Page:United States Statutes at Large Volume 115 Part 2.djvu/236

 115 STAT. 1220 PUBLIC LAW 107-107—DEC. 28, 2001 (B) Leveraging of ideas and technologies from the biological technology industry. Contracts. (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. Deadline. (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 longrange 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.

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