[Federal Register Volume 75, Number 43 (Friday, March 5, 2010)]
[Notices]
[Pages 10268-10272]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-4644]


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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 (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 or 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.
    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.
    Pandemic Phase: 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.
    Pre-pandemic Phase: 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.

    Dated: February 26, 2010.
Kathleen Sebelius,
Secretary.

APPENDIX

I. List of U.S. Government Contracts--Covered H5N1, H2, H6, H7, H9, and 
2009-H1N1 Vaccine Contracts

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
32. All present, completed and future Government H5N1, H2, H6, H7, 
H9, and 2009-H1N1 vaccine contracts not otherwise listed.

[FR Doc. 2010-4644 Filed 3-4-10; 8:45 am]
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