FDA Reauthorization Act of 2017

To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes. 1. Short title This Act may be cited as the FDA Reauthorization Act of 2017 2. Table of contents The table of contents for this Act is as follows: Sec. 1. Short title. Sec. 2. Table of contents. Title I—Fees relating to drugs Sec. 101. Short title; finding. Sec. 102. Authority to assess and use drug fees. Sec. 103. Reauthorization; reporting requirements. Sec. 104. Sunset dates. Sec. 105. Effective date. Sec. 106. Savings clause. Title II—Fees relating to devices Sec. 201. Short title; findings. Sec. 202. Definitions. Sec. 203. Authority to assess and use device fees. Sec. 204. Reauthorization; reporting requirements. Sec. 205. Conformity assessment pilot program. Sec. 206. Reauthorization of review. Sec. 207. Electronic format for submissions. Sec. 208. Savings clause. Sec. 209. Effective date. Sec. 210. Sunset clause. Title III—Fees relating to generic drugs Sec. 301. Short title; finding. Sec. 302. Definitions. Sec. 303. Authority to assess and use human generic drug fees. Sec. 304. Reauthorization; reporting requirements. Sec. 305. Sunset dates. Sec. 306. Effective date. Sec. 307. Savings clause. Title IV—Fees relating to biosimilar biological products Sec. 401. Short title; finding. Sec. 402. Definitions. Sec. 403. Authority to assess and use biosimilar fees. Sec. 404. Reauthorization; reporting requirements. Sec. 405. Sunset dates. Sec. 406. Effective date. Sec. 407. Savings clause. Title V—Reauthorizations and improvements related to drugs Sec. 501. Reauthorization of provision relating to exclusivity of certain drugs containing single enantiomers. Sec. 502. Reauthorization of orphan grants program. Sec. 503. Reauthorization of pediatric study of drugs. Sec. 504. Protecting and strengthening the drug supply chain. Sec. 505. Sense of Congress on lowering the cost of prescription drugs. Title VI—Device Inspection and regulatory improvements Subtitle A—Improving the process for inspections of device establishments Sec. 601. Risk-based inspections for devices. Sec. 602. Recognition of foreign government inspections. Sec. 603. Improvements to inspections process for device establishments. Sec. 604. Certificates to foreign governments for devices. Sec. 605. Facilitating international harmonization. Sec. 606. Reauthorization of inspection program. Subtitle B—Other provisions Sec. 611. Reauthorization of pediatric humanitarian device exceptions. Sec. 612. Reauthorization of pediatric device consortia. Sec. 613. Regulation of over-the-counter hearing aids. Sec. 614. Report on ensuring quality, safety, and continued effectiveness of devices that have been serviced. Sec. 615. Device pilot projects to generate reliable and timely safety and active surveillance data. Sec. 616. Risk-based classification of accessories. Title VII—Generic Drug Access and Competition Sec. 701. Competitive Generic Therapies. Sec. 702. Enhancing regulatory transparency To enhance generic competition. Sec. 703. Incentivizing competitive generic therapy development. Sec. 704. Tropical disease product application. Sec. 705. G AO Title VIII—Fostering Innovation in Medical Imaging Sec. 801. Approval of applications for certain diagnostic medical imaging devices. Sec. 802. Applications for approval of contrast agents intended for use with certain diagnostic medical imaging devices. Title IX—Additional Provisions Sec. 901. Technical corrections. Sec. 902. Reauthorization of the critical path public-private partnerships. I Fees relating to drugs 101. Short title; finding (a) Short Title This title may be cited as the Prescription Drug User Fee Amendments of 2017 (b) Finding The Congress finds that the fees authorized by the amendments made in this title will be dedicated toward expediting the drug development process and the process for the review of human drug applications, including postmarket drug safety activities, as set forth in the goals identified for purposes of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record. 102. Authority to assess and use drug fees (a) Types of fees (1) In general Section 736(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379h(a) (A) in the matter preceding paragraph (1), by striking fiscal year 2013 fiscal year 2018 (B) in the heading of paragraph (1), by striking and supplement (C) in paragraph (1), by striking or a supplement or supplement (D) in paragraph (1)(A)— (i) in clause (i), by striking (c)(4) (c)(5) (ii) in clause (ii), by striking A fee established are required. A fee established under subsection (c)(5) for a human drug application for which clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness are not required for approval. (E) in the heading of paragraph (1)(C), by striking or supplement (F) in paragraph (1)(F)— (i) in the heading, by striking or indication (ii) by striking the second sentence; (G) by striking paragraph (2) (relating to a prescription drug establishment fee); (H) by redesignating paragraph (3) as paragraph (2); (I) in the heading of paragraph (2), as so redesignated, by striking Prescription drug product fee Prescription drug program fee (J) in subparagraph (A) of such paragraph (2), by amending the first sentence to read as follows: Except as provided in subparagraphs (B) and (C), each person who is named as the applicant in a human drug application, and who, after September 1, 1992, had pending before the Secretary a human drug application or supplement, shall pay the annual prescription drug program fee established for a fiscal year under subsection (c)(5) for each prescription drug product that is identified in such a human drug application approved as of October 1 of such fiscal year. (K) in subparagraph (B) of such paragraph (2)— (i) in the heading of subparagraph (B), by inserting after Exception for certain prescription drug products (ii) by striking A prescription drug product shall not be assessed a fee A prescription drug program fee shall not be assessed for a prescription drug product (L) by adding at the end of such paragraph (2) the following: (C) Limitation A person who is named as the applicant in an approved human drug application shall not be assessed more than 5 prescription drug program fees for a fiscal year for prescription drug products identified in such approved human drug application. . (2) Conforming amendment Subparagraph (C) of section 740(a)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–12(a)(3) (C) Limitation An establishment shall be assessed only one fee per fiscal year under this section. . (b) Fee revenue amounts Subsection (b) of section 736 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379h (b) Fee revenue amounts (1) In general For each of the fiscal years 2018 through 2022, 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)); (C) the dollar amount equal to the capacity planning adjustment for the fiscal year (as determined under subsection (c)(2)); (D) the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(3)); (E) the dollar amount equal to the additional direct cost adjustment for the fiscal year (as determined under subsection (c)(4)); and (F) additional dollar amounts for each fiscal year as follows: (i) $20,077,793 for fiscal year 2018. (ii) $21,317,472 for fiscal year 2019. (iii) $16,953,329 for fiscal year 2020. (iv) $5,426,896 for fiscal year 2021. (v) $2,769,609 for fiscal year 2022. (2) Types of fees Of the total revenue amount determined for a fiscal year under paragraph (1)— (A) 20 percent shall be derived from human drug application fees under subsection (a)(1); and (B) 80 percent shall be derived from prescription drug program fees under subsection (a)(2). (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 2018, $878,590,000; and (B) for fiscal years 2019 through 2022, 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)(3) or (c)(4). . (c) Adjustments; annual fee setting Subsection (c) of section 736 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379h (c) Adjustments; annual fee setting (1) Inflation adjustment (A) In general For purposes of subsection (b)(1)(B), the dollar amount of the inflation adjustment to the annual base revenue for each fiscal year shall be equal to the product of— (i) such annual base revenue for the fiscal year under subsection (b)(1)(A); and (ii) the inflation adjustment percentage under subparagraph (B). (B) Inflation adjustment percentage The inflation adjustment percentage under this subparagraph for a fiscal year is equal to the sum of— (i) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years, multiplied by the proportion of personnel compensation and benefits costs to total costs of the process for the review of human drug applications (as defined in section 735(6)) for the first 3 years of the preceding 4 fiscal years; and (ii) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of the process for the review of human drug applications (as defined in section 735(6)) for the first 3 years of the preceding 4 fiscal years. (2) Capacity planning adjustment (A) In general For each fiscal year, after the annual base revenue established in subsection (b)(1)(A) is adjusted for inflation in accordance with paragraph (1), 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) Interim methodology (i) In general Until the capacity planning methodology described in subparagraph (C) is effective, the adjustment under this paragraph for a fiscal year shall be based on the product of— (I) the annual base revenue for such year, as adjusted for inflation under paragraph (1); and (II) the adjustment percentage under clause (ii). (ii) Adjustment percentage The adjustment percentage under this clause for a fiscal year is the weighted change in the 3-year average ending in the most recent year for which data are available, over the 3-year average ending in the previous year, for— (I) the total number of human drug applications, efficacy supplements, and manufacturing supplements submitted to the Secretary; (II) the total number of active commercial investigational new drug applications; and (III) the total number of formal meetings scheduled by the Secretary, and written responses issued by the Secretary in lieu of such formal meetings, as identified in section I.H of the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017 (C) Capacity planning methodology (i) Development; evaluation and report The Secretary shall obtain, through a contract with an independent accounting or consulting firm, a report evaluating options and recommendations for a new methodology to accurately assess changes in the resource and capacity needs of the process for the review of human drug applications. The capacity planning methodological options and recommendations presented in such report shall utilize and be informed by personnel time reporting data as an input. The report shall be published for public comment no later than the end of fiscal year 2020. (ii) Establishment and implementation After review of the report described in clause (i) and any public comments thereon, the Secretary shall establish a capacity planning methodology for purposes of this paragraph, which shall— (I) replace the interim methodology under subparagraph (B); (II) incorporate such approaches and attributes as the Secretary determines appropriate; and (III) be effective beginning with the first fiscal year for which fees are set after such capacity planning methodology is established. (D) 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) and (b)(1)(B) (the dollar amount of the inflation adjustment for the fiscal year). (E) 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. (3) Operating reserve adjustment (A) Increase For fiscal year 2018 and subsequent fiscal years, the Secretary may, in addition to adjustments under paragraphs (1) and (2), further increase the fee revenue and fees if such an adjustment is necessary to provide for not more than 14 weeks of operating reserves of carryover user fees for the process for the review of human drug applications. (B) Decrease If the Secretary has carryover balances for such process in excess of 14 weeks of such operating reserves, the Secretary shall decrease such fee revenue and fees to provide for not more than 14 weeks of such operating reserves. (C) Notice of rationale If an adjustment under subparagraph (A) or (B) is made, the rationale for the amount of the increase or decrease (as applicable) in fee revenue and fees shall be contained in the annual Federal Register notice under paragraph (5) establishing fee revenue and fees for the fiscal year involved. (4) Additional direct cost adjustment (A) In general The Secretary shall, in addition to adjustments under paragraphs (1), (2), and (3), further increase the fee revenue and fees— (i) for fiscal year 2018, by $8,730,000; and (ii) for fiscal year 2019 and subsequent fiscal years, by the amount determined under subparagraph (B). (B) Amount The amount determined under this subparagraph is— (i) $8,730,000, multiplied by (ii) the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All Items; Annual Index) for the most recent year of available data, divided by such Index for 2016. (5) Annual fee setting The Secretary shall, not later than 60 days before the start of each fiscal year that begins after September 30, 2017— (A) establish, for the next fiscal year, human drug application fees and prescription drug program fees under subsection (a), based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection; and (B) publish such fee revenue and fees in the Federal Register. (6) Limit The total amount of fees charged, as adjusted under this subsection, for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of human drug applications. . (d) Fee waiver or reduction Section 736(d) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379h(d) (1) in paragraph (1)— (A) by inserting or (B) by striking subparagraph (C); and (C) by redesignating subparagraph (D) as subparagraph (C); (2) by striking paragraph (3) (relating to use of standard costs); (3) by redesignating paragraph (4) as paragraph (3); and (4) in paragraph (3), as so redesignated— (A) in subparagraphs (A) and (B), by striking paragraph (1)(D) paragraph (1)(C) (B) in subparagraph (B)— (i) by striking clause (ii); (ii) by striking shall pay (i) application fees shall pay application fees (iii) by striking ; and (e) Effect of failure To pay fees Section 736(e) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379h(e) all fees all such fees (f) Limitations Section 736(f)(2) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379h(f)(2) supplements, prescription drug establishments, and prescription drug products prescription drug program fees (g) Crediting and availability of fees Section 736(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379h(g) (1) in paragraph (3)— (A) by striking 2013 through 2017 2018 through 2022 (B) by striking and paragraph (4) of this subsection (2) by striking paragraph (4). (h) Orphan drugs Section 736(k) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379h(k) product and establishment fees prescription drug program fees 103. Reauthorization; reporting requirements Section 736B of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379h–2 (1) in subsection (a)(1)— (A) in the matter before subparagraph (A), by striking 2013 2018 (B) in subparagraph (A), by striking Prescription Drug User Fee Amendments of 2012 Prescription Drug User Fee Amendments of 2017 (2) in subsection (b), by striking 2013 2018 (3) in subsection (d), by striking 2017 2022 104. Sunset dates (a) Authorization Sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379g (b) Reporting Requirements Section 736B of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379h–2 (c) Previous Sunset Provision Effective October 1, 2017, subsections (a) and (b) of section 105 of the Food and Drug Administration Safety and Innovation Act ( Public Law 112–144 105. Effective date The amendments made by this title shall take effect on October 1, 2017, 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 shall be assessed for all human drug applications received on or after October 1, 2017, regardless of the date of the enactment of this Act. 106. Savings clause Notwithstanding the amendments made by this title, part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, 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, 2012, but before October 1, 2017, 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 2018. II Fees relating to devices 201. Short title; findings (a) Short Title This title may be cited as the Medical Device User Fee Amendments of 2017 (b) Findings The Congress finds that the fees authorized under the amendments made by this title will be dedicated toward expediting the process for the review of device applications and for assuring the safety and effectiveness of devices, as set forth in the goals identified for purposes of part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record. 202. Definitions Section 737 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379i (1) by redesignating paragraphs (8) through (13) as paragraphs (9) through (14), respectively; (2) by inserting after paragraph (7) the following new paragraph: (8) The term de novo classification request ; (3) in subparagraph (D) of paragraph (10) (as redesignated by paragraph (1)), by striking and submissions submissions, and de novo classification requests (4) in paragraph (11) (as redesignated by paragraph (1)), by striking 2011 2016 203. Authority to assess and use device fees (a) Types of Fees Section 738(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j(a) (1) in paragraph (1), by striking fiscal year 2013 fiscal year 2018 (2) in paragraph (2)— (A) in subparagraph (A)— (i) in the matter preceding clause (i), by striking October 1, 2012 October 1, 2017 (ii) in clause (viii), by striking 2 3.4 (iii) by adding at the end the following new clause: (xi) For a de novo classification request, a fee equal to 30 percent of the fee that applies under clause (i). ; and (B) in subparagraph (B)(v)(I), by striking or premarket notification submission premarket notification submission, or de novo classification request (b) Fee Amounts Section 738(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j(b) (b) Fee Amounts (1) In General Subject to subsections (c), (d), (e), and (h), for each of fiscal years 2018 through 2022, fees under subsection (a) shall be derived from the base fee amounts specified in paragraph (2), to generate the total revenue amounts specified in paragraph (3). (2) Base fee amounts specified For purposes of paragraph (1), the base fee amounts specified in this paragraph are as follows: Fee Type Fiscal Year 2018 Fiscal Year 2019 Fiscal Year 2020 Fiscal Year 2021 Fiscal Year 2022 Premarket Application $294,000 $300,000 $310,000 $328,000 $329,000 Establishment Registration $4,375 $4,548 $4,760 $4,975 $4,978 (3) Total revenue amounts specified For purposes of paragraph (1), the total revenue amounts specified in this paragraph are as follows: (A) $183,280,756 for fiscal year 2018. (B) $190,654,875 for fiscal year 2019. (C) $200,132,014 for fiscal year 2020. (D) $211,748,789 for fiscal year 2021. (E) $213,687,660 for fiscal year 2022. . (c) Annual Fee Setting; Adjustments Section 738(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j(c) (1) in paragraph (1), by striking 2012 2017 (2) in paragraph (2)— (A) in subparagraph (A), by striking 2014 2018 (B) by striking subparagraph (B) and inserting the following new subparagraph: (B) Applicable inflation adjustment The applicable inflation adjustment for fiscal year 2018 and each subsequent fiscal year is the product of— (i) the base inflation adjustment under subparagraph (C) for such fiscal year; and (ii) the product of the base inflation adjustment under subparagraph (C) for each of the fiscal years preceding such fiscal year, beginning with fiscal year 2016. ; (C) in subparagraph (C), in the heading, by striking to total revenue amounts (D) by amending subparagraph (D) to read as follows: (D) Adjustment to base fee amounts For each of fiscal years 2018 through 2022, the Secretary shall— (i) adjust the base fee amounts specified in subsection (b)(2) for such fiscal year by multiplying such amounts by the applicable inflation adjustment under subparagraph (B) for such year; and (ii) if the Secretary determines necessary, increase (in addition to the adjustment under clause (i)) such base fee amounts, on a uniform proportionate basis, to generate the total revenue amounts under subsection (b)(3), as adjusted for inflation under subparagraph (A). ; and (3) in paragraph (3)— (A) by striking 2014 through 2017 2018 through 2022 (B) by striking further adjusted increased (d) Small businesses; Fee Waiver and Fee Reduction Regarding Premarket Approval Fees Section 738(d) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j(d) (1) in paragraph (1), by striking specified in clauses (i) through (v) and clauses (vii), (ix), and (x) specified in clauses (i) through (vii) and clauses (ix), (x), and (xi) (2) in paragraph (2)(C)— (A) by striking supplement, or supplement, (B) by inserting , or a de novo classification request class III device (e) Small Businesses; Fee Reduction Regarding Premarket Notification Submissions Section 738(e)(2)(C) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j(e)(2)(C) 50 25 (f) Fee Waiver or Reduction (1) Repeal Section 738 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j (2) Conforming changes (A) Section 515(c)(4)(A) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360e(c)(4)(A) 738(h) 738(g) (B) Section 738 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j (i) by redesignating subsections (g) through (l) as subsections (f) through (k); (ii) in subsection (a)(2)(A), by striking (d), (e), and (f) (d) and (e) (iii) in subsection (a)(3)(A), by striking and subsection (f) (g) Effect of failure To pay fees Subsection (f)(1), as redesignated, of section 738 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j (1) by striking or periodic reporting concerning a class III device periodic reporting concerning a class III device, or de novo classification request (2) by striking all fees all such fees (h) Conditions Subsection (g)(1)(A), as redesignated, of section 738 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j $280,587,000 $320,825,000 (i) Crediting and Availability of Fees Subsection (h), as redesignated, of section 738 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j (1) in paragraph (3)— (A) by striking 2013 through 2017 2018 through 2022 (B) by striking subsection (c) subsection (c). (2) by striking paragraph (4). 204. Reauthorization; reporting requirements (a) Performance Reports Section 738A(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–1(a) (1) in paragraph (1)— (A) in subparagraph (A)— (i) by striking 2013 2018 (ii) by striking the Medical Device User Fee Amendments of 2012 the Medical Device User Fee Amendments of 2017 (B) in subparagraph (B), by striking the Medical Device User Fee Amendments Act of 2012 the Medical Device User Fee Amendments of 2017 (2) in paragraph (2), by striking 2013 through 2017 2018 through 2022 (b) Reauthorization Section 738A(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–1(b) (1) in paragraph (1), by striking 2017 2022 (2) in paragraph (5), by striking 2017 2022 205. Conformity assessment pilot program (a) In general Section 514 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360d (d) Pilot accreditation scheme for conformity assessment (1) In general The Secretary shall establish a pilot program under which— (A) testing laboratories may be accredited, by accreditation bodies meeting criteria specified by the Secretary, to assess the conformance of a device with certain standards recognized under this section; and (B) subject to paragraph (2), determinations by testing laboratories so accredited that a device conforms with such standard or standards shall be accepted by the Secretary for purposes of demonstrating such conformity under this section unless the Secretary finds that a particular such determination shall not be so accepted. (2) Secretarial review of accredited laboratory determinations The Secretary may— (A) review determinations by testing laboratories accredited pursuant to this subsection, including by conducting periodic audits of such determinations or processes of accredited bodies or testing laboratories and, following such review, taking additional measures under this Act, such as suspension or withdrawal of accreditation of such testing laboratory under paragraph (1)(A) or requesting additional information with respect to such device, as the Secretary determines appropriate; and (B) if the Secretary becomes aware of information materially bearing on safety or effectiveness of a device assessed for conformity by a testing laboratory so accredited, take such additional measures under this Act as the Secretary determines appropriate, such as suspension or withdrawal of accreditation of such testing laboratory under paragraph (1)(A), or requesting additional information with regard to such device. (3) Implementation and reporting (A) Public meeting The Secretary shall publish in the Federal Register a notice of a public meeting to be held no later than September 30, 2018, to discuss and obtain input and recommendations from stakeholders regarding the goals and scope of, and a suitable framework and procedures and requirements for, the pilot program under this subsection. (B) Pilot program guidance The Secretary shall— (i) not later than September 30, 2019, issue draft guidance regarding the goals and implementation of the pilot program under this subsection; and (ii) not later than September 30, 2021, issue final guidance with respect to the implementation of such program. (C) Pilot program initiation Not later than September 30, 2020, the Secretary shall initiate the pilot program under this subsection. (D) Report The Secretary shall make available on the website of the Food and Drug Administration an annual report on the progress of the pilot program under this subsection. (4) Sunset As of October 1, 2022— (A) the authority for accreditation bodies to accredit testing laboratories pursuant to paragraph (1)(A) shall cease to have force or effect; (B) the Secretary— (i) may not accept a determination pursuant to paragraph (1)(B) made by a testing laboratory after such date; and (ii) may accept such a determination made prior to such date; (C) except for purposes of accepting a determination described in subparagraph (B)(ii), the Secretary shall not continue to recognize the accreditation of testing laboratories accredited under paragraph (1)(A); and (D) the Secretary may take actions in accordance with paragraph (2) with respect to the determinations made prior to such date and recognition of the accreditation of testing laboratories pursuant to determinations made prior to such date. . 206. Reauthorization of review Section 523 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360m (1) in subsection (a)(3)— (A) in subparagraph (A), by striking clauses (ii) and (iii) and inserting the following: (ii) a device classified under section 513(f)(2) or designated under section 515C(d); or (iii) a device that is of a type, or subset of a type, listed as not eligible for review under subparagraph (B)(iii). ; (B) by striking subparagraph (B) and inserting the following: (B) Designation for review The Secretary shall— (i) issue draft guidance on the factors the Secretary will use in determining whether a class I or class II device type, or subset of such device types, is eligible for review by an accredited person, including— (I) the risk of the device type, or subset of such device type; and (II) whether the device type, or subset of such device type, is permanently implantable, life sustaining, or life supporting; (ii) not later than 24 months after the date on which the Secretary issues such draft guidance, finalize such guidance; and (iii) beginning on the date such guidance is finalized, designate and post on the internet website of the Food and Drug Administration, an updated list of class I and class II device types, or subsets of such device types, and the Secretary’s determination with respect to whether each such device type, or subset of a device type, is eligible or not eligible for review by an accredited person under this section based on the factors described in clause (i). ; and (C) by adding at the end the following: (C) Interim rule Until the date on which the updated list is designated and posted in accordance with subparagraph (B)(iii), the list in effect on the date of enactment the Medical Device User Fee Amendments of 2017 ; (2) in subsection (b)— (A) in paragraph (2)— (i) by striking subparagraph (D); and (ii) by redesignating subparagraph (E) as subparagraph (D); and (B) in paragraph (3)— (i) by redesignating subparagraph (E) as subparagraph (F); (ii) in subparagraph (F) (as so redesignated), by striking The operations of it will— Such person shall agree, at a minimum, to include in its request for accreditation a commitment to, at the time of accreditation, and at any time it is performing any review pursuant to this section— (iii) by inserting after subparagraph (D) the following new subparagraph: (E) The operations of such person shall be in accordance with generally accepted professional and ethical business practices. ; and (3) in subsection (c), by striking 2017 2022 207. Electronic format for submissions Section 745A(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379k–1(b) (3) Presubmissions and submissions solely in electronic format (A) In general Beginning on such date as the Secretary specifies in final guidance issued under subparagraph (C), presubmissions and submissions for devices described in paragraph (1) (and any appeals of action taken by the Secretary with respect to such presubmissions or submissions) shall be submitted solely in such electronic format as specified by the Secretary in such guidance. (B) Draft guidance The Secretary shall, not later than October 1, 2019, issue draft guidance providing for— (i) any further standards for the submission by electronic format required under subparagraph (A); (ii) a timetable for the establishment by the Secretary of such further standards; and (iii) criteria for waivers of and exemptions from the requirements of this subsection. (C) Final guidance The Secretary shall, not later than 12 months after the close of the public comment period on the draft guidance issued under subparagraph (B), issue final guidance described in clauses (i) through (iii) of such subparagraph. . 208. Savings clause 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 209. Effective date The amendments made by this title shall take effect on October 1, 2017, or the date of the enactment of this Act, whichever is later, except that fees under part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act shall be assessed for all submissions listed in section 738(a)(2)(A) of such Act received on or after October 1, 2017, regardless of the date of the enactment of this Act. 210. Sunset clause (a) Authorization Sections 737 and 738 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 739i (b) Reporting requirements Section 738A ( 21 U.S.C. 739j–1 (c) Previous Sunset Provision Effective October 1, 2017, section 207(a) of the Medical Device User Fee Amendments of 2012 ( Public Law 112–144 III Fees relating to generic drugs 301. Short title; finding (a) Short title This title may be cited as the Generic Drug User Fee Amendments of 2017 (b) Finding The Congress finds that the fees authorized by the amendments made in this title will be dedicated to human generic drug activities, as set forth in the goals identified for purposes of part 7 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record. 302. Definitions Section 744A of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–41 (1) in paragraph (1)(B), by striking application for a positron emission tomography drug. (i) for a positron emission tomography drug; or (ii) submitted by a State or Federal governmental entity for a drug that is not distributed commercially. ; (2) by redesignating paragraphs (5) through (12) as paragraphs (6) through (13), respectively; and (3) by inserting after paragraph (4) the following: (5) The term contract manufacturing organization facility . 303. Authority to assess and use human generic drug fees (a) Types of fees Section 744B(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–42(a) (1) in the matter preceding paragraph (1), by striking fiscal year 2013 fiscal year 2018 (2) in paragraph (1), by adding at the end the following: (E) Sunset This paragraph shall cease to be effective October 1, 2022. ; (3) in paragraph (2)— (A) by amending subparagraph (C) to read as follows: (C) Notice Not later than 60 days before the start of each of fiscal years 2018 through 2022, the Secretary shall publish in the Federal Register the amount of the drug master file fee established by this paragraph for such fiscal year. ; and (B) in subparagraph (E)— (i) in clause (i)— (I) by striking no later than the date (I) the date ; (II) by striking the period and inserting ; or (III) by adding at the end the following: (II) the date on which the drug master file holder requests the initial completeness assessment. ; and (ii) in clause (ii), by striking notice provided for in clause (i) or (ii) of subparagraph (C), as applicable notice provided for in subparagraph (C) (4) in paragraph (3)— (A) in the heading, by striking and prior approval supplement (B) in subparagraph (A), by striking or a prior approval supplement to an abbreviated new drug application (C) by amending subparagraphs (B) and (C) to read as follows: (B) Notice Not later than 60 days before the start of each of fiscal years 2018 through 2022, the Secretary shall publish in the Federal Register the amount of the fees under subparagraph (A) for such fiscal year. (C) Fee due date The fees required by subparagraphs (A) and (F) shall be due no later than the date of submission of the abbreviated new drug application or prior approval supplement for which such fee applies. ; (D) in subparagraph (D)— (i) in the heading, by inserting , is withdrawn prior to being received, or is no longer received received (ii) by striking The Secretary shall (i) Applications not considered to have been received and applications withdrawn prior to being received The Secretary shall refund 75 percent of the fee paid under subparagraph (A) for any abbreviated new drug application that the Secretary considers not to have been received within the meaning of section 505(j)(5)(A) for a cause other than failure to pay fees, or that has been withdrawn prior to being received within the meaning of section 505(j)(5)(A). (ii) Applications no longer received The Secretary shall refund 100 percent of the fee paid under subparagraph (A) for any abbreviated new drug application if the Secretary initially receives the application under section 505(j)(5)(A) and subsequently determines that an exclusivity period for a listed drug should have prevented the Secretary from receiving such application, such that the abbreviated new drug application is no longer received within the meaning of section 505(j)(5)(A). ; (E) in subparagraph (E), by striking or prior approval supplement (F) in the matter preceding clause (i) of subparagraph (F)— (i) by striking 2012 2017 (ii) by striking subsection (d)(3) subsection (d)(2) (5) in paragraph (4)— (A) in subparagraph (A)— (i) in the matter preceding clause (i) and in clause (iii), by striking , or intended to be identified, in at least one generic drug submission that is pending or in at least one generic drug submission that is (ii) in clause (i), by striking or intended to be identified in at least one generic drug submission that is pending or in at least one generic drug submission that is (iii) in clause (ii), by striking produces, such a is identified in at least one generic drug submission in which the facility is approved to produce one or more active pharmaceutical ingredients or in a Type II active pharmaceutical ingredient drug master file referenced in at least one such (iv) in clause (iii), by striking to fees under both such clauses only to the fee attributable to the manufacture of the finished dosage forms (B) by amending subparagraphs (C) and (D) to read as follows: (C) Notice Within the timeframe specified in subsection (d)(1), the Secretary shall publish in the Federal Register the amount of the fees under subparagraph (A) for such fiscal year. (D) Fee due date For each of fiscal years 2018 through 2022, the fees under subparagraph (A) for such fiscal year shall be due on the later of— (i) the first business day on or after October 1 of each such year; or (ii) the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such year under this section for such year. ; (6) by redesignating paragraph (5) as paragraph (6); and (7) by inserting after paragraph (4) the following: (5) Generic drug applicant program fee (A) In general A generic drug applicant program fee shall be assessed annually as described in subsection (b)(2)(E). (B) Amount The amount of fees established under subparagraph (A) shall be established under subsection (d). (C) Notice Within the timeframe specified in subsection (d)(1), the Secretary shall publish in the Federal Register the amount of the fees under subparagraph (A) for such fiscal year. (D) Fee due date For each of fiscal years 2018 through 2022, the fees under subparagraph (A) for such fiscal year shall be due on the later of— (i) the first business day on or after October 1 of each such fiscal year; or (ii) the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section for such fiscal year. . (b) Fee revenue amounts Section 744B(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–42(b) (1) in paragraph (1)— (A) in subparagraph (A)— (i) in the heading, by striking 2013 2018 (ii) by striking 2013 2018 (iii) by striking $299,000,000 $493,600,000 (iv) by striking Of that amount (B) in subparagraph (B)— (i) in the heading, by striking 2014 through 2017 2019 through 2022 (ii) by striking 2014 through 2017 2019 through 2022 (iii) by striking paragraphs (2) through (4) paragraphs (2) through (5) (iv) by striking $299,000,000 $493,600,000 (2) in paragraph (2)— (A) in the matter preceding subparagraph (A)— (i) by striking paragraph (1)(A)(ii) for fiscal year 2013 and paragraph (1)(B) for each of fiscal years 2014 through 2017 such paragraph for a fiscal year (ii) by striking through (4) through (5) (B) in subparagraph (A), by striking Six percent Five percent (C) by amending subparagraphs (B) and (C) to read as follows: (B) Thirty-three percent shall be derived from fees under subsection (a)(3) (relating to abbreviated new drug applications). (C) Twenty percent shall be derived from fees under subsection (a)(4)(A)(i) (relating to generic drug facilities). The amount of the fee for a contract manufacturing organization facility shall be equal to one-third the amount of the fee for a facility that is not a contract manufacturing organization facility. The amount of the fee for a facility located outside the United States and its territories and possessions shall be $15,000 higher than the amount of the fee for a facility located in the United States and its territories and possessions. ; (D) in subparagraph (D)— (i) by striking Fourteen percent Seven percent (ii) by striking not less than $15,000 and not more than $30,000 $15,000 (iii) by striking , as determined (E) by adding at the end the following: (E) (i) Thirty-five percent shall be derived from fees under subsection (a)(5) (relating to generic drug applicant program fees). For purposes of this subparagraph, if a person has affiliates, a single program fee shall be assessed with respect to that person, including its affiliates, and may be paid by that person or any one of its affiliates. The Secretary shall determine the fees as follows: (I) If a person (including its affiliates) owns at least one but not more than 5 approved abbreviated new drug applications on the due date for the fee under this subsection, the person (including its affiliates) shall be assessed a small business generic drug applicant program fee equal to one-tenth of the large size operation generic drug applicant program fee. (II) If a person (including its affiliates) owns at least 6 but not more than 19 approved abbreviated new drug applications on the due date for the fee under this subsection, the person (including its affiliates) shall be assessed a medium size operation generic drug applicant program fee equal to two-fifths of the large size operation generic drug applicant program fee. (III) If a person (including its affiliates) owns 20 or more approved abbreviated new drug applications on the due date for the fee under this subsection, the person (including its affiliates) shall be assessed a large size operation generic drug applicant program fee. (ii) For purposes of this subparagraph, an abbreviated new drug application shall be deemed not to be approved if the applicant has submitted a written request for withdrawal of approval of such abbreviated new drug application by April 1 of the previous fiscal year. . (c) Adjustments Section 744B(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–42(c) (1) in paragraph (1)— (A) by striking 2014 2019 (B) by inserting to equal the product of the total revenues established in such notice for the prior fiscal year multiplied a fiscal year, (C) by striking the flush text following subparagraph (C); and (2) in paragraph (2)— (A) by striking 2017 2022 (B) by striking the first 3 months of fiscal year 2018 the first 3 months of fiscal year 2023 (C) by striking Such fees may only be used in fiscal year 2018. (d) Annual fee setting Section 744B(d) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–42(d) (1) by striking paragraphs (1) and (2) and inserting the following: (1) Fiscal years 2018 through 2022 Not more than 60 days before the first day of each of fiscal years 2018 through 2022, the Secretary shall establish the fees described in paragraphs (2) through (5) of subsection (a), based on the revenue amounts established under subsection (b) and the adjustments provided under subsection (c). ; (2) by redesignating paragraph (3) as paragraph (2); and (3) in paragraph (2) (as so redesignated), in the matter preceding subparagraph (A), by striking fees under paragraphs (1) and (2) fee under paragraph (1) (e) Identification of facilities Section 744B(f) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–42(f) (1) by striking paragraph (1); (2) by redesignating paragraphs (2) through (4) as paragraphs (1) through (3), respectively; (3) in paragraph (1) (as so redesignated)— (A) by striking paragraph (4) paragraph (3) (B) by striking Such information shall Such information shall, for each fiscal year, be submitted, updated, or reconfirmed on or before June 1 of the previous fiscal year. (4) in paragraph (2), as so redesignated— (A) in the heading, by striking Contents of notice Information required to be submitted (B) in the matter preceding subparagraph (A), by striking paragraph (2) paragraph (1) (C) in subparagraph (A), by striking or intended to be identified (D) in subparagraph (D), by striking and (E) in subparagraph (E), by striking the period and inserting ; and (F) by adding at the end the following: (F) whether the facility is a contract manufacturing organization facility. . (f) Effect of failure To pay fees Section 744B(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379–42(g) (1) in paragraph (1), by adding at the end the following: This paragraph shall cease to be effective on October 1, 2022. (2) in paragraph (2)(C)(ii), by striking of 505(j)(5)(A) of section 505(j)(5)(A) (3) by adding at the end the following: (5) Generic drug applicant program fee (A) In general A person who fails to pay a fee as required under subsection (a)(5) by the date that is 20 calendar days after the due date, as specified in subparagraph (D) of such subsection, shall be subject to the following: (i) The Secretary shall place the person on a publicly available arrears list. (ii) Any abbreviated new drug application submitted by the generic drug applicant or an affiliate of such applicant shall not be received, within the meaning of section 505(j)(5)(A). (iii) All drugs marketed pursuant to any abbreviated new drug application held by such applicant or an affiliate of such applicant shall be deemed misbranded under section 502(aa). (B) Application of penalties The penalties under subparagraph (A) shall apply until the fee required under subsection (a)(5) is paid. . (g) Limitations Section 744B(h)(2) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379–42(h)(2) for Type II active pharmaceutical ingredient drug master files, abbreviated new drug applications and prior approval supplements, and generic drug facilities and active pharmaceutical ingredient facilities (h) Crediting and availability of fees Section 744B(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379–42(i) (1) in paragraph (2)— (A) by striking subparagraph (C) (relating to fee collection during first program year); (B) in subparagraph (D)— (i) in the heading, by striking in subsequent years (ii) by striking (after fiscal year 2013) (C) by redesignating subparagraph (D) as subparagraph (C); and (2) in paragraph (3), by striking fiscal years 2013 through 2017 fiscal years 2018 through 2022 (i) Information on abbreviated new drug applications owned by applicants and their affiliates Section 744B of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379–42 (o) Information on abbreviated new drug applications owned by applicants and their affiliates (1) In general By April 1 of each year, each person that owns an abbreviated new drug application, or any affiliate of such person, shall submit, on behalf of the person and its affiliates, to the Secretary a list of— (A) all approved abbreviated new drug applications owned by such person; and (B) if any affiliate of such person also owns an abbreviated new drug application, all affiliates that own any such abbreviated new drug applications and all approved abbreviated new drug applications owned by any such affiliate. (2) Format and method The Secretary shall specify in guidance the format and method for submission of lists under this subsection. . 304. Reauthorization; reporting requirements Section 744C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–43 (1) in subsection (a)— (A) by striking 2013 2018 (B) by striking Generic Drug User Fee Amendments of 2012 Generic Drug User Fee Amendments of 2017 (2) in subsection (b), by striking 2013 2018 (3) in subsection (d), by striking 2017 2022 305. Sunset dates (a) Authorization Sections 744A and 744B of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–41 (b) Reporting requirements Section 744C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–43 (c) Previous sunset provision Effective October 1, 2017, subsections (a) and (b) of section 304 of the Food and Drug Administration Safety and Innovation Act ( Public Law 112–144 306. Effective date The amendments made by this title shall take effect on October 1, 2017, 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 shall be assessed for all abbreviated new drug applications received on or after October 1, 2017, regardless of the date of the enactment of this Act. 307. Savings clause Notwithstanding the amendments made by this title, part 7 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, 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 on or after October 1, 2012, but before October 1, 2017, 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) IV Fees relating to biosimilar biological products 401. Short title; finding (a) Short Title This title may be cited as the Biosimilar User Fee Amendments of 2017 (b) Finding The Congress finds that the fees authorized by the amendments made in this title will be dedicated to expediting the process for the review of biosimilar biological product applications, including postmarket safety activities, as set forth in the goals identified for purposes of part 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record. 402. Definitions (a) Adjustment factor Section 744G(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–51(1) (1) The term adjustment factor . (b) Biosimilar biological product Section 744G(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–51(3) means a product means a specific strength of a biological product in final dosage form 403. Authority to assess and use biosimilar fees (a) Types of fees Section 744H(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–52(a) (1) in the matter preceding paragraph (1), by striking fiscal year 2013 fiscal year 2018 (2) in the heading of paragraph (1), by striking Biosimilar Biosimilar biological product (3) in paragraph (1)(A)(i), by striking (b)(1)(A) (c)(5) (4) in paragraph (1)(B)(i), by striking (b)(1)(B) for biosimilar biological product development (c)(5) for the biosimilar biological product development program (5) in paragraph (1)(B)(ii), by striking annual biosimilar biological product development program fee annual biosimilar biological product development fee (6) in paragraph (1)(B)(iii), by striking annual biosimilar development program fee annual biosimilar biological product development fee (7) in paragraph (1)(B), by adding at the end the following: (iv) Refund If a person submits a marketing application for a biosimilar biological product before October 1 of a fiscal year and such application is accepted for filing on or after October 1 of such fiscal year, the person may request a refund equal to the annual biosimilar development fee paid by the person for the product for such fiscal year. To qualify for consideration for a refund under this clause, a person shall submit to the Secretary a written request for such refund not later than 180 days after the marketing application is accepted for filing. ; (8) in paragraph (1)(C), by striking for a product effective October 1 of a fiscal year by, for a product, effective October 1 of a fiscal year, by, (9) in paragraph (1)(D)— (A) in clause (i) in the matter preceding subclause (I), by inserting , if the person seeks to resume participation in such program, pay a fee (B) in clause (i)(I), by inserting after grants a request by such person (C) in clause (i)(II), by inserting after discontinued) by such person (10) in the heading of paragraph (1)(E), by striking biosimilar development program (11) in paragraph (1)(F)— (A) in the subparagraph heading, by striking biosimilar development program fees (B) by amending clause (i) to read as follows: (i) Refunds Except as provided in subparagraph (B)(iv), the Secretary shall not refund any initial or annual biosimilar biological product development fee paid under subparagraph (A) or (B), or any reactivation fee paid under subparagraph (D). ; (12) in paragraph (2)— (A) in the paragraph heading, by striking and supplement (B) by amending subparagraphs (A) and (B) to read as follows: (A) In general Each person that submits, on or after October 1, 2017, a biosimilar biological product application shall be subject to the following fees: (i) A fee established under subsection (c)(5) for a biosimilar biological product application for which clinical data (other than comparative bioavailability studies) with respect to safety or effectiveness are required for approval. (ii) A fee established under subsection (c)(5) for a biosimilar biological product application for which clinical data (other than comparative bioavailability studies) with respect to safety or effectiveness are not required for approval. Such fee shall be equal to half of the amount of the fee described in clause (i). (B) Rule of applicability; treatment of certain previously paid fees Any person who pays a fee under subparagraph (A), (B), or (D) of paragraph (1) for a product before October 1, 2017, but submits a biosimilar biological product application for that product after such date, shall— (i) be subject to any biosimilar biological product application fees that may be assessed at the time when such biosimilar biological product application is submitted; and (ii) be entitled to no reduction of such application fees based on the amount of fees paid for that product before October 1, 2017, under such subparagraphs (A), (B), or (D). ; (C) in the heading of subparagraph (D), by striking or supplement (D) in subparagraphs (C) through (F), by striking or supplement (E) in subparagraph (D), by striking or a supplement (13) by amending paragraph (3) to read as follows: (3) Biosimilar biological product program fee (A) In general Each person who is named as the applicant in a biosimilar biological product application shall pay the annual biosimilar biological product program fee established for a fiscal year under subsection (c)(5) for each biosimilar biological product that— (i) is identified in such a biosimilar biological product application approved as of October 1 of such fiscal year; and (ii) as of October 1 of such fiscal year, does not appear on a list, developed and maintained by the Secretary, of discontinued biosimilar biological products. (B) Due date The biosimilar biological product program fee for a fiscal year shall be due on the later of— (i) the first business day on or after October 1 of each such year; or (ii) the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such year under this section. (C) One fee per product per year The biosimilar biological product program fee shall be paid only once for each product for each fiscal year. (D) Limitation A person who is named as the applicant in a biosimilar biological product application shall not be assessed more than 5 biosimilar biological product program fees for a fiscal year for biosimilar biological products identified in such biosimilar biological product application. . (b) Fee revenue amounts Subsection (b) of section 744H of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–52 (b) Fee revenue amounts (1) Fiscal year 2018 For fiscal year 2018, fees under subsection (a) shall be established to generate a total revenue amount equal to the sum of— (A) $45,000,000; and (B) the dollar amount equal to the fiscal year 2018 adjustment (as determined under subsection (c)(4)). (2) Subsequent fiscal years For each of the fiscal years 2019 through 2022, 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 (4)); (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 capacity planning adjustment for the fiscal year (as determined under subsection (c)(2)); and (D) the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(3)). (3) Allocation of revenue amount among fees; limitations on fee amounts (A) Allocation The Secretary shall determine the percentage of the total revenue amount for a fiscal year to be derived from, respectively— (i) initial and annual biosimilar development fees and reactivation fees under subsection (a)(1); (ii) biosimilar biological product application fees under subsection (a)(2); and (iii) biosimilar biological product program fees under subsection (a)(3). (B) Limitations on fee amounts Until the first fiscal year for which the capacity planning adjustment under subsection (c)(2) is effective, the amount of any fee under subsection (a) for a fiscal year after fiscal year 2018 shall not exceed 125 percent of the amount of such fee for fiscal year 2018. (C) Biosimilar biological product development fees The initial biosimilar biological product development fee under subsection (a)(1)(A) for a fiscal year shall be equal to the annual biosimilar biological product development fee under subsection (a)(1)(B) for that fiscal year. (D) Reactivation fee The reactivation fee under subsection (a)(1)(D) for a fiscal year shall be equal to twice the amount of the annual biosimilar biological product development fee under subsection (a)(1)(B) for that fiscal year. (4) Annual base revenue For purposes of paragraph (2), the dollar amount of the annual base revenue for a fiscal year shall be the dollar amount of the total revenue amount for the previous fiscal year, excluding any adjustments to such revenue amount under subsection (c)(3). . (c) Adjustments; annual fee setting Section 744H of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–52 (1) by redesignating subsections (c) through (h) as subsections (d) through (i), respectively; (2) in subsections (a)(2)(F) and (h) (as redesignated by paragraph (1)), by striking subsection (c) subsection (d) (3) in subsection (a)(4)(A), by striking subsection (b)(1)(F) subsection (c)(5) (4) by inserting after subsection (b) the following: (c) Adjustments; annual fee setting (1) Inflation adjustment (A) In general For purposes of subsection (b)(2)(B), the dollar amount of the inflation adjustment to the annual base revenue for each fiscal year shall be equal to the product of— (i) such annual base revenue for the fiscal year under subsection (b); and (ii) the inflation adjustment percentage under subparagraph (B). (B) Inflation adjustment percentage The inflation adjustment percentage under this subparagraph for a fiscal year is equal to the sum of— (i) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years, multiplied by the proportion of personnel compensation and benefits costs to total costs of the process for the review of biosimilar biological product applications (as defined in section 744G(13)) for the first 3 years of the preceding 4 fiscal years; and (ii) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of the process for the review of biosimilar biological product applications (as defined in section 744G(13)) for the first 3 years of the preceding 4 fiscal years. (2) Capacity planning adjustment (A) In general Beginning with the fiscal year described in subparagraph (B)(ii)(II), 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 to reflect changes in the resource capacity needs of the Secretary for the process for the review of biosimilar biological product applications. (B) Capacity planning methodology (i) Development; evaluation and report The Secretary shall obtain, through a contract with an independent accounting or consulting firm, a report evaluating options and recommendations for a new methodology to accurately assess changes in the resource and capacity needs of the process for the review of biosimilar biological product applications. The capacity planning methodological options and recommendations presented in such report shall utilize and be informed by personnel time reporting data as an input. The report shall be published for public comment not later than September 30, 2020. (ii) Establishment and implementation After review of the report described in clause (i) and receipt and review of public comments thereon, the Secretary shall establish a capacity planning methodology for purposes of this paragraph, which shall— (I) incorporate such approaches and attributes as the Secretary determines appropriate; and (II) be effective beginning with the first fiscal year for which fees are set after such capacity planning methodology is established. (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)(2)(A) (the annual base revenue for the fiscal year) and (b)(2)(B) (the dollar amount of the inflation adjustment for the fiscal year). (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. (3) Operating reserve adjustment (A) Interim application; fee reduction Until the first fiscal year for which the capacity planning adjustment under paragraph (2) is effective, the Secretary may, in addition to the adjustment under paragraph (1), reduce the fee revenue and fees under this section for a fiscal year as the Secretary determines appropriate for long-term financial planning purposes. (B) General application and methodology Beginning with the first fiscal year for which the capacity planning adjustment under paragraph (2) is effective, the Secretary may, in addition to the adjustments under paragraphs (1) and (2)— (i) reduce the fee revenue and fees under this section as the Secretary determines appropriate for long-term financial planning purposes; or (ii) increase the fee revenue and fees under this section if such an adjustment is necessary to provide for not more than 21 weeks of operating reserves of carryover user fees for the process for the review of biosimilar biological product applications. (C) Federal register notice If an adjustment under subparagraph (A) or (B) is made, the rationale for the amount of the increase or decrease (as applicable) in fee revenue and fees shall be contained in the annual Federal Register notice under paragraph (5) establishing fee revenue and fees for the fiscal year involved. (4) Fiscal year 2018 adjustment (A) In general For fiscal year 2018, the Secretary shall adjust the fee revenue and fees under this section in such amount (if any) as needed to reflect an updated assessment of the workload for the process for the review of biosimilar biological product applications. (B) Methodology The Secretary shall publish under paragraph (5) a description of the methodology used to calculate the fiscal year 2018 adjustment under this paragraph in the Federal Register notice establishing fee revenue and fees for fiscal year 2018. (C) Limitation No adjustment under this paragraph shall result in an increase in fee revenue and fees under this section in excess of $9,000,000. (5) Annual fee setting For fiscal year 2018 and each subsequent fiscal year, the Secretary shall, not later than 60 days before the start of each such fiscal year— (A) establish, for the fiscal year, initial and annual biosimilar biological product development fees and reactivation fees under subsection (a)(1), biosimilar biological product application fees under subsection (a)(2), and biosimilar biological product program fees under subsection (a)(3), based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection; and (B) publish such fee revenue and fees in the Federal Register. (6) Limit The total amount of fees assessed for a fiscal year under this section may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of biosimilar biological product applications. . (d) Application fee waiver for small business Subsection (d)(1) of section 744H of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–52 (1) by striking subparagraph (B); (2) by striking shall pay— application fees shall pay application fees (3) by striking ; and (e) Effect of failure To pay fees Subsection (e) of section 744H of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–52 all fees all such fees (f) Crediting and availability of fees Subsection (f) of section 744H of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–52 (1) in paragraph (2)— (A) by striking subparagraph (C) (relating to fee collection during first program year) and inserting the following: (C) Compliance The Secretary shall be considered to have met the requirements of subparagraph (B) in any fiscal year if the costs described in such subparagraph are not more than 15 percent below the level specified in such subparagraph. ; and (B) in subparagraph (D)— (i) in the heading, by striking in subsequent years (ii) by striking (after fiscal year 2013) (2) in paragraph (3), by striking 2013 through 2017 2018 through 2022 404. Reauthorization; reporting requirements Section 744I of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–53 (1) in subsection (a)— (A) by striking 2013 2018 (B) by striking Biosimilar User Fee Act of 2012 Biosimilar User Fee Amendments of 2017 (2) in subsection (b), by striking 2013 2018 (3) by striking subsection (d); (4) by redesignating subsection (e) as subsection (d); and (5) in subsection (d), as so redesignated, by striking 2017 2022 405. Sunset dates (a) Authorization Sections 744G and 744H of the Federal Food, Drug, and Cosmetic Act, as amended by section 403 of this Act, shall cease to be effective October 1, 2022. (b) Reporting Requirements Section 744I of the Federal Food, Drug, and Cosmetic Act, as amended by section 404 of this Act, shall cease to be effective January 31, 2023. (c) Previous Sunset Provision (1) In general Effective October 1, 2017, section 404 of the Food and Drug Administration Safety and Innovation Act ( Public Law 112–144 (2) Conforming amendment The Food and Drug Administration Safety and Innovation Act ( Public Law 112–144 406. Effective date The amendments made by this title shall take effect on October 1, 2017, 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 shall be assessed for all biosimilar biological product applications received on or after October 1, 2017, regardless of the date of the enactment of this Act. 407. Savings clause Notwithstanding the amendments made by this title, part 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, 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, 2012, but before October 1, 2017, with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2018. V Reauthorizations and improvements related to drugs 501. Reauthorization of provision relating to exclusivity of certain drugs containing single enantiomers Section 505(u)(4) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(u)(4) 2017 2022 502. Reauthorization of orphan grants program Section 5(c) of the Orphan Drug Act ( 21 U.S.C. 360ee(c) 2013 through 2017 2018 through 2022 503. Reauthorization of pediatric study of drugs Section 409I(e)(1) of the Public Health Service Act ( 42 U.S.C. 284m(e)(1) 2013 through 2017 2018 through 2022 504. Protecting and strengthening the drug supply chain (a) Diverted drugs Paragraph (1) of section 801(d) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381(d) (1) by striking (d)(1) Except as (d)(1)(A) Except as (2) by adding at the end the following: (B) Except as authorized by the Secretary in the case of a drug that appears on the drug shortage list in effect under section 506E, no drug that would be subject to section 503(b), and which is manufactured outside the United States and intended by the manufacturer or labeled to be marketed outside the United States, may be imported into the United States for sale or commercial use. . (b) Counterfeit drugs Subsection (b) of section 303 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 333 (8) Notwithstanding subsection (a), any person who violates section 301(i)(3) by knowingly making, selling or dispensing, or holding for sale or dispensing, a counterfeit drug shall be imprisoned for not more than 10 years or fined in accordance with title 18, United States Code, or both. . 505. Sense of Congress on lowering the cost of prescription drugs It is the sense of the Congress that the Secretary of Health and Human Services should commit to engaging with the House of Representatives and the Senate to take administrative actions and enact legislative changes that— (1) will lower the cost of prescription drugs for consumers and reduce the burden of such cost on taxpayers; and (2) in lowering such cost, will— (A) balance the need to encourage innovation with the need to improve affordability; and (B) strive to increase competition in the pharmaceutical market, prevent anticompetitive behavior, and promote the timely availability of affordable, high-quality generic drugs and biosimilars. VI Device Inspection and regulatory improvements A Improving the process for inspections of device establishments 601. Risk-based inspections for devices Paragraph (2) of section 510(h) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(h) (2) Risk-based schedule for devices (A) In general The Secretary, acting through one or more officers or employees duly designated by the Secretary, shall inspect establishments described in paragraph (1) that are engaged in the manufacture, propagation, compounding, or processing of a device or devices (referred to in this subsection as device establishments (B) Factors and considerations In establishing the risk-based schedule under subparagraph (A), the Secretary shall— (i) apply, to the extent applicable for device establishments, the factors identified in paragraph (4); and (ii) consider the participation of the device establishment, as applicable, in international device audit programs in which the United States participates or which the United States recognizes for purposes of inspecting device establishments. . 602. Recognition of foreign government inspections Subsection (a)(1) of section 809 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 384e(a)(1) or 510(h)(2) (as applicable) 603. Improvements to inspections process for device establishments (a) In general Section 704 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 374 (h) (1) In the case of inspections other than for-cause inspections, the Secretary shall review processes and standards applicable to inspections of domestic and foreign device establishments in effect as of the date of the enactment of this subsection, and update such processes and standards through the adoption of uniform processes and standards applicable to such inspections. Such processes and standards shall provide for— (A) exceptions to such processes and standards, as appropriate; (B) announcing the inspection of the establishment within a reasonable time before such inspection occurs, including by providing to the owner, operator, or agent in charge of the establishment a notification regarding the type and nature of the inspection; (C) a reasonable estimate of the timeframe for the inspection, an opportunity for advance communications between the officers or employees carrying out the inspection under subsection (a)(1) and the owner, operator, or agent in charge of the establishment concerning appropriate working hours during the inspection, and, to the extent feasible, advance notice of some records that will be requested in order to expedite the inspection; and (D) regular communications during the inspection with the owner, operator, or agent in charge of the establishment regarding inspection status, which may be recorded by either party with advance notice and mutual consent. (2) (A) The Secretary shall, with respect to a request described in subparagraph (B), provide nonbinding feedback with respect to such request not later than 45 days after the Secretary receives such request. (B) A request described in this subparagraph is a request for feedback— (i) that is made by the owner, operator, or agent in charge of such establishment in a timely manner; and (ii) with respect to actions proposed to be taken by a device establishment in a response to a report received by such establishment pursuant to subsection (b) that involve a public health priority, that implicate systemic or major actions, or relate to emerging safety issues (as determined by the Secretary). (3) Nothing in this subsection limits the authority of the Secretary to conduct inspections otherwise permitted under this Act in order to ensure compliance with this Act. . (b) Guidance (1) Draft guidance Not later than 18 months after the date of enactment of this section, the Secretary of Health and Human Services shall issue draft guidance that— (A) specifies how the Food and Drug Administration will implement the process described in paragraph (1) of subsection (h) of section 704 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 374 (B) provides for standardized methods for communications described in such paragraphs; (C) establishes, with respect to inspections of both domestic and foreign device establishments (as referred to in section 510(h)(2) of the Federal Food, Drug, and Cosmetic Act, as amended by subsection (a)), a standard timeframe for such inspections— (i) that occurs over consecutive days; and (ii) to which each investigator conducting such an inspection shall adhere unless the investigator identifies to the establishment involved a reason that more time is needed to conduct such investigation; and (D) identifies practices for investigators and device establishments to facilitate the continuity of inspections of such establishments. (2) Final guidance Not later than 1 year after providing notice and opportunity for public comment on the draft guidance issued under paragraph (1), the Secretary of Health and Human Services shall issue final guidance to implement subsection (h) of section 704 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 374 604. Certificates to foreign governments for devices (a) In general Subsection (e)(4) of section 801 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381(e)(4) (1) by adding at the end the following: (E) (i) If the Secretary denies a request made under subparagraph (A)(ii) for certification with respect to a device, the Secretary shall provide, in writing, to the person seeking such certification the basis for such denial, and specifically identify the finding upon which such denial is based. (ii) If the denial of a request as described in clause (i) is based on— (I) grounds other than an injunction proceeding pursuant to section 302, seizure action pursuant to section 304, or a recall designated Class I or Class II pursuant to part 7, title 21, Code of Federal Regulations, and (II) an establishment being considered out of compliance with part 820, title 21, Code of Federal Regulations, the Secretary shall provide a substantive summary of the specific grounds for noncompliance so identified, if such grounds have not been previously communicated to the manufacturer. (iii) With respect to a device manufactured in an establishment that has received a report under section 704(b), the Secretary shall not deny a request for certification under subparagraph (A)(ii) based exclusively on the issuance of that report if the owner, operator, or agent in charge of such establishment has agreed to a plan of correction in response to such report. (F) (i) The Secretary shall provide a process for a person who is denied a certification as described in subparagraph (E)(i) to request a review that conforms to the standards of section 517A(b). (ii) Notwithstanding any previous review conducted pursuant to clause (i), a person who has been denied a certification for a device as described in subparagraph (E)(i) may, at any time, request a review of that denial in order to present new information relating to actions taken by such person to address the reasons identified by the Secretary for such denial, including evidence that corrective actions are being or have been implemented to address the grounds for noncompliance identified by the Secretary under subparagraph (E)(ii). (G) (i) This paragraph applies to requests for certification on behalf of any device establishment registered under section 510, whether the establishment is located in the United States or another country. (ii) The Secretary may charge a fee for the issuance of a certification described in clause (i), and such fee is subject to the same conditions and requirements as a fee charged under subparagraph (B) for a certification issued under such subparagraph. ; and (2) by moving the margins of subparagraphs (C) and (D) 4 ems to the left. (b) Guidance 21 U.S.C. 381(e)(4) 605. Facilitating international harmonization Section 704(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 374(g) (15) Notwithstanding any other provision of this subsection, for purposes of conducting inspections of establishments that manufacture, prepare, propagate, compound, or process devices except types of devices licensed under section 351 of the Public Health Service Act, which inspections are required under section 510(h) or are inspections of such establishments required to register pursuant to section 510(i), the Secretary may recognize auditing organizations that are recognized by organizations established by governments to facilitate international harmonization. Nothing in this paragraph affects the authority of the Secretary to inspect any device establishment pursuant to this Act. Nothing in this paragraph affects the authority of the Secretary to determine the official classification of an inspection. . 606. Reauthorization of inspection program Section 704(g)(11) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 374(g)(11) October 1, 2017 October 1, 2022 B Other provisions 611. Reauthorization of pediatric humanitarian device exceptions Section 520(m)(6)(A)(iv) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360j(m)(6)(A)(iv) 2017 2022 612. Reauthorization of pediatric device consortia Section 305(e) of the Pediatric Medical Device Safety and Improvement Act of 2007 ( Public Law 110–85 42 U.S.C. 282 2013 through 2017 2018 through 2022 613. Regulation of over-the-counter hearing aids (a) In general Section 520 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360j (p) Regulation of Over-the-Counter hearing aids (1) Definition (A) In this subsection, the term over-the-counter hearing aid (i) that uses the same fundamental scientific technology as air conduction hearing aids (as defined in section 874.3300 of title 21, Code of Federal Regulations) (or any successor regulation) or wireless air conduction hearing aids (as defined in section 874.3305 of title 21, Code of Federal Regulations) (or any successor regulation); (ii) that is intended to be used by adults over the age of 18 to compensate for perceived mild to moderate hearing impairment; (iii) that, through tools, tests, or software, allows the user to control the over-the-counter hearing aid and customize it to the user’s hearing needs; (iv) that may— (I) use wireless technology; or (II) include tests for self-assessment of hearing loss; and (v) that is available over-the-counter, without the supervision, prescription, or other order, involvement, or intervention of a licensed person, to consumers through in-person transactions, by mail, or online. (B) Such term does not include a personal sound amplification product intended to amplify sound for nonhearing impaired consumers in situations including hunting and bird-watching. (2) Regulation An over-the-counter hearing aid shall be subject to the regulations promulgated in accordance with section 613(b) of the FDA Reauthorization Act of 2017 . (b) Regulations To establish category (1) In general The Secretary of Health and Human Services (referred to in this section as the Secretary 21 U.S.C. 360j (2) Requirements In promulgating the regulations under paragraph (1), the Secretary shall— (A) include requirements that provide reasonable assurances of the safety and efficacy of over-the-counter hearing aids; (B) include requirements that establish or adopt output limits appropriate for over-the-counter hearing aids; (C) include requirements for appropriate labeling of the over-the-counter hearing aid, including requirements that such labeling include a conspicuous statement that the device is only intended for adults over the age of 18, information on how consumers may report adverse events, information on any contraindications, conditions, or symptoms of medically treatable causes of hearing loss, and advisements to consult promptly with a licensed physician; and (D) describe the requirements under which the sale of over-the-counter hearing aids is permitted, without the supervision, prescription, or other order, involvement, or intervention of a licensed person, to consumers through in-person transactions, by mail, or online. (3) Premarket notification The Secretary shall make findings under section 510(m) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(m) 21 U.S.C. 360j (4) Effect on state law No State or local government shall establish or continue in effect any law, regulation, order, or other requirement specifically related to hearing products that would restrict or interfere with the servicing, marketing, sale, dispensing, use, customer support, or distribution of over-the-counter hearing aids (as defined in section 520(p) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360j (5) No effect on private remedies Nothing in this section shall be construed to modify or otherwise affect the ability of any person to exercise a private right of action under any State or Federal product liability, tort, warranty, contract, or consumer protection law. (c) New guidance issued Not later than the date on which final regulations are issued under subsection (b), the Secretary shall update and finalize the draft guidance of the Department of Health and Human Services entitled Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products 21 U.S.C. 321 (d) Report Not later than 2 years after the date on which the final regulations described in subsection (b)(1) are issued, the Secretary of Health and Human Services shall submit to Congress a report analyzing any adverse events relating to over-the-counter hearing aids (as defined in subsection (p)(1) of section 520 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360j 614. Report on ensuring quality, safety, and continued effectiveness of devices that have been serviced (a) In general Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, 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 how the Food and Drug Administration intends to ensure the quality, safety, and continued effectiveness of devices (as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301(h) (b) Contents The report submitted under subsection (a) shall contain— (1) the status of, and findings to date with respect to, the notice entitled Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers; Request for Comments (2) a description of the statutory or regulatory authority of the Food and Drug Administration used to oversee and regulate servicing conducted with respect to devices; (3) details on how the Food and Drug Administration intends to protect the public health by ensuring consistent quality, safety, and continued effectiveness of devices with respect to which servicing has been performed by any entity engaging in such servicing; (4) information on how the Food and Drug Administration can better understand the device servicing industry, including the size, scope, location, and composition of entities performing such servicing and the rate of adverse events related to such servicing; (5) information regarding the current regulation by States, the Joint Commission, or other regulatory bodies of servicing conducted with respect to devices by all entities, including original equipment manufacturers, third-party entities, and hospitals; and (6) any additional information determined by the Secretary (acting through the Commissioner) to be relevant to ensuring the quality, safety, and continued effectiveness of devices with respect to which servicing has been performed, including whether additional Federal statutory authority is necessary to ensure such quality, safety, and continued effectiveness. (c) Servicing defined In this section, the term servicing 615. Device pilot projects to generate reliable and timely safety and active surveillance data (a) In general Section 519 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360i (i) Pilot projects To generate reliable and timely safety and active surveillance data (1) In general The Secretary shall, not later than one year after the date of the enactment of the FDA Reauthorization Act of 2017 (A) The project is designed to efficiently generate reliable and timely safety and active surveillance data for use by the Secretary or manufacturers of the devices that are involved in the pilot project. (B) The project informs, to the extent applicable, the development of methods, systems, data criteria, and programs that could be used to support safety and active surveillance activities for any device. (C) The project shall be designed and conducted in coordination with a comprehensive system for evaluating device technology that operates under a governing board with appropriate representation of stakeholders, including patient groups and device manufacturers. (D) The project uses electronic health data including, as appropriate, claims data, patient survey data, and any other data, as the Secretary determines appropriate. (E) The project prioritizes devices and device types that meet one or more of the following criteria: (i) Devices and device types for which the collection and analysis of real world evidence regarding a device’s safety and effectiveness is likely to advance public health. (ii) Devices and device types that are widely used. (iii) Devices and device types, the failure of which has significant health consequences. (iv) Devices and device types for which the Secretary— (I) has received public recommendations in accordance with paragraph (2)(B); and (II) has determined to meet one of the criteria under clause (i), (ii), or (iii) and is appropriate for such a pilot project. (2) Participation The Secretary shall establish the conditions and processes— (A) under which a manufacturer of a device may voluntarily participate in a pilot project described in paragraph (1); and (B) for facilitating public recommendations for devices to be prioritized under such a pilot project, including requirements for the data necessary to support such a recommendation. (3) Continuation of ongoing projects The Secretary may continue or expand projects, with respect to providing timely and reliable information on the safety and effectiveness of devices approved under section 515, cleared under section 510(k), or classified under section 513(f)(2), that are being carried out as of the date of the enactment of the FDA Reauthorization Act of 2017 (A) to ensure such projects meet the requirements of subparagraphs (A) through (E) of paragraph (1); and (B) to increase the voluntary participation in such projects of manufacturers of devices and facilitate public recommendations for any devices prioritized under such a project. (4) Implementation (A) Contracting authority The Secretary may carry out a pilot project meeting the criteria specified in subparagraphs (A) through (E) of paragraph (1) or a project continued or expanded under paragraph (3) by entering into contracts, cooperative agreements, grants, or other appropriate agreements with public or private entities that have a significant presence in the United States and meet the following conditions: (i) If such an entity is a component of another organization, the entity and the organization have established an agreement under which appropriate security measures are implemented to maintain the confidentiality and privacy of the data described in paragraph (1)(D) and such agreement ensures that the entity will not make an unauthorized disclosure of such data to the other components of the organization in breach of requirements with respect to confidentiality and privacy of such data established under such security measures. (ii) In the case of the termination or nonrenewal of such a contract, cooperative agreement, grant, or other appropriate agreement, the entity or entities involved shall comply with each of the following: (I) The entity or entities shall continue to comply with the requirements with respect to confidentiality and privacy referred to in clause (i) under this subparagraph with respect to all data disclosed to the entity under such an agreement. (II) The entity or entities shall return any data disclosed to such entity pursuant to this subsection and to which it would not otherwise have access or, if returning such data is not practicable, destroy the data. (iii) The entity or entities shall have one or more qualifications with respect to— (I) research, statistical, epidemiologic, or clinical capability and expertise to conduct and complete the activities under this subsection, including the capability and expertise to provide the Secretary access to de-identified data consistent with the requirements of this subsection; (II) an information technology infrastructure to support electronic data and operational standards to provide security for such data, as appropriate; (III) experience with, and expertise on, the development of research on, and surveillance of, device safety and effectiveness using electronic health data; or (IV) such other expertise which the Secretary determines necessary to carry out such a project. (B) Review of contract in the event of a merger or acquisition The Secretary shall review any contract, cooperative agreement, grant, or other appropriate agreement entered into under this paragraph with an entity meeting the conditions specified in subparagraph (A) in the event of a merger or acquisition of the entity in order to ensure that the requirements specified in this subsection will continue to be met. (5) Compliance with requirements for records or reports on devices The participation of a manufacturer in pilot projects under this subsection shall not affect the eligibility of such manufacturer to participate in any quarterly reporting program with respect to devices carried out under section 519 or 522. The Secretary may determine that, for a specified time period to be determined by the Secretary, a manufacturer’s participation in a pilot project under this subsection or a project continued or expanded under paragraph (3) may meet the applicable requirements of section 519 or 522, if— (A) the project has demonstrated success in capturing relevant adverse event information; and (B) the Secretary has established procedures for making adverse event and safety information collected from such project public, to the extent possible. (6) Privacy requirements With respect to the disclosure of any health information collected through a project conducted under this subsection— (A) individually identifiable health information so collected shall not be disclosed when presenting any information from such project; and (B) any such disclosure shall be made in compliance with regulations issued pursuant to section 264(c) of the Health Insurance Portability and Accountability Act of 1996 ( 42 U.S.C. 1320d–2 (7) Limitations (A) In general No pilot project under this subsection undertaken in coordination with the comprehensive system described in paragraph (1)(C), shall allow for an entity participating in such program, other than the Secretary or the Secretary’s designee, to make determinations of safety or effectiveness, or substantial equivalence, for purposes of the Act. (B) No use of fees Pilot projects initiated under this subsection may not primarily utilize funds collected pursuant to the Medical Device User Fee Amendments of 2017. (8) Other projects required To comply Paragraphs (1)(B), (4)(A)(i), (4)(A)(ii), (5), and (6) shall apply with respect to any pilot program undertaken in coordination with the comprehensive system described in paragraph (1)(C) that relates to the use of real world evidence for devices in the same manner and to the same extent as such paragraphs apply with respect to pilot projects conducted under this subsection. (9) Report to congress Not later than 18 months after the date of enactment of this Act, and annually 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 containing a description of the pilot projects being conducted under this subsection and projects continued or expanded pursuant to paragraph (3), including for each such project— (A) how the project is being implemented in accordance with paragraph (4), including how such project is being implemented through a contract, cooperative agreement, grant, or other appropriate agreement, if applicable; (B) the number of manufacturers that have agreed to participate in such project; (C) the data sources used to conduct such project; (D) the devices or device categories involved in such project; (E) the number of patients involved in such project; and (F) the findings of the project in relation to device safety, including adverse events, malfunctions, and other safety information. (10) Sunset The Secretary may not carry out a pilot project initiated by the Secretary under this subsection after October 1, 2022. . (b) Report Not later than January 31, 2021, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, may 21 U.S.C. 360i (1) for purposes of informing premarket and postmarket decisionmaking for multiple device types; and (2) to determine whether the methods, systems, and programs carried out through such pilot projects efficiently generate reliable and timely evidence about the effectiveness of the surveillance of devices with respect to safety. 616. Risk-based classification of accessories (a) In general Subsection (f) of section 513 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360c (6) (A) Subject to the succeeding subparagraphs of this paragraph, the Secretary shall, by written order, classify an accessory under this section based on the risks of the accessory when used as intended and the level of regulatory controls necessary to provide a reasonable assurance of safety and effectiveness of the accessory, notwithstanding the classification of any other device with which such accessory is intended to be used. (B) The classification of any accessory distinct from another device by regulation or written order issued prior to December 13, 2016, shall continue to apply unless and until the accessory is reclassified by the Secretary, notwithstanding the classification of any other device with which such accessory is intended to be used. Nothing in this section shall preclude the Secretary’s ability to initiate the classification of an accessory through regulation or written order, as appropriate. (C) (i) In the case of an accessory that has been granted marketing authorization as part of a submission under section 515(c), 510(k), or paragraph (2) of this subsection with another device with which such accessory is intended to be used, and with respect to which the Secretary has issued a written order classifying such accessory type distinct from another device in accordance with subparagraph (A), the manufacturer or importer of such accessory may, in lieu of submitting a request for classification of such accessory, submit a written request to the Secretary identifying such classification. A request under this clause shall include such information to support the request as may be specified by the Secretary. (ii) A request under clause (i) shall include a recommendation for the proper classification of the accessory pursuant to subparagraph (A), and shall include such information as may be necessary for the Secretary to evaluate, based on the least burdensome approach, the appropriate class for the accessory under subsection (a). (iii) The Secretary shall respond to a request under clause (i) within 90 calendar days by granting or denying the request for reclassification of the accessory. (iv) Within 30 calendar days after granting a request submitted under clause (i), the Secretary shall publish a notice in the Federal Register announcing such response. (v) A written notification that the Secretary disagrees with the classification recommended in a request pursuant to clause (ii) shall include a detailed description and justification for the determination to disagree. (D) (i) In the case of a device intended to be used with an accessory, where the accessory has been included in an application for premarket approval of such device under section 515 or a report under section 510(k) for clearance of such device and the Secretary has not classified such accessory distinctly from another device in accordance with subparagraph (A), the person filing the application or report (as applicable) at the time such application or report is filed— (I) may include a written request for the proper classification of the accessory pursuant to subparagraph (A); (II) shall include in any such request such information as may be necessary for the Secretary to evaluate, based on the least burdensome approach, the appropriate class for the accessory under subsection (a); and (III) shall, if the request under subclause (I) is requesting classification of the accessory in class II, include in the application an initial draft proposal for special controls, if special controls would be required pursuant to subsection (a)(1)(B). (ii) The Secretary’s response under section 515(d) or section 510(n) (as applicable) to an application or report described in clause (i) shall also contain the Secretary’s granting or denial of the request for classification of the accessory involved. (iii) The Secretary’s evaluation of an accessory under clause (i) shall constitute an order establishing a new classification for such accessory for the specified intended use or uses of such accessory and for any accessory with the same intended use or uses as such accessory. (E) For accessories that have been granted marketing authorization as part of a submission for another device with which the accessory involved is intended to be used, through an application for such other device under section 515(c), a report under section 510(k), or a request for classification under paragraph (2) of this subsection, and that have not been classified by the Secretary based on the risks and appropriate level of regulatory controls in accordance with subparagraph (A): (i) Not later than the date that is one year after the date of enactment of the FDA Reauthorization Act of 2017 and at least once every 5 years thereafter, and as the Secretary otherwise deems appropriate, pursuant to this paragraph, the Secretary shall publish in the Federal Register a notice proposing a list of such accessories that the Secretary believes may be suitable for a distinct classification in class I and the proposed regulations for such classifications. In developing such lists, the Secretary shall consider recommendations from sponsors of device submissions and other stakeholders for accessories to be included on such lists. The notices shall provide for a period of not less than 60 calendar days for public comment. Within 180 days after the end of the comment period, the Secretary shall publish in the Federal Register a final action classifying such suitable accessories into class I. (ii) A manufacturer or importer of an accessory that has been granted such marketing authorization may submit to the Secretary a written request for the appropriate classification of the accessory based on the risks and appropriate level of regulatory controls as described in subparagraph (A) or (C), and shall, if the request is requesting classification of the accessory in class II, include in the submission an initial draft proposal for special controls, if special controls would be required pursuant to subsection (a)(1)(B). Such request shall include such information as may be necessary for the Secretary to evaluate, based on the least burdensome approach, the appropriate class for the accessory under subsection (a). The Secretary shall provide an opportunity for a manufacturer or importer to meet with appropriate personnel of the Food and Drug Administration to discuss the appropriate classification of such accessory prior to submitting a written request under this clause for classification of the accessory. (iii) The Secretary shall respond to a request made under clause (ii) not later than 90 calendar days after receiving such submission by granting or denying the request for classification of the accessory, and the Secretary shall by written order classify such accessory or deny the request. If the Secretary does not agree with the recommendation for classification submitted by the manufacturer or importer, the response shall include a detailed description and justification for such determination. Within 30 calendar days after granting such a request, the Secretary shall publish a notice in the Federal Register announcing such response. (F) Nothing in this paragraph may be construed as precluding a manufacturer of an accessory of a new type from using the classification process described in subsection (f)(2) to obtain classification of such accessory in accordance with the criteria and requirements set forth in that subsection. . (b) Conforming change Section 513(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360c(b) (c) Effective date The amendments made by subsections (a) and (b) shall take effect on the date that is 60 days after the date of enactment of this Act. VII Generic Drug Access and Competition 701. Competitive generic therapies (a) In general Chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 351 506H. Competitive generic therapies (a) In general The Secretary shall, at the request of the sponsor of a drug that is designated as a competitive generic therapy pursuant to subsection (b), expedite the development and review of such drug pursuant to section 505(j). (b) Designation process (1) Request The sponsor of a drug may request the Secretary to designate the drug as a competitive generic therapy. (2) Timing A request under paragraph (1) may be made concurrently with, or at any time prior to, the submission of an abbreviated new drug application for the drug under section 505(j). (3) Criteria A drug is eligible for designation as a competitive generic therapy under this section if the Secretary determines that there is inadequate generic competition. (4) Designation Not later than 60 calendar days after the receipt of a request under paragraph (1), the Secretary shall— (A) determine whether the drug that is the subject of the request meets the criteria described in paragraph (3); and (B) if the Secretary finds that the drug meets such criteria, designate the drug as a competitive generic therapy. (c) Actions In expediting the development and review of a drug under subsection (a), the Secretary shall, as requested by the sponsor, take actions including the following: (1) Hold meetings with the sponsor and the review team throughout the development of the drug prior to submission of the application for such drug under section 505(j). (2) Provide timely advice to, and interactive communication with, the sponsor regarding the development of the drug to ensure that the development program to gather the data necessary for approval is as efficient as practicable. (3) Involve senior managers and experienced review staff, as appropriate, in a collaborative, coordinated review, including with respect to drug-device combination products and other complex products. (4) Assign a cross-disciplinary project lead for the Food and Drug Administration review team— (A) to facilitate an efficient review of the development program and application, including manufacturing inspections; and (B) to serve as a scientific liaison between the review team and the sponsor. (d) Definitions In this section: (1) The term generic drug (2) The term inadequate generic competition (A) the reference listed drug; or (B) a generic drug with the same reference listed drug as the drug for which designation as a competitive generic therapy is sought. (3) The term reference listed drug . (b) Guidance; amended regulations (1) In general (A) Issuance The Secretary of Health and Human Services shall— (i) not later than 18 months after the date of enactment of this Act, issue draft guidance on the provisions of section 506H of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a); and (ii) not later than 1 year after the close of the comment period for the draft guidance, issue final guidance on such provisions. (B) Contents The guidance issued under this subsection shall— (i) specify the process and criteria by which the Secretary makes a designation under section 506H of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a); (ii) specify the actions the Secretary will take to expedite the development and review of a competitive generic therapy pursuant to such a designation; and (iii) include good review management practices for competitive generic therapies. (2) Amended regulations (A) In general If the Secretary of Health and Human Services determines that it is necessary to amend the regulations under title 21, Code of Federal Regulations, in order to implement section 506H of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), the Secretary shall amend such regulations not later than 2 years after the date of enactment of this Act. (B) Procedure In carrying out subparagraph (A), and in issuing any other regulations to implement such section 506H, the Secretary shall— (i) issue a notice of proposed rulemaking that includes the proposed regulation; (ii) provide a period of not less than 60 days for comments on the proposed regulation; and (iii) publish the final regulation not less than 30 days before the effective date of the regulation. 702. Enhancing regulatory transparency to enhance generic competition Section 505(j) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 (11) Upon the request of an applicant regarding one or more specified pending applications under this subsection, the Secretary shall— (A) by telephone or electronic mail, provide review status updates; and (B) indicate in such updates the categorical status of the applications by each relevant review discipline. . 703. Incentivizing competitive generic therapy development Section 505(j)(5) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(5) (1) in subparagraph (B), by adding at the end the following: (v) 180-day exclusivity period for competitive generic therapies (I) Effectiveness of application Subject to subparagraph (D)(iv), if the application is for a drug that is the same as a competitive generic therapy for which any first approved applicant has commenced commercial marketing, the application shall be made effective on the date that is 180 days after the date of the first commercial marketing of the competitive generic therapy (including the commercial marketing of the listed drug) by any first approved applicant. (II) Limitation The exclusivity period under subclause (I) shall not apply with respect to a competitive generic therapy that has previously received an exclusivity period under subclause (I). (III) Definitions In this clause and subparagraph (D)(iv): (aa) The term competitive generic therapy (AA) that is designated as a competitive generic therapy under section 506H; and (BB) for which there are no unexpired patents or blocking exclusivities on the list of products described in section 505(j)(7)(A) at the time of approval. (bb) The term first approved applicant (AA) is for a competitive generic therapy that is approved on the first day on which any application for such competitive generic therapy is approved; (BB) is not eligible for a 180-day exclusivity period under clause (iv) for the drug that is the subject of the application for the competitive generic therapy; and (CC) is not for a drug for which all drug versions have forfeited eligibility for a 180-day exclusivity period under clause (iv) pursuant to subparagraph (D). ; and (2) in subparagraph (D), by adding at the end the following: (iv) Special forfeiture rule for competitive generic therapy The 180-day exclusivity period described in subparagraph (B)(v) shall be forfeited by a first approved applicant if the applicant fails to market the competitive generic therapy within 75 days after the date on which the approval of the first approved applicant’s application for the competitive generic therapy is made effective. . 704. Tropical disease product application Subparagraph (A) of section 524(a)(4) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360n(a)(4) (1) in clause (i), by striking and (2) by adding at the end the following: (iii) that contains reports of one or more new clinical investigations (other than bioavailability studies) that are essential to the approval of the application and conducted or sponsored by the sponsor of such application; and (iv) that contains an attestation from the sponsor of the application that such reports were not submitted as part of an application for marketing approval or licensure by a regulatory authority in India, Brazil, Thailand, or any country that is a member of the Pharmaceutical Inspection Convention or the Pharmaceutical Inspection Cooperation Scheme prior to September 27, 2007. . 705. G AO (a) Study by GAO The Comptroller General of the United States shall conduct a study to determine the following: (1) The rate of first cycle approvals and tentative approvals for generic drug applications submitted during the period beginning on October 1, 2012, and ending on September 30, 2017. The rate of first cycle approvals and tentative approvals shall be determined and reported per each GDUFA cohort year during this period. (2) If the rate determined pursuant to paragraph (1) for any GDUFA cohort year is lower than 20 percent, the reasons contributing to the relatively low rate of first cycle approvals and tentative approvals for generic drug applications shall be itemized, assessed, and reported. In making the assessment required by this paragraph, the Comptroller General shall consider, among other things, the role played by— (A) the Food and Drug Administration’s implementation of approval standards for generic drug applications; (B) the extent to which those approval standards are communicated clearly to industry and applied consistently during the review process; (C) the procedures for reviewing generic drug applications, including timelines for review activities by the Food and Drug Administration; (D) the extent to which those procedures are followed consistently (and those timelines are met) by the Food and Drug Administration; (E) the processes and practices for communication between the Food and Drug Administration and sponsors of generic drug applications; and (F) the completeness and quality of original generic drug applications submitted to the Food and Drug Administration. (3) Taking into account the determinations made pursuant to paragraphs (1) and (2) and any review process improvements implemented pursuant to this Act, whether there are ways the review process for generic drugs could be improved to increase the rate of first cycle approvals and tentative approvals for generic drug applications. In making this determination, the Comptroller General shall consider, among other things, options for increasing review efficiency and communication effectiveness. (b) Completion date Not later than the expiration of the 2-year period beginning on the date of enactment of this Act, the Comptroller General shall complete the study under subsection (a) and submit a report describing the findings and conclusions of the study to the Secretary, the Committee on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate. (c) Definitions For purposes of this section: (1) The term GDUFA cohort year (2) The term generic drug 21 U.S.C. 355(j) (3) The term generic drug application 21 U.S.C. 355(j) (4) The term Secretary (5) (A) The term first cycle approvals and tentative approvals (B) For purposes of this paragraph, the term complete response letter VIII Fostering Innovation in Medical Imaging 801. Approval of applications for certain diagnostic medical imaging devices Section 520 of the Federal Food, Drug, and Cosmetic Act ( 42 U.S.C. 360j (q) Diagnostic imaging devices intended for use with contrast agents (1) The Secretary may, subject to the succeeding provisions of this subsection, approve an application (or a supplement to such an application) submitted under section 515 with respect to an applicable medical imaging device, or, in the case of an applicable medical imaging device for which a notification is submitted under section 510(k), may make a substantial equivalence determination with respect to an applicable medical imaging device, or may grant a request submitted under section 513(f)(2) for an applicable medical imaging device, if the indications and conditions of use proposed in such application, notification, or request involve the use of a contrast agent that is not— (A) in a concentration, rate of administration, or route of administration that is different from those described in the approved labeling of the contrast agent, except that the Secretary may approve such application, make such substantial equivalence determination, or grant such request if the Secretary determines that such differences in concentration, rate of administration, or route of administration exist but do not adversely affect the safety and effectiveness of the contrast agent when used with the device; (B) in a region, organ, or system of the body that is different from those described in the approved labeling of the contrast agent, except that the Secretary may approve such application, make such substantial equivalence determination, or grant such request if the Secretary determines that such differences in region, organ, or system of the body exist but do not adversely affect the safety and effectiveness of the contrast agent when used with the device; (C) in a patient population that is different from those described in the approved labeling of the contrast agent, except that the Secretary may approve such application, make such substantial equivalence determination, or grant such request if the Secretary determines such differences in patient population exist but do not adversely affect the safety and effectiveness of the contrast agent when used with the device; or (D) in an imaging modality (such as an ultrasound, an x-ray, diagnostic radiopharmaceutical-based technologies, fluorescent imaging technology, or magnetic resonance) that is different from those described in the approved labeling of the contrast agent. (2) The agency center charged with premarket review of devices shall have primary jurisdiction with respect to the review of an application, notification, or request described in paragraph (1). In conducting such review, such agency center may— (A) consult with the agency center charged with the premarket review of drugs or biological products; and (B) review information and data provided to the Secretary by the sponsor of a contrast agent in an application submitted under section 505 of this Act or section 351 of the Public Health Service Act, so long as the sponsor of such contrast agent has provided to the sponsor of the applicable medical imaging device that is the subject of such review a right of reference and the application is submitted in accordance with this subsection. (3) An application submitted under section 515, a notification submitted under section 510(k), or a request submitted under section 513(f)(2), as described in paragraph (1), with respect to an applicable medical imaging device shall be subject to the requirements of such respective section. Such application, notification, or request shall only be subject to the requirements of this Act applicable to devices. (4) For purposes of this subsection and section 505(y)— (A) the term applicable medical imaging device (B) the term contrast agent (i) is a diagnostic radiopharmaceutical, as defined in section 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. . 802. Applications for approval of contrast agents intended for use with certain diagnostic medical imaging devices Section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 (y) Contrast agents intended for use with applicable medical imaging devices (1) The sponsor of a contrast agent for which an application has been approved under this section may submit a supplement to the application seeking approval for the use of the contrast agent for a new indication and conditions of use following the authorization of a premarket submission for an applicable medical imaging device for that use with the contrast agent pursuant to section 520(q)(1). (2) In reviewing a supplement submitted under this subsection, the agency center charged with the premarket review of drugs may— (A) consult with the center charged with the premarket review of devices; and (B) review information and data submitted to the Secretary by the sponsor of an applicable medical imaging device pursuant to section 515, 510(k), or 513(f)(2) so long as the sponsor of such applicable medical imaging device has provided to the sponsor of the contrast agent a right of reference. (3) For purposes of this subsection— (A) the term new indication (B) the term applicable medical imaging device contrast agent . IX Additional Provisions 901. Technical corrections (a) Section 3075(a) of the 21st Century Cures Act ( Public Law 114–255 (1) in the matter preceding paragraph (1), by striking as amended by section 2074 as amended by section 3102 (2) in paragraph (2), by striking section 2074(1)(C) section 3102(1)(C) (b) Section 506G(b)(1)(A) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356g(b)(1)(A) identity identify (c) Section 505F(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355g(b) randomized traditional (d) Section 505F(d) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355g(d) 2 3 (e) Effective as of the enactment of the 21st Century Cures Act ( Public Law 114–255 (1) section 3051(a) of such Act is amended by striking by inserting after section 515B by inserting after section 515A (2) section 515C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360e–3 (f) Section 515B(f)(2) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360e–3(f)(2) a proposed guidance a draft version of that guidance (g) Section 513(b)(5)(D) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360c(b)(5)(D) medical device submissions medical devices that may be specifically the subject of a review by a classification panel 902. Reauthorization of the critical path public-private partnerships Section 566(f) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–5(f) 2013 through 2017 2018 through 2022 July 11, 2017 Reported with an amendment, committed to the Committee of the Whole House on the State of the Union, and ordered to be printed

Summary: FDA Reauthorization Act of 2017 TITLE I--FEES RELATING TO DRUGS Prescription Drug User Fee Amendments of 2017 (Sec. 102) This bill amends the Federal Food, Drug, and Cosmetic Act to extend through FY2022 and revise Food and Drug Administration (FDA) user fees for brand name drugs. User fees are eliminated for supplemental new drug applications and drug manufacturing facilities. A prescription drug program fee replaces the prescription drug product fee. This annual fee is assessed on a new drug application holder for each approved drug for up to five drugs. The total user fee revenue amount is adjusted annually for changes in review process capacity needs, to provide for operational reserves, and for additional direct costs. Eighty percent of revenues must be generated by prescription drug program fees, with the remainder from application fees. (Sec. 103) The bill extends through FY2022 requirements for annual reports and consultation by the FDA on reauthorization of brand name drug user fees. TITLE II--FEES RELATING TO DEVICES Medical Device User Fee Amendments of 2017 (Sec. 203) The bill extends through FY2022 and revises FDA user fees for medical devices. A user fee is established for requests to classify devices that are not substantially equivalent to marketed devices. The FDA’s authority to waive or reduce device user fees in the interest of public health is eliminated. (Sec. 204) The bill extends through FY2022 requirements for annual reports and consultation by the FDA on reauthorization of user fees for medical devices. (Sec. 205) The FDA must establish a pilot program to accredit testing laboratories to determine whether medical devices conform to performance standards. (Sec. 206) The bill extends through FY2022 the FDA's authority to accredit third parties to review premarket notifications for medical devices. The bill revises the types of devices that third parties may review. (Sec. 207) Submissions to the FDA regarding medical devices must be solely in electronic format. TITLE III--FEES RELATING TO GENERIC DRUGS Generic Drug User Fee Amendments of 2017 (Sec. 302) Generic drug applications submitted by government entities for non-commercial drugs are not subject to user fees. (Sec. 303) The bill extends through FY2022 and revises FDA user fees for generic drugs. User fees are eliminated for supplements to generic drug applications. An annual generic drug applicant program fee is assessed on holders of approved generic drug applications. The amount of the fee is based on the number of applications held. Of total user fee revenue, 35% must be generated from this fee. Application holders who do not pay this fee may not market their drugs. (Sec. 304) The bill extends through FY2022 requirements for annual reports and consultation by the FDA on reauthorization of user fees for generic drugs. TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS Biosimilar User Fee Amendments of 2017 (Sec. 403) The bill extends through FY2022 and revises FDA user fees for biosimilars. (Biosimilars are biological products approved by the FDA based on their similarity to an already-approved biological product.) User fees are eliminated for supplemental biosimilar applications and biosimilar manufacturing facilities. An annual biosimilar biological product program fee is assessed on biosimilar application holders for each approved biosimilar for up to five biosimilars. The bill sets the annual amount of revenue that must be generated by user fees. The FDA must determine the percentage of revenue generated by each fee. The total fee revenue amount is adjusted annually for changes in review process capacity needs and to provide for operational reserves. TITLE V--PEDIATRIC DRUGS AND DEVICES (Sec. 501) The bill extends through FY2022 and revises the National Institutes of Health (NIH) program to conduct pediatric studies of drugs. The NIH, in developing its list of priority issues in pediatric therapeutics, must consider identification of biomarkers for pediatric conditions. (Sec. 502) The bill revises requirements for the FDA to report on pediatric use of medical devices. The bill extends and revises the authorization for certain medical devices for pediatric patients to be sold above cost under the humanitarian device exemption. The bill extends and revises grants for consortia to facilitate development of pediatric medical devices. The FDA must convene a meeting on the development, approval, and labeling of pediatric medical devices. (Sec. 503) The FDA must meet with applicants for approval of new drugs or biological products to discuss, upon request, the initial pediatric study plan for medications to treat serious conditions and to discuss deferral or waiver of pediatric assessments. (Sec. 504) The bill revises the requirement for pediatric assessments to be submitted with applications for FDA approval of new medications. Sponsors of new medications for adult cancer, including orphan drugs, that target a molecule relevant to pediatric cancer must complete an investigation to yield pediatric study data to inform potential pediatric labeling of the medication. (Orphan drugs are medications for rare conditions.) The FDA must publish a list of target molecules considered relevant to pediatric cancer and a list of molecules for which pediatric study requirements are waived. The FDA must convene a meeting regarding the lists and the revisions to the pediatric assessment requirement. The bill revises FDA reporting requirements regarding pediatric studies and assessments. The Government Accountability Office (GAO) must report on the effectiveness of requiring pediatric assessments and investigations in the development of medications for pediatric cancer. (Sec. 505) The FDA must provide additional information to the internal committee that reviews requests for pediatric studies. (Currently, completion of pediatric clinical studies requested by the FDA extends the patents or marketing exclusivity period for a medication by six months, with exceptions.) This committee must develop and implement a plan to achieve earlier submission of pediatric studies. The FDA must: (1) act within 120 days on proposed pediatric study requests and proposed amendments to requests, and (2) report on the lack of pediatric labeling for orphan drugs. The FDA's Office of Pediatric Therapeutics must have a staff member with expertise in neonatology. TITLE VI--REAUTHORIZATIONS AND IMPROVEMENTS RELATED TO DRUGS (Sec. 601) The bill extends through FY2022: (1) marketing exclusivity for certain chemical variants of approved drugs; (2) Critical Path Public-Private Partnerships; and (3) support to defray the costs of developing drugs, devices, and medical food for rare conditions. (Sec. 604) Except in cases of a drug shortage or certain importation of drugs from Canada, prescription drugs manufactured outside the United States may only be imported if authorized by the manufacturer and appropriately labeled. The bill establishes a penalty for manufacturing, dispensing, or selling a counterfeit drug. (Sec. 605) The bill revises the definition of patient experience data, for purposes of collecting such data as part of the medical product development process, to specifically include physical and psychosocial impacts of a condition, therapy, or clinical investigation. (Sec. 606) The communication plan for a risk evaluation and mitigation strategy may include informing health care providers about drug formulations or properties and how those formulations or properties may be related to serious adverse drug events. (Sec. 607) For a medication to be approved as an orphan drug with seven years of marketing exclusivity when it is the same medication for the same condition as an already approved orphan drug, the sponsor of the new medication must demonstrate that the new medication is clinically superior to the approved medication. (Sec. 608) The bill expands to cover brand name drugs provisions that allow generic drugs to be approved and marketed without labeling for pediatric indications when the pediatric indications are protected by patent or marketing exclusivity. (Sec. 610) The FDA, in coordination with the NIH, must convene a meeting to discuss clinical trial inclusion and exclusion criteria. The FDA must report on the meeting and issue guidance regarding eligibility criteria for clinical trials. The GAO must report on individual access to investigational drugs through the expanded access program. (Expanded access, also known as compassionate use, allows patients to be treated with an investigational drug outside of a clinical trial.) The FDA must streamline review by institutional review boards of expanded access protocols for individual patients. The manufacturer or distributor of an investigational drug for a serious condition must publish its expanded access policy not later than 15 days after the drug is designated a breakthrough therapy, fast track product, or regenerative advanced therapy. (Sec. 611) The bill revises the priority review program for medications for tropical diseases to limit eligibility to applications that include new clinical investigations that were not submitted as part of an application in certain foreign countries. TITLE VII--DEVICE INSPECTION AND REGULATORY IMPROVEMENTS (Sec. 701) The bill revises provisions regarding FDA inspections of establishments that manufacture or process medical devices. The biannual inspection schedule for medical device establishments handling higher risk devices is replaced with a risk-based schedule. In establishing the risk-based schedule, the FDA must consider an establishment's participation in international medical device audit programs. (Sec. 702) The FDA must adopt uniform processes and standards for inspections of domestic and foreign medical device establishments. Upon request, the FDA must provide to the person in charge of a medical device establishment feedback regarding the person's proposals to address certain issues identified during an inspection. (Sec. 703) The bill extends through FY2022 accreditation by the FDA of third parties to conduct inspections of medical device establishments. (Sec. 704) The bill revises provisions regarding FDA certification of medical devices for export. The FDA must provide the basis for denying requests for certification of products for export as meeting FDA requirements for domestic products. A person denied such a certification may request supervisory review of that decision. Products from a medical device establishment that an inspector found to be contaminated or insanitary may be certified for export if the person in charge of the establishment has agreed to a plan to correct the issues identified during the inspection. (Sec. 705) The FDA may recognize auditing organizations that are recognized by organizations established by governments to facilitate international harmonization for purposes of inspecting medical device establishments. (Sec. 706) The FDA may approve or classify a medical imaging device intended to be used with an approved contrast agent if differences from the approved use of the contrast agent do not adversely affect the safety and effectiveness of the contrast agent. (Contrast agents are substances used to enhance the visibility of body structures in medical imaging.) The FDA center that reviews medical devices has primary jurisdiction over such reviews. After authorization of a medical imaging device that makes new use of a contrast agent, the sponsor of the approved contrast agent may submit a supplemental application for the new use of the contrast agent. (Sec. 707) The bill revises how accessories to medical devices are classified. The FDA must classify accessories based on the risks when used as intended and the level of regulatory controls necessary to provide a reasonable assurance of safety and effectiveness. Applications for approval or clearance of a medical device used with an unclassified accessory may request that the FDA classify the accessory. The FDA's response to the application must grant or deny the request for classification of the accessory. The FDA must periodically classify suitable medical device accessories that have been approved for marketing as low risk devices. Manufacturers and importers of accessories approved for marketing may request classification of the accessories. (Sec. 708) In order to provide timely and reliable information on the safety and effectiveness of medical devices that have been approved, cleared, or classified, the FDA must support pilot projects that use electronic health data to generate safety and active surveillance data and inform methods and programs to support safety and active surveillance activities. (Sec. 709) The FDA must categorize certain hearing aids as over-the-counter hearing aids and issue regulations regarding those hearing aids. The regulations for over-the-counter hearing aids must: (1) provide reasonable assurances of safety and efficacy; (2) establish output limits and labeling requirements; and (3) describe requirements for the sale of hearing aids in-person, by mail, or online, without a prescription. The FDA must determine whether premarket notification is required for over-the-counter hearing aids to provide reasonable assurance of safety and effectiveness. State and local governments may not establish or continue in effect requirements specifically applicable to hearing products that are not identical to FDA requirements and that restrict or interfere with the servicing or sale of over-the-counter hearing aids. The FDA must update and finalize its draft guidance on hearing products. The guidance must clarify which products are medical devices. (Sec. 710) The FDA must report on the continued quality, safety, and effectiveness of medical devices after servicing. The report must contain information including the current authority of the FDA to regulate medical device servicing and how the FDA could improve its regulation of servicing. TITLE VIII--IMPROVING GENERIC DRUG ACCESS (Sec. 801) The FDA must prioritize review of, and act within eight months of submission on, generic drug applications for drugs for which there is a shortage or for which there are not more than three approved products and no blocking patents or exclusivities. To be eligible for priority review, an applicant must submit, at least 60 days in advance of the application, information to the FDA on facilities involved in the manufacturing and testing of the drug. The FDA may expedite inspection of such manufacturing facilities. The FDA must publish a list of brand name drugs for which all patents and exclusivities have expired and no generic drug application has been approved. (Sec. 802) Upon request, the FDA must provide review status updates to applicants with pending generic drug applications. (Sec. 803) The FDA may, upon the request of an applicant for approval of a generic drug, designate a generic drug as a competitive generic therapy and expedite the development and review of the application. A drug may be designated as a competitive generic therapy if there is not more than one approved, marketed drug that is the same drug. (Sec. 804) Holders of approved brand name or generic drug applications must notify the FDA: (1) 180 days prior to withdrawing a drug from sale, or as soon as practicable, and provide specified information including the reason for withdrawal; (2) within 180 days of approval of a drug if the drug will not be available for sale within 180 days of approval and provide specified information including the reason the drug is not for sale; and (3) within 180 days of enactment of this bill of whether their drugs on the FDA’s list of marketed drugs are marketed. The FDA must update its list of marketed drugs based on this information. (Sec. 805) The FDA must annually report information regarding petitions for permission to seek approval for a generic drug application for a drug that differs from the brand name drug. (Sec. 806) The FDA must implement a protocol to expedite review of responses to inspection reports pertaining to certain drug applications, including applications for drugs in a shortage or drugs for which approval is dependent on remediation of conditions identified in the inspection report. (Sec. 807) The FDA must report quarterly on generic drug applications, including information regarding applications subject to priority review or expedited development and review and withdrawals of generic drug applications. (Sec. 808) First approved applicants for a competitive generic therapy are granted a 180-day marketing exclusivity period. There may be only one such period for a drug. This exclusivity period is forfeited by an applicant if the applicant fails to market the drug within 75 days after approval. (Sec. 809) For FY2013-FY2017, the GAO must report on the rate of approval of generic drug applications upon completion of the FDA's first review of an application. For years when the rate is below 20%, the GAO must report on the reasons for the low rate. The GAO must report on whether there are ways the generic drug review process could be improved to increase the rate of approvals upon first review. TITLE IX--ADDITIONAL PROVISIONS (Sec. 902) The FDA must annually publish information regarding the past year’s inspections of drug or medical device facilities, including the amount of time between steps in the inspection process. (Sec. 903) The bill revises requirements for performance reports under user fee provisions for prescription drugs, medical devices, generic drugs, and biosimilars, including to require quarterly publication of information regarding guidance and meetings. Performance reports must include: (1) an analysis of changes in the number of full time equivalents hired under user fee agreements and the number funded under the FDA budget, (2) an analysis of changes in user fee revenue amounts and review costs, and (3) the number of employees in specified FDA offices for whom time reporting is required and the number for whom it is not required. (Sec. 904) User fee performance reports must include an analysis of: (1) the number of product applications filed and approved, (2) whether the relevant FDA review office has met performance enhancement goals, and (3) circumstances affecting the ability of the FDA to meet review time and performance enhancement goals. The FDA must annually submit a corrective action report to Congress as part of user fee reporting. If the FDA determines that fiscal year goals were met, the report must include recommendations on ways to improve the product review process. If goals were not met, the report must include a description of the circumstances under which goals were missed and efforts to improve the FDA’s ability to meet the goals. Each fiscal year, as requested, representatives of the FDA must meet with members of Congress and participate in a congressional hearing regarding user fee reports. (Sec. 905) The GAO must report on FDA expenses related to facility maintenance and renovation for FY2012-FY2019. The report must include an analysis of the FDA’s ability to further its public health mission and review medical products by incurring such expenses. Beginning FY2024, the bill prohibits the use of user fees for: (1) maintenance, renovation, and repair of facilities; and (2) acquisition, maintenance, and repair of materials and supplies that are not necessary scientific equipment.