[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
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-resistan t 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 ------------ --------- --------- --------- --------- ------- ------------ --------- --------- --------- --------- ------- -- Contract Manufacturer Covered countermeasure PL 85- 804 coverage* ------------ --------- --------- --------- --------- ------- ------------ --------- --------- --------- --------- ------- -- HHSO100200500007C. ......... ......... Cangene..... ......... .. Anthrax immune globulin-- No.
AI G. 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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[FR Doc. E8-23547 Filed 10-1-08; 4:15 pm]
BILLING CODE 4150-37-P
[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
Office of the Secretary
Determination and Declaration Regarding Emergency Use of Doxycycline Hyclate Tablets Accompanied by Emergency Use Information
AGENCY: Office of the Secretary (OS), HHS.
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).
DATES: This Notice and referenced HHS declaration are effective as of October 1, 2008.
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).
SUPPLEMENTARY INFORMATION:
I. Background
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.
II. Determination of the Secretary of Homeland Security
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.
III. Declaration of the Secretary of Health and Human Services
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).
Dated: October 1, 2008. Michael O. Leavitt, Secretary. [FR Doc. E8-23544 Filed 10-1-08; 4:15 pm]
