Notice2021-22179
Proposed Data Collection Submitted for Public Comment and Recommendations
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
October 13, 2021
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Emergency Cruise Ship Outbreak Investigations (CSOIs). This collection is designed to allow the CDC Vessel Sanitation Program (VSP) to prevent the introduction, transmission, or spread of acute gastroenteritis (AGE) via cruise ships entering the United States from foreign countries.
Full Text
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<title>Federal Register, Volume 86 Issue 195 (Wednesday, October 13, 2021)</title>
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[Federal Register Volume 86, Number 195 (Wednesday, October 13, 2021)]
[Notices]
[Pages 56955-56957]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-22179]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-22-1255; Docket No. CDC-2021-0109]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part
of its continuing effort to reduce public burden and maximize the
utility of government information, invites the general public and other
Federal agencies the opportunity to comment on a proposed and/or
continuing information collection, as required by the Paperwork
Reduction Act of 1995. This notice invites comment on a proposed
information collection project titled Emergency Cruise Ship Outbreak
Investigations (CSOIs). This collection is designed to allow the CDC
Vessel Sanitation Program (VSP) to prevent the introduction,
transmission, or spread of acute gastroenteritis (AGE) via cruise ships
entering the United States from foreign countries.
DATES: CDC must receive written comments on or before December 13,
2021.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2021-
0109 by any of the following methods:
<bullet> Federal eRulemaking Portal: <a href="http://Regulations.gov">Regulations.gov</a>. Follow the
instructions for submitting comments.
<bullet> Mail: Jeffrey M. Zirger, Information Collection Review
Office, Centers for Disease Control and Prevention, 1600 Clifton Road
NE, MS H21-8, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. CDC will post, without change, all relevant comments
to <a href="http://Regulations.gov">Regulations.gov</a>.
Please note: Submit all comments through the Federal eRulemaking
portal (regulations.gov) or by U.S. mail to the address listed above.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the information collection plan
and instruments, contact Jeffrey M. Zirger, Information Collection
Review Office, Centers for Disease Control and Prevention, 1600 Clifton
Road NE, MS
[[Page 56956]]
H21-8, Atlanta, Georgia 30329; phone: 404-639-7118; Email: <a href="/cdn-cgi/l/email-protection#77181a153714131459101801"><span class="__cf_email__" data-cfemail="315e5c53715255521f565e47">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from
the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. In addition, the PRA also requires
Federal agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information, including each new
proposed collection, each proposed extension of existing collection of
information, and each reinstatement of previously approved information
collection before submitting the collection to the OMB for approval. To
comply with this requirement, we are publishing this notice of a
proposed data collection as described below.
The OMB is particularly interested in comments that will help:
1. 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;
2. Evaluate the accuracy of the agency's estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to
be collected;
4. 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
submissions of responses; and
5. Assess information collection costs.
Proposed Project
Emergency Cruise Ship Outbreak Investigations (CSOIs) (OMB Control
No. 0920-1255, Exp. 03/31/2022)--Extension--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. 264
and 269), the VSP is requesting a three-year Extension Information
Collection Request (ICR) for an existing generic clearance. This ICR
will provide for 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)'' (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 >=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:
<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 clearance 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 two to five days of data collection;
data collection is completed in 30 days or less.
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.
The VSP estimates 10 CSOIs annually in response to cruise ship AGE
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.
[[Page 56957]]
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
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Cruise Ship Passengers or Crew Questionnaire... 24,750 1 15/60 6,188
Cruise Ship Passengers or Crew Interview....... 250 1 15/60 62
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Total..................... ................ .............. .............. .............. 6,250
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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. 2021-22179 Filed 10-12-21; 8:45 am]
BILLING CODE 4163-18-P
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