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Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Healthy Start Evaluation and Quality Improvement, OMB No. 0915-0338-Revision

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Health Resources and Services Administration (HRSA), Department of Health and Human Services.




In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.


Comments on this ICR should be received no later than December 9, 2019.


Submit your comments, including the ICR Title, to the desk officer for HRSA, either by email to or by fax to (202) 395-5806.

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To request a copy of the clearance requests submitted to OMB for review, email Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer at or call (301) 443-1984.

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Information Collection Request Title: Healthy Start Evaluation and Quality Improvement. OMB No. 0915-0338—Revision.

Abstract: The National Healthy Start Program, funded through HRSA's Maternal and Child Health Bureau (MCHB), has the goal of reducing racial and ethnic disparities in infant mortality and other adverse perinatal outcomes. The program began as a demonstration project with 15 grantees in 1991 and since then has expanded to 101 grantees serving communities in 34 states, Washington, DC, and Puerto Start Printed Page 60096Rico. Healthy Start grantees serve communities with high rates of poor perinatal outcomes, including infant mortality at least 1.5 times the U.S. national average. These communities are often low-income and in geographically, racially, ethnically, and linguistically diverse areas. Healthy Start offers services during the perinatal period (before, during, and after pregnancy) and the program works with women, infants, and families through the first 18 months after birth. The Healthy Start program uses four approaches to reduce infant mortality through individual services and community support to women, infants, and families: (1) Improve women's health, (2) improve family health and wellness, (3) promote systems change, and (4) assure impact and effectiveness. Over the past few years, MCHB has sought to implement a uniform set of data elements for monitoring and conducting an evaluation to assess grantees' progress towards these program approaches. Under the current OMB approval, the data collection instruments for this evaluation include the following: The National Healthy Start Program Survey; Community Action Network Survey; Healthy Start Site Visit Protocol; Healthy Start Participant Focus Group Protocol; and six client-level screening tools: (1) Demographic Intake Form, (2) Pregnancy Status/History, (3) Preconception, (4) Prenatal, (5) Postpartum, and (6) Interconception/Parenting.

In this proposed revision, MCHB plans to retain the client-level tools, and to eliminate the National Healthy Start Program Survey, Community Action Network Survey, Healthy Start Site Visit Protocol, and Healthy Start Participant Focus Group Protocol instruments. These instruments have been removed to streamline this data collection activity for the evaluation. For the six client-level tools, MCHB plans to consolidate these into three forms: (1) Background, (2) Prenatal, and (3) Parent/Child. These tools have been revised based on the public comments received during the 60-day comment period. The purpose of these changes is to consolidate items that are duplicated across the forms. In addition to consolidating questions across tools, many individual items have been eliminated or in some cases reworded in order to focus the evaluation more clearly on individual and programmatic progress on performance measures. This will shorten the revised instruments, center them more clearly on program improvement, and decrease the number of personal/sensitive questions.

In addition to the elimination, consolidation, and rewording of several items, questions designed to increase efficiency and accuracy in reporting have been added. Specifically, many of the grantees' annual reporting requirements require calculations based on infants' birth dates, estimated due dates, dates enrolled in the Healthy Start program, trimester in which certain health-related activities occurred, and so on. These revised tools include the information necessary to make these calculations so that annual aggregate reporting will be based on individual client-level data. This will increase accountability, efficiency, and accuracy in terms of the clients served as well as reduce overall burden on the grantees by streamlining reporting systems.

A 60-day notice was published in the Federal Register on January 31, 2019, vol. 84, no. 21, pp. 753-754. There were 16 public comments.

Need and Proposed Use of the Information: The purpose of the revised data collection instruments will be to assess grantee and client-level progress towards meeting Healthy Start program performance measures. The data will be used to conduct ongoing performance monitoring of the program; thus, meeting program needs for accountability, programmatic decision-making, and ongoing quality assurance.

Likely Respondents: Respondents include pregnant women and non-pregnant women of reproductive age who are served by the Healthy Start program as well as any of their spouses/partners or other caregivers who are participating in receiving Healthy Start services.

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; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and, to transmit or otherwise disclose the information. Compared to the versions submitted for the 60-day approval process in January, estimated burden hours have increased somewhat as a result of implementing the feedback provided in public comments during the 60-day comment period. The total annual burden hours estimated for this ICR are summarized in the table below.

Total Estimated Annualized Burden Hours

Form nameNumber of respondentsNumber of responses per respondentTotal responsesAverage burden per response (in hours)Total burden hours
Background* 55,550155,550.5027,775
Prenatal* 30,300130,300.175,151
Parent/Child* 30,300130,300.4212,726
* All participants (55,550) complete the Background form, and a subset of these same individuals (30,300) also complete the Prenatal or Parent/Child forms, for a total of 116,150 responses.
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Maria G. Button,

Director, Executive Secretariat.

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[FR Doc. 2019-24278 Filed 11-6-19; 8:45 am]