[NCEZID] EMERGENCY - B. multivorans Ice Machine Multistate Investigation

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Case Report Form (CRF) - B. multivorans	Form	New	Available
Burkholderia multivorans Outbreak Investigation Case Report Form	Form	New	Repair queued
Supporting Statement A_B multivorans.docx	Supporting Statement A	Uploaded 2024-04-04	Available
Supporting Statement A_B multivorans.docx	Supporting Statement A	Uploaded 2024-04-04	Repair queued
Attachment 4-PIA REDCap.pdf	Supplementary Document	Uploaded 2024-04-04	Available
Attachment 4-PIA REDCap.pdf	Supplementary Document	Uploaded 2024-04-04	Repair queued
Emergency Request Memo_B multivorans 2024 national call for cases dbj.pdf	Supplementary Document	Uploaded 2024-04-02	Available
Emergency Request Memo_B multivorans 2024 national call for cases dbj.pdf	Supplementary Document	Uploaded 2024-04-02	Repair queued
Attachment 5-Human Subjects Determination.pdf	Supplementary Document	Uploaded 2024-04-02	Available
Attachment 5-Human Subjects Determination.pdf	Supplementary Document	Uploaded 2024-04-02	Repair queued
Attachment 1-Section 301 of the Public Health Service Act (42 USC 241).pdf	Supplementary Document	Uploaded 2024-04-02	Available
Attachment 1-Section 301 of the Public Health Service Act (42 USC 241).pdf	Supplementary Document	Uploaded 2024-04-02	Repair queued
Supporting Statement B_B multivorans 2024 national call for cases.docx	Supporting Statement B	Uploaded 2024-04-02	Available
Supporting Statement B_B multivorans 2024 national call for cases.docx	Supporting Statement B	Uploaded 2024-04-02	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
266503	Burkholderia multivorans Outbreak Investigation Case Report Form	Form	New	Case Report Form (CRF) - B. multivorans
266503	Burkholderia multivorans Outbreak Investigation Case Report Form	Form	New

ICR Details

OMB Control No: 0920-1430	ICR Reference No: 202404-0920-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-24EK
Title: [NCEZID] EMERGENCY - B. multivorans Ice Machine Multistate Investigation
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: 04/05/2024
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/05/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 04/04/2024
Terms of Clearance: OMB is approving this Emergency ICR with the understanding that within 5 months from the approval date, CDC will complete a 60d and 30d public comment request to support the approval of the ICR ahead of the expiration date.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2024	5 Months From Approved
Responses	40	0	0
Time Burden (Hours)	120	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: CDC requests Emergency approval for an outbreak investigation which aims to evaluate the associations between Burkholderia multivorans infections among hospitalized patients and potential exposures to nonsterile ice and water from ice machines to help inform measures to prevent ongoing transmission. CDC will share findings and recommendations with public health and healthcare partners to prevent further spread of B. multivorans infections; findings may also be shared with other relevant stakeholders and/or published in scientific journals to disseminate investigation outcomes.

Emergency Justfication: CDC has been assisting state and local jurisdictions investigate clusters of B. multivorans infections among patients admitted across four hospitals in two non-contiguous states. The outbreak strain of the bacteria has been identified in environmental samples from ice machines. Molecular analysis has shown that the bacterial strain identified in ice machines is genetically highly similar to the patient isolates. Further investigation revealed that the same brand of ice machine and the same filters, descaling/cleaning, and sanitizing products were used by the four hospitals. Epidemiologic and laboratory evidence suggest the possibility of contaminated nonsterile ice and water from the same brand of ice machines as a common source of exposure. Further investigation is needed to identify the scope of the outbreak and the source of the ice machine contamination. CDC is issuing a national call for cases requesting that public health authorities report cases and clusters of B. multivorans. A case report form was developed by CDC to assist jurisdictions in this effort. Jurisdictions will gather information using this case report form to assist in determining epidemiologic characteristics and risk factors of patients with B. multivorans

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Authorizing Statute(s): US Code: 42 USC 241 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

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

table that charts list of burden

IC Title	Form No.	Form Name
Burkholderia multivorans Outbreak Investigation Case Report Form	N/A	Case Report Form (CRF) - B. multivorans

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ICR Summary of Burden

table that charts list 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	40	0	0	40	0	0
Annual Time Burden (Hours)	120	0	0	120	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 0920-24EK is an Emergency ICR for B. multivorans Outbreak Investigation.

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Annual Cost to Federal Government: $281,423

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.     Yes

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? No

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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: 04/04/2024

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