[Federal Register Volume 73, Number 246 (Monday, December 22, 2008)]
[Notices]
[Pages 78362-78364]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-30510]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Declaration Under the Public Readiness and Emergency Preparedness 
Act

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 pandemic influenza diagnostics, personal respiratory 
protection devices, and respiratory support devices 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 H5N1 
viruses have been spread by infected migratory birds and exports of 
poultry or poultry products from Asia through Europe and Africa since 
2003, and could spread into North America in 2008 or later, and have 
caused disease in humans, with over 60% of infected people dying from 
H5N1. In addition to H5N1, other animal influenza A viruses have also 
caused disease in humans, including H2N2, H7N7, H7N2, and H9N2 
influenza A viruses, and also pose a pandemic threat. Section 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 Pandemic Influenza Diagnostics, Personal 
Respiratory Protection Devices, and Respiratory Support Devices

    Whereas highly pathogenic avian H5N1 influenza A viruses have 
spread, through various mechanisms, from Asia through Europe and Africa 
since 2003 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 other animal influenza viruses such as H2N2, H7N2, H7N7 and 
H9N2 viruses have also caused illness among humans and pose a pandemic 
threat;
    Whereas avian H5N1 or other influenza A viruses might evolve into 
strains capable of causing a pandemic of human influenza;
    Whereas there are countermeasures to identify, reduce exposure to, 
or support patients infected by highly pathogenic avian H5N1 influenza 
A viruses, other animal influenza viruses that pose a pandemic threat, 
or pandemic influenza in humans;
    Whereas such countermeasures that currently exist or may be the 
subject of research and development include diagnostics to identify 
avian or other animal influenza A viruses that pose a pandemic threat, 
or to otherwise aid in the diagnosis of pandemic influenza; personal 
respiratory protection devices to reduce exposure to avian or other 
animal influenza A viruses; and respiratory support devices to support 
patients infected by avian or other animal influenza A viruses;
    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,

[[Page 78363]]

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 and other 
influenza viruses that pose a pandemic threat 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, clinical 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 pandemic influenza diagnostics, personal 
respiratory protection devices, and respiratory support devices, as 
defined in section IX of this declaration. 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 H5N1 
influenza A viruses or other animal influenza A viruses that are, or 
may be capable of developing into, a pandemic strain.

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, 
or otherwise uses a Covered Countermeasure under direction from, a 
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, or otherwise uses a Covered 
Countermeasure under direction 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.

[[Page 78364]]

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 Influenza Diagnostics: means diagnostics to identify avian 
or other animal influenza A viruses that pose a pandemic threat, or to 
otherwise aid in the diagnosis of pandemic influenza, when (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.
    Pandemic Influenza Personal Respiratory Protection Devices: means 
personal respiratory protection devices for use by the general public 
to reduce wearer exposure to pathogenic biological airborne 
particulates during public health medical emergencies, such as an 
influenza pandemic, when (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.
    Pandemic Influenza Respiratory Support Devices: means devices to 
support respiratory function for patients infected with highly 
pathogenic influenza A H5N1 viruses or other influenza viruses that 
pose a pandemic threat when (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.

    Dated: December 17, 2008.
Michael O. Leavitt,
Secretary.
 [FR Doc. E8-30510 Filed 12-18-08; 4:15 pm]
BILLING CODE 4150-37-P