42076 Federal Register / Vol. 74, No. 160 / Thursday, August 20, 2009 / Notices 

6 MONTHS ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Type of respondent Number of 

respondents 

Number of 

responses/ 

respondent 

Average burden hours per 

response 

Total burden 

hours 

Hospital staff (data collection) ......................................................................... 6000 96 1 576,000 

State/Territory Preparedness staff (training) ................................................... 62 1 1 62 

State/Territory Preparedness staff (data collection) ........................................ 62 288 3 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] 

BILLING CODE 4150–37–P 

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 http://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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–09–09AA] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

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. 

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 


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