Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Investigational New Drug Regulations, 42076 [E9-19972]

Download as PDF 42076 Federal Register / Vol. 74, No. 160 / Thursday, August 20, 2009 / Notices 6 MONTHS ESTIMATED ANNUALIZED BURDEN HOURS—Continued Number of respondents Type of respondent Number of responses/ respondent Average burden hours per response Total burden hours Hospital staff (data collection) ......................................................................... State/Territory Preparedness staff (training) ................................................... State/Territory Preparedness staff (data collection) ........................................ 6000 62 62 96 1 288 1 1 3 576,000 62 53,568 Total .......................................................................................................... ........................ 386 ........................ 635,630 The burden was determined by asking the States that participated in a pilot study to report who collected the data and how long it took them to gather the information. Terry Nicolosi, Paperwork Reduction Act Reports Clearance Officer, Office of the Secretary. [FR Doc. E9–20073 Filed 8–19–09; 8:45 am] information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. Dated: August 13, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E9–19972 Filed 8–19–09; 8:45 am] BILLING CODE 4160–01–S BILLING CODE 4150–37–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Centers for Disease Control and Prevention [Docket No. FDA–2009–N–0030] [30Day–09–09AA] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Investigational New Drug Regulations Agency Forms Undergoing Paperwork Reduction Act Review AGENCY: Food and Drug Administration, HHS. sroberts on DSKD5P82C1PROD with NOTICES ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Investigational New Drug Regulations’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of Information Management (HFA–710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, Elizabeth.Berbakos@fda.hhs.gov, 301– 796–3792. SUPPLEMENTARY INFORMATION: In the Federal Register of May 8, 2009 (74 FR 21690), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0014. The approval expires on August 31, 2011. A copy of the supporting statement for this VerDate Nov<24>2008 16:07 Aug 19, 2009 Jkt 217001 The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 639–5960 or send an e-mail to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to (202) 395–5806. Written comments should be received within 30 days of this notice. Proposed Project BioSense—Recruitment of Data Sources—Existing Data Collection Without an OMB Number—National Center for Public Health Informatics (NCPHI), Coordinating Center for Health Information and Service (CCHIS), Centers for Disease Control and Prevention (CDC). Background and Brief Description Congress passed the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which requires specific activities related to bioterrorism preparedness and response. This congressional mandate outlines the need for improving the overall public’s health through electronic surveillance. PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 The Department of Health and Human Services outlined strategies aimed at achieving this goal via the Public Health IT Initiative thereby creating the BioSense program. BioSense is a national, human health surveillance system designed to improve the nation’s capabilities for disease detection, monitoring, and realtime health situational awareness. This work is enhanced by providing public health real-time access to existing data from healthcare organizations, state syndromic surveillance systems, national laboratories, and others for just in time public health decisionmaking; this information is made available to users in the BioSense Application. The application provides data, charts, graphs, and maps through a secure Webbased interface which can be accessed by CDC and authorized users from state and local public health departments and healthcare organizations. In order to meet the congressional mandate, the BioSense program must have access to electronic health data. Recruitment of data sources includes collecting information on the types of data available, the types of computer systems used, and the approximate record volume. This information is used by BioSense personnel and contractors to determine technical requirements for linking a data source into the BioSense program. To collect this information, a series of questionnaires in an Excel spreadsheet have been designed. Information collection will take place during and after on-site visits by BioSense personnel and contractors. We estimate that such information will be collected from 20 new entities (each representing many facilities or clinics) each year. Since the publication of the 60-day Federal Register Notice, the information collection instrument for the provision of access to the BioSense Application has been included in this information collection request. Access to the BioSense Application is obtained using an automated data collection form. This form is completed on the Internet via the CDC Secure Data Network (SDN) in which a prospective user identifies what E:\FR\FM\20AUN1.SGM 20AUN1

Agencies

[Federal Register Volume 74, Number 160 (Thursday, August 20, 2009)]
[Notices]
[Page 42076]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-19972]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0030]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Investigational New Drug Regulations

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Investigational New Drug 
Regulations'' has been approved by the Office of Management and Budget 
(OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, Elizabeth.Berbakos@fda.hhs.gov, 301-
796-3792.

SUPPLEMENTARY INFORMATION: In the Federal Register of May 8, 2009 (74 
FR 21690), the agency announced that the proposed information 
collection had been submitted to OMB for review and clearance under 44 
U.S.C. 3507. An agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
a currently valid OMB control number. OMB has now approved the 
information collection and has assigned OMB control number 0910-0014. 
The approval expires on August 31, 2011. A copy of the supporting 
statement for this information collection is available on the Internet 
at https://www.reginfo.gov/public/do/PRAMain.

    Dated: August 13, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-19972 Filed 8-19-09; 8:45 am]
BILLING CODE 4160-01-S

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