[Federal Register Volume 74, Number 166 (Friday, August 28, 2009)]
[Notices]
[Page 44365]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-20793]


=======================================================================
-----------------------------------------------------------------------

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 [email protected], 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

----------------------------------------------------------------------------------------------------------------
                                                                    Number of     Average burden
               Type of respondent                   Number of     responses per      hours per      Total hour
                                                   respondents      respondent       response         burden
----------------------------------------------------------------------------------------------------------------
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
                                                ----------------------------------------------------------------
        Total..................................  ..............  ...............  ..............          18,285
----------------------------------------------------------------------------------------------------------------


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