Page:United States Statutes at Large Volume 111 Part 3.djvu/215

 PUBLIC LAW 105-115—NOV. 21, 1997 111 STAT. 2303 "(E) the applicant involved is a small business submitting its first human drug application to the Secretary for review."; and (6) by striking "In making the finding in paragraph (3)," and all that follows through "standard costs." and inserting the following: "(2) USE OF STANDARD COSTS.—In making the finding in paragraph (1)(C), the Secretary may use standard costs. " (3) RULES RELATING TO SMALL BUSINESSES. — "(A) DEFINITION. —In paragraph (1)(E), the term 'small business' means an entity that has fewer than 500 employ- ees, including employees of affiliates. "(B) WAIVER OF APPLICATION FEE. — The Secretary shall waive under paragraph (1)(E) the application fee for the first human drug application that a small business or its affiliate submits to the Secretary for review. After a small business or its affiliate is gramted such a waiver, the small business or its affiliate shall pay— "(i) application fees for all subsequent human drug applications submitted to the Secretary for review in the same manner as an entity that does not qualify as a small business; and " (ii) all supplement fees for all supplements to human drug applications submitted to the Secretary for review in the same manner as an entity that does not qualify as a small business.". (e) ASSESSMENT OF FEES.— Section 736(f)(1) (21 U.S.C. 379h(f)(l)) is amended— (1) by striking "fiscal year 1993" and inserting "fiscal year 1997"; and (2) by striking "fiscal year 1992" and inserting "fiscal year 1997 (excluding the amount of fees appropriated for such fiscal year)". (f) CREDITING AND AVAILABILITY OF FEES. — Section 736(g) (21 U.S.C. 379h(g)) is amended— (1) in paragraph (1), by adding at the end the following: "Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the review of human drug applications."; (2) in paragraph (2)— (A) in subparagraph (A), by striking "Acts" and inserting "Acts, or otherwise made available for obligation,"; and (B) in subparagraph (B), by striking "over such costs for fiscal year 1992 and inserting "over such costs, excluding costs paid from fees collected under this section, for fiscal year 1997"; and (3) by striking paragraph (3) and inserting the following: " (3) AUTHORIZATION OF APPROPRIATIONS.— There are authorized to be appropriated for fees under this section— "(A) $106,800,000 for fiscal year 1998; "(B) $109,200,000 for fiscal year 1999; "(C) $109,200,000 for fiscal year 2000; "(D) $114,000,000 for fiscal year 2001; and " (E) $110,100,000 for fiscal year 2002,

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