83 FR 17826 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 83, Issue 79 (April 24, 2018)
Health Resources and Services Administration
Federal Register Volume 83, Issue 79 (April 24, 2018)
| Page Range | 17826-17827 | |
| FR Document | 2018-08539 |
[Federal Register Volume 83, Number 79 (Tuesday, April 24, 2018)] [Notices] [Pages 17826-17827] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-08539] ----------------------------------------------------------------------- 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 AGENCY: Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: 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 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, 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 [[Page 17827]] 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 Average burden Instrument Number of responses per Total hours per Total burden respondents respondent responses response hours ---------------------------------------------------------------------------------------------------------------- Maternal, Infant, and Early 56 1 56 95.57 5,352 Childhood Home Visiting Program Statewide Needs Assessment Update......................... ------------------------------------------------------------------------------- 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] BILLING CODE 4165-15-P
![17826 Federal Register / Vol. 83, No. 79 / Tuesday, April 24, 2018 / Notices
SUPPLEMENTARY INFORMATION: Dated: April 19, 2018. non-profit organizations will submit
Leslie Kux, statewide needs assessment updates in
I. Background response to a forthcoming SIR.
Associate Commissioner for Policy.
FDA is announcing the availability of [FR Doc. 2018–08548 Filed 4–23–18; 8:45 am] The MIECHV Program, authorized by
section 511 of the Social Security Act,
a draft guidance for industry entitled BILLING CODE 4164–01–P
42 U.S.C. 711, and administered by
‘‘Severely Debilitating or Life-
HRSA in partnership with the
Threatening Hematologic Disorders: Administration for Children and
Nonclinical Development of DEPARTMENT OF HEALTH AND
HUMAN SERVICES Families, supports voluntary, evidence-
Pharmaceuticals.’’ The purpose of this based home visiting services during
guidance is to provide information to Health Resources and Services pregnancy and to parents with young
assist sponsors in the design of an Administration children up to kindergarten entry.
appropriate program of nonclinical States, territories, and tribal entities,
studies for the development of Agency Information Collection and nonprofit organizations, in certain
pharmaceuticals used to treat patients Activities: Proposed Collection: Public circumstances, are eligible to receive
with SDLTHDs. While FDA has Comment Request Information funding through MIECHV and have the
guidance for oncology indications (most Collection Request Title: The Maternal, flexibility, within the parameters of the
of which are considered severely Infant, and Early Childhood Home authorizing statute, to tailor the program
debilitating or life-threatening diseases) Visiting Program Statewide Needs to serve the specific needs of their
and for rare diseases (which include Assessment Update communities.
some SDLTHD conditions), FDA has no The statewide needs assessment is a
AGENCY: Health Resources and Services
guidance to facilitate nonclinical critical and foundational resource that
Administration (HRSA), Department of assists awardees in identifying and
development specifically for Health and Human Services.
pharmaceuticals used to treat understanding how to meet the needs of
ACTION: Notice. eligible families living in at-risk
nononcology patients with SDLTHDs.
SUMMARY: In compliance with the communities in their states.
The SDLTHDs include conditions in Need and Proposed Use of the
requirement for opportunity for public
which life expectancy is short or quality Information: Congress, through
comment on proposed data collection
of life is greatly diminished despite enactment of the Social Security Act,
projects of the Paperwork Reduction Act
available therapies. FDA has defined Title V, Section 511 (42 U.S.C. 711), as
of 1995, HRSA announces plans to
life-threatening and severely debilitating amended, established the MIECHV
submit a Supplemental Information
diseases in regulations (21 CFR 312.81). Program. The MIECHV Program is
Request (SIR), described below, to the
A streamlined approach to drug designed to: (1) Strengthen and improve
Office of Management and Budget
development is necessary to allow the programs and activities carried out
(OMB). Prior to submitting the SIR to
patients with SDLTHDs earlier and under Title V of the Social Security Act;
OMB, HRSA seeks comments from the
continued access to new and potentially (2) improve coordination of services for
public regarding the burden estimate,
effective therapies. This guidance, when at risk communities; and (3) identify
below, or any other aspect of the SIR.
finalized, is expected to reduce the use and provide comprehensive services to
DATES: Comments on this SIR should be improve outcomes for families who
of animals in accordance with the 3R received no later than June 25, 2018. reside in at risk communities. Section
(refine/reduce/replace) principles and ADDRESSES: Submit your comments to 50603 of the Bipartisan Budget Act of
allow faster and continuous access to paperwork@hrsa.gov or mail the HRSA 2018 (Pub. L. 115–123) amended section
pharmaceuticals for SDLTHDs. Information Collection Clearance 511(b)(1) of the Social Security Act, and
This draft guidance is being issued Officer, 14N39, 5600 Fishers Lane, requires that states review and update
consistent with FDA’s good guidance Rockville, MD 20857. their statewide needs assessments
practices regulation (21 CFR 10.115). FOR FURTHER INFORMATION CONTACT: To (which may be separate from, but in
The draft guidance, when finalized, will request more information on the coordination with, the Title V statewide
represent the current thinking of FDA proposed project or to obtain a copy of needs assessment) no later than October
on nonclinical development of the data collection plans and draft 1, 2020, as a condition of receiving
pharmaceuticals for severely instruments, email paperwork@hrsa.gov payments from Title V Block Grant
debilitating or life-threatening or call Lisa Wright-Solomon, the HRSA allotments.
hematologic disorders. It does not Information Collection Clearance Officer In response to the forthcoming SIR,
establish any rights for any person and at (301) 443–1984. state and territory awardees will be
is not binding on FDA or the public. SUPPLEMENTARY INFORMATION: required to submit an updated statewide
You can use an alternative approach if Information Collection Request Title: needs assessment that identifies all of
The Maternal, Infant, and Early the following information, as required
it satisfies the requirements of the
Childhood Home Visiting Program by the MIECHV authorizing statute:
applicable statutes and regulations. This (1) Communities with concentrations
Needs Assessment Update
guidance is not subject to Executive OMB No.: 0906–XXXX, New. of (a) premature birth, low-birth weight
Order 12866. Abstract: HRSA is requesting infants, and infant mortality, including
II. Electronic Access approval to collect updated statewide infant death due to neglect, or other
needs assessments from Maternal, indicators of at-risk prenatal, maternal,
daltland on DSKBBV9HB2PROD with NOTICES
Persons with access to the internet Infant, and Early Childhood Home newborn, or child health; (b) poverty; (c)
may obtain the draft guidance at either Visiting (MIECHV) Program awardees. crime; (d) domestic violence; (e) high
https://www.fda.gov/Drugs/Guidance The previous statewide needs rates of high-school drop-outs; (f)
ComplianceRegulatoryInformation/ assessment that was approved under substance abuse; (g) unemployment; or
Guidances/default.htm or https:// OMB control number 0915–0333 has (h) child maltreatment.
www.regulations.gov. been discontinued. Eligible entities that (2) The quality and capacity of
are states, the District of Columbia, and existing programs or initiatives for early
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![Federal Register / Vol. 83, No. 79 / Tuesday, April 24, 2018 / Notices 17827
childhood home visitation in the state are encouraged to work with nonprofit to require awardees to shift resources
including: the number and types of organizations that have received awards away from at-risk communities they
individuals and families who are to provide MIECHV services within the currently serve.
receiving services under such programs state and indicate whether they will Likely Respondents: MIECHV Program
or initiatives; the gaps in early submit their needs assessments directly Awardees that are states, territories,
childhood home visitation in the state; or through the nonprofit organization and, where applicable, nonprofit
and the extent to which such programs awardee. HRSA, states, and nonprofits organizations providing services within
or initiatives are meeting the needs of providing MIECHV services within states.
eligible families. states will use the information collected Burden Statement: Burden in this
(3) The state’s capacity for providing through the needs assessment update to context means the time expended by
substance abuse treatment and reaffirm the provision of MIECHV home persons to generate, maintain, retain,
counseling services to individuals and visiting services in at-risk communities. disclose, or provide the information
families in need of such treatment or The information will also be used to requested. This includes the time
services. support program planning, needed to review instructions and
The forthcoming SIR will provide improvement, and decision-making. The supporting materials; to collect and
further guidance to states in updating needs assessment update is not analyze data; engage with stakeholders
their statewide needs assessments and intended to disrupt current services or and coordinate with state level partners;
submitting the required information to negatively impact communities that and to draft and submit the report. The
HRSA. States that have elected not to have benefited from home visiting table below summarizes the total annual
apply for or be awarded MIECHV funds programs, nor is the intent of the update burden hours estimated for this SIR.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of Average
Number of Total Total burden
Instrument responses per burden hours
respondents responses hours
respondent per response
Maternal, Infant, and Early Childhood Home Visiting Pro-
gram Statewide Needs Assessment Update ................... 56 1 56 95.57 5,352
Total .............................................................................. 56 ........................ 56 ........................ 5,352
HRSA specifically requests comments grant applications and the discussions Review/DERA, National Heart, Lung, and
on (1) the necessity and utility of the could disclose confidential trade secrets Blood Institute, 6701 Rockledge Drive, Room
proposed information collection for the or commercial property such as 7206, Bethesda, MD 20892–7924, 301–435–
proper performance of the agency’s patentable material, and personal 0303, ssehnert@nhlbi.nih.gov.
functions, (2) the accuracy of the information concerning individuals (Catalogue of Federal Domestic Assistance
estimated burden, (3) ways to enhance associated with the contract proposals Program Nos. 93.233, National Center for
the quality, utility, and clarity of the Sleep Disorders Research; 93.837, Heart and
and grant applications, the disclosure of
Vascular Diseases Research; 93.838, Lung
information to be collected, and (4) the which would constitute a clearly Diseases Research; 93.839, Blood Diseases
use of automated collection techniques unwarranted invasion of personal and Resources Research, National Institutes
or other forms of information privacy. of Health, HHS)
technology to minimize the information Name of Committee: National Heart, Lung,
collection burden. Dated: April 18, 2018.
and Blood Institute Special Emphasis Panel;
Michelle Trout,
Amy P. McNulty, National Gene Vector Biorepository Contract
Review. Program Analyst, Office of Federal Advisory
Acting Director, Division of the Executive Date: May 14, 2018. Committee Policy.
Secretariat. Time: 11:00 a.m. to 12:00 p.m. [FR Doc. 2018–08443 Filed 4–23–18; 8:45 am]
[FR Doc. 2018–08539 Filed 4–23–18; 8:45 am] Agenda: To review and evaluate contract BILLING CODE 4140–01–P
BILLING CODE 4165–15–P proposals.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call). DEPARTMENT OF HEALTH AND
DEPARTMENT OF HEALTH AND HUMAN SERVICES
HUMAN SERVICES Contact Person: Charles Joyce, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and National Institutes of Health
National Institutes of Health
Blood Institute, 6701 Rockledge Drive, Room
7196, Bethesda, MD 20892–7924, 301–827– National Cancer Institute Cancellation
National Heart, Lung, and Blood Notice of Meeting
7939, cjoyce@nhlbi.nih.gov.
Institute; Notice of Closed Meetings
Name of Committee: National Heart, Lung,
Pursuant to section 10(d) of the and Blood Institute Special Emphasis Panel; Notice is hereby given of the
Federal Advisory Committee Act, as Acute Lung Injury Program Project Review. cancellation of the National Cancer
amended, notice is hereby given of the Date: May 15, 2018. Institute Special Emphasis Panel, May
daltland on DSKBBV9HB2PROD with NOTICES
following meetings of the NHLBI Time: 9:00 a.m. to 12:00 p.m. 21, 2018, 5:00 p.m. to May 22, 2018,
Agenda: To review and evaluate grant 5:00 p.m., Bethesda North Marriott
Special Emphasis Panel. applications.
The meetings will be closed to the Place: Sheraton BWI (Baltimore), 1100 Old
Hotel & Conference Center, 5701
public in accordance with the Elkridge Landing Road, Baltimore, MD Marinelli Road, Linden Oak, Rockville,
provisions set forth in sections 21090. MD, 20852 which was published in the
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Contact Person: Shelley S. Sehnert, Ph.D., Federal Register on April 6, 2018, 83 FR
as amended. The contract proposals and Scientific Review Officer, Office of Scientific 14869.
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Document Created: 2018-04-24 00:39:36
Document Modified: 2018-04-24 00:39:36
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments on this SIR should be received no later than June 25, 2018. | |
| 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. | |
| FR Citation | 83 FR 17826 |
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