Federal Register / Vol. 74, No. 191 / Monday, October 5, 2009 / Notices 51153 

substitutes for bulk de-icing salt to melt 

snow and ice. The relevant geographic 

markets in which to assess the impact 

of the proposed Acquisition are the 

states of Maine and Connecticut. 

The relevant markets are highly 

concentrated. ISCO and Morton are the 

two principal bidders in the states of 

Maine and Connecticut for the sale and 

delivery of bulk de-icing salt. Post 

acquisition, the combined entity will 

have a market share exceeding 70 

percent in both Maine and Connecticut. 

Post-merger HHIs for Maine and 

Connecticut are 5,142 and 5,834, and 

the acquisition will increase HHI levels 

by 1,914 and 2,642, respectively. These 

market concentration levels far exceed 

the thresholds set forth in the 

Horizontal Merger Guidelines and thus 

create a presumption that the proposed 

merger will create or enhance market 

power. 

Entry into the relevant markets is 

difficult because, among other things, 

there is a lack of acceptable stockpile 

space along the coasts of Maine and 

Connecticut. As a result, new entry 

sufficient to achieve a significant market 

impact within two years is unlikely. 

Finally, the Complaint alleges that the 

proposed Acquisition will reduce 

competition in the relevant markets by 

eliminating direct and substantial 

competition between ISCO and Morton, 

and by increasing the likelihood that 

ISCO would increase prices either 

unilaterally or through coordinated 

interaction with the few remaining firms 

in the relevant markets. 

IV. The Consent Agreement 

To preserve the competition that 

otherwise would be eliminated by the 

Acquisition, the proposed Consent 

Agreement requires ISCO to divest to 

Commission-approved buyers, Eastern 

Salt and Granite State, assets sufficient 

to enable these buyers to become viable 

competitors for the de-icing salt 

business in the relevant markets 

beginning with the 2010-2011 bidding 

cycle. ISCO will divest to Eastern Salt 

the Maine Divestiture Assets, including: 

1) stockpile space in the state, 2) all 

associated handling and trucking 

contracts, and 3) a book of de-icing salt 

business for the 2009-2010 winter 

season. ISCO will divest to Granite State 

the Connecticut Divestiture Assets, 

including: 1) stockpile space in the 

state, 2) all associated handling and 

trucking contracts, 3) a book of de-icing 

salt business for the 2009-2010 winter 

season, and 4) a three-year supply of deicing salt at a price that is no more than 

ISCO’s costs. 

The Commission has preliminarily 

determined that Eastern Salt is a wellqualified buyer of the Maine Divestiture 

Assets and is well situated to replace 

the competition Morton provided in the 

state. Eastern Salt is a family-owned 

company that has been a de-icing salt 

supplier in other geographic markets 

along the East Coast for roughly 60 

years. Eastern Salt is a verticallyintegrated supplier with a dependable, 

high-quality supply of de-icing salt. 

With the divested assets, Eastern Salt 

will be well positioned to compete for 

future business in Maine and to deliver 

salt to customers in a timely manner. 

The Commission has preliminarily 

determined that Granite State is a wellqualified buyer of the Connecticut 

Divestiture Assets and is well situated 

to replace the competition Morton 

provided in the state. Granite State has 

experience supplying de-icing salt to 

customers in a number of states along 

the East Coast. The Consent Agreement 

requires ISCO to provide Granite State 

with a three-year supply of bulk deicing salt at no more than ISCO’s costs. 

The supply requirement will ensure that 

Granite State has a supply of salt in 

Connecticut during the 2010-2011 and 

2011-2012 bid cycles while Granite 

State develops the necessary supply 

arrangements to serve Connecticut 

customers in subsequent years. With the 

divested assets, Granite State will be 

well positioned to compete for future 

business in Connecticut and to deliver 

salt to customers in a timely manner. 

The proposed Consent Agreement 

requires that the divestitures occur no 

later than twenty (20) days after the 

Acquisition is consummated. However, 

if ISCO divests the assets to Eastern Salt 

or Granite State during the public 

comment period, and if, at the time the 

Commission decides to make the Order 

final, the Commission notifies K+S or 

ISCO that either purchaser is not an 

acceptable acquirer or that the asset 

purchase agreement with the Maine 

Purchaser or Connecticut Purchaser is 

not an acceptable manner of divestiture, 

then ISCO must immediately rescind 

the transaction in question and divest 

those assets to another buyer within six 

(6) months of the date the Order 

becomes final. At that time, 

Respondents must divest those assets 

only to an acquirer and in a manner that 

receives the prior approval of the 

Commission. The proposed Consent 

Agreement also enables the Commission 

to appoint a trustee to divest any assets 

identified in the Order that K+S or ISCO 

has not divested to satisfy the 

requirements of the Order. 

The proposed Consent Agreement 

further requires K+S and ISCO to 

maintain the viability and marketability 

of the Maine Divestiture Assets and the 

Connecticut Divestiture Assets and to 

prevent the destruction, removal, 

wasting, deterioration, or impairment of 

those assets prior to divestiture. 

In order to ensure that the 

Commission remains informed about 

the status of the divestitures, the 

proposed Consent Agreement requires 

K+S and ISCO to file reports with the 

Commission periodically until the 

divestitures are completed. Written 

reports describing how K+S and ISCO 

are complying with the Order must be 

filed one year after the Order becomes 

final and annually for the next three (3) 

years. 

The purpose of this analysis is to 

facilitate public comment on the 

proposed Consent Agreement, and it is 

not intended to constitute an official 

interpretation of the proposed Consent 

Agreement or to modify its terms in any 

way. 

By direction of the Commission. 

Donald S. Clark 

Secretary. 

[FR Doc. E9–23826 Filed 10–2–09: 6:40 am] 

BILLING CODE: 6750–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Pandemic Influenza Vaccines— 

Amendment 

Authority: 42 U.S.C. 247d–6d. 

ACTION: Notice of first amendment to the 

June 15, 2009 Republished Declaration 

under the Public Readiness and 

Emergency Preparedness Act. 

SUMMARY: Amendment to declaration 

issued on June 15, 2009 (74 FR 30294) 

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 to add 

provisions consistent with other 

declarations issued under this authority 

that may facilitate vaccination 

campaigns, and republication of the 

declaration to reflect the declaration in 

its entirety, as amended. 

DATES: The first amendment of the 

republished declaration issued on June 

15, 2009 is effective as of September 28, 

2009. 

FOR FURTHER INFORMATION CONTACT: 

Nicole Lurie, MD, MSPH, Assistant 

Secretary for Preparedness and 

Response, Office of the Secretary, 

Department of Health and Human 

Services, 200 Independence Avenue, 

SW., Washington, DC 20201, Telephone 


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51154 Federal Register / Vol. 74, No. 191 / Monday, October 5, 2009 / Notices 

(202) 205–2882 (this is not a toll-free 

number). 

HHS Secretary’s Amendment to the 

June 15, 2009 Republished Declaration 

for the Use of the Public Readiness and 

Emergency Preparedness Act for H5N1, 

H2, H6, H9 and 2009–H1N1 Vaccines: 

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 that affects or has 

significant potential to affect the 

national security (now called ‘‘2009– 

H1N1 influenza’’); 

Whereas, on July 24, 2009, I renewed 

the determination by the Acting 

Secretary that a public health 

emergency exists nationwide involving 

the Swine influenza A virus (now called 

‘‘2009–H1N1 influenza’’); 

Whereas, the World Health 

Organization has established a 

Pandemic alert phase 6 for the 2009– 

H1N1 influenza virus currently 

circulating worldwide; 

Whereas, vaccination may be effective 

to protect persons from the threat of 

pandemic influenza; 

Whereas, provisions that appear in 

other declarations issued pursuant to 

section 319F–3 of the Public Health 

Service Act (42 U.S.C. 247d–6d) may 

assist in vaccination efforts; 

Whereas, Secretary Michael O. Leavitt 

issued a Declaration for the Use of the 

Public Readiness and Emergency 

Preparedness Act dated January 26, 

2007 (‘‘Original Declaration’’), as 

amended on November 30, 2007 and 

October 17, 2008 with respect to certain 

avian influenza viruses; 

Whereas, I amended the declaration 

on June 15, 2009 which was republished 

in its entirety; 

Whereas, modifications are necessary 

to aid States, Tribes, localities and other 

entities in conducting vaccination 

campaigns to make this declaration 

consistent with other declarations 

issued pursuant to section 319F–3 of the 

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

247d–6d), and to correct a previous, 

minor, editorial error; 

Whereas, the findings I made in the 

declaration issued on June 15, 2009 

continue to apply; 

Whereas, in accordance with section 

319F–3(b)(6) of the Act (42 U.S.C. 247d– 

6d(b)), 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 additional covered 

countermeasures with respect to the 

category of disease and population 

described in sections II and IV of the 

republished Original Declaration, and 

have found it desirable to encourage 

such activities for these additional 

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 of the 

June 15, 2009 Republished Declaration, 

as hereby amended, 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 other qualified persons as I 

have identified in section VI of the June 

15, 2009 Republished Declaration, as 

amended; 

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. In order to aid States, 

Tribes, localities and other entities in 

vaccination campaigns, to make this 

Declaration consistent with other 

Declarations issued pursuant to section 

319F–3 of the Public Health Service Act 

(42 U.S.C. 247d–6d) and to correct a 

previous, minor, editorial error, the June 

15, 2009 Republished Declaration, is 

hereby amended as follows: 

In the title, add ‘‘H7’’ before ‘‘or H9’’. 

After the fifth ‘‘whereas’’ clause, 

insert two new recitals as follows: 

Whereas, on July 24, 2009, I renewed 

the determination by the Acting 

Secretary that a public health 

emergency exists nationwide involving 

the Swine influenza A virus (now called 

‘‘2009–H1N1 influenza virus’’); 

Whereas, vaccination may be effective 

to protect persons from the threat of 

pandemic influenza; 

In section I, second paragraph, strike 

the second sentence, and insert after the 

first sentence: ‘‘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, or memoranda 

of understanding for pandemic 

countermeasure influenza A H5N1, H2, 

H6, H7, H9, and 2009 H1N1 vaccines 

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 pandemic 

countermeasures following a declaration 

of an emergency, as defined in section 

IX below. 

In section III, add a second paragraph 

as follows: ‘‘With respect to Covered 

Countermeasures administered and 

used in accordance with the public 

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; except 

that with respect to 2009 H1N1 

influenza vaccine, the effective period 

commences on June 15, 2009 and 

extends through March 31, 2013.’’ 

Section VI, strike the second sentence 

and insert after the first sentence: 

‘‘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.’’ 

After Section VII, insert new Section 

VIII as follows and renumber 

subsequent sections: 

VIII. Compensation Fund 

In addition to conferring immunity to 

manufacturers, distributors, and 

administrators of the Covered 

Countermeasures, the Act provides 

benefits to certain individuals who 

sustain a covered injury as the direct 

result of the administration of the 

Covered Countermeasure. The 

Countermeasure Injury Compensation 

Program (CICP) within the Health 

Resources and Services Administration 

(HRSA) administers the Act’s 

compensation program. Information 

about the CICP is available at 1–888– 

275–4772 or http://www.hrsa.gov/ 

countermeasurescomp/default.htm. 

Section VIII, strike the first sentence 

and insert: ‘‘The Declaration for the Use 

of the Public Readiness and Emergency 

Preparedness Act for H5N1 was 

published on January 26, 2007; 

amended on November 30, 2007 to add 


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H7 and H9 vaccines; amended on 

October 17, 2008 to add H2 and H6 

vaccines; amended on June 15, 2009 to 

add 2009 H1N1 vaccines and 

republished in its entirety.’’ 

Section IX, strike in its entirety, and 

insert: ‘‘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) 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 Phase: the following stages, 

as defined in the National Strategy for 

Pandemic Influenza: Implementation 

Plan (Homeland Security Council, May 

2006): (4) First Human Case in North 

America; and (5) Spread Throughout 

United States. 

Pre-pandemic Phase: the following 

stages, as defined in the National 

Strategy for Pandemic Influenza: 

Implementation Plan (Homeland 

Security Council, May 2006): (0) New 

Domestic Animal Outbreak in At-Risk 

Country; (1) Suspected Human Outbreak 

Overseas; (2) Confirmed Human 

Outbreak Overseas; and (3) Widespread 

Human Outbreaks in Multiple Locations 

Overseas.’’ 

Appendix I, ‘‘I. List of U.S 

Government Contracts—Covered H5N1 

Vaccine Contracts,’’ title, add ‘‘, H2, H6, 

H9, and 2009–H1N1’’ after ‘‘H5N1’’; 

delete ‘‘[January 26, 2007]’’ and add to 

the end of the list, ‘‘32. All present, 

completed and future Government 

H5N1, H2, H6, H9, and 2009–H1N1 

vaccine contracts not otherwise listed.’’ 

All other provisions of the June 15, 

2009 Republished Declaration remain in 

full force. 

Republication of HHS Secretary’s June 

15, 2009 Republished Declaration, as 

Amended, for the Use of the Public 

Readiness and Emergency Preparedness 

Act for H5N1, H2, H6, H9, and 2009 

H1N1 Vaccines. 

To the extent any term of the June 15, 

2009 Republished Declaration, as 

hereby amended, is inconsistent with 

any provision of this Republished 

Declaration, the terms of this 

Republished Declaration are controlling. 

HHS Secretary’s Declaration for the Use 

of the Public Readiness and Emergency 

Preparedness Act for H5N1, H2, H6, H7, 

H9, and 2009–H1N1 Vaccines 

Whereas highly pathogenic avian 

influenza A H5N1, H7, and H9 have 

spread by infected migratory birds and 

exports of live poultry from Asia 

through Europe and Africa since 2004, 

and could spread into North America in 

2006 or later, and have caused disease 

in humans with an associated high case 

fatality upon infection with this virus; 

Whereas, the H2 class of influenza 

viruses, which caused the human 

influenza pandemic of 1957 and 

reappeared recently in U.S. animals 

including swine, is viewed as a likely 

candidate to re-evolve into an influenza 

strain capable of causing a pandemic of 

human influenza; 

Whereas, the H6 class of influenza 

viruses, which appeared recently in 

animals including domestic fowl, is 

viewed as a likely candidate to evolve 

into an influenza strain capable of 

causing a pandemic of human influenza; 

Whereas, an H5N1, H2, H6, H7 or H9 

avian influenza virus may evolve into 

strain capable of causing a pandemic of 

human influenza; 

Whereas, on April 26, 2009, Acting 

Secretary Charles E. Johnson 

determined under section 319 of the 

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

247d), that a public health emergency 

exists nationwide involving the Swine 

Influenza A virus that affects or has 

significant potential to affect the 

national security (now called ‘‘2009– 

H1N1 influenza’’); 

Whereas, on July 24, 2009, I renewed 

the determination by the Acting 

Secretary that a public health 

emergency exists nationwide involving 

the Swine influenza A virus (now called 

‘‘2009–H1N1 influenza virus’’); 

Whereas, vaccination may be effective 

to protect persons from the threat of 

pandemic influenza; 

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 Public Health 

Service Act (42 U.S.C. 247d–6d(b)) (‘‘the 

Act’’); 

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, 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 section II and IV 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; 

Whereas, in accordance with section 

319F–3(b)(6) of the Public Health 

Service Act (42 U.S.C. 247d–6d(b)) (‘‘the 

Act’’), I have considered the desirability 

of encouraging the design, development, 

clinical testing or investigation, 

manufacturing and product formulation, 

labeling, distribution, packaging, 


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51156 Federal Register / Vol. 74, No. 191 / Monday, October 5, 2009 / Notices 

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, and have found it desirable to 

encourage such activities for the 

Covered Countermeasures; 

Therefore, pursuant to section 319F– 

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

is a credible risk that the spread of avian 

influenza viruses and resulting disease 

could in the future constitute a public 

health emergency, and that 2009 H1N1 

influenza 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 manufacture, testing, 

development, distribution, dispensing; 

and, with respect to the category of 

disease and population described in 

sections II and IV, below, the 

administration and usage of the 

pandemic countermeasures influenza A 

H5N1, H2, H6, H7, H9, and 2009 H1N1 

vaccines and any associated adjuvants. 

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, or memoranda of 

understanding for pandemic 

countermeasure influenza A H5N1, H2, 

H6, H7, H9, and 2009 H1N1 vaccines 

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 pandemic 

countermeasures 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 time period 

of the Declaration. 

II. Category of Disease (as Required by 

Section 319F–3(b)(2)(A) of the Act) 

The category of disease 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 following exposure to the virus 

with (1) highly pathogenic avian 

influenza A (H5N1, H2, H6, H7, or H9) 

virus; or (2) 2009 H1N1 influenza. 

III. Effective Time Period (as Required 

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

The effective period of time of this 

Declaration commences on December 1, 

2006 and extends through February 28, 

2010; except that with respect to 2009 

H1N1 influenza vaccine, the effective 

period commences on June 15, 2009 and 

extends through March 31, 2013. 

With respect to Covered 

Countermeasures administered and 

used in accordance with the public 

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; except 

that with respect to 2009 H1N1 

influenza vaccine, the effective period 

commences on June 15, 2009 and 

extends through March 31, 2013. 

IV. Population (as Required by Section 

319F–3(b)(2)(C) of the Act) 

Section 319F–3(a)(4)(A) confers 

immunity to manufacturers and 

distributors of the Covered 

Countermeasure, regardless of the 

defined population. 

Section 319F–3(a)(3)(C)(i) confers 

immunity to covered persons who could 

be program planners or qualified 

persons with respect to the Covered 

Countermeasure only if a member of the 

population specified in the Declaration 

administers or uses the Covered 

Countermeasure 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 the following: (1) All 

persons who use a Covered 

Countermeasure or to whom such a 

Covered Countermeasure is 

administered as an Investigational New 

Drug in a human clinical trial 

conducted directly by the Federal 

Government, or pursuant to a contract, 

grant or cooperative agreement with the 

Federal Government; (2) all persons 

who use a Covered Countermeasure or 

to whom such a Countermeasure is 

administered in a pre-pandemic phase, 

as defined below; and/or (3) all persons 

who use a Covered Countermeasure, or 

to whom such a Covered 

Countermeasure is administered in a 

pandemic phase, as defined below. 

V. Geographic Area (as Required by 

Section 319F–3(b)(2)(D) of the Act) 

Section 319F–3(a) 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 

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) 

A. I have determined that, upon 

expiration of the applicable 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 

of the Covered Countermeasure, 

including the return of such product to 


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Federal Register / Vol. 74, No. 191 / Monday, October 5, 2009 / Notices 51157 

the manufacturer, and for 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. 

B. The Federal Government shall 

purchase the entire production of 

Covered Countermeasures under the 

contracts specifically listed by contract 

number in section I for the stockpile 

under section 319F–2 of the Act, and 

shall be subject to the time-period 

extension of section 319F–3(b)(3)(C). 

Production under future contracts for 

the same vaccine will also be subject to 

the time-period extension of section 

319F–3(b)(3)(C). 

VIII. Compensation Fund 

In addition to conferring immunity to 

manufacturers, distributors, and 

administrators of the Covered 

Countermeasures, the Act provides 

benefits to certain individuals who 

sustain a covered injury as the direct 

result of the administration of the 

Covered Countermeasure. The 

Countermeasure Injury Compensation 

Program (CICP) within the Health 

Resources and Services Administration 

(HRSA) administers the Act’s 

compensation program. Information 

about the CICP is available at 1–888– 

275–4772 or http://www.hrsa.gov/ 

countermeasurescomp/default.htm. 

IX. Amendments 

The Declaration for the Use of the 

Public Readiness and Emergency 

Preparedness Act for H5N1 was 

published on January 26, 2007; 

amended on November 30, 2007 to add 

H7 and H9 vaccines; amended on 

October 17, 2008 to add H2 and H6 

vaccines; amended on June 15, 2009 to 

add 2009 H1N1 vaccines and 

republished in its entirety. This 

Declaration incorporates all 

amendments prior to the date of its 

publication in the Federal Register. Any 

future amendment to this Declaration 

will be published in the Federal 

Register, pursuant to section 319F– 

2(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) 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 Phase: The following 

stages, as defined in the National 

Strategy for Pandemic Influenza: 

Implementation Plan (Homeland 

Security Council, May 2006): (4) First 

Human Case in North America; and (5) 

Spread Throughout United States. 

Pre-pandemic Phase: The following 

stages, as defined in the National 

Strategy for Pandemic Influenza: 

Implementation Plan (Homeland 

Security Council, May 2006): (0) New 

Domestic Animal Outbreak in At-Risk 

Country; (1) Suspected Human Outbreak 

Overseas; (2) Confirmed Human 

Outbreak Overseas; and (3) Widespread 

Human Outbreaks in Multiple Locations 

Overseas. 

Dated: September 28, 2009. 

Kathleen Sebelius, 

Secretary. 

Appendix 

I. List of U.S. Government Contracts— 

Covered H5N1, H2, H6, H9, and 2009–H1N1 

Vaccine Contracts 

1. HHSN266200400031C 

2. HHSN266200400032C 

3. HHSN266200300039C 

4. HHSN266200400045C 

5. HHSN266200205459C 

6. HHSN266200205460C 

7. HHSN266200205461C 

8. HHSN266200205462C 

9. HHSN266200205463C 

10. HHSN266200205464C 

11. HHSN266200205465C 

12. HHSN266199905357C 

13. HHSN266200300068C 

14. HHSN266200005413C 

15. HHSO100200600021C (formerly 

200200409981) 

16. HHSO100200500004C 

17. HHSO100200500005I 

18. HHSO100200700026I 

19. HHSO100200700027I 

20. HHSO100200700028I 

21. HHSO100200600010C 

22. HHSO100200600011C 

23. HHSO100200600012C 

24. HHSO100200600013C 

25. HHSO100200600014C 

26. HHSO100200600022C (formerly 

200200511758) 

27. HHSO100200600023C (formerly 

200200410431) 

28. CRADA No. AI–0155 NIAID/MedImmune 

29. HHSO100200700029C 

30. HHSO100200700030C 

31. HHSO100200700031C 

32. All present, completed and future 

Government H5N1, H2, H6, H9, and 

2009–H1N1 vaccine contracts not 

otherwise listed. 

[FR Doc. E9–23844 Filed 10–2–09; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day-09–09CV] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

In compliance with the requirement 

of Section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995 for 

opportunity for public comment on 

proposed data collection projects, the 

Centers for Disease Control and 

Prevention (CDC) will publish periodic 

summaries of proposed projects. To 

request more information on the 

proposed projects or to obtain a copy of 

the data collection plans and 

instruments, call 404–639–5960 and 

send comments to Maryam I. Daneshvar, 

CDC Acting Reports Clearance Officer, 

1600 Clifton Road, MS–D74, Atlanta, 

GA 30333 or send an e-mail to 

omb@cdc.gov. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 


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