FRN Request for Information

Federal Register / Vol. 85, No. 140 / Tuesday, July 21, 2020 / Notices
By direction of the Commission,
Commissioner Slaughter not participating.
April J. Tabor,
Secretary.
[FR Doc. 2020–15724 Filed 7–20–20; 8:45 am]
BILLING CODE 6750–01–P

Agenda items for this meeting are
subject to change as priorities dictate.
Dated: July 15, 2020.
Virginia L. Mackay-Smith,
Associate Director.
[FR Doc. 2020–15684 Filed 7–20–20; 8:45 am]
BILLING CODE 4160–90–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Notice of Meeting
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:

The Agency for Healthcare
Research and Quality (AHRQ)
announces a Special Emphasis Panel
(SEP) meeting on ‘‘AHRQ–HEOR
COVID19 Revision.’’ This SEP meeting
will be closed to the public.
DATES: August 7, 2020.
ADDRESSES: Agency for Healthcare
Research and Quality (Video Assisted
Review), 5600 Fishers Lane, Rockville,
Maryland 20850.
FOR FURTHER INFORMATION CONTACT:
Jenny Griffith, Committee Management
Officer, Office of Extramural Research,
Education and Priority Populations,
Agency for Healthcare Research and
Quality, (AHRQ), 5600 Fishers Lane,
Rockville, Maryland 20850, Telephone:
(301) 427–1557.
SUPPLEMENTARY INFORMATION: A Special
Emphasis Panel is a group of experts in
fields related to health care research
who are invited by AHRQ, and agree to
be available, to conduct on an as-needed
basis, scientific reviews of applications
for AHRQ support. Individual members
of the Panel do not attend regularlyscheduled meetings and do not serve for
fixed terms or a long period of time.
Rather, they are asked to participate in
particular review meetings which
require their type of expertise.
The SEP meeting referenced above
will be closed to the public in
accordance with the provisions set forth
in 5 U.S.C. App. 2, section 10(d), 5
U.S.C. 552b(c)(4), and 5 U.S.C.
552b(c)(6). Grant applications for the
‘‘AHRQ–HEOR COVID19 Revision’’ is to
be reviewed and discussed at this
meeting. The grant applications and the
discussions could disclose confidential
trade secrets or commercial property
such as patentable material, and
personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.

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SUMMARY:

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2020–0087]

Request for Information Related to
Cruise Ship Planning and
Infrastructure, Resumption of
Passenger Operations, and Summary
Questions
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:

The Centers for Disease
Control and Prevention (CDC), a
component of the U.S. Department of
Health and Human Services (HHS),
announces a Request for Information
related to cruise ship planning and
infrastructure, resumption of passenger
operations, and additional summary
questions. This information may be
used to inform future public health
guidance and preventative measures
relating to travel on cruise ships.
DATES: Written comments must be
received on or before September 21,
2020.
SUMMARY:

You may submit comments,
identified by Docket No. CDC–2020–
0087 by any of the following methods
listed below. CDC does not accept
comment by email.
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: Maritime Unit, Centers for
Disease Control and Prevention, 1600
Clifton Road NE, MS V18–2, Atlanta,
GA 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. All relevant comments
received will be posted without change
to https://www.regulations.gov,
including any personal information
provided. For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov.

ADDRESSES:

FOR FURTHER INFORMATION CONTACT:

Jennifer Buigut, Division of Global
Migration and Quarantine, Centers for

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Disease Control and Prevention, 1600
Clifton Road NE, MS V18–2, Atlanta,
GA 30329. Phone: 404–498–1600.
Email: dgmqpolicyoffice@cdc.gov.
SUPPLEMENTARY INFORMATION:
Background
In response to the COVID–19
pandemic and the increased risk of
spread of COVID–19 on cruise ships,
HHS/CDC published an industry-wide
No Sail Order on March 14, 2020, to,
among other things, restrict the
embarkation of cruise ships. CDC
extended its No Sail Order, effective
April 15, 2020, to require cruise lines,
as a condition of obtaining controlled
free pratique to operate in international,
interstate, or intrastate waterways
subject to the jurisdiction of the United
States,1 to develop appropriate plans to
prevent, mitigate, and respond to the
spread of COVID–19 on their cruise
ships. Elsewhere in this issue of the
Federal Register, CDC is publishing a
companion notice announcing a further
extension of the ‘‘No Sail Order and
Suspension of Further Embarkation;
Second Modification and Extension of
No Sail Order and Other Measures
Related to Operations.’’ This Request for
Information requests comments from the
public that will be used to inform future
public health guidance and preventative
measures relating to travel on cruise
ships.
Public Participation
Interested persons or organizations
are invited to participate by submitting
comments specifically on the following
questions related to planning and
infrastructure, resumption of passenger
operations, and summary questions
raised in this document:
Planning and Infrastructure
1. Given the challenges of eliminating
COVID–19 on board cruise ships while
operating with reduced crew on board
during the period of the April 15, 2020
No Sail Order Extension, what methods,
strategies, and practices should cruise
ship operators implement to prevent
COVID–19 transmission when operating
with passengers?
2. How should cruise ship operators
bolster their internal public health
programs with public health experts and
invest in a robust public health
infrastructure to ensure compliance
with measures to detect, prevent, and
control the spread of COVID–19?
3. How should cruise ship operators
ensure internal public health programs
1 https://www.federalregister.gov/documents/
2020/04/15/2020-07930/no-sail-order-andsuspension-of-further-embarkation-notice-ofmodification-and-extension-and-other.

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Federal Register / Vol. 85, No. 140 / Tuesday, July 21, 2020 / Notices

are involved in all levels of decisionmaking processes relating to passenger
and crew operations, crew welfare and
mental health, occupational health, food
safety, potable and recreational water
safety, outbreak prevention and
management response, and illness
surveillance?
4. What is the feasibility of
conducting COVID–19 diagnostic testing
using FDA-approved or authorized
laboratory tests on board a cruise ship?
a. Should specimens be tested on
board or should specimens be collected
on board for commercial testing
onshore?
b. How frequently should cruise ship
operators test all passengers and crew?
c. What would be the anticipated
financial cost of testing all passengers
and crew?
5. Because reports of illness may lead
to restrictions on crew activities, how
should cruise ship operators encourage
crew members to report mild symptoms
of COVID-like illness to medical
personnel?
a. How should cruise ship operators
encourage medical personnel to report
these cases to CDC?
6. What should be the medical
capacity to manage an outbreak or a
severe case of COVID–19 on board the
ship?
a. What arrangements should cruise
ship operators have with private
companies to transport and obtain
medical care shoreside for passengers
and crew with severe COVID–19?
7. What pre-arrangements should be
made to ensure that all U.S. seaport
communities will accept a returning
ship after a COVID–19 outbreak is
identified?
8. What plans should cruise ship
operators have for operationalizing
shoreside quarantine facilities in the
event of a COVID–19 outbreak on board
a ship, without exposing the public and
without relying on Federal, State, or
local resources?
9. Due to obstacles with commercial
travel thus far, what pre-arrangements
should cruise ship operators make with
the airline industry to accept crew and
passengers from ships not affected by
COVID–19?
10. How should cruise ship operators
address specific country travel
restrictions that emerge as COVID–19
activity increases in geographical areas,
such as
a. border closures preventing
passengers and crew from repatriating?
b. seaport closures preventing porting
of ships?
c. embarking passengers originating
from countries with heightened COVID–
19 activity?

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11. What measures should cruise ship
operators be required to take to reduce
the burden on U.S. government
resources if foreign seaports deny cruise
ships the ability to come into port
during a voyage?
12. Given difficulties cruise ship
operators have experienced when
repatriating crew via non-commercial
transportation, what preparations
should the industry make to repatriate
passengers or crew via non-commercial
transportation after COVID–19 is
identified on board?
13. What innovations should cruise
ship operators develop to reduce
transmission of COVID–19 on board
ships and how would these innovations
be effective?
14. Should cruise ship operators
implement other interventions to
decrease or prevent the spread of
COVID–19 on board ships?
15. What evidence of efficacy or other
rationale exists for any public health
interventions that cruise ship operators
propose to take on board ships?
Resumption of Passenger Operations
16. What steps should cruise ship
operators take to prevent the
introduction of COVID–19 onto ships
after resuming passenger operations?
a. Should cruise ship operators deny
boarding to passengers with COVID-like
illness or confirmed infection with
COVID–19?
b. Should cruise ship operators deny
boarding to passengers with known
exposure to a person with COVID–19
during the previous 14 days?
c. What methods should cruise ship
operators use to screen for exposures
and detect COVID-like illness in
passengers seeking to board the ship?
d. Should cruise ship operators deny
boarding to passengers coming from
COVID–19 high-incidence geographic
areas?
e. How should cruise ship operators
manage embarking crew with COVIDlike illness, known exposure, or coming
from high-incidence geographic areas
after resuming passenger operations?
f. Should cruise ship operators test
passengers and crew pre-boarding? If
yes, what should the testing protocol
be?
g. Should cruise ship operators
transport and house passengers and
crew denied boarding at the seaport to
avoid exposing the public?
17. Should cruise ship operators plan
to reduce passenger and crew loads to
decrease the risk of transmission on
board the ship?
a. To what extent and for how long
should cruise ship operators reduce
passenger capacity?

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b. To what extent might reducing
passenger capacity affect the economic
viability of cruise lines?
c. Should cruise ship operators be
required to provide scientific evidence
that reducing passenger capacity will
prevent transmission on board?
18. Should cruise ship operators
decrease the length of voyages and, if so,
by how much?
a. How would decreasing the length of
voyages affect the transmission of
COVID–19 on board the ship and in U.S.
communities?
b. Should cruise ship operators be
required to provide scientific evidence
that reducing length of voyages would
decrease the risk of further introduction
of COVID–19 to U.S. communities?
19. Should cruise ship operators limit
shore excursions?
a. What precautions should cruise
ship operators take during shore
excursions to prevent passengers and
crew from being exposed to COVID–19?
b. During shore excursions, how
should cruise ship operators prevent
transmission of COVID–19 into landbased communities?
20. Should cruise ship operators
restrict the number of persons per room
(e.g., maximum capacity of 2 adults per
cabin)?
a. Should cruise ship operators be
required to provide single-occupancy
rooms with private bathrooms for crew
after resuming passenger operations?
21. What mental health services
should cruise ship operators provide to
crew and passengers during quarantine
or isolation?
22. What precautions should the
cruise line industry take to safely
disembark passengers and crew without
transmitting COVID–19 into local
seaport communities?
23. Should the cruise line industry
immediately cancel cruise voyages if
COVID–19 cases are identified on board
or after disembarkation?
24. Because of the economic costs
associated with cruising, some cruise
ship passengers may be reluctant to
cancel travel plans if they become ill or
are exposed to COVID–19 or may try to
hide symptoms of illness. Should cruise
ship operators fully refund or provide
incentives to passengers that:
a. Are denied boarding due to COVIDlike illness symptoms, confirmed
infection, or known exposure?
b. are denied boarding due to coming
from high-incidence geographic areas?
c. request last-minute cancellations
due to COVID–19 concerns?
25. Due to the costs associated with
seeking medical care on board, and the
likelihood that sick passengers will be
isolated and their travel companions

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Federal Register / Vol. 85, No. 140 / Tuesday, July 21, 2020 / Notices
quarantined for the remainder of their
voyage, how should cruise ship
operators encourage passengers to notify
the medical center when they
experience COVID–19 symptoms?
26. How should cruise ship operators
decrease or eliminate the risk for
COVID–19 transmission for both
passengers and crew in the following
group settings?
a. Embarkation and disembarkation?
b. Safety drills and trainings?
c. Dining?
d. Onboard entertainment events?
e. Shore excursions?
Summary Questions
27. What benefits can be expected in
terms of averted deaths and illnesses
and how does this compare to the
expected financial costs of the above
measures?
28. Should cruise ship operators be
required to designate a responsible
company official who will accept legal
responsibility for failure to implement
measures to protect public health?
Please note that comments received,
including attachments and other
supporting materials, are part of the
public record and are subject to public
disclosure. Comments will be posted on
https://www.regulations.gov. Therefore,
do not include any information in your
comment or supporting materials that
you consider confidential or
inappropriate for public disclosure. If
you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be on
public display. CDC will review all
submissions and may choose to redact,
or withhold, submissions containing
private or proprietary information such
as Social Security numbers, medical
information, inappropriate language, or
duplicate/near duplicate examples of a
mass-mail campaign. CDC will carefully
consider all comments submitted to this
docket. CDC does not accept public
comment by email.

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Dated: July 16, 2020.
Sandra Cashman,
Executive Secretary, Centers for Disease
Control and Prevention.
[FR Doc. 2020–15812 Filed 7–17–20; 11:15 am]
BILLING CODE 4163–18–P

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
No Sail Order and Suspension of
Further Embarkation; Second
Modification and Extension of No Sail
Order and Other Measures Related to
Operations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:

The Centers for Disease
Control and Prevention (CDC), a
component of the U.S. Department of
Health and Human Services (HHS),
announces a second modification and
extension of the No Sail Order and
Other Measures Related to Operations
that was issued on April 15, 2020. This
Order applies to cruise ships defined as
commercial, non-cargo, passengercarrying vessels with the capacity to
carry 250 or more individuals
(passengers and crew) and with an
itinerary anticipating an overnight stay
onboard or a 24-hour stay onboard for
either passengers or crew, that are
operating in international, interstate, or
intrastate waterways, subject to the
jurisdiction of the United States. This
Order shall additionally apply to cruise
ships operating outside of U.S. waters if
the cruise ship operator intends for the
ship to return to operating in
international, interstate, or intrastate
waterways, subject to the jurisdiction of
the United States during the period that
this Order is in effect.
DATES: This action was effective July 16,
2020.
FOR FURTHER INFORMATION CONTACT:
Jennifer Buigut, Division of Global
Migration and Quarantine, Centers for
Disease Control and Prevention, 1600
Clifton Road NE, MS V18–2, Atlanta,
GA 30329. Phone: 404–498–1600.
Email: dgmqpolicyoffice@cdc.gov.
SUPPLEMENTARY INFORMATION: This
Order renews the No Sail Order and
Other Measures Related to Operations
signed by the CDC Director on March
14, 2020, as further modified and
extended effective April 15, 2020,
subject to the modifications and
additional stipulated conditions as set
forth in this Order.
This Order shall remain in effect until
the earliest of (1) the expiration of the
Secretary of Health and Human
Services’ declaration that COVID–19
constitutes a public health emergency;
(2) the CDC Director rescinds or
modifies the order based on specific
SUMMARY:

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public health or other considerations; or
(3) September 30, 2020.
A copy of the order is provided below
and a copy of the signed order can be
found at https://www.cdc.gov/
quarantine/cruise/index.html.
U.S. Department of Health and Human
Services (HHS)
Centers for Disease Control and
Prevention (CDC)
Order Under Sections 361 & 365 of the
Public Health Service Act (42 U.S.C.
264, 268) and 42 Code of Federal
Regulations Part 70 (Interstate) and
Part 71 (Foreign)
Second Modification and Extension of
No Sail Order and Other Measures
Related to Operations
Executive Summary
The coronavirus disease 2019
(COVID–19) pandemic continues to
spread rapidly around the world with
no treatment or vaccine, with over 12.5
million confirmed cases and over
560,000 confirmed deaths worldwide as
of July 12, 2020. On July 12, 2020,
230,000 new COVID–19 cases were
reported, the largest single-day tally
worldwide since the epidemic began. It
took 3 months to reach the first million
cases of COVID–19, but during one
week in June 2020, 1 million new cases
were reported worldwide.
Since HHS/CDC’s original No Sail
Order, signed on March 14, 2020, which
restricted the embarkation of
passengers, CDC has worked to control
COVID–19 on cruise ships that
remained at sea, while protecting
against further introduction and spread
of COVID–19 into U.S. communities. As
of July 10, 2020, CDC has expended an
estimated 38,000 person-hours on the
cruise ship COVID–19 response since
March 14, 2020—in addition to the
thousands of hours invested by other
HHS components, other U.S.
government agencies, and state and
local authorities. CDC continues to have
regular conversations by phone and
email with cruise lines, often daily.
Cumulative CDC data from the period
of March 1 to July 10, 2020 reveal a total
of 2,973 COVID–19 or COVID-like
illness cases on cruise ships, in addition
to 34 deaths. These data have also
revealed a total of 99 outbreaks on 123
different cruise ships, meaning that 80%
of ships within U.S. jurisdiction were
affected by COVID–19 during this time
frame. In addition, 9 ships still have
ongoing or resolving COVID–19
outbreaks on board.
The challenges described in this
document highlight the need for further
action prior to cruise ships’ resuming

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