Declaration Under the Public Readiness and Emergency Preparedness Act, 61864-61866 [E8-24734]

Download as PDF 61864 Federal Register / Vol. 73, No. 202 / Friday, October 17, 2008 / Notices Contract Manufacturer Covered countermeasure HHSO1002006000015I ............................ HHSO1002006000016I ............................ HHSO100200600015I .............................. Roche ...................................................... GlaxoSmithKline ...................................... Roche ...................................................... HHSO100200600016I .............................. GlaxoSmithKline ...................................... 797HH7282 797HH7283 797HH8113 797HH8112 Roche ...................................................... GlaxoSmithKline ...................................... GlaxoSmithKline ...................................... Roche ...................................................... Oseltamivir Phosphate (Tamiflu) .......... Zanamivir (Relenza) ............................. Acquisiton of Tamiflu, 75 mg (state purchases). Acquisiton of Relenza, 5 mg (state purchases). Oseltamivir, 75 mg (Tamiflu) (SNS) ....... Relenza (Zanamivir) 5 mg (SNS) ........... Relenza (Zanamivir) 5 mg (SNS) ........... Oseltamivir 75 mg (Tamiflu) (SNS) ........ Oseltamivir 45 mg (Tamiflu). Oseltamivir 30 mg (Tamiflu). ............................................... ............................................... ............................................... ............................................... [FR Doc. E8–24733 Filed 10–14–08; 4:15 pm] BILLING CODE 4150–37–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Declaration Under the Public Readiness and Emergency Preparedness Act October 10, 2008. Office of the Secretary (OS), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: 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 Botulism countermeasures based on a credible risk that the threat of exposure to botulinum toxin(s) and the resulting disease(s) from a manmade or natural source constitutes a public health emergency. This notice and the attached declaration are effective as of the date of signature of the declaration. FOR FURTHER INFORMATION CONTACT: RADM W.C. Vanderwagen, 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). DATES: sroberts on PROD1PC70 with NOTICES HHS Secretary’s Declaration for Utilization of Public Readiness and Emergency Preparedness Act for Botulism Countermeasures Whereas exposure to botulinum toxin(s) and the resulting disease(s) from manmade or natural sources may cause harm to the general population sufficient to constitute a public health emergency; VerDate Aug<31>2005 19:18 Oct 16, 2008 Jkt 217001 Whereas the Secretary of the Department of Homeland Security has determined that botulinum toxins present a material threat against the United States population sufficient to affect national security; Whereas botulinum toxins are extremely potent and lethal; Whereas there are covered countermeasures to treat, identify, or prevent adverse health consequences or death from botulinum toxins; Whereas such botulism countermeasures, including antitoxins, for potential pre-exposure and for postexposure prevention and treatment, diagnostics to identify such exposure, and additional countermeasures for treatment of adverse events arising from use of these botulism countermeasures exist, or may be the subject of research and/or development; Whereas such countermeasures may be used and administered in accordance with Federal contracts, cooperative agreements, grants, interagency 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 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 PO 00000 Frm 00088 Fmt 4703 Sfmt 4703 Pub. L. 85– 804 coverage* No. No. No. No. No. No. No. No. 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 countermeasure; 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 there is a credible risk that botulinum toxin(s) and the resulting disease(s) from a E:\FR\FM\17OCN1.SGM 17OCN1 Federal Register / Vol. 73, No. 202 / Friday, October 17, 2008 / Notices sroberts on PROD1PC70 with NOTICES manmade or natural sources 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, and distribution of botulinum toxin countermeasures, as defined in section IX below; and, with respect to the category of disease and the population described in sections II and IV below, the administration and usage of botulinum toxin countermeasures. 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 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 VerDate Aug<31>2005 19:18 Oct 16, 2008 Jkt 217001 I am recommending the administration or use of the Covered Countermeasure is botulism resulting from exposure to botulinum toxin(s). 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, or memoranda of understanding, the effective period of time of this Declaration commences on signature of the declaration and extends through December 31, 2015. 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. 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 on 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 as persons who use the Covered Countermeasure or to whom such a Covered Countermeasure is administered, 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 are 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 PO 00000 Frm 00089 Fmt 4703 Sfmt 4703 61865 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 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 the Covered Countermeasure without geographic limitation. VI. 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 manufacturers 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 E:\FR\FM\17OCN1.SGM 17OCN1 61866 Federal Register / Vol. 73, No. 202 / Friday, October 17, 2008 / Notices 319F–3(a) of the Act shall extend for that period. VIII. 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. IX. 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 or Administration: 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 Covered Countermeasures to patients/recipients, management and operation of delivery systems, and management and operation of distribution and dispensing locations. Authority Having Jurisdiction: 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. Botulinum Toxin Countermeasure: Any vaccine; antimicrobial/antibiotic, other drug or antitoxin; or diagnostic or device to identify, prevent or treat botulinum toxin or adverse events from such countermeasures (1) licensed under section 351 of the Public Health Service Act; (2) approved under section 505 or section 515 of the Federal Food, Drug, and Cosmetic Act (FDCA); (3) cleared under section 510(k) of the FDCA; (4) authorized for emergency use under section 564 of the FDCA ; (5) used under section 505(i) of the FDCA or section 351(a)(3) of the PHS Act, and 21 CFR Part 312; or (6) used under section 520(g) of the FDCA and 21 CFR part 812. 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 an 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 botulinum toxin 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. This 10th day of October, 2008. Michael O. Leavitt, Secretary of Health and Human Services. Appendix I List of U.S. Government Contracts Contract Manufacturer Covered countermeasure HHSO0100200600017C ........................... 03FED03828 ............................................. CDC 200–2003–01010 ............................. CDC 200–2004–07625 ............................. CDC 200–2003–01052 ............................. Cangene .................................................. PerImmune .............................................. Cangene .................................................. Aventis Pasteur ....................................... Aventis Pasteur ....................................... Heptavalent antitoxin .............................. Heptavalent antitoxin .............................. Heptavalent antitoxin, Monovalent A ...... Monovalent E .......................................... Bivalent A and B ..................................... Pub.L. 85–804 coverage* No. No. No. No. No. *Status of indemnification coverage under Pub.L. 85–804 (An Act to authorize the making, amendment and modification of contracts to facilitate the national defense.) [FR Doc. E8–24734 Filed 10–14–08; 4:15 pm] BILLING CODE 4150–37–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Declaration Under the Public Readiness and Emergency Preparedness Act October 10, 2008. Office of the Secretary (OS), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: sroberts on PROD1PC70 with NOTICES VerDate Aug<31>2005 19:18 Oct 16, 2008 Jkt 217001 Acute Radiation Syndrome (ARS) is an acute illness that occurs when the entire body (or most of it) receives a high dose of radiation, usually over a short period of time. Radiation exposure can adversely affect a variety of cells, tissues, and organ systems, including the hematopoietic (or blood) system, the gastrointestinal (GI) tract, skin (cutaneous) system, and, at higher SUPPLEMENTARY INFORMATION: Declaration pursuant to section 319F–3 of the Public Health Service Act (42 U.S.C. 247d–6d) to provide targeted liability protections for Acute Radiation Syndrome countermeasures based on a credible risk that the threat of high dose radiation exposure following the deliberate detonation of a nuclear device, unintentional nuclear release, or SUMMARY: other radiological events and the Acute Radiation Syndrome resulting from such exposures 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: RADM W.C. Vanderwagen, 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). PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 radiation levels, the lung or kidney and cerebrovascular/central nervous system (CNS). HHS Secretary’s Declaration for Utilization of Public Readiness and Emergency Preparedness Act for Acute Radiation Syndrome Whereas the risk of a deliberate detonation of a nuclear device in the United States intended to cause harm to the general population, unintentional radioactive release, or other radiological/nuclear events are considered a credible threat to public health; Whereas the Secretary of the Department of Homeland Security has determined that radiological and nuclear agents present a material threat against the United States population sufficient to affect national security; Whereas Acute Radiation Syndrome (ARS) resulting from such incidents could cause potentially severe adverse human health effects, including damage to the following organ systems: Hematopoietic (blood-forming), E:\FR\FM\17OCN1.SGM 17OCN1

Agencies

[Federal Register Volume 73, Number 202 (Friday, October 17, 2008)]
[Notices]
[Pages 61864-61866]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-24734]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Declaration Under the Public Readiness and Emergency Preparedness 
Act

October 10, 2008.
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 Botulism countermeasures based on a credible risk that 
the threat of exposure to botulinum toxin(s) and the resulting 
disease(s) from a manmade or natural source 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: RADM W.C. Vanderwagen, 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).

HHS Secretary's Declaration for Utilization of Public Readiness and 
Emergency Preparedness Act for Botulism Countermeasures

    Whereas exposure to botulinum toxin(s) and the resulting disease(s) 
from manmade or natural sources may cause harm to the general 
population sufficient to constitute a public health emergency;
    Whereas the Secretary of the Department of Homeland Security has 
determined that botulinum toxins present a material threat against the 
United States population sufficient to affect national security;
    Whereas botulinum toxins are extremely potent and lethal;
    Whereas there are covered countermeasures to treat, identify, or 
prevent adverse health consequences or death from botulinum toxins;
    Whereas such botulism countermeasures, including antitoxins, for 
potential pre-exposure and for post-exposure prevention and treatment, 
diagnostics to identify such exposure, and additional countermeasures 
for treatment of adverse events arising from use of these botulism 
countermeasures exist, or may be the subject of research and/or 
development;
    Whereas such countermeasures may be used and administered in 
accordance with Federal contracts, cooperative agreements, grants, 
interagency 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 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 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 countermeasure; 
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 there is a credible risk that botulinum toxin(s) and the 
resulting disease(s) from a

[[Page 61865]]

manmade or natural sources 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, and 
distribution of botulinum toxin countermeasures, as defined in section 
IX below; and, with respect to the category of disease and the 
population described in sections II and IV below, the administration 
and usage of botulinum toxin countermeasures.
    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 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 
Countermeasure is botulism resulting from exposure to botulinum 
toxin(s).

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, or memoranda of 
understanding, the effective period of time of this Declaration 
commences on signature of the declaration and extends through December 
31, 2015.
    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.

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 on 
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 as persons who use the Covered 
Countermeasure or to whom such a Covered Countermeasure is 
administered, 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 are 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 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 the Covered Countermeasure without geographic limitation.

VI. 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 manufacturers 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

[[Page 61866]]

319F-3(a) of the Act shall extend for that period.

VIII. 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.

IX. 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 or Administration: 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 Covered 
Countermeasures to patients/recipients, management and operation of 
delivery systems, and management and operation of distribution and 
dispensing locations.
    Authority Having Jurisdiction: 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.
    Botulinum Toxin Countermeasure: Any vaccine; antimicrobial/
antibiotic, other drug or antitoxin; or diagnostic or device to 
identify, prevent or treat botulinum toxin or adverse events from such 
countermeasures (1) licensed under section 351 of the Public Health 
Service Act; (2) approved under section 505 or section 515 of the 
Federal Food, Drug, and Cosmetic Act (FDCA); (3) cleared under section 
510(k) of the FDCA; (4) authorized for emergency use under section 564 
of the FDCA ; (5) used under section 505(i) of the FDCA or section 
351(a)(3) of the PHS Act, and 21 CFR Part 312; or (6) used under 
section 520(g) of the FDCA and 21 CFR part 812.
    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 an 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 botulinum toxin 
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.

    This 10th day of October, 2008.
Michael O. Leavitt,
Secretary of Health and Human Services.

Appendix I

List of U.S. Government Contracts

----------------------------------------------------------------------------------------------------------------
             Contract                      Manufacturer          Covered countermeasure        Pub.L. 85-804
-------------------------------------------------------------------------------------------------coverage*------
HHSO0100200600017C................  Cangene..................  Heptavalent antitoxin....  No.
03FED03828........................  PerImmune................  Heptavalent antitoxin....  No.
CDC 200-2003-01010................  Cangene..................  Heptavalent antitoxin,     No.
                                                                Monovalent A.
CDC 200-2004-07625................  Aventis Pasteur..........  Monovalent E.............  No.
CDC 200-2003-01052................  Aventis Pasteur..........  Bivalent A and B.........  No.
----------------------------------------------------------------------------------------------------------------
*Status of indemnification coverage under Pub.L. 85-804 (An Act to authorize the making, amendment and
  modification of contracts to facilitate the national defense.)

[FR Doc. E8-24734 Filed 10-14-08; 4:15 pm]
BILLING CODE 4150-37-P
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