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
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.