60d FRN - published 4/30/2021

60d FRN published.pdf

[NCEZID] Phased Approach to the Resumption of Cruise Ship Passenger Operations

60d FRN - published 4/30/2021

OMB: 0920-1335

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Federal Register / Vol. 86, No. 82 / Friday, April 30, 2021 / Notices

in detail the information that the EPA
will be collecting, are available in the
public docket for this ICR. The docket
can be viewed online at
www.regulations.gov or in person at the
EPA Docket Center, WJC West, Room
3334, 1301 Constitution Ave. NW,
Washington, DC. The telephone number
for the Docket Center is 202–566–1744.
For additional information about EPA’s
public docket, visit http://www.epa.gov/
dockets.
Abstract: The information is collected
from applicants and recipients of EPA
assistance to monitor adherence to the
programmatic and administrative
requirements of the Agency’s financial
assistance program, which includes the
Agency’s DBE program. The information
collected is used to make awards, pay
recipients, and collect information on
how Federal funds are being spent. EPA
needs this information to meet its
Federal stewardship responsibilities.
This ICR renewal requests authorization
for the collection of information under
EPA’s General Regulation for Assistance
Programs, which establishes minimum
management requirements for all
recipients of EPA grants or cooperative
agreements (assistance agreements).
This ICR combines all of these
requirements under OMB Control
Number 2030–0020. The information
required by these regulations will be
used by EPA award officials to make
assistance awards and assistance
payments and to verify that the
recipient is using Federal funds
appropriately.
Form Numbers:
EPA Form 190–F–04–001, ‘‘EPA
Payment Request’’
EPA Form 190–F–05–001, ‘‘Fellowship
Stipend Payment Enrollment Form’’
EPA Form 4700–4, ‘‘Preaward
Compliance Review Report for All
Applicants and Recipients Requesting
Federal Financial Assistance’’
EPA Form 5700–52A, ‘‘MBE/WBE
Utilization Under Federal Grants and
Cooperative Agreements’’
EPA Form 5700–53, ‘‘Lobbying and
Litigation Certification for Grants and
Cooperative Agreements’’
EPA Form 5700–54, ‘‘Key Contacts
Form,’’ and EPA Form 5700–54–2,
‘‘Key Contacts Form for Multiple
Principal Investigators’’
EPA Form 5770–2, ‘‘Fellowship
Application’’
EPA Form 5770–3, ‘‘Fellowship
Facilities and Commitment
Statement’’
EPA Form 5770–5, ‘‘Agency Fellowship
Certification’’
EPA Form 5770–7, ‘‘EPA Fellowship
Activation Notice’’

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EPA Form 5770–8, ‘‘Fellowship
Agreement’’
EPA Form 5770–9, ‘‘Completion of
Studies Notice’’
EPA Form 6600–01, ‘‘EPA
Administrative and Financial Onsite
Review Questionnaire’’
EPA Form 6600–06, ‘‘Certification
Regarding Lobbying’’
EPA Form 6600–08A, ‘‘Certificate of
Indirect Costs for State & Local
Governments’’
EPA Form 6600–08B, ‘‘Lobbying
Indirect Cost Certificate for Non-Profit
Organizations’’ and ‘‘Certificate of
Indirect Costs for Indirect (F&A) Cost
Rate for Non-Profit Organizations’’
EPA Form 6600–09, ‘‘EPA
Administrative Capability
Questionnaire’’
NCER Form 5, ‘‘EPA Office of Research
and Development Current and
Pending Support’’
Respondents/affected entities: The
primary recipients of EPA assistance
agreements are State and local
governments, Indian Tribes, educational
institutions, and not-for-profit
institutions.
Respondent’s obligation to respond:
Required to obtain an assistance
agreement (40 CFR part 30, 40 CFR part
31, and 40 CFR part 33 for awards made
prior to December 26, 2014, and 2 CFR
200, 2 CFR 1500, and 40 CFR part 33 for
awards made after December 26, 2014).
Estimated number of respondents:
3,048 (total).
Frequency of response: On occasion,
quarterly, and annually.
Total estimated burden: 94,606 hours
(per year). Burden is defined at 5 CFR
1320.03(b).
Total estimated cost: $6,054,791 (per
year), includes $0 annualized capital or
operation & maintenance costs.
Changes in the Estimates: There is an
increase of 4,482 hours in the total
estimated respondent burden compared
with the ICR currently approved by
OMB. The increase is partially due to
the incorporation of burden into this
ICR associated with the relocation of the
DBE Program from OSDBU to OGD. EPA
also made adjustments to the estimated
number of respondents for each of the
requirements included in the ICR and to
the burden hour estimates for three of
the requirements.
Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2021–09016 Filed 4–29–21; 8:45 am]
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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
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

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)
SUMMARY:

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Federal Register / Vol. 86, No. 82 / Friday, April 30, 2021 / Notices
(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).

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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

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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

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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.

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Federal Register / Vol. 86, No. 82 / Friday, April 30, 2021 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent

Form name

Cruise ship operator .........................
Cruise ship operator .........................

Cruise ship operator .........................

No Sail Order Response Plan .........
Request for Embarkation of Essential Crew and Contractors submitted to USCG.
CDC an Attestation for Non-Commercial Travel of Disembarking
Crew for Cruise Ship Operators
During the No Sail Order.
Virtual Implementation Checks ........
Enhanced Data Collection (EDC)
During
COVID–19
Pandemic
Form (Daily).
CLIA Certified Laboratory Information—Onshore.
Approval of Onboard COVID–19
Testing Instrument.
Request for Embarkation of Essential Crew and Contractors.
Attestation for Commercial Transportation of Disembarking Crew
for Cruise Ship Operators During
the Initial Phases of CDC’s
Framework for Conditional Sailing
Order (CSO).
Agreement with Health Care Organization with signoff from Local
Health Authorities.
Agreement with Port of Entry with
signoff from Local Health Authority.
Agreement with Housing Facility
with signoff from Local Health Authority.
Request for Embarkation of Non-Essential Crew and contractors.
Request for Approval to Conduct a
Simulated
Voyage
Prior
to
Issuance of COVID–19 Conditional Sailing Certificate.
Informed Consent and Medical Certification with no pre-existing conditions for Simulated Voyage.
Remote and In-person Inspections ..
After Action Report, Simulated Voyage.
COVID–19 Conditional Sailing Certificate Application.
Remote and In-person Inspections ..

Total ...........................................

...........................................................

Cruise ship operator .........................

Cruise ship operator .........................
Cruise ship operator .........................
Cruise ship operator .........................
Cruise ship operator .........................
Cruise ship operator .........................
Cruise ship operator .........................

Cruise ship operator .........................
Cruise ship operator .........................
Cruise ship operator .........................
Cruise ship operator .........................
Cruise ship operator .........................

Passenger (3rd party disclosure) ......
Cruise shop operator ........................
Cruise shop operator ........................

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Cruise ship operator .........................

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Number of
responses per
respondent

Number of
respondents

Fmt 4703

Average
burden
per
response
(in hrs.)

Total burden
(in hrs.)

5
5

1
1

2,400/60
10/60

200
1

5

5

15/60

7

5
130

2
365

75/60
15/60

13
11,863

20

25

5/60

42

20

25

5/60

42

130

5

10/60

109

130

5

15/60

163

130

1

600/60

1,300

130

1

600/60

1,300

130

1

600/60

1,300

130

1

10/60

10

130

1

600/60

1,300

39,000

1

75/60

48,750

130
130

1
1

120/60
600/60

260
1,300

130

1

600/60

1,300

130

1

120/60

260

........................

........................

........................

69,530

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Federal Register / Vol. 86, No. 82 / Friday, April 30, 2021 / Notices
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]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–21–0891; Docket No. CDC–2021–
0045]

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

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 World Trade Center Health
Program Enrollment, Petitions,
Designated Representative/HIPAA
Authorization, and Member
Satisfaction. Data collection is designed
to provide healthcare monitoring and
treatment to responders of the 9/11/
2001 terrorist attacks at the World Trade
Center in New York City, the Pentagon
in Washington, DC, and Shanksville,
Pennsylvania, as well as survivors in the
New York City area.
DATES: CDC must receive written
comments on or before June 29, 2021.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2021–
0045 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

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SUMMARY:

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(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)
(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
World Trade Center Health Program
Enrollment, Petitions, Designated
Representative/HIPAA Authorization,
and Member Satisfaction. (OMB Control
No. 0920–0891, Exp. 12/31/2021)—
Revision—National Institute for
Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention (CDC).

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Background and Brief Description
NIOSH seeks to request OMB
approval to revise the currently
approved information collection
activities that support the World Trade
Center (WTC) Health Program. The
James Zadroga 9/11 Health and
Compensation Act of 2010 (Pub. L. 111–
347, as amended by Pub. L. 114–113)
created the WTC Health Program to
provide medical monitoring and
treatment benefits to eligible firefighters
and related personnel, law enforcement
officers, and rescue, recovery, and
cleanup workers who responded to the
September 11, 2001, terrorist attacks in
New York City, at the Pentagon, and in
Shanksville, Pennsylvania (responders),
and to eligible persons who were
present in the dust or dust cloud on
September 11, 2001, or who worked,
resided, or attended school, childcare,
or adult daycare in the New York City
disaster area (survivors).
Since its inception in 2011, the WTC
Health Program has been approved to
collect information from applicants and
program members (enrolled WTC
responders and survivors) concerning
enrollment, appointment of a designated
representative or third party, and
petitions regarding adding a new WTCrelated health condition in order to
determine coverage under the Program.
The current approved total estimated
burden is 14,063 hours annually (OMB
Control No. 0920–0891, Exp. December
31, 2021).
The WTC Health Program has
determined that some existing forms
need to be updated (WTC Health
Program Applications for Enrollment
and Designated Representative
Appointment/Designated Representative
HIPAA Authorization Forms). For this
revision, the burden hours on the WTC
Health Program Applications for
Enrollment increased due to an
expected increase of application
volume. The Program updated the
enrollment applications for plain
language and improved processing. We
estimate 15,837 individuals will submit
either a FDNY (+95 from previous
package), General Responder (+3,740
from previous package), Pentagon/
Shanksville Responder (¥388 from
previous package), or WTC Survivor
(+7,881 from previous package)
application annually. The applications
will take approximately 0.5 hours to
complete. The burden estimate for the
applications is 7,919 hours. This is an
increase from 2018 when the estimated
annualized burden was 2,251.
Of the Applications for Enrollment we
expect to receive each year, CDC
estimates 3,830 (+1,355 from 2018) are

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