[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]


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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

[[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