Maritime Illness Database and Reporting System (MIDRS)

Forms and Documents

Document Name	Status
71.21 (c) 72-hour food/activity history - AGE Passenger and Crew cases Form and Instruction	New
71.21 (c) Recordkeeping - medical records (72-hour food/activity history) Form and Instruction	New
71.21 (c) Recordkeeping – medical records (Documentation of date/time of last symptom and clearance to return to work for food and nonfood employees) Form and Instruction	New
71.21 (c) Documentation of date/time of last symptom and clearance to return to work for food and nonfood employees Form and Instruction	New
71.21(c) Recordkeeping - medical records (Documentation of 3-day pre-embarkation AGE illness assessment for all crew members) Form and Instruction	New
71.21 (c) Documentation of 3-day pre-embarkation AGE illness assessment for all crew members Form and Instruction	New
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) Form and Instruction	New
71.21 (c) Interviews with AGE crew case cabin mates and immediate contacts to determine AGE illness status and documentation of interview dates/times Form and Instruction	New
71.21 (c) Recordkeeping – medical records (AGE Logs) Form and Instruction	New
71.21 (c) AGE Logs Form and Instruction	New
71.21(c) Recordkeeping - Gastrointestinal Illnesses Report 24 and 4 hours before arrival Form and Instruction	New
71.21(c) Gastrointestinal Illness Report - 24 and 4 hours before arrival (MIDRS) Form and Instruction	New
Att10.PIA.pdf Supplementary Document	2019-02-21
Att9.IntlConventionofSafetyofLifeatSea.pdf Supplementary Document	2019-02-21
Att6.ResearchDeterminationForm.pdf Supplementary Document	2019-02-21
Att4b.VSP2018OperationsManual.pdf Supplementary Document	2019-02-21
Att3b. 1987FRN_VSPfromDGMQtoNCEH.pdf Supplementary Document	2019-02-20
Att3a.1985FRN_VSPinDGMQ.pdf Supplementary Document	2019-02-20
Att2.60dayFRN.pdf Supplementary Document	2019-02-20
Att1c. 42CFRPart71.pdf Supplementary Document	2019-02-20
Att1b.42USCSection269.pdf Supplementary Document	2019-02-20
Att1a. 42USCSection264.pdf Supplementary Document	2019-02-20
SSB_MIDRS.docx Supporting Statement B	2019-03-01
SSA_MIDRS.docx Supporting Statement A	2019-03-01

IC Document Collections

IC ID	Document Title	Status
235080	71.21 (c) 72-hour food/activity history - AGE Passenger and Crew cases Form and Instruction	New
235079	71.21 (c) Recordkeeping - medical records (72-hour food/activity history) Form and Instruction	New
235078	71.21 (c) Recordkeeping – medical records (Documentation of date/time of last symptom and clearance to return to work for food and nonfood employees) Form and Instruction	New
235077	71.21 (c) Documentation of date/time of last symptom and clearance to return to work for food and nonfood employees Form and Instruction	New
235076	71.21(c) Recordkeeping - medical records (Documentation of 3-day pre-embarkation AGE illness assessment for all crew members) Form and Instruction	New
235075	71.21 (c) Documentation of 3-day pre-embarkation AGE illness assessment for all crew members Form and Instruction	New
235074	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) Form and Instruction	New
235073	71.21 (c) Interviews with AGE crew case cabin mates and immediate contacts to determine AGE illness status and documentation of interview dates/times Form and Instruction	New
235072	71.21 (c) Recordkeeping – medical records (AGE Logs) Form and Instruction	New
235071	71.21 (c) AGE Logs Form and Instruction	New
235070	71.21(c) Recordkeeping - Gastrointestinal Illnesses Report 24 and 4 hours before arrival Form and Instruction	New
235047	71.21(c) Gastrointestinal Illness Report - 24 and 4 hours before arrival (MIDRS) Form and Instruction	New

ICR Details

OMB Control No: 0920-1260	ICR Reference No: 201812-0920-009
Status: Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-18AXG
Title: Maritime Illness Database and Reporting System (MIDRS)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/02/2019
	Date Received in OIRA: 03/04/2019
Terms of Clearance: OMB is approving this information collection request for a period of three years during which time CDC will request approval to extend or revise the collection if CDC seeks to continue the information collection activity beyond the period approved under this action.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2022	36 Months From Approved
Responses	13,750	0	0
Time Burden (Hours)	1,538	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Centers for Disease Control's (CDC) Vessel Sanitation Program (VSP) is requesting a new three-year PRA clearance to transition approval for Maritime Illness Database and Reporting System (MIDRS) and related medical records (AGE Log and 72 hour food/activity history) currently approved under Foreign Quarantine Regulations (OMB Control No. 0920-0134, expiration date 05/31/2019), sponsored by the CDC National Center for Emerging and Zoonotic Infectious Diseases (NCEZID). The MIDRS collection will monitor Acute Gastrointenteritis (AGE) illness on passenger ships (“cruise ships”), conduct sanitation inspections and epidemiologic investigations, and provide public health guidance when outbreaks occur, and formulating public health recommendations to prevent future outbreaks.

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Authorizing Statute(s): US Code: 42 USC 264 Name of Law: U.S. PHSA
   US Code: 42 USC 269 Name of Law: U.S. PHSA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 48425	09/25/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 2518	02/07/2019
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 12

IC Title	Form No.	Form Name
71.21(c) Recordkeeping - Gastrointestinal Illnesses Report 24 and 4 hours before arrival	NA	Recordkeeping - MIDRS Template
71.21 (c) AGE Logs	NA	VSP AGE Log
71.21 (c) Recordkeeping – medical records (AGE Logs)	NA	VSP AGE Log
71.21 (c) Interviews with AGE crew case cabin mates and immediate contacts to determine AGE illness status and documentation of interview dates/times	NA	Documentation of Interviews with AGE Crew Case Cabin Mates and Immediate Contacts to Determine AGE Illness Status
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)	NA	Documentation of Interviews with AGE Crew Case Cabin Mates and Immediate Contacts to Determine AGE Illness Status
71.21 (c) Documentation of 3-day pre-embarkation AGE illness assessment for all crew members	NA	Documentation of 3-day pre-embarkation AGE illness assessment
71.21(c) Recordkeeping - medical records (Documentation of 3-day pre-embarkation AGE illness assessment for all crew members)	NA	Documentation of 3-day pre-embarkation AGE illness assessment
71.21 (c) Documentation of date/time of last symptom and clearance to return to work for food and nonfood employees	NA	Documentation of Last Symptom and Clearance to Return to Work
71.21 (c) Recordkeeping – medical records (Documentation of date/time of last symptom and clearance to return to work for food and nonfood employees)	NA	Documentation of Last Symptom and Clearance to Return to Work
71.21 (c) Recordkeeping - medical records (72-hour food/activity history)	NA	Gastrointestinal Illness Surveillance System Questionnaire
71.21 (c) 72-hour food/activity history - AGE Passenger and Crew cases	NA	72-hr Food/Activity History Template
71.21(c) Gastrointestinal Illness Report - 24 and 4 hours before arrival (MIDRS)	NA, NA	Gastrointestinal Illness (GI) Template ,   MIDRS Template - screenshot

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	13,750	0	0	13,750	0	0
Annual Time Burden (Hours)	1,538	0	0	1,538	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: Submission of 0920-18AXG is a New ICR (MIDRS) that will monitor Acute Gastrointenteritis (AGE) illness on passenger ships (“cruise ships”), conduct sanitation inspections and epidemiologic investigations, and provide public health guidance when outbreaks occur, and formulating public health recommendations to prevent future outbreaks.

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Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 03/04/2019

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