ACCELERATION OF RESEARCH, DEVELOPMENT, AND PRODUCTION OF MEDICAL COUNTERMEASURES FOR DEFENSE AGAINST BIOLOGICAL WARFARE AGENTS.

SEC. 1044. ACCELERATION OF RESEARCH, DEVELOPMENT, AND PRODUCTION OF MEDICAL COUNTERMEASURES FOR DEFENSE AGAINST BIOLOGICAL WARFARE AGENTS. (a) Aggressive Program Required.—(1) The Secretary of Defense shall carry out a program to aggressively accelerate the research, development, testing, and licensure of new medical countermeasures for defense against the biological warfare agents that are the highest threat. (2) The program shall include the following activities: (A) As the program’s first priority, investment in multiple new technologies for medical countermeasures for defense against the biological warfare agents that are the highest threat, including for the prevention and treatment of anthrax. 115 STAT. 1220 (B) Leveraging of ideas and technologies from the biological technology industry. (b) Study Required.—(1) The Secretary of Defense shall enter into a contract with the Institute of Medicine and the National Research Council under which the Institute and Council, in consultation with the Secretary, shall carry out a study of the review and approval process for new medical countermeasures for biological warfare agents. The purpose of the study shall be to identify— (A) new approaches to accelerating such process; and (B) definitive and reasonable methods for assuring the agencies responsible for regulating such countermeasures that such countermeasures will be effective in preventing disease in humans or in providing safe and effective therapy against such agents. (2) Not later than June 1, 2002, the Institute and Council shall jointly submit to Congress a report on the results of the study. (c) Facility for Production of Vaccines.—(1) Subject to paragraph (2) and to the availability of funds for such purposes appropriated pursuant to an authorization of appropriations, the Secretary of Defense may— (A) design and construct a facility on a Department of Defense installation for the production of vaccines to meet the requirements of the Department of Defense to prevent or mitigate the physiological effects of exposure to biological warfare agents; (B) operate that facility; (C) qualify and validate that facility for the production of vaccines in accordance with the requirements of the Food and Drug Administration; and (D) contract with a private-sector source for the production of vaccines in that facility. (2) The authority under paragraph (1)(A) to construct a facility may be exercised only to the extent that a project for such construction is authorized by law in accordance with section 2802 of title 10, United States Code. (3) The Secretary shall use competitive procedures under chapter 137 of title 10, United States Code, to enter into contracts to carry out subparagraphs (A), (B), and (D) of paragraph (1). (d) Plan Required.—(1) The Secretary shall develop a long-range plan to provide for the production and acquisition of vaccines to meet the requirements of the Department of Defense to prevent or mitigate the physiological effects of exposure to biological warfare agents. (2) The plan shall include the following: (A) An evaluation of the need for one or more vaccine production facilities that are specifically dedicated to meeting the requirements of the Department of Defense and other national interests. (B) An evaluation of the options for the means of production of such vaccines, including— (i) use of public facilities, private facilities, or a combination of public and private facilities; and (ii) management and operation of the facilities by the Federal Government, one or more private persons, or a combination of the Federal Government and one or more private persons. 115 STAT. 1221 (C) A specification of the means that the Secretary determines is most appropriate for the production of such vaccines. (3) The Secretary shall ensure that the plan is consistent with the requirement for safe and effective vaccines approved by the Food and Drug Administration. (4) In preparing the plan, the Secretary shall— (A) consider and, as the Secretary determines appropriate, include the information compiled and the analyses developed in preparing the reports required by sections 217 and 218 of the Floyd D. Spence National Defense Authorization Act for Fiscal Year 2001 (as enacted into law by Public Law 106–398; 114 Stat. 1654A-36, 1654A-37); and (B) consult with the heads of other appropriate departments and agencies of the Federal Government. (e) Report.—Not later than February 1, 2002, the Secretary shall submit to the congressional defense committees a report on the plan required by subsection (d). The report shall include, at a minimum, the contents of the plan and the following matters: (1) A description of the policies and requirements of the Department of Defense regarding acquisition and use of such vaccines. (2) The estimated schedule for the acquisition of such vaccines in accordance with the plan. (3) A discussion of the options considered under subsection (d)(2)(B) for the means of production of such vaccines. (4) The Secretary’s recommendations for the most appropriate course of action to meet the requirements specified in subsection (d)(1), together with the justification for such recommendations and the long-term cost of implementing such recommendations. (f) Funding.—Of the amount authorized to be appropriated under section 201(4) for research, development, test, and evaluation, Defense-wide, $5,000,000 may be available in Program Element 62384BP, and $5,000,000 may be available in Program Element 63384BP, for the program required by subsection (a).