2019-01324. 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 [phone] or send an email to [e-mail]. 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 [phone]. 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 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

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)
Cruise ship medical staff or other designated personnel	71.21(c) Gastrointestinal Illnesses reports 24 and 4 hours before arrival (MIDRS)	250	10	3/60
	71.21(c) Recordkeeping—Gastrointestinal Illnesses reports 24 and 4 hours before arrival (MIDRS)	250	1	1/60
	71.21(c) AGE Logs	250	10	10/60
	71.21 (c) Recordkeeping—medical records (AGE Logs)	250	1	1/60
	71.21(c) Interviews with AGE crew case cabin mates and immediate contacts to determine AGE illness status and documentation of interview dates/times	250	3	5/60
	71.21(c) Recordkeeping—medical records (Interviews with AGE crew case cabin mates and immediate contacts to determine AGE illness status and documentation of interview dates/times)	250	1	1/60
	71.21(c) Documentation of 3-day pre-embarkation AGE illness assessment for all crew members	250	5	3/60
	71.21(c) Recordkeeping—medical records (Documentation of 3-day pre-embarkation AGE illness assessment for all crew members)	250	1	1/60
	71.21(c) Documentation of date/time of last symptom and clearance to return to work for food and nonfood employees	250	1	3/60
	71.21(c) Recordkeeping—medical records (Documentation of date/time of last symptom and clearance to return to work for food and nonfood employees)	250	1	1/60
	71.21(c) Recordkeeping—medical records (72 hour food/activity histories)	250	1	1/60
AGE passenger and crew cases	71.21(c) 72-hour food/activity history	5,000	1	10/60

Jeffrey M. Zirger,

Acting Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention.