Notice2021-23555
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
October 29, 2021
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
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<title>Federal Register, Volume 86 Issue 207 (Friday, October 29, 2021)</title>
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[Federal Register Volume 86, Number 207 (Friday, October 29, 2021)]
[Notices]
[Pages 60043-60047]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-23555]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-22-1355]
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 Phased Approach to the Resumption of Cruise
Ship Passenger Operations 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'' on April
30, 2021, to obtain comments from the public and affected agencies.
This collection accompanies a CDC Order entitled Temporary Extension
and Modification of Framework for Conditional Sailing Order (CSO). CDC
received twenty (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 60044]]
Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide
written comments within 30 days of notice publication.
Proposed Project
Phased Approach to the Resumption of Cruise Ship Passenger
Operations (OMB Control No. 0920-1335, Exp. 10/31/2021)--Extension--
National Center for Emerging Zoonotic and Infectious Diseases (NCEZID),
Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The Temporary Extension and Modification Framework for Conditional
Sailing Order (here on referred to as the ``CSO Extension'') extends
The Framework for Conditional Sailing Order published in the Federal
Register on November 4, 2020, and continues to prohibit a cruise ship
operator from commencing or continuing any regular passenger operations
without a COVID-19 Conditional Sailing Certificate issued by HHS/CDC.
This information collection request outlines the reporting and document
retention requirements that are part of a phased approach to resuming
passenger operations.
The CSO Extension builds upon the phased-in approach to resume
cruise ship passenger operations introduced by the CSO. Cruise ship
operators who have already completed the process under the CSO will not
have to resubmit any information under the CSO Extension and can
continue sailing with passengers without interruption. As many cruise
ship operators are now familiar with the CSO and its requirements, many
aspects of the phased-in approach can be completed concurrently under
the CSO Extension.
Phase 1
Per CDC's CSO Extension, cruise ships operating or intending to
operate in U.S. waters must acknowledge that a complete and accurate
COVID-19 response plan (formerly referred to as ``No Sail Order (NSO)
response plan'') is observed. The COVID-19 response plan, which can be
submitted by a cruise ship holding company and apply to all cruise
ships operated by the holding company's brands, must include: (1)
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); (2) protocols for on board surveillance of passengers
and crew with COVID-19 and COVID-19-like illness; (3) protocols for
training all crew on COVID-19 prevention, mitigation, and response
activities; (4) protocols for on board isolation and quarantine,
including how to increase capacity in case of an outbreak; (5)
protocols for COVID-19 testing that aligns with CDC technical
instructions; (6) 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; and (7) procedures for
disembarkation of passengers who test positive for COVID-19.
Phase 1 also includes requirements for COVID-19 testing
capabilities and reporting for cruise ship operators operating or
intending to operate cruise ships in U.S. waters. Cruise ship operators
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) point-of-care
equipment that meets the requirements specified by CDC in technical
instructions or orders and have received CDC approval. For the Phase 1
mass crew 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 technical
instructions or orders and have received CDC approval.
Finally, Phase 1 also includes reporting requirements using the CDC
Enhanced Data Collection during COVID-19 Pandemic (EDC) 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
specific cases of COVID-19, the CDC will require daily submission of
the EDC form during the period of the CSO Extension. Data points for
this form include number of travelers (crew and passengers) currently
onboard; case counts and diagnostic testing data for COVID-19 and
COVID-19-like Illness (CLI); screening and testing of asymptomatic
travelers, isolation practices, and the percentage of travelers who are
fully vaccinated. The data collected in the EDC form are used to inform
CDC's COVID-19 Color-Coding System for Cruise Ships. This 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 operating or
planning to operate in U.S. waters. 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. 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.
Phase 2A
The next phase, Phase 2A, focuses on preparation for simulated and
restricted voyages. As required under the CSO Extension, a cruise ship
operator's agreement with U.S. port authorities and local health
authorities must include the following elements: (1) A port agreement
between the cruise ship operator and port authority that takes into
consideration the public health response resources of the jurisdiction
in the event of a COVID-19 outbreak, a plan and timeline for
vaccination of cruise ship crew prior to resuming passenger operations,
and vaccination strategies to maximally protect passengers and crew
from introduction, amplification, and spread of COVID-19 in the
maritime environment and in land-based communities; (2) medical care
agreements between the cruise ship operator and health care entities,
addressing evacuation and medical transport to onshore hospitals for
passengers and crew in need of medical care, in accordance with CDC
technical instructions and orders; and (3) housing agreements between
the cruise ship operator and one or more shoreside facilities for
isolation and quarantine of passengers or crew members with COVID-19
and their close contacts, identified from the day of embarkation
through disembarkation for each voyage. Cruise lines/brands may submit
these agreements for all the ships in their fleet. Note, these
agreements can remain in place for restricted voyages, as long as the
agreements remain valid.
In lieu of documenting the approval of all local health authorities
of jurisdiction, the cruise ship operator may instead submit to CDC a
signed statement from a local health authority, on the health
authority's official letterhead, indicating that the health
[[Page 60045]]
authority has declined to participate in deliberations and/or sign the
port agreement (i.e., a ``Statement of Non-Participation'').
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 posted specific guidance online and has provided a checklist
for additional reference.
Phase 2B
Phase 2B of the CSO Extension establishes the requirements for
simulated voyages where volunteers play the role of passengers to test
cruise ship operators' ability to mitigate COVID-19 onboard. Passengers
on simulated voyages must be at least 12 years old, provide their
informed consent, and submit a medical certification to the cruise ship
operator prior to embarkation.
Before conducting a simulated voyage, a cruise ship operator must
submit a Request for Approval to Conduct a Simulated Voyage Prior to
Issuance of COVID-19 Conditional Sailing Certificate at least five
business days prior to the voyage. A cruise ship operator shall not
apply for approval to conduct a simulated voyage until all of CDC's
requirements relating to onboard laboratory capacity and screening
testing of crew in U.S. waters have been satisfied.
A simulated voyage must include the following simulated activities:
(1) Embarkation and disembarkation procedures, including terminal
check-in, (2) on board activities, including at dining and
entertainment venues, (3) private island shore excursions, if any are
planned during restricted passenger voyages, (4) evacuation procedures,
(5) transfer of symptomatic passengers or crew, or those who test
positive for SARS-CoV-2, from cabins to isolation rooms, (6) quarantine
of all remaining passengers and non-essential crew, and (7) other
activities as may be listed in CDC technical instructions and orders.
Additionally, the cruise ship operator must: (1) Meet standards for
hand hygiene, facemasks, and physical distancing for passengers and
crew, as well as ship sanitation, as may be required by CDC technical
instructions or orders, (2) conduct laboratory testing of all
passengers and crew on the day of embarkation and the day of
disembarkation as required by CDC technical instructions or orders, and
(3) immediately conduct laboratory testing of any passengers and crew
who report illness consistent with COVID-19 during the simulated voyage
with rapid point-of-care results as required by CDC technical
instructions or orders. Note, CDC may require the cruise ship operator
to immediately end the simulated voyage and take other action to
protect the health and safety of volunteer passengers and crew if
during the simulation a threshold of COVID-19 cases, as determined by
CDC in technical instructions, is met or exceeded.
During simulated voyages, the cruise ships are subject to virtual
and in-person inspections by CDC. 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. Following each simulated
voyage, the cruise ship operator must document any deficiencies in its
health and safety protocols through a Simulated Voyage After-Action
Report and address how the cruise ship operator intends to address
those deficiencies. This After-Action Report must also include COVID-19
test results for any volunteer passengers or crew on the simulated
voyage. The After-Action Report must be submitted to the CDC as soon as
practicable at the end of the simulation and as part of the cruise ship
operator's application for a COVID-19 Conditional Sailing Certificate.
In lieu of conducting a simulated voyage, a cruise ship operator's
responsible officials, at their discretion, may sign and submit to CDC
an acknowledgement that 95% of crew (excluding any newly embarking crew
in quarantine) are fully vaccinated and submit to CDC a clear and
specific vaccination plan and timeline to limit cruise ship sailings to
95% of passengers who have been verified by the cruise ship operator as
fully vaccinated prior to sailing.
Furthermore, cruise ships that have been operating restricted
passenger voyages under an Acknowledgement by a Cruise Ship Operator In
Lieu of a Simulated Voyage may, at their discretion, transition to
operating restricted passenger voyages with less than 95% of passengers
fully vaccinated without first conducting a simulated voyage if the
following are met: (1) The ship must maintain a percentage of fully
vaccinated crew that is greater than or equal to 95%. (2) The ship must
have operated on restricted passenger voyages under an acknowledgement
by the cruise ship operator's responsible officials that they will only
operate with 95% of crew (excluding any newly embarking crew in
quarantine) and 95% of passengers who are fully vaccinated for at least
60 days. (3) At least 14 days prior to the transition to voyages with
less than 95% of passengers fully vaccinated, the cruise ship operator
must submit the following to CDC: (1) Protocols for how dining and
entertainment venues, and recreational activities including buffets,
seated dining, bars (including between bartenders and patrons),
theaters, other performance venues, casinos, arcade room, spa services,
fitness classes/gymnasiums, muster drills, and other areas where
passengers congregate will be modified to incorporate mask use,
physical distancing, and other public health measures as outlined in
CDC technical instructions. (2) Plans for training crew on new
procedures for mask use, physical distancing, and other public health
measures as outlined in CDC technical instructions. (3) Protocols for
increasing the number of isolation and quarantine cabins and on-board
support staff (e.g., administrative personnel, testing personnel,
contact tracers, medical personnel) as determined by the cruise ship
operator and as needed in the event of an outbreak. (4) Procedures for
how crew will identify and distinguish between passengers who are fully
vaccinated and passengers who are not fully vaccinated. (5) Procedures
for notifying passengers who booked a 95% passenger vaccinated cruise
that their cruise will no longer operate as a 95% passenger vaccinated
cruise. (6) The cruise ship operator must submit photographs or videos,
no later than seven days after commencing the first voyage with less
than 95% of passengers fully vaccinated, showing compliance with indoor
mask use and physical distancing, such as signage in elevators, dining
table arrangements, and blocking out seats/bar stools.
Similarly, cruise ship operators that have been conducting
passenger operations outside of U.S. waters and intend to operate
cruise ships with less than 95% of passengers fully vaccinated after
repositioning to U.S. waters may, at their discretion, follow the
[[Page 60046]]
procedures in this paragraph for conducting a modified simulated voyage
instead of conducting a full simulated voyage if the following are met:
(1) The ship must maintain a percentage of fully vaccinated crew that
is greater than or equal to 95%. (2) The ship must have operated with
passengers outside of U.S. waters for at least 60 days before entering
U.S. waters. (3) The cruise ship operator must conduct at least one
simulation of embarkation screening and testing at the port terminal it
intends to use in the U.S.--to include the number of passengers not
fully vaccinated expected on the first voyage--unless the ship will be
operating at the terminal already in use by the same cruise line/brand
for passenger operations. (4) At least 14 days prior to entering U.S.
waters, the cruise ship operator must submit the following to CDC: (i)
Protocols for how dining and entertainment venues, and recreational
activities, including buffets, seated dining, bars (including between
bartenders and patrons), theaters, other performance venues, casinos,
arcade room, spa services, fitness classes/gymnasiums, muster drills,
and other areas where passengers congregate will incorporate mask use,
physical distancing, and other public health measures as outlined in
technical instructions. (ii) Plans for training crew on procedures for
mask use, physical distancing, and other public health measures as
outlined in CDC technical instructions. (iii) Protocols for increasing
the number of isolation and quarantine cabins and on-board support
staff (e.g., administrative personnel, testing personnel, contact
tracers, medical personnel) as determined by the cruise ship operator
and as needed in the event an outbreak. (iv) Procedures for how crew
will identify and distinguish between passengers who are fully
vaccinated and passengers who are not fully vaccinated. (v) Procedures
for notifying passengers who booked a 95% vaccinated cruise that their
cruise will no longer operate as a 95% vaccinated cruise, if
applicable. (vi) An after-action report explaining lessons learned from
sailing outside of U.S. waters and from the simulated embarkation
screening and testing (if such a simulation was conducted). (vii) The
cruise ship operator must submit photographs or videos, no later than
seven days after commencing the first voyage with less than 95% of
passengers fully vaccinated, showing compliance with indoor mask use
and physical distancing, such as signage in elevators, dining table
arrangements, and blocking out seats/bar stools.
Phase 3
As a condition of applying for a COVID-19 Conditional Sailing
Certificate (Phase 3), a cruise ship operator must have successfully
conducted a simulated voyage, submitted an Acknowledgement by a Cruise
Ship Operator In Lieu of a Simulated Voyage, or--if applicable--
completed the specific modified simulated voyage procedures described
above. The CDC COVID-19 Conditional Sailing Certificate Application
must include: (1) A completed CDC registration/application form that
includes the signatures of the cruise ship operator's responsible
officials; (2) The name, titles, and contact information for the cruise
ship operator's responsible officials; (3) A completed statement of
intent stating the name, carrying capacity for passengers and crew,
itinerary, ports of call, length of voyage, and expected onboard or
shoreside activities, for the cruise ship that the cruise ship operator
intends to have certified for restricted passenger operations; (4) a
certification statement signed by the responsible officials attesting
that the cruise ship operator has complied and remains in compliance
with CDC's requirements for a COVID-19 Response Plan and EDC reporting
prior to applying for a COVID-19 Conditional Sailing Certificate; (5) a
certification statement signed by the responsible officials attesting
that the cruise ship operator has adopted health and safety protocols
that meet CDC's standards for mitigating the risk of COVID-19 among
passengers and crew onboard the cruise ship that will be commencing
restricted passenger operations, and will modify these protocols as
needed to protect the public's health as required by CDC technical
instructions or orders; (6) a certification statement signed by the
responsible officials attesting that the cruise ship operator has
sufficient medical and point of care laboratory capabilities and staff
on board the cruise ship that will be commencing restricted passenger
operations to manage severe COVID-19 cases and outbreaks in exigent
circumstances as required by CDC technical instructions or orders; and
(7) a certification statement signed by the responsible officials
attesting that the cruise ship operator is in compliance with the other
requirements contained in this framework for mitigating the risk of
COVID-19 on board cruise ships and agrees to continue to comply with
these requirements.
These documents must be submitted at least five business days prior
to any proposed restricted voyage. If the Certificate is denied,
revoked or suspended, a cruise ship operator may submit a written
appeal of a denial of its application for a COVID-19 Conditional
Sailing Certificate or a revocation or suspension of its COVID-19
Conditional Sailing Certificate.
During restricted voyages, the cruise ships are subject to virtual
and in-person inspections by CDC. 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, the technical instructions for each phase as they
are released through a non-substantive change request.
CDC requests OMB approval for an estimated 24,146 annual burden
hours to respondents and record keepers.
Estimated Annualized Burden Hours
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Number Average burden
Type of respondent Form name Number of responses per per response
respondents respondent (in hrs.)
----------------------------------------------------------------------------------------------------------------
Cruise ship holding company........ COVID-19 Response Plan..... 3 1 2400/60
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).
[[Page 60047]]
Cruise ship physician.............. Cruise COVID-19 Contact 24 1 30/60
Investigation Worksheet
(if necessary).
Cruise ship brand/operator......... Approval of Onboard COVID- 60 1 60/60
19 Testing Instrument.
Cruise ship brand/operator......... Mass Crew Testing 60 1 5/60
Requirement.
Cruise ship brand/operator......... Agreement with Health Care 60 1 600/60
Organization with signoff
from Local Health
Authorities.
Cruise ship brand/operator......... Agreement with Port of 60 1 600/60
Entry with signoff from
Local Health Authority.
Cruise ship brand/operator......... Agreement with Housing 60 1 600/60
Facility with signoff from
Local Health Authority.
Cruise ship operator............... Request for Approval to 30 1 600/60
Conduct a Simulated Voyage
Prior to Issuance of COVID-
19 Conditional Sailing
Certificate.
Passenger (3rd party disclosure)... Informed Consent and 18,000 1 15/60
Medical Certification with
no pre-existing conditions
for Simulated Voyage.
Cruise ship operator............... Remote and In-person 30 1 120/60
Inspections.
Cruise ship operator............... After Action Report, 30 1 600/60
Simulated Voyage.
Cruise ship operator............... COVID-19 Conditional 60 1 600/60
Sailing Certificate
Application.
Cruise ship operator............... Remote and In-person 130 2 120/60
Inspections.
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2021-23555 Filed 10-28-21; 8:45 am]
BILLING CODE 4163-18-P
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