Notice2022-25007
Agency Forms Undergoing Paperwork Reduction Act Review
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 17, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 87 Issue 221 (Thursday, November 17, 2022)</title>
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[Federal Register Volume 87, Number 221 (Thursday, November 17, 2022)]
[Notices]
[Pages 69024-69025]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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
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Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
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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
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