[Federal Register Volume 84, Number 26 (Thursday, February 7, 2019)]
[Notices]
[Pages 2518-2520]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01324]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30-Day-19-18AXG]


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). CDC previously published a ``Proposed Data Collection 
Submitted for Public Comment and Recommendations'' notice on September 
25, 2018 to obtain comments from the public and affected agencies. CDC 
did not receive public comment 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

    Maritime Illness Database and Reporting System (MIDRS)--NEW--
National Center for Environmental Health (NCEH), Centers for Disease 
Control and Prevention (CDC).

Background and Brief Description

    The purpose of this new information collection request (ICR) is to 
request a three-year Paperwork Reduction Act (PRA) clearance for CDC's 
Maritime Illness Database and Reporting System (MIDRS). MIDRS is 
currently approved under Foreign Quarantine Regulations (42 CFR part 
71) (OMB Control No. 0920-0134, Expiration Date: 05/31/2019), sponsored 
by the National Center for Emerging and Zoonotic Infectious Diseases 
(NCEZID), Centers for Disease Control and Prevention (CDC).
    Operationally, CDC has divided the responsibilities for enforcing 
foreign quarantine regulations between the Vessel Sanitation Program 
(VSP) and the Division of Global Migration and Quarantine (DGMQ). VSP 
takes the lead on overseeing acute gastroenteritis (AGE) illness 
surveillance and outbreak investigation activities on passenger

[[Page 2519]]

ships, while DGMQ monitors all non-AGE illnesses and deaths on 
passenger vessels as well as all diseases of public health concern on 
all other conveyances with international itineraries bound for the 
United States. From 2012 to 2014 all ships submitted their AGE, non-
AGE, and death reports to MIDRS using a common web portal; however 
program and reporting needs changed and dictated a need to move non-AGE 
illness and death reporting to a separate system. As of June 10, 2014, 
DGMQ has changed its routing method for receiving reports from ships. 
It no longer accepts non-AGE illness and death reports via MIDRS.
    To complete the separation of shipboard quarantine and inspection 
functions across the two CDC national centers, the VSP seeks to 
transition all federally mandated AGE illness reporting activities to a 
new ICR housed within its own Center, since MIDRS is housed in and used 
exclusively by VSP. DGMQ will continue to surveil non-AGE illnesses on 
cruise ships and all illnesses on other foreign to U.S. conveyances 
under Foreign Quarantine Regulations (42 CFR part 71) (OMB Control No. 
0920-0134, expiration date 05/31/2019).
    The MIDRS data collection system consists of a surveillance system 
that receives information electronically through a web-based reporting 
portal; 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. The AGE log, 72-hour food/
activity history and other required documentation are completed and 
maintained on the ship.
    Data collected will allow 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.
    There are two types of respondents for this data collection: Cruise 
ship medical staff or other designated personnel who report AGE cases, 
and AGE cases who provide information for the 72-hour food/activity 
histories. Of note, VSP will not receive any 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. 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.
    CDC estimates the total annualized time burden is 1,537 hours. A 
summary of the estimated annualized burden hours is shown in the table 
below.

                                        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      71.21(c)                             250              10            3/60
 designated personnel.                   Gastrointestinal
                                         Illnesses reports 24
                                         and 4 hours before
                                         arrival (MIDRS).
                                        71.21(c) Recordkeeping--             250               1            1/60
                                         Gastrointestinal
                                         Illnesses reports 24
                                         and 4 hours before
                                         arrival (MIDRS).
                                        71.21(c) AGE Logs.......             250              10           10/60
                                        71.21 (c) Recordkeeping--            250               1            1/60
                                         medical records (AGE
                                         Logs).
                                        71.21(c) Interviews with             250               3            5/60
                                         AGE crew case cabin
                                         mates and immediate
                                         contacts to determine
                                         AGE illness status and
                                         documentation of
                                         interview dates/times.
                                        71.21(c) Recordkeeping--             250               1            1/60
                                         medical records
                                         (Interviews with AGE
                                         crew case cabin mates
                                         and immediate contacts
                                         to determine AGE
                                         illness status and
                                         documentation of
                                         interview dates/times).
                                        71.21(c) Documentation               250               5            3/60
                                         of 3-day pre-
                                         embarkation AGE illness
                                         assessment for all crew
                                         members.
                                        71.21(c) Recordkeeping--             250               1            1/60
                                         medical records
                                         (Documentation of 3-day
                                         pre-embarkation AGE
                                         illness assessment for
                                         all crew members).
                                        71.21(c) Documentation               250               1            3/60
                                         of date/time of last
                                         symptom and clearance
                                         to return to work for
                                         food and nonfood
                                         employees.
                                        71.21(c) Recordkeeping--             250               1            1/60
                                         medical records
                                         (Documentation of date/
                                         time of last symptom
                                         and clearance to return
                                         to work for food and
                                         nonfood employees).
                                        71.21(c) Recordkeeping--             250               1            1/60
                                         medical records (72
                                         hour food/activity
                                         histories).
AGE passenger and crew cases..........  71.21(c) 72-hour food/             5,000               1           10/60
                                         activity history.
----------------------------------------------------------------------------------------------------------------



[[Page 2520]]

Jeffrey M. Zirger,
Acting Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2019-01324 Filed 2-6-19; 8:45 am]
 BILLING CODE 4163-18-P