OMB NonSubstantive Change Request_0906-0095

5600 Fishers Lane

Rockville, MD 20857

DATE: July 30, 2024

TO: Dan Cline, OMB Desk Officer

FROM: Joella Roland, HRSA Information Collection Clearance Officer

______________________________________________________________________________

Request: The Health Resources and Services Administration (HRSA) MCHB requests approval for changes to the Assessing the Use of Coaching to Promote Positive Caregiver-Child Interactions in Early Childhood Home Visiting Through Rapid Cycle Learning (OMB 0906-0095, expiration date 06/30/2027).

Purpose: The purpose of this request is to correct the phone number for the Health Media Lab Institutional Review Board (IRB), which is listed at the bottom of each instrument associated with this study. Updating this number ensures study participants can contact the Health Media Lab IRB if they have questions about their rights as a research volunteer.

This memo explains the changes and supporting rationale.

Changes: Table A lists the instruments that were changed, a description of the change, and the rationale for the change. Also included are copies of the data collection instrument with changes tracked, for reference.

All instruments have been updated to include the corrected phone number for the Health Media Lab Institutional Review Board (IRB) at the bottom of the document. There has been no change to the content of the instruments. The edit is to address a change in the contact information for the Health Media Lab IRB, which is the IRB that reviewed the study materials.

Time Sensitivity: The update to the phone number must be completed as soon as possible to ensure that survey and focus group data collection will not experience significant delay. Approval of these changes is needed, at latest, by August 9, 2024, to prepare for timely data collection.

Burden: The change reflects no change to the estimated reporting burden.

PROPOSED CLARIFICATIONS AND NON-SUBSTANTIVE CHANGES:

Table A

Instrument	Variable	Change implemented	Rationale
Program Eligibility Protocol	n/a	Phone number for the Health Media Lab Institutional Review Board, listed at the bottom of the instrument, updated to (202) 246-8504.	The Health Media Lab Institutional Review Board has changed their phone number since the instrument was submitted to OMB.
Program Staff Focus Group Protocol 1 (Co-definition Phase)	n/a	Phone number for the Health Media Lab Institutional Review Board, listed at the bottom of the instrument, updated to (202) 246-8504.	The Health Media Lab Institutional Review Board has changed their phone number since the instrument was submitted to OMB.
Program Staff Focus Group Protocol 2 (Co-definition Phase)	n/a	Phone number for the Health Media Lab Institutional Review Board, listed at the bottom of the instrument, updated to (202) 246-8504.	The Health Media Lab Institutional Review Board has changed their phone number since the instrument was submitted to OMB.
Family Focus Group Protocol – Co-definition and Summary Phases	n/a	Phone number for the Health Media Lab Institutional Review Board, listed at the bottom of the instrument, updated to (202) 246-8504.	The Health Media Lab Institutional Review Board has changed their phone number since the instrument was submitted to OMB.
Program Staff Focus Group Protocol (Installation & Refinement Phases)	n/a	Phone number for the Health Media Lab Institutional Review Board, listed at the bottom of the instrument, updated to (202) 246-8504.	The Health Media Lab Institutional Review Board has changed their phone number since the instrument was submitted to OMB.
Home Visitor Learning Cycle Form – Installation & Refinement Phases	n/a	Phone number for the Health Media Lab Institutional Review Board, listed at the bottom of the instrument, updated to (202) 246-8504.	The Health Media Lab Institutional Review Board has changed their phone number since the instrument was submitted to OMB.
Family Post-Visit Form – Refinement Phase	n/a	Phone number for the Health Media Lab Institutional Review Board, listed at the bottom of the instrument, updated to (202) 246-8504.	The Health Media Lab Institutional Review Board has changed their phone number since the instrument was submitted to OMB.
Program Staff Focus Group Protocol (Summary Phase)	n/a	Phone number for the Health Media Lab Institutional Review Board, listed at the bottom of the instrument, updated to (202) 246-8504.	The Health Media Lab Institutional Review Board has changed their phone number since the instrument was submitted to OMB.
Focus Group Participant Characteristics Form – All Phases	n/a	Phone number for the Health Media Lab Institutional Review Board, listed at the bottom of the instrument, updated to (202) 246-8504.	The Health Media Lab Institutional Review Board has changed their phone number since the instrument was submitted to OMB.

Attachments:

1. Program Eligibility Protocol (Change is tracked)

2. Program Staff Focus Group Protocol 1 (Co-definition Phase) (Change is tracked)

3. Program Staff Focus Group Protocol 2 (Co-definition Phase) (Change is tracked)

4. Family Focus Group Protocol – Co-definition and Summary Phases (Change is tracked)

5. Program Staff Focus Group Protocol (Installation & Refinement Phases) (Change is tracked)

6. Home Visitor Learning Cycle Form – Installation & Refinement Phases (Change is tracked)

7. Family Post-Visit Form – Refinement Phase (Change is tracked)

8. Program Staff Focus Group Protocol (Summary Phase) (Change is tracked)

9. Focus Group Participant Characteristics Form – All Phases (Change is tracked)