[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

[[Page 58240]]

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.

[[Page 58241]]

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

[[Page 58242]]

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