Page:United States Statutes at Large Volume 111 Part 2.djvu/748

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Ill STAT. 1828 PUBLIC LAW 105-85—NOV. 18, 1997 "(3) Information regarding the possible side effects of the investigational new drug or drug unapproved for its applied use, including any known side effects possible as a result of the interaction of such drug with other drugs or treatments being administered to the members receiving such drug. "(4) Such other information that, as a condition of authorizing the use of the investigational new drug or drug imapproved for its applied use, the Secretary of Health and Humein Services may require to be disclosed. "(e) RECORDS OF USE. — The Secretary of Defense shall ensure that the medical records of members accurately document— "(1) the receipt by members of any investigational new drug or drug imapproved for its applied use; and "(2) the notice required by subsection (a)(1). "(f) DEFINITIONS.— In this section: "(1) The term 'investigational new drug* means a drug covered by rection 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)). "(2) The term 'drug unapproved for its applied use' means a drug administered for a use not described in the approved labeling of the drug under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355).". (b) CLERICAL AMENDMENT.— The table of sections at the beginning of such chapter is amended by adding at the end the following new item: "1107. Notice of use of an investigational new drug or a drug unapproved for its applied use.". SEC. 767. REPORT ON PLANS TO TRACK LOCATION OF MEMBERS IN A THEATER OF OPERATIONS. Not later than March 1, 1998, the Secretary of Defense shall submit to Congress a report containing a plan for collecting and maintaining information regarding the daily location of units of the Armed Forces, and to the extent practicable individual members of such luiits, serving in a theater of operations during a contingency operation or combat operation. SEC. 768. SENSE OF CONGRESS REGARDING THE DEPLOYMENT OF SPECIALIZED UNITS FOR DETECTING AND MONITORING CHEMICAL, BIOLOGICAL, AND SIMILAR HAZARDS IN A THEATER OF OPERATIONS. It is the sense of Congress that the Secretary of Defense, in conjimction with the Chairmein of the Joint Chiefs of Staff, should take such actions as are necessary to ensure that the units of the Armed Forces deployed in the theater of operations for each contingency operation or combat operation include specialized units with sufficient capability (including personnel with the appropriate training and expertise, and the appropriate equipment) to detect and monitor the presence of chemical, biological, and similar hazards to which members of the Armed Forces could be exposed in that theater during the operation. SEC. 769. REPORT ON EFFECTIVENESS OF RESEARCH EFFORTS REGARDING GULF WAR ILLNESSES. Not later than March 1, 1998, the Secretary of Defense shall submit to Congress a report evaluating the effectiveness of medical research initiatives regarding Gulf War illnesses. The report shall address the following: