[Federal Register Volume 74, Number 121 (Thursday, June 25, 2009)]
[Notices]
[Pages 30294-30297]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-14948]


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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 third amendment to the January 26, 2007 Declaration 
under the Public Readiness and Emergency Preparedness Act, and 
Republication of the Declaration, as Amended.

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SUMMARY: Amendment to 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 Acting 
Secretary's determination, under section 319F-3(b) of the Act, that the 
risk that the spread of H1N1 swine influenza viruses (now known as 2009 
H1N1 Influenza A, or 2009 H1N1 influenza) and resulting disease 
constitutes a public health emergency; and republication of the 
declaration to reflect the declaration in its entirety, as amended.

DATES: The third amendment and republication of the declaration are 
effective as of June 15, 2009.

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 (202) 205-2882 (this is not a toll-free 
number).

HHS Secretary's Amendment to the Declaration for the Use of the Public 
Readiness and Emergency Preparedness Act for H5N1, H2, H6, and H9 
Vaccines

    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 that affects or has 
significant potential to affect the national security (``2009 H1N1 
influenza'');
    Whereas, the World Health Organization has established a Pandemic 
alert phase 5 for the 2009 H1N1 influenza virus currently circulating 
worldwide;
    Whereas, vaccination may be effective to protect persons from the 
threat of 2009 H1N1 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

[[Page 30295]]

October 17, 2008 with respect to certain avian influenza viruses; minor 
modifications are necessary to correct previous, minor, editorial 
errors; and republication of the Original Declaration, as amended, in 
its entirety is necessary for clarity;
    Whereas, the findings made by the Secretary in the Original 
Declaration, as amended, continue to apply generally, and apply with 
equal force as to the 2009 H1N1 influenza;
    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 as hereby further 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 Original Declaration, 
as amended, and as hereby further 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 
Original Declaration, as amended;
    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. In order to extend the Original Declaration, 
as amended, to apply to the 2009 H1N1 influenza and to correct 
previous, minor, editorial errors, the Original Declaration, as 
amended, is hereby further amended and republished as follows:
    In the title, strike ``and H9'' and insert ``H9, and 2009 H1N1''.
    In the first ``whereas'' clause, first sentence, strike ``(H5N1). 
H7 and H9 vaccines'' and insert ``H5N1, H7, and H9''.
    After the fourth ``whereas'' clause, insert a new recital as 
follows:
    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 emergency exists nationwide involving the 
2009 H1N1 influenza virus that affects or has significant potential to 
affect the national security (now called ``2009 H1N1 influenza'');
    In the ninth ``whereas'' clause, insert ``,'' after ``IV''; strike 
``of the Original Declaration, as amended,''; insert ``;'' after 
``VI''; and strike ``of the Original Declaration;''.
    In the ``therefore'' clause concluding the recitals, strike the 
period and insert ``, and that the 2009 H1N1 influenza constitutes a 
public health emergency.''.
    In section I, second paragraph, first sentence, strike all after 
``influenza A'' and insert ``H5N1, H2, H6, H7, H9, and 2009 H1N1 
vaccines and any associated adjuvants.''.
    In section I, second paragraph, second sentence, strike all after 
``influenza A'' and insert ``H5N1, H2, H6, H7, H9, and 2009 H1N1 
vaccines used and administered in accordance with this declaration.''.
    Strike the current section II, ``Category of Disease,'' in its 
entirety and replace as follows:

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 the virus with (1) highly pathogenic avian 
influenza A (H5N1, H2, H6, H7, or H9) virus; or (2) 2009 H1N1 
influenza.
    In section III, strike the period and insert ``; except that with 
respect to 2009 H1N1 influenza vaccine, the effective period commences 
on June 15, 2009 and extends through March 31, 2013.''
    In Section VIII, strike the section in its entirety and replace it 
with the following:
    The Declaration for the Use of the Public Readiness and Emergency 
Preparedness Act for H5N1 vaccines was published on January 26, 2007 
and amended on November 30, 2007 to add H7 and H9 vaccines and on 
October 17, 2008 to add H2 and H6 vaccines. 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.
    All other provisions of the Original Declaration, as amended, 
remain in full force.

Republication of HHS Secretary's Original Declaration, as Amended, for 
the Use of the Public Readiness and Emergency Preparedness Act for 
H5N1, H2, H6, H9, and 2009 H1N1 Vaccines

    To the extent any term of the original January 27, 2007 Declaration 
or any amendment thereto is inconsistent with any provision of this 
republished Declaration, the terms of this republished Declaration are 
controlling.

HHS Secretary's Declaration for the Use of the Public Readiness and 
Emergency Preparedness Act for H5N1, H2, H6, H9, and 2009 H1N1 Vaccines

    Whereas highly pathogenic avian influenza A H5N1, H7, and H9 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, 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, an H5N1, H2, H6, H7 or H9 avian influenza virus may evolve 
into strain capable of causing a pandemic of human influenza;
    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, 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'');

[[Page 30296]]

    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 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.

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 the pandemic countermeasure influenza A 
H5N1, H2, H6, H7, H9, and 2009 H1N1 Vaccines and any associated 
adjuvants. 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, H2, H6, H7, 
H9, and 2009 H1N1 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.

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 the virus with (1) highly pathogenic avian 
influenza A (H5N1, H2, H6, H7, or H9) virus; or (2) 2009 H1N1 
influenza.

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; except that 
with respect to 2009 H1N1 influenza vaccine, the effective period 
commences on June 15, 2009 and extends through March 31, 2013.

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,

[[Page 30297]]

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 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. Amendments

    The Declaration for the Use of the Public Readiness and Emergency 
Preparedness Act for H5N1 vaccines was published on January 26, 2007 
and amended on November 30, 2007 to add H7 and H9 vaccines and on 
October 17, 2008 to add H2 and H6 vaccines. 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.

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: June 15, 2009.
Kathleen Sebelius,
Secretary.

Appendix

I. List of U.S. Government Contracts--Covered H5N1 Vaccine Contracts 
[January 26, 2007]
    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

[FR Doc. E9-14948 Filed 6-24-09; 8:45 am]
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