[NCEZID] B. multivorans Ice Machine Multistate Investigation

Forms and Documents

Document Name	Status
Burkholderia multivorans Outbreak Investigation Case Report Form Form	Modified
Attachment 5-Human Subjects Determination.pdf Supplementary Document	2024-09-09
Attachment 4-PIA REDCap.pdf Supplementary Document	2024-09-09
Attachment 2-Published 60-day FRN.pdf Supplementary Document	2024-09-09
Supporting Statement A_B multivorans_2024.8.21_final.docx Supporting Statement A	2024-09-09
Attachment 1-Section 301 of the Public Health Service Act (42 USC 241).pdf Supplementary Document	2024-09-09
Supporting Statement B_B multivorans 2024.docx Supporting Statement B	2024-09-09

IC Document Collections

IC ID	Document Title	Status
266503	Burkholderia multivorans Outbreak Investigation Case Report Form Form	Modified

ICR Details

OMB Control No: 0920-1430	ICR Reference No: 202408-0920-017
Status: Received in OIRA	Previous ICR Reference No: 202404-0920-002
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1430
Title: [NCEZID] B. multivorans Ice Machine Multistate Investigation
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 09/11/2024

	Requested	Previously Approved
Expiration Date	36 Months From Approved	09/30/2024
Responses	40	40
Time Burden (Hours)	120	120
Cost Burden (Dollars)	0	0

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Abstract: CDC requests 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.

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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
60-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 25875	04/12/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 73093	09/09/2024
Did the Agency receive public comments on this ICR? No

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

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

	Total Request	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	40	0	0	0	0
Annual Time Burden (Hours)	120	120	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement:

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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: 09/11/2024

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