2022-14218. Proposed Data Collection Submitted for Public Comment and Recommendations

AGENCY:

Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

ACTION:

Notice with comment period.

SUMMARY:

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Pregnancy Risk Assessment Monitoring System (PRAMS). PRAMS is a surveillance project of the Centers for Disease Control and Prevention (CDC) and state health departments that collects jurisdiction-specific, population-based data on maternal attitudes and experiences before, during, and shortly after pregnancy.

DATES:

CDC must receive written comments on or before September 6, 2022.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-2022-0080 by either of the following methods:

• Federal eRulemaking Portal: www.regulations.gov. Follow the instructions for submitting comments.

• Mail: Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS H21-8, Atlanta, Georgia 30329.

Instructions: All submissions received must include the agency name and Docket Number. CDC will post, without change, all relevant comments to www.regulations.gov.

Please note: Submit all comments through the Federal eRulemaking portal (www.regulations.gov) or by U.S. mail to the address listed above.

FOR FURTHER INFORMATION CONTACT:

To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS H21-8, Atlanta, Georgia 30329; Telephone: [phone]; Email: [e-mail].

SUPPLEMENTARY INFORMATION:

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

1. 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;

2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

3. Enhance the quality, utility, and clarity of the information to be collected;

4. 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 submissions of responses; and

5. Assess information collection costs.

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 state 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 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. 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 piloted a web mode for data collection, with plans to scale up to all jurisdictions in 2023. 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 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 demographic and background, 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.

CDC is seeking approval for a Revision of the PRAMS collection to include Phase 8, which will conclude March 2023, and to incorporate Phase 9, which will 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 from Phase 8. The content on some topics will be expanded, for example, questions related to the social context of childbearing has been broadened with new questions such as those on experiences of racism and food, housing, and transportation insecurity. For Phase 9, some questions have been added and 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.

Because PRAMS infrastructure was developed to access a specific population, the PRAMS infrastructure is uniquely suited for rapid adaption for information collection that would not be feasible with other surveillance methods. At times, states may also be funded to address emerging topics of interest with supplemental modules (pre-grouped questions on a select topic). These supplemental modules address national and site-specific priorities. Supplemental modules, for which continued collection for Phase 8 of PRAMS births is planned include disabilities, marijuana use, prescription and illicit opioid use, COVID-19 experience, COVID-19 vaccine, and social determinants of health. New supplemental modules may be developed to address other emergent issues as they arise.

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) at a later date (most recent opioid call back survey occurred approximately nine months 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 in the state of Utah only. It includes a single 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. For subsequent phases of PRAMS questionnaires, new or substantively revised questions for the core or standard questions will be conducted prior to a new phase. Cognitive and field testing will be conducted among women with infants one year or younger. Cognitive testing is conducted to evaluate interpretive and cognitive processes used by respondents when responding to survey questions to identify difficulties experienced by respondents when answering the questions and as well as identify potential response errors. Field testing is conducted to identify issues that may affect implementation or quality of the data collected.

OMB approval is requested for three years. The total estimated annual burden is 30,992 hours which is an increase of 1,227 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 five to eight minutes (increase of 1,836 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 cognitive testing to aid in the development of new or modification of existing questions (increase of 150 hours), 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)	Total burden 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	22,341
	Supplemental Modules	52,040	1	8/60	6,939
	Call Back Surveys	2,790	1	30/60	1,395
	Cognitive Testing	150	1	60/60	150
	Field Testing	150	1	40/60	100
Women who recently delivered a stillbirth	PRAMS Stillbirth Questionnaire	160	1	25/60	67
Total					30,992

Jeffrey M. Zirger,

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