[Federal Register Volume 86, Number 82 (Friday, April 30, 2021)]
[Notices]
[Pages 22964-22967]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09094]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-21-21DA; Docket No. CDC-2021-0011]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing effort to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled Phased Approach to the Resumption 
of Passenger Operations. The proposed collection outlines a number of 
information collection activities required as part of the process to 
returning to passenger operations.

DATES: CDC must receive written comments on or before June 29, 2021.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2021-
0011 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to Regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (regulations.gov) or by U.S. mail to the address listed above.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact Jeffrey M. Zirger, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7118; Email: 
[email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA)

[[Page 22965]]

(44 U.S.C. 3501-3520), Federal agencies must obtain approval from the 
Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to the OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    The OMB is particularly interested in comments that will help:
    1. Evaluate whether the proposed collection of information is 
necessary for the proper performance of the functions of the agency, 
including whether the information will have practical utility;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected;
    4. Minimize the burden of the collection of information on those 
who are to respond, including through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology, e.g., permitting electronic 
submissions of responses; and
    5. Assess information collection costs.

Proposed Project

    Phased Approach to the Resumption of Passenger Operations--Existing 
Collection in use without an OMB Control Number--National Center for 
Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease 
Control and Prevention (CDC).

Background and Brief Description

    The Framework for Conditional Sailing Order published in the 
Federal Register on November 4, 2020 prohibits 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.
    Per CDC's Framework for Conditional Sailing Order, cruise ship 
operators with ships that have not been in U.S. waters during the 
period of the No Sail Order (NSO) or voluntarily withdrew their ships, 
must have a NSO response plan deemed complete and accurate, including 
having submitted to CDC a signed Acknowledgment of No Sail Order 
Response Plan Completeness and Accuracy. In addition, cruise ship 
operators must continue to follow their cruise lines' complete, 
accurate, and acknowledged NSO response plans per the No Sail Order and 
Suspension of Further Embarkation; Notice of Modification and Extension 
and Other Measures Related to Operations published at 85 FR 21004 
(April 15, 2020) (i.e., ``No Sail Order response plan''), as modified 
and extended July 16, 2020 (published at 85 FR 44085 (July 21, 2020)), 
and September 30, 2020 (published at 85 FR 62732 (October 5, 2020)).
    The Framework for Conditional Sailing Order introduced a phased-in 
approach to the resumption of cruise ship passenger operations. This 
Framework Order details the requirements of the initial phase, which 
focuses on mass testing of crew and building the laboratory capacity 
needed to test both crew and future passengers.
    The Second Phase of the Framework Order focuses on preparation for 
simulated voyages. As required under the CSO, 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 to determine the number of cruise 
ships operating out of any single port in order to not overburden the 
public health response resources of any single jurisdiction in the 
event of a COVID-19 outbreak; (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 close contacts, identified 
from the day of embarkation through disembarkation for each voyage. 
This Phase also includes a shift in reporting requirements using the 
CDC (EDC) form previously approved in OMB Control Number 0920-0134 
Foreign Quarantine Regulations. Starting in this phase, the form will 
be required from cruise ships on a daily, rather than weekly, rhythm.
    Phase 2B of the Framework Order focuses on simulated voyages with 
volunteers playing the role of passengers to test cruise ship 
operators' ability to mitigate COVID-19 risk. A cruise ship operator 
must submit a Request for Approval to Conduct a Simulated Voyage Prior 
to Issuance of COVID-19 Conditional Sailing Certificate to conduct a 
simulated voyage at least 30 calendar days prior to the voyage. CDC 
will issue 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 an 
``after-action'' report and address how the cruise ship operator 
intends to address those deficiencies prior to applying for a COVID-19 
Conditional Sailing Certificate. This after-action report must also 
include test results for any volunteer passengers or crew on the 
simulated voyage.
    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 or series of simulated voyages 
demonstrating the cruise ship operator's ability to mitigate the risks 
of COVID-19 onboard its cruise ship. The CDC COVID-19 Conditional 
Sailing Certificate Application form includes certain minimum 
requirements that must be met prior to a restricted voyage and burden 
for these requirements is outlined in section 12 below. These documents 
must be submitted 60 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.
    Compliance with the Framework for Conditional Sailing Order, beyond 
the information collections outline above, are primarily associated 
with the testing required, both onshore and onboard. This estimate 
includes the cost of onboard testing and lab equipment and maintenance 
on the ship.

[[Page 22966]]



                                        Estimated Annualized Burden Hours
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                                                                                      Average
                                                     Number of       Number of      burden  per    Total burden
      Type of respondent            Form name       respondents    responses per   response (in      (in hrs.)
                                                                    respondent         hrs.)
----------------------------------------------------------------------------------------------------------------
Cruise ship operator..........  No Sail Order                  5               1        2,400/60             200
                                 Response Plan.
Cruise ship operator..........  Request for                    5               1           10/60               1
                                 Embarkation of
                                 Essential Crew
                                 and Contractors
                                 submitted to
                                 USCG.
Cruise ship operator..........  CDC an                         5               5           15/60               7
                                 Attestation for
                                 Non-Commercial
                                 Travel of
                                 Disembarking
                                 Crew for Cruise
                                 Ship Operators
                                 During the No
                                 Sail Order.
Cruise ship operator..........  Virtual                        5               2           75/60              13
                                 Implementation
                                 Checks.
Cruise ship operator..........  Enhanced Data                130             365           15/60          11,863
                                 Collection
                                 (EDC) During
                                 COVID-19
                                 Pandemic Form
                                 (Daily).
Cruise ship operator..........  CLIA Certified                20              25            5/60              42
                                 Laboratory
                                 Information--On
                                 shore.
Cruise ship operator..........  Approval of                   20              25            5/60              42
                                 Onboard COVID-
                                 19 Testing
                                 Instrument.
Cruise ship operator..........  Request for                  130               5           10/60             109
                                 Embarkation of
                                 Essential Crew
                                 and Contractors.
Cruise ship operator..........  Attestation for              130               5           15/60             163
                                 Commercial
                                 Transportation
                                 of Disembarking
                                 Crew for Cruise
                                 Ship Operators
                                 During the
                                 Initial Phases
                                 of CDC's
                                 Framework for
                                 Conditional
                                 Sailing Order
                                 (CSO).
Cruise ship operator..........  Agreement with               130               1          600/60           1,300
                                 Health Care
                                 Organization
                                 with signoff
                                 from Local
                                 Health
                                 Authorities.
Cruise ship operator..........  Agreement with               130               1          600/60           1,300
                                 Port of Entry
                                 with signoff
                                 from Local
                                 Health
                                 Authority.
Cruise ship operator..........  Agreement with               130               1          600/60           1,300
                                 Housing
                                 Facility with
                                 signoff from
                                 Local Health
                                 Authority.
Cruise ship operator..........  Request for                  130               1           10/60              10
                                 Embarkation of
                                 Non-Essential
                                 Crew and
                                 contractors.
Cruise ship operator..........  Request for                  130               1          600/60           1,300
                                 Approval to
                                 Conduct a
                                 Simulated
                                 Voyage Prior to
                                 Issuance of
                                 COVID-19
                                 Conditional
                                 Sailing
                                 Certificate.
Passenger (3rd party            Informed Consent          39,000               1           75/60          48,750
 disclosure).                    and Medical
                                 Certification
                                 with no pre-
                                 existing
                                 conditions for
                                 Simulated
                                 Voyage.
Cruise shop operator..........  Remote and In-               130               1          120/60             260
                                 person
                                 Inspections.
Cruise shop operator..........  After Action                 130               1          600/60           1,300
                                 Report,
                                 Simulated
                                 Voyage.
Cruise ship operator..........  COVID-19                     130               1          600/60           1,300
                                 Conditional
                                 Sailing
                                 Certificate
                                 Application.
Cruise ship operator..........  Remote and In-               130               1          120/60             260
                                 person
                                 Inspections.
                               ---------------------------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............          69,530
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[[Page 22967]]

Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2021-09094 Filed 4-29-21; 8:45 am]
BILLING CODE 4163-18-P