FACILITIES MANAGEMENT.

SEC. 3625. FACILITIES MANAGEMENT.(a) PDUFA Authority.—Section 736(g)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)(2)) is amended—(1) in subparagraph (A)(ii)—(A) by striking “shall be available to defray” and inserting the following: “shall be available—“(I) for fiscal year 2023, to defray” ; (B) by striking the period and inserting “; and”; and (C) by adding at the end the following:“(II) for fiscal year 2024 and each subsequent fiscal year, to defray the costs of the resources allocated for the process for the review of human drug 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 human drug applications, is no less than the amount allocated for such costs, excluding any such costs paid from fees collected under this section, for fiscal year 1997, multiplied by the adjustment factor.” ; and (2) in subparagraph (B), by striking “for the process for the review of human drug applications” and inserting “as described in subclause (I) or (II) of such subparagraph, as applicable”. (b) BsUFA Authority.—Section 744H(f)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–52(f)(2)) is amended—(1) in subparagraph (B)(i)—136 STAT. 5881(A) by striking “available for a fiscal year beginning after fiscal year 2012” and inserting the following: “available—“(I) for fiscal year 2023,” ; (B) by striking “the fiscal year involved.” and inserting “such fiscal year; and”; and (C) by adding at the end the following:“(II) 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.” ; and (2) in subparagraph (C), by striking “subparagraph (B) in any fiscal year if the costs described in such subparagraph” and inserting “subparagraph (B)(i) in any fiscal year if the costs allocated as described in subclause (I) or (II) of such subparagraph, as applicable,”. (c) GDUFA Authority.—Section 744B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42) is amended—(1) in subsection (e)(2), by striking “744A(11)(C)” and inserting “744A(12)(C)”; and (2) in subsection (i)(2)—(A) in subparagraph (A)(ii)—(i) by striking “available for a fiscal year beginning after fiscal year 2012” and inserting the following: “available—“(I) for fiscal year 2023,” ; (ii) by striking “the fiscal year involved.” and inserting “such fiscal year; and”; and (iii) by adding at the end the following:“(II) for fiscal year 2024 and each subsequent fiscal year, to defray the costs of human generic drug activities (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 activities), 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 human generic drug activities, is no less than $97,000,000 multiplied by 136 STAT. 5882 the adjustment factor defined in section 744A(3) applicable to the fiscal year involved.” ; and (B) in subparagraph (B), by striking “for human generic activities” and inserting “as described in subclause (I) or (II) of such subparagraph, as applicable,”. (d) MDUFA Authority.—Section 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j), as amended by section 3309, is further amended—(1) in subsection (e)(2)(B)(iii), by inserting “, if extant,” after “national taxing authority”; (2) in subsection (h)(2)—(A) in subparagraph (A)(ii)—(i) by striking “shall be available to defray” and inserting the following: “shall be available—“(I) for fiscal year 2023, to defray” ; (ii) by striking the period and inserting “; and”; and (iii) by adding at the end the following:“(II) for fiscal year 2024 and each subsequent fiscal year, to defray the costs of the resources allocated for the process for the review of device 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 device applications, is no less than the amount allocated for such costs, excluding any such costs paid from fees collected under this section, for fiscal year 2009 multiplied by the adjustment factor.” ; and (B) in subparagraph (B)(i), in the matter preceding subclause (I), by striking “for the process for the review of device applications” and inserting “as described in subclause (I) or (II) of such subparagraph, as applicable”; and (3) in subsection (g)(3), by striking “737(9)(C)” and inserting “737(10)(C)”. (e) Technical Correction.—(1) In general.—Section 905(b)(2) of the FDA Reauthorization Act of 2017 (Public Law 115–52) is amended by striking “Section 738(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(h)) is amended” and inserting “Subsection (g) of section 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j), as so redesignated by section 203(f)(2)(B)(i), is amended”. (2) Effective date.—The amendment made by paragraph (1) shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52).136 STAT. 5883