Agency Forms Undergoing Paperwork Reduction Act Review, 2792-2794 [2022-00856]
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2792
Federal Register / Vol. 87, No. 12 / Wednesday, January 19, 2022 / Notices
an electronic version of the draft policy
statement, go to https://
www.regulations.gov. Please be aware
that comments and other submissions
from members of the public are made
available for public viewing without
changes.
FOR FURTHER INFORMATION CONTACT:
Samuel S. Edwin Ph.D., Director,
Division of Select Agents and Toxins,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE,
Mailstop H21–7, Atlanta, Georgia 30329.
Telephone: (404) 718–2000.
SUPPLEMENTARY INFORMATION:
A. Legal Authority
HHS/CDC is issuing this draft policy
under the authority of sections 201–204
and 221 of Title II of Public Law 107–
188, (42 U.S.C. 262a).
jspears on DSK121TN23PROD with NOTICES1
B. Background
For entities that possess select agents
and toxins, the HHS select agent and
toxin regulations (42 CFR part 73)
require that ‘‘biosafety and containment
procedures must be sufficient to contain
the select agent or toxin (e.g., physical
structure and features of the entity, and
operational and procedural safeguards)’’
(42 CFR 73.12(b)). BSL–4 and ABSL–4
laboratory facility specifications and
operational procedures are used for
work with dangerous and exotic
biological agents that could easily be
aerosol transmitted within the
laboratory, cause severe to fatal disease
in humans, and typically do not have
available vaccines or treatments.
Therefore, these laboratories must
implement and maintain the highest
level of biosafety precautions for
containment.
HHS/CDC reviews how entities that
maintain BSL–4 and/or ABSL–4
laboratories have verified that the
design and operational parameters,
including HVAC, are functioning
properly when determining if entities
have met the sufficiency requirement in
section 12(b) of the HHS select agent
and toxin regulations. In developing a
biosafety plan, an individual or entity
should consider requirements found in
the Biosafety in Microbiological and
Biomedical Laboratories (BMBL) (42
CFR 73.12(c)). HHS/CDC has developed
a draft policy statement for BSL–4 and
ABSL–4 laboratory verification based on
the standards found in the 6th edition
of the BMBL:
• BSL–4 D16(a): The ventilation
system is designed to maintain the
laboratory at negative pressure to
surrounding areas and to provide
differential pressure or directional
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airflow as appropriate between adjacent
areas within the laboratory.
• ABSL–4 D16(a): The supply and
exhaust components of the ventilation
system are designed to maintain the
ABSL–4 facility at negative pressure to
surrounding areas and to provide
differential pressure or directional
airflow as appropriate between adjacent
areas within the facility.
• BSL–4 D20: The facility design
parameters and operational procedures
are documented. The facility is tested to
verify that the design and operational
parameters have been met prior to
operation. Facilities are also re-tested
annually or after significant
modification to ensure operational
parameters are maintained. Verification
criteria are modified, as necessary, by
operational experience.
• ABSL–4 D21: The ABSL–4 facility
design parameters and operational
procedures are documented. The facility
is tested to verify that the design and
operational parameters have been met
prior to operation. Facilities are also retested annually or after significant
modification to ensure operational
parameters are maintained. Verification
criteria are modified, as necessary, by
operational experience.
HHS/CDC is requesting public
comment on a draft policy statement on
BSL–4/ABSL–4 laboratory verifications
standards, including HVAC, to aid
individuals and entities in verifying that
these laboratories are properly
functioning. We are making this policy
document available to the public in the
Supplementary Materials tab of the
docket at www.regulations.gov for
review and comment. All comments,
such as items related to the appropriate
acceptance criteria used to ensure
systems are functioning as intended and
documentation to demonstrate the
sufficiency requirement has been met,
that we receive on or before March 21,
2022 will be carefully reviewed and
considered.
Dated: January 13, 2022.
Angela K. Oliver,
Executive Secretary, Centers for Disease
Control and Prevention.
[FR Doc. 2022–00928 Filed 1–18–22; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–22–1255]
Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled ‘‘Emergency
Cruise Ship Outbreak Investigations
(CSOIs)’’ 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 10/13/
2021 to obtain comments from the
public and affected agencies. CDC did
not receive 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
E:\FR\FM\19JAN1.SGM
19JAN1
Federal Register / Vol. 87, No. 12 / Wednesday, January 19, 2022 / Notices
Management and Budget, 725 17th
Street NW, Washington, DC 20503 or by
fax to (202) 395–5806. Provide written
comments within 30 days of notice
publication.
jspears on DSK121TN23PROD with NOTICES1
Proposed Project
Emergency Cruise Ship Outbreak
Investigations (CSOIs) (OMB Control
No. 0920–1255, Exp. 03/30/2022)—
Revision—National Center for
Environmental Health (NCEH), Centers
for Disease Control and Prevention
(CDC).
Background and Brief Description
Established in 1975 as a cooperative
activity with the cruise ship industry,
the Centers for Disease Control and
Prevention (CDC) Vessel Sanitation
Program (VSP) develops and
implements comprehensive sanitation
programs to minimize the risk of
gastrointestinal diseases, by
coordinating and conducting
operational inspections, ongoing
surveillance of gastrointestinal illness,
and outbreak investigations on vessels.
Under the authority of the Public
Health Service Act (42 U.S.C. Sections
264 and 269), the VSP is requesting a
three-year Paperwork Reduction Act
(PRA) clearance for a revision of an
existing generic clearance information
collection request (Generic ICR), titled
‘‘Emergency Cruise Ship Outbreak
Investigations (CSOIs)’’ (OMB Control
Number 0020–1255, expiration date 03/
30/2022). This Generic ICR provides the
quick turn-around necessary to conduct
emergency CSOIs in response to acute
gastroenteritis (AGE) outbreaks. CSOIs
are used to determine the causative
agents and their sources, modes of
transmission, or risk factors. The VSP’s
jurisdiction includes passenger vessels
carrying 13 or more people sailing from
foreign ports and within 15 days of
arriving at a U.S. port.
VSP uses its syndromic surveillance
system called the ‘‘Maritime Illness and
Death Reporting System (MIDRS)’’
(OMB Control No. 0920–1260,
expiration date 04/30/2022) to collect
aggregate data about the number of
people onboard ships in VSP’s
jurisdiction who are experiencing AGE
symptoms. When the levels of illness
meet VSP’s alert threshold (i.e., at least
2% in either the passenger or crew
populations), a special report is made to
VSP via MIDRS, and remote
environmental health and
epidemiologic assistance is provided.
VSP considers an outbreak to be
greater than or equal to 3% of reportable
AGE cases in either guest or crew
VerDate Sep<11>2014
16:58 Jan 18, 2022
Jkt 256001
populations. When outbreaks occur,
cruise ships submit daily reports of
cases in the form of AGE logs to VSP.
When assistance is needed due to AGE
outbreaks on cruise ships, this often
requires VSP to deploy a response team
to meet the ship in port within 24 hours
of reaching the outbreak threshold, and
in some cases deploying the response
team to board the ship before its U.S.
arrival and sail back to the U.S. port of
disembarkation to conduct a more
detailed and comprehensive
epidemiologic and environmental
health evaluation of the outbreak.
Causative agent, sources of exposure,
modes of transmission, and risk factors
can be ascertained by gathering the
following types of information from
both the affected and (seemingly)
unaffected populations:
• Demographic information,
• Pre-embarkation travel information,
• Symptoms, including type, onset,
duration,
• Contact with people who were sick
or their body fluids,
• Participation in ship and shore
activities,
• Locations of eating and drinking,
and
• Foods and beverages consumed
both on the ship and on shore.
Rapid and flexible data collection is
imperative given the mobile
environment, the remaining duration of
the voyage left for investigation, and the
loss to follow-up if delays allow
passengers to disembark and leave the
ship, including those returning to
locations outside of the U.S.
This Generic ICR will cover
investigations that meet all of the
following criteria:
• The investigation is urgent in
nature (i.e., timely data are needed to
inform rapid public health action to
prevent or reduce morbidity or
mortality).
• The investigation is characterized
by undetermined agents, undetermined
sources, undetermined modes of
transmission, or undetermined risk
factors.
• One or more CDC staff (including
trainees and fellows) will be deployed
to the field.
• Most CSOIs involve 2 to 5 days of
data collection; data collection is
completed in 30 days or less.
This Generic ICR excludes each of the
following:
• Investigations related to non-urgent
outbreaks or events.
• Investigations conducted for the
primary purpose of program evaluation,
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2793
needs assessment, or research (e.g., to
contribute to generalizable knowledge).
• Investigations with data collection
expected for greater than 30 days.
The cruise ship industry experience
in 2020 and 2021 was largely not
considered in this revision due to the
disruption caused by the COVID–19
pandemic. Since the first quarter of
2020, the COVID–19 pandemic
disrupted the number of cruise ship
voyages operating to U.S. ports of call.
Between March 2020 and October 2021,
cruise industry operations were
suspended under a federally issued No
Sail Order, and then subsequently under
a Conditional Sailing Order to prevent
the risk of introducing, transmitting,
and spreading COVID–19 by cruise ship
travelers. The VSP conducted the
following number of remote
environmental health and
epidemiologic consultations for
outbreaks, greater than or equal to 3%
of reportable AGE cases, by reviewing
existing MIDRS records: 10 in 2019,
none in 2020, and one in 2021. No new
information was collected. Additionally,
the VSP conducted no CSOIs in the past
three years.
Under the most recent MIDRS
revision, cruise ships report an
estimated 3,370 AGE cases (575 crew
and 2,795 passenger) per voyage;
therefore, VSP uses this same increase
of 870 over the previously approved
2,500 AGE cases per voyage for each
CSOI. Previously, respondents were
counted as either taking the selfadministered questionnaire or the
interview. Currently, all AGE cases are
requested to complete a selfadministered questionnaire. Then a
15% subset of these AGE cases may be
interviewed for additional information
about their illness. Furthermore, a 40%
subset of AGE cases may be asked for
biospecimens for laboratory
confirmation of the causative agent. The
VSP uses existing laboratory
biospecimen collection forms approved
under other CDC ICRs (OMB Control
No. 0920–0004, exp. date 10/31/2020;
OMB Control No. 0920–1309, exp. date
11/30/2023).
As previously approved, up to 10
CSOIs may be conducted annually in
response to cruise ship AGE outbreaks.
This results in a revised total of 52,234
responses for 10 CSOIs per year; this is
an increase of 27,232 responses over the
previously approved 25,000. The total
annualized time burden has increased to
13,060 hours. There is no cost to
respondents other than their time.
E:\FR\FM\19JAN1.SGM
19JAN1
2794
Federal Register / Vol. 87, No. 12 / Wednesday, January 19, 2022 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Cruise ship crew .............................................
Self-administered Questionnaire ....................
Interview .........................................................
Biospecimen Collection ..................................
Self-administered Questionnaire ....................
Interview .........................................................
Biospecimen Collection ..................................
Cruise ship passengers ..................................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2022–00856 Filed 1–18–22; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–22–0607]
Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled ‘‘The National
Violent Death Reporting System
(NVDRS)’’ 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 August 6,
2021, to obtain comments from the
public and affected agencies. CDC
received one non-substantive comment
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:
jspears on DSK121TN23PROD with NOTICES1
Number of
respondents
Type of respondent
(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,
VerDate Sep<11>2014
16:58 Jan 18, 2022
Jkt 256001
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
Street NW, Washington, DC 20503 or by
fax to (202) 395–5806. Provide written
comments within 30 days of notice
publication.
Proposed Project
The National Violent Death Reporting
System (NVDRS) (OMB Control No.
0920–0607, Exp. 7/31/2023)—
Revision—National Center for Injury
Prevention and Control (NCIPC),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Violence is a public health problem.
The World Health Organization has
estimated that 804,000 suicides and
475,000 homicides occurred in the year
2012 worldwide. Violence in the United
States is a particular problem for the
young; suicide and homicide were
among the top four leading causes of
death for Americans 10–34 and 1–34
years of age in 2015, respectively. In
2002 Congress approved the first
appropriation to start the National
Violent Death Reporting System
(NVDRS). NVDRS is coordinated and
funded at the federal level but is
dependent on separate data collection
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Frm 00049
Fmt 4703
Sfmt 4703
5,750
862
2,300
27,950
4,192
11,180
Number of
responses per
respondent
1
1
1
1
1
1
Average
burden per
response
(in hours)
15/60
15/60
15/60
15/60
15/60
15/60
efforts managed by the state health
department (or their bona fide agent) in
each state.
NVDRS, implemented by the Centers
for Disease Control and Prevention
(CDC), is a state-based surveillance
system developed to monitor the
occurrence of violent deaths (i.e.,
homicide, suicide, undetermined
deaths, and unintentional firearm
deaths) in the United States (U.S.) by
collecting comprehensive, detailed,
useful, and timely data from multiple
sources (e.g., death certificates, coroner/
medical examiner reports, law
enforcement reports) into a useable,
anonymous database. NVDRS is an
ongoing surveillance system that
captures annual violent death counts
and circumstances that precipitate each
violent incident. Violent deaths are
defined as any death resulting from the
intentional use of physical force or
power (e.g., threats or intimidation)
against oneself, another person, or
against a group or community. CDC
aggregates de-identified data from each
state into one large national database
that is analyzed and released in annual
reports and publications. Descriptive
analyses such as frequencies and rates
are employed. A restricted access
database is available for researchers to
request access to NVDRS data for
analysis and a web-based query system
is open for public use that allows for
electronic querying of data. NVDRS
generates public health surveillance
information at the national, state, and
local levels that is more detailed, useful,
and timely. Government, state and local
communities have used NVDRS data to
develop and evaluate prevention
programs and strategies. NVDRS is also
used to understand magnitude, trends,
and characteristics of violent death and
what factors protect people or put them
at risk for experiencing violence.
CDC has received OMB approval for
NVDRS since 2004. In this revision
request CDC describes plans to (1)
implement updates to the web-based
system to improve performance,
functionality, and accessibility, (2) add
E:\FR\FM\19JAN1.SGM
19JAN1
]]>Agencies
[Federal Register Volume 87, Number 12 (Wednesday, January 19, 2022)]
[Notices]
[Pages 2792-2794]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-00856]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-22-1255]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request titled ``Emergency Cruise Ship Outbreak
Investigations (CSOIs)'' 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
10/13/2021 to obtain comments from the public and affected agencies.
CDC did not receive 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
[[Page 2793]]
Management and Budget, 725 17th Street NW, Washington, DC 20503 or by
fax to (202) 395-5806. Provide written comments within 30 days of
notice publication.
Proposed Project
Emergency Cruise Ship Outbreak Investigations (CSOIs) (OMB Control
No. 0920-1255, Exp. 03/30/2022)--Revision--National Center for
Environmental Health (NCEH), Centers for Disease Control and Prevention
(CDC).
Background and Brief Description
Established in 1975 as a cooperative activity with the cruise ship
industry, the Centers for Disease Control and Prevention (CDC) Vessel
Sanitation Program (VSP) develops and implements comprehensive
sanitation programs to minimize the risk of gastrointestinal diseases,
by coordinating and conducting operational inspections, ongoing
surveillance of gastrointestinal illness, and outbreak investigations
on vessels.
Under the authority of the Public Health Service Act (42 U.S.C.
Sections 264 and 269), the VSP is requesting a three-year Paperwork
Reduction Act (PRA) clearance for a revision of an existing generic
clearance information collection request (Generic ICR), titled
``Emergency Cruise Ship Outbreak Investigations (CSOIs)'' (OMB Control
Number 0020-1255, expiration date 03/30/2022). This Generic ICR
provides the quick turn-around necessary to conduct emergency CSOIs in
response to acute gastroenteritis (AGE) outbreaks. CSOIs are used to
determine the causative agents and their sources, modes of
transmission, or risk factors. The VSP's jurisdiction includes
passenger vessels carrying 13 or more people sailing from foreign ports
and within 15 days of arriving at a U.S. port.
VSP uses its syndromic surveillance system called the ``Maritime
Illness and Death Reporting System (MIDRS)'' (OMB Control No. 0920-
1260, expiration date 04/30/2022) to collect aggregate data about the
number of people onboard ships in VSP's jurisdiction who are
experiencing AGE symptoms. When the levels of illness meet VSP's alert
threshold (i.e., at least 2% in either the passenger or crew
populations), a special report is made to VSP via MIDRS, and remote
environmental health and epidemiologic assistance is provided.
VSP considers an outbreak to be greater than or equal to 3% of
reportable AGE cases in either guest or crew populations. When
outbreaks occur, cruise ships submit daily reports of cases in the form
of AGE logs to VSP. When assistance is needed due to AGE outbreaks on
cruise ships, this often requires VSP to deploy a response team to meet
the ship in port within 24 hours of reaching the outbreak threshold,
and in some cases deploying the response team to board the ship before
its U.S. arrival and sail back to the U.S. port of disembarkation to
conduct a more detailed and comprehensive epidemiologic and
environmental health evaluation of the outbreak.
Causative agent, sources of exposure, modes of transmission, and
risk factors can be ascertained by gathering the following types of
information from both the affected and (seemingly) unaffected
populations:
Demographic information,
Pre-embarkation travel information,
Symptoms, including type, onset, duration,
Contact with people who were sick or their body fluids,
Participation in ship and shore activities,
Locations of eating and drinking, and
Foods and beverages consumed both on the ship and on
shore.
Rapid and flexible data collection is imperative given the mobile
environment, the remaining duration of the voyage left for
investigation, and the loss to follow-up if delays allow passengers to
disembark and leave the ship, including those returning to locations
outside of the U.S.
This Generic ICR will cover investigations that meet all of the
following criteria:
The investigation is urgent in nature (i.e., timely data
are needed to inform rapid public health action to prevent or reduce
morbidity or mortality).
The investigation is characterized by undetermined agents,
undetermined sources, undetermined modes of transmission, or
undetermined risk factors.
One or more CDC staff (including trainees and fellows)
will be deployed to the field.
Most CSOIs involve 2 to 5 days of data collection; data
collection is completed in 30 days or less.
This Generic ICR excludes each of the following:
Investigations related to non-urgent outbreaks or events.
Investigations conducted for the primary purpose of
program evaluation, needs assessment, or research (e.g., to contribute
to generalizable knowledge).
Investigations with data collection expected for greater
than 30 days.
The cruise ship industry experience in 2020 and 2021 was largely
not considered in this revision due to the disruption caused by the
COVID-19 pandemic. Since the first quarter of 2020, the COVID-19
pandemic disrupted the number of cruise ship voyages operating to U.S.
ports of call. Between March 2020 and October 2021, cruise industry
operations were suspended under a federally issued No Sail Order, and
then subsequently under a Conditional Sailing Order to prevent the risk
of introducing, transmitting, and spreading COVID-19 by cruise ship
travelers. The VSP conducted the following number of remote
environmental health and epidemiologic consultations for outbreaks,
greater than or equal to 3% of reportable AGE cases, by reviewing
existing MIDRS records: 10 in 2019, none in 2020, and one in 2021. No
new information was collected. Additionally, the VSP conducted no CSOIs
in the past three years.
Under the most recent MIDRS revision, cruise ships report an
estimated 3,370 AGE cases (575 crew and 2,795 passenger) per voyage;
therefore, VSP uses this same increase of 870 over the previously
approved 2,500 AGE cases per voyage for each CSOI. Previously,
respondents were counted as either taking the self-administered
questionnaire or the interview. Currently, all AGE cases are requested
to complete a self-administered questionnaire. Then a 15% subset of
these AGE cases may be interviewed for additional information about
their illness. Furthermore, a 40% subset of AGE cases may be asked for
biospecimens for laboratory confirmation of the causative agent. The
VSP uses existing laboratory biospecimen collection forms approved
under other CDC ICRs (OMB Control No. 0920-0004, exp. date 10/31/2020;
OMB Control No. 0920-1309, exp. date 11/30/2023).
As previously approved, up to 10 CSOIs may be conducted annually in
response to cruise ship AGE outbreaks. This results in a revised total
of 52,234 responses for 10 CSOIs per year; this is an increase of
27,232 responses over the previously approved 25,000. The total
annualized time burden has increased to 13,060 hours. There is no cost
to respondents other than their time.
[[Page 2794]]
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent Form name Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Cruise ship crew...................... Self-administered 5,750 1 15/60
Questionnaire.
Interview............... 862 1 15/60
Biospecimen Collection.. 2,300 1 15/60
Cruise ship passengers................ Self-administered 27,950 1 15/60
Questionnaire.
Interview............... 4,192 1 15/60
Biospecimen Collection.. 11,180 1 15/60
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2022-00856 Filed 1-18-22; 8:45 am]
BILLING CODE 4163-18-P
