50968 Federal Register / Vol. 74, No. 190 / Friday, October 2, 2009 / Notices 

all (both rural and non–rural) 

incumbent local exchange 

carriers(LECs) must provide the 

National Exchange Carrier Association 

(NECA) with the loop cost and loop 

count data required by 47 CFR 63.611 of 

the Commission’s rules for each of its 

study areas and, if applicable, for each 

wire center (that term is defined in 47 

CFR Part 54). 

Loops are the telephone lines running 

from the carrier’s switching facilities to 

the customer. The loop cost and loop 

count information is to be field annually 

with NECA by July 31st of each year, 

and may be updated quarterly pursuant 

to 47 CFR 63.612. Pursuant to section 

36.613, the information filed on July 

31st of each year will be used to 

calculate universal service support for 

each study area and is filed by NECA 

with the Commission by October 1 of 

each year. An incumbent LEC is define 

as a carrier that meets the definition of 

‘‘incumbent local exchange carrier’’ in 

47 CFR 51.5 of the Commission’s rules. 

Section 63.612(a) also requires non– 

rural carriers to file loop counts (no loop 

cost data) on a quarterly basis. The 

Commission requires that non–rural 

carriers submit quarterly loop counts in 

order to ensure that universal service 

fund (USF) support for non–rural 

carriers is accurately calculated when 

competitive eligible 

telecommunications carriers (ETCs) are 

present in the incumbent LECs’ 

operating areas. Quarterly loop cost and 

loop count data filings are voluntary for 

rural carriers. When a competitive ETC, 

however, is operating in an incumbent 

rural carrier’s territory, the incumbent 

rural carrier is required to submit 

quarterly loop count data. Quarterly 

filings of loop counts are necessary 

because if an incumbent rural carrier 

does not update its loop count data 

more often than annually, but its 

competitor does, the competitor’s more 

recent data may include loops captured 

from the incumbent since the 

incumbent’s last filing. Thus, the 

incumbent would continue to receive 

USF support at the same per line 

support amount that the incumbent LEC 

receives in the same operating territory. 

In order to receive such support, the 

competitive ETC must file loop count 

data with the USAC on a quarterly basis. 

The reporting requirements are 

necessary to implement the 

congressional mandate for universal 

service. The requirements are necessary 

to verify that rural and non–rural LECs 

are eligible to receive universal service 

support. Information filed with NECA 

pursuant to section 36.611 is used to 

calculate universal service support 

payments to eligible carriers. Without 

this information, NECA and USAC 

(Universal Service Administration 

Company) would not be able to 

calculate such payments to eligible 

carriers. 

Federal Communications Commission. 

Marlene H. Dortch, 

Secretary. 

[FR Doc. E9–23768 Filed 10–1–09; 8:45 am] 

BILLING CODE: 6712–01–S 

FEDERAL ACCOUNTING STANDARDS 

ADVISORY BOARD 

Notice of Issuance of Statement of 

Federal Financial Accounting Standard 

36, Reporting Comprehensive LongTerm Fiscal Projections for the U.S. 

Government 

AGENCY: Federal Accounting Standards 

Advisory Board. 

ACTION: Notice. 

Board Action: Pursuant to 31 U.S.C. 

3511(d), the Federal Advisory 

Committee Act (Pub. L. 92–463), as 

amended, and the FASAB Rules of 

Procedure, as amended in April, 2004, 

notice is hereby given that the Federal 

Accounting Standards Advisory Board 

(FASAB) has issued Statement of 

Federal Financial Accounting Standard 

36, Reporting Comprehensive LongTerm Fiscal Projections for the U.S. 

Government. 

The standard is available on the 

FASAB home page http:// 

www.fasab.gov/standards.html. Copies 

can be obtained by contacting FASAB at 

(202) 512–7350. 

FOR FURTHER INFORMATION CONTACT: 

Wendy Payne, Executive Director, at 

(202) 512–7350. 

Authority: Federal Advisory Committee 

Act, Public Law 92–463. 

Dated: September 29, 2009. 

Charles Jackson, 

Federal Register Liaison Officer. 

[FR Doc. E9–23816 Filed 10–1–09; 8:45 am] 

BILLING CODE 1610–02–P 

FEDERAL RESERVE SYSTEM 

Change in Bank Control Notices; 

Acquisition of Shares of Bank or Bank 

Holding Companies 

The notificants listed below have 

applied under the Change in Bank 

Control Act (12 U.S.C. 1817(j)) and 

§ 225.41 of the Board’s Regulation Y (12 

CFR 225.41) to acquire a bank or bank 

holding company. The factors that are 

considered in acting on the notices are 

set forth in paragraph 7 of the Act (12 

U.S.C. 1817(j)(7)). 

The notices are available for 

immediate inspection at the Federal 

Reserve Bank indicated. The notices 

also will be available for inspection at 

the office of the Board of Governors. 

Interested persons may express their 

views in writing to the Reserve Bank 

indicated for that notice or to the offices 

of the Board of Governors. Comments 

must be received not later than October 

19, 2009. 

A. Federal Reserve Bank of 

Minneapolis (Jacqueline G. King, 

Community Affairs Officer) 90 

Hennepin Avenue, Minneapolis, 

Minnesota 55480–0291: 

1. Earl E. Geiger, Bloomington, 

Minnesota; to acquire voting shares of 

Heritage Bancshares Group, Inc., 

Willmar, Minnesota, and thereby 

indirectly acquire voting shares of 

Heritage Bank, NA, Spicer, Minnesota, 

and Heritage Bank, NA, Holstein, Iowa. 

Board of Governors of the Federal Reserve 

System, September 29, 2009. 

Robert deV. Frierson, 

Deputy Secretary of the Board. 

[FR Doc. E9–23804 Filed 10–1–09; 8:45 am] 

BILLING CODE 6210–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Declaration Under the Public 

Readiness and Emergency 

Preparedness Act 

September 28, 2009. 

AGENCY: Office of the Secretary (OS), 

Department of Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: Declaration pursuant to 

section 319F–3 of the Public Health 

Service Act (42 U.S.C. 247d–6d) to 

provide targeted liability protections for 

pandemic countermeasures based on the 

Secretary’s finding under the Act that 

the 2009–H1N1 virus strain and the 

resulting disease, 2009–H1N1 influenza, 

constitutes a public health emergency. 

DATES: This notice and the attached 

declaration are effective as of the date of 

signature of the declaration. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Nicole Lurie, Assistant Secretary for 

Preparedness and Response, Office of 

the Secretary, Department of Health and 

Human Services, 200 Independence 

Avenue, SW., Washington, DC 20201, 

Telephone (202) 205–2882 (this is not a 

toll-free number). 


pwalker on DSK8KYBLC1PROD with NOTICES
Federal Register / Vol. 74, No. 190 / Friday, October 2, 2009 / Notices 50969 

HHS Secretary’s Declaration for the Use 

of the Public Readiness and Emergency 

Preparedness Act for the Influenza 

Antiviral Peramivir 

Whereas, on April 26, 2009, Acting 

Secretary Charles Johnson determined 

under section 319 of the Public Health 

Service Act, (42 U.S.C. 247d) (‘‘the 

Act’’), that a public health emergency 

exists nationwide involving the Swine 

influenza A virus (now known as 

‘‘2009–H1N1 influenza’’) that affects or 

has significant potential to affect the 

national security; 

Whereas, on July 24, 2009, Secretary 

Kathleen Sebelius renewed the 

determination under section 319 of the 

Public Health Service Act, (42 U.S.C. 

247d) (‘‘the Act’’), that a public health 

emergency exists nationwide involving 

the Swine influenza A virus (now 

known as ‘‘2009–H1N1 influenza’’) that 

affects or has significant potential to 

affect the national security; 

Whereas, the World Health 

Organization has established a 

Pandemic alert phase 6 for the 2009– 

H1N1 influenza virus currently 

circulating worldwide; 

Whereas there are countermeasures 

under development to treat, identify, or 

prevent adverse health consequences or 

death from exposure to 2009–H1N1 

influenza; 

Whereas such countermeasures 

include peramivir; 

Whereas such countermeasures may 

be used and administered in accordance 

with Federal contracts, cooperative 

agreements, grants, interagency 

agreements, clinical trials agreements 

and memoranda of understanding, and 

may also be used and administered at 

the Regional, State, and local level in 

accordance with the public health and 

medical response of the Authority 

Having Jurisdiction; 

Whereas, the possibility of 

governmental program planners 

obtaining stockpiles from private sector 

entities except through voluntary means 

such as commercial sale, donation, or 

deployment would undermine national 

preparedness efforts and should be 

discouraged as provided for in section 

319F–3(b)(2)(E) of the Act (42 U.S.C. 

247d–6d(b)); 

Whereas, immunity under section 

319F–3(a) of the Act should be available 

to governmental program planners for 

distributions of Covered 

Countermeasures obtained voluntarily, 

such as by (1) donation; (2) commercial 

sale; (3) deployment of Covered 

Countermeasures from Federal 

stockpiles; or (4) deployment of 

donated, purchased, or otherwise 

voluntarily obtained Covered 

Countermeasures from State, local, or 

private stockpiles; 

Whereas, the extent of immunity 

under section 319F–3(a) of the Act 

afforded to a governmental program 

planner that obtains Covered 

Countermeasures except through 

voluntary means is not intended to 

affect the extent of immunity afforded 

other covered persons with respect to 

such Covered Countermeasures; 

Whereas, in accordance with section 

319F–3(b)(6) of the Act, I have 

considered the desirability of 

encouraging the design, development, 

clinical testing or investigation, 

manufacturing, labeling, distribution, 

formulation, packaging, marketing, 

promotion, sale, purchase, donation, 

dispensing, prescribing, administration, 

licensing, and use of such 

countermeasures with respect to the 

category of disease and population 

described in sections II and IV below, 

and have found it desirable to encourage 

such activities for the covered 

countermeasures; and 

Whereas, to encourage the design, 

development, clinical testing or 

investigation, manufacturing and 

product formulation, labeling, 

distribution, packaging, marketing, 

promotion, sale, purchase, donation, 

dispensing, prescribing, administration, 

licensing, and use of medical 

countermeasures with respect to the 

category of disease and population 

described in sections II and IV below, it 

is advisable, in accordance with section 

319F–3(a) and (b) of the Act, to provide 

immunity from liability for covered 

persons, as that term is defined at 

section 319F–3(i)(2) of the Act, and to 

include as such covered persons such 

other qualified persons as I have 

identified in section VI of this 

declaration; 

Therefore, pursuant to section 319F– 

3(b) of the Act, I have determined that 

2009–H1N1 influenza and resulting 

disease constitutes a public health 

emergency. 

I. Covered Countermeasures (As 

Required by Section 319F–3(b)(1) of the 

Act) 

Covered Countermeasures are defined 

at section 319F–3(i) of the Act. 

At this time, and in accordance with 

the provisions contained herein, I am 

recommending the manufacturing, 

testing, development, and distribution; 

and, with respect to the category of 

disease and population described in 

sections II and IV below, the 

administration and usage of the 

pandemic countermeasure peramivir. 

The immunity specified in section 

319F–3(a) of the Act shall only be in 

effect with respect to: (1) Present or 

future Federal contracts, cooperative 

agreements, grants, interagency 

agreements, clinical trials agreements or 

memoranda of understanding involving 

countermeasures that are used and 

administered in accordance with this 

declaration, and (2) activities authorized 

in accordance with the public health 

and medical response of the Authority 

Having Jurisdiction to prescribe, 

administer, deliver, distribute or 

dispense the Covered Countermeasure 

following a declaration of an emergency, 

as defined in section IX below. In 

accordance with section 319F–3(b)(2)(E) 

of the Act, for governmental program 

planners, the immunity specified in 

section 319F–3(a) of the Act shall be in 

effect to the extent they obtain Covered 

Countermeasures through voluntary 

means of distribution, such as (1) 

donation; (2) commercial sale; (3) 

deployment of Covered 

Countermeasures from Federal 

stockpiles; or (4) deployment of 

donated, purchased, or otherwise 

voluntarily obtained Covered 

Countermeasures from State, local, or 

private stockpiles. For all other covered 

persons, including other program 

planners, the immunity specified in 

section 319F–3(a) of the Act shall, in 

accordance with section 319F–3(b)(2)(E) 

of the Act, be in effect pursuant to any 

means of distribution. 

This declaration shall subsequently 

refer to the countermeasures identified 

above as ‘‘Covered Countermeasures.’’ 

This declaration shall apply to all 

Covered Countermeasures administered 

or used during the effective period of 

the declaration. 

II. Category of Disease (As Required by 

Section 319F–3(b)(2)(A) of the Act) 

The category of disease, health 

condition, or threat to health for which 

I am recommending the administration 

or use of the Covered Countermeasures 

is the threat of or actual human 

influenza that results from the infection 

of humans with 2009–H1N1 influenza. 

III. Effective Time Period (As Required 

by Section 319F–3(b)(2)(B) of the Act) 

With respect to Covered 

Countermeasures administered and 

used in accordance with present or 

future Federal contracts, cooperative 

agreements, grants, interagency 

agreements, clinical trials agreements or 

memoranda of understanding involving 

countermeasures, the effective period of 

time of this Declaration commenced on 

April 26, 2009, and extends through 

June 1, 2010. With respect to Covered 

Countermeasures administered and 

used in accordance with the public 


pwalker on DSK8KYBLC1PROD with NOTICES
50970 Federal Register / Vol. 74, No. 190 / Friday, October 2, 2009 / Notices 

health and medical response of the 

Authority Having Jurisdiction, the 

effective period of time of this 

Declaration commences on the date of a 

declaration of an emergency, and lasts 

through and includes the final day that 

the emergency declaration is in effect, 

including any extensions thereof, or 

until June 1, 2010, whichever is earlier. 

IV. Population (As Required by Section 

319F–3(b)(2)(C) of the Act) 

Section 319F–3(a)(4)(A) of the Act 

confers immunity to manufacturers and 

distributors of the Covered 

Countermeasure, regardless of the 

defined population. 

Section 319F–3(a)(3)(C)(i) of the Act 

confers immunity to covered persons 

who may be a program planner or 

qualified persons with respect to the 

Covered Countermeasure only if a 

member of the population specified in 

the declaration uses the Covered 

Countermeasure or has the Covered 

Countermeasure administered to him 

and is in or connected to the geographic 

location specified in this declaration, or 

the program planner or qualified person 

reasonably could have believed that 

these conditions were met. 

The populations specified in this 

declaration are all persons who use a 

Covered Countermeasure or to whom a 

Covered Countermeasure is 

administered in accordance with this 

declaration, including, but not limited 

to: (1) Any person conducting research 

and development of Covered 

Countermeasures directly for the 

Federal government or pursuant to a 

contract, grant, or cooperative 

agreement with the Federal government; 

(2) any person who receives a Covered 

Countermeasure from persons 

authorized in accordance with the 

public health and medical emergency 

response of the Authority Having 

Jurisdiction to prescribe, administer, 

deliver, distribute, or dispense the 

Covered Countermeasure, and their 

officials, agents, employees, contractors, 

and volunteers following a declaration 

of an emergency; (3) any person who 

receives a Covered Countermeasure 

from a person authorized to prescribe, 

administer or dispense the 

countermeasure or who is otherwise 

authorized under an Emergency Use 

Authorization; and (4) any person who 

receives a Covered Countermeasure 

pursuant to an Investigational New Drug 

Application (IND) in effect, including in 

human clinical trials being conducted 

directly by the Federal Government or 

pursuant to a contract, grant, or 

cooperative agreement with the Federal 

Government. 

V. Geographic Area (As Required by 

Section 319F–3(b)(2)(D) of the Act) 

Section 319F–3(a) of the Act applies 

to the administration and use of a 

Covered Countermeasure without 

geographic limitation. 

VI. Other Qualified Persons (As 

Required by Section 319F–3(i)(8)(B) of 

the Act) 

With regard to the administration or 

use of a Covered Countermeasure, 

section 319F–3(i)(8)(A) of the Act 

defines the term ‘‘qualified person’’ as a 

licensed individual who is authorized to 

prescribe, administer, or dispense the 

Covered Countermeasure under the law 

of the State in which such covered 

countermeasure was prescribed, 

administered or dispensed. 

Additional persons who are qualified 

persons pursuant to section 319F– 

3(i)(8)(B) are the following: (1) Any 

person authorized in accordance with 

the public health and medical 

emergency response of the Authority 

Having Jurisdiction to prescribe, 

administer, deliver, distribute or 

dispense Covered Countermeasures, and 

their officials, agents, employees, 

contractors and volunteers, following a 

declaration of an emergency, and (2) 

Any person authorized to prescribe, 

administer, or dispense Covered 

Countermeasures or who is otherwise 

authorized under an Emergency Use 

Authorization. 

VII. Additional Time Periods of 

Coverage After Expiration of 

Declaration (As Required by Section 

319F–3(b)(3)(B) of the Act) 

I have determined that, upon 

expiration of the time period specified 

in section III above, an additional 

twelve (12) months is a reasonable 

period to allow for the manufacturer to 

arrange for disposition and covered 

persons to take such other actions as are 

appropriate to limit the administration 

or use of the Covered Countermeasure, 

and the liability protection of section 

319F–3(a) of the Act shall extend for 

that period. 

VIII. Compensation Fund 

Section 319F–4 of the Act provides 

benefits to eligible individuals who 

sustain a covered injury directly caused 

by the administration or use of a 

Covered Countermeasure. The 

Countermeasure Injury Compensation 

Program (CICP), within the Health 

Resources and Services Administration 

(HRSA), administers this compensation 

program. Information about the CICP is 

available at 1–888–275–4772 or http:// 

www.hrsa.gov/countermeasurescomp/ 

default.htm. 

IX. Amendments 

This Declaration has not previously 

been amended. Any future amendment 

to this Declaration will be published in 

the Federal Register, pursuant to 

section 319F–3(b)(4) of the Act. 

X. Definitions 

For the purpose of this declaration, 

including any claim for loss brought in 

accordance with section 319F–3 of the 

PHS Act against any covered persons 

defined in the Act or this declaration, 

the following definitions will be used: 

Administration of a Covered 

Countermeasure: As used in section 

319F–3(a)(2)(B) of the Act includes, but 

is not limited to, public and private 

delivery, distribution, and dispensing 

activities relating to physical 

administration of the countermeasures 

to recipients, management and 

operation of delivery systems, and 

management and operation of 

distribution and dispensing locations. 

Authority Having Jurisdiction: Means 

the public agency or its delegate that has 

legal responsibility and authority for 

responding to an incident, based on 

political or geographical (e.g., city, 

county, tribal, State, or Federal 

boundary lines) or functional (e.g. law 

enforcement, public health) range or 

sphere of authority. 

Covered Persons: As defined at 

section 319F–3(i)(2) of the Act, include 

the United States, manufacturers, 

distributors, program planners, and 

qualified persons. The terms 

‘‘manufacturer,’’ ‘‘distributor,’’ 

‘‘program planner,’’ and ‘‘qualified 

person’’ are further defined at sections 

319F–3(i)(3), (4), (6), and (8), 

respectively, of the Act. 

Declaration of Emergency: A 

declaration by any authorized local, 

regional, State, or Federal official of an 

emergency specific to events that 

indicate an immediate need to 

administer and use pandemic 

countermeasures, with the exception of 

a Federal declaration in support of an 

emergency use authorization under 

section 564 of the FDCA unless such 

declaration specifies otherwise. 

Pandemic Countermeasures: Means 

peramivir, an antiviral from the 

neuraminidase inhibitor class of 

influenza antiviral drugs. 

Dated: September 25, 2009. 

Kathleen Sebelius, 

Secretary. 

[FR Doc. E9–23761 Filed 10–1–09; 8:45 am] 

BILLING CODE 4150–37–P 


pwalker on DSK8KYBLC1PROD with NOTICES