Attachment 3 - MIECHV Needs Assessment 60-day FRN

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Federal Register / Vol. 83, No. 79 / Tuesday, April 24, 2018 / Notices
Dated: April 19, 2018.
Leslie Kux,
Associate Commissioner for Policy.

SUPPLEMENTARY INFORMATION:

I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Severely Debilitating or LifeThreatening Hematologic Disorders:
Nonclinical Development of
Pharmaceuticals.’’ The purpose of this
guidance is to provide information to
assist sponsors in the design of an
appropriate program of nonclinical
studies for the development of
pharmaceuticals used to treat patients
with SDLTHDs. While FDA has
guidance for oncology indications (most
of which are considered severely
debilitating or life-threatening diseases)
and for rare diseases (which include
some SDLTHD conditions), FDA has no
guidance to facilitate nonclinical
development specifically for
pharmaceuticals used to treat
nononcology patients with SDLTHDs.
The SDLTHDs include conditions in
which life expectancy is short or quality
of life is greatly diminished despite
available therapies. FDA has defined
life-threatening and severely debilitating
diseases in regulations (21 CFR 312.81).
A streamlined approach to drug
development is necessary to allow
patients with SDLTHDs earlier and
continued access to new and potentially
effective therapies. This guidance, when
finalized, is expected to reduce the use
of animals in accordance with the 3R
(refine/reduce/replace) principles and
allow faster and continuous access to
pharmaceuticals for SDLTHDs.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on nonclinical development of
pharmaceuticals for severely
debilitating or life-threatening
hematologic disorders. It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations. This
guidance is not subject to Executive
Order 12866.
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II. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.

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[FR Doc. 2018–08548 Filed 4–23–18; 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 Statewide Needs
Assessment Update
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 June 25, 2018.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, 14N39, 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
Needs Assessment Update
OMB No.: 0906–XXXX, New.
Abstract: HRSA is requesting
approval to collect updated statewide
needs assessments from Maternal,
Infant, and Early Childhood Home
Visiting (MIECHV) Program awardees.
The previous statewide needs
assessment that was approved under
OMB control number 0915–0333 has
been discontinued. Eligible entities that
are states, the District of Columbia, and
SUMMARY:

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non-profit organizations will submit
statewide needs assessment updates in
response to a forthcoming SIR.
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, evidencebased home visiting services during
pregnancy and to parents with young
children up to kindergarten entry.
States, territories, and tribal entities,
and nonprofit organizations, in certain
circumstances, 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.
The statewide needs assessment is a
critical and foundational resource that
assists awardees in identifying and
understanding how to meet the needs of
eligible families living in at-risk
communities in their states.
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. Section
50603 of the Bipartisan Budget Act of
2018 (Pub. L. 115–123) amended section
511(b)(1) of the Social Security Act, and
requires that states review and update
their statewide needs assessments
(which may be separate from, but in
coordination with, the Title V statewide
needs assessment) no later than October
1, 2020, as a condition of receiving
payments from Title V Block Grant
allotments.
In response to the forthcoming SIR,
state and territory awardees will be
required to submit an updated statewide
needs assessment that identifies all of
the following information, as required
by the MIECHV authorizing statute:
(1) Communities with concentrations
of (a) premature birth, low-birth weight
infants, and infant mortality, including
infant death due to neglect, or other
indicators of at-risk prenatal, maternal,
newborn, or child health; (b) poverty; (c)
crime; (d) domestic violence; (e) high
rates of high-school drop-outs; (f)
substance abuse; (g) unemployment; or
(h) child maltreatment.
(2) The quality and capacity of
existing programs or initiatives for early

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Federal Register / Vol. 83, No. 79 / Tuesday, April 24, 2018 / Notices
childhood home visitation in the state
including: the number and types of
individuals and families who are
receiving services under such programs
or initiatives; the gaps in early
childhood home visitation in the state;
and the extent to which such programs
or initiatives are meeting the needs of
eligible families.
(3) The state’s capacity for providing
substance abuse treatment and
counseling services to individuals and
families in need of such treatment or
services.
The forthcoming SIR will provide
further guidance to states in updating
their statewide needs assessments and
submitting the required information to
HRSA. States that have elected not to
apply for or be awarded MIECHV funds

are encouraged to work with nonprofit
organizations that have received awards
to provide MIECHV services within the
state and indicate whether they will
submit their needs assessments directly
or through the nonprofit organization
awardee. HRSA, states, and nonprofits
providing MIECHV services within
states will use the information collected
through the needs assessment update to
reaffirm the provision of MIECHV home
visiting services in at-risk communities.
The information will also be used to
support program planning,
improvement, and decision-making. The
needs assessment update is not
intended to disrupt current services or
negatively impact communities that
have benefited from home visiting
programs, nor is the intent of the update

to require awardees to shift resources
away from at-risk communities they
currently serve.
Likely Respondents: MIECHV Program
Awardees that are states, territories,
and, where applicable, nonprofit
organizations providing 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; engage with stakeholders
and coordinate with state level partners;
and to draft and submit the report. 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

Maternal, Infant, and Early Childhood Home Visiting Program Statewide Needs Assessment Update ...................

56

1

56

95.57

5,352

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

56

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

56

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

5,352

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.
Amy P. McNulty,
Acting Director, Division of the Executive
Secretariat.
[FR Doc. 2018–08539 Filed 4–23–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meetings

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Number of
responses per
respondent

Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings of the NHLBI
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 contract proposals and

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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 contract proposals
and grant applications, the disclosure of
which would constitute a clearly
unwarranted invasion of personal
privacy.

Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7206, Bethesda, MD 20892–7924, 301–435–
0303, ssehnert@nhlbi.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)

Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
National Gene Vector Biorepository Contract
Review.
Date: May 14, 2018.
Time: 11:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Charles Joyce, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7196, Bethesda, MD 20892–7924, 301–827–
7939, cjoyce@nhlbi.nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Acute Lung Injury Program Project Review.
Date: May 15, 2018.
Time: 9:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Sheraton BWI (Baltimore), 1100 Old
Elkridge Landing Road, Baltimore, MD
21090.
Contact Person: Shelley S. Sehnert, Ph.D.,
Scientific Review Officer, Office of Scientific

Dated: April 18, 2018.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.

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[FR Doc. 2018–08443 Filed 4–23–18; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute Cancellation
Notice of Meeting
Notice is hereby given of the
cancellation of the National Cancer
Institute Special Emphasis Panel, May
21, 2018, 5:00 p.m. to May 22, 2018,
5:00 p.m., Bethesda North Marriott
Hotel & Conference Center, 5701
Marinelli Road, Linden Oak, Rockville,
MD, 20852 which was published in the
Federal Register on April 6, 2018, 83 FR
14869.

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