[Federal Register Volume 74, Number 190 (Friday, October 2, 2009)]
[Notices]
[Pages 50968-50970]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-23761]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Declaration Under the Public Readiness and Emergency Preparedness 
Act

September 28, 2009.
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 countermeasures based on the Secretary's 
finding under the Act that the 2009-H1N1 virus strain and the resulting 
disease, 2009-H1N1 influenza, 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: Dr. Nicole Lurie, 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).

[[Page 50969]]

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

    Whereas, on April 26, 2009, Acting Secretary Charles Johnson 
determined under section 319 of the Public Health Service Act, (42 
U.S.C. 247d) (``the Act''), that a public health emergency exists 
nationwide involving the Swine influenza A virus (now known as ``2009-
H1N1 influenza'') that affects or has significant potential to affect 
the national security;
    Whereas, on July 24, 2009, Secretary Kathleen Sebelius renewed the 
determination under section 319 of the Public Health Service Act, (42 
U.S.C. 247d) (``the Act''), that a public health emergency exists 
nationwide involving the Swine influenza A virus (now known as ``2009-
H1N1 influenza'') that affects or has significant potential to affect 
the national security;
    Whereas, the World Health Organization has established a Pandemic 
alert phase 6 for the 2009-H1N1 influenza virus currently circulating 
worldwide;
    Whereas there are countermeasures under development to treat, 
identify, or prevent adverse health consequences or death from exposure 
to 2009-H1N1 influenza;
    Whereas such countermeasures include peramivir;
    Whereas such countermeasures may be used and administered in 
accordance with Federal contracts, cooperative agreements, grants, 
interagency agreements, clinical trials 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 Act (42 U.S.C. 247d-6d(b));
    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 that 2009-H1N1 influenza and resulting disease 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 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 countermeasure peramivir. 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, clinical trials 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 2009-H1N1 influenza.

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, clinical trials agreements 
or memoranda of understanding involving countermeasures, the effective 
period of time of this Declaration commenced on April 26, 2009, and 
extends through June 1, 2010. With respect to Covered Countermeasures 
administered and used in accordance with the public

[[Page 50970]]

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, or until June 1, 2010, whichever is earlier.

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 pursuant to an 
Investigational New Drug Application (IND) in effect, including 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. Compensation Fund

    Section 319F-4 of the Act provides benefits to eligible individuals 
who sustain a covered injury directly caused by the administration or 
use of a Covered Countermeasure. The Countermeasure Injury Compensation 
Program (CICP), within the Health Resources and Services Administration 
(HRSA), administers this compensation program. Information about the 
CICP is available at 1-888-275-4772 or http://www.hrsa.gov/countermeasurescomp/default.htm.

IX. 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.

X. 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), 
respectively, 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 peramivir, an antiviral from the 
neuraminidase inhibitor class of influenza antiviral drugs.

    Dated: September 25, 2009.
Kathleen Sebelius,
Secretary.
[FR Doc. E9-23761 Filed 10-1-09; 8:45 am]
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