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

Issuing agencies

Abstract

In compliance with the Paperwork Reduction Act of 1995, HRSA 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. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.

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<title>Federal Register, Volume 91 Issue 196 (Tuesday, October 13, 2026)</title>
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[Federal Register Volume 91, Number 196 (Tuesday, October 13, 2026)]
[Notices]
[Pages 64933-64935]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-20867]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


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

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

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, HRSA 
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. OMB may act on HRSA's ICR only after the 30-day 
comment period for this notice has closed.

DATES: Comments on this ICR should be received no later than November 
12, 2026.

ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this particular 
information collection by selecting ``Currently under Review--Open for 
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance 
requests submitted to OMB for review, email Samantha Miller, the HRSA 
Information Collection Clearance Officer, at <a href="/cdn-cgi/l/email-protection#b1c1d0c1d4c3c6dec3daf1d9c3c2d09fd6dec7"><span class="__cf_email__" data-cfemail="e696879683949189948da68e949587c8818990">[email&#160;protected]</span></a> or call 
(301) 443-9094.

SUPPLEMENTARY INFORMATION: 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 (Sec.  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 previously 
approved OMB collection, the data collection instruments for the 
program's reporting requirements include four participant-level 
screening tools: (1) Demographic, (2) Background Information, (3) 
Prenatal, and (4) Parent/Child forms. The primary purpose of this 
information collection request is to reinstate the four data collection 
forms included in the information collection that expired on September 
30, 2026. HRSA is proposing a limited number of minor revisions to the 
forms for the purposes described below.
    HRSA also anticipates seeking OMB approval for additional revisions 
to the information collection in advance of the 2029-2034 Healthy Start 
grant cycle. Consistent with recommendations from the U.S. Government 
Accountability Office (GAO), HRSA plans to revise certain Healthy Start 
measures to better align with measures used by other Maternal and Child 
Health Bureau programs, including the Title V Maternal and Child Health 
Services Block Grant and the Maternal, Infant, and Early Childhood Home 
Visiting Program. GAO also recommended that changes to Healthy Start 
measures and related data collection materials be completed prior to 
the start of a new grant cycle. To inform the future revisions, HRSA 
plans to solicit input from internal and external interested parties 
beginning in late 2026 as part of the process for updating the data 
collection forms for the 2029-2034 grant cycle. HRSA has also compiled 
comments received in response to the 60-day notice for consideration in 
developing the future information collection request.
    In this reinstatement with change, HRSA plans to retain the 
participant-level tools as approved by OMB in 2020 and updated in 2024, 
with minor changes to: (1) clarify instructions, (2) update select 
response options to improve accuracy in reporting, and (3) add fields 
to capture the month of infant birth and/or death. These revisions are 
intended to improve the quality and usability of the data collection 
instruments 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.
    The 60-day notice described four categories of proposed changes to 
the data collection instruments. Following publication of that notice, 
HRSA further reviewed the proposed revisions and determined that 
certain changes should be deferred. Specifically, HRSA is no longer 
proposing changes to separate response options to reflect current 
program priorities and has narrowed the proposed updates to select 
response

[[Page 64934]]

options to those needed to improve reporting accuracy. Consistent with 
the GAO recommendation to limit changes to data collection measures 
during a grant cycle, HRSA determined that more substantive revisions 
would be more appropriately considered as part of the planned update to 
the information collection for the 2029-2034 Healthy Start grant cycle. 
The 60-day notice also identified reducing respondent burden as one 
purpose of the proposed revisions. Because the revisions proposed in 
this notice are limited in scope and are not expected to result in a 
meaningful reduction in respondent burden, HRSA has removed that 
description from the stated purposes of the revisions.
    A 60-day notice published in the Federal Register on July 10, 2026, 
vol. 91, No. 131; pp. 42,737-42,739 (91 FR 42737). HRSA received six 
comments: four from current Healthy Start grantees, one from a company 
that provides data system services to Healthy Start grantees, and one 
from a national coalition that works to advance policies and practices 
supporting breastfeeding and human milk feeding in the United States. 
The following summarizes the key themes raised by commenters and the 
responses that HRSA provided directly to the commenters prior to the 
publication of this 30-day notice:
    <bullet> Data collection forms and reporting guidance: Five 
commenters, including the four Healthy Start grantees and the data 
system representative, recommended changes to specific items in the 
proposed data collection forms and related guidance. Recommendations 
included clarifying instructions in the reporting system implementation 
guide; providing greater flexibility in administering data collection 
forms to Group-Based Education participants; incorporating skip logic 
where appropriate; considering alternatives to certain sensitive 
questions (e.g., using participation in the Supplemental Nutrition 
Assistance Program as a proxy for financial information rather than 
household income); and relocating certain questions to forms where the 
information may be more likely to be collected before a participant is 
lost to follow-up. Commenters also suggested adding administrative 
elements, such as an indicator for participants lost to follow-up, and 
developing a mechanism to document the history of participant 
screenings and updates. Such a mechanism could help identify when 
information was last verified, track changes over time, and support 
interpretation of longitudinal data. HRSA expressed appreciation for 
these recommendations and noted plans to consider them with internal 
and external interested parties beginning in late fall/winter 2026 as 
part of the process for updating the data collection forms for the 
2029-2034 grant cycle.
    <bullet> Estimated burden and data collection processes: One 
grantee recommended reassessing the estimated burden to more fully 
account for the workload associated with the information collection. 
The commenter noted that participant records may require updates after 
the initial screening and that staff time is also required for quality 
assurance, data management, and preparation for reporting. The 
commenter also recommended the use of automated collection techniques 
to reduce burden and improve system functionality. HRSA acknowledged 
these recommendations and expressed plans to reassess burden estimates 
beginning in late fall/winter 2026 as part of the process for updating 
the data collection forms for the 2029-2034 grant cycle. This 
assessment will consider the time associated with form administration, 
participant record updates, data management, and reporting activities.
    <bullet> Federal data coordination on lactation and infant feeding: 
A national breastfeeding coalition recommended strengthening Healthy 
Start data on lactation, infant feeding, and postpartum support and 
improving alignment of relevant Healthy Start data elements with 
Centers for Disease Control and Prevention (CDC) maternal mortality 
review data. Specific recommendations included collecting more 
structured information on lactation and infant feeding at key 
postpartum intervals, lactation-related clinical conditions and other 
maternal health circumstances, and postpartum support and referral 
pathways. The coalition also recommended coordinating with CDC to align 
relevant definitions and data elements across programs, where 
appropriate, to improve data utility and comparability while minimizing 
unnecessary respondent burden. HRSA expressed appreciation for these 
recommendations and noted plans to consider them with internal and 
external interested parties beginning in late fall/winter 2026 as part 
of the process for updating the data collection forms for the 2029-2034 
grant cycle.
    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 Information, 
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.

                                     Total Estimated Annualized Burden Hours
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                                                                                      Average
                                     Number of       Number of         Total        burden per     Total  burden
            Form name               respondents    responses per     responses     response  (in       hours
                                                    respondent                        hours)
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Demographic Form................          76,975               1          76,975            0.17          13,086

[[Page 64935]]

 
Background Form.................          44,600               1          44,600            0.42          18,732
Prenatal Form...................          31,500               1          31,500            0.25           7,875
Parent/Child Form...............          39,100               1          39,100            0.42          16,422
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    Total.......................         192,175  ..............         192,175  ..............          56,115
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    Note: Total Burden Hours are rounded up to the nearest whole 
number.


Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2026-20867 Filed 10-9-26; 8:45 am]
BILLING CODE 4165-15-P


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