ASPR Assessment of Mechanical Ventilators in US Acute Care Hospitals

Forms and Documents

Document Name	Status
Form 1 Positive Pressure Ventilation Survey Form and Instruction	New
Vent Survey_OMB 8.26.2009 FINAL.doc Supporting Statement A	2009-08-26

IC Document Collections

IC ID	Document Title	Status
190469	Positive Pressure Ventilation Survey Form and Instruction	New

ICR Details

OMB Control No: 0990-0341	ICR Reference No: 200908-0990-008
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/HHSDM	Agency Tracking No:
Title: ASPR Assessment of Mechanical Ventilators in US Acute Care Hospitals
Type of Information Collection: Existing collection in use without an OMB Control Number	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 08/28/2009
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/27/2009
	Date Received in OIRA: 08/26/2009
Terms of Clearance: 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
Expiration Date	02/28/2010	6 Months From Approved
Responses	5,678	0	0
Time Burden (Hours)	7,098	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

Emergency Justfication: 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.

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Authorizing Statute(s): US Code: 42 USC 2811 Name of Law: US Public Health Service Act
  

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

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

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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	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

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: An emergency clearance is being requested to bring the data oollection into compliance with the PRA.

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Annual Cost to Federal Government: $136,200

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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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: 08/26/2009

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