E7-1635. Pandemic Countermeasures; Declaration Under the Public Readiness and Emergency Preparedness Act

January 26, 2007.

AGENCY:

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

ACTION:

Notice.

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

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 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 December 1, 2006.

FOR FURTHER INFORMATION CONTACT:

RADM W.C. Vanderwagen, Assistant Secretary for Public Health Emergency Preparedness, 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).

SUPPLEMENTARY INFORMATION:

Highly pathogenic avian influenza A (H5N1) viruses have spread by infected migratory birds and exports of live poultry from Asia through Europe and Africa since 2004, and could spread into North America in 2006 or later, and have caused disease in humans with an associated high case fatality upon infection with this virus. Section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d), which was established by the Public Readiness and Emergency Preparedness Act of 2005, 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 H5N1 Vaccine

Whereas highly pathogenic avian influenza A (H5N1) viruses have spread by infected migratory birds and exports of live poultry from Asia through Europe and Africa since 2004, and could spread into North America in 2006 or later, and have caused disease in humans with an associated high case fatality upon infection with this virus;

Whereas an H5N1 avian influenza virus might evolve into a strain capable of causing a pandemic of human influenza;

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 avian influenza viruses 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 preparation of virus reference strains; 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 influenza A (H5N1) vaccine. The immunity specified in section 319F-3(a) of the Act shall be in effect with respect to those activities, pursuant to any means of distribution. The immunity specified in section 319F-3(a) of the Act shall only be in effect with respect to present (see Appendix I) and any future U.S. Government grants, cooperative agreements, and contracts for pandemic countermeasure influenza A (H5N1) vaccine used and administered in accordance with this declaration, irrespective of the means of distribution.

This declaration shall apply to all product administered during the effective period of the declaration in the United States by program planners and qualified persons covered by this declaration, pursuant to any means of distribution.

This declaration shall subsequently refer to the countermeasures identified above as “Covered Countermeasures.”

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 with highly pathogenic avian influenza A (H5N1) virus following exposure to the virus.

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

The effective period of time of this Declaration commences on December 1, 2006 and extends through February 28, 2010.

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: None.

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 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. 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-2(b)(4) of the Act.

IX. Definitions

For the purposes of this declaration, “pre-pandemic phase” means the following stages, as defined in the National Strategy for Pandemic Influenza: Implementation Plan (Homeland Security Council, May 2006): (0) New Domestic Animal Outbreak in At-Risk Country; (1) Suspected Human Outbreak Overseas; (2) Confirmed Human Outbreak Overseas; and (3) Widespread Human Outbreaks in Multiple Locations Overseas.

For the purposes of this declaration, “pandemic phase” means the following stages, as defined in the National Strategy for Pandemic Influenza: Implementation Plan (Homeland Security Council, May 2006): (4) First Human Case in North America; and (5) Spread Throughout United States.

Dated: January 26, 2007.

Michael O. Leavitt,

Secretary of Health and Human Services.

Appendix I

1. HHSN266200400031C

2. HHSN266200400032C

3. HHSN266200300039C

4. HHSN266200400045C

5. HHSN266200205459C

6. HHSN266200205460C

7. HHSN266200205461C

8. HHSN266200205462C

9. HHSN266200205463C

10. HHSN266200205464C

11. HHSN266200205465C

12. HHSN266199905357C

13. HHSN266200300068C

14. HHSN266200005413C

15. HHSO100200600021C (formerly 200200409981)

16. HHSO100200500004C

17. HHSO100200500005I

18. HHSO100200700026I

19. HHSO100200700027I

20. HHSO100200700028I

21. HHSO100200600010C

22. HHSO100200600011C

23. HHSO100200600012C

24. HHSO100200600013C

25. HHSO100200600014C

26. HHSO100200600022C (formerly 200200511758)

27. HHSO100200600023C (formerly 200200410431)

28. CRADA No. AI-0155 NIAID/MedImmune

29. HHSO100200700029C

30. HHSO100200700030C

31. HHSO100200700031C