Declaration Under the Public Readiness and Emergency Preparedness Act, 61861-61864 [E8-24733]

Agencies

• Office of the Secretary
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 73, Number 202 (Friday, October 17, 2008)]
[Notices]
[Pages 61861-61864]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-24733]


=======================================================================
-----------------------------------------------------------------------

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 pandemic countermeasures based on a credible risk that 
an avian influenza virus spreads and evolves into a strain capable of 
causing a pandemic of human influenza.

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).

SUPPLEMENTARY INFORMATION: Highly pathogenic avian influenza A viruses 
have been spread by infected migratory birds and exports of poultry or 
poultry products from Asia through Europe and Africa since 2004, and 
could be spread into North America in 2008 or later, and have caused 
disease in humans with an associated high case fatality. Section

[[Page 61862]]

319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d), which was 
enacted by the Public Readiness and Emergency Preparedness Act, is 
intended to alleviate certain liability concerns associated with 
pandemic countermeasures, and, therefore, ensure that the 
countermeasures are available and can be administered in the event an 
avian influenza virus spreads and evolves into a strain capable of 
causing a pandemic of human influenza.

HHS Secretary's Declaration for the Use of the Public Readiness and 
Emergency Preparedness Act for the Influenza Antivirals

Oseltamivir Phosphate (Tamiflu[reg]) and Zanamivir (Relenza[reg])

    Whereas highly pathogenic avian H5N1 influenza A viruses have 
spread, through various mechanisms, from Asia through Europe and Africa 
since 2004 and have caused disease in humans with an associated high 
case fatality. The real possibility that these viruses could be spread 
into North America exists as well as the possibility that these H5N1 
viruses could participate directly or indirectly in development of a 
human pandemic strain;
    Whereas avian influenza A viruses might evolve into strains capable 
of causing a pandemic of human influenza;
    Whereas there are countermeasures to treat, identify, or prevent 
adverse health consequences or death from exposure to highly pathogenic 
avian influenza A viruses or pandemic influenza in humans;
    Whereas such countermeasures include Oseltamivir Phosphate 
(Tamiflu[supreg]) and Zanamivir (Relenza[supreg]);
    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 countermeasures; 
and
    Whereas, to encourage the design, development, clinical testing or 
investigation, manufacturing and product formulation, labeling, 
distribution, packaging, marketing, promotion, sale, purchase, 
donation, dispensing, prescribing, administration, licensing, and use 
of medical countermeasures with respect to the category of disease and 
population described in sections II and IV below, it is advisable, in 
accordance with section 319F-3(a) and (b) of the Act, to provide 
immunity from liability for covered persons, as that term is defined at 
section 319F-3(i)(2) of the Act, and to include as such covered persons 
such other qualified persons as I have identified in section VI of this 
declaration;
    Therefore, pursuant to section 319F-3(b) of the Act, I have 
determined there is a credible risk that the spread of avian influenza 
viruses and resulting disease could in the future constitute a public 
health emergency.

I. Covered Countermeasures (As Required by Section 319F-3(b)(1) of the 
Act)

    Covered Countermeasures are defined at section 319F-3(i) of the 
Act.
    At this time, and in accordance with the provisions contained 
herein, I am recommending the manufacturing, testing, development, and 
distribution; and, with respect to the category of disease and 
population described in sections II and IV below, the administration 
and usage of the pandemic countermeasures, influenza antiviral drugs 
oseltamivir phosphate (Tamiflu[supreg]) and Zanamivir 
(Relenza[supreg]). 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 
Countermeasures is the threat of or actual human influenza that results 
from the infection of humans with highly pathogenic avian influenza A 
viruses or other highly pathogenic influenza viruses causing a pandemic 
following exposure to the viruses.

[[Page 61863]]

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 to 
manufacturers and distributors of the Covered Countermeasure, 
regardless of the defined population.
    Section 319F-3(a)(3)(C)(i) of the Act confers immunity to covered 
persons who may be a program planner or qualified persons with respect 
to the Covered Countermeasure only if a member of the population 
specified in the declaration uses the Covered Countermeasure or has the 
Covered Countermeasure administered to him and is in or connected to 
the geographic location specified in this declaration, or the program 
planner or qualified person reasonably could have believed that these 
conditions were met.
    The populations specified in this declaration are all persons who 
use a Covered Countermeasure or to whom a Covered Countermeasure is 
administered in accordance with this declaration, including, but not 
limited to: (1) Any person conducting research and development of 
Covered Countermeasures directly for the Federal government or pursuant 
to a contract, grant, or cooperative agreement with the Federal 
government; (2) any person who receives a Covered Countermeasure from 
persons authorized in accordance with the public health and medical 
emergency response of the Authority Having Jurisdiction to prescribe, 
administer, deliver, distribute, or dispense the Covered 
Countermeasure, and their officials, agents, employees, contractors, 
and volunteers following a declaration of an emergency; (3) any person 
who receives a Covered Countermeasure from a person authorized to 
prescribe, administer or dispense the countermeasure or who is 
otherwise authorized under an Emergency Use Authorization; and (4) any 
person who receives a Covered Countermeasure in human clinical trials 
being conducted directly by the Federal Government or pursuant to a 
contract, grant, or cooperative agreement with the Federal Government.

V. Geographic Area (As Required by Section 319F-3(b)(2)(D) of the Act)

    Section 319F-3(a) of the Act applies to the administration and use 
of a Covered Countermeasure without geographic limitation.

VI. Other Qualified Persons (As Required by Section 319F-3(i)(8)(B) of 
the Act)

    With regard to the administration or use of a Covered 
Countermeasure, section 319F-3(i)(8)(A) of the Act defines the term 
``qualified person'' as a licensed individual who is authorized to 
prescribe, administer, or dispense the Covered Countermeasure under the 
law of the State in which such covered countermeasure was prescribed, 
administered or dispensed.
    Additional persons who are qualified persons pursuant to section 
319F-3(i)(8)(B) are the following: (1) Any person authorized in 
accordance with the public health and medical emergency response of the 
Authority Having Jurisdiction to prescribe, administer, deliver, 
distribute or dispense Covered Countermeasures, and their officials, 
agents, employees, contractors and volunteers, following a declaration 
of an emergency, and (2) Any person authorized to prescribe, 
administer, or dispense Covered Countermeasures or who is otherwise 
authorized under an Emergency Use Authorization.

VII. Additional Time Periods of Coverage After Expiration of 
Declaration (As required by section 319F-3(b)(3)(B) of the Act)

    I have determined that, upon expiration of the time period 
specified in section III above, an additional twelve (12) months is a 
reasonable period to allow for the manufacturer to arrange for 
disposition and covered persons to take such other actions as are 
appropriate to limit the administration or use of the Covered 
Countermeasure, and the liability protection of section 319F-3(a) of 
the Act shall extend for that period.

VIII. 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: 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 Countermeasures: Means the neuraminidase class of 
Antivirals Oseltamivir Phosphate (e.g., Tamiflu[reg] and Zanamivir 
(e.g., Relenza[reg]).

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

Appendix I

List of U.S. Government Contracts

[[Page 61864]]



----------------------------------------------------------------------------------------------------------------
                                                                                              Pub. L. 85-804
             Contract                      Manufacturer          Covered countermeasure          coverage*
----------------------------------------------------------------------------------------------------------------
HHSO1002006000015I................  Roche....................  Oseltamivir Phosphate      No.
                                                                (Tamiflu[reg]).
HHSO1002006000016I................  GlaxoSmithKline..........  Zanamivir (Relenza[reg]).  No.
HHSO100200600015I.................  Roche....................  Acquisiton of Tamiflu, 75  No.
                                                                mg (state purchases).
HHSO100200600016I.................  GlaxoSmithKline..........  Acquisiton of Relenza, 5   No.
                                                                mg (state purchases).
797HH7282.........................  Roche....................  Oseltamivir, 75 mg         No.
                                                                (Tamiflu) (SNS).
797HH7283.........................  GlaxoSmithKline..........  Relenza (Zanamivir) 5 mg   No.
                                                                (SNS).
797HH8113.........................  GlaxoSmithKline..........  Relenza (Zanamivir) 5 mg   No.
                                                                (SNS).
797HH8112.........................  Roche....................  Oseltamivir 75 mg          No.
                                                                (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