Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; The Maternal, Infant, and Early Childhood Home Visiting Program Statewide Needs Assessment Update, 42308-42309 [2018-17972]
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Federal Register / Vol. 83, No. 162 / Tuesday, August 21, 2018 / Notices
III. Electronic Access
INFORMATION section for electronic
access to the guidance document.
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Adebayo Laniyonu, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5400,
Silver Spring, MD 20993–0002, 301–
796–1392.
Dated: August 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2018–17961 Filed 8–20–18; 8:45 am]
I. Background
BILLING CODE 4164–01–P
FDA is announcing the availability of
a guidance for industry entitled
‘‘Microdose Radiopharmaceutical
Diagnostic Drugs: Nonclinical Study
Recommendations.’’ This guidance is
intended to assist sponsors of microdose
radiopharmaceutical diagnostic drugs
on the nonclinical studies
recommended to support human
clinical trials and marketing
applications. This guidance
incorporates comments received and
finalizes the draft guidance of the same
name issued on September 13, 2017 (82
FR 43025). The guidance includes a few
editorial changes and a new sentence
clarifying the definition of the term
diagnostic radiopharmaceutical.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on nonclinical study
recommendations for microdose
radiopharmaceutical diagnostic drugs. 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.
sradovich on DSK3GMQ082PROD with NOTICES
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR parts 312 and
314 have been approved under OMB
control numbers 0910–0014 and 0910–
0001, respectively. The collection of
information for radioactive drug
research committees in 21 CFR 361.1
has been approved under OMB control
number 0910–0053. The collection of
information for the regulations on in
vivo radiopharmaceuticals used for
diagnosis and monitoring in 21 CFR
315.4, 315.5, and 315.6 has been
approved under OMB control number
0910–0409.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; 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 of the
Paperwork Reduction Act of 1995,
HRSA has submitted a Supplemental
Information Request (SIR) to the Office
of Management and Budget (OMB) for
review and approval. A 60-day Federal
Register Notice was published in the
Federal Register on April 24, 2018.
There were seven public comments.
Comments submitted during the first
public review of this SIR will be
provided to OMB. OMB will accept
further comments from the public
during the review and approval period.
DATES: Comments on this SIR should be
received no later than September 20,
2018.
SUMMARY:
Submit your comments,
including the Information Collection
Request (ICR) Title, to the desk officer
for HRSA, either by email to OIRA_
submission@omb.eop.gov or by fax to
202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email Lisa
Wright-Solomon, the HRSA Information
Collection Clearance Officer at
paperwork@hrsa.gov or call (301) 443–
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
The Maternal, Infant, and Early
Childhood Home Visiting Program
ADDRESSES:
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
Statewide Needs Assessment Update,
OMB No. 0906–XXX, 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
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, 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.
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.
After taking into consideration public
comments in response to the 60-day
Notice published in the Federal
Register on April 24, 2018 (83 FR
17826), HRSA is proposing final
revisions to the SIR guidance for the
needs assessment update by making the
following changes:
• Inserting references to the statutory
requirements for each section of the
guidance—specifically the sections of
statute that require an assessment of
state capacity to provide substance
abuse treatment and counseling
services.
• Increasing the burden estimate for
respondents from 95.57 to 120 in
response to comments that the original
estimate was too low.
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. 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
E:\FR\FM\21AUN1.SGM
21AUN1
42309
Federal Register / Vol. 83, No. 162 / Tuesday, August 21, 2018 / Notices
needs assessment) no later than October
1, 2020. The Bipartisan Budget Act of
2018 further establishes that conducting
a MIECHV statewide needs assessment
update is a condition of receiving Title
V Maternal and Child Health Service
(MCH) Block Grant funding; submission
of the MIECHV needs assessment
update in accordance with the guidance
in the SIR will meet this requirement.
In response to the forthcoming SIR,
states 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
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 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. Nonprofit awardees will need
to provide documentation to
demonstrate that they have been
authorized or requested by the state in
which they provide services to submit a
needs assessment on behalf of the state.
Documentation, such as a letter, may
come from a state’s Title V agency; an
other health, education or human
services state agency; or the governor’s
office.
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
purpose of updating the statewide needs
assessments is for awardees to gather
more recent information on community
needs and ensure that MIECHV
programs are being operated in areas of
high need. However, the requirement for
such an update should not be construed
as requiring moving MIECHV-funded
home visiting programs, defunding of
programs for the sole purpose of moving
services to other communities, or
otherwise disrupting existing home
visiting programs, their relationships in
the community, and their services to
eligible families. The statutory
requiremenets of a needs assessment
update also apply to territory awardees,
but this ICR does not include guidance,
nor a burden estimate, for these
awardees. Recognizing potential
challenges related to the availability of
population health data for the
territories, a separate SIR will provide
guidance on the needs assessment
update to territories eligible to apply for
MIECHV funds.
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
Number of
responses per
respondent
Total
responses
Average
burden hours
per response
Total burden
hours
Maternal, Infant, and Early Childhood Home Visiting Program Statewide Needs Assessment Update ...................
51
1
51
120
6,120
Total ..............................................................................
51
........................
51
........................
6,120
Amy P. McNulty,
Acting Director, Division of the Executive
Secretariat.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2018–17972 Filed 8–20–18; 8:45 am]
Substance Abuse and Mental Health
Services Administration
BILLING CODE 4165–15–P
sradovich on DSK3GMQ082PROD with NOTICES
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and
Mental Health Services Administration
(SAMHSA) will publish a summary of
information collection requests under
OMB review, in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
VerDate Sep<11>2014
19:37 Aug 20, 2018
Jkt 244001
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
documents, call the SAMHSA Reports
Clearance Officer on (240) 276–1243.
Project: Government Performance and
Results Act (GPRA) Client/Participant
Outcomes Measure—(OMB No. 0930–
0208)—Revision
SAMHSA is requesting approval to
add 13 new questions to its existing
CSAT Client-level GPRA instrument.
Grantees will only be required to answer
no more than four additional questions,
per CSAT grant awarded, in addition to
the other questions on the instrument.
Currently, the information collected
from this instrument is entered and
stored in SAMHSA’s Performance
E:\FR\FM\21AUN1.SGM
21AUN1
]]>Agencies
[Federal Register Volume 83, Number 162 (Tuesday, August 21, 2018)]
[Notices]
[Pages 42308-42309]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17972]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request; The Maternal, Infant, and
Early Childhood Home Visiting Program Statewide Needs Assessment Update
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with of the Paperwork Reduction Act of 1995,
HRSA has submitted a Supplemental Information Request (SIR) to the
Office of Management and Budget (OMB) for review and approval. A 60-day
Federal Register Notice was published in the Federal Register on April
24, 2018. There were seven public comments. Comments submitted during
the first public review of this SIR will be provided to OMB. OMB will
accept further comments from the public during the review and approval
period.
DATES: Comments on this SIR should be received no later than September
20, 2018.
ADDRESSES: Submit your comments, including the Information Collection
Request (ICR) Title, to the desk officer for HRSA, either by email to
[email protected] or by fax to 202-395-5806.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email Lisa Wright-Solomon, the
HRSA Information Collection Clearance Officer at [email protected] or
call (301) 443-1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: The Maternal, Infant, and
Early Childhood Home Visiting Program Statewide Needs Assessment
Update, OMB No. 0906-XXX, 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 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, 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.
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.
After taking into consideration public comments in response to the
60-day Notice published in the Federal Register on April 24, 2018 (83
FR 17826), HRSA is proposing final revisions to the SIR guidance for
the needs assessment update by making the following changes:
Inserting references to the statutory requirements for
each section of the guidance--specifically the sections of statute that
require an assessment of state capacity to provide substance abuse
treatment and counseling services.
Increasing the burden estimate for respondents from 95.57
to 120 in response to comments that the original estimate was too low.
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. 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
[[Page 42309]]
needs assessment) no later than October 1, 2020. The Bipartisan Budget
Act of 2018 further establishes that conducting a MIECHV statewide
needs assessment update is a condition of receiving Title V Maternal
and Child Health Service (MCH) Block Grant funding; submission of the
MIECHV needs assessment update in accordance with the guidance in the
SIR will meet this requirement.
In response to the forthcoming SIR, states 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 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 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.
Nonprofit awardees will need to provide documentation to demonstrate
that they have been authorized or requested by the state in which they
provide services to submit a needs assessment on behalf of the state.
Documentation, such as a letter, may come from a state's Title V
agency; an other health, education or human services state agency; or
the governor's office.
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 purpose of
updating the statewide needs assessments is for awardees to gather more
recent information on community needs and ensure that MIECHV programs
are being operated in areas of high need. However, the requirement for
such an update should not be construed as requiring moving MIECHV-
funded home visiting programs, defunding of programs for the sole
purpose of moving services to other communities, or otherwise
disrupting existing home visiting programs, their relationships in the
community, and their services to eligible families. The statutory
requiremenets of a needs assessment update also apply to territory
awardees, but this ICR does not include guidance, nor a burden
estimate, for these awardees. Recognizing potential challenges related
to the availability of population health data for the territories, a
separate SIR will provide guidance on the needs assessment update to
territories eligible to apply for MIECHV funds.
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 Average burden
Instrument Number of responses per Total hours per Total burden
respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
Maternal, Infant, and Early 51 1 51 120 6,120
Childhood Home Visiting Program
Statewide Needs Assessment
Update.........................
-------------------------------------------------------------------------------
Total....................... 51 .............. 51 .............. 6,120
----------------------------------------------------------------------------------------------------------------
Amy P. McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2018-17972 Filed 8-20-18; 8:45 am]
BILLING CODE 4165-15-P
