Page:United States Statutes at Large Volume 106 Part 5.djvu/856

 106 STAT. 4494 PUBLIC LAW 102-571—OCT. 29, 1992 The terms 'budget authority* and 'category* in subparagraph (B) are as defined in the Balanced Budget and Emergency Deficit Control Act of 1985, as in effect as of September 1, 1992. 21 USC 379h. -SEC. 736. AUTHORITY TO ASSESS AND USE DRUG FEES. "(a) TYPES OF FEES. — Beginning in fiscal year 1993, the Secretary shall assess and collect fees in accordance with this section as follows: "(1) HUMAN DRUG APPLICATION AND SUPPLEMENT FEE.— "(A) IN GENERAL. —Each person that submits, on or after September 1, 1992, a human drug application or a supplement shall be subject to a fee as follows: "(i) A fee established in subsection (b) for a himian drug application for which clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness are required for approval, "(ii) A fee established in subsection (b) for a human drug application for which clinical data with respect to safety or effectiveness are not required or a supplement for which clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness are required. "(B) PAYMENT SCHEDULE. — by subparagraph (A) shall be due upon submission of the application or supplement. "(ii) FINAL PAYMENT.— The remaining 50 percent of the fee required by subparagraph (A) shall be due upon— "(I) the expiration of 30 days from the date the Secretary sends to the applicant a letter designated by the Secretary as an action letter described in section 735(6)(B), or " (11) the withdrawal of the application or supplement after it is filed unless the Secretary waives the fee or a portion of the fee because no substantial work was performed on such application or supplement after it was filed. The designation under subclause (I) or the waiver under subclause (II) shall be solely in the discretion of the Secretary and shall not be reviewable. "(C) EXCEPTION FOR PREVIOUSLY FILED APPLICATION OR SUPPLEMENT.— If a human drug application or supplement was submitted by a person that paid the fee for such application or supplement, was accepted for filing, and was not approved or was withdrawn (without a waiver), the submission of a human drug application or a supplement for the same product by the same person (or the person's licensee, assignee, or successor) shall not be subject to a fee under subparagraph (A). "(D) REFUND OF FEE IF APPLICATION NOT ACCEPTED FOR FILING.—The Secretary shall refund 50 percent of the fee paid under subparagraph (B)(i) for any application or supplement which is not accepted for filing. "(2) PRESCRIPTION DRUG ESTABLISHMENT FEE. — Each person that—
 * (i) FIRST PAYMENT.— 50 percent of the fee required

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