ASPR Assessment of Mechanical Ventilators in US Acute Care Hospitals

ICR 200908-0990-008

OMB: 0990-0341

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
New
Supporting Statement A
2009-08-26
IC Document Collections
ICR Details
0990-0341 200908-0990-008
Historical Active
HHS/HHSDM
ASPR Assessment of Mechanical Ventilators in US Acute Care Hospitals
Existing collection in use without an OMB Control Number   No
Emergency 08/28/2009
Approved without change 08/27/2009
Retrieve Notice of Action (NOA) 08/26/2009
This information collection request is approved for 6 months, as requested. OMB notes that Part B of the Supporting STatement is included in the same document as Part A.
  Inventory as of this Action Requested Previously Approved
02/28/2010 6 Months From Approved
5,678 0 0
7,098 0 0
0 0 0

The overarching purpose of this initiative is to determine the types and quantities of mechanical ventilators in US acute care hospitals so that patients with respiratory failure during the pandemic will have access to adequate mechanical ventilation and have an optimal chance of survival. This information will be used to populate baseline mechanical ventilation equipment assumptions in HHS 2009-H1N1 prediction models to predict possible resource vulnerabilities. This information will be used to assist policymakers and scientific advisors to determine if additional respiratory equipment needs to be made available to US hospitals through strategies such as enhancing the numbers of ventilators and ancillary respiratory equipment in the Strategic National Stockpile. Also, this information will be used to work with industry partners through the HHS/ASPR Critical Infrastructure Program to maximize supply chain support of mechanical ventilation.
The Department of Health and Human Services (HHS), Office of the Assistant Secretary for Preparedness and Response (ASPR) is requesting Office of Management and Budget (OMB) emergency review and approval of this mission critical data collection effort to determine the quantities and types of mechanical ventilators in US acute care hospitals. Since its emergence in North America during early 2009, novel influenza A (H1N1) virus has spread among people worldwide to cause a pandemic. While most ill persons experience self-limited mild illness, approximately 20% of hospitalized patients with severe complications have required intensive care unit (ICU) admission. Most of the adult patients and many of the children requiring ICU care due to 2009-H1N1 have required mechanical ventilation for survival; despite being very ill, the majority of patients have survived. The severity of illness described within the current case-series descriptions of critically ill patients with 2009-H1N1 (albeit this scope and breadth of clinical ICU data to date has been quite limited) suggest that if these patients were not able to access resource-intensive ICU care including mechanical ventilation then the vast majority would have almost assuredly died. Therefore, one of the mission critical elements of 2009-H1N1 HHS planning and response is to support hospitals across the nation to have sufficient quantities of mechanical ventilators and ancillary respiratory equipment to care for their patients.

US Code: 42 USC 2811 Name of Law: US Public Health Service Act
  
None

Not associated with rulemaking

No

1
IC Title Form No. Form Name
Positive Pressure Ventilation Survey 1 Positive Pressure Ventilation Survey

  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 5,678 0 0 5,678 0 0
Annual Time Burden (Hours) 7,098 0 0 7,098 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
An emergency clearance is being requested to bring the data oollection into compliance with the PRA.

$136,200
No
No
Uncollected
Uncollected
No
Uncollected
Saleda Perryman

  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.
08/26/2009


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