[Federal Register Volume 83, Number 228 (Tuesday, November 27, 2018)]
[Notices]
[Pages 60868-60870]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25752]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-19-19BN; Docket No. CDC-2018-0104]


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)''. The purpose of this study is 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 January 28, 2019.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0104 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to Regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (regulations.gov) or by U.S. mail to the address listed above.

[[Page 60869]]


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-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: 
[email protected].

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; and
    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.
    5. Assess information collection costs.

Proposed Project

    Emergency Cruise Ship Outbreak Investigations (COIs)--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 
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 60870]]



                                        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,
Acting Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2018-25752 Filed 11-26-18; 8:45 am]
 BILLING CODE 4163-18-P