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 (emphasis added – G)
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
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.