[Federal Register Volume 87, Number 127 (Tuesday, July 5, 2022)]
[Notices]
[Pages 39837-39839]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-14218]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-22-1273; Docket No. CDC-2022-0080]


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.

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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:
    <bullet> Federal eRulemaking Portal: www.regulations.gov. Follow 
the instructions for submitting comments.
    <bullet> 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: 404-639-7118; 
Email: <a href="/cdn-cgi/l/email-protection#a6c9cbc4e6c5c2c588c1c9d0"><span class="__cf_email__" data-cfemail="66090b042605020548010910">[email protected]</span></a>.

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,

[[Page 39838]]

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

[[Page 39839]]

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
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
Women who recently delivered a  PRAMS Phase 8/            51,556               1           26/60          22,341
 live birth.                     Phase 9 (Core
                                 Questions plus
                                 state selected
                                 standard
                                 modules).
                                Supplemental              52,040               1            8/60           6,939
                                 Modules.
                                Call Back                  2,790               1           30/60           1,395
                                 Surveys.
                                Cognitive                    150               1           60/60             150
                                 Testing.
                                Field Testing...             150               1           40/60             100
Women who recently delivered a  PRAMS Stillbirth             160               1           25/60              67
 stillbirth.                     Questionnaire.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............          30,992
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2022-14218 Filed 7-1-22; 8:45 am]
BILLING CODE 4163-18-P


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