2022-25007. Agency Forms Undergoing Paperwork Reduction Act Review

In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled “Pregnancy Risk Assessment Monitoring System (PRAMS)” to the Office of Management and Budget (OMB) for review and approval. CDC previously published a a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on July 5, 2022, to obtain comments from the public and affected agencies. CDC received two comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.

CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:

(a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(c) Enhance the quality, utility, and clarity of the information to be collected;

(d) Minimize the burden of the collection of information on those who are to respond, including, through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and

(e) Assess information collection costs.

To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call [phone]. Comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/​public/​do/​PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to [phone]. Provide written comments within 30 days of notice publication.

Proposed Project

Pregnancy Risk Assessment Monitoring System (PRAMS) (OMB Control No. 0920-1273, Exp. 11/30/2022)—Revision—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The Pregnancy Risk Assessment Monitoring System (PRAMS) is a surveillance project of the Centers for Disease Control and Prevention (CDC) and jurisdiction ( e.g., state, city, territory) health departments. Developed in 1987, PRAMS collects jurisdiction-specific, population-based data on maternal attitudes and experiences before, during, and shortly after pregnancy.

PRAMS provides data on the experiences of women with a recent live or stillbirth not available from other sources. These data can be used to identify groups of women and infants at high risk for health problems, to monitor changes in health status, and to measure progress towards goals in improving the health of mothers and infants. PRAMS data are used by researchers to investigate emerging issues in the field of reproductive health and by federal, state and local governments to plan and review programs and policies aimed at reducing health problems among mothers and babies.

PRAMS is a jurisdiction-customized survey conducted in 50 sites and covers 81% of all live births in the United States. Because PRAMS uses standardized data collection methods, it allows data to be compared among sites. Jurisdictions can implement the survey on an ongoing basis or as a point-in-time survey. In participating jurisdictions, a sample of women who have recently given birth to a live born or stillborn infant is selected from birth certificates or fetal death files. The sample is stratified based on the site's population of interest to ensure high-risk populations are adequately represented in the data.

The PRAMS survey instrument for live births is based on a core set of questions common across all jurisdictions that remain the same throughout each phase of data collection. In addition, CDC provides optional standardized modules (pre-grouped questions on a select topic) that a jurisdiction may use to customize survey content at the beginning of each phase of data collection. Topics for both the core and standard modules include health conditions (which includes chronic conditions such as diabetes, hypertension, mental health, oral health, cancer, as well as pregnancy-induced health conditions and family history of select conditions); health behaviors (including tobacco and alcohol use, substance use [licit and illicit], injury prevention and safety, nutrition, and physical activity); health care services (such as preconception care, prenatal care, postpartum care, contraceptive care, vaccinations, access to care and insurance coverage, receipt of recommended services and provider counseling received); infant health and development; infant care practices (such as breastfeeding, safe sleep practices); social services received (such as WIC or home visiting); the social context of childbearing (such as intimate partner violence, social support, adverse childhood experiences, stressful life experiences and racism); attitudes and feeling about the pregnancy including pregnancy intentions.

PRAMS Phase 8 includes births that occur/will have occurred during calendar years 2016-2022. Phase 8 data collection will cease for December 2022 births by the end of June 2023. For calendar year 2023 births, PRAMS will transition to Phase 9 (data collection for January 2022 births to begin in April 2023). The Phase 9 survey will include the same question topics and most of the same questions for core and standard modules listed above from Phase 8. The content on some topics will be expanded, for example, questions related to social determinants of health have been broadened with new questions such as those on experiences of racism and food, housing, and transportation insecurity. For Phase 9, some Phase 8 questions have been modified ( e.g., by reducing the number of response choices). Additionally, some questions from the Phase 8 core modules will not be included in the Phase 9 core modules. These questions are still available for jurisdictions to use as part of the standard modules.

The PRAMS infrastructure is uniquely suited for rapid adaption for information collection that would not be feasible with other surveillance methods. At times, jurisdictions may choose to implement (funded or unfunded) CDC-developed supplemental modules (pre-grouped questions on a select topic) to address emerging topics of interest. Supplemental modules for continued collection during Phase 8 of PRAMS include disabilities, marijuana use, prescription and illicit opioid use, COVID-19 experience, COVID-19 vaccine, and social determinants of health. Jurisdictions may elect to include these supplements during Phase 9, except for the disability supplement which is now integrated into the core. These supplements can be added for one or more birth years but can be discontinued at the end of a year of data collection. Core and standard questions remain the same for the entire questionnaire phase. New supplemental modules may be developed to address other emergent issues as they arise during implementation of Phase 9.

PRAMS can also be adapted to do call back surveys. Women who respond to the PRAMS survey may be re-contacted (opt-out consent process used) later (six months or more post-birth) to collect additional information about post-pregnancy experiences and infant and toddler health. No call back survey is currently being fielded or planned but call back surveys may be developed to address other emergent issues as they arise.

The stillbirth survey is currently administered just in the state of Utah. It only includes one survey instrument.

As part of the questionnaire development process, cognitive and field testing will be conducted prior to implementation of new supplemental modules and call back surveys, as well as before adding or substantively revising questions prior to a new phase of the PRAMS survey. Cognitive testing will be handled under a separate approval mechanism. Field testing will be conducted among women with infants one year or younger. Field testing is conducted to identify issues that may affect implementation or quality of the data collected.

For Phase 8 (which is in the final data collection year), information is collected 2-6 months after live birth or stillbirth by mail survey with telephone follow-up for non-responders. In 2022, five jurisdictions implemented an additional web mode for data collection for women with recent live birth. The web mode was collected simultaneously with the mail mode, with telephone follow up for non-responders. Based on data from the five jurisdictions, PRAMS plans to implement the additional web mode of data collection in all jurisdictions in 2023 (Phase 9).

OMB approval is requested for three years. The total estimated annual burden is 31,268 hours which is an increase of 1,503 hours. The change in overall burden results from: (1) a slightly reduced estimate of the number of responses to the PRAMS survey (core questions plus jurisdiction selected standard module) based on responses received in 2019 (decrease of 223 hours); (2) an increase in the anticipated number of supplemental modules and the time to complete each module from 5 to 8 min (increase of 1,959 hours) based on current supplemental modules being implemented by jurisdictions; (3) a decrease in the estimated annual burden for call back surveys (decrease of 586 hours) with current estimates based on responses to the most recent call back survey; (4) the addition of time spent by jurisdictions in creating the survey sample and uploading the sampled women's information; and (5) an increase in the amount of time allotted for each field testing interview resulting in an overall increase for field testing from 20 to 40 minutes (increase of 50 hours). There are no costs to respondents other than their time.

Estimated Annualized Burden Hours

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)
Women who recently delivered a live birth	PRAMS Phase 8/Phase 9 (Core Questions plus state selected standard modules)	51,556	1	26/60
	Supplemental Modules	52,984	1	8/60
	Call Back Surveys	2,790	1	30/60
	Field Testing	150	1	40/60
Women who recently delivered a stillbirth	PRAMS Stillbirth Questionnaire	160	1	25/60
Jurisdictions	Submission of data file to CDC	50	12	30/60

Jeffrey M. Zirger,

Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention.