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