[Federal Register: August 28, 2009 (Volume 74, Number 166)]
[Notices]
[Page 44365]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28au09-52]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-New]
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 Sherette.funncoleman@hhs.gov, or call
the Reports Clearance Office on (202) 690-6162. 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
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Number of Average burden
Type of respondent Number of responses per hours per Total hour
respondents respondent response burden
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IRB Submission (Research Coordinator).......... 120 1 20 2400
IRB Submission (Site Coordinator).............. 120 1 2 240
Prospective Patient Data Collection and 2000 1 6 12000
Transmittal to Coordinating Center (Research
Coordinator)..................................
(Site Investigator)............................ 2000 1 30/60 1000
Retrospective Patient Data Collection and 250 1 8 2000
Transmittal to Coordinating Center (Research
Coordinator)..................................
(Site Investigator)............................ 250 1 30/60 125
NHLBI Clinical Coordinating Center, 0.5 FTE.... 1 1 520 520
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Total.................................. .............. ............... .............. 18,285
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Seleda Perryman,
Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. E9-20793 Filed 8-27-09; 8:45 am]
BILLING CODE 4150-37-P