[Federal Register Volume 83, Number 186 (Tuesday, September 25, 2018)]
[Notices]
[Pages 48425-48427]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20808]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-18-18AXG; Docket No. is CDC-2018-0086]


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.

-----------------------------------------------------------------------

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 ``Maritime Illness Database and 
Reporting System (MIDRS)''. The purpose of this data collection is to 
provide U.S.-bound passenger vessel operators an electronic reporting 
system to assist with their legal requirement to notify CDC of the 
number of passengers and crew members onboard their ship who have 
reportable acute gastroenteritis (AGE) as defined by federal quarantine 
regulations.

DATES: CDC must receive written comments on or before November 26, 
2018.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0086 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.

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,

[[Page 48426]]

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

    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 
MIDRS surveillance system. 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 Infections 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 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 U.S. 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 is 
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 (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.
    The total annualized time burden requested is 1,537 burden 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    Total burden
                                                                                            respondents     respondent      (in hours)      (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cruise ship medical staff or other designated    71.21(c) Gastrointestinal Illnesses                 250              10            3/60             125
 personnel.                                       reports 24 and 4 hours before arrival
                                                  (MIDRS).
                                                 71.21(c) Recordkeeping--                            250               1            1/60               4
                                                  Gastrointestinal Illnesses reports 24
                                                  and 4 hours before arrival (MIDRS).
                                                 71.21(c) AGE Logs......................             250              10           10/60             417
                                                 71.21(c) Recordkeeping--medical records             250               1            1/60               4
                                                  (AGE Logs).
                                                 71.21(c) Interviews with AGE crew case              250               3            5/60            62.5
                                                  cabin mates and immediate contacts to
                                                  determine AGE illness status and
                                                  documentation of interview dates/times.

[[Page 48427]]

 
                                                 71.21(c) Recordkeeping--medical records             250               1            1/60               4
                                                  (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 of 3-day pre-                250               5            3/60            62.5
                                                  embarkation AGE illness assessment for
                                                  all crew members.
                                                 71.21(c) Recordkeeping--medical records             250               1            1/60               4
                                                  (Documentation of 3-day pre-
                                                  embarkation AGE illness assessment for
                                                  all crew members).
                                                 71.21(c) Documentation of date/time of              250               1            3/60            12.5
                                                  last symptom and clearance to return
                                                  to work for food and nonfood employees.
                                                 71.21(c) Recordkeeping--medical records             250               1            1/60               4
                                                  (Documentation of date/time of last
                                                  symptom and clearance to return to
                                                  work for food and nonfood employees).
                                                 71.21(c) Recordkeeping--medical records             250               1            1/60               4
                                                  (72 hour food/activity histories).
AGE passenger and crew cases...................  71.21(c) 72-hour food/activity history.           5,000               1           10/60             833
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............  ..............           1,537
--------------------------------------------------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Acting Chief, Information Collection Review Office, Office of 
Scientific Integrity, Office of the Associate Director for Science, 
Office of the Director, Centers for Disease Control and Prevention.
[FR Doc. 2018-20808 Filed 9-24-18; 8:45 am]
 BILLING CODE 4163-18-P