SUPPLEMENTARY INFORMATION:

When submitting comments or requesting information, please include the ICR title for reference.

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

Abstract: The National Healthy Start Program, authorized by 42 U.S.C. 254c-8 (§ 330H of the Public Health Service Act), seeks to improve maternal and infant health outcomes and reduce infant mortality and other adverse perinatal outcomes. Established in 1991 as a demonstration project with 15 grantees, the program has expanded to 114 grantees serving communities in 37 states, the District of Columbia, and Puerto Rico. Healthy Start operates in communities experiencing disproportionately high rates of infant mortality and adverse birth outcomes and provides outreach; case management; care coordination; health education; and other supportive services to women, infants, children up to 18 months of age, fathers, and families. Healthy Start programs tailor services to meet the unique needs of their communities. Serving as comprehensive care hubs, they provide outreach, one-on-one case management, care coordination, clinical services ( e.g., behavioral health care, midwifery care), and individual and group-based health and parenting education. Programs work across health care and social service systems to help pregnant women and families access prenatal and postpartum care, mental health therapy, substance use treatment, nutrition and breastfeeding support, transportation, and other essential resources that contribute to healthier pregnancies and improved infant and maternal health outcomes.

Over the past few years, HRSA has sought to implement a uniform set of data elements for monitoring and conducting an evaluation to assess grantees' progress towards these program goals. Under the current OMB approval, the data collection instruments for the program's reporting requirements include four participant-level screening tools: (1) Demographic, (2) Background, (3) Prenatal, and (4) Parent/Child forms.

In this proposed revision, HRSA plans to retain the participant-level tools as approved by OMB in 2020 and updated in 2024; however, HRSA does introduce minor changes to the forms. These changes are limited to: (1) clarifying instructions, (2) updating response options to replace obsolete categories, (3) separating response options to better reflect current program priorities, and (4) adding fields to capture the month of infant birth and/or death. The purpose of these revisions is to improve the quality and usability of the data collection instruments, reduce respondent burden, and enhance the accuracy of tracking infant birth and death outcomes. The revised instructions were developed in response to grantee feedback and are expected to reduce confusion and improve consistency in form completion.

Need and Proposed Use of the Information: The purpose of the revised data collection instruments will be to assess grantee and participant-level progress towards meeting Healthy Start program performance measures and other key indicators central to the program's mission. Findings from monitoring and evaluation efforts will provide actionable evidence to support continuous program improvement and inform decision-making. The data will also enhance understanding of participant characteristics; behaviors; and health outcomes; enabling assessment of how these factors, in combination with Healthy Start interventions, influence program outcomes.

Likely Respondents: For the Demographic; Background; Prenatal; and Parent/Child participant-level forms respondents include preconceptive, pregnant, and postpartum women, as well as fathers/partners. Additionally, a small number of forms may be completed by non-enrolled guardians ( e.g., foster parents, grandparents) of children in the program.

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. The total annual burden hours estimated for this ICR are summarized in the table below.

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 ( printed page 42739) or other forms of information technology to minimize the information collection burden.