Attachment 3 - PFO 60-day FRN

Federal Register / Vol. 85, No. 131 / Wednesday, July 8, 2020 / Notices
before the committee. All electronic and
written submissions submitted to the
Docket (see ADDRESSES) on or before
July 10, 2020, will be provided to the
committee. Oral presentations from the
public will be scheduled between
approximately 1 p.m. and 2 p.m. Those
individuals interested in making formal
oral presentations should notify the
contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before July 8, 2020. Time allotted for
each presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by July 9, 2020.
For press inquiries, please contact the
Office of Media Affairs at fdaoma@
fda.hhs.gov or 301–796–4540.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Joyce Yu (see
FOR FURTHER INFORMATION CONTACT) at
least 7 days in advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: July 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–14719 Filed 7–7–20; 8:45 am]

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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 Pay for Outcomes
Supplemental Information Request,
0906–XXXX, NEW
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 a Supplemental Information
Request (SIR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the SIR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the SIR.
DATES: Comments on this SIR should be
received no later than September 8,
2020.
SUMMARY:

Submit your comments to
paperwork@hrsa.gov 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 paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
The Maternal, Infant, and Early
Childhood Home Visiting Program
(MIECHV) Pay for Outcomes
Supplemental Information Request,
OMB No. 0906–XXXX, New.
Abstract: HRSA is requesting
approval to collect information in
response to a SIR, which will include
eligible entities’ plans for
implementation and evaluation of Pay
for Outcomes (PFO) initiatives to be
applied for through the MIECHV
Program. The Bipartisan Budget Act of
2018 (Pub. L. 115–123) added
subsection (c)(3) to Section 511 of the
Social Security Act, 42 U.S.C. 711. The
new provision authorizes MIECHV
Program funding recipients to use up to
ADDRESSES:

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25 percent of the funds awarded under
subsection 511(c)(1) ‘‘to enable eligible
entities to deliver services under early
childhood home visitation programs’’
for ‘‘outcomes or success payments
related to a pay for outcomes initiative
that will not result in a reduction of
funding for services delivered by the
entity under a childhood home
visitation program under this section
while the eligible entity develops or
operates such an initiative.’’ Subsection
511(j)(3)(B) further requires that ‘‘funds
made available to an eligible entity
under this section for a fiscal year (or
portion of a fiscal year) for a pay for
outcomes initiative shall remain
available for expenditure by the eligible
entity for not more than 10 years after
the funds are so made available.’’
Eligible entities may propose to use
MIECHV funds for outcomes or success
payments related to a PFO initiative in
response to the upcoming fiscal year
2021 MIECHV Notice of Funding
Opportunity and in succeeding fiscal
years pending availability of future
funds, and will submit their plans
(henceforth referred to as a PFO SIR
Response) in response to the
forthcoming SIR.
Need and Proposed Use of the
Information: Congress, through
enactment of the Social Security Act,
Title V, Section 511 (42 U.S.C. 711), as
amended, established the MIECHV
Program. The MIECHV Program is
designed to: (1) Strengthen and improve
the programs and activities carried out
under Title V of the Social Security Act;
(2) improve coordination of services for
at risk communities; and (3) identify
and provide comprehensive services to
improve outcomes for families who
reside in at risk communities. The
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, evidence-based home visiting
services during pregnancy and to
parents with young children up to
kindergarten entry. States, territories,
tribal entities, and in certain
circumstances, nonprofit organizations
are eligible to receive funding through
MIECHV and have the flexibility, within
the parameters of the authorizing
statute, to tailor the program to serve the
specific needs of their communities.
Section 50603 of the Bipartisan
Budget Act of 2018 (Pub. L. 115–123)
amended section 511 of the Social
Security Act, and provides new
authority for MIECHV awardees to use
up to 25 percent of MIECHV grant funds
awarded under section 511(c) for
outcomes or success payments related to

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Federal Register / Vol. 85, No. 131 / Wednesday, July 8, 2020 / Notices

a PFO initiative. HRSA considers PFO
initiatives to be an innovative approach
to funding home visiting service
delivery, which may result in social
benefit, as well as cost savings or cost
avoidance to the public sector.
In response to the forthcoming SIR,
MIECHV awardees planning to use
MIECHV grant funds for outcomes or
success payments related to a PFO
initiative will be required to submit a
PFO SIR Response outlining how their
plans will meet all of the applicable
statutory requirements and identifying
what specific MIECHV funds (e.g., fiscal
year 2021 formula funding) they
propose to use to (1) develop and
implement their PFO initiative; and (2)
make PFO outcomes or success
payments based on the planned PFO
initiative.
Regarding a PFO initiative, the
MIECHV authorizing statute requires the
following:
(1) A PFO initiative may not result in
a reduction of funding for services
delivered by the entity under a
childhood home visitation program
under this section while the eligible
entity develops or operates such an
initiative (section 711(c)(3)); and

(2) The PFO initiative for which
outcome or success payments may be
made must include:
(a) A feasibility study that describes
how the proposed intervention is based
on evidence of effectiveness;
(b) A rigorous, third-party evaluation
that uses experimental or quasiexperimental design or other research
methodologies that allow for the
strongest possible causal inferences to
determine whether the initiative has
met its proposed outcomes as a result of
implementation;
(c) An annual, publicly available
report on the progress of the initiative;
and
(d) A requirement that payments are
made to the recipient of the grant,
contract, or cooperative agreement only
when agreed upon outcomes are
achieved, excluding payments made to
a third party conducting the evaluation.
See 42 U.S.C. 711(k)(4).
The forthcoming SIR will provide
further instructions to awardees in
proposing a PFO initiative and
submitting the required information to
HRSA. Awardees are not required to
propose or implement a PFO initiative,
but if they wish to do so, they must
submit a PFO SIR Response describing
how their PFO initiative will meet all of

the applicable statutory requirements.
HRSA will use the information collected
through the PFO SIR Response to ensure
that MIECHV awardees proposals to use
grant funds for PFO initiatives meet
statutory requirements and to provide
technical assistance to awardees. The
implementation of a PFO initiative is
not intended to disrupt current services
or negatively impact communities that
have benefited from home visiting
programs and must not result in a
reduction of funding for home visiting
services.
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 and
supporting materials; to collect and
analyze data and information to develop
the PFO SIR Response; engage with
stakeholders and coordinate with state
level partners; and to draft and submit
the PFO SIR Response. The table below
summarizes the total annual burden
hours estimated for this SIR.

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Instrument

Total
responses

Average
burden hours
per response

Total burden
hours

MIECHV PAY FOR OUTCOMES SIR .................................

15

1

15

92

1,380

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

15

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

15

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

1,380

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, Executive Secretariat.
[FR Doc. 2020–14658 Filed 7–7–20; 8:45 am]
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Number of
responses per
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier OS–0990–0379]

Agency Information Collection
Request: 30-Day Public Comment
Request
Office of the Secretary, HHS.
ACTION: Notice.
AGENCY:

In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before August 7, 2020.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
SUMMARY:

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notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT:

Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 795–7714. When submitting
comments or requesting information,
please include the document identifier
0990-New-30D and project title for
reference.
Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (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

SUPPLEMENTARY INFORMATION:

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