[Federal Register Volume 84, Number 42 (Monday, March 4, 2019)]
[Notices]
[Pages 7377-7378]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03774]



[[Page 7377]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30 Day-19-19BN]


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 November 
27, 2018 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 or send an email to [email protected]. 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

    Emergency Cruise Ship Outbreak Investigations (CSOIs)--Existing 
Collection in Use without an OMB Control Number--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 approval for 
a new generic clearance information collection request (ICR). This ICR 
will provide the quick turn-around necessary to conduct emergency 
cruise ship outbreak investigations (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) (approved under ``Foreign 
Quarantine Regulations'' [OMB Control No. 0920-0134, expiration date 
05/31/2019]) 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 >=3% of 
reportable AGE cases in either guest or crew populations. 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 new generic clearance 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 two to five days of data collection; 
data collection is completed in 30 days or less.
    This new generic clearance excludes each of the following:
     Investigations related to non-urgent outbreaks or events.
     Investigations conducted for the primary purpose of 
program evaluation, surveillance, needs assessment, or research (e.g., 
to contribute to generalizable knowledge).
     Investigations with data collection expected for greater 
than 30 days.
    The VSP estimates 10 CSOIs annually in response to cruise ship AGE

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outbreaks. The estimated number of respondents is 2,500 per CSOI, for a 
total of 25,000 respondents per year. The average time burden is 15 
minutes for each respondent. Therefore, the total estimated annual 
burden in hours is 6,250. There is no cost to respondents other than 
their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
        Type of respondents                   Form name              Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Cruise Ship Passengers or Crew.....  Questionnaire..............          24,750               1           15/60
                                     Interview..................             250               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. 2019-03774 Filed 3-1-19; 8:45 am]
 BILLING CODE 4163-18-P