Assessment for 2009-H1N1 Influenza Critical Illness

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 1 ARDS_NET ICU form for all data collction under this request - NHILBI Clinical CC	Form and Instruction	New	Repair queued
Form 1 ARDS_NET ICU form for all data collction under this request - Retrospective Collection - Site Investigator	Form and Instruction	New	Repair queued
Form 1 ARDS_NET ICU form for all data collction under this request - Retrospective Collection- Research Coordinator	Form and Instruction	New	Repair queued
Form 1 ARDS_NET ICU form for all data collction under this request - Prospective Collection- Site Investigator	Form and Instruction	New	Repair queued
Form 1 ARDS_NET ICU form for all data collction under this request -- Prospective Collection - Research Coordinator	Form and Instruction	New	Repair queued
Form 1 ARDS_NET ICU form for all data collction under this request --IRB Clearance	Form and Instruction	New	Repair queued
Form 1 ARDS_NET ICU form for all data collction under this request --IRB clearance	Form and Instruction	New	Repair queued
CriticalCare Emergency Request 8.31.2009.doc	Supporting Statement A	Uploaded 2009-08-31	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
190535	ARDS_NET ICU form for all data collction under this request - NHILBI Clinical CC	Form and Instruction	New
190534	ARDS_NET ICU form for all data collction under this request - Retrospective Collection - Site Investigator	Form and Instruction	New
190533	ARDS_NET ICU form for all data collction under this request - Retrospective Collection- Research Coordinator	Form and Instruction	New
190532	ARDS_NET ICU form for all data collction under this request - Prospective Collection- Site Investigator	Form and Instruction	New
190531	ARDS_NET ICU form for all data collction under this request -- Prospective Collection - Research Coordinator	Form and Instruction	New
190530	ARDS_NET ICU form for all data collction under this request --IRB Clearance	Form and Instruction	New
190529	ARDS_NET ICU form for all data collction under this request --IRB clearance	Form and Instruction	New

ICR Details

OMB Control No:	ICR Reference No: 200908-0990-011
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/HHSDM	Agency Tracking No:
Title: Assessment for 2009-H1N1 Influenza Critical Illness
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: 09/01/2009
OIRA Conclusion Action: Withdrawn	Conclusion Date: 09/01/2009
	Date Received in OIRA: 08/31/2009
Terms of Clearance: This is being withdrawn for correction, and will be resubmitted immediately thereafter.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		6 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The overarching purpose of this initiative is to better understand critical illness in 2009-H1N1 patients and to be able to better respond to the needs of these patients. Currently our main source of data is case reports, which lacks timeliness and sufficient numbers of patients to assure that these non-scientific snapshots represent the broad experience across US ICUs. Collecting patient level data through a research network will allow us to understand the disease course of critically ill patients, what clinical resources they require, and what conditions they may be at increased risk for (e.g., secondary bacterial infections and pulmonary thromboembolism).

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. As part of the National Framework for 2009-H1N1 Influenza Preparedness and Response, Surveillance pillar, HHS is tasked with mobilizing all national resources to develop and implement novel strategies to enhance domestic surveillance and clinical data sharing. A comprehensive assessment of public health and medical data streams has been undertaken by HHS, and information regarding critically ill has been determined to be woefully inadequate to meet HHS's mission to assist public health and local healthcare systems minimize suffering and maximize lives saved. Hence, a novel data collection mechanism must collect and report data faster than the current surveillance mechanisms for ICU patients and also include much more detailed clinical information.

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Authorizing Statute(s): US Code: 42 USC 2811 Name of Law: US Public Health Service Act
   US Code: 42 USC 301 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: 7

table that charts list of burden

IC Title	Form No.	Form Name
ARDS_NET ICU form for all data collction under this request -- Prospective Collection - Research Coordinator	1	ARDS NET ICU Reporting Form
ARDS_NET ICU form for all data collction under this request - Prospective Collection- Site Investigator	1	ARDS NET ICU Reporting Form
ARDS_NET ICU form for all data collction under this request - Retrospective Collection- Research Coordinator	1	ARDS NET ICU Reporting Form
ARDS_NET ICU form for all data collction under this request - Retrospective Collection - Site Investigator	1	ARDS NET ICU Reporting Form
ARDS_NET ICU form for all data collction under this request --IRB clearance	1	ARDS NET ICU Reporting Form
ARDS_NET ICU form for all data collction under this request --IRB Clearance	1	ARDS NET ICU Reporting Form
ARDS_NET ICU form for all data collction under this request - NHILBI Clinical CC	1	ARDS NET ICU Reporting Form

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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: This is a new emergency data collection request.

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Annual Cost to Federal Government: $0

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: 08/31/2009

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