[Federal Register Volume 84, Number 119 (Thursday, June 20, 2019)]
[Notices]
[Pages 28817-28819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13053]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-19-16JO]
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 ``Proposed Data Collection
Submitted for Public Comment and Recommendations'' notice on August 31,
2018 to obtain comments from the public and affected agencies. CDC
received four comments related to the previous notice, two non-
substantive, two in support of the data collection; no modifications
were made to the PRAMS plan in response to comments. 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,
[[Page 28818]]
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 or send an email to [email protected]. 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
The Pregnancy Risk Assessment Monitoring System (PRAMS)--Existing
Collection in Use without an OMB Control Number--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
state-specific, population-based data on maternal attitudes and
experiences before, during, and shortly after pregnancy. The Centers
for Disease Control and Prevention (CDC) seeks OMB approval to collect
information through the Pregnancy Risk Assessment Monitoring System
(PRAMS) for three years.
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 state customized survey conducted in 51 sites and covers
83% of all live births in the United States. Information is collected
by 2-6 months after live birth or stillbirth by mail survey with
telephone follow-up for non-responders. In addition, call back surveys
may be implemented as a follow up to the initial survey to gather
additional information on post-pregnancy experiences and infant and
toddler health. Because PRAMS uses standardized data collection
methods, it allows data to be compared among states. States can
implement the survey on an ongoing basis or as a point-in-time survey.
In participating states, 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 state'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 states that remain the same for each
three-year phase of data collection. PRAMS is currently in Phase 8,
which began in 2016. In addition, CDC provides optional standardized
modules (pre-grouped questions on a select topic) that states may use
to customize survey content at the beginning of each phase of data
collection. For each state, the time for a respondent with a recent
live birth to complete the core and selected standard module questions
does not exceed 35 minutes in length. 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 child bearing (such as intimate
partner violence, social support, adverse childhood experiences,
stressful life experiences and racism); attitudes and feeling about the
pregnancy including pregnancy intentions.
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 state-specific
priorities and are typically fielded for one year. In the recent past,
they have been used to address pandemic influenza H1N1 (2009),
electronic cigarettes (2014), marijuana (2016), Zika (2017), and
emergency preparedness and response as they impact pregnancy (2017).
Supplemental modules planned for collection for 2019 births will
include family history of breast and ovarian cancer, disabilities and
prescription and illicit opioid use. Additional supplemental modules
(estimated respondents and burden the same each year) may be developed
to address other emergent issues as they arise, such as paternal
involvement, emerging infectious diseases, environmental disasters, and
other public health problems affecting women of reproductive age and
their pregnancies. The estimated time for a respondent to complete
supplemental modules is five minutes. Because PRAMS infrastructure was
developed to access a specific and vulnerable subpopulation, the PRAMS
infrastructure can be rapidly adapted for targeted information
collection that would not be feasible with other surveillance methods.
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 (approximately nine months post-birth) to collect
additional information about post-pregnancy experiences and infant and
toddler health. The currently planned call back survey will be targeted
to areas with a high burden of opioid overdose deaths and include
topics such as opioid misuse and access to medication assisted therapy,
experiences with respectful care, postpartum care, rapid repeat
pregnancy, infant feeding practices, infant health and social services
such as well child visit attendance, home visitation, developmental
delays, and social supports. The time for a respondent to complete the
call back survey is 30 minutes. Additional call back surveys (estimated
burden assumed the same each year) may be developed to address other
emergent issues as they arise.
The stillbirth survey, administered in the state of Utah only at
this current time, only includes a core survey instrument. Total time
estimated for women with a recent stillbirth completing the survey,
inclusive of informed consent is 25 minutes.
[[Page 28819]]
As part of the questionnaire development process, field testing
will be conducted prior to implementation of new supplemental modules
and call back surveys, as well as new or substantively revised
questions for the core module prior to a new phase. Field testing will
be conducted among women with infants one year or younger in health
clinics to identify issues that may affect implementation or quality of
the data collected. Field testing will only be conducted for new or
substantively changed questions. Total time estimated to complete the
field testing process inclusive of verbal consent, survey
administration and debriefing questions is approximately 20 minutes.
The burden estimate for PRAMS includes five types of information
collection: (1) Information collection associated with the PRAMS data
collection for women with recent live births (PRAMS core questions and
state-selected standard modules); (2) supplemental modules for emerging
issues; (3) call back surveys; (4) PRAMS data collection for women with
recent stillbirths; and (5) PRAMS field testing data collection to
inform questionnaire development. Participation is voluntary and there
are no costs to respondents other than their time. The total estimated
annualized burden hours are 29,765.
Estimated Annualized Burden Hours
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Average
Number of Number of burden per
Type of respondent Form name respondents responses per response (in
respondent hours)
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Women who recently delivered a live PRAMS Phase 8 (Core 52,076 1 26/60
birth. Questions plus state
selected standard
modules).
Supplemental modules.... 61,230 1 5/60
Call Back Surveys....... 3,961 1 30/60
Field Testing........... 150 1 20/60
Women who recently delivered a still PRAMS Stillbirth 160 1 25/60
birth. Questionnaire.
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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. 2019-13053 Filed 6-19-19; 8:45 am]
BILLING CODE 4163-18-P