Supporting Statement Part A_MIECHV PFO_3.1.21

This is a new Supplemental Information Request (SIR). The Health Resources and Services Administration (HRSA) requests Office of Management and Budget (OMB) approval to initiate data collection for the initiation of a Pay for Outcomes initiative leveraging funding from the Maternal, Infant, and Early Childhood Home Visiting (MIECHV) Program, as required through statutory changes included in the Bipartisan Budget Act of 2018 (P.L. 115-123).

A.1.1 Background

The MIECHV Program is authorized by Social Security Act, Title V, § 511(c) (42 U.S.C. § 711(c)) to support voluntary, evidence-based home visiting services for pregnant women and parents with young children up to kindergarten entry living in at-risk communities.
scientific research have shown that home visits by a nurse, social worker, early childhood educator, or other trained professional during pregnancy and in the first years of a child’s life improve the lives of children and families. Home visiting helps prevent child abuse and neglect, supports positive parenting, improves maternal and child health, and promotes child development and school readiness.

Evidence-based home visiting can be cost-effective in the long term, with the most significant benefits identified as reduced spending on government programs and increased individual earnings. Costs for evidence-based home visiting programs are incurred at the time of service provision, yet participating parents and children may benefit over the course of their lives, and the economic value of improved outcomes typically exceeds costs over the long-term.
instance, evidence-based home visiting programs may reduce government spending on special education (Individuals with Disabilities Education Act, Parts C and B), and reduce the need for public assistance programs such as Temporary Assistance for Needy Families (TANF), the Supplemental Nutrition Assistance Program (SNAP), and Medicaid. Further, improved outcomes for children and families can also produce social benefit more broadly through the life-long gains associated with better birth outcomes and maternal health, reductions in child abuse and neglect, and increases in family self-sufficiency.

Section 50605 of the Bipartisan Budget Act (BBA) of 2018 (Pub. L. 115- 123) added new Section 511(c)(3), which authorizes MIECHV recipients the option to use up to 25% of MIECHV funding for “outcomes or success payments related to a pay for outcomes (PFO) initiative that will not result in reduction of funding for home visiting services.” The new authority establishes new requirements, including that the PFO initiative “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.” Under Section 511(j)(3)(A), funds used by recipients for a PFO initiative remain available for expenditure by the eligible entity for not more than 10 years after the funds are made available.

To meet statutory requirements for a PFO initiative, the initiative must include:

A feasibility study that describes how the proposed intervention is based on evidence of effectiveness;
A rigorous, third-party evaluation that uses experimental or quasi-experimental 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;
An annual, publicly available report on the progress of the initiative; and
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.

To collect the information described above, the SIR guidance (Attachment 1) specifies that a complete PFO SIR Response includes:

PFO Narrative – a report that describes the results of the feasibility study, the proposed PFO initiative in detail, and the proposed evaluation plan.
Required Attachments:
1. Attachment A - PFO Workplan Timeline (Attachment 2)
2. Attachment B - Completed Feasibility Study
3. Attachment C - Partnership Agreements with Key PFO Partners

A.1.2. Overview of the Data Collection System

Information will be collected from MIECHV awardees through the PFO SIR Response. Once the application for MIECHV formula funding been approved, awardees will have until 120 days after the project period start date to submit their completed PFO SIR Response. The timeline for completion and submission of the PFO SIR Response is outlined in the PFO SIR and the MIECHV Awardee Notice of Grant Award. Awardees will submit the PFO SIR Response as either a Word Document or PDF through HRSA’s Electronic Handbooks (EHBs), the software HRSA uses to maintain official grant records.

The PFO SIR Response will be used to evaluate proposals, provide technical assistance and support to awardees interested in implementing PFO initiatives, and ensure that awardees are proposing PFO projects that meet the statutory requirements.

Items of Information to Be Collected

No individually identifiable information will be collected. Information collected during the OMB approval period will be maintained for a period of time specified in accordance with federal records management requirements.

In the PFO SIR Response awardees will include:

Introduction and Project Summary
PFO Feasibility Study Summary
Target Population and Evidence-Based Models
Stakeholders and Partnership Structure
PFO Budget and Budget Narrative
Selected Outcome Measure(s)
Outcome Payments Criteria and Timing
Third-Party Evaluation
Verifications and Assurances

An outline of the required report and specific instructions for how to respond to each section is described in Section 4 of PFO SIR (Attachment 1). In addition to the PFO SIR Response, awardees will provide a detailed workplan for implementation of the PFO initiative, based on the PFO Workplan Timeline Template Attachment (Attachment 2). Awardees will also be required to submit their completed feasibility studies and partnership agreements with key PFO partners. The PFO SIR guidance provides specific instructions for submitting this information.

The information submitted in response to the PFO SIR will be used to verify the feasibility and implementation planning of PFO initiatives proposed by MIECHV awardees meets statutory requirements. The information collected through the PFO SIR Response will be maintained by HRSA and will comply with federal records management requirements.

A.2 Purposes and Use of the Information Collection

HRSA considers PFO initiatives to be an innovative approach to funding home visiting service delivery, which may result in program improvements including:

Strategically targeting and investing in new or underserved populations;
Improving service delivery and performance through a focus on targeted outcomes;
Expanding service delivery to meet unmet needs by leveraging investors or other funding streams; and
Improving data capacity, collection, reporting and management, particularly regarding program performance and achievement of outcomes.

Information collected to implement a PFO initiative may reveal population trends, identify areas of increasing or decreasing risk, and identify resources to support families in need. The information collected may also inform strategic decision-making among MIECHV awardees and their stakeholders, in addition to identifying opportunities for collaboration to strengthen and expand services for at-risk families. To meet statutory requirements for a PFO initiative, the proposed initiative must include:

A feasibility study that describes how the proposed intervention is based on evidence of effectiveness;
A rigorous, third-party evaluation that uses experimental or quasi-experimental 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;
An annual, publicly available report on the progress of the initiative; and
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.

A PFO initiative may not result in a reduction of funding for home visiting services, must be demonstrated as being feasible to implement, and include a rigorous, third-party evaluation to determine whether the initiative has met its proposed outcomes.

Instructions in the SIR provide flexibility for awardees in how they meet the requirement to assess the feasibility of implementing a PFO initiative and to choose outcome measures for the PFO initiative. The requirement of completion of a feasibility study may be satisfied in one of two ways:

Complete a new MIECHV PFO feasibility study based on the PFO feasibility study instructions found in the SIR, or
Use and submit a feasibility study completed within the past five years that assessed the same intervention and target population you are proposing in the PFO SIR Response. This feasibility study, which may have been supported by non-MIECHV funding sources, can be supplemented with any additional information necessary to submit a complete response to the SIR.

When selecting one or more outcome measures for the PFO initiative, awardees may choose either impact outcomes or process outcomes (or both), as long as the methodology for evaluating whether or not the outcomes have been achieved allows for the strongest possible causal inference. The outcome measure(s) and methodology quantifying its measurement may also be chosen by the awardee. It should be noted that possible outcomes are not limited to those that have been monetized in the literature, but they must align with the six MIECHV benchmark areas and at least one of the 19 MEICHV constructs. Further, awardees have the flexibility to choose the methodology used to determine payment amounts (in the form of outcome payments) for each of the target outcomes chosen. Outcome payments can only be made for those outcomes included in the PFO evaluation and payments can only be made after the evaluator has determined whether the outcomes have been achieved. The rationale for selecting the payment amounts and describe how the payment amounts take into consideration federal, state and local public sector savings, cost avoidance, and social benefit must be provided.

In addition to satisfying statutory requirements, HRSA anticipates MIECHV awardees may use proposed PFO initiatives to:

Understand the current needs of families and children, and at-risk counties;
Target home visiting services to at-risk counties with evidence-based and promising approach home visiting models that meet community needs;
Support statewide planning to develop and implement a continuum of home visiting services for eligible families and children prenatally through kindergarten entry;
Inform public and private stakeholders about the unmet need for home visiting and other services in the state;
Identify opportunities for collaboration with state and local partners to establish appropriate linkages and referral networks to other community resources and supports and strengthen strong early childhood systems; and
Direct technical assistance resources to enhance home visiting service delivery and improve coordination of services in at-risk counties.
Support home visiting sustainability through strategic partnerships.

HRSA intends to use the SIR Response to evaluate proposals, provide technical assistance and support for those interested in implementing PFO initiatives, and ensure that awardees are proposing PFO projects that meet statutory requirements. Additionally, HRSA may use the data collected through the PFO SIR response to assess a national picture of feasibility for PFO initiatives, and analyze the data provided with other program data to understand how MIECHV-funded services reach at-risk families across the country. Analyses may inform future program policy-making, research papers or journal articles, and conference presentations.

A.2.1 Privacy Impact Assessment Information

The proposed collection will have little or no effect on the respondent’s privacy. No information in identifiable form (IIF) will be collected. Data will be collected and used in aggregate form by HRSA.

A.3 Use of Improved Information Technology and Burden Reduction

A.3.1 Use of Improved Information Technology

All required information will be collected electronically via HRSA’s Electronic Handbooks (EHBs). Awardees will submit the SIR Response, which includes the PFO Narrative and required attachments, directly to HRSA via the Electronic Handbooks (EHB) grant management application. The EHBs is a web-based system that allows for easy submission of information directly to HRSA. The system is an electronic reporting tool used by MIECHV Program awardees for grant-related reporting requirements, and allows for the appropriate storage, extraction, and management of needs assessment update information by federal staff. HRSA staff can also use the system to seek clarifications or additions to the submitted information, and request updated information to be resubmitted before approval through the EHBs.

A.3.2 Burden Reduction

To reduce burden, HRSA has identified points of flexibility in planning and made efforts to ensure awardees can use existing information when possible. Awardees may choose the outcome measures used for their PFO initiative, either impact outcomes or process outcomes (or both), as long as the methodology for evaluation allows for the strongest possible causal inference. The target outcome and methodology quantifying its measurement may also be chosen by the awardee. Further, potential outcomes are not limited to those that have been monetized in the literature. However, they must align with the six MIECHV benchmark areas (though addressing all of them is not required) and at least one of the 19 MIECHV constructs.

Additionally, to reduce burden, awardees are not required to complete a new PFO feasibility study to satisfy the requirements of the SIR if they have a previously completed feasibility study that qualifies. The requirement of completion of a feasibility study may be satisfied in one of two ways:

Complete a new MIECHV PFO feasibility study based on the PFO feasibility study instructions found in the SIR, or
Use and submit a feasibility study completed within the past five years that assessed the same intervention and target population you are proposing in the PFO SIR Response. This feasibility study, which may have been supported by non-MIECHV funding sources, can be supplemented with any additional information necessary to submit a complete response to the SIR.

The SIR provides more information about conducting a feasibility study and proposing a PFO initiative. The instructions further describe the flexibility to reduce burden and support the implementation of PFO initiatives.

A.4 Efforts to Identify Duplication and Use of Similar Information

The information collected through this request is not available from another source. Only MIECHV Program awardees can supply the requested information, though other sources of data, including administrative data and data collected through the needs assessment, may support the PFO SIR Response. This SIR is the first guidance from HRSA to address the implementation of a PFO initiative; however, some states may have explored PFO as an innovative funding model and completed a feasibility study prior to the release of the SIR. Therefore, the PFO SIR requirement of completion of a feasibility study may be satisfied by completing a new MIECHV PFO feasibility study, or by reporting on a recently completed feasibility study that meets HRSA’s requirements to reduce any potential duplication of effort.

A.5 Impact on Small Businesses or Other Small Entities

Awardees may choose to contract with a small business or other small entities to support the completion of their PFO SIR Response and proposed PFO initiative. Local implementing agencies (LIAs) are contracted by MIECHV awardees to implement evidence-based home visiting programs and may be small businesses; awardees may also currently work closely with model developers, research organizations, and academic institutions to satisfy MIECHV requirements. HRSA anticipates that some awardees may choose to involve similar entities to meet the requirements of the PFO SIR; therefore, the information requested has been held to the minimum necessary to meet statutory requirements and to provide information that may inform program policy.

A.6 Consequences of Collecting the Information Less Frequently

The information collected through this request will only be collected from applicable awardee once, 120 days after the project period start date. The intended use of this information is to allow HRSA to ensure that awardees have complied with the statutory requirements for a PFO initiative. The information will also allow HRSA to provide technical assistance and support for awardees interested in implementing a PFO initiative. The completion of the PFO SIR Response and implementation of a PFO initiative is not required of MIECHV awardees; a PFO SIR Response is only required for awardees proposing to implement a PFO initiative that includes funding for outcome payments.

A.7 Special Circumstances Relating to the Guidelines of 5 CFR1320.5

This request fully complies with all guidelines of 5 CFR 1320.5. There are no special circumstances required.

A.8 Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency

A 60-day notice for public comments on the proposed data collection activities required by Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 was published in the Federal Register on July 8, 2020 (Document Number 2020-14658; document citation 85 FR 41055, pages 41055-41056) (Attachment 3). Public comments were requested by September 8, 2020.

HRSA received 4 comments. An abbreviated version of the comments and HRSA’s responses are provided below (a full description of the comments is provided in Attachment 4):

Comment: Respondents indicated that the guidance around third-party evaluators and those conducting the feasibility study should be further clarified.
1. HRSA response: Revised the SIR to further describe expectations and best practices associated with conducting a feasibility study and ensuring independence and accountability in the process. HRSA does not, however, recommend specifying credentials or level of experience of evaluators or researchers as awardees should have the flexibility to determine what will work best for their context.
Comment: Respondents indicated that the requirements specified in the SIR related to the selection of outcome measure allow for significant flexibility, and should be further clarified.
1. HRSA response: Revised the SIR to further clarify that applicants are to select outcome measure that will have meaningful impacts for the children and families served.
Comment: Respondents indicated that the requirement that recipients submit signed partnerships agreements with each PFO partner would be overly burdensome and unnecessary to the success of the PFO initiative.
1. HRSA response: Revised the SIR to broaden the requirements around obtaining signed partnership agreements so that a “draft agreement” or letter of intent would be acceptable as well as a signed partnership agreement.
Comment: Respondents noted that guidance provide around how to budget MIECHV funds for a PFO initiative needed further clarification. In particular, respondents sought further clarification on how to set aside fund for this purpose and re-budget if necessary.
1. HRSA response: Revised the SIR to clarify that recipients can set aside funds in multiple years as part of one PFO initiative. Recipients must propose a PFO project period that reflects the project period of the entire initiative, and must work closely with HRSA to ensure appropriate monitoring of PFO funds over the 10-year period of availability.
Comment: Respondents indicated that the annual reports produced by recipients, that are required by statute as part of PFO initiative, should be made public.
1. HRSA response: Revised the SIR to clarify that the required annual reports must be made available to the public by the recipient and removed language implying that the report will include outcomes that have been achieved and/or payments made.
Comment: Respondents noted that further guidance to ensure that implementation of a PFO initiative does not inhibit programs from maintaining existing MIECHV service delivery supports such as home visitor compensation and appropriate caseloads.
1. HRSA response: Revised the SIR to clarify expectation that recipients continue to meet program and model fidelity requirements in the context of the requirement of no reduction of funding for services. HRSA will further develop and apply criteria as part of the review and approval process of any proposed PFO initiatives to ensure PFO initiatives have no negative impact on high-quality service delivery.

Other comments did not merit changes to the SIR guidance, but highlighted topics that would benefit from specific technical assistance, indicated support for various aspects of the guidance, or offered suggestions that were outside the intended scope of the guidance. HRSA will develop technical assistance materials designed to support MIECHV awardees in completing the requirements of the SIR guidance, conducting a feasibility study, and carrying out a PFO initiative. Technical assistance materials will be available after the release of the PFO SIR guidance.

HRSA also held a listening session with MIECHV awardees on July 20, 2020 to provide an overview of our anticipated approach to PFO, to answer any questions, and to solicit feedback and input. HRSA sought input on the SIR guidance from federal partners including a number of federal staff within HRSA.

A.9 Explanation of Any Payment or Gift to Respondents

Respondents will not receive any payments or gifts.

A.10 Assurance of Confidentiality Provided to Respondents

Respondents are staff members of MIECHV awardees, specifically state, jurisdiction, and nonprofit awardees. Awardee staff members, such as program managers, third-party evaluators, and/or data analysts will be asked to complete the PFO Narrative and provide information assessing the feasibility of implementation, the design of the proposed PFO initiative, and the design of the accompanying rigorous, third-party evaluation. MIECHV awardees may contract with other entities, such as academic institutions, research organizations or consultants, to complete their PFO SIR Response, but state, jurisdiction, and nonprofit MIECHV awardees will submit their PFO SIR Responses to HRSA. No personally identifiable information (PII) is being collected through this SIR. All data will be reported in aggregate at the PFO initiative geographic level by the awardee. This project does not need IRB approval.

A.11 Justification for Sensitive Questions

HRSA is collecting information assessing PFO feasibility and statewide or local capacities for implementation, not individual-level data. The PFO Narrative does not request sensitive or personally identifiable information.

A.12 Estimates of Annualized Burden Hours and Costs to Respondents

A.12.1 Estimated Annualized Burden Hour

The data collection process will be conducted only once, and the estimated burden per awardee is 92 hours. This burden estimate is based on the average time needed to gather, organize and provide the information required by the SIR and has been revised to reflect comments received in response to the 60-day Federal Register Notice public comment period.

We anticipate that the persons completing the SIR Response will be home visiting program managers or other administrative directors employed by the awardee, or contracted persons engaged to support awardees in completing the SIR Response. The individuals responding should be familiar with everyday operations, management, and administration of all home visiting activities, as well as data collection and analysis. We expect that the primary respondent may require assistance from another program staff member. Exhibit A.12-1 summarizes the annualized burden hours.

Exhibit A.12-1. Estimated Annualized Burden Hours

Types of Respondent	Number of Respondents	No. Responses per Respondent	Average Burden per Response (hours)	Total Burden (hours)
MIECHV awardee staff	15	1	92	1,380

A.12.2 Estimated Annualized Cost to Respondents

The estimated total cost to respondents is approximately $90,000 (Exhibit A.12-2). This annualized cost to respondents is based on the average wage of state government employed social and community service manager from the 2019 Bureau of Labor Statistics report on Wage Estimates (Bureau of Labor Statistics, 2019). The average hourly wage was multiplied by 2 to account for the costs of fringe benefits and overhead.

Exhibit A.12-2. Estimated Annualized Cost to Respondents

Type of Respondent	Number of Respondents	Total Burden (hours)	Average Hourly Wage	Total Respondent Cost ($)
State Government Social and Community Service Manager	15	1,380	$32.58 ($65.16 accounting for fringe benefits and overhead)	$89,921

A.13 Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers

HRSA’s FY 2021 MIECHV Formula NOFO includes guidance on PFO budget authority. Up to 25% of the MIECHV award may be allocated for outcome payments related to a PFO Initiative; the 25% PFO outcome payment limit does not apply to funds allocated to support other aspects of a PFO Initiative which may exceed the 25% limit.

Awardees may use MIECHV funds to support the development, implementation, and evaluation of the PFO initiative as long as funding for the PFO Initiative does not result in a reduction of funding for services. In addition, MIECHV funds budgeted for a PFO initiative are subject to the standard MIECHV 10% statutory limit on use of funds for administrative expenditures. The 10% administrative expenditure cap applies to the total MIECHV Formula Award, including typical MIECHV program administration and any costs associated with PFO administration. Activity costs associated with a PFO initiative that would typically be subject to the 10% administrative cap (such as reporting costs, subrecipient monitoring expenses, etc.) are subject to the 10% cap. Costs for PFO Initiative activities typically subject to the 25% recipient-level infrastructure limit (such as professional development and training for recipient-level staff, model affiliation and accreditation fees, technical assistance provided by the recipient to the local implementing agencies, etc.) are also subject to the 25% recipient -level infrastructure limit.

Funds made available for a PFO Initiative within a fiscal year remain available for expenditure for up to 10 years after the funds are made available.

A.14 Annualized Cost to the Federal Government

Exhibit A.14-1 presents the types of costs to the government that will be incurred, which fall into the following categories:

Cost of federal staff time for project oversight and development
Cost of federal staff time for technical assistance and review and approval of PFO SIR Response
Cost of federal and contractual support for subject matter expert review and analysis

Exhibit A.14-1. Estimated Cost to the Federal Government

Type of Cost	Description of Services	Annual Cost
Government Public Health Advisor (30%)	Project management and oversight, consultation, and development of data collection tools	$39,200
Government Project Officers (10%)	2 regional project officers to provide TA to awardees and review and approve PFO SIR Response submissions	$23,425
Government contracted support (80%)	Support development of data collection tools, provide TA and technical support to awardees to report requested information, review and analysis	$20,983
Total Estimated Annual Cost		$83,608

HRSA estimates the average annual cost for the federal government will include personnel costs for project and contract oversight, instrument design, and analysis. This will include federal public health advisor at Grade 14 Step 3 ($62.62 hourly rate) (Office of Personnel Management, 2021) for 626 hours.

Government costs will also include personnel costs for providing technical assistance to awardees and time for federal project officers to review and approve needs assessment updates. These tasks will be completed by 2 federal project officers at an average Grade 13 Step 5 ($56.31hourly rate) (Office of Personnel Management, 2021) for 208 hours each, or a total annual level of effort of 416 hours.

The total annual cost to the Federal Government of this requirement is $83,608.

A.15 Explanation for Program Changes or Adjustments

This is a new data collection requirement.

A.16 Plans for Tabulation and Publication and Project Time Schedule

Data and information submitted through the PFO Narrative and required attachments will be reviewed and synthesized by HRSA staff and contracted persons to inform program monitoring. Additional analysis may be conducted to examine the feasibility and implementation of PFO Initiatives across awardees. Findings from this analysis may be used in publications or other public facing products.

The findings from this information collection and analyses may be complied and presented in a report by HRSA to inform technical assistance and support that can be provided to awardees implementing PFO Initiatives. The expected time schedule for project activities is presented in Exhibit A.16-2. HRSA is requesting a three-year clearance for this data collection activity.

Exhibit A.16-1. Estimated Time Schedule for Project Activities

Activity	Expected Timeline
Development of final version Supplemental Information Request based on feedback from the 60-day FRN and the 30-Day FRN	March 2021
Receive OMB approval	By June 2021 (estimated)
Technical assistance	Ongoing, after the release of the final SIR guidance
Data collection	For projects proposed with FY 2021 funds, SIR Response can be submitted after the release of the final SIR, and no later than 120 days after start of the respective project period September 30, 2021 or no later than January 28, 2022
Synthesis and Publication	After January 28, 2022 information may be synthesized. Findings from this analysis may be used in publications or other public facing products.

A.17 Reason(s) Display of OMB Expiration Date Is Inappropriate

No request for an exemption from displaying the expiration date for OMB approval is being sought. The OMB number and expiration date will be displayed on every page of every form/instrument.

A.18 Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

References

Bureau of Labor Statistics (2019). May 2019 National Occupational Employment and Wage Estimates, 11-9151 Social and Community Service Managers. Retrieved from https://www.bls.gov/oes/2019/may/oes119151.htm

Office of Personnel Management (2021). SALARY TABLE 2020-DCB. Retrieved from https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2021/DCB_h.pdf

File Type	application/vnd.openxmlformats-officedocument.wordprocessingml.document
File Title	Supporting Statement Part A_MIECHV Pay for Outcomes Guidance_jd
Author	RTI_DP
File Modified	0000-00-00
File Created	2021-05-13