E8-24736. Pandemic Influenza Vaccine-Amendment

October 10, 2008.

AGENCY:

Office of the Secretary (OS), Department of Health and Human Services (HHS).

ACTION:

Notice of amendment (to the January 26, 2007 Declaration under the Public Readiness and Emergency Preparedness Act, as amended on February 1, 2007).

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 avian influenza viruses spread and evolve into strains capable of causing a pandemic of human influenza.

DATES:

This notice and the attached amendment 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 [phone] (this is not a toll-free number).

HHS Secretary's Amendment to the H5N1 Declaration for the Use of the Public Readiness and Emergency Preparedness Act Dated January 26, 2007

Whereas the January 26, 2007 declaration for H5N1 vaccine (“Original Declaration”) was amended on February 1, 2007 to add H7 and H9 vaccines and additional, minor modifications to that amendment are necessary to ensure internal, editorial consistency of the Original Declaration, as amended.

Whereas the H2 class of influenza viruses, which caused the human influenza pandemic of 1957 and reappeared recently in U.S. animals including swine, is viewed as a likely candidate to re-evolve into an influenza strain capable of causing a pandemic of human influenza;

Whereas the H6 class of influenza viruses, which appeared recently in animals including domestic fowl, is viewed as a likely candidate to evolve into an influenza strain capable of causing a pandemic of human 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 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 Original Declaration, as 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 section II and IV of the Original Declaration, as 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 such other qualified persons as I have identified in section VI of the Original Declaration, as amended;

Therefore pursuant to section 319F-3(b) of the Act, I have determined there is a credible risk that the spread of the H2 and H6 subtypes of avian influenza viruses and resulting disease could in the future constitute a public health emergency. In order to: (1) Reflect the addition of medical countermeasures specific to the H2 and H6 subtypes of influenza viruses; (2) specify the means of distribution pursuant to section 319F-3(b)(2)(E) of the Act for which immunity specified in section 319F-3(a) of the Act shall be in effect; (3) clarify the applicability of immunity for covered persons and qualified persons as those terms are defined in the Act and provided for in the Original Declaration, as amended; and (4) ensure internal, editorial consistency in the Original Declaration arising from the February 1, 2007 amendment, the Original Declaration, as amended, is hereby further amended as follows:

In the title, insert “H2, H6, H7 and H9” after “H5N1” and replace “Vaccine” with “Vaccines” to read: “HHS Secretary's Declaration for the Use of the Public Readiness and Emergency Preparedness Act for H5N1, H2, H6, H7 and H9 Vaccines”.

In the second Whereas clause, insert “H2, H6, H7 or H9” after “H5N1”, replace “viruses” with “virus”, and replace “strains” with “strain” to read: “Whereas an H5N1, H2, H6, H7 or H9 avian influenza virus * * *”.

Insert the following Whereas clauses after the first Whereas clause:

“Whereas, the H2 class of influenza viruses, which caused the human influenza pandemic of 1957 and reappeared recently in U.S. animals including swine, is viewed as a likely candidate to re-evolve into an influenza strain capable of causing a pandemic of human influenza;

Whereas, the H6 class of influenza viruses, which appeared recently in animals including domestic fowl, is viewed as a likely candidate to evolve into an influenza strain capable of causing a pandemic of human influenza;”

Insert the following Whereas clauses after the second Whereas clause:

“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 of the Original Declaration, as 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 such other qualified persons as I have identified in section VI of the Original Declaration, as amended;”

In Section I, strike the entire section and replace it with the following:

“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 of the Original Declaration, the administration and usage of the pandemic countermeasure influenza A (H5N1) vaccine and H2, H6, H7, and H9 vaccines. The immunity specified in section 319F-3(a) of the Act shall only be in effect with respect to: present or future Federal contracts, cooperative agreements, grants, interagency agreements, or memoranda of understanding for pandemic countermeasure influenza A (H5N1) vaccine and H2, H6, H7 and H9 vaccines used and administered in accordance with this declaration. 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 time period of the declaration.”

In Section II, insert “H2, H6, H7 or H9” following “H5N1.” to read “* * * highly pathogenic avian influenza A (H5N1, H2, H6, H7 or H9) virus * * *”.

In Section VIII, strike the section in its entirety and replace it with the following: “This Declaration has been amended twice. The Original Declaration was published in the Federal Register at 72 FR 4710. The first amendment to the Original Declaration was published in the Federal Register at 72 FR 67731. This is the second amendment to the Original Declaration. Any future amendment to this Declaration will be published in the Federal Register, pursuant to section 319F-3(b)(4) of the Act.”

All other provisions of the Original declaration remain in full force.

This amendment to the Declaration will be published in the Federal Register, pursuant to section 319F-3(b)(4) of the Act.

This 10th day of October, 2008.

Michael O. Leavitt,

Secretary of Health and Human Services.

Appendix I

List of U.S. Government Contracts

Contract	Manufacturer	Covered countermeasure	Pub. L. 85-804 Coverage*
HHSN266200700005C	St. Jude Children's Research Hospital	H5N1, H2, H6, H7, H9	No.