[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]


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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 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
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                                                                                      Number        Avg. burden
          Type of respondent               Form or information       Number of     responses per   per response
                                             collection name        respondents     respondent        (hours)
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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