- [Federal Register: October 6, 2008 (Volume 73, Number 194)]
[Notices] [Page 58239-58242] From the Federal Register Online via GPO Access
[wais.access.gpo.gov] [DOCID:fr06oc08-76]
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- DEPARTMENT OF HEALTH AND HUMAN SERVICES
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- Office of the Secretary
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- Declaration Under the Public Readiness and Emergency
Preparedness Act
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- October 1, 2008. AGENCY: Office of the Secretary (OS),
Department of Health and Human Services (HHS).
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- 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.
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- DATES: This notice and the attached declaration are effective
as of the date of signature of the declaration.
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- 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).
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- HHS Secretary's Declaration for Utilization of Public
Readiness and Emergency Preparedness Act for Anthrax Countermeasures
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- 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.
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- I. Covered Countermeasures (As Required by Section 319F-3(b)(1)
of the Act)
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- 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.
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- II. Category of Disease (As Required by Section 319F-
3(b)(2)(A) of the Act)
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- 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.
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- III. Effective Time Period (As Required by Section 319F-3(b)(2)(B)
of the Act)
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- 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)
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- 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.
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- V. Geographic Area (As Required by Section 319F- 3(b)(2)(D)
of the Act)
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- Section 319F-3(a) of the Act applies to the administration
and use of a Covered Countermeasure without geographic limitation.
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- VI. Qualified Persons (As Required by Section 319F- 3(i)(8)(B)
of the Act)
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- 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.
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- VII. Additional Time Periods of Coverage After Expiration
of Declaration (As Required by Section 319F-3(b)(3)(B) of the Act)
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- 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.
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- VIII. Amendments
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- 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.
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- IX. Definitions
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- 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.
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- This first day of October, 2008. Michael O. Leavitt,
Secretary of Health and Human Services.
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- Appendix I--List of U.S. Government Contracts -------------------------------------------------------
------------------------------------------------------- -- Contract Manufacturer
Covered countermeasure PL 85- 804 coverage* -------------------------------------------------------
------------------------------------------------------- -- HHSO100200500007C...................
Cangene................ Anthrax immune globulin-- No.
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- AI G. HHSO100200500006C................... HGS....................
Anthrax monoclonal antibody- No.
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- ABThrax. HHSO100200600019C................... Emergent
Biodefense BioThrax (Anthrax Vaccine Yes.
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- Operations. Adsorbed, AVA). HHSO100200700037C...................
Emergent Biodefense BioThrax (Anthrax Vaccine No.
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- Operations. Adsorbed, AVA). W9113M-04-D-0002....................
BioPort (Emergent BioThrax (Anthrax Vaccine Yes.
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- Biosolutions). Adsorbed, AVA). DAMD 17-97-D-00003..................
BioPort (Emergent BioThrax (Anthrax Vaccine Yes.
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- Biosolutions). Adsorbed, AVA) Shipping. HHSN 272200700035C..................
Elusys................. Anthrax monoclonal No.
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- antibody--ETI-204. HHSN 272200700033C..................
Pharmathene............ Anthrax monoclonal No.
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- antibody--Valortim. HHSN 272200700034C..................
Emergent BioSolutions.. Anthrax immune globulin-- No.
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- AIG. NO1-A1-30052........................ Avecia (Pharmathene)...
Recombinant protective No.
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- antigen (rPA) anthrax
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- vaccine. V797P-5777x......................... Shering
Corp........... Cipro 250mg/5ml; 100ml No.
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- 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.
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- 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.
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- 100ml suspension. V797BPA0015.........................
Bedford Labs........... Rifampin 600mg vial IV..... No. V797P-5396x.........................
Hospira................ Clindamycin 150mg/ml 6ml No.
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- vial IV. V797P-5669x......................... Abraxis
Bioscience, Inc Vancomycin 1 g vial IV..... No. V797P-1020x.........................
McKesson............... Penicillin GK 20 million No.
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- unit vial IV. V797P-5387x......................... Johnson
and Johnson Levofloxacin 5mg/ml 150ml No.
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- 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.)
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- [FR Doc. E8-23547 Filed 10-1-08; 4:15 pm]
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- BILLING CODE 4150-37-P
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- [Federal Register: October 6, 2008 (Volume 73, Number
194)] [Notices] [Page 58242-58243] From the Federal Register Online via
GPO Access [wais.access.gpo.gov] [DOCID:fr06oc08-77]
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- DEPARTMENT OF HEALTH AND HUMAN SERVICES
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- Office of the Secretary
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- Determination and Declaration Regarding Emergency Use
of Doxycycline Hyclate Tablets Accompanied by Emergency Use Information
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- AGENCY: Office of the Secretary (OS), HHS.
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- ACTION: Notice.
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- SUMMARY: The Secretary of the Department of Health and
Human Services (HHS) is issuing this notice pursuant to section 564(b)(4)
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 360bbb-3(b)(4),
to justify the emergency use of doxycycline hyclate tablets accompanied
by emergency use information, contained in emergency kits for eligible
United States Postal Service (USPS) Cities Readiness Initiative (CRI) participants
and their household members in advance of a potential attack involving
Bacillus anthracis. Bacillus anthracis is a biological agent known to cause
anthrax. The Secretary, HHS, provides notice of the determination of the
Secretary of Homeland Security on September 23, 2008 that there is a significant
potential for a domestic emergency involving a heightened risk of attack
with a specified biological, chemical, radiological, or nuclear agent or
agents--in this case, Bacillus anthracis, although there is no current
domestic emergency involving anthrax, no current heightened risk of an
anthrax attack, and no credible information indicating an imminent threat
of an attack involving Bacillus anthracis. The Secretary also provides
notice that, on the basis of such determination, he has declared an emergency
justifying the authorization of emergency use of doxycycline hyclate tablets
accompanied by emergency use information subject to the terms of any authorization
issued by the Food and Drug Commissioner under 21 U.S.C. 360bbb-3(a).
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- DATES: This Notice and referenced HHS declaration are
effective as of October 1, 2008.
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- FOR FURTHER INFORMATION CONTACT: RADM W.C. Vanderwagen,
M.D., 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).
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- SUPPLEMENTARY INFORMATION:
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- I. Background
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- The CRI, begun in 2004, is a federally supported effort
to prepare 72 major U.S. metropolitan areas to effectively respond to a
large- scale bioterrorist event by dispensing antibiotics to their entire
identified population within 48 hours of the decision to do so. Over the
past several years, HHS and the USPS have developed and tested in three
U.S. cities--Seattle, Philadelphia and Boston-- the ability of letter carriers
to quickly deliver door-to-door a few days' worth of antibiotics to residential
addresses. This quick-strike capability is intended to buy time for State
and local public health authorities to set up points of dispensing for
further provision of antibiotics across the community, as needed. Under
Section 564 of the FFDCA, the Secretary of Homeland Security may determine
that there is a domestic emergency, or a significant potential for a domestic
emergency, involving a heightened risk of attack with a specified biological
chemical, radiological or nuclear agent or agents.
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- Based on such a determination, the Secretary of Health
and Human Services may declare an emergency that justifies the authorization
of a product that is not otherwise approved, licensed or cleared for commercial
use (``unapproved product'') or is not approved, licensed, or cleared for
a particular use (``unapproved use of an approved product.''). Following
that declaration, the Commissioner of the Food and Drug Administration
(FDA) may issue an Emergency Use Authorization (EUA). The Biomedical Advanced
Research and Development Authority (BARDA) of the HHS Office of the Assistant
Secretary for Preparedness and Response (ASPR) has requested that FDA issue
an EUA for doxycycline hyclate tablets accompanied by emergency use information
for use by eligible USPS participants in the CRI and their household members.
Doxycyline hyclate tablets are approved by the FDA for the post- exposure
prophylaxis of anthrax. However, the doxycycline hyclate tablets for which
BARDA seeks an EUA would be accompanied by emergency use information that
is not included in any of the approved applications for doxyclycline hyclate
tablets. For this reason, an EUA is necessary. The September 23, 2008 determination
by the Secretary of Homeland Security that there is a significant potential
for a domestic emergency, involving a heightened risk of attack with a
specified biological, chemical, radiological, or nuclear agent or agents--in
this case, Bacillus anthracis, and the October 1, 2008 declaration by the
Secretary of Health and Human Services based on that determination that
there is an emergency justifying the authorization of emergency use of
doxycycline hyclate tablets accompanied by emergency use information, enables
the FDA Commissioner to issue an EUA for doxycyline hyclate tablet emergency
kits under section 564(a) of the FFDCA, 21 U.S.C. 360bbb-3(a). With issuance
of the EUA, eligible letter carriers participating in the CRI may receive
the doxycycline hyclate tablet emergency kits, if not medically contraindicated,
for future use by them and other members of their households during an
anthrax emergency, subject to the terms of the authorization. The antibiotics
and accompanying information may help protect these letter carriers and
household members against contracting anthrax if, following an outdoor
anthrax attack, the USPS is called upon to deliver the same or similar
antibiotics to homes across their community where people may have been
exposed to Bacillus anthracis. In an anthrax attack, time is of the essence
in preventing illness and death by getting antibiotics to people who may
have been exposed. By providing advance protection to letter carriers who
willingly put themselves at risk by delivering antibiotics in an affected
community, the unique capabilities of the USPS may be used to get antibiotics
to those who need them quickly. The USPS initiative and EUA are one part
of the Federal Government's strategy to encourage preparedness at all levels
of government to enable the nation to respond effectively in the event
of an anthrax emergency.
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- II. Determination of the Secretary of Homeland Security
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- On September 23, 2008, pursuant to section 564(b)(1)(A)
of the FFDCA, 21 U.S.C. 360bbb-3(b)(1)(A), the Secretary of Homeland Security
determined that there is a significant potential for a domestic emergency,
involving a heightened risk of attack with a specified biological, chemical,
radiological, or nuclear agent or agents--in this case, Bacillus anthracis.
The Secretary of Homeland Security made this determination in a September
23, 2008 memorandum addressed to the Secretary of Health and Human Services.
In that memorandum, the Secretary of Homeland Security stated that there
is not currently a domestic emergency involving anthrax, there is not currently
a heightened risk of an anthrax attack, and his Department has no credible
information indicating an imminent threat of an attack involving Bacillus
anthracis. The Secretary of Homeland Security determined that there is
a significant potential for a domestic emergency, involving a heightened
risk of attack with Bacillus anthracis, on two bases: (1) The Department
of Homeland Security has already found that an anthrax attack poses a material
threat to the United States population sufficient to affect national security,
which allows the Secretary to conclude that there is a non-negligible possibility
that a heightened risk of attack will arise. The finding that an anthrax
attack poses a material threat to the United States population sufficient
to affect national security was made on January 20, 2004 regarding anthrax,
and on September 22, 2006 regarding multi-drug resistant Bacillus anthracis,
pursuant to section 319F-2(c)(2) of the Public Health Service (PHS) Act,
42 U.S.C. 247d-6b(c)(2). (2) Were the government to determine in the future
that there is a heightened risk of an anthrax attack--if, for example,
there were credible information about an imminent threat of such an attack--that
would almost certainly result in a domestic emergency. That is so, among
other important reasons, because those exposed to Bacillus anthracis need
to take appropriate antimicrobials rapidly after exposure to avoid contracting
anthrax and because of the significant challenges to rapidly delivering
such antimicrobials to those at risk in an anthrax emergency. Given his
determination that there is a significant potential for a domestic emergency,
the Secretary of Homeland Security also urged the Secretary of Health and
Human Services to employ all relevant emergency powers under section 564
of the FFDCA to ensure distribution of pre- need countermeasures that may
be effective in preventing the contracting of anthrax by people in the
delivery chain, such as USPS workers; first responders, including law enforcement;
to essential government and non-government workers; and to the general
public.
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- III. Declaration of the Secretary of Health and Human
Services
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- On September 23, 2008, the Secretary of the Department
of Homeland Security determined that there is a significant potential for
a domestic emergency, involving a heightened risk of attack with a specified
biological, chemical, radiological, or nuclear agent or agents--in this
case, Bacillus anthracis. Pursuant to section 564(b) of the Federal Food,
Drug and Cosmetic Act, 21 U.S.C. 360bbb-3(b), and on the basis of such
determination, on October 1, 2008, I declared an emergency justifying the
authorization of the emergency use of doxycycline hyclate tablets accompanied
by emergency use information subject to the terms of any authorization
issued under 21 U.S.C. 360bbb-3(a).
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- Dated: October 1, 2008. Michael O. Leavitt, Secretary.
[FR Doc. E8-23544 Filed 10-1-08; 4:15 pm]
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- BILLING CODE 4150-37-P
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