Undetermined Cause of Cardiac Arrest during Hemodialysis — Connecticut 2015-2016

Forms and Documents

Document Name	Status
Dialysis–related Cardiac Arrest Data Collection Tool for data received through Case Finding Form and Instruction	New
Questionnaire for Staff at the Clinic at the time of the Event Form and Instruction	New
Questionnaire for Other Patients who were receiving Dialysis at the same time of the Event Form and Instruction	New
Questionnaire for Patients who Suffered from Cardiac Arrest but Survived Form and Instruction	New
Emergency SSB Cardiac Arrest in CT.docx Supporting Statement B	2016-01-26
Emergency SSA Cardiac Arrest in CT.docx Supporting Statement A	2016-01-26
Att 7 - Chart Abstraction Tool.docx Supplementary Document	2016-01-25
Att 8 - IRB Determination.pdf Supplementary Document	2016-01-25
Cluster cardiac arrest emergency memo.pdf Supplementary Document	2016-01-25
Att 2 - Cardiac arrest in CT 60 day FRN.docx Supplementary Document	2016-01-25
Att 1 - Authorizing Legislation T42 Section 241.doc Supplementary Document	2016-01-25

IC Document Collections

IC ID	Document Title	Status
219766	Dialysis–related Cardiac Arrest Data Collection Tool for data received through Case Finding Form and Instruction	New
219762	Questionnaire for Staff at the Clinic at the time of the Event Form and Instruction	New
219761	Questionnaire for Other Patients who were receiving Dialysis at the same time of the Event Form and Instruction	New
219759	Questionnaire for Patients who Suffered from Cardiac Arrest but Survived Form and Instruction	New

ICR Details

OMB Control No: 0920-1095	ICR Reference No: 201601-0920-014
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-16
Title: Undetermined Cause of Cardiac Arrest during Hemodialysis — Connecticut 2015-2016
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 01/27/2016
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/27/2016
	Date Received in OIRA: 01/27/2016
Terms of Clearance: CDC will submit an extension or revision if it is anticipated that this collection will continue for longer than six months. That decision must be made within two months before the expiration in order to leave sufficient time to prepare the package in an orderly fashion.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2016	6 Months From Approved
Responses	114	0	0
Time Burden (Hours)	57	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Seven patients in Connecticut have experienced sudden and unexpected cardiovascular collapse leading to cardiac arrest during routine outpatient hemodialysis since December 18, 2015. Three of the affected patients had evidence suggesting an anaphylactic reaction; all three of these patients died. Five of these events occurred in a single clinic and the remaining two events were in two nearby dialysis clinics owned by the same company. CDC is currently conducting an Epi-Aid to support the Connecticut Department of Public Health (CT DPH) with their investigation of these events. Because these events could be linked to a healthcare product (e.g., medical device or pharmaceutical) with widespread distribution, broad case-finding efforts are needed. CDC has determined that this information must be collected prior to the expiration of time period established under Part 1320, and that this information is essential to the CDC’s ability to identify a cause of these events and prevent additional events from occurring.

Emergency Justfication: Seven patients in Connecticut have experienced sudden and unexpected cardiovascular collapse leading to cardiac arrest during routine outpatient hemodialysis since December 18, 2015. Three of the affected patients had evidence suggesting an anaphylactic reaction; all three of these patients died. Five of these events occurred in a single clinic and the remaining two events were in two nearby dialysis clinics owned by the same company. CDC is currently conducting an Epi-Aid to support the Connecticut Department of Public Health (CT DPH) with their investigation of these events. Because these events could be linked to a healthcare product (e.g., medical device or pharmaceutical) with widespread distribution, broad case-finding efforts are needed. CDC has determined that this information must be collected prior to the expiration of time period established under Part 1320, and that this information is essential to the CDC’s ability to identify a cause of these events and prevent additional events from occurring.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: 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

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Questionnaire for Patients who Suffered from Cardiac Arrest but Survived	NA	Questionnaire for Patients who Suffered Cardiac Arrest but Survived
Questionnaire for Staff at the Clinic at the time of the Event	NA	Questionnaire for Staff at the Clinic at the time of the Event
Questionnaire for Other Patients who were receiving Dialysis at the same time of the Event	NA	Questionnaire for Other Patients who were receiving Dialysis at the same time of the Event
Dialysis–related Cardiac Arrest Data Collection Tool for data received through Case Finding	NA	Dialysis-related Cardiac Arrest Data Collection Tool for data received through Case Finding

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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	114	0	0	114	0	0
Annual Time Burden (Hours)	57	0	0	57	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 is a New Emergency ICR

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Annual Cost to Federal Government: $26,329

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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: 01/27/2016

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