Page:United States Statutes at Large Volume 111 Part 2.djvu/747

 PUBLIC LAW 105-85—NOV. 18, 1997 111 STAT. 1827 (2) The table of sections at the beginning of such chapter is amended by inserting after the item relating to section 1074e (as added by section 764) the following new item: "1074f. Medical tracking system for members deployed overseas.". (b) REPORT.— Not later than March 1, 1998, the Secretary of Defense shall submit to Congress an analysis of the administrative implications of establishing and administering the medical tracking system required by section 1074f of title 10, United States Code, as added by subsection (a). The report shall include, for fiscal year 1999 and the 5 successive fiscal years, a separate analysis and specification of the projected costs and operational considerations for each of the following required aspects of the system: (1) Predeployment medical examinations. (2) Postdeployment medical examinations. (3) Recordkeeping. SEC. 766. NOTICE OF USE OF INVESTIGATIONAL NEW DRUGS OR DRUGS UNAPPROVED FOR THEIR APPLIED USE. (a) NOTICE REQUIREMENTS.— Chapter 55 of title 10, United States Code, is amended by adding at the end the following new section: ^§ 1107. Notice of use of an investigational new drug or a drug iinapproved for its applied use "(a) NOTICE REQUIRED.— (1) Whenever the Secretary of Defense requests or requires a member of the armed forces to receive an investigational new drug or a drug unapproved for its applied use, the Secretary shall provide the member with notice containing the information specified in subsection (d). "(2) The Secretary shall also ensure that health care providers who administer an investigational new drug or a drug unapproved for its applied use, or who are likely to treat members who receive such a drug, receive the information required to be provided under paragraphs (3) and (4) of subsection (d). "(b) TIME OF NOTICE.— The notice required to be provided to a member under subsection (a)(1) shall be provided before the investigational new drug or drug unapproved for its applied use is first administered to the member, if practicable, but in no case later than 30 days after the drug is first administered to the member. "(c) FORM OP NOTICE.— The notice required under subsection (a)(l) shall be provided in writing unless the Secretary of Defense determines that the use of written notice is impractical because of the number of members receiving the investigational new drug or drug unapproved for its applied use, time constraints, or similar reasons. If the Secretary provides notice under subsection (a)(1) in a form other than in writing, the Secretary shall submit to Congress a report describing the notification method used and the reasons for the use of the alternative method. "(d) CONTENT OF NOTICE.—The notice required under subsection (a)(1) shall include the following: "(1) Clear notice that the drug being administered is an investigational new drug or a drug unapproved for its applied use. "(2) The reasons why the investigational new drug or drug unapproved for its applied use is being administered.

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