[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
[[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
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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