83_FR_42470 83 FR 42308 - 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

83 FR 42308 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 83, Issue 162 (August 21, 2018)

Page Range42308-42309
FR Document2018-17972

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.

Federal Register, Volume 83 Issue 162 (Tuesday, August 21, 2018) 
[Federal Register Volume 83, Number 162 (Tuesday, August 21, 2018)]
[Notices]
[Pages 42308-42309]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-17972]


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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

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 
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 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
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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

42308 Federal Register / Vol. 83, No. 162 / Tuesday, August 21, 2018 / Notices INFORMATION section for electronic III. Electronic Access Statewide Needs Assessment Update, access to the guidance document. Persons with access to the internet OMB No. 0906–XXX, New. Abstract: HRSA is requesting FOR FURTHER INFORMATION CONTACT: may obtain the guidance at either approval to collect updated statewide Adebayo Laniyonu, Center for Drug https://www.fda.gov/Drugs/Guidance needs assessments from Maternal, Evaluation and Research, Food and ComplianceRegulatoryInformation/ Infant, and Early Childhood Home Drug Administration, 10903 New Guidances/default.htm or https:// Visiting (MIECHV) Program awardees. Hampshire Ave., Bldg. 22, Rm. 5400, www.regulations.gov. The previous statewide needs Silver Spring, MD 20993–0002, 301– Dated: August 15, 2018. assessment that was approved under 796–1392. Leslie Kux, OMB control number 0915–0333 has SUPPLEMENTARY INFORMATION: Associate Commissioner for Policy. been discontinued. Eligible entities that [FR Doc. 2018–17961 Filed 8–20–18; 8:45 am] are states, the District of Columbia, and I. Background BILLING CODE 4164–01–P non-profit organizations will submit statewide needs assessment updates in FDA is announcing the availability of response to a forthcoming SIR. The a guidance for industry entitled MIECHV Program, authorized by section DEPARTMENT OF HEALTH AND ‘‘Microdose Radiopharmaceutical 511 of the Social Security Act, 42 U.S.C. HUMAN SERVICES Diagnostic Drugs: Nonclinical Study 711, and administered by HRSA in Recommendations.’’ This guidance is Health Resources and Services partnership with the Administration for intended to assist sponsors of microdose Administration Children and Families, supports radiopharmaceutical diagnostic drugs voluntary, evidence-based home visiting on the nonclinical studies Agency Information Collection services during pregnancy and to recommended to support human Activities: Submission to OMB for parents with young children up to clinical trials and marketing Review and Approval; Public Comment kindergarten entry. States, territories, applications. This guidance Request; The Maternal, Infant, and tribal entities, and in certain incorporates comments received and Early Childhood Home Visiting circumstances nonprofit organizations finalizes the draft guidance of the same Program Statewide Needs Assessment are eligible to receive funding through name issued on September 13, 2017 (82 Update MIECHV and have the flexibility, within FR 43025). The guidance includes a few the parameters of the authorizing editorial changes and a new sentence AGENCY: Health Resources and Services statute, to tailor the program to serve the clarifying the definition of the term Administration (HRSA), Department of specific needs of their communities. diagnostic radiopharmaceutical. Health and Human Services. The statewide needs assessment is a ACTION: Notice. critical and foundational resource that This guidance is being issued consistent with FDA’s good guidance assists awardees in identifying and SUMMARY: In compliance with of the understanding how to meet the needs of practices regulation (21 CFR 10.115). Paperwork Reduction Act of 1995, The guidance represents the current eligible families living in at-risk HRSA has submitted a Supplemental communities in their states. thinking of FDA on nonclinical study Information Request (SIR) to the Office After taking into consideration public recommendations for microdose of Management and Budget (OMB) for comments in response to the 60-day radiopharmaceutical diagnostic drugs. It review and approval. A 60-day Federal Notice published in the Federal does not establish any rights for any Register Notice was published in the Register on April 24, 2018 (83 FR person and is not binding on FDA or the Federal Register on April 24, 2018. 17826), HRSA is proposing final public. You can use an alternative There were seven public comments. revisions to the SIR guidance for the approach if it satisfies the requirements Comments submitted during the first needs assessment update by making the of the applicable statutes and public review of this SIR will be following changes: regulations. This guidance is not subject provided to OMB. OMB will accept • Inserting references to the statutory to Executive Order 12866. further comments from the public requirements for each section of the II. Paperwork Reduction Act of 1995 during the review and approval period. guidance—specifically the sections of DATES: Comments on this SIR should be statute that require an assessment of This guidance refers to previously received no later than September 20, state capacity to provide substance approved collections of information that 2018. abuse treatment and counseling are subject to review by the Office of services. ADDRESSES: Submit your comments, Management and Budget (OMB) under • Increasing the burden estimate for the Paperwork Reduction Act of 1995 including the Information Collection respondents from 95.57 to 120 in (44 U.S.C. 3501–3520). The collections Request (ICR) Title, to the desk officer response to comments that the original of information in 21 CFR parts 312 and for HRSA, either by email to OIRA_ estimate was too low. 314 have been approved under OMB submission@omb.eop.gov or by fax to Need and Proposed Use of the control numbers 0910–0014 and 0910– 202–395–5806. Information: Congress, through 0001, respectively. The collection of FOR FURTHER INFORMATION CONTACT: To enactment of the Social Security Act, information for radioactive drug request a copy of the clearance requests Title V, Section 511 (42 U.S.C. 711), as research committees in 21 CFR 361.1 submitted to OMB for review, email Lisa amended, established the MIECHV has been approved under OMB control Wright-Solomon, the HRSA Information Program. Section 50603 of the sradovich on DSK3GMQ082PROD with NOTICES number 0910–0053. The collection of Collection Clearance Officer at Bipartisan Budget Act of 2018 (Pub. L. information for the regulations on in paperwork@hrsa.gov or call (301) 443– 115–123) amended section 511(b)(1) of vivo radiopharmaceuticals used for 1984. the Social Security Act, and requires diagnosis and monitoring in 21 CFR SUPPLEMENTARY INFORMATION: that states review and update their 315.4, 315.5, and 315.6 has been Information Collection Request Title: statewide needs assessments (which approved under OMB control number The Maternal, Infant, and Early may be separate from, but in 0910–0409. Childhood Home Visiting Program coordination with, the Title V statewide VerDate Sep<11>2014 19:37 Aug 20, 2018 Jkt 244001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\21AUN1.SGM 21AUN1

Federal Register / Vol. 83, No. 162 / Tuesday, August 21, 2018 / Notices 42309 needs assessment) no later than October counseling services to individuals and programs are being operated in areas of 1, 2020. The Bipartisan Budget Act of families in need of such treatment or high need. However, the requirement for 2018 further establishes that conducting services. such an update should not be construed a MIECHV statewide needs assessment The forthcoming SIR will provide as requiring moving MIECHV-funded update is a condition of receiving Title further guidance to states in updating home visiting programs, defunding of V Maternal and Child Health Service their statewide needs assessments and programs for the sole purpose of moving (MCH) Block Grant funding; submission submitting the required information to services to other communities, or of the MIECHV needs assessment HRSA. States that have elected not to otherwise disrupting existing home update in accordance with the guidance apply or be awarded MIECHV funds are visiting programs, their relationships in in the SIR will meet this requirement. encouraged to work with nonprofit the community, and their services to In response to the forthcoming SIR, organizations that have received awards eligible families. The statutory states will be required to submit an to provide MIECHV services within the requiremenets of a needs assessment updated statewide needs assessment state and indicate whether they will update also apply to territory awardees, that identifies all of the following submit their needs assessments directly but this ICR does not include guidance, information, as required by the MIECHV or through the nonprofit organization nor a burden estimate, for these authorizing statute: awardee. Nonprofit awardees will need awardees. Recognizing potential (1) Communities with concentrations to provide documentation to challenges related to the availability of of (a) premature birth, low-birth weight demonstrate that they have been population health data for the infants, and infant mortality, including authorized or requested by the state in territories, a separate SIR will provide infant death due to neglect, or other which they provide services to submit a guidance on the needs assessment indicators of at-risk prenatal, maternal, needs assessment on behalf of the state. update to territories eligible to apply for newborn, or child health; (b) poverty; (c) Documentation, such as a letter, may MIECHV funds. crime; (d) domestic violence; (e) high come from a state’s Title V agency; an Likely Respondents: MIECHV Program rates of high-school drop-outs; (f) other health, education or human Awardees that are states, territories, substance abuse; (g) unemployment; or services state agency; or the governor’s and, where applicable, nonprofit (h) child maltreatment. office. organizations providing services within (2) The quality and capacity of HRSA, states, and nonprofits states. existing programs or initiatives for early providing MIECHV services within Burden Statement: Burden in this childhood home visitation in the state states will use the information collected context means the time expended by including: The number and types of through the needs assessment update to persons to generate, maintain, retain, individuals and families who are reaffirm the provision of MIECHV home disclose, or provide the information receiving services under such programs visiting services in at-risk communities. requested. This includes the time or initiatives; the gaps in early The information will also be used to needed to review instructions and childhood home visitation in the state; support program planning, supporting materials; to collect and and the extent to which such programs improvement, and decision-making. The analyze data; engage with stakeholders or initiatives are meeting the needs of purpose of updating the statewide needs and coordinate with state level partners; eligible families. assessments is for awardees to gather and to draft and submit the report. The (3) The state’s capacity for providing more recent information on community table below summarizes the total annual substance abuse treatment and needs and ensure that MIECHV 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 ................... 51 1 51 120 6,120 Total .............................................................................. 51 ........................ 51 ........................ 6,120 Amy P. McNulty, DEPARTMENT OF HEALTH AND documents, call the SAMHSA Reports Acting Director, Division of the Executive HUMAN SERVICES Clearance Officer on (240) 276–1243. Secretariat. Project: Government Performance and [FR Doc. 2018–17972 Filed 8–20–18; 8:45 am] Substance Abuse and Mental Health Results Act (GPRA) Client/Participant Services Administration BILLING CODE 4165–15–P Outcomes Measure—(OMB No. 0930– Agency Information Collection 0208)—Revision Activities: Submission for OMB SAMHSA is requesting approval to Review; Comment Request add 13 new questions to its existing CSAT Client-level GPRA instrument. sradovich on DSK3GMQ082PROD with NOTICES Periodically, the Substance Abuse and Grantees will only be required to answer Mental Health Services Administration no more than four additional questions, (SAMHSA) will publish a summary of per CSAT grant awarded, in addition to information collection requests under the other questions on the instrument. OMB review, in compliance with the Currently, the information collected Paperwork Reduction Act (44 U.S.C. from this instrument is entered and Chapter 35). To request a copy of these stored in SAMHSA’s Performance VerDate Sep<11>2014 19:37 Aug 20, 2018 Jkt 244001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\21AUN1.SGM 21AUN1


Document Created: 2018-08-21 00:07:46
Document Modified: 2018-08-21 00:07:46
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesComments on this SIR should be received no later than September 20, 2018.
ContactTo 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.
FR Citation83 FR 42308 
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