§ 379j–62. Authority to assess and use outsourcing facility fees

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For fiscal year 2015 and each subsequent fiscal year, the Secretary shall, in accordance with this subsection, assess and collect— an annual establishment fee from each outsourcing facility; and a reinspection fee from each outsourcing facility subject to a reinspection in such fiscal year. An outsourcing facility subject to multiple reinspections in a fiscal year shall be subject to a reinspection fee for each reinspection. The Secretary shall— 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 publish such fee amounts in a Federal Register notice not later than 60 calendar days before the start of each such year.

For each outsourcing facility in a fiscal year— except as provided in paragraph (4), the amount of the annual establishment fee under subsection

(b)shall be equal to the sum of— $15,000, multiplied by the inflation adjustment factor described in paragraph (2); plus the small business adjustment factor described in paragraph (3); and 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). For 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— 1; 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 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. The adjustment made each fiscal year under subparagraph

(A)shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2014 under subparagraph (A). The 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— the number of small businesses that will pay a reduced establishment fee for such fiscal year; and 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). In the case of an outsourcing facility with gross annual sales of $1,000,000 or less in the 12 months ending April 1 of the fiscal year immediately preceding the fiscal year in which the fees under this section are assessed, the amount of the establishment fee under subsection

(b)for a fiscal year shall be equal to \1/3\ of the amount calculated under paragraph (1)(A)(i) for such fiscal year. To qualify for the exception under this paragraph, a small business shall submit to the Secretary a written request for such exception, in a format specified by the Secretary in guidance, certifying its gross annual sales for the 12 months ending April 1 of the fiscal year immediately preceding the fiscal year in which fees under this subsection are assessed. Any such application shall be submitted to the Secretary not later than April 30 of such immediately preceding fiscal year. In establishing the small business adjustment factor under paragraph

(3)for a fiscal year, the Secretary shall— 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 consider the need to account for any adjustment of fees and such other factors as the Secretary determines appropriate. The Secretary shall make all of the fees collected pursuant to subparagraphs

(A)and

(B)of subsection (a)(1) available solely to pay for the costs of oversight of outsourcing facilities. Funds received by the Secretary pursuant to this section shall be used to supplement and not supplant any other Federal funds available to carry out the activities described in this section. Fees authorized under this section shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended. 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 purpose of paying the costs of oversight of outsourcing facilities. An outsourcing facility shall remit the establishment fee due under this section in a fiscal year when submitting a registration pursuant to section 353b(b) of this title for such fiscal year. The Secretary shall specify in the Federal Register notice described in subsection (b)(2) the manner in which reinspection fees assessed under this section shall be collected and the timeline for payment of such fees. Such a fee shall be collected after the Secretary has conducted a reinspection of the outsourcing facility involved. An outsourcing facility shall not be considered registered under section 353b(b) of this title in a fiscal year until the date that the outsourcing facility remits the establishment fee under this subsection for such fiscal year. All drugs manufactured, prepared, propagated, compounded, or processed by an outsourcing facility for which any establishment fee or reinspection fee has not been paid, as required by this section, shall be deemed misbranded under section 352 of this title until the fees owed for such outsourcing facility under this section have been paid. In any case where the Secretary does not receive payment of a fee assessed under this section within 30 calendar days after it is due, such fee shall be treated as a claim of the United States Government subject to provisions of subchapter II of chapter 37 of title 31. Not later than 120 calendar days after each fiscal year in which fees are assessed and collected under this section, the Secretary shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to include a description of fees assessed and collected for such year, a summary description of entities paying the fees, a description of the hiring and placement of new staff, a description of the use of fee resources to support inspecting outsourcing facilities, and the number of inspections and reinspections of such facilities performed each year. For fiscal year 2014 and each subsequent fiscal year, there is authorized to be appropriated for fees under this section an amount equivalent to the total amount of fees assessed for such fiscal year under this section. ( June 25, 1938, ch. 675, § 744K , as added Pub. L. 113–54, title I, § 102(b) , Nov. 27, 2013 , 127 Stat. 594 .)

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Drug Quality and Security Act
Public Law 113-54

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127 Stat. 594

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§ 379j–62

Authority to assess and use outsourcing facility fees

Fed. Reg.×20

Stat. Comp.×12

Pub. L.Public Law 113-54

Stat.127 Stat. 594

Cites 2Cited by 32 across 2 sources