60-day Federal Register Notice

Federal Register / Vol. 87, No. 127 / Tuesday, July 5, 2022 / Notices
The Centers for Disease
Control and Prevention (CDC), located
within the Department of Health and
Human Services (HHS), is interested in
obtaining information on available
platforms for nucleic acid amplification
or detection that meet criteria outlined
below in the SUPPLEMENTARY
INFORMATION section below.
DATES: Manufacturers are asked to
contact CDC at the address below by
August 19, 2022.
FOR FURTHER INFORMATION CONTACT:
Laura Hughes-Baker, Centers for Disease
Control and Prevention, 1600 Clifton
Road NE, MS H24–12, Atlanta, GA
30329–4027. Telephone: (404) 639–
1402; Email: [email protected].
SUPPLEMENTARY INFORMATION:
Background: Nucleic acid
amplification or detection is used in
many diagnostic tests. Rapid and
accurate results that can specifically
detect small amounts of pathogen
material are essential to identifying and
tracking diseases. The recent pandemic
has demonstrated the need for tests that
can be used in public health laboratories
across the United States and
internationally.
Many CDC laboratories across the
agency use a particular diagnostic
platform for nucleic acid detection.
Because this current platform will be
retired in the future, CDC is interested
in hearing from manufacturers regarding
the availability of current and potential
platforms that could support CDC’s
overall diagnostics and surveillance.
Criteria: Ideally, the replacement
platform should:
• Be suitable for research,
surveillance, or assay development, and
in vitro diagnostic purposes;
• Have Food and Drug
Administration (FDA) clearance for
diagnostic use or a research platform
capable of obtaining FDA clearance;
• Be compatible with a 96 well
format;
• Be compatible with diagnostic,
surveillance, or characterization tests
targeting a variety of pathogens; and
• Have software that allows for
flexibility in analysis.
Manufactures who may have a
platform that meets these criteria should
submit information to CDC at
[email protected] or the address
provided in the FOR FURTHER
INFORMATION section above.
All information submitted to CDC will
be kept confidential as allowed by
relevant federal law, including the
Freedom of Information Act (5 U.S.C.
552) and the Trade Secrets Act (18
U.S.C. 1905).

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SUMMARY:

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Disclaimer and Important Notes
This notice is for planning purposes;
it does not constitute a formal
announcement for comprehensive
applications. In accordance with
Federal Acquisition Regulation 48 CFR
15.201(e), responses to this notice are
not offers and cannot be accepted by the
Government to form a binding award.
CDC will not provide reimbursement for
costs incurred in responding to this
notice.
Dated: June 29, 2022.
Angela K. Oliver,
Executive Secretary, Centers for Disease
Control and Prevention.
[FR Doc. 2022–14211 Filed 7–1–22; 8:45 am]
BILLING CODE 4163–18–P

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
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

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.
SUMMARY:

You may submit comments,
identified by Docket No. CDC–2022–
0080 by either of the following methods:
• Federal eRulemaking Portal:
www.regulations.gov. Follow the
instructions for submitting comments.

ADDRESSES:

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39837

• 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: omb@
cdc.gov.
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,

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Federal Register / Vol. 87, No. 127 / Tuesday, July 5, 2022 / Notices

e.g., permitting electronic submissions
of responses; and
5. Assess information collection costs.

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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-

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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 pregnancyinduced 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

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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

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Federal Register / Vol. 87, No. 127 / Tuesday, July 5, 2022 / Notices
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
Average
burden per
response
(in hours)

Total burden
hours

Form name

Women who recently delivered a live
birth.

PRAMS Phase 8/Phase 9 (Core
Questions plus state selected
standard modules).
Supplemental Modules .....................
Call Back Surveys ............................
Cognitive Testing .............................
Field Testing .....................................
PRAMS Stillbirth Questionnaire .......

51,556

1

26/60

22,341

52,040
2,790
150
150
160

1
1
1
1
1

8/60
30/60
60/60
40/60
25/60

6,939
1,395
150
100
67

...........................................................

........................

........................

........................

30,992

Women who recently delivered a
stillbirth.
Total ...........................................

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

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day-FY–2022; Docket No. CDC–2022–
0082]

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

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 proposed and/or continuing
information collection, as required by
the Paperwork Reduction Act of 1995.
This notice invites comment on a
proposed information collection project
titled Requirement for Proof of COVID–
19 Vaccination for Noncitizen,
Nonimmigrant Air Passengers Arriving
into the United States from a Foreign
Country. A Revision for this collection
is being submitted to ensure that,
consistent with the terms of the April 4,
2022 Amended Order Under the
Presidential Proclamation titled

SUMMARY:

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Number of
responses per
respondent

Number of
respondents

Type of respondents

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Advancing Safe Resumption of Global
Travel During the COVID–19 Pandemic
and CDC’s Order Implementing
Proclamation on Advancing Safe
Resumption of Global Travel During the
COVID–19 Pandemic, public health
authorities can confirm that non-U.S
Citizen, Non-U.S. Immigrant passengers
are fully vaccinated against COVID–19
before boarding a plane to the United
States.
DATES: CDC must receive written
comments on or before September 6,
2022.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2022–
0082 by either of the following methods:
• Federal eRulemaking Portal:
www.regulations.gov. Follow the
instructions for submitting comments.
• 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
(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: 404–639–7570; Email: omb@
cdc.gov.

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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,
e.g., permitting electronic submissions
of responses; and
5. Assess information collection costs.

SUPPLEMENTARY INFORMATION:

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