[Congressional Bills 105th Congress] [From the U.S. Government Publishing Office] [H.R. 1294 Introduced in House (IH)] 105th CONGRESS 1st Session H. R. 1294 To amend title 10, United States Code, to require the Secretary of Defense to provide to members of the Armed Forces who receive an investigational new drug relevant information regarding the drug, including the possible side effects of the drug. _______________________________________________________________________ IN THE HOUSE OF REPRESENTATIVES April 10, 1997 Mr. Kennedy of Rhode Island introduced the following bill; which was referred to the Committee on National Security _______________________________________________________________________ A BILL To amend title 10, United States Code, to require the Secretary of Defense to provide to members of the Armed Forces who receive an investigational new drug relevant information regarding the drug, including the possible side effects of the drug. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. NOTICE OF USE OF INVESTIGATIONAL NEW DRUGS. (a) Notice to Members Receiving Drugs.--(1) Chapter 55 of title 10, United States Code, is amended by adding at the end the following new section: ``Sec. 1107. Notice of use of investigational new drugs ``(a) Notice Required.--Whenever the Secretary of Defense requests or requires a member of the armed forces to receive an investigational new drug, the Secretary shall provide the member with notice containing the information specified in subsection (c). The notice shall be provided before the investigational new drug is first administered to the member, if practicable, but in no case later than 30 days after the investigational new drug is first administered to the member. ``(b) Form of Notice.--The notice required under subsection (a) 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, time constraints, or similar reasons. If the Secretary provides notice under subsection (a) 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. ``(c) Content of Notice.--The notice required under subsection (a) shall include the following: ``(1) Clear notice that drug being administered is an investigational new drug. ``(2) The reasons why the investigational new drug is being administered. ``(3) Information regarding the possible side effects of the investigational new drug, including any known side effects possible as a result of the interaction of the investigational new drug with other drugs or treatments being administered to the members receiving the investigational new drug. ``(4) Such other information that, as a condition of authorizing the use of the investigational new drug, the Secretary of Health and Human Services may require to be disclosed. ``(d) Definition.--In this section, the term `investigational new drug' means a drug covered by section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)).''. (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 investigational new drugs.''. <all>