Pandemic Countermeasures; Declaration Under the Public Readiness and Emergency Preparedness Act, 4710-4711 [E7-1635]

Agencies

• Office of the Secretary
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 72, Number 21 (Thursday, February 1, 2007)]
[Notices]
[Pages 4710-4711]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-1635]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


 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.

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    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 (202) 205-2882 (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.

[[Page 4711]]

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

    List of U.S. Government Contracts--Covered H5N1 Vaccine Contracts
                           [January 26, 2007]
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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
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 [FR Doc. E7-1635 Filed 1-31-07; 8:45 am]
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