[Federal Register Volume 73, Number 202 (Friday, October 17, 2008)]
[Notices]
[Pages 61864-61866]
From the Federal Register Online via the Government Publishing 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.

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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

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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

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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

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             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.
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*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