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Federal Register/ NoticesAugust 20, 2009/ Thursday,74, No. 160/ Vol.
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Bank and Trust Company, Hannibal,and OS document identifier, tohealth officials and healthcare systems Missouri, into a state nonmember bank.Sherette.funncoleman@hhs.gov, or callto ensure effective integration of Federal B. Federal Reserve Bank of Sanpublic health and medical assets duringthe Reports Clearance Office on (202) Francisco(Kenneth Binning, Vicean emergency. ASPR’s National Hospital690–6162. Written comments and President, Applications andrecommendations for the proposedPreparedness Program (HPP) awards Enforcement) 101 Market Street, Saninformation collections must be directedcooperative agreements to each of the 50 Francisco, California 94105–1579:to the OS Paperwork Clearance Officerstates, the Pacific Islands, and US SP Acquisition Holdings, Inc.territories (for a total of 62 awardees) toat the above email address within 7, New York, New York; to become a bankdays. improvesurge capacity and enhance Proposed Project:HAvBED holding company by acquiring 100community and hospital preparedness Assessment for 2009–H1N1 Influenza percent of the voting shares of Frontierfor public health emergencies. These 62 Serious Illness, OMB No. 0990–NEW– Financial Corporation, and therebyawardees are responsible for enhancing HHS Office of the Assistant Secretary indirectly acquire voting shares ofthe preparedness of the nation’s nearly for Preparedness and Response (ASPR), Frontier Bank, both of Everett,6000 hospitals. These awards are Office of Preparedness and Emergency Washington. authorizedunder section 391C–2 of the Operations (OPEO). Public Health Service (PHS) Act. For Board of Governors of the Federal Reserve Abstract:The Office of the Secretary this data collection the 62 HPP System, August 17, 2009. (OS) is requesting emergency action for awardees will gather data from the 6000 Robert deV. Frierson, this clearance by the Office of hospitals using a Webbased interface Deputy Secretary of the Board. Management and Budget no later than known as HAvBED. The data gathered [FR Doc. E9–19991 Filed 8–19–09; 8:45 am] August 28, 2009. ASPR is requesting from the hospitals will be reported to BILLING CODE 6210–01–S emergency processing procedures for the HHS Secretary’s Operations Center this application because this weekly for 6 months. If the seriousness information is needed immediately to of the stress on the hospitals increases DEPARTMENT OF HEALTH ANDhelp reduce morbidity and mortality daily reporting may be requested. HUMAN SERVICESfrom 2009–H1N1 by providing decision Depending on the nature of the makers with timely, usable information [Document Identifier: OS–0990–New] existing systems at the hospitals, the regarding the status of the health care data may be obtained manually or system. The urgent timeline is Agency Emergency Information readily available electronically through supported by the fact that Americans are Collection Clearance Request for existing systems. States would have already becoming ill and even dying Public Comment their own procedures for training staff due to 2009–H1N1 infection, and that on how to use their existing systems, so AGENCY:numerous countries in the SouthernOffice of the Secretary, HHS. there would not be an additional In compliance with the requirementHemisphere (who are currently training burden for learning those of section 3506(c)(2)(A) of theexperiencing their traditional influenza systems. For manual data collection Paperwork Reduction Act of 1995, theseason) have had a large surge in using the HAvBED system personnel Office of the Secretary (OS), Departmentseriously ill patients. The Southern would need to be trained. The system is of Health and Human Services, isHemisphere experience is leading to easy to use and intuitive. The user guide publishing the following summary of avalid anticipation of many additional provides information to help people proposed information collection requestseriously ill patients in the US over the quickly understand how to use the for public comment. Interested personsupcoming months. During the spring system. See Attachment 2 for a copy of are invited to send comments regardingand summer novel H1N1 response in the user guide. Based on the experience this burden estimate or any other aspectthe US, we did not have an adequate of the system administrator in working of this collection of information,understanding of disease severity, with users, training time to learn the including any of the following subjects:health care system resource needs such HAvBED data entry procedures is no (1) The necessity and utility of theas ventilators and ICU beds, and did not more than one hour. On average it takes proposed information collection for thelearn from our collective experiences 40 minutes of explanation and 20 proper performance of the agency’scaring for these seriously ill patients. If minutes of hands on practice with the functions; (2) the accuracy of thewe do not develop a national data training site. estimated burden; (3) ways to enhancecollection mechanism for seriously ill the quality, utility, and clarity of thepeople infected with H1N1 then weThe actual data collection time for the information to be collected; and (4) thecannot adequately support hospitals tohospitals is approximately 1 hour and use of automated collection techniquescare for these patients.the states will spend approximately 3 or other forms of informationPursuant to section 2811 of the PHShours compiling the information from technology to minimize the informationAct, the ASPR serves as the principalall of the hospitals in their State/ collection burden. To obtain copies ofadvisor to the Secretary on all mattersterritory. For automated systems the the supporting statement and anyrelated to Federal public health andtime would be less. These estimates are related forms for the proposedmedical preparedness and response forbased on a pilot test of the system. This paperwork collections referenced above,public health emergencies. In additioncost model assumes daily data email your request, including yourto other tasks, the ASPR coordinatescollection over 3 months and weekly for address, phone number, OMB number,with State, local, and tribal public3 months. 6 MONTHSESTIMATEDANNUALIZEDBURDENHOURSNumber ofAverage bur Number ofTotal burden Type of respondentresponses/ denhours per respondents hours respondent response Hospital staff (Training)................................................................................... 60001 16000
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Federal Register/ Thursday,August 20, 2009/ Vol.74, No. 160/ Notices
6 MONTHSESTIMATEDANNUALIZEDBURDENHOURS—Continued Number ofAverage bur Number ofTotal burden Type of respondentresponses/ denhours per respondents hours respondent response Hospital staff (data collection)......................................................................... 600096 1576,000 State/Territory Preparedness staff (training)................................................... 621 162 State/Territory Preparedness staff (data collection) ........................................62 2883 53,568 Total .................................................................................................................................. 386........................ 635,630
The burden was determined by askinginformation collection is available onThe Department of Health and Human the States that participated in a pilotthe Internet athttp://www.reginfo.gov/Services outlined strategies aimed at study to report who collected the datapublic/do/PRAMainthis goal via the Public Health. achieving and how long it took them to gather theIT Initiative thereby creating the Dated: August 13, 2009. information. BioSenseprogram. Jeffrey Shuren, BioSense is a national, human health Terry Nicolosi,Associate Commissioner for Policy and surveillance system designed to Planning. Paperwork Reduction Act Reports Clearance improve the nation’s capabilities for Officer, Office of the Secretary.[FR Doc. E9–19972 Filed 8–19–09; 8:45 am] disease detection, monitoring, and real [FR Doc. E9–20073 Filed 8–19–09; 8:45 am]BILLING CODE 4160–01–S time health situational awareness. This BILLING CODE 4150–37–P work is enhanced by providing public health realtime access to existing data DEPARTMENT OF HEALTH AND from healthcare organizations, state DEPARTMENT OF HEALTH ANDHUMAN SERVICES syndromic surveillance systems, HUMAN SERVICES national laboratories, and others for just Centers for Disease Control and in time public health decisionmaking; Food and Drug AdministrationPrevention this information is made available to [Docket No. FDA–2009–N–0030] [30Day–09–09AA] users in the BioSense Application. The application provides data, charts, Agency Information Collection Agency Forms Undergoing Paperwork graphs, and maps through a secure Web Activities; Announcement of Office of Reduction Act Review based interface which can be accessed Management and Budget Approval; by CDC and authorized users from state The Centers for Disease Control and Investigational New Drug Regulations and local public health departments and Prevention (CDC) publishes a list of AGENCY:Food and Drug Administration,healthcare organizations. information collection requests under HHS. Inorder to meet the congressional review by the Office of Management and mandate, the BioSense program must ACTION:(OMB) in compliance with theNotice. Budget have access to electronic health data. Paperwork Reduction Act (44 U.S.C. SUMMARY:The Food and Drug Recruitment of data sources includes Chapter 35). To request a copy of these Administration (FDA) is announcing collecting information on the types of requests, call the CDC Reports Clearance that a collection of information entitled data available, the types of computer Officer at (404) 639–5960 or send an ‘‘Investigational New Drug Regulations’’ systems used, and the approximate email toomb@cdc.gov. Send written has been approved by the Office of record volume. This information is used comments to CDC Desk Officer, Office of Management and Budget (OMB) under by BioSense personnel and contractors Management and Budget, Washington, the Paperwork Reduction Act of 1995. to determine technical requirements for DC or by fax to (202) 395–5806. Written FOR FURTHER INFORMATION CONTACT:linking a data source into the BioSense comments should be received within 30 Elizabeth Berbakos, Office ofprogram. To collect this information, a days of this notice. Information Management (HFA–710),series of questionnaires in an Excel Proposed Project Food and Drug Administration, 5600spreadsheet have been designed. Fishers Lane, Rockville, MD 20857, BioSense—Recruitment of DataInformation collection will take place Elizabeth.Berbakos@fda.hhs.gov,301– duringand after onsite visits by Sources—Existing Data Collection 796–3792. BioSensepersonnel and contractors. We Without an OMB Number—National SUPPLEMENTARY INFORMATION:Center for Public Health InformaticsIn theestimate that such information will be Federal Register(NCPHI),of May 8, 2009 (74 FRCoordinating Center for Healthcollected from 20 new entities (each 21690), the agency announced that theInformation and Service (CCHIS), representingmany facilities or clinics) proposed information collection hadCenters for Disease Control andeach year. been submitted to OMB for review andPrevention (CDC).Since the publication of the 60day clearance under 44 U.S.C. 3507. AnFederal RegisterNotice, the information Background and Brief Description agency may not conduct or sponsor, andcollection instrument for the provision a person is not required to respond to,Congress passed the Public Healthof access to the BioSense Application a collection of information unless itSecurity and Bioterrorism Preparednesshas been included in this information displays a currently valid OMB controland Response Act of 2002, whichcollection request. Access to the number. OMB has now approved therequires specific activities related toBioSense Application is obtained using information collection and has assignedbioterrorism preparedness and response.an automated data collection form. This OMB control number 0910–0014. TheThis congressional mandate outlines theform is completed on the Internet via approval expires on August 31, 2011. Aneed for improving the overall public’sthe CDC Secure Data Network (SDN) in copy of the supporting statement for thishealth through electronic surveillance.which a prospective user identifies what
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