Federal Register / Vol. 74, No. 160 / Thursday, August 20, 2009 / Notices 42075 

Bank and Trust Company, Hannibal, 

Missouri, into a state nonmember bank. 

B. Federal Reserve Bank of San 

Francisco (Kenneth Binning, Vice 

President, Applications and 

Enforcement) 101 Market Street, San 

Francisco, California 94105–1579: 

SP Acquisition Holdings, Inc., New 

York, New York; to become a bank 

holding company by acquiring 100 

percent of the voting shares of Frontier 

Financial Corporation, and thereby 

indirectly acquire voting shares of 

Frontier Bank, both of Everett, 

Washington. 

Board of Governors of the Federal Reserve 

System, August 17, 2009. 

Robert deV. Frierson, 

Deputy Secretary of the Board. 

[FR Doc. E9–19991 Filed 8–19–09; 8:45 am] 

BILLING CODE 6210–01–S 

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: HAvBED 

Assessment for 2009–H1N1 Influenza 

Serious Illness, OMB No. 0990–NEW– 

HHS 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 decision 

makers with timely, usable information 

regarding the status of the health care 

system. The urgent timeline is 

supported by the fact that Americans are 

already becoming ill and even dying 

due to 2009–H1N1 infection, and that 

numerous countries in the Southern 

Hemisphere (who are currently 

experiencing their traditional influenza 

season) have had a large surge in 

seriously ill patients. The Southern 

Hemisphere experience is leading to 

valid anticipation of many additional 

seriously ill patients in the US over the 

upcoming months. During the spring 

and summer novel H1N1 response in 

the US, we did not have an adequate 

understanding of disease severity, 

health care system resource needs such 

as ventilators and ICU beds, and did not 

learn from our collective experiences 

caring for these seriously ill patients. If 

we do not develop a national data 

collection mechanism for seriously ill 

people infected with H1N1 then we 

cannot adequately support hospitals to 

care for these patients. 

Pursuant to section 2811 of the PHS 

Act, the ASPR serves as the principal 

advisor to the Secretary on all matters 

related to Federal public health and 

medical preparedness and response for 

public health emergencies. In addition 

to other tasks, the ASPR coordinates 

with State, local, and tribal public 

health officials and healthcare systems 

to ensure effective integration of Federal 

public health and medical assets during 

an emergency. ASPR’s National Hospital 

Preparedness Program (HPP) awards 

cooperative agreements to each of the 50 

states, the Pacific Islands, and US 

territories (for a total of 62 awardees) to 

improve surge capacity and enhance 

community and hospital preparedness 

for public health emergencies. These 62 

awardees are responsible for enhancing 

the preparedness of the nation’s nearly 

6000 hospitals. These awards are 

authorized under section 391C–2 of the 

Public Health Service (PHS) Act. For 

this data collection the 62 HPP 

awardees will gather data from the 6000 

hospitals using a Web-based interface 

known as HAvBED. The data gathered 

from the hospitals will be reported to 

the HHS Secretary’s Operations Center 

weekly for 6 months. If the seriousness 

of the stress on the hospitals increases 

daily reporting may be requested. 

Depending on the nature of the 

existing systems at the hospitals, the 

data may be obtained manually or 

readily available electronically through 

existing systems. States would have 

their own procedures for training staff 

on how to use their existing systems, so 

there would not be an additional 

training burden for learning those 

systems. For manual data collection 

using the HAvBED system personnel 

would need to be trained. The system is 

easy to use and intuitive. The user guide 

provides information to help people 

quickly understand how to use the 

system. See Attachment 2 for a copy of 

the user guide. Based on the experience 

of the system administrator in working 

with users, training time to learn the 

HAvBED data entry procedures is no 

more than one hour. On average it takes 

40 minutes of explanation and 20 

minutes of hands on practice with the 

training site. 

The actual data collection time for the 

hospitals is approximately 1 hour and 

the states will spend approximately 3 

hours compiling the information from 

all of the hospitals in their State/ 

territory. For automated systems the 

time would be less. These estimates are 

based on a pilot test of the system. This 

cost model assumes daily data 

collection over 3 months and weekly for 

3 months. 

6 MONTHS ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Number of 

respondents 

Number of 

responses/ 

respondent 

Average burden hours per 

response 

Total burden 

hours 

Hospital staff (Training) ................................................................................... 6000 1 1 6000 


sroberts on DSKD5P82C1PROD with NOTICES
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 


sroberts on DSKD5P82C1PROD with NOTICES