Sec. 905. FACILITIES MANAGEMENT

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## SEC. 905 FACILITIES MANAGEMENT ###

(a)Evaluation ####

(1)Study The Comptroller General of the United States shall conduct a study on the expenses incurred by the Food and Drug Administration related to facility maintenance and renovation in fiscal years 2012 through 2019. The study under this paragraph shall include the following: #####

(A)A review of purchases and expenses differentiated by appropriated funds, and resources authorized by the Food and Drug Administration Safety and Innovation Act (Public Law 112-144) and this Act, as applicable, that contributed to— ######

(i)the maintenance of scientific equipment and any existing facility plan or plans to maintain previously purchased scientific equipment; ######

(ii)the renovation of facilities in the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health, and the purpose of such renovation including the need for the renovation; ######

(iii)the assets purchased or repaired under the “repair of facilities and acquisition” authority under parts 2, 3, 7, and 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379f et seq.); ######

(iv)the maintenance and repair of facilities and fixtures, including a description of any unanticipated repairs and maintenance as well as scheduled repairs maintenance, and the budget plan for the scheduled or anticipated maintenance; ######

(v)the acquisition of furniture, a description of the furniture purchased, and the purpose of the furniture including purchases for the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health; and ######

(vi)the acquisition of other necessary materials and supplies by product category under the authority under parts 2, 3, 7, and 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379f et seq.). #####

(B)An analysis of the Food and Drug Administration’s ability to further its public health mission and review medical products by incurring the expenses listed in clauses

(i)through

(vi)of subparagraph (A). In conducting the analysis, the Comptroller General shall request information from and consult with appropriate employees, including staff and those responsible for the fiscal decisions regarding facility maintenance and renovation for the agency. ####

(2)Report #####

(A)In general The Comptroller General shall issue 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 not later than July 30, 2020, containing the results of the study under paragraph (1). #####

(B)Recommendations As part of the report under this paragraph, the Comptroller General may provide recommendations, as applicable, on methods through which the Food and Drug Administration may improve planning for— ######

(i)the maintenance, renovation, and repair of facilities; ######

(ii)the purchase of furniture or other acquisitions; and ######

(iii)ways the Food and Drug Administration may allocate the expenses described in clauses

(i)and

(ii)of paragraph (1)(A), as informed by the analysis under paragraph (1)(B). ###

(b)Administration ####

(1)PDUFA Section 736(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(f)) is amended by adding at the end the following: > > #### “(3) Limitation > > Beginning on October 1, 2023, the authorities under section 735(7)(C) shall include only expenditures for leasing and necessary scientific equipment.” > . ####

(2)MDUFA Subsection

(g)of section 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j), as redesignated by section 203(f)(2)(B)(i), is amended by adding at the end the following: > > #### “(3) Limitation > > Beginning on October 1, 2023, the authorities under section 737(9)(C) shall include only leasing and necessary scientific equipment.” > . ####

(3)GDUFA Section 744B(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(e)) is amended— #####

(A)in the subsection heading, by striking “Limit” and inserting “Limitations”; #####

(B)by striking “ The total amount ” and inserting the following: > > #### “(1) In general > > The total amount” > ; and #####

(C)by adding at the end the following: > > #### “(2) Leasing and necessary equipment > > Beginning on October 1, 2023, the authorities under section 744A(11)(C) shall include only leasing and necessary scientific equipment.” > . ####

(4)BsUFA Section 744H(f)(2)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52(e)(2)(B)5) is amended— 5So in law. The corresponding USC reference probably should be to “379j-52(f)(2)(B)” and should have referenced the amendment in section 403(c)(1) of this Act that redesignates subsection

(e)as subsection (f). #####

(A)in the subparagraph heading, by striking “limitation” and inserting “limitations”; #####

(B)by striking “ The fees authorized ” and inserting the following: > > ###### “(i) In general > > The fees authorized” > ; and #####

(C)by adding at the end the following: > > ###### “(ii) Leasing and necessary equipment > > Beginning on October 1, 2023, the authorities under section 744G(9)(C) shall include only leasing and necessary scientific equipment.” > .

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Pub. L. 112-144

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Sec. 905

FACILITIES MANAGEMENT

Pub. L.Pub. L. 112-144

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