60-day FRN MCHB BAT 0025 Rev

Federal Register / Vol. 84, No. 148 / Thursday, August 1, 2019 / Notices
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics or http://
www.regulations.gov.
Dated: July 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–16375 Filed 7–31–19; 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; Maternal, Infant,
and Early Childhood Home Visiting
Program Home Visiting Budget
Assistance Tool, OMB No. 0906–
0025—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 must be
received no later than September 30,
2019.
ADDRESSES: Submit your comments to
[email protected] or mail the HRSA
Information Collection Clearance
Officer, 14N136B, 5600 Fishers Lane,
Rockville, Maryland 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.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Maternal, Infant, and Early Childhood
Home Visiting Program Home Visiting
Budget Assistance Tool, OMB No. 0906–
0025—Revision.

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SUMMARY:

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Abstract: HRSA is requesting
continued approval and revision to the
Home Visiting Budget Assistance Tool
(HV-BAT) based on results of the
previous pilot test. The tool collects
information on standardized cost
metrics from programs that deliver
home visiting services, as outlined in
the HV-BAT. Prior to Fiscal Year (FY)
2021, entities receiving Maternal, Infant,
and Early Childhood Home Visiting
(MIECHV) formula funds that are states,
jurisdictions, territories, and nonprofit
awardees may submit cost data using
the HV-BAT to HRSA. HRSA will
review the data submitted for accuracy
and quality control, to test the tool’s
capacity to support state program
functions such as program planning and
budgeting, and to collect data to
estimate national program costs.
Beginning in FY 2021, HRSA will
require reporting of HV-BAT data for
one-third of awardees in each year for
the purpose of informing program
planning and budgeting described in
awardee submissions of the annual
formula funding application.
MIECHV Program, authorized by
section 511 of the Social Security Act,
42 U.S.C. 711, and administered by
HRSA in partnership with the
Administration for Children and
Families, supports voluntary, evidencebased home visiting services during
pregnancy and to parents with young
children up to kindergarten entry.
States, Tribal entities, and certain
nonprofit organizations 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. Funding
recipients may subaward grant funds to
local implementing agencies (LIAs) in
order to provide services to eligible
families in at-risk communities.
HRSA revised the intended purpose
of the data collection using the HV-BAT.
Original clearance under this OMB
control number was for pilot testing the
reliability of a standardized cost
reporting tool among evidence-based
home visiting programs. HRSA revised
the data collection tool to reflect
findings and recommendations from the
pilot study to ensure ease of use among
LIAs. Changes were made to
instructions and definitions based on
feedback collected from participants in
the pilot study. As this revision seeks to
continue collection of comprehensive
home visiting cost data for all LIAs in
each state, the data can be aggregated to
produce state and national cost
estimates in addition to supporting
procurement activities and sub-recipient
monitoring. The burden increased as the
pilot study identified a longer average

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amount of time to complete the tool
than was originally estimated.
Need and Proposed Use of the
Information: Immediately following
OMB clearance, HRSA intends to make
the tool available as an optional
resource for all awardees. If awardees
choose to immediately use the HV-BAT
as an optional tool, awardees will be
required to submit the data collected
with the tool to HRSA. This will allow
HRSA to test the feasibility of collecting
comprehensive cost data at the state
level; estimate national level costs for
use in conducting research and analysis
of home visiting costs; understand cost
variation; assess how comprehensive
program cost data can inform other
policy priorities, such as innovative
financing strategies; review the data to
ensure accuracy; and analyze the data
for the purpose of federal research.
Beginning in FY 2021, HRSA will
require reporting of HV-BAT data for
one-third of awardees in each year for
the purpose of informing program
planning and budgeting described in
awardee submissions of the annual
formula funding application. HRSA
anticipates that one-third of the
awardees will participate in this data
collection each year and HRSA will
identify which third of the awardees
will be required to submit HV-BAT data
in that year. This process will ease
burden on awardees by requiring data
collection for each awardee once every
3 years and allowing HRSA to capture
a national data set every three years.
Likely Respondents: MIECHV Program
awardees (n=19).
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 Information
Collection Request are summarized in
the table below.
Total Estimated Annualized burden
hours:

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Federal Register / Vol. 84, No. 148 / Thursday, August 1, 2019 / Notices

Number of
respondents

Form name

Number of
responses per
respondent

Total
responses

Average
burden
per response
(in hours)

Total
burden hours

Home Visiting Budget Assistance Tool (HV-BAT) ...............

19

13

247

11

2,717

Total ..............................................................................

19

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

247

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

2,717

Note: The burden estimate assumes that 1⁄3 of all MIECHV awardees will respond in each year. On average awardees have 13 LIAs (based
on 2018 MIECHV program data) that will complete the HV-BAT, and on average it took LIAs 11 hours to complete the HV-BAT in the pilot study
(OMB Control No. 0906–0025) of the tool.

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.
Maria G. Button,
Director, Division of the Executive Secretariat.
[FR Doc. 2019–16376 Filed 7–31–19; 8:45 am]
BILLING CODE 4165–15–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meetings

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Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings 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 Cancer
Institute Special Emphasis Panel; Innovative
Molecular Analysis Technologies.
Date: September 19, 2019.
Time: 9:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute, Shady
Grove, 9609 Medical Center Drive, Room
7W260, Rockville, MD 20850 (Telephone
Conference Call).
Contact Person: Nadeem Khan, Ph.D.,
Scientific Review Officer, Research
Technology and Contract Review Branch,
Division of Extramural Activities, 9609

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Medical Center Drive, Room 7W260, National
Cancer Institute, NIH, Bethesda, MD 20892–
9745, (240) 276–5856, nadeem.khan@
nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Program
Project 1.
Date: September 19–20, 2019.
Time: 5:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Washington/Rockville, 1750
Rockville Pike Rockville, MD 20852.
Contact Person: Clifford W Schweinfest,
Ph.D., Scientific Review Officer, Special
Review Branch, Division of Extramural
Activities, National Cancer Institute, NIH,
9609 Medical Center Drive, Room 7W108,
Bethesda, MD 20892–8329, 240–276–6343,
[email protected].
Name of Committee: National Cancer
Institute Special Emphasis Panel; Traceback
Testing: Outreach for Genetic Counseling of
Mutation Carriers.
Date: September 25, 2019.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
7W234, Rockville, MD 20850 (Telephone
Conference Call).
Contact Person: Adriana Stoica, Ph.D.,
Scientific Review Officer, Resources and
Training Review Branch, Division of
Extramural Activities, National Cancer
Institute, NIH, 9609 Medical Center Drive,
Room 7W234, Bethesda, MD 20892–9750,
240–276–6368, [email protected].
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: July 29, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–16446 Filed 7–31–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Biomedical
Imaging and Bioengineering; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Institute of
Biomedical Imaging and Bioengineering
Special Emphasis Panel.
The meetings 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 of
Biomedical Imaging and Bioengineering
Special Emphasis Panel; Team-Based Design
Review.
Date: October 24, 2019.
Time: 10:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, Suite 920, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: Ruixia Zhou, Ph.D.,
Scientific Review Officer, National Institute
of Biomedical Imaging and Bioengineering,
National Institutes of Health, 6707
Democracy Boulevard, Suite 957, Bethesda,
MD 20892, 301–496–4773, [email protected].
Name of Committee: National Institute of
Biomedical Imaging and Bioengineering
Special Emphasis Panel; T32 Institutional
Training Program Review Meeting.
Date: October 28–29, 2019.
Time: 9:30 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, Suite 920, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: John K. Hayes, Ph.D.,
Scientific Review Officer, National Institute

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