Page:United States Statutes at Large Volume 111 Part 3.djvu/268

 Ill STAT. 2356 PUBLIC LAW 105-115—NOV. 21, 1997 "(iii) For the last six months of fiscal year 1999, the applicable amount under this clause is $1,500,000, or the amount specified in the budget request of the President for the six-month period involved for carrying out the notification program in fiscal year 1999, whichever is less. "(iv) For fiscal year 2000 and subsequent fiscal years, the applicable amount under this clause is $3,000,000, or the amount specified in the budget request of the President for the fiscal year involved for carrying out the notification program under this subsection, whichever is less. "(B) For purposes of carrying out the notification program under this subsection, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1999 through fiscal year 2003, except that such authorization of appropriations is not effective for a fiscal year for any amount that is less than the applicable amount under clause (iii) or (iv) of subparagraph (A), whichever is applicable. "(C) Not later than April 1 of fiscal year 1998 and February 1 of each subsequent fiscal year, the Secretary shall submit a report to the Committees on Appropriations of the House of Representatives and the Senate, the Committee on Commerce of the House of Representatives, and the Committee on Labor and Human Resources of the Senate that provides an estimate of the Secretary of the costs of carrying out the notification program established under this subsection for the next fiscal year. "(6) In this section, the term 'food contact substance' means any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food. "; (3) in subsection (i), as so redesignated by paragraph (1), by adding at the end the following: "The Secretary shall by regulation prescribe the procedure by which the Secretary may deem a notification under subsection (h) to no longer be effective."; and (4) in subsection (j), as so redesignated by paragraph (1), by striking "subsections (b) to (h)" and inserting "subsections (b)to(i)". TITLE IV—GENERAL PROVISIONS SEC. 401. DISSEMINATION OF INFORMATION ON NEW USES. (a) IN GENERAL. —Chapter V (21 U.S.C. 351 et seq.) is amended by inserting after subchapter C the following: "SUBCHAPTER D—DISSEMINATION OF TREATMENT INFORMATION 21 USC 360AAA. "SEC. 551. REQUIREMENTS FOR DISSEMINATION OF TREATMENT INFORMATION ON DRUGS OR DEVICES. "(a) IN GENERAL. — Notwithstanding sections 301(d), 502(f), and 505, and section 351 of the Public Health Service Act (42 U.S.C. 262), a manufacturer may disseminate to— "(1) a health care practitioner; "(2) a pharmacy benefit manager; "(3) a health insureuice issuer; "(4) a group health plan; or

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