Notice2022-00856
Agency Forms Undergoing Paperwork Reduction Act Review
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 19, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 87 Issue 12 (Wednesday, January 19, 2022)</title>
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[Federal Register Volume 87, Number 12 (Wednesday, January 19, 2022)]
[Notices]
[Pages 2792-2794]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-00856]
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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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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:
<bullet> Demographic information,
<bullet> Pre-embarkation travel information,
<bullet> Symptoms, including type, onset, duration,
<bullet> Contact with people who were sick or their body fluids,
<bullet> Participation in ship and shore activities,
<bullet> Locations of eating and drinking, and
<bullet> 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:
<bullet> 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).
<bullet> The investigation is characterized by undetermined agents,
undetermined sources, undetermined modes of transmission, or
undetermined risk factors.
<bullet> One or more CDC staff (including trainees and fellows)
will be deployed to the field.
<bullet> 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:
<bullet> Investigations related to non-urgent outbreaks or events.
<bullet> Investigations conducted for the primary purpose of
program evaluation, needs assessment, or research (e.g., to contribute
to generalizable knowledge).
<bullet> 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
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Number of Average burden
Type of respondent Form name Number of responses per per response
respondents respondent (in hours)
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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
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2022-00856 Filed 1-18-22; 8:45 am]
BILLING CODE 4163-18-P
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