Notice2025-10516
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
June 11, 2025
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 90 Issue 111 (Wednesday, June 11, 2025)</title>
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[Federal Register Volume 90, Number 111 (Wednesday, June 11, 2025)]
[Notices]
[Pages 24618-24619]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-10516]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-25-1255]
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
November 25, 2024, 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 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. 3/31/2025)--
[[Page 24619]]
Reinstatement--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
operational public health programs to minimize the risk of
gastrointestinal illness. VSP coordinates and conducts public health
inspections, ongoing surveillance of gastrointestinal illness, and
outbreak investigations on cruise ships.
Under the authority of the Public Health Service Act (42 U.S.C. 264
and 269), VSP is requesting a three-year Extension for an existing
Generic Clearance Information Collection Request (ICR). This ICR will
provide for the quick turnaround necessary to conduct emergency Cruise
Ship Outbreak Investigations (CSOIs) in response to acute
gastroenteritis (AGE) outbreaks. CSOIs are used to determine causative
agents and their sources, modes of transmission, or risk factors. 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, Exp. 3/31/2026) 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 VSP provides environmental health
and epidemiologic assistance. VSP considers an outbreak to be >=3% of
reportable AGE cases in either passenger or crew populations.
When a cruise ship has an AGE outbreak, VSP often must deploy a
response team to meet the ship in port within 24 hours of reaching the
outbreak threshold. In some cases, the response team must 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.
VSP can ascertain causative agent, sources of exposure, modes of
transmission, and risk factors 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 onshore 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 United States.
This Generic Clearance will cover investigations that meet all 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> Data collection is completed in 30 days or less (most
CSOIs involve two to five days of data collection).
This Generic Clearance excludes each of the following:
<bullet> Investigations related to non-urgent outbreaks or events.
<bullet> Investigations conducted for the primary purpose of
program evaluation, surveillance, needs assessment, or research (e.g.,
to contribute to generalizable knowledge).
<bullet> Investigations with data collection expected for greater
than 30 days.
VSP estimates 10 CSOIs annually in response to cruise ship AGE
outbreaks. The estimated number of respondents is 1,300 per CSOI, for a
total of 13,000 respondents per year. The average time burden is 15
minutes for each respondent. Therefore, the total estimated annual
burden in hours is 4,063. 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 crew..................... Self-administered 3,000 1 15/60
questionnaire.
Cruise ship crew..................... Interview............... 450 1 15/60
Cruise ship crew..................... Biospecimen collection.. 300 1 15/60
Cruise ship passenger................ Self-administered 10,000 1 15/60
questionnaire.
Cruise ship passenger................ Interview............... 1,500 1 15/60
Cruise ship passenger................ Biospecimen collection.. 1,000 1 15/60
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health
Ethics and Regulations, Office of Science, Centers for Disease Control
and Prevention.
[FR Doc. 2025-10516 Filed 6-10-25; 8:45 am]
BILLING CODE 4163-18-P
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