H.R. 7667 — what changed

changed “(B) Such term does not include”include whole blood”

“(C)

“(i) If a written request to place a product in the discontinued section of either of the lists referenced in subparagraph (A)(iii) is submitted to the Secretary on behalf of an applicant, and the request identifies the date the product is withdrawn from sale, then for purposes of assessing the prescription drug program fee under section 736(a)(2), the Secretary shall consider such product to have been included in the discontinued section on the later of—

“(I) the date such request was received; or

“(II) if the product will be withdrawn from sale on a future date, such future date when the product is withdrawn from sale.

“(ii) For purposes of this subparagraph, a product shall be considered withdrawn from sale once the applicant has ceased its own distribution of the product, whether or not the applicant has ordered recall of all previously distributed lots of the product, except that a routine, temporary interruption in supply shall not render a product withdrawn from sale.”

“(12) The term skin-test diagnostic product—

“(A) means a product—

“(i) for prick, scratch, intradermal, or subcutaneous administration;

“(ii) expected to produce a limited, local reaction at the site of administration (if positive), rather than a systemic effect;

“(iii) not intended to be a preventive or therapeutic intervention; and

“(iv) intended to detect an immediate- or delayed-type skin hypersensitivity reaction to aid in the diagnosis of—

“(I) an allergy to an antimicrobial agent;

“(II) an allergy that is not to an antimicrobial agent, if the diagnostic product was authorized for marketing prior to October 1, 2022; or

“(III) infection with fungal or mycobacterial pathogens; and

changed “(B) includes positive and negative controls required to interpret the results of a product described in subparagraph (A)”(A).”

“(H) Exception for skin-test diagnostic products—A human drug application for a skin-test diagnostic product shall not be subject to a fee under subparagraph (A).”

“(i) Fee—Except as provided in subparagraphs (B) and (C)”

“(ii) Special rule—If a drug product that is identified in a human drug application approved as of October 1 of a fiscal year is not a prescription drug product as of that date because the drug product is in the discontinued section of a list referenced in section 735(3)(A)(iii), and on any subsequent day during such fiscal year the drug product is a prescription drug product, then except as provided in subparagraphs (B) and (C), each person who is named as the applicant in a human drug application with respect to such product, and who, after September 1, 1992, had pending before the Secretary a human drug application or supplement with respect to such product, shall pay the annual prescription drug program fee established for a fiscal year under subsection (c)(6) for such prescription drug product. Such fee shall be due on the last business day of such fiscal year and shall be paid only once for each such product for a fiscal year in which the fee is payable.”

“(B) Exception for certain prescription drug products—A prescription drug program fee shall not be assessed for a prescription drug product under subparagraph (A) if such product is—

“(i) a large volume parenteral product (a sterile aqueous drug product packaged in a single-dose container with a volume greater than or equal to 100 mL, not including powders for reconstitution or pharmacy bulk packages) identified on the list compiled under section 505(j)(7);

“(ii) pharmaceutically equivalent (as defined in section 314.3 of title 21, Code of Federal Regulations (or any successor regulation)) to another product on the list of products compiled under section 505(j)(7) (not including the discontinued section of such list); or

“(iii) a skin-test diagnostic product.”

“(1) In general—For each of the fiscal years 2023 through 2027, fees under subsection (a) shall, except as provided in subsections (c), (d), (f), and (g), be established to generate a total revenue amount under such subsection that is equal to the sum of—

“(A) the annual base revenue for the fiscal year (as determined under paragraph (3));

“(B) the dollar amount equal to the inflation adjustment for the fiscal year (as determined under subsection (c)(1));

changed “(C) the dollar amount equal to the strategic hiring and reserve retention adjustment for the fiscal year (as determined under subsection (c)(2));

“(D) the dollar amount equal to the capacity planning adjustment for the fiscal year (as determined under subsection (c)(3));

“(E) the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(4));

“(F) the dollar amount equal to the additional direct cost adjustment for the fiscal year (as determined under subsection (c)(5)); and

“(G) additional dollar amounts for each fiscal year as follows:

“(i) $65,773,693 for fiscal year 2023.

“(ii) $25,097,671 for fiscal year 2024.

“(iii) $14,154,169 for fiscal year 2025.

“(iv) $4,864,860 for fiscal year 2026.

“(v) $1,314,620 for fiscal year 2027.”

“(3) Annual base revenue—For purposes of paragraph (1), the dollar amount of the annual base revenue for a fiscal year shall be—

“(A) for fiscal year 2023, $1,151,522,958; and

“(B) for fiscal years 2024 through 2027, the dollar amount of the total revenue amount established under paragraph (1) for the previous fiscal year, not including any adjustments made under subsection (c)(4) or (c)(5).”

“(2) Strategic hiring and retention adjustment—For each fiscal year, after the annual base revenue established in subsection (b)(1)(A) is adjusted for inflation in accordance with paragraph (1), the Secretary shall further increase the fee revenue and fees by the following amounts:

“(A) For fiscal year 2023, $9,000,000.

“(B) For each of fiscal years 2024 through 2027, $4,000,000.”

“(3) Capacity planning adjustment

“(A) In general—For each fiscal year, after the annual base revenue established in subsection (b)(1)(A) is adjusted in accordance with paragraphs (1) and (2), such revenue shall be adjusted further for such fiscal year, in accordance with this paragraph, to reflect changes in the resource capacity needs of the Secretary for the process for the review of human drug applications.

“(B) Methodology—For purposes of this paragraph, the Secretary shall employ the capacity planning methodology utilized by the Secretary in setting fees for fiscal year 2021, as described in the notice titled “Prescription Drug User Fee Rates for Fiscal Year 2021” published in the Federal Register on August 3, 2020 (85 Fed. Reg. 46651). The workload categories used in applying such methodology in forecasting shall include only the activities described in that notice and, as feasible, additional activities that are also directly related to the direct review of applications and supplements, including additional formal meeting types, the direct review of postmarketing commitments and requirements, the direct review of risk evaluation and mitigation strategies, and the direct review of annual reports for approved prescription drug products. Subject to the exceptions in the preceding sentence, the Secretary shall not include as workload categories in applying such methodology in forecasting any non-core review activities, including those activities that the Secretary referenced for potential future use in such notice but did not utilize in setting fees for fiscal year 2021.

“(C) Limitation—Under no circumstances shall an adjustment under this paragraph result in fee revenue for a fiscal year that is less than the sum of the amounts under subsections (b)(1)(A) (the annual base revenue for the fiscal year), (b)(1)(B) (the dollar amount of the inflation adjustment for the fiscal year), and (b)(1)(C) (the dollar amount of the strategic hiring and retention adjustment for the fiscal year).

“(D) Publication in Federal Register—The Secretary shall publish in the Federal Register notice under paragraph (6) of the fee revenue and fees resulting from the adjustment and the methodologies under this paragraph.”

“(A) Increase—For fiscal year 2023 and subsequent fiscal years, the Secretary shall, in addition to adjustments under paragraphs (1), (2), and (3), further increase the fee revenue and fees if such an adjustment is necessary to provide for operating reserves of carryover user fees for the process for the review of human drug applications for each fiscal year in at least the following amounts:

“(i) For fiscal year 2023, at least 8 weeks of operating reserves.

“(ii) For fiscal year 2024, at least 9 weeks of operating reserves.

“(iii) For fiscal year 2025 and subsequent fiscal years, at least 10 weeks of operating reserves.”

“(5) Additional direct cost adjustment

“(A) Increase—The Secretary shall, in addition to adjustments under paragraphs (1), (2), (3), and (4), further increase the fee revenue and fees—

“(i) for fiscal year 2023, by $44,386,150; and

“(ii) for each of fiscal years 2024 through 2027, by the amount set forth in clauses (i) through (iv) of subparagraph (B), as applicable, multiplied by the Consumer Price Index for urban consumers (Washington-Arlington-Alexandria, DC–VA–MD–WV; Not Seasonally Adjusted; All Items; Annual Index) for the most recent year of available data, divided by such Index for 2021.

“(B) Applicable amounts—The amounts referred to in subparagraph (A)(ii) are the following:

“(i) For fiscal year 2024, $60,967,993.

“(ii) For fiscal year 2025, $35,799,314.

“(iii) For fiscal year 2026, $35,799, 314.

“(iv) For fiscal year 2027, $35,799,314.”

“(i) Written requests for waivers, reductions, exemptions, and returns; disputes concerning fees—To qualify for consideration for a waiver or reduction under subsection (d), an exemption under subsection (k), or the return of any fee paid under this section, including if the fee is claimed to have been paid in error, a person shall—

“(1) not later than 180 days after such fee is due, submit to the Secretary a written request justifying such waiver, reduction, exemption, or return; and

“(2) include in the request any legal authorities under which the request is made.”

“(2) Evidence of qualification—An exemption under paragraph (1) applies with respect to a drug only if the applicant involved submits a certification that the applicant’s gross annual revenues did not exceed $50,000,000 for the last calendar year ending prior to the fiscal year for which the exemption is requested. Such certification shall be supported by—

“(A) tax returns submitted to the United States Internal Revenue Service; or

“(B) as necessary, other appropriate financial information.”

changed The amendments made by this title shall take effect on October 1, 2022, or the date of the enactment of this Act, whichever is later, except that fees under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.) shall be assessed for all human drug applications received on or after October 1, 2022, regardless of the date of the enactment of this Act.

changed Notwithstanding the amendments made by this title, part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, Act (21 U.S.C. 379g et seq.), as in effect on the day before the date of the enactment of this title, shall continue to be in effect with respect to human drug applications and supplements (as defined in such part as of such day) that on or after October 1, 2017, but before October 1, 2022, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2023.

“(2) Base fee amounts specified—For purposes of paragraph (1), the base fee amounts specified in this paragraph are as follows:”

“(3) Total revenue amounts specified—For purposes of paragraph (1), the total revenue amounts specified in this paragraph are as follows:

“(A) $312,606,000 for fiscal year 2023.

“(B) $335,750,000 for fiscal year 2024.

“(C) $350,746,400 for fiscal year 2025.

“(D) $366,486,300 for fiscal year 2026.

“(E) $418,343,000 for fiscal year 2027.”

“(4) Performance improvement adjustment

“(A) In general—For each of fiscal years 2025 through 2027, after the adjustments under paragraphs (2) and (3), the base establishment registration fee amounts for such fiscal year shall be increased to reflect changes in the resource needs of the Secretary due to improved review performance goals for the process for the review of device applications identified in the letters described in section 201(b) of the Medical Device User Fee Amendments of 2022, as the Secretary determines necessary to achieve an increase in total fee collections for such fiscal year equal to the following amounts:

“(i) For fiscal year 2025, the product of—

“(I) the amount determined under subparagraph (B)(i)(I); and

“(II) the applicable inflation adjustment under paragraph (2)(B) for such fiscal year.

“(ii) For fiscal year 2026, the product of—

“(I) the sum of the amounts determined under subparagraphs (B)(i)(II), (B)(ii)(I), and (B)(iii)(I); and

“(II) the applicable inflation adjustment under paragraph (2)(B) for such fiscal year.

“(iii) For fiscal year 2027, the product of—

“(I) the sum of the amounts determined under subparagraphs (B)(i)(III), (B)(ii)(II), and (B)(iii)(II); and

“(II) the applicable inflation adjustment under paragraph (2)(B) for such fiscal year.

“(B) Amounts

“(i) Pre-submission amount—For purposes of subparagraph (A), with respect to the pre-submission written feedback goal, the amounts determined under this subparagraph are as follows:

“(I) For fiscal year 2025, $15,396,600 if such goal for fiscal year 2023 is met.

“(II) For fiscal year 2026:

“(aa) $15,396,600 if such goal for fiscal year 2023 is met and such goal for fiscal year 2024 is not met.

“(bb) $36,792,200 if such goal for fiscal year 2024 is met.

“(III) For fiscal year 2027:

“(aa) $15,396,600 if such goal for fiscal year 2023 is met and such goal for each of fiscal years 2024 and 2025 is not met.

“(bb) $36,792,200 if such goal for fiscal year 2024 is met and such goal for fiscal year 2025 is not met.

“(cc) $40,572,600 if such goal for fiscal year 2025 is met.

“(ii) De novo classification amount—For purposes of subparagraph (A), with respect to the de novo decision goal, the amounts determined under this subparagraph are as follows:

“(I) For fiscal year 2026, $6,323,500 if such goal for fiscal year 2023 is met.

changed “(II) For fiscal year 2027—2027:

“(aa) $6,323,500 if such goal for fiscal year 2023 is met and such goal for fiscal year 2024 is not met.

“(bb) $11,765,400 if such goal for fiscal year 2024 is met.

“(iii) Premarket notification and premarket approval amount—For purposes of subparagraph (A), with respect to the 510(k) decision goal, 510(k) shared outcome total time to decision goal, PMA decision goal, and PMA shared outcome total time to decision goal, the amounts determined under this subparagraph are as follows:

“(I) For fiscal year 2026, $1,020,000 if the four goals for fiscal year 2023 are met.

“(II) For fiscal year 2027:

changed “(aa) $1,020,000 if the four goals for fiscal year 2023 are met and one or more of the four goals for fiscal year 2024 is are not met.

“(bb) $3,906,000 if the four goals for fiscal year 2024 are met.

“(C) Performance calculation—For purposes of this paragraph, performance of the goals listed in subparagraph (D) shall be determined as specified in the letters described in section 201(b) of the Medical Device User Fee Amendments of 2022 and based on data available as of the following dates:

“(i) The performance of the pre-submission written feedback goal shall be based on data available as of—

“(I) for fiscal year 2023, March 31, 2024;

“(II) for fiscal year 2024, March 31, 2025; and

“(III) for fiscal year 2025, March 31, 2026.

“(ii) The performance of the de novo decision goal, 510(k) decision goal, 510(k) shared outcome total time to decision goal, PMA decision goal, and PMA shared outcome total time to decision goal shall be based on data available as of—

“(I) for fiscal year 2023, March 31, 2025; and

“(II) for fiscal year 2024, March 31, 2026.

“(D) Goals defined—For purposes of this paragraph, the terms pre-submission written feedback goal, de novo decision goal, 510(k) decision goal, 510(k) shared outcome total time to decision goal, PMA decision goal, and PMA shared outcome total time to decision goal refer to the goals identified by the same names in the letters described in section 201(b) of the Medical Device User Fee Amendments of 2022.

“(5) Hiring adjustment

“(A) In general—For each of fiscal years 2025 through 2027, after the adjustments under paragraphs (2), (3), and (4), if applicable, if the number of hires to support the process for the review of device applications falls below the thresholds specified in subparagraph (B) for the applicable fiscal years, the base establishment registration fee amounts shall be decreased as the Secretary determines necessary to achieve a reduction in total fee collections equal to the hiring adjustment amount under subparagraph (C).

“(B) Thresholds—The thresholds specified in this subparagraph are as follows:

“(i) For fiscal year 2025, the threshold is 123 hires for fiscal year 2023.

“(ii) For fiscal year 2026, the threshold is 38 hires for fiscal year 2024.

“(iii) For fiscal year 2027, the threshold is—

“(I) 22 hires for fiscal year 2025 if the base establishment registration fees are not increased by the amount determined under paragraph (4)(A)(i); or

“(II) 75 hires for fiscal year 2025 if such fees are so increased.

“(C) Hiring adjustment amount—The hiring adjustment amount for fiscal year 2025 and each subsequent fiscal year is the product of—

“(i) the number of hires by which the hiring goal specified in subparagraph (D) for the fiscal year before the prior fiscal year was not met;

“(ii) $72,877; and

“(iii) the applicable inflation adjustment under paragraph (2)(B) for the fiscal year for which the hiring goal was not met.

“(D) Hiring goals—The hiring goals for each of fiscal years 2023 through 2025 are as follows:

“(i) For fiscal year 2023, 144 hires.

“(ii) For fiscal year 2024, 42 hires.

“(iii) For fiscal year 2025:

“(I) 24 hires if the base establishment registration fees are not increased by the amount determined under paragraph (4)(A)(i).

“(II) 83 hires if the base establishment registration fees are increased by the amount determined under paragraph (4)(A)(i).

“(E) Number of hires—For purposes of this paragraph, the number of hires shall be determined by the Secretary as set forth in the letters described in section 201(b) of the Medical Device User Fee Amendments of 2022.

“(6) Operating reserve adjustment

“(A) In general—For each of fiscal years 2023 through 2027, after the adjustments under paragraphs (2), (3), (4), and (5), if applicable, if the Secretary has operating reserves of carryover user fees for the process for the review of device applications in excess of the designated amount in subparagraph (B), the Secretary shall decrease the base establishment registration fee amounts to provide for not more than such designated amount of operating reserves.

“(B) Designated amount—Subject to subparagraph (C), for each fiscal year, the designated amount in this subparagraph is equal to the sum of—

“(i) 13 weeks of operating reserves of carryover user fees; and

“(ii) 1 month of operating reserves maintained pursuant to paragraph (8).

“(C) Excluded amount—For the period of fiscal years 2023 through 2026, a total amount equal to $118,000,000 shall not be considered part of the designated amount under subparagraph (B) and shall not be subject to the decrease under subparagraph (A).”

“(3) Authorization of appropriations

“(A) In general—For each of fiscal years 2023 through 2027, there is authorized to be appropriated for fees under this section an amount equal to the revenue amount determined under subparagraph (B), less the amount of reductions determined under subparagraph (C).

“(B) Revenue amount—For purposes of this paragraph, the revenue amount for each fiscal year is the sum of—

“(i) the total revenue amount under subsection (b)(3) for the fiscal year, as adjusted under paragraphs (2) and (3) of subsection (c); and

“(ii) the performance improvement adjustment amount for the fiscal year under subsection (c)(4), if applicable.

“(C) Reductions—For purposes of this paragraph, the amount of reductions for each fiscal year is the sum of—

“(i) the hiring adjustment amount for the fiscal year under subsection (c)(5), if applicable; and

“(ii) the operating reserve adjustment amount for the fiscal year under subsection (c)(6), if applicable.”

removed Notwithstanding the amendments made by this title, part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the day before the date of the enactment of this title, shall continue to be in effect with respect to the submissions listed in section 738(a)(2)(A) of such Act (as defined in such part as of such day) that on or after October 1, 2017, but before October 1, 2022, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2023.

added Notwithstanding the amendments made by this title, part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the day before the date of the enactment of this title, shall continue to be in effect with respect to the submissions listed in section 738(a)(2)(A) of such Act (as defined in such part as of such day) that on or after October 1, 2017, but before October 1, 2022, were received by the Food and Drug Administration with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2023.

“(B) Fiscal years 2024 through 2027

“(i) In general—For each of the fiscal years 2024 through 2027, fees under paragraphs (2) through (5) of subsection (a) shall be established to generate a total estimated revenue amount under such subsection that is equal to the base revenue amount for the fiscal year under clause (ii), as adjusted pursuant to subsection (c).

“(ii) Base revenue amount—The base revenue amount for a fiscal year referred to in clause (i) is equal to the total revenue amount established under this paragraph for the previous fiscal year, not including any adjustments made for such previous fiscal year under subsection (c)(3).”

“(2) Capacity planning adjustment

“(A) In general—Beginning with fiscal year 2024, the Secretary shall, in addition to the adjustment under paragraph (1), further increase the fee revenue and fees under this section for a fiscal year, in accordance with this paragraph, to reflect changes in the resource capacity needs of the Secretary for human generic drug activities.

“(B) Capacity planning methodology—The Secretary shall establish a capacity planning methodology for purposes of this paragraph, which shall—

“(i) be derived from the methodology and recommendations made in the report titled “Independent Evaluation of the GDUFA Resource Capacity Planning Adjustment Methodology: Evaluation and Recommendations” announced in the Federal Register on August 3, 2020;

“(ii) incorporate approaches and attributes determined appropriate by the Secretary, including approaches and attributes made in such report, except that in incorporating such approaches and attributes the workload categories used in forecasting resources shall only be the workload categories specified in section VIII.B.2.e. of the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2022; and

“(iii) be effective beginning with fiscal year 2024.

“(C) Limitations

“(i) In general—Under no circumstances shall an adjustment under this paragraph result in fee revenue for a fiscal year that is less than the sum of the amounts under subsection (b)(1)(B)(ii) (the base revenue amount for the fiscal year) and paragraph (1) (the dollar amount of the inflation adjustment for the fiscal year).

“(ii) Percentage limitation—An adjustment under this paragraph shall not exceed three percent of the sum described in clause (i) for the fiscal year, except that such limitation shall be four percent if—

“(I) for purposes of a fiscal year 2024 adjustment, the Secretary determines that during the period from April 1, 2021, through March 31, 2023—

“(aa) the total number of abbreviated new drug applications submitted was greater than or equal to 2,000; or

“(bb) thirty-five percent or more of abbreviated new drug applications submitted related to complex products (as that term is defined in section XI of the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2022);

“(II) for purposes of a fiscal year 2025 adjustment, the Secretary determines that during the period from April 1, 2022, through March 31, 2024—

“(aa) the total number of abbreviated new drug applications submitted was greater than or equal to 2,300; or

“(bb) thirty-five percent or more of abbreviated new drug applications submitted related to complex products (as so defined);

“(III) for purposes of a fiscal year 2026 adjustment, the Secretary determines that during the period from April 1, 2023, through March 31, 2025—

“(aa) the total number of abbreviated new drug applications submitted was greater than or equal to 2,300; or

“(bb) thirty-five percent or more of abbreviated new drug applications submitted related to complex products (as so defined); and

“(IV) for purposes of a fiscal year 2027 adjustment, the Secretary determines that during the period from April 1, 2024, through March 31, 2026—

“(aa) the total number of abbreviated new drug applications submitted was greater than or equal to 2,300; or

“(bb) thirty-five percent or more of abbreviated new drug applications submitted related to complex products (as so defined).

“(D) Publication in Federal Register—The Secretary shall publish in the Federal Register notice referred to in subsection (a) the fee revenue and fees resulting from the adjustment and the methodology under this paragraph.

“(3) Operating reserve adjustment

“(A) In general—For fiscal year 2024 and each subsequent fiscal year, the Secretary may, in addition to adjustments under paragraphs (1) and (2), further increase the fee revenue and fees under this section for such fiscal year if such an adjustment is necessary to provide operating reserves of carryover user fees for human generic drug activities for not more than the number of weeks specified in subparagraph (B) with respect to that fiscal year.

“(B) Number of weeks—The number of weeks specified in this subparagraph is—

“(i) 8 weeks for fiscal year 2024;

“(ii) 9 weeks for fiscal year 2025; and

“(iii) 10 weeks for each of fiscal year 2026 and 2027.

“(C) Decrease—If the Secretary has carryover balances for human generic drug activities in excess of 12 weeks of the operating reserves referred to in subparagraph (A), the Secretary shall decrease the fee revenue and fees referred to in such subparagraph to provide for not more than 12 weeks of such operating reserves.

“(D) Rationale for adjustment—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 subsection (a) publishing the fee revenue and fees for the fiscal year involved.”

changed The amendments made by this title shall take effect on October 1, 2022, or the date of the enactment of this Act, whichever is later, except that fees under part 7 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–41 et seq.) shall be assessed for all abbreviated new drug applications received on or after October 1, 2022, regardless of the date of the enactment of this Act.

changed Notwithstanding the amendments made by this title, part 7 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, Act (21 U.S.C. 379j–41 et seq.), as in effect on the day before the date of the enactment of this title, shall continue to be in effect with respect to abbreviated new drug applications (as defined in such part as of such day) that were received by the Food and Drug Administration within the meaning of section 505(j)(5)(A) of such Act (21 U.S.C. 355(j)(5)(A)), prior approval supplements that were submitted, and drug master files for Type II active pharmaceutical ingredients that were first referenced on or after October 1, 2017, but before October 1, 2022, with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2023.

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

“(D) Reactivation fee

“(i) In general—A person that has discontinued participation in the biosimilar biological product development program for a product under subparagraph (C), or who has been administratively removed from the biosimilar biological product development program for a product under subparagraph (E)(v), shall, if the person seeks to resume participation in such program, pay all annual biosimilar biological product development fees previously assessed for such product and still owed and a fee (referred to in this section as “reactivation fee”) by the earlier of the following:

“(I) 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).

“(II) 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.

“(ii) Application of annual fee—A person that pays a reactivation fee for a product shall pay for such product, beginning in the next fiscal year, the annual biosimilar biological product development fee under subparagraph (B), except where such product (including, where applicable, ownership of the relevant investigational new drug application) is transferred to a licensee, assignee, or successor of such person, and written notice of such transfer is provided to the Secretary, in which case such licensee, assignee, or successor shall pay the annual biosimilar biological product development fee.”

“(v) Administrative removal from the biosimilar biological product development program—If a person has failed to pay an annual biosimilar biological product development fee for a product as required under subparagraph (B) for a period of two consecutive fiscal years, the Secretary may administratively remove such person from the biosimilar biological product development program for the product. At least 30 days prior to administratively removing a person from the biosimilar biological product development program for a product under this clause, the Secretary shall provide written notice to such person of the intended administrative removal.”

“(ii) may be dispensed only under prescription pursuant to section 503(b); and”

“(E) Movement to discontinued list

“(i) Date of inclusion—If a written request to place a product on the list referenced in subparagraph (A) of discontinued biosimilar biological products is submitted to the Secretary on behalf of an applicant, and the request identifies the date the product is withdrawn from sale, then for purposes of assessing the biosimilar biological product program fee, the Secretary shall consider such product to have been included on such list on the later of—

“(I) the date such request was received; or

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

“(ii) Treatment as withdrawn from sale—For purposes of clause (i), a product shall be considered withdrawn from sale once the applicant has ceased its own distribution of the product, whether or not the applicant has ordered recall of all previously distributed lots of the product, except that a routine, temporary interruption in supply shall not render a product withdrawn from sale.

“(iii) Special rule—If a biosimilar biological product that is identified in a biosimilar biological product application approved as of October 1 of a fiscal year appears, as of October 1 of such fiscal year, on the list referenced in subparagraph (A) of discontinued biosimilar biological products, and on any subsequent day during such fiscal year the biosimilar biological product does not appear on such list, then except as provided in subparagraph (D), each person who is named as the applicant in a biosimilar biological product application with respect to such product shall pay the annual biosimilar biological product program fee established for a fiscal year under subsection (c)(5) for such biosimilar biological product. Notwithstanding subparagraph (B), such fee shall be due on the last business day of such fiscal year and shall be paid only once for each such product for each fiscal year.”

“(1) In general—For each of the fiscal years 2023 through 2027, fees under subsection (a) shall, except as provided in subsection (c), be established to generate a total revenue amount equal to the sum of—

“(A) the annual base revenue for the fiscal year (as determined under paragraph (3));

“(B) the dollar amount equal to the inflation adjustment for the fiscal year (as determined under subsection (c)(1));

“(C) the dollar amount equal to the strategic hiring and retention adjustment (as determined under subsection (c)(2));

“(D) the dollar amount equal to the capacity planning adjustment for the fiscal year (as determined under subsection (c)(3));

“(E) the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(4));

“(F) for fiscal year 2023 an additional amount of $4,428,886; and

“(G) for fiscal year 2024 an additional amount of $320,569.”

“(3) Annual base revenue—For purposes of paragraph (1), the dollar amount of the annual base revenue for a fiscal year shall be—

“(A) for fiscal year 2023, $43,376,922; and

“(B) for fiscal years 2024 through 2027, the dollar amount of the total revenue amount established under paragraph (1) for the previous fiscal year, excluding any adjustments to such revenue amount under subsection (c)(4).”

“(2) Strategic hiring and retention adjustment—For each fiscal year, after the annual base revenue under subsection (b)(1)(A) is adjusted for inflation in accordance with paragraph (1), the Secretary shall further increase the fee revenue and fees by $150,000.

“(3) Capacity planning adjustment

“(A) In general—For each fiscal year, the Secretary shall, in addition to the adjustments under paragraphs (1) and (2), further adjust the fee revenue and fees under this section for a fiscal year to reflect changes in the resource capacity needs of the Secretary for the process for the review of biosimilar biological product applications.

“(B) Methodology—For purposes of this paragraph, the Secretary shall employ the capacity planning methodology utilized by the Secretary in setting fees for fiscal year 2021, as described in the notice titled “Biosimilar User Fee Rates for Fiscal Year 2021” published in the Federal Register on August 4, 2020 (85 Fed. Reg. 47220). The workload categories used in applying such methodology in forecasting shall include only the activities described in that notice and, as feasible, additional activities that are also directly related to the direct review of biosimilar biological product applications and supplements, including additional formal meeting types, the direct review of postmarketing commitments and requirements, the direct review of risk evaluation and mitigation strategies, and the direct review of annual reports for approved biosimilar biological products. Subject to the exceptions in the preceding sentence, the Secretary shall not include as workload categories in applying such methodology in forecasting any non-core review activities, including those activities that the Secretary referenced for potential future use in such notice but did not utilize in setting fees for fiscal year 2021.

changed “(C) Limitations—Under no circumstances shall an adjustment under this paragraph result in fee revenue for a fiscal year that is less than the sum of the amounts under subsections (b)(1)(A)(the (b)(1)(A) (the annual base revenue for the fiscal year), (b)(1)(B) (the dollar amount of the inflation adjustment for the fiscal year), and (b)(1)(C) (the dollar amount of the strategic hiring and retention adjustment).

“(D) Publication in Federal Register—The Secretary shall publish in the Federal Register notice under paragraph (5) the fee revenue and fees resulting from the adjustment and the methodologies under this paragraph.

“(4) Operating reserve adjustment

“(A) Increase—For fiscal year 2023 and subsequent fiscal years, the Secretary shall, in addition to adjustments under paragraphs (1), (2), and (3), further increase the fee revenue and fees if such an adjustment is necessary to provide for at least 10 weeks of operating reserves of carryover user fees for the process for the review of biosimilar biological product applications.

“(B) Decrease

“(i) Fiscal year 2023—For fiscal year 2023, if the Secretary has carryover balances for such process in excess of 33 weeks of such operating reserves, the Secretary shall decrease such fee revenue and fees to provide for not more than 33 weeks of such operating reserves.

“(ii) Fiscal year 2024—For fiscal year 2024, if the Secretary has carryover balances for such process in excess of 27 weeks of such operating reserves, the Secretary shall decrease such fee revenue and fees to provide for not more than 27 weeks of such operating reserves.

“(iii) Fiscal year 2025 and subsequent fiscal years—For fiscal year 2025 and subsequent fiscal years, if the Secretary has carryover balances for such process in excess of 21 weeks of such operating reserves, the Secretary shall decrease such fee revenue and fees to provide for not more than 21 weeks of such operating reserves.

“(C) Federal Register notice—If an adjustment under subparagraph (A) or (B) is made, the rationale for the amount of the increase or decrease in fee revenue and fees shall be contained in the annual Federal Register notice under paragraph (5)(B) establishing fee revenue and fees for the fiscal year involved.”

“(h) Written requests for waivers and returns; disputes concerning fees—To qualify for consideration for a waiver under subsection (d), or for the return of any fee paid under this section, including if the fee is claimed to have been paid in error, a person shall submit to the Secretary a written request justifying such waiver or return and, except as otherwise specified in this section, such written request shall be submitted to the Secretary not later than 180 days after such fee is due. A request submitted under this paragraph shall include any legal authorities under which the request is made.”

changed The amendments made by this title shall take effect on October 1, 2022, or the date of the enactment of this Act, whichever is later, except that fees under part 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–51 et seq.) shall be assessed for all biosimilar biological product applications received on or after October 1, 2022, regardless of the date of the enactment of this Act.

changed Notwithstanding the amendments made by this title, part 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, Act (21 U.S.C. 379j–51 et seq.), as in effect on the day before the date of the enactment of this title, shall continue to be in effect with respect to biosimilar biological product applications and supplements (as defined in such part as of such day) that were accepted by the Food and Drug Administration for filing on or after October 1, 2017, but before October 1, 2022, with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2023.

“(5)

changed “(A) In order for a new drug that is being studied in a phase 3 study, as defined in section 312.21(c) of title 21, Code of Federal Regulations (or successor regulations), or other pivotal study (other than bioavailability or bioequivalence studies), to be exempt pursuant to this subsection, the sponsor of a clinical investigation of such new drug shall submit to the Secretary a diversity action plan.

“(B) Such diversity action plan shall include—

changed “(i) the sponsor’s goals for enrollment in such clinical investigation;study;

“(ii) the sponsor’s rationale for such goals; and

“(iii) an explanation of how the sponsor intends to meet such goals.

changed “(C) The sponsor shall, in shall submit such diversity action plan in the form and manner as specified in the guidance required by section 524B, submit such diversity action plan 524B as soon as practicable during drug development, but not no later than—than when the sponsor seeks feedback regarding such a phase 3 study or other pivotal study of the drug.

changed “(i) one month prior to an End-of-Phase 2 meeting, as described “(D) The Secretary may waive the requirement in section 312.47(b) subparagraph (A) if the Secretary determines that a waiver is necessary based on what is known about the prevalence of title 21, Code the disease in terms of Federal Regulations (or successor regulations); orthe patient population that may use the new drug.

changed “(ii) if there is no End-of-Phase 2 meeting, one month prior to commencing enrollment “(E) No diversity action plan shall be required for a Phase 3 study.submission described in section 561.”

removed “(D) The Secretary may waive the requirement in subparagraph (A) if the Secretary determines that a waiver is necessary based on what is known about the prevalence of the disease in terms of the patient population that may use the new drug.”

removed “(B)

removed “(i) In order for a biological product to be exempt pursuant to this paragraph, the sponsor of a clinical investigation of such biological product shall submit to the Secretary a diversity action plan.

removed “(ii) Such diversity action plan shall include—

removed “(I) the sponsor’s goals for enrollment in such clinical investigation;

removed “(II) the sponsor’s rationale for such goals; and

removed “(III) an explanation of how the sponsor intends to meet such goals.

removed “(iii) The sponsor shall, in such form and manner as specified in the guidance required by section 524B, submit such diversity action plan as soon as practicable during biological product development, but not later than—

removed “(I) one month prior to an End-of-Phase 2 meeting, as described in section 312.47(b) of title 21, Code of Federal Regulations (or successor regulations); or

removed “(II) if there is no End-of-Phase 2 meeting, one month prior to commencing enrollment for a Phase 3 study.

removed “(iv) The Secretary may waive the requirement in subparagraph (A) if the Secretary determines that a waiver is necessary based on what is known about the prevalence of the disease in terms of the patient population that may use the biological product.”

“(9)

added “(A)

added “(i) In order for a device in a clinical study for which submission of an application for an investigational device exemption is required to be exempt under this subsection, the sponsor of such study shall submit to the Secretary in such application a diversity action plan in the form and manner specified in the guidance required by section 524B.

added “(ii) In order for a device in a clinical study for which submission of an application for an investigational device exemption is not required, except for a device being studied as described in section 812.2(c) of title 21, Code of Federal Regulations (or successor regulations), to be exempt under this subsection, the sponsor of such study shall develop and implement a diversity action plan. Such diversity action plan shall be submitted to the Secretary in any premarket notification under section 510(k), request for classification under section 513(f)(2), or application for premarket approval under section 515 for such device.

added “(B) A diversity action plan under clause (i) or (ii) of subparagraph (A) shall include—

added “(i) the sponsor’s goals for enrollment in the clinical study;

removed “(A) In order for a device to be exempt under this subsection, the sponsor of a clinical investigation of such device shall submit to the Secretary a diversity action plan the sponsor of a clinical investigation of such device shall submit to the Secretary a diversity action plan.

removed “(B) Such diversity action plan shall include—

removed “(i) the sponsor’s goals for enrollment in such clinical investigation;

“(ii) the sponsor’s rationale for such goals; and

“(iii) an explanation of how the sponsor intends to meet such goals.

added “(C) The Secretary may waive the requirement in subparagraph (A) or (B) if the Secretary determines that a waiver is necessary based on what is known about the prevalence of the disease in terms of the patient population that may use the device.

added “(D) No diversity action plan shall be required for a submission described in section 561.”

removed “(C) Such diversity action plan shall be—

removed “(i) if submission of an application for an investigational device exemption is required, submitted in such application; and

removed “(ii) if submission of an application for investigational device exemption is not required, submitted as soon as practicable during device development, but no later than one month prior to commencing enrollment for a study.

removed “(D) The Secretary may waive the requirement in subparagraph (A) if the Secretary determines that a waiver is necessary based on what is known about the prevalence of the disease in terms of the patient population that may use the device.”

added “524B. Guidance on diversity action plans for clinical studies

added “(a) In general—The Secretary shall issue guidance relating to—

added “(1) the format and content of the diversity action plans required by sections 505(i)(5) and 520(g)(9) pertaining to the sponsor’s goals for clinical study enrollment, disaggregated by age group, sex, race, geographic location, socioeconomic status, and ethnicity, including with respect to—

removed “524B. Guidance on diversity action plans for clinical trials and studies

removed “(a) In general—The Secretary shall by guidance provide recommendations relating to—

removed “(1) the format and content of the diversity action plans required by sections 505(i)(5) and 520(g)(9) of this Act, and section 351(a)(3) of the Public Health Service Act, pertaining to the sponsor’s goals for clinical trial enrollment, disaggregated by age group, sex, race, geographic location, and ethnicity, including with respect to—

“(A) the rationale for the sponsor’s enrollment goals, which may include—

added “(i) the estimated prevalence or incidence in the United States of the disease or condition for which the drug or device is being developed or investigated, if such estimated prevalence or incidence is known or can be determined based on available data;

removed “(i) the estimated prevalence in the United States of the disease or condition for which the drug or device is being developed or investigated, if such estimated prevalence is known or can be determined based on available data;

“(ii) what is known about the disease or condition for which the drug or device is being developed or investigated;

“(iii) any relevant pharmacokinetic or pharmacogenomic data;

“(iv) what is known about the patient population for such disease or condition, including, to the extent data is available—

added “(I) demographic information, including age group, sex, race, geographic location, socioeconomic status, and ethnicity;

added “(II) non-demographic factors, including co-morbidities affecting the patient population; and

added “(III) potential barriers to enrolling diverse participants, such as patient population size, geographic location, and socioeconomic status; and

added “(v) any other data or information relevant to selecting appropriate enrollment goals, disaggregated by demographic subgroup, such as the inclusion of pregnant and lactating women;

added “(B) an explanation for how the sponsor intends to meet such goals, including demographic-specific outreach and enrollment strategies, study-site selection, clinical study inclusion and exclusion practices, and any diversity training for study personnel; and

added “(C) procedures for the public posting of key information from the diversity action plan that would be useful to patients and providers on the sponsor’s website, as appropriate; and

removed “(I) demographic information, including age group, sex, race, geographic location and ethnicity;

removed “(II) co-morbidities frequently affecting the patient population; and

removed “(III) potential barriers to enrolling diverse participants, such as patient population size and geographic location; and

removed “(v) any other data or information the sponsor deems relevant to selecting appropriate enrollment goals, disaggregated by demographic subgroup, such as the inclusion of pregnant and lactating women;

removed “(B) an explanation for how the sponsor intends to meet such goals, including demographic-specific outreach and enrollment strategies, study-site selection, clinical trial inclusion and exclusion practices, and any diversity training for trial personnel; and

removed “(C) procedures for the public posting of key information from the diversity action plan that would be useful to patients and providers on the sponsor’s website; and

“(2) how sponsors should include in regular reports to the Secretary—

“(A) the sponsor’s progress in meeting the goals referred to in paragraph (1)(A); and

“(B) if the sponsor does not expect to meet such goals—

“(i) any updates needed to be made to a diversity action plan referred to in paragraph (1) to help meet such goals; and

“(ii) the sponsor’s reasons for why the sponsor does not expect to meet such goals.

“(b) Issuance—The Secretary shall—

“(1) not later than 12 months after the date of enactment of this section, issue new draft guidance or update existing draft guidance described in subsection (a); and

added “(2) not later than 9 months after closing the comment period on such draft guidance, finalize such guidance.”

removed “(2) not later than 6 months after closing the comment period on such draft guidance, finalize such guidance.”

“(H)

changed “(i) Upon request (in controlled correspondence or otherwise) by a person that has submitted or intends to submit an abbreviated application for a new drug under this subsection for which the Secretary has specified in regulation, including under section 314.94(a)(9), title 21, Code of Federal Regulations (or a successor regulation), or recommended in applicable guidance, certain qualitative or quantitative criteria with respect to an inactive ingredient, or on the Secretary’s own initiative during the review of such abbreviated application, the Secretary shall inform the person whether such new drug is qualitatively and quantitatively the same as the listed drug.

changed “(ii) If Notwithstanding section 301(j), if the Secretary determines that such new drug is not qualitatively or quantitatively the same as the listed drug, the Secretary shall identify and disclose to the person—

“(I) the ingredient or ingredients that cause the new drug not to be qualitatively or quantitatively the same as the listed drug; and

“(II) for any ingredient for which there is an identified quantitative deviation, the amount of such deviation.

“(iii) If the Secretary determines that such new drug is qualitatively and quantitatively the same as the listed drug, the Secretary shall not change or rescind such determination after the submission of an abbreviated application for such new drug under this subsection unless—

“(I) the formulation of the listed drug has been changed and the Secretary has determined that the prior listed drug formulation was withdrawn for reasons of safety or effectiveness; or

“(II) the Secretary makes a written determination that the prior determination must be changed because an error has been identified.

“(iv) If the Secretary makes a written determination described in clause (iii)(II), the Secretary shall provide notice and a copy of the written determination to the person making the request under clause (i).

changed “(v) The disclosures required by this subparagraph are disclosures authorized by law under including for purposes of section 1905 of title 18, United States Code.”

changed Section 505(j)(10)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(10)(A)) is amended by striking clauses (i) through (iv) (iii) and inserting the following:

“(i) a revision to the labeling of the listed drug has been approved by the Secretary within 90 days of when the application is otherwise eligible for approval under this subsection;

changed “(ii) the sponsor of the application agrees to submit revised labeling for the drug that is the subject of the application not later than 60 days after approval under this subsection of the application; andapplication;

changed “(iii) the labeling revision described under clause (i) does not include a change to the “Warnings” section of the labeling.”labeling; and”

Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended—

“(z) Nonclinical test defined—For purposes of this section, the term nonclinical test means a test conducted in vitro, in silico, or in chemico, or a nonhuman in vivo test, that occurs before or during the clinical trial phase of the investigation of the safety and effectiveness of a drug. Such test may include the following:

“(1) Cell-based assays.

“(2) Organ chips and microphysiological systems.

changed “(3) Sophisticated computer Computer modeling.

“(4) Other nonhuman or human biology-based test methods.

“(5) Animal tests.”

Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 201 et seq.) is amended by inserting after section 566 of such Act (21 U.S.C. 360bbb–5) the following:

“566A. Emerging technology program

“(a) Program establishment

“(1) In general—The Secretary shall establish a program to support the adoption of, and improve the development of, innovative approaches to drug product design and manufacturing.

“(2) Actions—In carrying out the program under paragraph (1), the Secretary may—

“(A) facilitate and increase communication between public and private entities, consortia, and individuals with respect to innovative drug product design and manufacturing;

“(B) solicit information regarding, and conduct or support research on, innovative approaches to drug product design and manufacturing;

“(C) convene meetings with representatives of industry, academia, other Federal agencies, international agencies, and other interested persons, as appropriate;

“(D) convene working groups to support drug product design and manufacturing research and development;

“(E) support education and training for regulatory staff and scientists related to innovative approaches to drug product design and manufacturing;

“(F) advance regulatory science related to the development and review of innovative approaches to drug product design and manufacturing;

“(G) convene or participate in working groups to support the harmonization of international regulatory requirements related to innovative approaches to drug product design and manufacturing; and

“(H) award grants or contracts to carry out or support the program under paragraph (1).

“(3) Grants and contracts—To seek a grant or contract under this section, an entity shall submit an application—

“(A) in such form and manner as the Secretary may require; and

“(B) containing such information as the Secretary may require, including a description of—

“(i) how the entity will conduct the activities to be supported through the grant or contract; and

“(ii) how such activities will further research and development related to, or adoption of, innovative approaches to drug product design and manufacturing.

“(b) Guidance—The Secretary shall—

“(1) issue or update guidance to help facilitate the adoption of, and advance the development of, innovative approaches to drug product design and manufacturing; and

“(2) include in such guidance descriptions of—

“(A) any regulatory requirements related to the development or review of technologies related to innovative approaches to drug product design and manufacturing, including updates and improvements to such technologies after product approval; and

“(B) data that can be used to demonstrate the identity, safety, purity, and potency of drugs manufactured using such technologies.

“(c) Report to Congress—Not later than 4 years after the date of enactment of this section, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report containing—

“(1) an annual accounting of the allocation of funds made available to carry out this section;

“(2) a description of how Food and Drug Administration staff were utilized to carry out this section and, as applicable, any challenges or limitations related to staffing;

changed “(3) the number of public meetings held or participated in by the Food and Drug Administration, Administration pursuant to this section, including meetings convened as part of a working group described in subparagraph (D) or (G) of subsection (a)(2), and the topics of each such meeting; and

“(4) the number of drug products approved or licensed, after the date of enactment of this section, using an innovative approach to drug product design and manufacturing.

“(d) Authorization of appropriations—To carry out this section, there is authorized to be appropriated $20,000,000 for each fiscal year 2023 through 2027.”

“(C) Small population studies—The external experts on the list maintained pursuant to subparagraph (A) may include experts on the science of small population studies.”

Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 506J (21 U.S.C. 356j) the following:

“506K. Advanced manufacturing technologies designation pilot program

“(a) In general—Not later than 1 year after the date of enactment of this section, the Secretary shall initiate a pilot program under which persons may request designation of an advanced manufacturing technology as described in subsection (b).

“(b) Designation process—The Secretary shall establish a process for the designation under this section of methods of manufacturing drugs, including biological products, and active pharmaceutical ingredients of such drugs, as advanced manufacturing technologies. A method of manufacturing, or a combination of manufacturing methods, is eligible for designation as an advanced manufacturing technology if such method or combination of methods incorporates a novel technology, or uses an established technique or technology in a novel way, that will substantially improve the manufacturing process for a drug and maintain equivalent or provide superior drug quality, including by—

“(1) reducing development time for a drug using the designated manufacturing method; or

“(2) increasing or maintaining the supply of—

“(A) a drug that is described in section 506C(a) and is intended to treat a serious or life-threatening condition; or

“(B) a drug that is on the drug shortage list under section 506E.

“(c) Evaluation and designation of an advanced manufacturing technology

“(1) Submission—A person who requests designation of a method of manufacturing as an advanced manufacturing technology under this section shall submit to the Secretary data or information demonstrating that the method of manufacturing meets the criteria described in subsection (b) in a particular context of use. The Secretary may facilitate the development and review of such data or information by—

“(A) providing timely advice to, and interactive communication with, such person regarding the development of the method of manufacturing; and

“(B) involving senior managers and experienced staff of the Food and Drug Administration, as appropriate, in a collaborative, cross-disciplinary review of the method of manufacturing, as applicable.

“(2) Evaluation and designation—Not later than 180 calendar days after the receipt of a request under paragraph (1), the Secretary shall determine whether to designate such method of manufacturing as an advanced manufacturing technology, in a particular context of use, based on the data and information submitted under paragraph (1) and the criteria described in subsection (b).

“(d) Review of advanced manufacturing technologies—If the Secretary designates a method of manufacturing as an advanced manufacturing technology, the Secretary shall—

changed “(1) expedite the development and review of an application submitted under section 505 of this Act or section 351 of the Public Health Service Act, including supplemental applications, for drugs that are manufactured using a designated advanced manufacturing technology and could help mitigate or prevent a shortage or substantially improve manufacturing processes for a drug and maintain equivalent or provide superior drug quality, as described in subsection (b); and

“(2) allow the holder of an advanced technology designation, or a person authorized by the advanced manufacturing technology designation holder, to reference or rely upon, in an application submitted under section 505 of this Act or section 351 of the Public Health Service Act, including a supplemental application, data and information about the designated advanced manufacturing technology for use in manufacturing drugs in the same context of use for which the designation was granted.

“(e) Implementation and evaluation of advanced manufacturing technologies pilot

changed “(1) Public meeting—The Secretary shall publish in the Federal Register a notice of a public meeting, to be held not later than 180 days after the date of enactment of this section, to discuss, discuss and obtain input and recommendations from relevant stakeholders regarding—

“(A) the goals and scope of the pilot program, and a suitable framework, procedures, and requirements for such program; and

“(B) ways in which the Food and Drug Administration will support the use of advanced manufacturing technologies and other innovative manufacturing approaches for drugs.

“(2) Pilot program guidance

“(A) In general—The Secretary shall—

“(i) not later than 180 days after the public meeting under paragraph (1), issue draft guidance regarding the goals and implementation of the pilot program under this section; and

“(ii) not later than 2 years after the date of enactment of this section, issue final guidance regarding the implementation of such program.

“(B) Content—The guidance described in subparagraph (A) shall address—

“(i) the process by which a person may request a designation under subsection (b);

“(ii) the data and information that a person requesting such a designation is required to submit under subsection (c), and how the Secretary intends to evaluate such submissions;

“(iii) the process to expedite the development and review of applications under subsection (d); and

“(iv) the criteria described in subsection (b) for eligibility for such a designation.

“(3) Report—Not later than 3 years after the date of enactment of this section and annually thereafter, the Secretary shall publish on the website of the Food and Drug Administration 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 containing a description and evaluation of the pilot program being conducted under this section, including the types of innovative manufacturing approaches supported under the program. Such report shall include the following:

“(A) The number of persons that have requested designations and that have been granted designations.

“(B) The number of methods of manufacturing that have been the subject of designation requests and that have been granted designations.

“(C) The average number of calendar days for completion of evaluations under subsection (c)(2).

changed “(D) An analysis of the factors in data submissions that result in are relevant to determinations to designate and not to designate after evaluation under subsection (c)(2).

“(E) The number of applications received under section 505 of this Act or section 351 of the Public Health Service Act, including supplemental applications, that have included an advanced manufacturing technology designated under this section, and the number of such applications approved.

“(f) Sunset—The Secretary—

“(1) may not consider any requests for designation submitted under subsection (c) after October 1, 2029; and

“(2) may continue all activities under this section with respect to advanced manufacturing technologies that were designated pursuant to subsection (d) prior to such date, if the Secretary determines such activities are in the interest of the public health.”

changed Not later than 3 years after the date of the enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall convene a public workshop with relevant stakeholders to discuss best practices on generating scientific data necessary to further facilitate the development of certain human cell-, tissue-, and cellular-based medical products, and products (and the latest scientific information about such products.products) that are regulated as drugs under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and biological products under section 351 of the Public Health Service Act (42 U.S.C. 262), namely, stem-cell and other cellular therapies.

changed Section 409I(d)(1) of the Public Health Service Act (42 U.S.C. 284m) 284m(d)(1)) is amended by striking “2018 through 2022” and inserting “2023 through 2027”.

Section 5 of the Orphan Drug Act (21 U.S.C. 360ee) is amended—

“(5) Bioresearch monitoring inspections

“(A) In general—The Secretary may, to ensure the accuracy and reliability of studies and records or other information described in subparagraph (B) and to assess compliance with applicable requirements under this Act or the Public Health Service Act, enter sites and facilities specified in subparagraph (C) in order to inspect such records or other information.

“(B) Information subject to inspection—An inspection under this paragraph shall extend to all records and other information related to the studies and submissions described in subparagraph (E), including records and information related to the conduct, results, and analyses of, and the protection of human and animal trial participants participating in, such studies.

“(C) Sites and facilities subject to inspection

“(i) Sites and facilities described—The sites and facilities subject to inspection by the Secretary under this paragraph are those owned or operated by a person described in clause (ii) and which are (or were) utilized by such person in connection with—

“(I) developing an application or other submission to the Secretary under this Act or the Public Health Service Act related to marketing authorization for a product described in paragraph (1);

“(II) preparing, conducting, or analyzing the results of a study described in subparagraph (E); or

“(III) holding any records or other information described in subparagraph (B).

“(ii) Persons described—A person described in this clause is—

added “(I) the sponsor of an application or submission specified in subparagraph (E);

removed “(I) the sponsor of an application or submission specified in clause (i)(I);

“(II) a person engaged in any activity described in clause (i) on behalf of such a sponsor, through a contract, grant, or other business arrangement with such sponsor;

“(III) an institutional review board, or other individual or entity, engaged by contract, grant, or other business arrangement with a nonsponsor in preparing, collecting, or analyzing records or other information described in subparagraph (B); or

“(IV) any person not otherwise described in this clause that conducts, or has conducted, a study described in subparagraph (E) yielding records or other information described in subparagraph (B).

“(D) Conditions of inspection

“(i) Access to information subject to inspection—Subject to clause (ii), an entity that owns or operates any site or facility subject to inspection under this paragraph shall provide the Secretary with access to records and other information described in subparagraph (B) that is held by or under the control of such entity, including—

“(I) permitting the Secretary to record or copy such information for purposes of this paragraph;

“(II) providing the Secretary with access to any electronic information system utilized by such entity to hold, process, analyze, or transfer any records or other information described in subparagraph (B); and

“(III) permitting the Secretary to inspect the facilities, equipment, written procedures, processes, and conditions through which records or other information described in subparagraph (B) is or was generated, held, processed, analyzed, or transferred.

“(ii) No effect on applicability of provisions for protection of proprietary information or trade secrets—Nothing in clause (i) shall negate, supersede, or otherwise affect the applicability of provisions, under this or any other Act, preventing or limiting the disclosure of confidential commercial information or other information considered proprietary or trade secret.

“(iii) Reasonableness of inspections—An inspection under this paragraph shall be conducted at reasonable times and within reasonable limits and in a reasonable manner.

“(E) Studies and submissions described—The studies and submissions described in this subparagraph are each of the following:

“(i) Clinical and nonclinical studies submitted to the Secretary in support of, or otherwise related to, applications and other submissions to the Secretary under this Act or the Public Health Service Act for marketing authorization of a product described in paragraph (1).

“(ii) Postmarket safety activities conducted under this Act or the Public Health Service Act.

“(iii) Any other clinical investigation of—

“(I) a drug subject to section 505 or 512 of this Act or section 351 of the Public Health Service Act; or

“(II) a device subject to section 520(g).

“(iv) Any other submissions made under this Act or the Public Health Service Act with respect to which the Secretary determines an inspection under this paragraph is warranted in the interest of public health.

“(F) Clarification—This paragraph clarifies the authority of the Secretary to conduct inspections of the type described in this paragraph and shall not be construed as a basis for inferring that, prior to the date of enactment of this paragraph, the Secretary lacked the authority to conduct such inspections, including under this Act or the Public Health Service Act.”

changed Section 703 of the of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 373) is amended by adding at the end the following:

changed “(c) Applicability—The limitations on the Secretary’s use of evidence obtained under this section, or any evidence which is directly or indirectly derived from such evidence, in a criminal prosecution of the person from whom such evidence was obtained shall not apply to evidence evidence, including records or other information, obtained under authorities other than this section, unless such limitations are specifically incorporated by reference in such other authorities.”

“(F) The compliance history of establishments in the country or region in which the establishment is located that are subject to regulation under this Act, including the history of violations related to products exported from such country or region that are subject to such regulation.”

changed “(C) The Secretary may rely on any records or other information that the Secretary may inspect under this section to satisfy requirements that may pertain to a preapproval or risk-based surveillance inspection, or to resolve deficiencies found in identified during such inspections, if applicable and appropriate.”

“(c) Periodic review

changed “(1) In general—Beginning not later than 1 year after the date of the enactment of the Food and Drug Amendments of 2022 2022, the Secretary shall periodically assess whether additional arrangements and agreements with a foreign government or an agency of a foreign government, as allowed under this section, are appropriate.

changed “(2) Reports to Congress—Beginning not later than 4 years after the date of the enactment of the Food and Drug Amendments of 2022, and every 4 years thereafter, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report describing the findings and conclusions of each review conducted under paragraph (1).”

Section 902 of the FDA Reauthorization Act of 2017 (21 U.S.C. 355 note) is amended to read as follows:

“902. Annual report on inspections

changed “Not later than 120 days after the end of each fiscal year, the Secretary of Health and Human Services shall post on the public website of the Food and Drug Administration information related to inspections of facilities, including inspections that are facilities necessary for approval of a drug under subsection (c) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), approval of a device under section 515 of such Act (21 U.S.C. 360e), or clearance of a device under section 510(k) of such Act (21 U.S.C. 360(k)) that were conducted during the previous fiscal year. Such information shall include the following:

“(1) The median time following a request from staff of the Food and Drug Administration reviewing an application or report to the beginning of the inspection, including—

“(A) the median time for drugs described in section 505(j)(11)(A)(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(11)(A)(i));

“(B) the median time for drugs described in section 506C(a) of such Act (21 U.S.C. 356c(a)) only; and

changed “(C) the median time for drugs on the drug shortage list in effect under section 506E of such Act (21 U.S.C. 356f).356e).

“(2) The median time from the issuance of a report pursuant to section 704(b) of such Act (21 U.S.C. 374(b)) to the sending of a warning letter, issuance of an import alert, or holding of a regulatory meeting for inspections for which the Secretary concluded that regulatory or enforcement action was indicated, including the median time for each category of drugs listed in subparagraphs (A) through (C) of paragraph (1).

“(3) The median time from the sending of a warning letter, issuance of an import alert, or holding of a regulatory meeting to resolution of the actions indicated to address the conditions or practices observed during an inspection.

changed “(4) The number of facilities that were unable failed to implement requested adequate corrective or preventive actions following a report pursuant to such section 704(b), resulting in a withhold recommendation, including the number of such times for each category of drugs listed in subparagraphs (A) through (C) of paragraph (1).”

“(c) Additional one-Time report—Within 180 days of the date of enactment of the Food and Drug Amendments of 2022, all holders of applications approved under subsection (a) or (k) of section 351 of the Public Health Service Act shall review the information in the list published under section 351(k)(9)(A) and shall submit a written notice to the Secretary—

changed “(1) stating that all of the application holder’s biological products in the list published under section 351(k)(9)(a) 351(k)(9)(A) that are not listed as discontinued are available for sale; or

changed “(2) including the information required pursuant to subsection (a) or (b), as applicable, for each of the application holder’s biological products that are in the list published under section 351(k)(9)(a) 351(k)(9)(A) and not listed as discontinued, but have been discontinued from sale or never have been available for sale.”

changed “(d) Failure to To meet requirements—If a holder of an approved application fails to submit the information required under subsection (a), (b), or (c), the Secretary may—

changed “(1) move the application holder’s drugs from the active section of the list published under section 505(j)(7)(A) to the discontinued section of the list, except that the Secretary shall remove from the list in accordance with section 505(j)(7)(C) drugs the Secretary determines have been withdrawn from sale for reasons of safety of or effectiveness; and

“(2) identify the application holder’s biological products as discontinued in the list published under section 351(k)(9)(A) of the Public Health Service Act, except that the Secretary shall remove from the list in accordance with section 351(k)(9)(B) of such Act biological products for which the license has been revoked or suspended for reasons of safety, purity, or potency.”

added “3003. Streamlining patient and blood donor input

added “Chapter 35 of title 44, United States Code, shall not apply to the collection of information to which a response is voluntary, to solicit—

added “(1) the views and perspectives of patients under section 569C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–8c) (as amended by section 3001) or section 3002; or

added “(2) information from blood donors or potential blood donors to support the development of recommendations by the Secretary of Health and Human Services acting through the Commissioner of Food and Drugs concerning blood donation.”

removed Section 3003 of the 21st Century Cures Act (21 U.S.C. 360bbb–8c note) is amended to read as follows:

removed “3003. Streamlining patient and blood donor input

removed “Chapter 35 of title 44, United States Code, shall not apply to the collection of information to which a response is voluntary, to solicit—

removed “(1) the views and perspectives of patients under section 569C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–8c) (as amended by section 3001) or section 3002; or

removed “(2) information from blood donors or potential blood donors to support the development of recommendations by the Secretary of Health and Human Services concerning blood donation.”

Section 503 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353) is amended by adding at the end the following:

“(h)

“(1) Any contrast agent, radioactive drug, or OTC monograph drug shall be deemed to be a drug under section 201(g) and not a device under section 201(h).

“(2) For purposes of this subsection:

changed “(A) The term contrast agent means a drug an article that is intended for use in conjunction with an applicable a medical imaging device, and—

“(i) is a diagnostic radiopharmaceutical, as defined in sections 315.2 and 601.31 of title 21, Code of Federal Regulations (or any successor regulations); or

“(ii) is a diagnostic agent that improves the visualization of structure or function within the body by increasing the relative difference in signal intensity within the target tissue, structure, or fluid.

“(B) The term ‘radioactive drug’ has the meaning given such term in section 310.3(n) of title 21, Code of Federal Regulations (or any successor regulations), except that such term does not include—

“(i) an implant or article similar to an implant;

“(ii) an article that applies radiation from outside of the body; or

changed “(iii) the radiation source of an article described in clause (i) or (ii).

“(C) The term ‘OTC monograph drug’ has the meaning given such term in section 744L.

changed “(3) Nothing in this subsection shall be construed as allowing for the classification of a product as a drug (as defined in section 201(g)) if such product—

“(A) is not described in paragraph (1); and

changed “(B) meets the definition of a device under section 201(h).”201(h),”

“(2) Limitation

“(A) In general—Approval of a product under this subsection may be subject to 1 or both of the following requirements:

“(i) That the sponsor conduct an appropriate postapproval study or studies (which may be augmented or supported by real world evidence) to verify and describe the predicted effect on irreversible morbidity or mortality or other clinical benefit.

“(ii) That the sponsor submit copies of all promotional materials related to the product during the preapproval review period and, following approval and for such period thereafter as the Secretary determines to be appropriate, at least 30 days prior to dissemination of the materials.

“(B) Studies not required—If the Secretary does not require that the sponsor of a product approved under accelerated approval conduct a postapproval study under this paragraph, the Secretary shall publish on the website of the Food and Drug Administration the rationale for why such study is not appropriate or necessary.

“(C) Postapproval study conditions—Not later than the time of approval of a product under accelerated approval, the Secretary shall specify the conditions for a postapproval study or studies required to be conducted under this paragraph with respect to such product, which may include enrollment targets, the study protocol, and milestones, including the target date of study completion.

“(D) Studies begun before approval—The Secretary may require such study or studies to be underway prior to approval.”

“(3) Expedited withdrawal of approval

“(A) In general—The Secretary may withdraw approval of a product approved under accelerated approval using expedited procedures described in subparagraph (B), if—

“(i) the sponsor fails to conduct any required postapproval study of the product with due diligence, including with respect to conditions specified by the Secretary under paragraph (2)(C);

“(ii) a study required to verify and describe the predicted effect on irreversible morbidity or mortality or other clinical benefit of the product fails to verify and describe such effect or benefit;

“(iii) other evidence demonstrates that the product is not shown to be safe or effective under the conditions of use; or

“(iv) the sponsor disseminates false or misleading promotional materials with respect to the product.

“(B) Expedited procedures described—Expedited procedures described in this subparagraph shall consist of, prior to the withdrawal of accelerated approval—

“(i) providing the sponsor with—

“(I) due notice;

“(II) an explanation for the proposed withdrawal;

“(III) an opportunity for a meeting with the Commissioner of Food and Drugs or the Commissioner’s designee; and

“(IV) an opportunity for written appeal to—

“(aa) the Commissioner of Food and Drugs; or

“(bb) a designee of the Commissioner who has not participated in the proposed withdrawal of approval (other than a meeting pursuant to subclause (III)) and is not a subordinate of an individual (other than the Commissioner) who participated in such proposed withdrawal;

“(ii) providing an opportunity for public comment on the notice proposing to withdraw approval;

“(iii) the publication of a summary of the public comments received, and the Secretary’s response to such comments, on the website of the Food and Drug Administration; and

“(iv) convening and consulting an advisory committee on issues related to the proposed withdrawal, if requested by the sponsor and if no such advisory committee has previously advised the Secretary on such issues with respect to the withdrawal of the product prior to the sponsor’s request.

“(4) Labeling

changed “(A) In general—Subject to subparagraph (B), the label labeling for a product approved under accelerated approval shall include—

“(i) a statement indicating that the product was approved under accelerated approval;

“(ii) a statement indicating that continued approval of the product is subject to postmarketing studies to verify clinical benefit;

“(iii) identification of the surrogate or intermediate endpoint or endpoints that supported approval and any known limitations of such surrogate or intermediate endpoint or endpoints in determining clinical benefit; and

“(iv) a succinct description of the product and any uncertainty about anticipated clinical benefit and a discussion of available evidence with respect to such clinical benefit.

“(B) Applicability—The labeling requirements of subparagraph (A) shall apply only to products approved under accelerated approval for which the predicted effect on irreversible morbidity or mortality or other clinical benefit has not been verified.

added “(C) Rule of construction—With respect to any application pending before the Secretary on the date of enactment of the Food and Drug Amendments of 2022, the Secretary shall allow any applicable changes to the product labeling required to comply with subparagraph (A) to be made by supplement after the approval of such application.

“(5) Reporting—Not later than September 30, 2025, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report describing circumstances in which the Secretary considered real world evidence submitted to support postapproval studies required under this subsection that were completed after the date of enactment of the Food and Drug Amendments of 2022.”

changed “(2) Accelerated approval—Notwithstanding paragraph (1), a sponsor of a drug approved under accelerated approval shall submit to the Secretary a report of the progress of any study required under section 506(c), including progress toward any agreed upon enrollment targets, milestones, and other information as required by the Secretary, not later than 180 days after the approval of such drug and not less frequently than every 180 days thereafter, until the study is completed or terminated.”

added Section 513 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c) is amended by adding at the end the following:

added “(k) For a device authorized for emergency use under section 564 for which, in accordance with section 564(m), the Secretary has deemed a laboratory examination or procedure associated with such device to be in the category of examinations and procedures described in section 353(d)(3) of the Public Health Service Act, the sponsor of such device may, when submitting a request for classification under section 513(f)(2), submit a single submission containing—

added “(1) the information needed for such a request; and

added “(2) sufficient information to enable the Secretary to determine whether such laboratory examination or procedure satisfies the criteria to be categorized under section 353(d)(3) of the Public Health Service Act.”

removed “524C. Ensuring cybersecurity of devices

removed “(a) In general—For purposes of ensuring cybersecurity throughout the lifecycle of a cyber device, any person who submits a premarket submission for the cyber device shall include such information as the Secretary may require to ensure that the cyber device meets such cybersecurity requirements as the Secretary determines to be appropriate to demonstrate a reasonable assurance of safety and effectiveness, including at a minimum the cybersecurity requirements under subsection (b).

removed “(b) Cybersecurity requirements—At a minimum, the manufacturer of a cyber device shall meet the following cybersecurity requirements:

removed “(1) The manufacturer shall have a plan to appropriately monitor, identify, and address in a reasonable time postmarket cybersecurity vulnerabilities and exploits, including coordinated vulnerability disclosure and procedures.

removed “(2) The manufacturer shall design, develop, and maintain processes and procedures to ensure the device and related systems are cybersecure, and shall make available updates and patches to the cyber device and related systems throughout the lifecycle of the cyber device to address—

removed “(A) on a reasonably justified regular cycle, known unacceptable vulnerabilities; and

removed “(B) as soon as possible out of cycle, critical vulnerabilities that could cause uncontrolled risks.

removed “(3) The manufacturer shall provide in the labeling of the cyber device a software bill of materials, including commercial, open-source, and off-the-shelf software components.

removed “(4) The manufacturer shall comply with such other requirements as the Secretary may require to demonstrate reasonable assurance of the safety and effectiveness of the device for purposes of cybersecurity, which the Secretary may require by an order published in the Federal Register.

removed “(c) Substantial equivalence—In making a determination of substantial equivalence under section 513(i) for a cyber device, the Secretary may—

removed “(1) find that cybersecurity information for the cyber device described in the relevant premarket submission in the cyber device’s use environment is inadequate; and

removed “(2) issue a nonsubstantial equivalence determination based on this finding.

removed “(d) Definition—In this section:

removed “(1) Cyber device—The term cyber device means a device that—

removed “(A) includes software, including software as or in a device;

removed “(B) is intended to connect to the internet; or

removed “(C) contains any such technological characteristics that could be vulnerable to cybersecurity threats.

removed “(2) Lifecycle of the cyber device—The term lifecycle of the cyber device includes the postmarket lifecycle of the cyber device.

removed “(3) Premarket submission—The term premarket submission means any submission under section 510(k), 513, 515(c), 515(f), or 520(m).

removed “(e) Exemption—The Secretary may identify devices or types of devices that are exempt from meeting the cybersecurity requirements established by this section and regulations promulgated pursuant to this section. The Secretary shall publish in the Federal Register, and update, as appropriate, a list of the devices and types of devices so identified by the Secretary.”

removed “(3) The failure to comply with any requirement under section 524C (relating to ensuring device cybersecurity).”

removed “(k) If it is a device subject to the requirements set forth in section 524C (relating to ensuring device cybersecurity) and fails to comply with any requirement under that section.”

added “524C. Ensuring cybersecurity of devices

added “(a) In general—For purposes of ensuring cybersecurity throughout the lifecycle of a cyber device, any person who submits a premarket submission for the cyber device shall include such information as the Secretary may require to ensure that the cyber device meets such cybersecurity requirements as the Secretary determines to be appropriate to demonstrate a reasonable assurance of safety and effectiveness, including at a minimum the cybersecurity requirements under subsection (b).

added “(b) Cybersecurity requirements—At a minimum, the manufacturer of a cyber device shall meet the following cybersecurity requirements:

added “(1) The manufacturer shall have a plan to appropriately monitor, identify, and address in a reasonable time postmarket cybersecurity vulnerabilities and exploits, including coordinated vulnerability disclosure and procedures.

added “(2) The manufacturer shall design, develop, and maintain processes and procedures to ensure the device and related systems are cybersecure, and shall make available updates and patches to the cyber device and related systems throughout the lifecycle of the cyber device to address—

added “(A) on a reasonably justified regular cycle, known unacceptable vulnerabilities; and

added “(B) as soon as possible out of cycle, critical vulnerabilities that could cause uncontrolled risks.

added “(3) The manufacturer shall provide in the labeling of the cyber device a software bill of materials, including commercial, open-source, and off-the-shelf software components.

added “(4) The manufacturer shall comply with such other requirements as the Secretary may require to demonstrate reasonable assurance of the safety and effectiveness of the device for purposes of cybersecurity, which the Secretary may require by an order published in the Federal Register.

added “(c) Substantial equivalence—In making a determination of substantial equivalence under section 513(i) for a cyber device, the Secretary may—

added “(1) find that cybersecurity information for the cyber device described in the relevant premarket submission in the cyber device’s use environment is inadequate; and

added “(2) issue a nonsubstantial equivalence determination based on this finding.

added “(d) Definition—In this section:

added “(1) Cyber device—The term cyber device means a device that—

added “(A) includes software, including software as or in a device;

added “(B) has the ability to connect to the internet; or

added “(C) contains any such technological characteristics that could be vulnerable to cybersecurity threats.

added “(2) Lifecycle of the cyber device—The term lifecycle of the cyber device includes the postmarket lifecycle of the cyber device.

added “(3) Premarket submission—The term premarket submission means any submission under section 510(k), 513, 515(c), 515(f), or 520(m).

added “(e) Exemption—The Secretary may identify devices or types of devices that are exempt from meeting the cybersecurity requirements established by this section and regulations promulgated pursuant to this section. The Secretary shall publish in the Federal Register, and update, as appropriate, a list of the devices and types of devices so identified by the Secretary.”

added “(3) The failure to comply with any requirement under section 524C (relating to ensuring device cybersecurity).”

added “(k) If it is a device subject to the requirements set forth in section 524C (relating to ensuring device cybersecurity) and fails to comply with any requirement under that section.”

removed “(gg)

removed “(1) Unless its labeling bears adequate directions for use in accordance with paragraph (f), except that (in addition to drugs or devices that conform with exemptions pursuant to such paragraph) no drug or device shall be considered misbranded under such paragraph through the provision of product information to a payor, formulary committee, or other similar entity with knowledge and expertise in the area of health care economic analysis carrying out its responsibilities for the selection of drugs or devices for coverage or reimbursement if the product information relates to an investigational drug or device or investigational use of a drug or device that is approved, cleared, granted marketing authorization, or licensed under section 505, 510(k), 513(f)(2), or 515 of this Act or section 351 of the Public Health Service Act (as applicable), provided—

removed “(A) the product information includes—

removed “(i) a clear statement that the investigational drug or device or investigational use of a drug or device has not been approved, cleared, granted marketing authorization, or licensed under section 505, 510(k), 513(f)(2), or 515 of this Act or section 351 of the Public Health Service Act (as applicable) and that the safety and effectiveness of the drug or device or use has not been established;

removed “(ii) information related to the stage of development of the drug or device involved, such as—

removed “(I) the status of any study or studies in which the investigational drug or device or investigational use is being investigated;

removed “(II) how the study or studies relate to the overall plan for the development of the drug or device; and

removed “(III) whether a premarket application, premarket notification, or request for classification for the investigational drug or device or investigational use has been submitted to the Secretary and when such a submission is planned;

removed “(iii) in the case of information that includes factual presentations of results from studies, which shall not be selectively presented, a description of—

removed “(I) all material aspects of study design, methodology, and results; and

removed “(II) all material limitations related to the study design, methodology, and results;

removed “(iv) where applicable, a prominent statement disclosing the indication or indications for which the Food and Drug Administration has approved, granted marketing authorization, cleared, or licensed the product pursuant to section 505, 510(k), 513(f)(2), or 515 of this Act or section 351 of the Public Health Service Act, and a copy of the most current approved labeling; and

removed “(v) updated information, if previously communicated information becomes materially outdated as a result of significant changes or as a result of new information regarding the product or its review status; and

removed “(B) the product information does not include—

removed “(i) information that represents that an unapproved product—

removed “(I) has been approved, cleared, granted marketing authorization, or licensed under section 505, 510(k), 513(f)(2), or 515 of this Act or section 351 of the Public Health Service Act (as applicable); or

removed “(II) has otherwise been determined to be safe or effective for the purpose or purposes for which the drug or device is being studied; or

removed “(ii) information that represents that an unapproved use of a drug or device that has been so approved, granted marketing authorization, cleared, or licensed—

removed “(I) is so approved, granted marketing authorization, cleared, or licensed; or

removed “(II) that the product is safe or effective for the use or uses for which the drug or device is being studied.

removed “(2) For purposes of this subsection, the term product information includes—

removed “(A) information describing the drug or device (such as drug class, device description, and features);

removed “(B) information about the indication or indications being investigated;

removed “(C) the anticipated timeline for a possible approval, clearance, marketing authorization, or licensure pursuant to section 505, 510(k), 513, or 515 of this Act or section 351 of the Public Health Service Act;

removed “(D) drug or device pricing information;

removed “(E) patient utilization projections;

removed “(F) product-related programs or services; and

removed “(G) factual presentations of results from studies that do not characterize or make conclusions regarding safety or efficacy.”

added “(gg)

added “(1) Unless its labeling bears adequate directions for use in accordance with paragraph (f), except that (in addition to drugs or devices that conform with exemptions pursuant to such paragraph) no drug or device shall be deemed to be misbranded under such paragraph through the provision of product information to a payor, formulary committee, or other similar entity with knowledge and expertise in the area of health care economic analysis carrying out its responsibilities for the selection of drugs or devices for coverage or reimbursement if the product information relates to an investigational drug or device or investigational use of a drug or device that is approved, cleared, granted marketing authorization, or licensed under section 505, 510(k), 513(f)(2), or 515 of this Act or section 351 of the Public Health Service Act (as applicable), provided—

added “(A) the product information includes—

added “(i) a clear statement that the investigational drug or device or investigational use of a drug or device has not been approved, cleared, granted marketing authorization, or licensed under section 505, 510(k), 513(f)(2), or 515 of this Act or section 351 of the Public Health Service Act (as applicable) and that the safety and effectiveness of the drug or device or use has not been established;

added “(ii) information related to the stage of development of the drug or device involved, such as—

added “(I) the status of any study or studies in which the investigational drug or device or investigational use is being investigated;

added “(II) how the study or studies relate to the overall plan for the development of the drug or device; and

added “(III) whether an application, premarket notification, or request for classification for the investigational drug or device or investigational use has been submitted to the Secretary and when such a submission is planned;

added “(iii) in the case of information that includes factual presentations of results from studies, which shall not be selectively presented, a description of—

added “(I) all material aspects of study design, methodology, and results; and

added “(II) all material limitations related to the study design, methodology, and results;

added “(iv) where applicable, a prominent statement disclosing the indication or indications for which the Secretary has approved, granted marketing authorization, cleared, or licensed the product pursuant to section 505, 510(k), 513(f)(2), or 515 of this Act or section 351 of the Public Health Service Act, and a copy of the most current required labeling; and

added “(v) updated information, if previously communicated information becomes materially outdated as a result of significant changes or as a result of new information regarding the product or its review status; and

added “(B) the product information does not include—

added “(i) information that represents that an unapproved product—

added “(I) has been approved, cleared, granted marketing authorization, or licensed under section 505, 510(k), 513(f)(2), or 515 of this Act or section 351 of the Public Health Service Act (as applicable); or

added “(II) has otherwise been determined to be safe or effective for the purpose or purposes for which the drug or device is being studied; or

added “(ii) information that represents that an unapproved use of a drug or device that has been so approved, granted marketing authorization, cleared, or licensed—

added “(I) is so approved, granted marketing authorization, cleared, or licensed; or

added “(II) that the product is safe or effective for the use or uses for which the drug or device is being studied.

added “(2) For purposes of this paragraph, the term product information includes—

added “(A) information describing the drug or device (such as drug class, device description, and features);

added “(B) information about the indication or indications being investigated;

added “(C) the anticipated timeline for a possible approval, clearance, marketing authorization, or licensure pursuant to section 505, 510(k), 513, or 515 of this Act or section 351 of the Public Health Service Act;

added “(D) drug or device pricing information;

added “(E) patient utilization projections;

added “(F) product-related programs or services; and

added “(G) factual presentations of results from studies that do not characterize or make conclusions regarding safety or efficacy.”

removed “(c) Specific device banned—Electrical stimulation devices that apply a noxious electrical stimulus to a person’s skin intended to reduce or cease self-injurious behavior or aggressive behavior are deemed to be banned devices, as described in subsection (a). Such devices are banned unless or until the Secretary promulgates a regulation to make such devices no longer banned based on a finding that such devices do not present an unreasonable and substantial risk of illness or injury, or that such risk can be corrected or eliminated by labeling.”

removed Section 527 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360cc) is amended—

added “(c) Specific device banned—Electrical stimulation devices that apply a noxious electrical stimulus to a person’s skin intended to reduce or cease self-injurious behavior or aggressive behavior are deemed to be banned devices, as described in subsection (a).

added “(d) Reversal by regulation—Devices banned under this section are banned devices unless or until the Secretary promulgates a regulation to make such devices or use of such devices no longer banned based on a finding that such devices or use of such devices does not present substantial deception or an unreasonable and substantial risk of illness or injury, or that such risk can be corrected or eliminated by labeling.”

removed Not later than September 30, 2026, the Comptroller General of the United States shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the third-party review program described in section 523 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360m). Such report shall include—

changed Section 519(i)(10) Not later than September 30, 2026, the Comptroller General of the United States shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the third-party review program described in section 523 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i(i)(10)) is amended by striking “2022” and inserting “2027”.360m). Such report shall include—