Page:United States Statutes at Large Volume 111 Part 3.djvu/217

 PUBLIC LAW 105-115 —NOV. 21, 1997 111 STAT. 2305 a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected during such fiscal year for which the report is made. SEC. 105. SAVINGS. 21 USC 379g Notwithstanding section 105 of the Prescription Drug User Fee Act of 1992, the Secretary shall retain the authority to assess and collect any fee required by part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act for a human drug application or supplement accepted for filing prior to October 1, 1997, and to assess and collect any product or establishment fee required by such Act for a fiscal year prior to fiscal year 1998. SEC. 106. EFFECTIVE DATE. 21 USC 379g The amendments made by this subtitle shall take effect October 1, 1997. SEC. 107. TERMINATION OF EFFECTIVENESS. 21 USC 379g The amendments made by sections 102 and 103 cease to be effective October 1, 2002, and section 104 ceases to be effective 120 days after such date. Subtitle B—Other Improvements SEC. 111. PEDLVTRIC STUDIES OF DRUGS. Chapter V (21 U.S.C. 351 et seq.) is amended by inserting after section 505 the following: "SEC. 505A. PEDIATRIC STUDIES OF DRUGS. 21 USC 355a. "(a) MARKET EXCLUSIVITY FOR NEW DRUGS.— If, prior to approval of an application that is submitted under section 505(b)(1), the Secretary determines that information relating to the use of a new drug in the pediatric population may produce health benefits in that population, the Secretary makes a written request for pediatric studies (which shall include a timeframe for completing such studies), and such studies are completed within any such timeframe and the reports thereof submitted in accordance with subsection (d)(2) or accepted in accordance with subsection (d)(3)— "(l)(A)(i) the period referred to in subsection (c)(3)(D)(ii) of section 505, and in subsection (j)(4)(D)(ii) of such section, is deemed to be five years and six months rather than five years, and the references in subsections (c)(3)(D)(ii) and (j)(4)(D)(ii) of such section to four years, to forty-eight months, and to seven and one-half years are deemed to be four and one-half years, fifty-four months, and eight years, respectively; or "(ii) the period referred to in clauses (iii) and (iv) of subsection (c)(3)(D) of such section, and in clauses (iii) and (iv) of subsection (j)(4)(D) of such section, is deemed to be three years and six months rather than three years; and "(B) if the drug is designated under section 526 for a rare disease or condition, the period referred to in section 527(a) is deemed to be seven years and six months rather than seven years; and "(2)(A) if the drug is the subject of—

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