Collapse to view only § 379j-61. Definitions
§ 379j–61. Definitions
In this subpart:
(1) The term “affiliate” has the meaning given such term in section 379g(11) of this title.
(2) The term “gross annual sales” means the total worldwide gross annual sales, in United States dollars, for an outsourcing facility, including the sales of all the affiliates of the outsourcing facility.
(3) The term “outsourcing facility” has the meaning given to such term in section 353b(d)(4) of this title.
(4) The term “reinspection” means, with respect to an outsourcing facility, 1 or more inspections conducted under section 374 of this title subsequent to an inspection conducted under such provision which identified noncompliance materially related to an applicable requirement of this chapter, specifically to determine whether compliance has been achieved to the Secretary’s satisfaction.
(June 25, 1938, ch. 675, § 744J, as added Pub. L. 113–54, title I, § 102(b), Nov. 27, 2013, 127 Stat. 593.)
§ 379j–62. Authority to assess and use outsourcing facility fees
(a) Establishment and reinspection fees
(1) In generalFor fiscal year 2015 and each subsequent fiscal year, the Secretary shall, in accordance with this subsection, assess and collect—
(A) an annual establishment fee from each outsourcing facility; and
(B) a reinspection fee from each outsourcing facility subject to a reinspection in such fiscal year.
(2) Multiple reinspections
(b) Establishment and reinspection fee settingThe Secretary shall—
(1) establish the amount of the establishment fee and reinspection fee to be collected under this section for each fiscal year based on the methodology described in subsection (c); and
(2) publish such fee amounts in a Federal Register notice not later than 60 calendar days before the start of each such year.
(c) Amount of establishment fee and reinspection fee
(1) In generalFor each outsourcing facility in a fiscal year—
(A) except as provided in paragraph (4), the amount of the annual establishment fee under subsection (b) shall be equal to the sum of—
(i) $15,000, multiplied by the inflation adjustment factor described in paragraph (2); plus
(ii) the small business adjustment factor described in paragraph (3); and
(B) the amount of any reinspection fee (if applicable) under subsection (b) shall be equal to $15,000, multiplied by the inflation adjustment factor described in paragraph (2).
(2) Inflation adjustment factor
(A) In generalFor fiscal year 2015 and subsequent fiscal years, the fee amounts established in paragraph (1) shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year by the amount equal to the sum of—
(i) 1;
(ii) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years, multiplied by the proportion of personnel compensation and benefits costs to total costs of an average full-time equivalent position of the Food and Drug Administration for the first 3 years of the preceding 4 fiscal years; plus
(iii) the average annual percent change that occurred in the Consumer Price Index for urban consumers (U.S. City Average; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of an average full-time equivalent position of the Food and Drug Administration for the first 3 years of the preceding 4 fiscal years.
(B) Compounded basis
(3) Small business adjustment factorThe small business adjustment factor described in this paragraph shall be an amount established by the Secretary for each fiscal year based on the Secretary’s estimate of—
(A) the number of small businesses that will pay a reduced establishment fee for such fiscal year; and
(B) the adjustment to the establishment fee necessary to achieve total fees equaling the total fees that the Secretary would have collected if no entity qualified for the small business exception in paragraph (4).
(4) Exception for small businesses
(A) In general
(B) Application
(5) Crediting of feesIn establishing the small business adjustment factor under paragraph (3) for a fiscal year, the Secretary shall—
(A) provide for the crediting of fees from the previous year to the next year if the Secretary overestimated the amount of the small business adjustment factor for such previous fiscal year; and
(B) consider the need to account for any adjustment of fees and such other factors as the Secretary determines appropriate.
(d) Use of fees
(e) Supplement not supplant
(f) Crediting and availability of fees
(g) Collection of fees
(1) Establishment fee
(2) Reinspection fee
(3) Effect of failure to pay fees
(A) Registration
(B) Misbranding
(4) Collection of unpaid fees
(h) Annual report to Congress
(i) Authorization of appropriations
(June 25, 1938, ch. 675, § 744K, as added Pub. L. 113–54, title I, § 102(b), Nov. 27, 2013, 127 Stat. 594.)