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Federal forms, ICRs, and supporting documents

Information Collection Request

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

ICR 202409-0920-008 · OMB 0920-1442 · Active

Forms and Documents
DocumentTypeStatusAvailability
Form 57.109 Becton Dickinson BACTECTM Blood Culture Media Bottles Shortage Impact Questionnaire (Nov-Mar) Form and Instruction New Available
Form 57.109 Becton Dickinson BACTECTM Blood Culture Media Bottles Shortage Impact Questionnaire (Jul-Oct) Form and Instruction New Repair queued
Supporting Statement B.docx Supporting Statement B Uploaded 2024-09-26 Available
Supporting Statement A.docx Supporting Statement A Uploaded 2024-09-26 Available
Emergency Request Memo_Becton Dickinson BACTECTM Blood Culture Media Bottles Shortage_V2.pdf Supplementary Document Uploaded 2024-09-26 Available
G. Human Subject Determination Memo.pdf Supplementary Document Uploaded 2024-09-20 Repair queued
F. Privacy Impact Assessment.pdf Supplementary Document Uploaded 2024-09-20 Available
Emergency Request Memo_Becton Dickinson BACTECTM Blood Culture Media Bottles Shortage.pdf Supplementary Document Uploaded 2024-09-20 Available
D3. Health Alert Network (HAN) - 00512 _ Disruptions in Availability of Becton Dickinson (BD) BACTEC™ Blood Culture Bottles.pdf Supplementary Document Uploaded 2024-09-20 Repair queued
D2. Disruptions in Availability of BD BACTEC Blood Culture Bottles_ Current Situation _ HAIs _ CDC.mhtml Supplementary Document Uploaded 2024-09-20 Repair queued
D1. BD BACTEC™ Update.mhtml Supplementary Document Uploaded 2024-09-20 Repair queued
C. Disruptions in Availability of BD BACTEC Blood Culture Media Bottles - Letter to Health Care Providers _ FDA.pdf Supplementary Document Uploaded 2024-09-20 Available
A3. 42 USC 242m.pdf Supplementary Document Uploaded 2024-09-19 Available
A2. 42 USC 242k.pdf Supplementary Document Uploaded 2024-09-19 Repair queued
A1. 42 USC 242b.pdf Supplementary Document Uploaded 2024-09-19 Repair queued
IC Document Collections
IC IDCollectionTypeStatusForm
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
0920-1442 202409-0920-008
Active
HHS/CDC 0920-24IW
[NCEZID] Becton Dickinson BACTEC(TM) Blood Culture Media Bottles Shortage Impact Questionnaire (NHSN)
New collection (Request for a new OMB Control Number)   No
Emergency 09/27/2024
Approved with change 09/27/2024
Retrieve Notice of Action (NOA) 09/27/2024
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
02/28/2025 5 Months From Approved
7,000 0 0
2,334 0 0
0 0 0
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.
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.
US Code: 42 USC 242 Name of Law: U.S. PHSA
  
None
Not associated with rulemaking
No
  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
Yes
Miscellaneous Actions
No
Submission of Becton Dickinson BACTECTM Blood Culture Media Bottles Shortage is a NEW EMERGENCY ICR
$167,357
Yes Part B of Supporting Statement
    No
    No
No
No
Yes
No
Jeffrey Zirger 404 639-7118 [email protected]
  No
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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
09/27/2024