E9-20793. Agency Emergency Information Collection Clearance Request for Public Comment

AGENCY:

Office of the Secretary, HHS.

In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed information collection request for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, e-mail your request, including your address, phone number, OMB number, and OS document identifier, to [e-mail], or call the Reports Clearance Office on [phone]. Written comments and recommendations for the proposed information collections must be directed to the OS Paperwork Clearance Officer at the above e-mail address within 7 days.

Proposed Project: Rapid Assessment of Critical Illness Due to 2009-H1N1 Influenza OMB No. 0990-New—Office of the Assistant Secretary for Preparedness and Response (ASPR), Office of Preparedness and Emergency Operations (OPEO).

Abstract: The Office of the Secretary (OS) is requesting emergency action for this clearance by the Office of Management and Budget no later than August 28, 2009. ASPR is requesting emergency processing procedures for this application because this information is needed immediately to help reduce morbidity and mortality from 2009-H1N1 by providing near real-time critical care data streams and analyses to strengthen our response to 2009-H1N1 influenza. Specifically, HHS officials will use this information to inform up-to-date clinical practice guidance to front-line clinicians. Also, this data will be used by HHS to guide resource planning actions to assure that healthcare systems have optimal access to treatments and supportive care medical material for critically ill patients. Lastly, this data stream network can serve as platform for which to build critical care clinical trials for H1N1. 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).

Estimate Annualized Burden Hours

Type of respondent	Number of respondents	Number of responses per respondent	Average burden hours per response	Total hour burden
IRB Submission (Research Coordinator)	120	1	20	2400
IRB Submission (Site Coordinator)	120	1	2	240
Prospective Patient Data Collection and Transmittal to Coordinating Center (Research Coordinator)	2000	1	6	12000
(Site Investigator)	2000	1	30/60	1000
Retrospective Patient Data Collection and Transmittal to Coordinating Center (Research Coordinator)	250	1	8	2000
(Site Investigator)	250	1	30/60	125
NHLBI Clinical Coordinating Center, 0.5 FTE	1	1	520	520
Total				18,285

Seleda Perryman,

Paperwork Reduction Act Reports Clearance Officer, Office of the Secretary.