PUBLIC LAW 106-398 —APPENDIX 114 STAT. 1654A-37 (B) Establishing an additional source (other than or in conjunction with the current manufacturer) for the production of anthrax vaccine. (C) Any action that the Secretary determines necessary to ensure production of anthrax vaccine for meeting an urgent and immediate national defense requirement. (2) Not later than seven days after the total amount of the funds obligated (or obligated and expended) for purposes specified in paragraph (1) exceeds $5,000,000, the Secretary shall submit to Congress a notification that the total obligations exceed that amount, together with a written justification for the obligation of funds in excess of that amount. (d) CURRENT MANUFACTURER.— In this section, the term "current manufacturer" means the manufacturing source from which the Department of Defense is procuring anthrax vaccine as of the date of the enactment of this Act. SEC. 218. REPORT ON BIOLOGICAL WARFARE DEFENSE VACCINE RESEARCH AND DEVELOPMENT PROGRAMS. (a) REPORT REQUIRED.— Not later than February 1, 2001, the Secretary of Defense shall submit to the congressional defense committees a report on the acquisition of biological warfare defense vaccines for the Department of Defense. (b) CONTENTS. — The report shall include the following: (1) The Secretary's evaluation of the implications of reliance on the commercial sector to meet the requirements of the Department of Defense for biological warfare defense vaccines. (2) A design for a government-owned, contractor-operated facility for the production of biological warfare defense vaccines that meets the requirements of the Department for such vaccines, and the assumptions on which that design is based. (3) A preliminary cost estimate of, and schedule for, establishing and bringing into operation such a facility, and the estimated annual cost of operating such a facility thereafter. (4) A determination, developed in consultation with the Surgeon General, of the utility of such a facility to support the production of vaccines for the civilian sector, and a discussion of the effects that the use of such a facility for that purpose might have on— (A) the production of vaccines for the Armed Forces; and (B) the annual cost of operating such a facility. (5) An analysis of the effects that international requirements for vaccines, and the production of vaccines in response to those requirements, might have on— (A) the production of vaccines for the Armed Forces; and (B) the annual cost of operating such a facility. (c) BIOLOGICAL WARFARE DEFENSE VACCINE DEFINED.— In this section, the term "biological warfare defense vaccine" means a vaccine useful for the immunization of military personnel to protect against biological agents on the Validated Threat List issued by the Joint Chiefs of Staff, whether such vaccine is in production or is being developed.
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