Page:United States Statutes at Large Volume 116 Part 2.djvu/809

 PUBLIC LAW 107-250—OCT. 26, 2002 116 STAT. 1591 "(I) Any activity undertaken under section 513 or 515(i) in connection with the initial classification or reclassification of a device or under section 515(b) in connection with any requirement for approval of a device. "(J) Evaluation of postmarket studies required as a condition of an approval of a premarket application under section 515 or section 351 of the Public Health Service Act. "(K) Compiling, developing, and reviewing information on relevant devices to identify safety and effectiveness issues for devices subject to premarket applications, premarket reports, supplements, or premarket notification submissions. "(6) The term 'costs of resources allocated for the process for the review of device applications' means the expenses incurred in connection with the process for the review of device applications for— "(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers, employees, and committees and to contracts with such contractors; "(B) management of information, and the acquisition, maintenance, and repair of computer resources; "(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and "(D) collecting fees and accounting for resources allocated for the review of premarket applications, premarket reports, supplements, and submissions. "(7) The term 'adjustment factor' applicable to a fiscal year is the Consumer Price Index for all urban consumers (all items; United States city average) for April of the preceding fiscal year divided by such Index for April 2002. "(8) The term 'affiliate' means a business entity that has a relationship with a second business entity if, directly or indirectly— "(A) one business entity controls, or has the power to control, the other business entity; or "(B) a third party controls, or has power to control, both of the business entities. "SEC. 738. AUTHORITY TO ASSESS AND USE DEVICE FEES. 21 USC 379j. "(a) TYPES OF FEES. — Beginning on the date of the enactment of the Medical Device User Fee and Modernization Act of 2002, the Secretary shall assess and collect fees in accordance with this section as follows: "(1) PREMARKET APPLICATION, PREMARKET REPORT, SUPPLE- MENT, AND SUBMISSION FEE. — "(A) IN GENERAL. —Except as provided in subparagraph (B) and subsection (d), each person who submits any of the following, on or after October 1, 2002, shall be subject to a fee established under subsection (c)(5) for the fiscal year involved in accordance with the following: "(i) A premarket application.

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