Non-Substantive Change Memo

5600 Fishers Lane

Rockville, MD 20857

DATE: December 17, 2024

TO: Dan Cline, OMB Desk Officer

FROM: Joella Roland, HRSA Information Collection Clearance Officer

______________________________________________________________________________

Request: The Health Resources and Services Administration (HRSA) Maternal and Child Health Bureau (MCHB) requests approval for changes to the Healthy Start Evaluation and Quality Improvement information collection (OMB No. 0915-0338 expiration date 09/30/2026).

Purpose: The purpose of this request is to make minor additions to the Prenatal and Parent/Child Healthy Start Data Collection Forms to increase the accuracy of calculated perinatal outcomes. Collection of this information will improve the quality of data reported annually for key programmatic indicators, such as Infant Mortality Rate (IMR), allowing HRSA to better track and demonstrate the impact of the Healthy Start program over time.

This memo explains the changes and supporting rationale.

Changes: Instruments:

Table A outlines the instrument that received the changes, the variable names that were altered/added, descriptions of the changes, and the rationale for the changes. Attached are the Prenatal Form (Attachment 1), and Parent/Child Form (Attachment 2) with changes tracked, for reference. The overall scope of changes to the data collection forms is minimal, consisting of an update to existing instructions, revision of the wording of Q22 on the Parent/Child form, and the addition of 4 questions to collect Birth Year and Death Year of enrolled children across the two forms.

Time Sensitivity: The data collection changes must be completed in a timely manner to ensure accurate perinatal outcomes can be captured prior to the end of the first year of the current grant period. Approval of these changes is requested by early January 2025, to implement the changes in the data collection forms and to ensure the Healthy Start Monitoring and Evaluation Data System (HSMED) can be updated to collect the new data elements by March 2025.

Burden: These changes included herein are expected to have minimal impact on reporting burden for Healthy Start grant recipients. The number of questions across the revised data collection forms increase from 91 to 95 total. As a result, the burden is not expected to significantly increase.

PROPOSED CLARIFICATIONS AND NON-SUBSTANTIVE CHANGES:

Table A

*Please note that “Q” refers to “Question”, for example “Q1” is “Question 1”

Instrument	Variable	Change implemented	Rationale
Prenatal Form	Post-Pregnancy Follow-Up Instructions	Instructions were added for sensitively collecting and reporting the loss of a child within the first 27 days of life (neonatal period)	The Prenatal Form will only collect information on child loss that occurs within the first 27 days of life; providing clarifying instructions regarding which questions to complete (Post-Pregnancy Follow-Up: Q5 and Q5a) in the event of a loss directs program staff in how to record these events.
Prenatal Form: Post-Pregnancy Follow-Up	Q2a (pg. 7)	Question 2a was added to collect a child’s year of birth	To accurately calculate annual perinatal outcomes, HRSA must be able to determine when a child was born, and when a recorded event occurred. Collecting the child’s year of birth allows the program to determine in which year’s denominator the child should be counted.
Prenatal Form: Post-Pregnancy Follow-Up	Q5a (pg. 9)	Question 5a was added to collect a child’s year of death.	To accurately calculate Infant Mortality Rate (IMR), HRSA must be able to determine when a child’s death occurred. Collecting the child’s year of death allows the program to determine the year in which their death should be counted.
Parent/Child Form	Instructions (pg. 2)	The instructions for recording the loss of a child were updated to include the new Q23.	Updated instructions ensure program staff know how to accurately record the loss of a child on the revised form.
Parent/Child Form	Q1a	Question 1a was added to collect a child’s year of birth.	To accurately calculate annual perinatal outcomes, HRSA must be able to determine when a child was born, and when a recorded event occurred. Collecting the child’s year of birth allows the program to determine in which year’s denominator the child should be counted. Additionally, because some children enroll in Healthy Start after birth, the Parent/Child form will allow collection of this information when a Prenatal form is not completed (the Prenatal form is only completed when a mother enrolls while pregnant).
Parent/Child Form	Q22	The wording of Q22 was revised.	Quality assurance activities revealed the previous wording of this question was confusing, resulting in programs incorrectly reporting death events. Adjusting the wording will improve accurate reporting of death events.
Parent/Child Form	Q23	Q23 was added to collect a child’s year of death.	To accurately calculate Infant Mortality Rate (IMR), HRSA must be able to determine when a child’s death occurred. Collecting the child’s year of death allows the program to determine the year in which their death should be counted. Additionally, because the Prenatal Form only records deaths that occur in the first 27 days of life, adding this variable to the Parent/Child form will allow collection of death events that occur up to the first year of life.

Attachments:

1. Prenatal Form (All changes and additions are tracked in the attached document)

2. Parent/Child Form (All changes and additions are tracked in the attached document)