Sec. 202. Authority to access and use fees
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Subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379f et seq.) is amended by adding at the end the following: For purposes of this part: The term affiliate means a business entity that has a relationship with a second business entity if, directly or indirectly— one business entity controls, or has the power to control, the other business entity; or a third party controls, or has power to control, both of the business entities. the term contract manufacturing organization facility means a monograph drug facility where neither the owner of such manufacturing facility nor any affiliate of such owner or facility sells such monograph drug produced at such facility directly to wholesalers, retailers, or consumers in the United States.
The term costs of resources allocated for monograph drug activities means the expenses in connection with monograph drug activities for— 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; management of information, and the acquisition, maintenance, and repair of computer resources; leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and collecting fees under section 744L–1 and accounting for resources allocated for monograph drug activities.
The term firm establishment identifier is the unique number automatically generated by the Field Accomplishments and Compliance Tracking System of the Food and Drug Administration. The term monograph drug shall have the meaning given the term under section 505G. The term monograph drug activities means activities of the Secretary associated with monograph drug products and inspection of facilities associated with such products, including— the activities necessary for review and evaluation of monograph drugs and monograph drug order requests, including— orders proposing or finalizing applicable requirements of use for monograph drugs products; orders affecting status regarding general recognition of safety and effectiveness of a monograph drug ingredient or combination of ingredients under specified requirements of use; all monograph drug development and review activities, including intra-agency collaboration; regulation and policy development activities related to monograph drugs; development of product standards for products subject to review and evaluation; meetings regarding monograph drug activities; review of labeling prior to issuance of orders related to monograph drugs or conditions of use; and regulatory science activities related to monograph drugs; inspections related to monograph drugs; monitoring of clinical and other research conducted in connection with monograph drugs; safety activities with respect to monograph drugs, including— collecting, developing, and reviewing safety information on monograph drugs, including adverse event reports; developing and using improved adverse event data-collection systems, including information technology systems; and developing and using improved analytical tools to assess potential safety risks, including access to external databases; and other activities necessary for implementation of section 505G.
The term monograph drug facility means a foreign or domestic business or other entity— that is under one management, either direct or indirect; at one geographic location or address engaged in manufacturing or processing a monograph drug in finished dosage form; includes a finished dosage form manufacturer facility or an affiliate thereof in a contractual relationship with a monograph drug requestor or requestors to manufacture or process monograph drugs; and does not include a business or other entity whose only manufacturing or processing activities relate to— production of clinical research supplies; testing; or packaging of packaged final dosages in a manner that does not affect the drug.
For purposes of subparagraph (A), separate buildings or locations within close proximity are considered to be at 1 geographic location or address if the activities conducted in them are— closely related to the same business enterprise; under the supervision of the same local management; and under a single firm establishment identifier and capable of being inspected by the Food and Drug Administration during a single inspection. If a business or other entity would meet the definition of a facility under this paragraph but for being under multiple management, the business or other entity is deemed to constitute multiple facilities, one per management entity, for purposes of this paragraph.
The term monograph drug meeting means any meeting regarding the content of a proposed monograph drug order request. The term monograph drug product means a monograph drug product that is marketed without an approved new drug application in accordance with section 505G. The term monograph drug order request means a request for an order under section 505G for the issuance of an administrative order for a change to the monograph drug product. The term monograph drug requestor means an entity submitting a monograph drug order request or a monograph drug meeting request or any other inquiry relating to a request for an order or development of a monograph drug order request.
The term person includes an affiliate thereof. The term Tier 1 monograph drug order request means any monograph drug order request not determined to be a Tier 2 monograph drug order request. The term Tier 2 monograph drug order request means subject to subparagraph (B), a monograph drug order request for— the reordering of existing information in the drug facts label of a monograph drug product; the addition of information to the other information section of the drug facts label of a nonprescription drug product, as limited by part 201.66(c)(7) of title 21, Code of Federal Regulations; modification to the directions for use section of the drug facts label of a nonprescription drug product, if such changes conform to changes made pursuant to section 505G(d); the standardization of the concentration or dose of a specific finalized ingredient within a particular finalized monograph; a change to ingredient nomenclature to align with nomenclature of a standards-setting organization; or addition of an interchangeable term in accordance with part 330.1 of title 21, Code of Federal Regulations.
The Secretary may, based on program implementation experience or other factors found appropriate by the Secretary, characterize any monograph drug order request as a Tier 2 monograph drug order request (including recategorizing a request from Tier 1 to Tier 2) and publish such determination in a proposed order issued pursuant to section 505G(c). Beginning with fiscal year 2018, the Secretary shall assess and collect fees in accordance with this section as follows: Except as provided in subparagraph (B), each person that owns a facility identified as a monograph drug facility on December 31 of the fiscal year or at any time during the preceding 12-month period shall be assessed an annual fee for each such facility as determined under subsection (c).
A fee shall not be assessed under subparagraph
(A)if the identified monograph drug facility has ceased all activities related to monograph drug products prior to the publication of the Notice under subparagraph C and has updated its registration to reflect such change under the requirements for drug establishment registration set forth in section 510. The amount of the fee for a contract manufacturing organization facility shall be equal to two-thirds the amount of the fee for a monograph drug facility that is not a contract manufacturing organization facility. For each fiscal year, the facility fees required under subparagraph
(A)shall be due on the later of— the first business day of April of such year; and the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees under this section for such year. Each person that submits a monograph drug order request shall be subject to a fee for a monograph drug order request. The monograph drug order request fee under paragraph
(2)shall be— for a Tier 1 monograph drug order request, $500,000, adjusted for inflation for the fiscal year (as determined under subsection (c)(1)); and for a Tier 2 monograph drug order request other than a Tier 1 request, $100,000 adjusted for inflation for the fiscal year (as determined under subsection (c)(1)). The monograph drug order request fees required under subparagraph
(A)shall be due on the date of submission of the monograph drug order request. A person who is named as the requestor in a monograph drug order shall not be subject to a fee under subparagraph
(A)if the Secretary finds that the monograph drug order request seeks to change the Drug Facts labeling of a monograph drug product in a way that would add to or strengthen— a contraindication, warning, or precaution; a statement about risk associated with misuse or abuse; or an instruction about dosage and administration that is intended to increase the safe use of the monograph drug product. If the Secretary determines that a monograph drug request initially characterized as Tier 1 should be re-characterized as a Tier 2 monograph drug order request, and the requestor has paid a Tier 1 fee in accordance with subparagraph (A)(i), the Secretary shall refund the requestor the difference between the Tier 1 and Tier 2 fees determined under subparagraphs (A)(i) and (A)(ii), respectively. The Secretary shall refund 75 percent of the fee paid under subparagraph
(B)for any order request that is refused for filing. A monograph drug order request that was submitted but was refused for filing, or was withdrawn before being accepted or refused for filing, shall be subject to the full fee under subparagraph
(A)upon being resubmitted or filed over protest. If an order request is withdrawn after the order request was filed, the Secretary may refund the fee or a portion of the fee if no substantial work was performed on the order request after the application was filed. The Secretary shall have the sole discretion to refund a fee or a portion of the fee under this subparagraph. A determination by the Secretary concerning a refund under this paragraph shall not be reviewable. Other than refunds under subparagraphs
(D)through
(G)of paragraph (2), the Secretary shall not refund any fee paid under this subsection, except as provided in subparagraph (B). To qualify for the return of a fee claimed to have been paid in error under this paragraph, a person shall submit to the Secretary a written request justifying such return within 180 calendar days after such fee was paid. For fiscal year 2018, fees under subsection (a)(1) shall be established to generate a total facility fee revenue amount equal to the sum of— the annual base revenue for fiscal year 2018 (as determined under paragraph (3)); the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(2)); and additional direct cost adjustments (as determined under subsection (c)(3)). For each of the fiscal years 2019 through 2022, fees under subsection (a)(1) shall be established to generate a total facility fee revenue amount equal to the sum of— the annual base revenue for the fiscal year (as determined under paragraph (3)); the dollar amount equal to the inflation adjustment for the fiscal year (as determined under subsection (c)(1)); the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(2)); additional direct cost adjustments (as determined under subsection (c)(3)); and additional dollar amounts for each fiscal year as follows: $7,000,000 for fiscal year 2019. $6,000,000 for fiscal year 2020. $7,000,000 for fiscal year 2021. $3,000,000 for fiscal year 2022. For purposes of paragraphs (1)(A) and (2)(A), the dollar amount of the annual base revenue for a fiscal year shall be— for fiscal year 2018, $8,000,000; and for fiscal years 2019 through 2022, the dollar amount of the total revenue amount established under this subsection for the previous fiscal year, not including any adjustments made under subsection (c)(2) or (c)(3). For purposes of subsection (b)(2)(B), the dollar amount of the inflation adjustment to the annual base revenue for fiscal year 2019 and each subsequent fiscal year shall be equal to the product of— such annual base revenue for the fiscal year under subsection (b)(2); and the inflation adjustment percentage under subparagraph (B). The inflation adjustment percentage under this subparagraph for a fiscal year is equal to— for each of fiscal years 2019 through 2020, the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data; and for each of fiscal years 2021 and 2022, the sum of— 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 monograph drug activities (as defined in subsection (a)) for the first 3 years of the preceding 4 fiscal years; and the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; 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 monograph drug activities for the first 3 years of the preceding 4 fiscal years. For fiscal year 2018 and subsequent fiscal years, the Secretary may, in addition to adjustments under paragraphs
(1)and (2), further increase the fee revenue and fees if such an adjustment is necessary to provide operating reserves of carryover user fees for monograph drug activities for the number of weeks specified in subparagraph (B). For each fiscal year the number of weeks of operating reserves shall be no more than— 3 weeks for fiscal year 2018; 7 weeks for fiscal year 2019; 10 weeks for fiscal year 2020; 10 weeks for fiscal year 2021; and 10 weeks for fiscal year 2022. If, for fiscal years 2019 through 2022, the Secretary has carryover balances for monograph drug activities in excess of the number of weeks of such operating reserves specified in subparagraph B, the Secretary shall reduce such fee revenue and fees to provide for not more than the number of weeks of such operating reserves specified in subparagraph (B)(v). If an adjustment under this paragraph is made, the rationale for the amount of the increase or decrease (as applicable) in fee revenue and fees shall be contained in the annual Federal Register notice under paragraph
(5)establishing fee revenue and fees for the fiscal year involved. The Secretary shall, in addition to adjustments under paragraphs
(1)and (2), further increase the fee revenue by an amount equal to— 14,000,000 for fiscal year 2018; 7,000,000 for fiscal year 2019; 4,000,000 for fiscal year 2020; 3,000,000 for fiscal year 2021; and 3,000,000 for fiscal year 2022. The Secretary shall, not later than January 31, 2018— establish monograph drug facility fees for fiscal year 2018 under subsection (a)(1), based on the revenue amount for such year under subsection
(b)and the adjustments provided under this subsection; and publish such fee revenue and facility fees in the Federal Register. The Secretary shall, not later than January 31 of each fiscal year that begins after September 30, 2018, establish for each such fiscal year, based on the revenue amounts under subsection
(b)and the adjustments provided under this subsection— monograph drug facility fees under subsection (a)(1); monograph drug order request fees under subsection (a)(2); and publish such fee revenue, facility fees, and monograph drug order request fees in the Federal Register. Each person that owns a monograph drug facility shall submit to the Secretary the information required under this subsection each year. Such information shall, for each fiscal year— be submitted as part of the requirements for drug establishment registration set forth in section 510; and include for each such facility, at a minimum, identification of the facility’s business operation as that of a monograph drug facility. A monograph drug order request submitted by a person subject to fees under subsection
(a)shall be considered incomplete and shall not be accepted for filing by the Secretary until all fees owed by such person have been paid. If a monograph drug requestor fails to pay a fee assessed under subsection (a), the requestor shall be considered ineligible for monograph drug meetings. Failure to pay the fee under subsection (a)(1) within 20 calendar days of the due date as specified in subparagraph
(D)of such subsection shall result in the Secretary placing the facility on a publicly available arrears list until such fee has been paid. Subject to paragraph (2)(D), fees authorized under subsection
(a)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 monograph drug activities. Subject to subparagraphs
(C)and (D), the fees authorized by this section shall be collected and available in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation, for such fiscal year. The fees authorized by this section shall be available to defray increases in the costs of the resources allocated for monograph drug activities (including increases in such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such activities), only if the Secretary allocates for such purpose an amount for such fiscal year (excluding amounts from fees collecting under this section) no less than $12,000,000, multiplied by the adjustment factor applicable to the fiscal year involved. The Secretary shall be considered to have met the requirements of subparagraph
(B)in any fiscal year if the costs funded by appropriations and allocated for the monograph drug activities are not more than 15 percent below the level specified in such subparagraph. Until the date of enactment of an Act making appropriations and providing for the collection and obligation of fees under this section through September 30, 2018, for the salaries and expenses account of the Food and Drug Administration, fees authorized by this section for fiscal year 2018 may be collected and shall be credited to such account and remain available until expended. Payment of fees authorized under this section for a fiscal year (after fiscal year 2018), prior to the due date for such fees, may be accepted by the Secretary in accordance with authority provided in advance in a prior year appropriations Act. For each of the fiscal years 2018 through 2022, there is authorized to be appropriated for fees under this section an amount equal to the total amount of fees assessed for such fiscal year under this section. In any case where the Secretary does not receive payment of a fee assessed under subsection
(a)within 30 calendar days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of chapter 37 of title 31. This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employers, and advisory committees not engaged in monograph drug activities, be reduced to offset the number of officers, employees, and advisory committees so engaged. Beginning with fiscal year 2018, and not later than 120 calendar days after the end of each fiscal year thereafter for which fees are collected under this part, the Secretary shall prepare and submit to the Committee on the Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 201 of the during such fiscal year and the future plans of the Food and Drug Administration for meeting such goals. Not later than 120 calendar days after the end of fiscal year 2018 and each subsequent fiscal year for which fees are collected under this part, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected for such fiscal year. The Secretary shall make the reports required under subsections
(a)and
(b)available to the public on the internet website of the Food and Drug Administration. In developing recommendations to present to Congress with respect to the goals described in subsection (a), and plans for meeting the goals, for monograph drug activities for the first 5 fiscal years after fiscal year 2022, and for the reauthorization of this part for such fiscal years, the Secretary shall consult with— the Committee on Health, Education, Labor, and Pensions of the Senate; the Committee on Energy and Commerce of the House of Representatives; scientific and academic experts; health care professionals; representatives of patient and consumer advocacy groups; and the regulated industry. After negotiations with the regulated industry, the Secretary shall— present the recommendations developed under paragraph
(1)to the congressional committees specified in such paragraph; publish such recommendations in the Federal Register; provide for a period of 30 calendar days for the public to provide written comments on such recommendations; hold a meeting at which the public may present its views on such recommendations; and after consideration of such public views and comments, revise such recommendations as necessary. Not later than January 15, 2022, the Secretary shall transmit to Congress the revised recommendations under paragraph (2), a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments. .
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Sec. 202
Authority to access and use fees
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