[NCEZID] Becton Dickinson BACTEC(TM) Blood Culture Media Bottles Shortage Impact Questionnaire (NHSN)

Forms and Documents

Document Name	Status
Form 57.109 Becton Dickinson BACTECTM Blood Culture Media Bottles Shortage Impact Questionnaire (Nov-Mar) Form and Instruction	New
Form 57.109 Becton Dickinson BACTECTM Blood Culture Media Bottles Shortage Impact Questionnaire (Jul-Oct) Form and Instruction	New
Supporting Statement B.docx Supporting Statement B	2024-09-26
Supporting Statement A.docx Supporting Statement A	2024-09-26
Emergency Request Memo_Becton Dickinson BACTECTM Blood Culture Media Bottles Shortage_V2.pdf Supplementary Document	2024-09-26
G. Human Subject Determination Memo.pdf Supplementary Document	2024-09-20
F. Privacy Impact Assessment.pdf Supplementary Document	2024-09-20
Emergency Request Memo_Becton Dickinson BACTECTM Blood Culture Media Bottles Shortage.pdf Supplementary Document	2024-09-20
D3. Health Alert Network (HAN) - 00512 _ Disruptions in Availability of Becton Dickinson (BD) BACTEC™ Blood Culture Bottles.pdf Supplementary Document	2024-09-20
D2. Disruptions in Availability of BD BACTEC Blood Culture Bottles_ Current Situation _ HAIs _ CDC.mhtml Supplementary Document	2024-09-20
D1. BD BACTEC™ Update.mhtml Supplementary Document	2024-09-20
C. Disruptions in Availability of BD BACTEC Blood Culture Media Bottles - Letter to Health Care Providers _ FDA.pdf Supplementary Document	2024-09-20
A3. 42 USC 242m.pdf Supplementary Document	2024-09-19
A2. 42 USC 242k.pdf Supplementary Document	2024-09-19
A1. 42 USC 242b.pdf Supplementary Document	2024-09-19

IC Document Collections

IC ID	Document Title	Status
271080	Becton Dickinson BACTECTM Blood Culture Media Bottles Shortage Impact Questionnaire (Nov-Mar) Form and Instruction	New
271079	Becton Dickinson BACTECTM Blood Culture Media Bottles Shortage Impact Questionnaire (Jul-Oct) Form and Instruction	New

ICR Details

OMB Control No: 0920-1442	ICR Reference No: 202409-0920-008
Status: Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-24IW
Title: [NCEZID] Becton Dickinson BACTEC(TM) Blood Culture Media Bottles Shortage Impact Questionnaire (NHSN)
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: 09/27/2024
OIRA Conclusion Action: Approved with change	Conclusion Date: 09/27/2024
	Date Received in OIRA: 09/27/2024
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 (if needed).

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2025	5 Months From Approved
Responses	7,000	0	0
Time Burden (Hours)	2,334	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Study is designed to assess how facilities that are enrolled in the NHSN Patient Safety Component are impacted by the shortage of the Becton Dickinson (BD) BACTEC(TM) blood culture media bottles and how that impact might affect NHSN bloodstream infection surveillance.

Emergency Justfication: CDC and CMS work closely and are fully committed to ensuring complete and accurate reporting of HAI data, which are critical for protecting patients and guiding national, state, and local prevention priorities. The interruptions in the supply of Becton Dickinson (BD) BACTECTM blood culture media bottles will likely affect facility reporting of HAIs (bloodstream infection surveillance data) to NHSN and may ultimately affect facility payment from CMS. CDC NHSN cannot reasonably comply with the normal clearance process given the fact that this shortage may affect mandated CMS pay-for-performance quality reporting programs.

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Authorizing Statute(s): US Code: 42 USC 242 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: 2

IC Title	Form No.	Form Name
Becton Dickinson BACTECTM Blood Culture Media Bottles Shortage Impact Questionnaire (Jul-Oct)	57.109	Becton Dickinson BACTECTM Blood Culture Media Bottles Shortage Impact Questionnaire (Jul-Oct)
Becton Dickinson BACTECTM Blood Culture Media Bottles Shortage Impact Questionnaire (Nov-Mar)	57.109	Becton Dickinson BACTECTM Blood Culture Media Bottles Shortage Impact Questionnaire (Nov-Mar)

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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	7,000	0	0	7,000	0	0
Annual Time Burden (Hours)	2,334	0	0	2,334	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 Becton Dickinson BACTECTM Blood Culture Media Bottles Shortage is a NEW EMERGENCY ICR

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Annual Cost to Federal Government: $167,357

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.     No

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)? Yes

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: 09/27/2024

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