Human Subjects Document-CDC

Project Determination

Assessment and Monitoring of Breastfeeding-related Maternity Care Practices in US and Territorial Hospitals

Project ID:	0900f3eb82254582
Accession #:	NCCDPHP-IF-10/27/23-54582
Project Contact:	Daurice Grossniklaus
Organization:	NCCDPHP/OD/OMS
Status:	Pending Clearance
Intended Use:	Project Determination
Estimated Start Date:	08/01/24
Estimated Completion Date:	12/31/29
CDC/ATSDR HRPO/IRB Protocol#:	Not applicable
OMB Control#:	0920-0743

Description

Priority

Standard

Date Needed

11/17/23

Determination Start Date

10/31/23

Description

In 2007, CDC administered the first national survey of maternity practices supportive of breastfeeding, known as the Maternity Practices in Infant Nutrition and Care (mPINC) survey (OMB Control Number 0920-0743). Since then, to monitor and examine changes in these practices over time, it has been administered every two years to every hospital in the U.S. that routinely provides maternity care services. It is completed by a key informant on behalf of their hospital in their capacity as the person most knowledgeable about the relevant practices. The mPINC survey is a census and every hospital in the United States and territories that routinely provides maternity care services (approximately 2,700 hospitals) is eligible to participate in the mPINC survey. CDC has completed eight survey cycles. For the 2018-2022 cycles approximately 2,000-2,100 maternity hospitals participated per cycle (>70% response rate per cycle). The first survey in 2007 established a measure of the prevalence of specific breastfeeding-supportive maternity care practices at facilities across the United States and territories at that point in time and the extent to which these practices varied by state/territory. Data from subsequent surveys provide important information about changes and trends in practices since the initial baseline assessment. Because maternity care practices are rapidly changing, CDC revised the mPINC survey in 2018. The core questions of the survey have been maintained in each subsequent cycle. As part of CDC’s Data Modernization Initiative (DMI) (https://www.cdc.gov/surveillance/data-modernization/index.html), the 2026 mPINC cycle will use an updated data architecture leveraging enterprise tools with CDC systems to screen hospitals, administer the survey, process and analyze the data, and report results. This includes the use of the CDC-hosted Research Electronic Data Capture software (REDCap®) for data collection. This project addresses the CDC’s need to monitor the nation’s progress on 1) breastfeeding initiation and exclusivity rates during the birth hospitalization and 2) reducing racial/ethnic and geographic disparities in breastfeeding. CDC has the capacity and expertise to collect high quality data and is considered the prime federal agency responsible for gathering and analyzing data related to maternity practices supportive of optimal infant nutrition. These data are critical to move the nation closer to the Healthy People 2030 breastfeeding duration and exclusivity goals. This data collection system is a surveillance tool used by the CDC’s Division of Nutrition, Physical Activity, and Obesity (DNPAO) to understand and identify gaps in the capacity of hospitals to increase coverage and adherence to evidence-based nutrition interventions and monitor progress on this strategic priority.

IMS/CIO/Epi-Aid/Lab-Aid/Chemical Exposure Submission

No

IMS Activation Name

Not selected

Select the primary priority of the project

Not selected

Select the secondary priority(s) of the project

Not selected

Select the task force associated with the response

Not selected

CIO Emergency Response Name

Not selected

Epi-Aid Name

Not selected

Lab-Aid Name

Not selected

Assessment of Chemical Exposure Name

Not selected

Goals/Purpose

The purpose of this contract is to plan, design, and conduct the 2026 mPINC survey cycle (Core Task), and if funded, plan, design, and conduct the 2028 mPINC survey cycle (Optional Task One), using the recently developed tools within the CDC-hosted REDCap® data collection system and to disseminate individualized hospital reports to participating hospitals for each survey cycle. The Core task is to carry out activities for the 2026 mPINC survey cycle. If funded, Optional Task One task is to carry out activities for the 2028 mPINC survey cycle.

Objective

The objectives of this task order are to assess and monitor maternity care and infant feeding practices and policies occurring at US and territorial maternity hospitals and to disseminate individualized reports to participating hospitals. Data collected from this survey will be used to inform public health agencies and other partners of the prevalence of these practices and policies.

Does your project measure health disparities among populations/groups experiencing social, economic, geographic, and/or environmental disadvantages?

No

Does your project investigate underlying contributors to health inequities among populations/groups experiencing social, economic, geographic, and/or environmental disadvantages?

No

Does your project propose, implement, or evaluate an action to move towards eliminating health inequities?

No

Activities or Tasks

New Collection of Information, Data, or Biospecimens

Target Population to be Included/Represented

Other-US and territorial hospitals providing maternity care

Tags/Keywords

Breast Feeding; Hospitals, Maternity

CDC's Role

CDC is providing funding

Method Categories

Survey

Methods

The Contractor will develop a plan for the survey administration which shall contain the methodology for contacting and screening facilities, reviewing, testing, finalizing the survey instrument and conducting the survey. Screening may be conducted using a dual online- and telephone-based approach or another innovative approach which will leverage existing REDCap® tools. The plan must describe how the Contractor will use multiple modalities and multiple contacts during the survey administration to attain the minimum response rate. The survey must be implemented using the CDC-hosted REDCap® system and will leverage existing instruments developed therein. Conducting the survey includes the following: 1) screening hospitals to determine eligibility; 2) providing hospitals with a secure, unique link to their hospital’s survey; 3) following up with non-responding hospitals; 4) maintaining survey data in the CDC-hosted REDCap® data collection system; 5) tracking survey participation and progress to determine response rates at various points in survey administration; 6) providing complete raw datasets (including all survey responses and hospital identifiers) to the COR for analysis by the CDC epidemiologist; and 7) communicating results back to participating hospitals. The Contractor will support CDC compliance with all federal requirements and regulations for data collection such as OMB and FISMA. b. The Contractor shall contact each maternity care hospital determined to be eligible for participation in the survey, inviting them to participate. The Contractor shall have a system and process to document inquires received from hospitals and respond to these inquiries within two business days of receipt of inquiry. The Contractor shall develop and follow a non-response protocol to facilitate hospitals’ completion of the survey to ensure a minimum response rate of 70%. The contractor shall collect data from hospitals, using the CDC-hosted REDCap® data collection system, and will follow up, as needed, with participating hospitals to clarify unexpected or invalid responses. The Contractor shall conduct quality control checks weekly on the CDC-hosted REDCap® data collection system to ensure that skips and other patterns are working as expected, verify that data load accurately into the database, review data collected in order to assure analytic integrity, and maintain all data collected in an organized fashion. The Contractor shall deliver a dataset(s) containing the raw data as collected by REDCap® within 30 days of completion of data collection. This can be done using the capabilities of the REDCap® system. These data will be identifiable by hospital and include assigned unique, numeric hospital identifiers. The Contractor shall provide CDC with a complete data dictionary and an archive of all data cleaning outcomes and decisions made during the course of conducting the mPINC surveys. Throughout the duration of this task order award, the Contractor will maintain and store data gathered under this task order on a Contractor-hosted and/or CDC-hosted data collection system.

Collection of Info, Data, or Bio specimens

Maternity hospitals eligible to participate will receive an unique link to the online survey instrument. Maternity hospitals will enter their information into the CDC-hosted REDCap® data collection system. The contractor shall collect data from hospitals, using the CDC-hosted REDCap® data collection system, and will follow up, as needed, with participating hospitals to clarify unexpected or invalid responses, and will follow up, as needed, with non-respondent hospitals.

Expected Use of Findings/Results and their impact

The mPINC survey is a surveillance tool used by the CDC’s Division of Nutrition, Physical Activity, and Obesity (DNPAO) to understand and identify gaps in the capacity of hospitals to increase coverage and adherence to evidence-based nutrition interventions and monitor progress on this strategic priority. Data collected from this survey will be used to inform public health agencies and other partners of the prevalence of these practices and policies. CDC disseminates individualized hospital reports to all participating hospitals. These hospital reports can be used celebrate strengths as well as improve care practices and policies to better support their maternity patients and breastfeeding families. State health departments and other partners can use mPINC data to work together with partner agencies, organizations, policy makers, and health professionals to improve evidence-based maternity care practices and policies at hospitals in their state.

Could Individuals potentially be identified based on Information Collected?

No

Funding
Funding Type	Funding Title	Funding #	Original Fiscal Year	# of Years of Award	Budget Amount
CDC Contract	Assessment and Monitoring of Breastfeeding-related Maternity Care Practices in US and Territorial Hospitals		2024	5	1500000.00

HSC Review

Regulation and Policy

Do you anticipate this project will need IRB review by the CDC IRB, NIOSH IRB, or through reliance on an external IRB?

No

Institutions
Institution	FWA #	FWA Exp. Date	IRB Title	IRB Exp. Date	Funding #

Staff
Staff Member	SIQT Exp. Date	Citi Biomedical Exp. Date	Citi Social and Behavioral Exp. Date	Citi Good Clinical Exp. Date	Staff Role	Email	Phone #	Organization/ Institution
DauriceGrossniklaus	10/28/2025				Contract Officer Representative	[email protected]	770-488-5249	INFANT FEEDING
KristinMarks	06/26/2026	06/07/2025	02/04/2023	08/29/2022	Statistician	[email protected]	770-488-1837	INFANT FEEDING

DMP
Proposed Data Collection Start Date	08/01/24
Proposed Data Collection End Date	12/31/29
Proposed Public Access Level	Restricted
Data Use Type	Data Sharing Agreement
Data Use Type Data Use Type URL	https://www.cdc.gov/breastfeeding/data/mpinc/index.htm
Data Use Contact	[email protected]
Public Access justification	Access to individual institutional data is restricted to protect the privacy and confidentiality of institutions from which data are collected. An approved data sharing agreement is required to access individual institutional data and is available upon request via email: [email protected]. CDC will publicly release state-specific mPINC data.
How Access Will Be Provided for Data	CDC will publicly release state-specific mPINC data (https://www.cdc.gov/breastfeeding/data/mpinc/index.htm). Data is released approximately within 6 months after each data collection. For additional information see http://www.reginfo.gov/ (search #OMB Control Number: 0920-0743# for complete records of 2007-2015, 2018-2020, and 2022-2024 related OMB activity). Data dictionary and methodologies are released upon request with approved data sharing agreement.
Plans for archival and long-term preservation of the data	Historic data are archived at CDC and are available for public use upon request via email: [email protected]

Spatiality (Geographic Location)
Country	State/Province	County/Region
United States

Determinations
Determination	Justification	Completed	Entered By & Role
HSC: Does NOT Require HRPO Review	Not Research - Public Health Surveillance 45 CFR 46.102(l)(2)	11/20/23	Redmond Leonard_Joan (jrl3) CIO HSC
PRA: PRA Applies		11/20/23	Still-LeMelle_Terri (cse6) OMB / PRA