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###### Department of Health and Human Services

###### Office of the Secretary

# 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 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).                              ( print 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                               ( print 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]

BILLING CODE 4150-37-P