Notice2022-04668
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
March 7, 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 44 (Monday, March 7, 2022)</title>
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[Federal Register Volume 87, Number 44 (Monday, March 7, 2022)]
[Notices]
[Pages 12706-12709]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-04668]
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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 <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
[[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:
<bullet> 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.
<bullet> 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.
<bullet> 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:
<bullet> 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).
<bullet> Protocols for on board surveillance of passengers and crew
with COVID-19 and COVID-19-like-illness.
<bullet> Protocols for training all crew on COVID-19 prevention,
mitigation, and response activities.
<bullet> Protocols for on board isolation and quarantine, including
how to increase capacity in case of an outbreak.
<bullet> Protocols for COVID-19 testing that aligns with CDC
technical instructions.
<bullet> 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.
<bullet> Procedures for disembarkation of passengers who test
positive for COVID-19.
<bullet> 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
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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. 2022-04668 Filed 3-4-22; 8:45 am]
BILLING CODE 4163-18-P
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</html>Indexed from Federal Register on March 7, 2022.
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