Agency Forms Undergoing Paperwork Reduction Act Review, 12706-12709 [2022-04668]
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Federal Register / Vol. 87, No. 44 / Monday, March 7, 2022 / Notices
Partner and Sexual Violence Survey
(NISVS) (OMB Control No. 0920–0822,
Exp. 03/31/2023). NISVS is a
surveillance system used to monitor the
magnitude of sexual violence (SV),
stalking, and intimate partner violence
(IPV) victimization among adults in the
U.S. This Revision is being requested to
continue collection of this data
annually. Data are used by the federal
government, states, partner
organizations, and stakeholders to
inform prevention programs and
policies related to SV, stalking, and IPV.
Additionally, NISVS data will be used
in training programs, peer reviewed
journals, technical reports, factsheets
and other media. Datasets are made
public for external researchers to use as
well. NISVS data has also been used in
the context of health equity by looking
at race and ethnicity and sexual
orientation. In 2010, NISVS collected
data for the National Institute of Justice
(NIJ) to examine IPV, SV, and stalking
among American Indian and Alaska
optional call-in telephone option,
increasing the response rate, decreasing
costs, and reducing respondent burden.
NISVS data will be collected using
address-based randomized sampling
with push-to-web design, whereby
respondents will complete the survey
on the internet. A call-in telephone
option will be available to those who
prefer to take the survey by phone.
The subpopulation to be studied is
non-institutionalized, English- and
Spanish-speaking women and men aged
18 years or older in the United States.
Data are analyzed using appropriate
statistical software to account for the
complexity of the survey design to
compute weighted counts, percentages,
and confidence intervals using national
and state-level data.
CDC requests OMB approval for an
estimated total of 7,938 annualized
burden hours. There are no costs to
respondents other than their time to
participate.
Native people. NISVS collected data in
2010, and again in 2016–17 for the
Department of Defense (DoD) to
understand the prevalence of violence
among active-duty women, active-duty
men, and the wives of active-duty men.
Continuing to document and monitor
the prevalence of IPV, SV, and stalking
is a critical step to improving the health
of individuals, making communities
safer, and reducing the social and
healthcare costs currently burdening
state and federal governments and
programs. NISVS data can be used to
inform public policies and prevention
strategies and to help guide and
evaluate progress towards reducing the
substantial health and social burden
associated with IPV, SV, and stalking.
The modification in this Revision
request is to fully implement the
redesigned methodology and
questionnaire for full national-level data
collection. The redesigned NISVS will
use an address-based sampling frame
with push-to-web collection and
ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden
per response
(in hours)
Number of
responses per
respondent
Total
burden
(in hours)
Form name
Individuals and Households ..............
Letter ................................................
Screener ...........................................
Web Questionnaire ..........................
Phone Questionnaire .......................
15,000
15,000
14,250
750
1
1
1
1
6/60
3/60
25/60
40/60
1,500
750
5,938
500
Total ...........................................
...........................................................
........................
........................
........................
7,938
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2022–04669 Filed 3–4–22; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–22–1335]
Agency Forms Undergoing Paperwork
Reduction Act Review
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
respondents
Type of respondents
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
submitted the information collection
request titled ‘‘CDC’s COVID–19
Program for Cruise Ships Operating in
U.S. Waters’’ to the Office of
Management and Budget (OMB) for
review and approval. CDC previously
published a ‘‘Proposed Data Collection
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Submitted for Public Comment and
Recommendations’’ notice on April 30,
2021, to obtain comments from the
public and affected agencies. CDC
received 20 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;
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(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
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Federal Register / Vol. 87, No. 44 / Monday, March 7, 2022 / Notices
Street NW, Washington, DC 20503 or by
fax to (202) 395–5806. Provide written
comments within 30 days of notice
publication.
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Proposed Project
CDC’s COVID–19 Program for Cruise
Ships Operating in U.S. Waters (OMB
Control No. 0920–1335, Exp. 4/30/
2022)—Extension—National Center for
Emerging Zoonotic and Infectious
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
As the COVID–19 pandemic has
unfolded, this information collection
has evolved. CDC’s COVID–19
regulatory requirements in the
Framework for a Conditional Sailing
Order (CSO) expired on January 15,
2022, at 12:01 a.m. EST. CDC is
transitioning to a new COVID–19 riskmitigation program for cruise ships
operating in U.S. waters. Cruise ship
operators will have the option to
participate in this program at their
discretion. This program will include
recommendations and guidance for
cruise ships to continue to operate in a
way that provides a safer and healthier
environment for crew, passengers, and
communities.
Through the implementation of the
CSO, CDC has identified best practices
for controlling the spread of COVID–19
on cruise ships and has coordinated
with cruise ship operators and other
stakeholders to implement these
measures. CDC remains committed to
working with the cruise industry, state,
territorial, and local health authorities,
and seaport partners to continue to
implement these measures.
Cruise ship operators choosing to
participate in the CDC’s COVID–19
Program for Cruise Ships Operating in
U.S. Waters on a voluntary basis agree
to follow all recommendations and
guidance issued by CDC as part of this
program. These recommendations are
aimed at further reducing the
introduction and spread of SARS–CoV–
2 onboard. CDC will work closely with
cruise ships opting into the program and
continue to monitor compliance with
COVID–19 preventive measures and
cases onboard these cruise ships
through daily enhanced data collection
and inspections.
Cruise lines that decide not to
participate in CDC’s COVID–19 Program
for Cruise Ships Operating in U.S.
Waters will receive a designation
showing that CDC has neither reviewed
nor confirmed the cruise ship operator’s
COVID–19 health and safety protocols.
Additionally, these ships will be subject
to other CDC orders and regulations to
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the same extent as other ships and
conveyances subject to the jurisdiction
of the United States.
The guidance and recommendations
included in CDC’s COVID–19 Program
for Cruise Ships Operating in U.S.
Waters are aligned with previous health
and safety protocols under the CSO. As
such, cruise ship operators who have
resumed operations under the CSO will
already be familiar with the components
of the program, and operators who
choose to participate in the program
will be able to continue sailing with
passengers without interruption.
This information collection request
outlines the reporting and document
retention requirements that are part of
CDC’s COVID–19 Program for Cruise
Ships Operating in U.S. Waters. Note,
many of the data collection elements
included in CDC’s COVID–19 Program
for Cruise Ships are currently approved
as part of OMB Package 0920–1335
Phased Approach to the Resumption of
Cruise Ship Passenger Operations,
submitted on April 30, 2021.
CDC will provide cruise ship
operators with information about the
program and how to contact CDC to opt
in or opt out of the program.
Opting Into the COVID–19 Program for
Cruise Ships
Cruise lines operating cruise ships in
U.S. waters choosing to participate in
this program (‘‘opting in’’) are requested
to notify the CDC in writing of their
decision to opt in by February 18, 2022.
Cruise lines choosing to participate in
this program will be required to follow
all recommendations and guidance as a
condition of their participation—i.e.,
they will not be able to pick and choose
which recommendations they follow.
Those opting in will continue to receive
a color status for cruise ships operating
in U.S. waters on CDC’s Cruise Ship
Color Status web page.
Cruise lines with ships not currently
in U.S. waters—but that are expecting to
return to U.S. waters after February 18,
2022—are requested to contact CDC via
email at least 28 days prior to their
ships’ arrival. Instructions on how to
participate in the program will be
provided.
Cruise lines that initially decide to
participate in the program but then later
decide not to participate should contact
CDC via email for instructions.
Opting Out of the COVID–19 Program
Cruise lines operating in U.S. waters
choosing not to participate in the
program (‘‘opting out’’) are requested to
notify CDC in writing by February 18,
2022.
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Cruise lines that do not notify CDC by
5:00 p.m. ET on February 18, 2022, will
be considered to have opted out of this
program. Cruise lines that decide to opt
out will have any cruise ships operating
in U.S. waters listed as ‘‘Gray’’ ships on
CDC’s Cruise Ship Color Status web
page. This designation means that CDC
has neither reviewed nor confirmed the
cruise ship operator’s health and safety
protocols. Additionally, these ships will
be subject to other CDC orders and
regulations to the same extent as other
ships and conveyances subject to the
jurisdiction of the United States.
Cruise lines that initially decide to
opt out but later decide to opt into the
program should contact CDC via email
at least 28 days prior to the day they
intend to join the program. Instructions
on how to participate in the program
will be provided.
Cruise Ship Vaccination Status
Classification
Cruise lines that choose to participate
in CDC’s COVID–19 Program for Cruise
Ships Operating in U.S. Waters must
advise CDC of the vaccination status
classification for each participating
ship. This information will be included
on CDC’s Cruise Ship Color Status
webpage.
As part of CDC’s COVID–19 Program
for Cruise Ships Operating in U.S.
Waters, cruise ship vaccination status
classifications are defined as:
• Not Highly Vaccinated: Ships with
less than 95% of passengers and 95% of
crew who are fully vaccinated.
Æ Cruise ship operators that select
this vaccination status classification
will be required to enforce mask use and
physical distancing onboard according
to CDC guidance.
• Highly Vaccinated: Ships with at
least 95% of passengers and 95% of
crew who are fully vaccinated, but less
than 95% of passengers and 95% of
crew are up to date with their COVID–
19 vaccines.
Æ Cruise ship operators that select
this vaccination status classification
will be required to enforce mask use—
but not physical distancing—onboard
according to CDC guidance. These
cruise ship operators may implement
physical distancing policies at their
discretion.
• Vaccination Standard of Excellence:
Ships with at least 95% of passengers
(including children) and 95% of crew
who are up to date with their COVID–
19 vaccines.
Æ Cruise ship operators that select
this vaccination status classification
will not be required to enforce mask use
or physical distancing onboard. These
cruise ship operators may implement
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Federal Register / Vol. 87, No. 44 / Monday, March 7, 2022 / Notices
mask use and physical distancing
policies at their discretion.
Ships adhering to the ‘‘Highly
Vaccinated’’ or ‘‘Vaccination Standard
of Excellence’’ classifications must
maintain these thresholds for each
voyage.
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COVID–19 Response Plans
Cruise ship operators choosing to
participate in CDC’s COVID–19 Program
for Cruise Ships Operating in U.S.
Waters must have a COVID–19 response
plan that includes the following
components:
• Terminology and use of definitions
that align with how CDC uses and
defines the following terms: ‘‘Confirmed
COVID–19,’’ ‘‘COVID–19-like illness,’’
‘‘close contact,’’ ‘‘fully vaccinated for
COVID–19,’’ and ‘‘isolation’’ and
‘‘quarantine’’ (including timeframes for
isolation and quarantine).
• Protocols for on board surveillance
of passengers and crew with COVID–19
and COVID–19-like-illness.
• Protocols for training all crew on
COVID–19 prevention, mitigation, and
response activities.
• Protocols for on board isolation and
quarantine, including how to increase
capacity in case of an outbreak.
• Protocols for COVID–19 testing that
aligns with CDC technical instructions.
• Protocols for onboard medical
staffing—including number and type of
staff—and equipment in sufficient
quantity to provide a hospital level of
care (e.g., ventilators, face masks,
personal protective equipment) for the
infected without the immediate need to
rely on shoreside hospitalization.
• Procedures for disembarkation of
passengers who test positive for COVID–
19.
• Statement that the cruise ship
operator has observed and will continue
to observe all elements of its COVID–19
response plan including following the
most current CDC recommendations and
guidance for any public health actions
related to COVID–19.
Surveillance and Reporting
For cruise ships that have chosen to
participate in the program, CDC requires
daily submission of the ‘‘Enhanced Data
Collection (EDC) During COVID–19
Pandemic Form’’, in lieu of submitting
the Maritime Conveyance Cumulative
Influenza/Influenza-Like Illness (ILI)
Form for COVID–19-like illness and the
Maritime Conveyance Illness or the
Death Investigation Form for individual
cases of COVID–19. This EDC Form will
be used to conduct surveillance for
COVID–19 on board cruise ships using
cumulative reports of confirmed
COVID–19 and COVID–19-like illness,
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which includes acute respiratory illness
(ARI), influenza-like illness (ILI),
pneumonia, and additional COVID–19like illness (aCLI) clinical criteria. Data
points for this form include number of
travelers (passengers and crew)
currently onboard; case counts and
diagnostic testing data for COVID–19
and COVID–19-like Illness (CLI);
screening testing of asymptomatic
travelers, isolation practices, and the
percentage of travelers who are fully
vaccinated.
Access to the online EDC form has
been provided to cruise lines by the
Cruise Lines International Association
(CLIA) and/or CDC. Cruise lines that do
not have access should contact CLIA or
CDC.
To address industry concerns about
the burden of daily EDC submission,
CDC will add an option in the online
form (i.e., a check box) to streamline
reporting if no cases were identified or
no testing was conducted for that day.
Additionally, to reduce reporting
burden for cruise ships, CDC will
continue to submit aggregate data to
seaport authorities, state, local, and
territorial health departments that
oversee seaports, federal partners, and
international maritime public health
agencies.
The data collected in the EDC form
are used to inform CDC’s COVID–19
Color-Coding System for Cruise Ships.
These data will greatly increase the
transparency of the overall health of the
crew members and passengers, and
better allow the CDC to manage
potential outbreaks and offer
recommendations to the ship and port
partners.
The color-coding system is only
applicable to cruise ships that meet one
of the following criteria:
1. Foreign-flagged cruise ships
currently operating in U.S. waters; or
2. Foreign-flagged cruise ships
currently operating outside of U.S.
waters but planning to return to
operation in international, interstate, or
intrastate waterways subject to the
jurisdiction of the United States; or
3. U.S.-flagged cruise ships choosing
to participate in CDC’s COVID–19
Program for Cruise Ships.
Status of ships is contingent upon
daily submission of the EDC form.
When a cruise ship notifies CDC of
suspected or confirmed cases of COVID–
19 on board, CDC determines whether
an investigation is needed based on a
predetermined threshold. If an
investigation is deemed necessary, CDC
will solicit extra information from the
cruise ship operator to determine what
public health interventions may be
necessary. This investigation gives CDC
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and the cruise industry the ability to
work closely together to protect the
health and safety of those on board and
in communities.
COVID–19 Testing Capabilities
As part of CDC’s COVID–19 Program
for Cruise Ships Operating in U.S.
Waters, the purpose of testing is to
quickly identify cases of COVID–19—
and test and quarantine their close
contacts who are not fully vaccinated—
to prevent ongoing transmission
between voyages. Cruise ship operators
participating in the program must have
onboard testing capabilities to test all
symptomatic crew and passengers for
COVID–19 and their close contacts. This
includes having onboard rapid nucleic
acid amplification test (NAAT) and
antigen point-of-care equipment that
meets the requirements specified by
CDC in technical instructions (e.g.,
authorized by FDA for use in a CLIAwaived setting); however, CDC will no
longer need to pre-approve these tests.
Instead, CDC will verify the cruise ship
operator’s COVID–19 testing capabilities
during routine cruise ship inspections.
For the program’s mass crew (and
passenger, if applicable) testing
requirement, cruise ship operators may
use an onboard viral test (NAAT or
antigen test) or arrange shoreside testing
at a Clinical Laboratory Improvement
Amendments (CLIA)-certified laboratory
so long as it meets the requirements
specified by CDC in its technical
instructions. Additionally, cruise ship
operators must have onboard viral tests
for routine crew screening testing. Note,
CDC will no longer need to pre-approve
these tests. Cruise ship operators may
contact CDC to request a list of
acceptable NAAT and antigen tests.
Port Agreements
A cruise ship operator that chooses to
participate in CDC’s COVID–19 Program
for Cruise Ships in U.S. Waters must
document the approval of all U.S. port
and local health authorities where their
ships intend to dock or make port
during one or more passenger voyages.
The agreement must include a port
operations component, a medical care
plan component, and a housing
component meeting the requirements of
CDC’s technical instructions. Note,
cruise ship operators will not need to
produce signed contracts between
medical and housing facilities when
submitting their port agreements. Cruise
lines/brands may submit these
agreements for all the ships in their
fleet.
In lieu of documenting the approval
of all local health authorities of
jurisdiction, the cruise ship operator
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Federal Register / Vol. 87, No. 44 / Monday, March 7, 2022 / Notices
may instead submit to CDC a signed
statement from a local health authority,
on the health authority’s official
letterhead, indicating that the health
authority has declined to participate in
deliberations and/or sign the port
agreement, i.e., a ‘‘Statement of NonParticipation.’’ The cruise ship operator
can submit to CDC documentation of
attempted communication with the
local health authority regarding the port
agreement if a response is not received
or if the local health authority declines
to provide a signed statement.
Additionally, the cruise ship operator
may enter into a multi-port agreement
(as opposed to a single port agreement)
provided that all relevant port and local
health authorities (including the state
health authorities) are signatories to the
agreement.
During discussions with cruise ship
operators, port authorities, and state and
local health authorities, all parties
requested CDC assistance with the
required agreements. In response to
these requests, CDC has created specific
guidance for additional reference.
Inspections
Cruise ships participating in CDC’s
program are subject to in-person
inspections by CDC inspectors. The
cruise ship operator’s properties and
records must be made available for
inspection to allow CDC to ascertain
compliance with its requirements. Such
properties and records include but are
not limited to vessels, facilities,
vehicles, equipment, communications,
manifests, list of passengers, laboratory
test results, and employee and
passenger health records. CDC has
issued additional technical guidance
outlining the specific areas that may be
inspected and corresponding
recommendations.
CDC has provided, and will continue
to provide as necessary, the technical
instructions for the COVID–19 Program
for Cruise Ships. CDC will work closely
with cruise industry, state, territorial,
and local health authorities, and seaport
partners to evaluate the program
components no later than March 18,
2022, and update them as needed. The
evaluation will include a review of all
public health recommendations and
guidance issued as part of the program
based on public health conditions and
available scientific evidence.
CDC requests OMB approval for an
estimated 17,532 annual burden hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondent
Form or information collection name
Cruise ship brand/operator .............................
COVID–19 Program for Cruise Ships Notice
of Participation/Nonparticipation.
Cruise Ship Vaccination Status Classification
COVID–19 Response Plan ............................
Enhanced Data Collection (EDC) During
COVID–19 Pandemic Form (Daily).
Cruise COVID–19 Case Investigation Worksheet (if necessary).
Cruise COVID–19 Contact Investigation
Worksheet (if necessary).
Agreement with Health Care Organization
with signoff from Local Health Authorities.
Agreement with Port of Entry with signoff
from Local Health Authority.
Agreement with Housing Facility with signoff
from Local Health Authority.
Inspections .....................................................
Cruise ship brand/operator .............................
Cruise ship parent company ...........................
Cruise ship physician ......................................
Cruise ship physician ......................................
Cruise ship physician ......................................
Cruise ship brand/operator .............................
Cruise ship brand/operator .............................
Cruise ship brand/operator .............................
Cruise ship operator .......................................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2022–04668 Filed 3–4–22; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
khammond on DSKJM1Z7X2PROD with NOTICES
Centers for Disease Control and
Prevention
Solicitation of Nominations for
Appointment to CDC’s Advisory
Committee to the Director (ACD)
Health Equity Workgroup (HEW)
ACTION:
Notice.
The Centers for Disease
Control and Prevention (CDC), within
the Department of Health and Human
SUMMARY:
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Services (HHS), is seeking nominations
for membership on the Advisory
Committee to the Director (ACD) Health
Equity Workgroup (HEW). The HEW
will consist of approximately 15
members who are experts in fields
associated with health equity; public
health science and practice; public
health policy development, analysis,
and implementation.
DATES: Nominations for membership on
the HEW workgroup must be received
no later than March 17, 2022. Late
nominations will not be considered for
membership.
ADDRESSES: All nominations (cover
letters and curriculum vitae) should be
emailed to ACDirector@cdc.gov with the
subject line: ‘‘Nomination for CDC ACD
HEW Workgroup.’’
FOR FURTHER INFORMATION CONTACT:
Kerry Caudwell, MPA, Centers for
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Number of
respondents
Number
responses
per
respondent
Avg. burden
per response
(hours)
20
1
300/60
130
3
130
1
1
365
5/60
2,400/60
20/60
104
1
30/60
24
1
30/60
30
1
600/60
30
1
600/60
30
1
600/60
130
2
120/60
Disease Control and Prevention, Office
of the Chief of Staff, 1600 Clifton Road
NE, MS H21–10, Atlanta, Georgia
30329–4027, Telephone: (404) 639–
7000; Email Address: ACDirector@
cdc.gov.
SUPPLEMENTARY INFORMATION:
Background: The purpose of the ACD,
CDC is to advise the Secretary, HHS,
and the Director, CDC, on policy and
broad strategies that will enable CDC to
fulfill its mission of protecting health
through health promotion, prevention,
and preparedness. The ACD, CDC
consists of up to 15 non-federal
members, including the Chair,
knowledgeable in areas pertinent to the
CDC mission, such as health policy,
public health, global health,
preparedness, preventive medicine, the
faith-based and community-based
sector, and allied fields.
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]]>Agencies
[Federal Register Volume 87, Number 44 (Monday, March 7, 2022)]
[Notices]
[Pages 12706-12709]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04668]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-22-1335]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) submitted the information
collection request titled ``CDC's COVID-19 Program for Cruise Ships
Operating in U.S. Waters'' 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
April 30, 2021, to obtain comments from the public and affected
agencies. CDC received 20 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
[[Page 12707]]
Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide
written comments within 30 days of notice publication.
Proposed Project
CDC's COVID-19 Program for Cruise Ships Operating in U.S. Waters
(OMB Control No. 0920-1335, Exp. 4/30/2022)--Extension--National Center
for Emerging Zoonotic and Infectious Diseases (NCEZID), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
As the COVID-19 pandemic has unfolded, this information collection
has evolved. CDC's COVID-19 regulatory requirements in the Framework
for a Conditional Sailing Order (CSO) expired on January 15, 2022, at
12:01 a.m. EST. CDC is transitioning to a new COVID-19 risk-mitigation
program for cruise ships operating in U.S. waters. Cruise ship
operators will have the option to participate in this program at their
discretion. This program will include recommendations and guidance for
cruise ships to continue to operate in a way that provides a safer and
healthier environment for crew, passengers, and communities.
Through the implementation of the CSO, CDC has identified best
practices for controlling the spread of COVID-19 on cruise ships and
has coordinated with cruise ship operators and other stakeholders to
implement these measures. CDC remains committed to working with the
cruise industry, state, territorial, and local health authorities, and
seaport partners to continue to implement these measures.
Cruise ship operators choosing to participate in the CDC's COVID-19
Program for Cruise Ships Operating in U.S. Waters on a voluntary basis
agree to follow all recommendations and guidance issued by CDC as part
of this program. These recommendations are aimed at further reducing
the introduction and spread of SARS-CoV-2 onboard. CDC will work
closely with cruise ships opting into the program and continue to
monitor compliance with COVID-19 preventive measures and cases onboard
these cruise ships through daily enhanced data collection and
inspections.
Cruise lines that decide not to participate in CDC's COVID-19
Program for Cruise Ships Operating in U.S. Waters will receive a
designation showing that CDC has neither reviewed nor confirmed the
cruise ship operator's COVID-19 health and safety protocols.
Additionally, these ships will be subject to other CDC orders and
regulations to the same extent as other ships and conveyances subject
to the jurisdiction of the United States.
The guidance and recommendations included in CDC's COVID-19 Program
for Cruise Ships Operating in U.S. Waters are aligned with previous
health and safety protocols under the CSO. As such, cruise ship
operators who have resumed operations under the CSO will already be
familiar with the components of the program, and operators who choose
to participate in the program will be able to continue sailing with
passengers without interruption.
This information collection request outlines the reporting and
document retention requirements that are part of CDC's COVID-19 Program
for Cruise Ships Operating in U.S. Waters. Note, many of the data
collection elements included in CDC's COVID-19 Program for Cruise Ships
are currently approved as part of OMB Package 0920-1335 Phased Approach
to the Resumption of Cruise Ship Passenger Operations, submitted on
April 30, 2021.
CDC will provide cruise ship operators with information about the
program and how to contact CDC to opt in or opt out of the program.
Opting Into the COVID-19 Program for Cruise Ships
Cruise lines operating cruise ships in U.S. waters choosing to
participate in this program (``opting in'') are requested to notify the
CDC in writing of their decision to opt in by February 18, 2022.
Cruise lines choosing to participate in this program will be
required to follow all recommendations and guidance as a condition of
their participation--i.e., they will not be able to pick and choose
which recommendations they follow. Those opting in will continue to
receive a color status for cruise ships operating in U.S. waters on
CDC's Cruise Ship Color Status web page.
Cruise lines with ships not currently in U.S. waters--but that are
expecting to return to U.S. waters after February 18, 2022--are
requested to contact CDC via email at least 28 days prior to their
ships' arrival. Instructions on how to participate in the program will
be provided.
Cruise lines that initially decide to participate in the program
but then later decide not to participate should contact CDC via email
for instructions.
Opting Out of the COVID-19 Program
Cruise lines operating in U.S. waters choosing not to participate
in the program (``opting out'') are requested to notify CDC in writing
by February 18, 2022.
Cruise lines that do not notify CDC by 5:00 p.m. ET on February 18,
2022, will be considered to have opted out of this program. Cruise
lines that decide to opt out will have any cruise ships operating in
U.S. waters listed as ``Gray'' ships on CDC's Cruise Ship Color Status
web page. This designation means that CDC has neither reviewed nor
confirmed the cruise ship operator's health and safety protocols.
Additionally, these ships will be subject to other CDC orders and
regulations to the same extent as other ships and conveyances subject
to the jurisdiction of the United States.
Cruise lines that initially decide to opt out but later decide to
opt into the program should contact CDC via email at least 28 days
prior to the day they intend to join the program. Instructions on how
to participate in the program will be provided.
Cruise Ship Vaccination Status Classification
Cruise lines that choose to participate in CDC's COVID-19 Program
for Cruise Ships Operating in U.S. Waters must advise CDC of the
vaccination status classification for each participating ship. This
information will be included on CDC's Cruise Ship Color Status webpage.
As part of CDC's COVID-19 Program for Cruise Ships Operating in
U.S. Waters, cruise ship vaccination status classifications are defined
as:
Not Highly Vaccinated: Ships with less than 95% of
passengers and 95% of crew who are fully vaccinated.
[cir] Cruise ship operators that select this vaccination status
classification will be required to enforce mask use and physical
distancing onboard according to CDC guidance.
Highly Vaccinated: Ships with at least 95% of passengers
and 95% of crew who are fully vaccinated, but less than 95% of
passengers and 95% of crew are up to date with their COVID-19 vaccines.
[cir] Cruise ship operators that select this vaccination status
classification will be required to enforce mask use--but not physical
distancing--onboard according to CDC guidance. These cruise ship
operators may implement physical distancing policies at their
discretion.
Vaccination Standard of Excellence: Ships with at least
95% of passengers (including children) and 95% of crew who are up to
date with their COVID-19 vaccines.
[cir] Cruise ship operators that select this vaccination status
classification will not be required to enforce mask use or physical
distancing onboard. These cruise ship operators may implement
[[Page 12708]]
mask use and physical distancing policies at their discretion.
Ships adhering to the ``Highly Vaccinated'' or ``Vaccination
Standard of Excellence'' classifications must maintain these thresholds
for each voyage.
COVID-19 Response Plans
Cruise ship operators choosing to participate in CDC's COVID-19
Program for Cruise Ships Operating in U.S. Waters must have a COVID-19
response plan that includes the following components:
Terminology and use of definitions that align with how CDC
uses and defines the following terms: ``Confirmed COVID-19,'' ``COVID-
19-like illness,'' ``close contact,'' ``fully vaccinated for COVID-
19,'' and ``isolation'' and ``quarantine'' (including timeframes for
isolation and quarantine).
Protocols for on board surveillance of passengers and crew
with COVID-19 and COVID-19-like-illness.
Protocols for training all crew on COVID-19 prevention,
mitigation, and response activities.
Protocols for on board isolation and quarantine, including
how to increase capacity in case of an outbreak.
Protocols for COVID-19 testing that aligns with CDC
technical instructions.
Protocols for onboard medical staffing--including number
and type of staff--and equipment in sufficient quantity to provide a
hospital level of care (e.g., ventilators, face masks, personal
protective equipment) for the infected without the immediate need to
rely on shoreside hospitalization.
Procedures for disembarkation of passengers who test
positive for COVID-19.
Statement that the cruise ship operator has observed and
will continue to observe all elements of its COVID-19 response plan
including following the most current CDC recommendations and guidance
for any public health actions related to COVID-19.
Surveillance and Reporting
For cruise ships that have chosen to participate in the program,
CDC requires daily submission of the ``Enhanced Data Collection (EDC)
During COVID-19 Pandemic Form'', in lieu of submitting the Maritime
Conveyance Cumulative Influenza/Influenza-Like Illness (ILI) Form for
COVID-19-like illness and the Maritime Conveyance Illness or the Death
Investigation Form for individual cases of COVID-19. This EDC Form will
be used to conduct surveillance for COVID-19 on board cruise ships
using cumulative reports of confirmed COVID-19 and COVID-19-like
illness, which includes acute respiratory illness (ARI), influenza-like
illness (ILI), pneumonia, and additional COVID-19-like illness (aCLI)
clinical criteria. Data points for this form include number of
travelers (passengers and crew) currently onboard; case counts and
diagnostic testing data for COVID-19 and COVID-19-like Illness (CLI);
screening testing of asymptomatic travelers, isolation practices, and
the percentage of travelers who are fully vaccinated.
Access to the online EDC form has been provided to cruise lines by
the Cruise Lines International Association (CLIA) and/or CDC. Cruise
lines that do not have access should contact CLIA or CDC.
To address industry concerns about the burden of daily EDC
submission, CDC will add an option in the online form (i.e., a check
box) to streamline reporting if no cases were identified or no testing
was conducted for that day. Additionally, to reduce reporting burden
for cruise ships, CDC will continue to submit aggregate data to seaport
authorities, state, local, and territorial health departments that
oversee seaports, federal partners, and international maritime public
health agencies.
The data collected in the EDC form are used to inform CDC's COVID-
19 Color-Coding System for Cruise Ships. These data will greatly
increase the transparency of the overall health of the crew members and
passengers, and better allow the CDC to manage potential outbreaks and
offer recommendations to the ship and port partners.
The color-coding system is only applicable to cruise ships that
meet one of the following criteria:
1. Foreign-flagged cruise ships currently operating in U.S. waters;
or
2. Foreign-flagged cruise ships currently operating outside of U.S.
waters but planning to return to operation in international,
interstate, or intrastate waterways subject to the jurisdiction of the
United States; or
3. U.S.-flagged cruise ships choosing to participate in CDC's
COVID-19 Program for Cruise Ships.
Status of ships is contingent upon daily submission of the EDC
form. When a cruise ship notifies CDC of suspected or confirmed cases
of COVID-19 on board, CDC determines whether an investigation is needed
based on a predetermined threshold. If an investigation is deemed
necessary, CDC will solicit extra information from the cruise ship
operator to determine what public health interventions may be
necessary. This investigation gives CDC and the cruise industry the
ability to work closely together to protect the health and safety of
those on board and in communities.
COVID-19 Testing Capabilities
As part of CDC's COVID-19 Program for Cruise Ships Operating in
U.S. Waters, the purpose of testing is to quickly identify cases of
COVID-19--and test and quarantine their close contacts who are not
fully vaccinated--to prevent ongoing transmission between voyages.
Cruise ship operators participating in the program must have onboard
testing capabilities to test all symptomatic crew and passengers for
COVID-19 and their close contacts. This includes having onboard rapid
nucleic acid amplification test (NAAT) and antigen point-of-care
equipment that meets the requirements specified by CDC in technical
instructions (e.g., authorized by FDA for use in a CLIA-waived
setting); however, CDC will no longer need to pre-approve these tests.
Instead, CDC will verify the cruise ship operator's COVID-19 testing
capabilities during routine cruise ship inspections.
For the program's mass crew (and passenger, if applicable) testing
requirement, cruise ship operators may use an onboard viral test (NAAT
or antigen test) or arrange shoreside testing at a Clinical Laboratory
Improvement Amendments (CLIA)-certified laboratory so long as it meets
the requirements specified by CDC in its technical instructions.
Additionally, cruise ship operators must have onboard viral tests for
routine crew screening testing. Note, CDC will no longer need to pre-
approve these tests. Cruise ship operators may contact CDC to request a
list of acceptable NAAT and antigen tests.
Port Agreements
A cruise ship operator that chooses to participate in CDC's COVID-
19 Program for Cruise Ships in U.S. Waters must document the approval
of all U.S. port and local health authorities where their ships intend
to dock or make port during one or more passenger voyages. The
agreement must include a port operations component, a medical care plan
component, and a housing component meeting the requirements of CDC's
technical instructions. Note, cruise ship operators will not need to
produce signed contracts between medical and housing facilities when
submitting their port agreements. Cruise lines/brands may submit these
agreements for all the ships in their fleet.
In lieu of documenting the approval of all local health authorities
of jurisdiction, the cruise ship operator
[[Page 12709]]
may instead submit to CDC a signed statement from a local health
authority, on the health authority's official letterhead, indicating
that the health authority has declined to participate in deliberations
and/or sign the port agreement, i.e., a ``Statement of Non-
Participation.'' The cruise ship operator can submit to CDC
documentation of attempted communication with the local health
authority regarding the port agreement if a response is not received or
if the local health authority declines to provide a signed statement.
Additionally, the cruise ship operator may enter into a multi-port
agreement (as opposed to a single port agreement) provided that all
relevant port and local health authorities (including the state health
authorities) are signatories to the agreement.
During discussions with cruise ship operators, port authorities,
and state and local health authorities, all parties requested CDC
assistance with the required agreements. In response to these requests,
CDC has created specific guidance for additional reference.
Inspections
Cruise ships participating in CDC's program are subject to in-
person inspections by CDC inspectors. The cruise ship operator's
properties and records must be made available for inspection to allow
CDC to ascertain compliance with its requirements. Such properties and
records include but are not limited to vessels, facilities, vehicles,
equipment, communications, manifests, list of passengers, laboratory
test results, and employee and passenger health records. CDC has issued
additional technical guidance outlining the specific areas that may be
inspected and corresponding recommendations.
CDC has provided, and will continue to provide as necessary, the
technical instructions for the COVID-19 Program for Cruise Ships. CDC
will work closely with cruise industry, state, territorial, and local
health authorities, and seaport partners to evaluate the program
components no later than March 18, 2022, and update them as needed. The
evaluation will include a review of all public health recommendations
and guidance issued as part of the program based on public health
conditions and available scientific evidence.
CDC requests OMB approval for an estimated 17,532 annual burden
hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number Avg. burden
Type of respondent Form or information Number of responses per per response
collection name respondents respondent (hours)
----------------------------------------------------------------------------------------------------------------
Cruise ship brand/operator............ COVID-19 Program for 20 1 300/60
Cruise Ships Notice of
Participation/
Nonparticipation.
Cruise ship brand/operator............ Cruise Ship Vaccination 130 1 5/60
Status Classification.
Cruise ship parent company............ COVID-19 Response Plan.. 3 1 2,400/60
Cruise ship physician................. Enhanced Data Collection 130 365 20/60
(EDC) During COVID-19
Pandemic Form (Daily).
Cruise ship physician................. Cruise COVID-19 Case 104 1 30/60
Investigation Worksheet
(if necessary).
Cruise ship physician................. Cruise COVID-19 Contact 24 1 30/60
Investigation Worksheet
(if necessary).
Cruise ship brand/operator............ Agreement with Health 30 1 600/60
Care Organization with
signoff from Local
Health Authorities.
Cruise ship brand/operator............ Agreement with Port of 30 1 600/60
Entry with signoff from
Local Health Authority.
Cruise ship brand/operator............ Agreement with Housing 30 1 600/60
Facility with signoff
from Local Health
Authority.
Cruise ship operator.................. Inspections............. 130 2 120/60
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2022-04668 Filed 3-4-22; 8:45 am]
BILLING CODE 4163-18-P
