Not later than 7 days after the Secretary grants a request for a biosimilar biological product development meeting.

The date of submission of an investigational new drug application describing an investigation that the Secretary determines is intended to support a biosimilar biological product application.

Not later than 60 days after July 9, 2012, if the Secretary determines that the investigational new drug application describes an investigation that is intended to support a biosimilar biological product application.

Not later than 7 days after the Secretary grants a request for a biosimilar biological product development meeting.

the first business day on or after October 1 of each such year; or

the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such year under this section.

submitted a marketing application for the biological product that was accepted for filing;

discontinued participation in the biosimilar biological product development program for the product under subparagraph (C); or

been administratively removed from the biosimilar biological product development program for the product under subparagraph (E)(v).

if no investigational new drug application concerning the product has been submitted, submitting to the Secretary a written declaration that the person has no present intention of further developing the product as a biosimilar biological product; or

if an investigational new drug application concerning the product has been submitted, withdrawing the investigational new drug application in accordance with part 312 of title 21, Code of Federal Regulations (or any successor regulations).

Not later than 7 days after the Secretary grants a request by such person for a biosimilar biological product development meeting for the product (after the date on which such participation was discontinued or the date of administrative removal, as applicable).

Upon the date of submission (after the date on which such participation was discontinued or the date of administrative removal, as applicable) by such person of an investigational new drug application describing an investigation that the Secretary determines is intended to support a biosimilar biological product application for that product.

the Secretary determines that the investigation is intended to support a biosimilar biological product application; and

the sponsor has failed to pay an initial or annual biosimilar biological product development fee for the product as required under subparagraph (A) or (B), or a reactivation fee as required under subparagraph (D).

the Secretary determines that the investigation is intended to support a biosimilar biological product application; and

the sponsor has failed to pay an initial or annual biosimilar biological product development fee for the product as required under subparagraph (A) or (B), or a reactivation fee for the product as required under subparagraph (D).

A fee established under subsection (c)(5) for a biosimilar biological product application for which clinical data (other than comparative bioavailability studies) with respect to safety or effectiveness are required for approval.

A fee established under subsection (c)(5) for a biosimilar biological product application for which clinical data (other than comparative bioavailability studies) with respect to safety or effectiveness are not required for approval. Such fee shall be equal to half of the amount of the fee described in clause (i).

be subject to any biosimilar biological product application fees that may be assessed at the time when such biosimilar biological product application is submitted; and

be entitled to no reduction of such application fees based on the amount of fees paid for that product before October 1, 2017, under such subparagraph (A), (B), or (D).

is identified in such a biosimilar biological product application approved as of October 1 of such fiscal year;

may be dispensed only under prescription pursuant to section 353(b) of this title; and

as of October 1 of such fiscal year, does not appear on a list, developed and maintained by the Secretary, of discontinued biosimilar biological products.

the first business day on or after October 1 of each such year; or

the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such year under this section.

the date such request was received; or

if the product will be withdrawn from sale on a future date, such future date when the product is withdrawn from sale.

initial and annual biosimilar biological product development fees and reactivation fees under subsection (a)(1);

biosimilar biological product application fees under subsection (a)(2); and

biosimilar biological product program fees under subsection (a)(3).

such annual base revenue for the fiscal year under subsection (b)(1)(A); and

the inflation adjustment percentage under subparagraph (B).

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 the process for the review of biosimilar biological product applications (as defined in section 379j–51(13) of this title) 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-Arlington-Alexandria, DC–VA–MD–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 the process for the review of biosimilar biological product applications (as defined in section 379j–51(13) of this title) for the first 3 years of the preceding 4 fiscal years.

for fiscal year 2023, to defray the costs of the process for the review of biosimilar biological product applications (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process), only if the Secretary allocates for such purpose an amount for such fiscal year (excluding amounts from fees collected under this section) no less than $20,000,000, multiplied by the adjustment factor applicable to such fiscal year; and

for fiscal year 2024 and each subsequent fiscal year, to defray the costs of the process for the review of biosimilar biological product applications (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process), only if the sum of the amounts allocated by the Secretary for such costs, excluding costs paid from fees collected under this section, plus other costs for the maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, and other necessary materials and supplies in connection with the process for the review of biosimilar biological product applications, is no less than $20,000,000, multiplied by the adjustment factor applicable to the fiscal year involved.