[Federal Register Volume 73, Number 194 (Monday, October 6, 2008)]
[Notices]
[Pages 58239-58242]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-23547]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Declaration Under the Public Readiness and Emergency Preparedness
Act
October 1, 2008.
AGENCY: Office of the Secretary (OS), Department of Health and Human
Services (HHS).
ACTION: Notice.
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SUMMARY: Declaration pursuant to section 319F-3 of the Public Health
Service Act (42 U.S.C. 247d-6d) to provide targeted liability
protections for anthrax countermeasures based on a credible risk that
the threat of exposure to Bacillus anthracis and the resulting disease
constitutes a public health emergency.
DATES: This notice and the attached declaration are effective as of the
date of signature of the declaration.
FOR FURTHER INFORMATION CONTACT: RADM W.C. Vanderwagen, Assistant
Secretary for Preparedness and Response, Office of the Secretary,
Department of Health and Human Services, 200 Independence Avenue, SW.,
Washington, DC 20201, Telephone (202) 205-2882 (this is not a toll-free
number).
HHS Secretary's Declaration for Utilization of Public Readiness and
Emergency Preparedness Act for Anthrax Countermeasures
Whereas significant changes in the nature, regularity and degree of
threats to health posed by the use of infectious agents as weapons of
biological warfare have generated increased concern for the safety of
the general American population particularly following the deliberate
exposure of citizens in the
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United States to Bacillus anthracis (B. anthracis) spores in 2001 that
demonstrated the ease of dissemination, infectivity, and mortality;
Whereas the Secretary of Homeland Security has determined that B.
anthracis and multi-drug-resistant B. anthracis present a material
threat against the United States population, sufficient to affect
national security;
Whereas there are covered countermeasures to treat, identify, or
prevent adverse health consequences or death from exposure to B.
anthracis;
Whereas such countermeasures, including vaccines, antimicrobials/
antibiotics, and antitoxins for pre-exposure and post-exposure
prevention and treatment, diagnostics to identify such exposure, and
additional countermeasures for treatment of adverse events arising from
use of these countermeasures exist or may be the subject of research
and/or development;
Whereas such countermeasures may be used and administered in
accordance with Federal contracts, cooperative agreements, grants,
interagency agreements, and memoranda of understanding, and may also be
used and administered at the Regional, State, and local level in
accordance with the public health and medical response of the Authority
Having Jurisdiction;
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, in accordance with section 319F-3(b)(6) of the Act, 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 such 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;
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 below, 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 of this
declaration;
Therefore, pursuant to section 319F-3(b) of the Act, I have
determined there is a credible risk that the threat of exposure of B.
anthracis and the resulting disease 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 anthrax countermeasures as defined in
section IX below. The immunity specified in section 319F-3(a) of the
Act shall only be in effect with respect to: (1) Present (see Appendix
I) or future Federal contracts, cooperative agreements, grants,
interagency agreements, or memoranda of understanding involving
countermeasures that are 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 Covered
Countermeasure 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 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. This declaration also shall apply to all Covered
Countermeasures (see Appendix I) administered or used by or on behalf
of the Department of Defense.
II. Category of Disease (As Required by Section 319F-3(b)(2)(A) of the
Act)
The category of disease, health condition, or threat to health for
which I am recommending the administration or use of the Covered
Countermeasures is anthrax, which may result from exposure to B.
anthracis.
III. Effective Time Period (As Required by Section 319F-3(b)(2)(B) of
the Act)
With respect to Covered Countermeasures administered and used in
accordance with present or future Federal contracts, cooperative
agreements, grants, interagency agreements, or memoranda of
understanding, the effective period of time of this Declaration
commences on signature of the declaration and extends through December
31, 2015.
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.
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IV. Population (As Required by Section 319F-3(b)(2)(C) of the Act)
Section 319F-3(a)(4)(A) of the Act confers immunity to
manufacturers and distributors of the Covered Countermeasure,
regardless of the defined population.
Section 319F-3(a)(3)(C)(i) of the Act confers immunity to covered
persons who may be a program planner or qualified persons with respect
to the Covered Countermeasure only if a member of the population
specified in the declaration as persons who use the Covered
Countermeasure or to whom such a Covered Countermeasure is
administered, 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 are met.
The populations specified in this declaration are all persons who
use a Covered Countermeasure or to whom a Covered Countermeasure is
administered in accordance with this declaration, including, but not
limited to: Department of Defense military personnel and supporting
civilian-employee and contractor personnel; any person conducting
research and development of Covered Countermeasures directly by the
Federal government or pursuant to a contract, grant, or cooperative
agreement with the Federal government; any person who receives a
Covered Countermeasure from persons authorized in accordance with the
public health and medical emergency response of the Authority Having
Jurisdiction to prescribe, administer, deliver, distribute, or dispense
the Covered Countermeasure, and their officials, agents, employees,
contractors, and volunteers following a declaration of an emergency;
any person who receives a Covered Countermeasure from a person
authorized to prescribe, administer or dispense the countermeasure or
who is otherwise authorized under an Emergency Use Authorization; any
person who receives a Covered Countermeasure as an investigational new
drug in human clinical trials being conducted directly by the Federal
government or pursuant to a contract, grant, or cooperative agreement
with the Federal government.
V. Geographic Area (As Required by Section 319F-3(b)(2)(D) of the Act)
Section 319F-3(a) of the Act applies to the administration and use
of a Covered Countermeasure without geographic limitation.
VI. 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 Covered 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
who is authorized to prescribe, administer, deliver, distribute or
dispense Covered Countermeasures to Department of Defense military
personnel and supporting civilian-employee and contractor personnel,
(2) 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 (3) Any
person authorized to prescribe, administer, or dispense Covered
Countermeasures or who is otherwise authorized under an Emergency Use
Authorization, including, but not limited to Department of Defense
military personnel and supporting civilian employee and contractor
personnel.
VII. Additional Time Periods of Coverage After Expiration of
Declaration (As Required by Section 319F-3(b)(3)(B) of the Act)
I have determined that, upon expiration of the time period
specified in Section III above, an additional twelve (12) months is a
reasonable period to allow for manufacturers and other 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. Further, as to doses shipped by the CDC to the DoD pursuant to
the DoD/CDC Interagency Agreement (IAA) dated March 10, 2008, an
additional period of time of liability protection shall extend for as
long as the SNS or its successor exists and the IAA remains in effect,
plus, if the additional twelve (12) months following the time period in
Section III above has expired, an additional twelve (12) months upon
expiration of the IAA.
VIII. Amendments
This declaration has not previously been amended. Any future
amendment to this declaration will be published in the Federal
Register, pursuant to section 319F-3(b)(4) of the Act.
IX. 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 Covered Countermeasures to patients/
recipients, management and operation of delivery systems, and
management and operation of distribution and dispensing locations.
Anthrax Countermeasure: Any vaccine; antimicrobial/antibiotic,
other drug or antitoxin; or diagnostic or device to identify, prevent
or treat anthrax or adverse events from such countermeasures (1)
Licensed under section 351 of the Public Health Service Act; (2)
approved under section 505 or section 515 of the Federal Food, Drug,
and Cosmetic Act (FDCA); (3) cleared under section 510(k) of the FDCA;
(4) authorized for emergency use under section 564 of the FDCA ; (5)
used under section 505(i) of the FDCA or section 351(a)(3) of the PHS
Act, and 21 CFR Part 312; or (6) used under section 520(g) of the FDCA
and 21 CFR part 812.
Authority Having Jurisdiction: 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 an 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 anthrax
countermeasures, with the exception of
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a federal declaration in support of an emergency use authorization
under section 564 of the FDCA unless such declaration specifies
otherwise.
This first day of October, 2008.
Michael O. Leavitt,
Secretary of Health and Human Services.
Appendix I--List of U.S. Government Contracts
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Contract Manufacturer Covered countermeasure PL 85-804 coverage*
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HHSO100200500007C................... Cangene................ Anthrax immune globulin-- No.
AIG.
HHSO100200500006C................... HGS.................... Anthrax monoclonal antibody- No.
ABThrax.
HHSO100200600019C................... Emergent Biodefense BioThrax (Anthrax Vaccine Yes.
Operations. Adsorbed, AVA).
HHSO100200700037C................... Emergent Biodefense BioThrax (Anthrax Vaccine No.
Operations. Adsorbed, AVA).
W9113M-04-D-0002.................... BioPort (Emergent BioThrax (Anthrax Vaccine Yes.
Biosolutions). Adsorbed, AVA).
DAMD 17-97-D-00003.................. BioPort (Emergent BioThrax (Anthrax Vaccine Yes.
Biosolutions). Adsorbed, AVA) Shipping.
HHSN 272200700035C.................. Elusys................. Anthrax monoclonal No.
antibody--ETI-204.
HHSN 272200700033C.................. Pharmathene............ Anthrax monoclonal No.
antibody--Valortim.
HHSN 272200700034C.................. Emergent BioSolutions.. Anthrax immune globulin-- No.
AIG.
NO1-A1-30052........................ Avecia (Pharmathene)... Recombinant protective No.
antigen (rPA) anthrax
vaccine.
V797P-5777x......................... Shering Corp........... Cipro 250mg/5ml; 100ml No.
suspension.
V797P-5977x......................... Cobalt Pharmaceuticals. Cipro 500mg tablets........ No.
V797P-5941x......................... Blu Pharmaceuticals.... Doxycycline 100mg tablets.. No.
V797P-5883x......................... Pfizer, Inc............ Doxycycline 25mg/5ml No.
suspension 60ml.
V797P-5669x......................... Abraxis Bioscience, Inc Doxycycline 100mg vial IV.. No.
V797-DSNS-8002...................... Sandoz, Inc............ Amoxicillin 500mg capsules. No.
V797-DSNS-8002...................... Sandoz, Inc............ Amoxicillin 400mg/5ml; No.
100ml suspension.
V797BPA0015......................... Bedford Labs........... Rifampin 600mg vial IV..... No.
V797P-5396x......................... Hospira................ Clindamycin 150mg/ml 6ml No.
vial IV.
V797P-5669x......................... Abraxis Bioscience, Inc Vancomycin 1 g vial IV..... No.
V797P-1020x......................... McKesson............... Penicillin GK 20 million No.
unit vial IV.
V797P-5387x......................... Johnson and Johnson Levofloxacin 5mg/ml 150ml No.
Healthcare. bag IV.
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* Status of indemnification coverage under P.L. 85-804 (An Act to authorize the making, amendment and
modification of contracts to facilitate the national defense.)
[FR Doc. E8-23547 Filed 10-1-08; 4:15 pm]
BILLING CODE 4150-37-P