.
.
.
*Special thanks goes to Eileen D. for bringing this to our attention.
See bolded Excerpt such as:
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.
…and extends through February 28, 2012.
Section 319F-3(a)(4)(A) confers immunity to manufacturers and distributors of the Covered Countermeasure, regardless of the defined population.
…and amended on September 28, 2009 to provide targeted liability protections for pandemic countermeasures to enhance distribution
100226 Sec HHS Sebelius Pandemic Influenza Vaccines Amendment
[Federal Register: March 5, 2010 (Volume 75, Number 43)] [Notices] [Page 10268-10272] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr05mr10-76]=======================================================================
———————————————————————–
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Pandemic Influenza Vaccines–Amendment
Authority: Â 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.
———————————————————————–
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”)
(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        (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
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
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        1-888-275-4772 or http://www.hrsa.gov/countermeasurescomp/
default.htm
<http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html\
&log=linklog&to=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
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.