Pandemic Influenza Vaccines-Amendment, 51153-51157 [E9-23844]
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Federal Register / Vol. 74, No. 191 / Monday, October 5, 2009 / Notices
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substitutes for bulk de-icing salt to melt
snow and ice. The relevant geographic
markets in which to assess the impact
of the proposed Acquisition are the
states of Maine and Connecticut.
The relevant markets are highly
concentrated. ISCO and Morton are the
two principal bidders in the states of
Maine and Connecticut for the sale and
delivery of bulk de-icing salt. Post
acquisition, the combined entity will
have a market share exceeding 70
percent in both Maine and Connecticut.
Post-merger HHIs for Maine and
Connecticut are 5,142 and 5,834, and
the acquisition will increase HHI levels
by 1,914 and 2,642, respectively. These
market concentration levels far exceed
the thresholds set forth in the
Horizontal Merger Guidelines and thus
create a presumption that the proposed
merger will create or enhance market
power.
Entry into the relevant markets is
difficult because, among other things,
there is a lack of acceptable stockpile
space along the coasts of Maine and
Connecticut. As a result, new entry
sufficient to achieve a significant market
impact within two years is unlikely.
Finally, the Complaint alleges that the
proposed Acquisition will reduce
competition in the relevant markets by
eliminating direct and substantial
competition between ISCO and Morton,
and by increasing the likelihood that
ISCO would increase prices either
unilaterally or through coordinated
interaction with the few remaining firms
in the relevant markets.
IV. The Consent Agreement
To preserve the competition that
otherwise would be eliminated by the
Acquisition, the proposed Consent
Agreement requires ISCO to divest to
Commission-approved buyers, Eastern
Salt and Granite State, assets sufficient
to enable these buyers to become viable
competitors for the de-icing salt
business in the relevant markets
beginning with the 2010-2011 bidding
cycle. ISCO will divest to Eastern Salt
the Maine Divestiture Assets, including:
1) stockpile space in the state, 2) all
associated handling and trucking
contracts, and 3) a book of de-icing salt
business for the 2009-2010 winter
season. ISCO will divest to Granite State
the Connecticut Divestiture Assets,
including: 1) stockpile space in the
state, 2) all associated handling and
trucking contracts, 3) a book of de-icing
salt business for the 2009-2010 winter
season, and 4) a three-year supply of deicing salt at a price that is no more than
ISCO’s costs.
The Commission has preliminarily
determined that Eastern Salt is a well-
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qualified buyer of the Maine Divestiture
Assets and is well situated to replace
the competition Morton provided in the
state. Eastern Salt is a family-owned
company that has been a de-icing salt
supplier in other geographic markets
along the East Coast for roughly 60
years. Eastern Salt is a verticallyintegrated supplier with a dependable,
high-quality supply of de-icing salt.
With the divested assets, Eastern Salt
will be well positioned to compete for
future business in Maine and to deliver
salt to customers in a timely manner.
The Commission has preliminarily
determined that Granite State is a wellqualified buyer of the Connecticut
Divestiture Assets and is well situated
to replace the competition Morton
provided in the state. Granite State has
experience supplying de-icing salt to
customers in a number of states along
the East Coast. The Consent Agreement
requires ISCO to provide Granite State
with a three-year supply of bulk deicing salt at no more than ISCO’s costs.
The supply requirement will ensure that
Granite State has a supply of salt in
Connecticut during the 2010-2011 and
2011-2012 bid cycles while Granite
State develops the necessary supply
arrangements to serve Connecticut
customers in subsequent years. With the
divested assets, Granite State will be
well positioned to compete for future
business in Connecticut and to deliver
salt to customers in a timely manner.
The proposed Consent Agreement
requires that the divestitures occur no
later than twenty (20) days after the
Acquisition is consummated. However,
if ISCO divests the assets to Eastern Salt
or Granite State during the public
comment period, and if, at the time the
Commission decides to make the Order
final, the Commission notifies K+S or
ISCO that either purchaser is not an
acceptable acquirer or that the asset
purchase agreement with the Maine
Purchaser or Connecticut Purchaser is
not an acceptable manner of divestiture,
then ISCO must immediately rescind
the transaction in question and divest
those assets to another buyer within six
(6) months of the date the Order
becomes final. At that time,
Respondents must divest those assets
only to an acquirer and in a manner that
receives the prior approval of the
Commission. The proposed Consent
Agreement also enables the Commission
to appoint a trustee to divest any assets
identified in the Order that K+S or ISCO
has not divested to satisfy the
requirements of the Order.
The proposed Consent Agreement
further requires K+S and ISCO to
maintain the viability and marketability
of the Maine Divestiture Assets and the
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51153
Connecticut Divestiture Assets and to
prevent the destruction, removal,
wasting, deterioration, or impairment of
those assets prior to divestiture.
In order to ensure that the
Commission remains informed about
the status of the divestitures, the
proposed Consent Agreement requires
K+S and ISCO to file reports with the
Commission periodically until the
divestitures are completed. Written
reports describing how K+S and ISCO
are complying with the Order must be
filed one year after the Order becomes
final and annually for the next three (3)
years.
The purpose of this analysis is to
facilitate public comment on the
proposed Consent Agreement, and it is
not intended to constitute an official
interpretation of the proposed Consent
Agreement or to modify its terms in any
way.
By direction of the Commission.
Donald S. Clark
Secretary.
[FR Doc. E9–23826 Filed 10–2–09: 6:40 am]
BILLING CODE: 6750–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Pandemic Influenza Vaccines—
Amendment
Authority: 42 U.S.C. 247d–6d.
Notice of first amendment to the
June 15, 2009 Republished Declaration
under the Public Readiness and
Emergency Preparedness Act.
ACTION:
SUMMARY: Amendment to declaration
issued on June 15, 2009 (74 FR 30294)
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 to add
provisions consistent with other
declarations issued under this authority
that may facilitate vaccination
campaigns, and republication of the
declaration to reflect the declaration in
its entirety, as amended.
DATES: The first amendment of the
republished declaration issued on June
15, 2009 is effective as of September 28,
2009.
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
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51154
Federal Register / Vol. 74, No. 191 / Monday, October 5, 2009 / Notices
(202) 205–2882 (this is not a toll-free
number).
HHS Secretary’s Amendment to the
June 15, 2009 Republished Declaration
for the Use of the Public Readiness and
Emergency Preparedness Act for H5N1,
H2, H6, H9 and 2009–H1N1 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 (now called ‘‘2009–
H1N1 influenza’’);
Whereas, on July 24, 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’’);
Whereas, the World Health
Organization has established a
Pandemic alert phase 6 for the 2009–
H1N1 influenza virus currently
circulating worldwide;
Whereas, vaccination may be effective
to protect persons from the threat of
pandemic influenza;
Whereas, provisions that appear in
other declarations issued pursuant to
section 319F–3 of the Public Health
Service Act (42 U.S.C. 247d–6d) may
assist in vaccination efforts;
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 which was republished
in its entirety;
Whereas, modifications are necessary
to aid States, Tribes, localities and other
entities in conducting vaccination
campaigns to make this declaration
consistent with other declarations
issued pursuant to section 319F–3 of the
Public Health Service Act (42 U.S.C.
247d–6d), and to correct a previous,
minor, editorial error;
Whereas, the findings I made in the
declaration issued on June 15, 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
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countermeasures with respect to the
category of disease and population
described in sections II and IV of the
republished Original Declaration, 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
June 15, 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 June
15, 2009 Republished 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 aid States,
Tribes, localities and other entities in
vaccination campaigns, to make this
Declaration consistent with other
Declarations issued pursuant to section
319F–3 of the Public Health Service Act
(42 U.S.C. 247d–6d) and to correct a
previous, minor, editorial error, the June
15, 2009 Republished Declaration, is
hereby amended as follows:
In the title, add ‘‘H7’’ before ‘‘or H9’’.
After the fifth ‘‘whereas’’ clause,
insert two new recitals as follows:
Whereas, on July 24, 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;
In section I, second paragraph, strike
the second sentence, and insert after the
first sentence: ‘‘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 pandemic
countermeasure influenza A H5N1, H2,
H6, H7, H9, and 2009 H1N1 vaccines
used and administered in accordance
with this Declaration, and (2) activities
authorized in accordance with the
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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
IX below.
In section III, add a second paragraph
as follows: ‘‘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; except
that with respect to 2009 H1N1
influenza vaccine, the effective period
commences on June 15, 2009 and
extends through March 31, 2013.’’
Section VI, strike the second sentence
and insert after the first sentence:
‘‘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.’’
After Section VII, insert new Section
VIII as follows and renumber
subsequent sections:
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 of the
Covered Countermeasure. The
Countermeasure Injury Compensation
Program (CICP) within the Health
Resources and Services Administration
(HRSA) administers the Act’s
compensation program. Information
about the CICP is available at 1–888–
275–4772 or https://www.hrsa.gov/
countermeasurescomp/default.htm.
Section VIII, strike the first sentence
and insert: ‘‘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
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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.’’
Section IX, strike in its entirety, and
insert: ‘‘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 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
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Human Outbreaks in Multiple Locations
Overseas.’’
Appendix I, ‘‘I. List of U.S
Government Contracts—Covered H5N1
Vaccine Contracts,’’ title, add ‘‘, H2, H6,
H9, and 2009–H1N1’’ after ‘‘H5N1’’;
delete ‘‘[January 26, 2007]’’ and add to
the end of the list, ‘‘32. All present,
completed and future Government
H5N1, H2, H6, H9, and 2009–H1N1
vaccine contracts not otherwise listed.’’
All other provisions of the June 15,
2009 Republished Declaration remain in
full force.
Republication of HHS Secretary’s June
15, 2009 Republished 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 June 15,
2009 Republished Declaration, as
hereby amended, 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, H7,
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’’);
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Whereas, on July 24, 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,
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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 countermeasures 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: (1) 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, 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
IX 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
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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.
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; 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.
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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
E:\FR\FM\05OCN1.SGM
05OCN1
Federal Register / Vol. 74, No. 191 / Monday, October 5, 2009 / Notices
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 of the
Covered Countermeasure. The
Countermeasure Injury Compensation
Program (CICP) within the Health
Resources and Services Administration
(HRSA) administers the Act’s
compensation program. Information
about the CICP is available at 1–888–
275–4772 or https://www.hrsa.gov/
countermeasurescomp/default.htm.
cprice-sewell on DSK2BSOYB1PROD with NOTICES
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. 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
VerDate Nov<24>2008
14:59 Oct 02, 2009
Jkt 220001
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 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: September 28, 2009.
Kathleen Sebelius,
Secretary.
Appendix
I. List of U.S. Government Contracts—
Covered H5N1, H2, H6, H9, and 2009–H1N1
Vaccine Contracts
1. HHSN266200400031C
2. HHSN266200400032C
3. HHSN266200300039C
4. HHSN266200400045C
5. HHSN266200205459C
6. HHSN266200205460C
7. HHSN266200205461C
8. HHSN266200205462C
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
51157
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, H9, and
2009–H1N1 vaccine contracts not
otherwise listed.
[FR Doc. E9–23844 Filed 10–2–09; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day-09–09CV]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–5960 and
send comments to Maryam I. Daneshvar,
CDC Acting Reports Clearance Officer,
1600 Clifton Road, MS–D74, Atlanta,
GA 30333 or send an e-mail to
omb@cdc.gov.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
E:\FR\FM\05OCN1.SGM
05OCN1
]]>Agencies
[Federal Register Volume 74, Number 191 (Monday, October 5, 2009)]
[Notices]
[Pages 51153-51157]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-23844]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Pandemic Influenza Vaccines--Amendment
Authority: 42 U.S.C. 247d-6d.
ACTION: Notice of first amendment to the June 15, 2009 Republished
Declaration under the Public Readiness and Emergency Preparedness Act.
-----------------------------------------------------------------------
SUMMARY: Amendment to declaration issued on June 15, 2009 (74 FR 30294)
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 to add provisions consistent with other declarations
issued under this authority that may facilitate vaccination campaigns,
and republication of the declaration to reflect the declaration in its
entirety, as amended.
DATES: The first amendment of the republished declaration issued on
June 15, 2009 is effective as of September 28, 2009.
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
[[Page 51154]]
(202) 205-2882 (this is not a toll-free number).
HHS Secretary's Amendment to the June 15, 2009 Republished
Declaration for the Use of the Public Readiness and Emergency
Preparedness Act for H5N1, H2, H6, H9 and 2009-H1N1 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 (now called
``2009-H1N1 influenza'');
Whereas, on July 24, 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'');
Whereas, the World Health Organization has established a Pandemic
alert phase 6 for the 2009-H1N1 influenza virus currently circulating
worldwide;
Whereas, vaccination may be effective to protect persons from the
threat of pandemic influenza;
Whereas, provisions that appear in other declarations issued
pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C.
247d-6d) may assist in vaccination efforts;
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 which was
republished in its entirety;
Whereas, modifications are necessary to aid States, Tribes,
localities and other entities in conducting vaccination campaigns to
make this declaration consistent with other declarations issued
pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C.
247d-6d), and to correct a previous, minor, editorial error;
Whereas, the findings I made in the declaration issued on June 15,
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 republished Original
Declaration, 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 June 15, 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 June
15, 2009 Republished 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 aid States, Tribes, localities and
other entities in vaccination campaigns, to make this Declaration
consistent with other Declarations issued pursuant to section 319F-3 of
the Public Health Service Act (42 U.S.C. 247d-6d) and to correct a
previous, minor, editorial error, the June 15, 2009 Republished
Declaration, is hereby amended as follows:
In the title, add ``H7'' before ``or H9''.
After the fifth ``whereas'' clause, insert two new recitals as
follows:
Whereas, on July 24, 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;
In section I, second paragraph, strike the second sentence, and
insert after the first sentence: ``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 pandemic
countermeasure influenza A H5N1, H2, H6, H7, H9, and 2009 H1N1 vaccines
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 IX below.
In section III, add a second paragraph as follows: ``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; except that with respect to
2009 H1N1 influenza vaccine, the effective period commences on June 15,
2009 and extends through March 31, 2013.''
Section VI, strike the second sentence and insert after the first
sentence: ``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.''
After Section VII, insert new Section VIII as follows and renumber
subsequent sections:
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 of the Covered Countermeasure. The
Countermeasure Injury Compensation Program (CICP) within the Health
Resources and Services Administration (HRSA) administers the Act's
compensation program. Information about the CICP is available at 1-888-
275-4772 or https://www.hrsa.gov/countermeasurescomp/default.htm.
Section VIII, strike the first sentence and insert: ``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
[[Page 51155]]
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.''
Section IX, strike in its entirety, and insert: ``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 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.''
Appendix I, ``I. List of U.S Government Contracts--Covered H5N1
Vaccine Contracts,'' title, add ``, H2, H6, H9, and 2009-H1N1'' after
``H5N1''; delete ``[January 26, 2007]'' and add to the end of the list,
``32. All present, completed and future Government H5N1, H2, H6, H9,
and 2009-H1N1 vaccine contracts not otherwise listed.''
All other provisions of the June 15, 2009 Republished Declaration
remain in full force.
Republication of HHS Secretary's June 15, 2009 Republished
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 June 15, 2009 Republished
Declaration, as hereby amended, 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, H7, 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, on July 24, 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,
[[Page 51156]]
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 countermeasures 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: (1) 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, 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 IX 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 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.
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; 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,
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
[[Page 51157]]
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 of the Covered Countermeasure. The
Countermeasure Injury Compensation Program (CICP) within the Health
Resources and Services Administration (HRSA) administers the Act's
compensation program. Information about the CICP is available at 1-888-
275-4772 or https://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. 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 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: September 28, 2009.
Kathleen Sebelius,
Secretary.
Appendix
I. List of U.S. Government Contracts--Covered H5N1, H2, H6, 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, H9,
and 2009-H1N1 vaccine contracts not otherwise listed.
[FR Doc. E9-23844 Filed 10-2-09; 8:45 am]
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