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US extends pandemic emergency to 2012

Eileen Danneman

"SEBELIUS: HHS document EXTENDING THE PANDEMIC to 2012 (Federal Register March 5, 2010)

Therefore, pursuant to section 319F-3(b) of the Act, I have

determined there is a credible risk that the spread of pandemic

influenza A viruses and those with pandemic potential and resulting

disease does or could constitute a public health emergency.

...and extends

through February 28, 2012.

Section 319F-3(a)(4)(A) confers immunity to manufacturers and

distributors of the Covered Countermeasure, regardless of the defined

population.

...and amended on September 28, 2009 to

provide targeted liability protections for pandemic countermeasures to

enhance distribution

100226 Sec HHS Sebelius Pandemic Influenza Vaccines Amendment

[Federal Register: March 5, 2010 (Volume 75, Number 43)]

[Notices]

[Page 10268-10272]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr05mr10-76]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

Pandemic Influenza Vaccines--Amendment

Authority: 42 U.S.C. 247d-6d.

ACTION: Notice of amendment to the September 28, 2009 Republished

Declaration under the Public Readiness and Emergency Preparedness Act.

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SUMMARY: Amendment to declaration issued on September 28, 2009 (74 FR

51153) pursuant to section 319F-3 of the Public Health Service Act

(``the Act'')

[[Page 10269]]

(42 U.S.C. 247d-6d) to revise covered countermeasures and extend

effective date and republication of the declaration to reflect the

declaration in its entirety, as amended.

DATES: The amendment of the republished declaration issued on September

28, 2009 is effective as of March 1, 2010.

FOR FURTHER INFORMATION CONTACT: Nicole Lurie, MD, MSPH, 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 (202) 205-2882 (this is not a toll-free

number).

HHS Secretary's Amendment to the September 28, 2009 Republished

Declaration for the Use of the Public Readiness and Emergency

Preparedness Act for H5N1, H2, H6, H7, H9 and 2009-H1N1 Vaccines:

Whereas there are or may be multiple animal influenza A viruses,

circulating in wild birds and/or domestic animals that cause, or have

significant potential to cause, sporadic human infections or have

mutated to cause pandemics in humans;

Whereas, these viruses may evolve into virus strains capable of

causing a pandemic of human influenza because these viruses may cause

infection in and spread among humans and because humans have little or

no immunity to these viruses;

Whereas, one such virus is the 2009 H1N1 Influenza Virus;

Whereas, vaccination may be effective to protect persons from the

threat of pandemic influenza;

Whereas, Secretary Michael O. Leavitt issued a Declaration for the

Use of the Public Readiness and Emergency Preparedness Act dated

January 26, 2007 (``Original Declaration''), as amended on November 30,

2007 and October 17, 2008 with respect to certain avian influenza

viruses;

Whereas, I amended the declaration on June 15, 2009 with respect to

2009 H1N1 influenza virus and on September 28, 2009 to provide targeted

liability protections for pandemic countermeasures to enhance

distribution and to add provisions consistent with other declarations,

and republished the declaration each time in its entirety;

Whereas, the September 28, 2009 declaration extended through

February 28, 2010 for vaccines against influenza virus strains named in

the Declaration other than 2009 H1N1 influenza vaccine;

Whereas, modifications are necessary to revise covered

countermeasures and to extend the effective date of the Declaration;

Whereas, the findings I made in the declaration issued on September

28, 2009 continue to apply;

Whereas, in accordance with section 319F-3(b)(6) of the Act (42

U.S.C. 247d-6d(b)), 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 additional covered

countermeasures with respect to the category of disease and population

described in sections II and IV of the September 28, 2009 Republished

Declaration, as hereby amended, and have found it desirable to

encourage such activities for these additional 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 of the September 28, 2009

Republished Declaration, as hereby amended, 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

other qualified persons as I have identified in section VI of the

September 28, 2009 Republished Declaration, as amended;

Therefore, pursuant to section 319F-3(b) of the Act, I have

determined that there is a credible risk that the spread of influenza A

viruses with pandemic potential and resulting disease could in the

future constitute a public health emergency and that spread of one of

these viruses (2009 H1N1 Influenza) has caused a disease that

constitutes a public health emergency.

In order to extend the scope of covered countermeasures and to

extend the effective date of the Declaration, the September 28, 2009

Republished Declaration, is hereby amended as follows:

In the title, delete ``for H5N1, H2, H6, H7, H9 and 2009 H1N1

Vaccines'' and replace with ``for Vaccines Against Pandemic Influenza A

Viruses and Those with Pandemic Potential''.

In the recitals, delete the first through the fourth ``whereas''

clauses, and insert two new recitals as follows:

Whereas there are or may be multiple animal influenza A viruses

circulating in wild birds and/or domestic animals that cause, or have

significant potential to cause, sporadic human infections or have

mutated to cause pandemics in humans;

Whereas, these viruses may evolve or have evolved into virus

strains capable of causing a pandemic of human influenza because these

viruses may cause infection in, and spread among, humans and because

humans have little or no immunity to these viruses;

In the sixth ``whereas'' clause, insert ``October 1, 2009, and

December 28, 2009'' after ``July 24, 2009''.

In the ``therefore'' clause, delete ``avian influenza viruses and

resulting disease could in the future constitute a public health

emergency, and that 2009 H1N1 influenza constitutes a public health

emergency'' and replace with: ``pandemic influenza A viruses and those

with pandemic potential and resulting disease does or could constitute

a public health emergency''.

In section I, first paragraph, delete ``the pandemic

countermeasures influenza A H5N1, H2, H6, H7, H9, and 2009 H1N1

vaccines'' each time it appears and replace with ``vaccines against

pandemic influenza A viruses with pandemic potential''.

In section I, at the end of the second sentence, replace ``IX''

with ``X''.

In section II, delete ``the virus with (1) highly pathogenic avian

influenza A (H5N1, H2, H6, H7, or H9) virus; or (2) 2009 H1N1

influenza'' and replace with ``animal and/or human influenza A viruses

against which most humans do not have immunity, except those included

in seasonal influenza vaccines and/or covered under the National

Vaccine Injury Compensation Program, that are circulating in wild birds

and/or domestic animals causing or having significant potential to

cause sporadic human infections or have mutated to cause pandemics in

humans''.

In section III, first paragraph, delete in its entirety and replace

with: ``The effective period of time of this Declaration commenced as

described in the September 28, 2009 Republished Declaration, and

extends through February 28, 2012.

In section III, second paragraph, delete ``; except that with

respect to 2009 H1N1 influenza vaccine, the effective period commences

on June 15, 2009 and extends through March 31, 2013'' and replace with

``through February 28, 2012.''

In section III, add to the end of the section as a new paragraph:

``With respect to any covered countermeasure subsequently covered under

the

[[Page 10270]]

National Vaccine Injury Compensation Program, the effective time period

expires immediately upon such coverage.''

In section VIII, insert ``and use'' after ``administration in the

first sentence, delete ``the Act's'' from the second sentence and

replace with ``this'', and delete ``Countermeasure'' from the second

sentence and replace with ``Countermeasures''.

In section IX, add to the end of the first sentence: ``; and

amended on September 28, 2009 to provide targeted liability protections

for pandemic countermeasures to enhance distribution and to add

provisions consistent with other declarations and republished in its

entirety.''

In section X, after the fifth paragraph, insert a new definition as

follows:

Pandemic influenza A viruses and those with pandemic potential:

Animal and/or human influenza A viruses, except those included in

seasonal influenza vaccines and/or covered under the National Vaccine

Injury Compensation Program, that are circulating in wild birds and/or

domestic animals, that cause, or have significant potential to cause,

sporadic or ongoing human infections, or historically have caused

pandemics in humans, or have mutated to cause pandemics in humans, and

for which the majority of the population is immunologically na[iuml]ve.

In Appendix I, title and item 32, add ``H7,'' after ``H6''.

Throughout, insert ``National'' before ``Vaccine Injury

Compensation Fund''.

All other provisions of the June 15, 2009 Republished Declaration

remain in full force.

Republication of HHS Secretary's September 28, 2009 Republished

Declaration, as Amended, for the Use of the Public Readiness and

Emergency Preparedness Act for Vaccines Against Pandemic Influenza A

Viruses and Those with Pandemic Potential.

To the extent any term of the September 28 Republished Declaration,

as hereby amended, is inconsistent with any provision of this

Republished Declaration, the terms of this Republished Declaration are

controlling.

Whereas there are or may be multiple animal influenza A viruses

circulating in wild birds and/or domestic animals that cause, or have

significant potential to cause, sporadic human infections or have

mutated to cause pandemics in humans;

Whereas, these viruses may evolve or have evolved into virus

strains capable of causing a pandemic of human influenza because these

viruses may cause infection in, and spread among, humans and because

humans have little immunity to these viruses;

Whereas, on April 26, 2009, Acting Secretary Charles E. Johnson

determined under section 319 of the Public Health Service Act, (42

U.S.C. 247d), that a public health emergency exists nationwide

involving the Swine Influenza A virus that affects or has significant

potential to affect the national security (now called ``2009-H1N1

influenza'');

Whereas, on July 24, 2009, October 1, 2009, and December 28, 2009 I

renewed the determination by the Acting Secretary that a public health

emergency exists nationwide involving the Swine influenza A virus (now

called ``2009-H1N1 influenza virus'');

Whereas, vaccination may be effective to protect persons from the

threat of pandemic influenza;

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, 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 section II and IV 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;

Whereas, in accordance with section 319F-3(b)(6) of the Public

Health Service Act (42 U.S.C. 247d-6d(b)) (``the Act''), I have

considered the desirability of encouraging 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, and have found it desirable to encourage such activities for the

Covered Countermeasures;

Therefore, pursuant to section 319F-3(b) of the Act, I have

determined there is a credible risk that the spread of pandemic

influenza A viruses and those with pandemic potential and resulting

disease does or could 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 manufacture, testing, development,

distribution, dispensing; and, with respect to the category of disease

and population described in sections II and IV, below, the

administration and usage of vaccines against influenza A viruses with

pandemic potential and any associated adjuvants. 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 for

vaccines against pandemic influenza A viruses with pandemic potential

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 pandemic countermeasures following

a declaration of an emergency, as defined in section X 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

[[Page 10271]]

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 time period of the

Declaration.

II. Category of Disease (as Required by Section 319F-3(b)(2)(A) of the

Act)

The category of disease 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

following exposure to animal and/or human influenza A viruses, against

which most humans do not have immunity, except those included in

seasonal influenza vaccines and/or covered under the National Vaccine

Injury Compensation Program, that are circulating in wild birds and/or

domestic animals causing or have significant potential to cause

sporadic human infections or have mutated to cause pandemics in humans.

III. Effective Time Period (as Required by Section 319F-3(b)(2)(B) of

the Act)

The effective period of time of this Declaration commenced as

described in the September 28, 2009 Republished Declaration and extends

through February 28, 2012.

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 through February 28, 2012.

With respect to any covered countermeasure subsequently covered

under the National Vaccine Injury Compensation Program, the effective

time period expires immediately upon such coverage.

IV. Population (as Required by Section 319F-3(b)(2)(C) of the Act)

Section 319F-3(a)(4)(A) confers immunity to manufacturers and

distributors of the Covered Countermeasure, regardless of the defined

population.

Section 319F-3(a)(3)(C)(i) confers immunity to covered persons who

could be program planners or qualified persons with respect to the

Covered Countermeasure only if a member of the population specified in

the Declaration administers or uses the Covered Countermeasure 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 the following:

(1) All persons who use a Covered Countermeasure or to whom such a

Covered Countermeasure is administered as an Investigational New Drug

in a human clinical trial conducted directly by the Federal Government,

or pursuant to a contract, grant or cooperative agreement with the

Federal Government; (2) all persons who use a Covered Countermeasure or

to whom such a Countermeasure is administered in a pre-pandemic phase,

as defined below; and/or (3) all persons who use a Covered

Countermeasure, or to whom such a Covered Countermeasure is

administered in a pandemic phase, as defined below.

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

Section 319F-3(a) 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 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)

A. I have determined that, upon expiration of the applicable 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 of the Covered Countermeasure, including the return of such

product to the manufacturer, and for 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.

B. The Federal Government shall purchase the entire production of

Covered Countermeasures under the contracts specifically listed by

contract number in section I for the stockpile under section 319F-2 of

the Act, and shall be subject to the time-period extension of section

319F-3(b)(3)(C). Production under future contracts for the same vaccine

will also be subject to the time-period extension of section 319F-

3(b)(3)(C).

VIII. Compensation Fund

In addition to conferring immunity to manufacturers, distributors,

and administrators of the Covered Countermeasures, the Act provides

benefits to certain individuals who sustain a covered injury as the

direct result of the administration or use of the Covered

Countermeasure. The Countermeasures 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 1-888-275-4772 or http://www.hrsa.gov/countermeasurescomp/

default.htm

<http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html\

&log=linklog&to=http://www.hrsa.gov/countermeasurescomp/default.htm> .

IX. Amendments

The Declaration for the Use of the Public Readiness and Emergency

Preparedness Act for H5N1 was published on January 26, 2007; amended on

November 30, 2007 to add H7 and H9 vaccines; amended on October 17,

2008 to add H2 and H6 vaccines; amended on June 15, 2009 to add 2009

H1N1 vaccines and

[[Page 10272]]

republished in its entirety; and amended on September 28, 2009 to

provide targeted liability protections for pandemic countermeasures to

enhance distribution and to add provisions consistent with other

declarations and republished in its entirety. This Declaration

incorporates all amendments prior to the date of its publication in the

Federal Register. Any future amendment to this Declaration will be

published in the Federal Register, pursuant to section 319F-2(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) 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.