[Federal Register Volume 87, Number 221 (Thursday, November 17, 2022)]
[Notices]
[Pages 69024-69025]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25007]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day--23-1273]


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 
(404) 639-7570. 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 (202) 
395-5806. 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

[[Page 69025]]

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
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Women who recently delivered a live     PRAMS Phase 8/Phase 9             51,556               1           26/60
 birth.                                  (Core Questions plus
                                         state selected standard
                                         modules).
                                        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          PRAMS Stillbirth                     160               1           25/60
 stillbirth.                             Questionnaire.
Jurisdictions.........................  Submission of data file               50              12           30/60
                                         to CDC.
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2022-25007 Filed 11-16-22; 8:45 am]
BILLING CODE 4163-18-P