[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
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
          Type of respondent                    Form name           respondents    responses per   response  (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------


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