[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]
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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.
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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 ``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
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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 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
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Total...................................... ....................................... .............. .............. .............. 1,537
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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