Program awardees. The
information is also used to provide
quality improvement guidance and
technical assistance to awardees and
help inform the development of early
childhood systems at the national, state,
and local level. HRSA is seeking to
revise demographic, service utilization,
and select clinical indicators for
participants enrolled in home visiting
services. In addition, HRSA will collect
a set of standardized performance and
outcome indicators that correspond
with the statutorily identified
benchmark areas.
This information will be used to
demonstrate awardees’ compliance with
legislative and programmatic
requirements. It will also be used to
monitor and provide continued
oversight for awardee performance and
to target technical assistance resources
to awardees. In the future, HRSA
anticipates that MIECHV funding
decisions may be allocated, in part,
based on awardee performance,
including on benchmark performance
areas. This notice is subject to the
appropriation of funds, and is a
contingency action taken to ensure that,
should funds become available for this
purpose, information can be collected in
a timely manner.
Likely Respondents: MIECHV Program
awardees that are states, territories, and,
where applicable, nonprofit
organizations providing home visiting
services within states.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.

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82491

Federal Register / Vol. 85, No. 244 / Friday, December 18, 2020 / Notices
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Form name

Form 1: Demographic, Service Utilization, and Select Clinical Indicators ...................................................................
Form 2: Performance Indicators and Systems Outcome
Measures ..........................................................................
Total ..............................................................................

HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.

Number of
responses per
respondent

56

560

31,360

56

1

56

221

12,376

56

........................

56

........................

43,736

Review Branch, National Institute on Aging,
National Institutes of Health, Gateway
Building, Suite 2W200, 7201 Wisconsin
Avenue, Bethesda, MD 20892, (301) 827–
7428, [email protected].
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)

Contact Person: Helen Huang, Ph.D.,
Scientific Review Officer, Eunice
Kennedy Shriver National Institute of
Child Health and Human Development,
6710B Rockledge Drive, Room 2137D,
Bethesda, MD 20892, 301–435–8207,
[email protected].

Dated: December 15, 2020.
Miguelina Perez,
Program Analyst,Office of Federal Advisory
Committee Policy.

(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

National Institutes of Health

National Institute on Aging; Notice of
Closed Meeting

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Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Diabetes and
Aging.
Date: February 18, 2021.
Time: 1:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Video
Meeting).
Contact Person: Anita H. Undale, MD,
Ph.D., Scientific Review Officer, Scientific

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Dated: December 14, 2020.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–27859 Filed 12–17–20; 8:45 am]
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National Institutes of Health

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Total burden
hours

1

[FR Doc. 2020–27919 Filed 12–17–20; 8:45 am]

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Average
burden per
response
(in hours)

56

[FR Doc. 2020–27943 Filed 12–17–20; 8:45 am]

Maria G. Button,
Director, Executive Secretariat.

Total
responses

Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
discussions could disclose confidential
trade secrets or commercial property
such as patentable material, and
personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute clearly unwarranted
invasion of personal privacy.
Name of Committee: National
Institute of Child Health and Human
Development Initial Review Group
Function, Integration, and
Rehabilitation Sciences Subcommittee.
Date: February 19, 2021.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: NICHD/NIH, 6710B Rockledge
Drive, Bethesda, MD 20892 (Virtual
Meeting).

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director, National
Institutes of Health Notice of Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Council of Councils.
The meeting will be held as a virtual
meeting and will be open to the public.
Individuals who plan to view the virtual
meeting and need special assistance or
other reasonable accommodations to
view the meeting, should notify the
Contact Person listed below in advance
of the meeting. The meeting will be
videocast and can be accessed from the
NIH Videocasting and Podcasting
website (https://videocast.nih.gov/
watch=41242).
Name of Committee: Council of Councils.
Open: December 30, 2020.
Time: 2:00 p.m. to 3:00 p.m.
Agenda: Presentation and Discussion of the
Proposed Addition of a New Office to
Division of Program Coordination, Planning,
and Strategic Initiatives.
Place: National Institutes of Health,
Building 1, One Center Drive, Bethesda, MD
20892, (Virtual Meeting).

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