[Federal Register Volume 87, Number 63 (Friday, April 1, 2022)]
[Notices]
[Pages 19095-19097]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06911]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-22-1260]


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 ``Maritime Illness Database and Reporting 
System (MIDRS)'' 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 
October 25, 2021 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

[[Page 19096]]

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 www.reginfo.gov/public/do/PRAMain. 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

    Maritime Illness Database and Reporting System (MIDRS)(OMB Control 
No. 0920-1260, Exp. 04/30/2022)--Revision--National Center for 
Environmental Health (NCEH), Centers for Disease Control and Prevention 
(CDC).

Background and Brief Description

    Under Foreign Quarantine Regulations (45 CFR 71), Sec.  71.21(c) 
for ``report of illness'' and Sec.  71.41 ``general provisions'' for 
sanitary inspections, the Vessel Sanitation Program (VSP) in the 
National Center for Environmental Health (NCEH) takes the CDC lead on 
overseeing acute gastroenteritis (AGE) illness surveillance, AGE 
outbreak investigations, and sanitary inspections. 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. Data collected allows VSP to quickly detect AGE outbreaks, 
provide epidemiologic and sanitation guidance to stop the outbreak, 
craft public health recommendations to prevent future outbreaks, and 
monitor AGE illness trends to identify important changes over time.
    To continue this AGE surveillance, NCEH is requesting a revision of 
a three-year Paperwork Reduction Act (PRA) clearance for the Maritime 
Illness Database and Reporting System (MIDRS) (OMB Control No. 0920-
1260; expiration date 04/30/2022). This information collection request 
(ICR) is revised to refine and update respondent types, frequencies of 
responses, information collection forms, recordkeeping requirements, 
and time burden requested for AGE surveillance. CDC is also updating 
this ICR to include recordkeeping requirements related to VSP 
sanitation inspections.
    The MIDRS data collection system consists of an electronic 
surveillance system that receives information through a web-based 
reporting portal 24 hours and four hours prior to arrival at a U.S. 
port. This data can also be submitted by phone, email, or fax and 
entered into MIDRS by VSP. AGE cases reported to MIDRS are totals for 
the entire voyage and do not represent the number of active AGE cases 
at any given port of call or at disembarkation.
    In the past three years, the VSP has received 13,352 AGE reports to 
MIDRS. Since the first quarter of 2020, the COVID-19 pandemic disrupted 
the number of cruise ship voyages operating to U.S. ports of call. 
Between March 2020 and October 2021, cruise industry operations were 
suspended under a federally issued No Sail Order, and then subsequently 
under a Conditional Sailing Order to prevent the risk of introducing, 
transmitting, and spreading COVID-19 by cruise ship travelers. As a 
result, the number of AGE reports submitted to MIDRS in 2020 and 2021 
were substantially lower (n=2,667 and n=1,717, respectively), compared 
to 2019 (n=8,968).
    Thus, VSP revises its annual estimates to 9,000 MIDRS reports from 
approximately 300 ships arriving at U.S. ports 30 times per year. This 
number of arrivals reflects the number of times each cruise ship must 
submit a report to MIDRS in a given year (n=300*30=9,000). All arriving 
ships send 24-hour MIDRS reports (44% electronically [n=132]; 56% by 
phone, email, or fax [n=168]) to the VSP. A subset of approximately 80% 
of these ships may need to send four-hour MIDRS reports either 
electronically (n=106) or by phone, email, or fax (n=201) if the number 
of cases changes after submission of the initial report.
    When AGE cases exceed the 2% alert threshold and the 3% outbreak 
threshold, special reports are sent to VSP. VSP estimates that 2% of 
ships reporting to MIDRS (n=180) per year are required to send up to 
four special report updates until they are four hours from port. VSP 
also requires these ships to begin sending at least one and up to 12 
daily reports in the form of AGE logs to monitor and assess whether a 
cruise ship outbreak investigation (CSOI) may be warranted. If so, VSP 
conducts CSOIs under OMB Control Number 0020-1255 (expiration date 03/
30/2022).
    The daily report in the form of AGE logs and the 72-hour food/
activity history template are used to document AGE cases among crew 
(n=575 per year) and passengers (n=2,795 per year). The ship's crew 
undergo additional worker assessments. For example, all crew members 
undergo a three-day pre-embarkation AGE illness assessment (n=197,640 
per year based on an average of 1,080 crew per ship in 2019). Assuming 
five contacts and cabin mates per crew AGE cases, approximately 2,875 
crew per year undergo additional screening and assessments such as 
initial, 24-hour, and 48-hour verbal interviews to assess AGE status. 
Crew AGE cases must also undergo a last symptom check to obtain a 
return-to-work clearance. Documentation of these assessments and 
reports are maintained on the ship for at least 12 months (8,760 hours 
per year).
    There are three types of respondents involved in AGE surveillance: 
Cruise ship medical staff or other designated personnel who treat and 
report AGE cases to VSP, and the cruise ship crew and the cruise ship 
passengers who may become AGE cases. Of note, VSP does not request any 
identifiable information from or about the AGE cases; this information 
is collected and owned by the cruise line and maintained on the ship as 
part of the AGE case's medical record.
    A fourth type of respondent is the cruise ship engineering staff 
who perform shipboard engineering and sanitation system maintenance. 
Such records must be maintained for at least 12 months (8,760 hours). 
VSP reviews these records during operational inspections to confirm 
they are available if needed, and if there is an AGE outbreak or report 
of unusual AGE illness for a particular voyage.
    After careful consideration of the VSP and cruise industry 
experience in 2019 and the standard practices outlined in the VSP 
Operations Manual, CDC has revised its burden estimates for an

[[Page 19097]]

increase of 6,312,230 annual responses (n=6,325,980) compared to that 
approved in 2019 (n=13,750). CDC also estimates the total annualized 
time burden is 5,592,688 hours, which is an increase of 5,591,150 hours 
compared to the previously approved 1,538 hours. This increase in 
annual time burden is based largely on more accurate estimation of the 
number of respondents, the number of responses, and adding the 12-month 
recordkeeping burden for both AGE surveillance records and for 
maintenance and sanitation records; this recordkeeping burden was not 
accurately accounted for in the prior ICR. There are no other costs to 
the 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 medical staff or other      AGE Illness Report 24                132              30            3/60
 designated personnel.                   hours before arrival
                                         (web).
                                        AGE Illness Report 24                168              30            3/60
                                         hours before arrival
                                         (phone/email/fax).
                                        AGE Illness Report 4                 106              30            3/60
                                         hours before arrival
                                         (web).
                                        AGE Illness Report 4                 134              30            3/60
                                         hours before arrival
                                         (phone/email/fax).
                                        Special Reports                      180               4            3/60
                                         exceeding 2%-3% AGE
                                         Threshold (web/phone/
                                         email/fax).
                                        Daily Reports of AGE                 180              12            3/60
                                         Logs.
                                        Recordkeeping of AGE                 300               1           8,760
                                         Surveillance Records.
----------------------------------------------------------------------------------------------------------------
Cruise ship crew......................  72-hour Food/Activity                575              30           10/60
                                         History Template (AGE
                                         cases).
                                        Three-day Pre-                   197,640              30            3/60
                                         embarkation AGE Illness
                                         Assessment (all crew
                                         members).
                                        Interviews to Determine            2,875              90            5/60
                                         AGE Status (initial, 24-
                                         hr, 48-hr)(asymptomatic
                                         cabin mates and
                                         immediate contacts of
                                         symptomatic crew).
                                        Last Symptom Check and               575              30            3/60
                                         Return to Work
                                         Clearance (food and
                                         nonfood employees).
----------------------------------------------------------------------------------------------------------------
Cruise ship passengers................  72-hour Food/Activity              2,795              30           10/60
                                         History Template (AGE
                                         cases).
----------------------------------------------------------------------------------------------------------------
Cruise ship engineering staff or other  Recordkeeping of                     300               1           8,760
 designated personnel.                   Engineering and
                                         Sanitation Records.
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2022-06911 Filed 3-31-22; 8:45 am]
BILLING CODE 4163-18-P