H.R. 2430 — what changed

“(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.”

“(C) Limitation—An establishment shall be assessed only one fee per fiscal year under this section.”

“(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

“(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).

changed “(E) Publication in federal register—The Secretary shall publish in the Federal Register notice under paragraph (5) of 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—

changed “(A) establish, for the next each such 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.”

removed Section 737 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i) is amended—

“(8) The term “de novo classification request” means a request made under section 513(f)(2)(A) with respect to the classification of a device.”

“(xi) For a de novo classification request, a fee equal to 30 percent of the fee that applies under clause (i).”

“(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:

“(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.”

“(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.”

“(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).”

“(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.

changed “(D) Report—The Secretary shall make available on the internet 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.”

Section 523 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360m) is amended—

changed “(ii) a device classified under section 513(f)(2) or designated under section 515C(d); or515C(d);

changed “(iii) a device that is of a type, intended to be permanently implantable, life sustaining, or subset of a type, life supporting, unless otherwise determined by the Secretary in accordance with subparagraph (B)(i)(II) and listed as not eligible for review under subparagraph (B)(iii).”(B)(iii); or

added “(iv) a device that is of a type, or subset of a type, listed as not eligible for review under subparagraph (B)(iii).”

“(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

changed “(II) whether the device type, or subset of such device type, is permanently implantable, life sustaining, or life supporting;supporting, and whether there is a detailed public health justification for permitting the review by an accredited person of such device type or subset;

“(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).”

“(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 shall be in effect.”

“(E) The operations of such person shall be in accordance with generally accepted professional and ethical business practices.”

Section 745A(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379k–1(b)) is amended by adding at the end the following new paragraph:

“(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.

changed “(C) Final guidance—The Secretary shall, not later than 12 months 1 year 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.”guidance.”

“(E) Sunset—This paragraph shall cease to be effective October 1, 2022.”

“(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.”

“(I) the date”

“(II) the date on which the drug master file holder requests the initial completeness assessment.”

“(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.”

“(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).”

“(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.”

“(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) 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.”

“(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.”

“(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).”

“(F) whether the facility is a contract manufacturing organization facility.”

“(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.”

“(o) Information on abbreviated new drug applications owned by applicants and their affiliates

changed “(1) In general—By April 1 of each year, each person that owns an abbreviated new drug application, or any a designated affiliate of such person, shall submit, on behalf of the person and its affiliates, the affiliates of such person, to the Secretary a list of—

“(A) all approved abbreviated new drug applications owned by such person; and

changed “(B) if any affiliate of such person also owns an abbreviated new drug application, all affiliates that own any such abbreviated new drug applications application 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.”

changed 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)), prior approval supplements that were submitted, and drug master files for Type II active pharmaceutical ingredients that were first referenced on or after October 1, 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.

changed “(1) The term adjustment factor applicable to a fiscal year is the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items; Annual Index) items) for October of the preceding fiscal year divided by such Index for October 2011.”

changed “(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 biological product 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.”

“(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).”

“(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

changed “(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 subparagraph (A), (B), or (D).”

“(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

“(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—

changed “(i) initial and annual biosimilar biological product 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

“(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.

changed “(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) (5)(B) 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.

changed “(B) Methodology—The Secretary shall publish under paragraph (5) (5)(B) 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.”

“(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.”

changed Section 505(u)(4) 409I of the Federal Food, Drug, and Cosmetic Public Health Service Act (21 (42 U.S.C. 355(u)(4)) 284m) is amended by striking “2017” and inserting “2022”.amended—

added “(B) Availability of reports

added “(i) In general—Each report submitted under subparagraph (A) shall be considered to be in the public domain (subject to section 505A(d)(4) of the Federal Food, Drug, and Cosmetic Act) and not later than 90 days after submission of such report, shall be—

added “(I) posted on the internet website of the National Institutes of Health in a manner that is accessible and consistent with all applicable Federal laws and regulations, including such laws and regulations for the protection of—

added “(aa) human research participants, including with respect to privacy, security, informed consent, and protected health information; and

added “(bb) proprietary interests, confidential commercial information, and intellectual property rights; and

added “(II) assigned a docket number by the Commissioner of Food and Drugs and made available for the submission of public comments.

added “(ii) Submission of comments—An interested person may submit written comments concerning such pediatric studies to the Commissioner of Food and Drugs, and the submitted comments shall become part of the docket file with respect to each of the drugs.”

added “(B) any information, based on a review of data available to the Secretary, regarding devices used in pediatric patients but not labeled for such use for which the Secretary determines that approved pediatric labeling could confer a benefit to pediatric patients;

added “(C) the number of pediatric devices that receive a humanitarian use exemption under section 520(m);”

added “(G) the number of devices for which the Secretary relied on data with respect to adults to support a determination of a reasonable assurance of safety and effectiveness in pediatric patients; and

added “(H) the number of devices for which the Secretary relied on data from one pediatric subpopulation to support a determination of a reasonable assurance of safety and effectiveness in another pediatric subpopulation.”

added “(6) providing regulatory consultation to device sponsors in support of the submission of an application for a pediatric device, where appropriate.”

removed Section 5(c) of the Orphan Drug Act (21 U.S.C. 360ee(c)) is amended by striking “2013 through 2017” and inserting “2018 through 2022”.

added “(i) shall meet with the applicant—

added “(I) if requested by the applicant with respect to a drug or biological product that is intended to treat a serious or life-threatening disease or condition, to discuss preparation of the initial pediatric study plan, not later than the end-of-Phase 1 meeting (as such term is used in section 312.82(b) of title 21, Code of Federal Regulations, or successor regulations) or within 30 calendar days of receipt of such request, whichever is later;

added “(II) to discuss the initial pediatric study plan as soon as practicable, but not later than 90 calendar days after the receipt of such plan under subparagraph (A); and

added “(III) to discuss the bases for the deferral under subsection (a)(4) or a full or partial waiver under subsection (a)(5);”

removed Section 409I(e)(1) of the Public Health Service Act (42 U.S.C. 284m(e)(1)) is amended by striking “2013 through 2017” and inserting “2018 through 2022”.

added “(A) General requirements—Except with respect to an application for which subparagraph (B) applies, a person”

added “(B) Certain molecularly targeted cancer indications—A person that submits, on or after the date that is 3 years after the date of enactment of the FDA Reauthorization Act of 2017, an original application for a new active ingredient under section 505 of this Act or section 351 of the Public Health Service Act, shall submit with the application reports on the investigation described in paragraph (3) if the drug or biological product that is the subject of the application is—

added “(i) intended for the treatment of an adult cancer; and

added “(ii) directed at a molecular target that the Secretary determines to be substantially relevant to the growth or progression of a pediatric cancer.”

added “(3) Molecularly targeted pediatric cancer investigation

added “(A) In general—With respect to a drug or biological product described in paragraph (1)(B), the investigation described in this paragraph is a molecularly targeted pediatric cancer investigation, which shall be designed to yield clinically meaningful pediatric study data, gathered using appropriate formulations for each age group for which the study is required, regarding dosing, safety, and preliminary efficacy to inform potential pediatric labeling.

added “(B) Extrapolation of data—Paragraph (2)(B) shall apply to investigations described in this paragraph to the same extent and in the same manner as paragraph (2)(B) applies with respect to the assessments required under paragraph (1)(A).

added “(C) Deferrals and waivers—Deferrals and waivers under paragraphs (4) and (5) shall apply to investigations described in this paragraph to the same extent and in the same manner as such deferrals and waivers apply with respect to the assessments under paragraph (2)(B).”

added “(m) List of primary molecular targets

added “(1) In general—Within one year of the date of enactment of the FDA Reauthorization Act of 2017, the Secretary shall establish and update regularly, and shall publish on the internet website of the Food and Drug Administration—

added “(A) a list of molecular targets considered, on the basis of data the Secretary determines to be adequate, to be substantially relevant to the growth and progression of a pediatric cancer, and that may trigger the requirements under this section; and

added “(B) a list of molecular targets of new cancer drugs and biological products in development for which pediatric cancer study requirements under this section will be automatically waived.

added “(2) Consultation—In establishing the lists described in paragraph (1), the Secretary shall consult the National Cancer Institute, members of the internal committee under section 505C, and the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee, and shall take into account comments from the meeting under subsection (c).

added “(3) Rule of construction—Nothing in paragraph (1) shall be construed—

added “(A) to require the inclusion of a molecular target on the list published under such paragraph as a condition for triggering the requirements under subsection (a)(1)(B) with respect to a drug or biological product directed at such molecular target; or

added “(B) to authorize the disclosure of confidential commercial information, as prohibited under section 301(j) of this Act or section 1905 of title 18, United States Code.”

removed “(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.”

changed “(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.”“(k) Relation to orphan drugs

added “(1) In general; exemption for orphan indications—Unless the Secretary requires otherwise by regulation and except as provided in paragraph (2), this section does not apply to any drug or biological product for an indication for which orphan designation has been granted under section 526.

added “(2) Applicability despite orphan designation of certain indications—This section shall apply with respect to a drug or biological product for which an indication has been granted orphan designation under 526 if the investigation described in subsection (a)(3) applies to the drug or biological product as described in subsection (a)(1)(B).”

added “(11) an assessment of the impact of the amendments to such section 505B made by the FDA Reauthorization Act of 2017 on pediatric research and labeling of drugs and biological products and pediatric labeling of molecularly targeted drugs and biological products for the treatment of cancer;

added “(12) an assessment of the efforts of the Secretary to implement the plan developed under section 505C–1 of the Federal Food, Drug, and Cosmetic Act, regarding earlier submission of pediatric studies under sections 505A and 505B of such Act and section 351(m) of the Public Health Service Act, including—

added “(A) the average length of time after the approval of an application under section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)(1)) or section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)) before studies conducted pursuant to such section 505A, 505B, or section 351(m) are completed, submitted, and incorporated into labeling;

added “(B) the average length of time after the receipt of a proposed pediatric study request before the Secretary responds to such request;

added “(C) the average length of time after the submission of a proposed pediatric study request before the Secretary issues a written request for such studies;

added “(D) the number of written requests issued for each investigational new drug or biological product prior to the submission of an application under section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act or section 351(a) of the Public Health Service Act; and

added “(E) the average number, and range of numbers, of amendments to written requests issued, and the time the Secretary requires to review and act on proposed amendments to written requests;

added “(13) a list of sponsors of applications or holders of approved applications who received exclusivity under such section 505A or such section 351(m) after receiving a letter issued under such section 505B(d)(1) for any drug or biological product before the studies referred to in such letter were completed and submitted;

added “(14) a list of assessments and investigations required under such section 505B;

added “(15) how many requests under such section 505A for molecular targeted cancer drugs, as defined by subsection (a)(1)(B) of such section 505B, approved prior to 3 years after the date of enactment of the FDA Reauthorization Act of 2017, have been issued by the Food and Drug Administration, and how many such requests have been completed; and

added “(16) the Secretary’s assessment of the overall impact of the amendments made by section 504 of the FDA Reauthorization Act of 2017 on the conduct and effectiveness of pediatric cancer research and the orphan drug program, as well any subsequent recommendations.”

added “(7) Informing internal review committee—The Secretary shall provide to the committee referred to in paragraph (1) any response issued to an applicant or holder with respect to a proposed pediatric study request.”

added “(3) Action on submissions—The Secretary shall review and act upon a submission by a sponsor or holder of a proposed pediatric study request or a proposed amendment to a written request for pediatric studies within 120 calendar days of the submission.”

removed 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—

changed Paragraph (2) of section 510(h) Section 505(u)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(h)) 355(u)(4)) is amended to read as follows:by striking “2017” and inserting “2022”.

removed “(2) Risk-based schedule for devices

removed “(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”) in accordance with a risk-based schedule established by the Secretary.

removed “(B) Factors and considerations—In establishing the risk-based schedule under subparagraph (A), the Secretary shall—

removed “(i) apply, to the extent applicable for device establishments, the factors identified in paragraph (4); and

removed “(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.”

changed Subsection (a)(1) of section 809 Section 566(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384e(a)(1)) 360bbb–5(f)) is amended by striking “2013 through 2017” and inserting “or 510(h)(2) (as applicable)” before the semicolon at the end.“2018 through 2022”.

added Section 5(c) of the Orphan Drug Act (21 U.S.C. 360ee(c)) is amended by striking “2013 through 2017” and inserting “2018 through 2022”.

removed “(h)

removed “(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—

removed “(A) exceptions to such processes and standards, as appropriate;

removed “(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;

removed “(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

removed “(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.

removed “(2)

removed “(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.

removed “(B) A request described in this subparagraph is a request for feedback—

removed “(i) that is made by the owner, operator, or agent in charge of such establishment in a timely manner; and

removed “(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).

removed “(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.”

added “(B) Except as authorized by the Secretary in the case of a drug that appears on the drug shortage list under section 506E or in the case of importation pursuant to section 804, no drug that is subject to section 503(b)(1) may be imported into the United States for commercial use if such drug is manufactured outside the United States, unless the manufacturer has authorized the drug to be marketed in the United States and has caused the drug to be labeled to be marketed in the United States.”

removed “(E)

removed “(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.

removed “(ii) If the denial of a request as described in clause (i) is based on—

removed “(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

removed “(II) an establishment being considered out of compliance with part 820, title 21, Code of Federal Regulations,

removed “(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.

removed “(F)

removed “(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).

removed “(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).

removed “(G)

removed “(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.

removed “(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.”

added “(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.”

changed Section 704(g) 569C(c)(2)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(g)) 360bbb–8c(c)(2)(A)) is amended by adding at the end the following:striking “impact of such disease or condition, or a related therapy,” and inserting “impact (including physical and psychosocial impacts) of such disease or condition, or a related therapy or clinical investigation”.

removed “(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.”

changed Section 704(g)(11) 505–1(e)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(g)(11)) 355–1(e)(3)) is amended by striking “October 1, 2017” and inserting “October 1, 2022”.amended—

added “(D) disseminating information to health care providers about drug formulations or properties, including information about the limitations or patient care implications of such formulations or properties, and how such formulations or properties may be related to serious adverse drug events associated with use of the drug.”

added “(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

added “(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.”

removed Section 520(m)(6)(A)(iv) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(6)(A)(iv)) is amended by striking “2017” and inserting “2022”.

added “(2) Risk-based schedule for devices

added “(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”) in accordance with a risk-based schedule established by the Secretary.

added “(B) Factors and considerations—In establishing the risk-based schedule under subparagraph (A), the Secretary shall—

added “(i) apply, to the extent applicable for device establishments, the factors identified in paragraph (4); and

added “(ii) consider the participation of the device establishment, as applicable, in international device audit programs in which the United States participates or the United States recognizes for purposes of inspecting device establishments.”

removed “506H. Competitive generic therapies

removed “(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).

removed “(b) Designation process

removed “(1) Request—The sponsor of a drug may request the Secretary to designate the drug as a competitive generic therapy.

removed “(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).

removed “(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.

removed “(4) Designation—Not later than 60 calendar days after the receipt of a request under paragraph (1), the Secretary shall—

removed “(A) determine whether the drug that is the subject of the request meets the criteria described in paragraph (3); and

removed “(B) if the Secretary finds that the drug meets such criteria, designate the drug as a competitive generic therapy.

removed “(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:

removed “(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).

removed “(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.

removed “(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.

removed “(4) Assign a cross-disciplinary project lead for the Food and Drug Administration review team—

removed “(A) to facilitate an efficient review of the development program and application, including manufacturing inspections; and

removed “(B) to serve as a scientific liaison between the review team and the sponsor.

removed “(d) Definitions—In this section:

removed “(1) The term “generic drug” means a drug that is approved pursuant to section 505(j).

removed “(2) The term “inadequate generic competition” means, with respect to a product, there is not more than one approved drug product on the list of products described in section 505(j)(7)(A) (not including products on the discontinued section of such list) that is—

removed “(A) the reference listed drug; or

removed “(B) a generic drug with the same reference listed drug as the drug for which designation as a competitive generic therapy is sought.

removed “(3) The term “reference listed drug” means the listed drug (as such term is used in section 505(j)) for the drug involved.”

added “(h)

added “(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 uniform processes and standards shall provide for—

added “(A) exceptions to such processes and standards, as appropriate;

added “(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;

added “(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; and

added “(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.

added “(2)

added “(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.

added “(B) A request described in this subparagraph is a request for feedback—

added “(i) that is made by the owner, operator, or agent in charge of such establishment in a timely manner; and

added “(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).

added “(3) Nothing in this subsection affects the authority of the Secretary to conduct inspections otherwise permitted under this Act in order to ensure compliance with this Act.”

removed Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended by adding at the end the following:

removed “(11) Upon the request of an applicant regarding one or more specified pending applications under this subsection, the Secretary shall—

removed “(A) by telephone or electronic mail, provide review status updates; and

removed “(B) indicate in such updates the categorical status of the applications by each relevant review discipline.”

changed Section 505(j)(5) 704(g)(11) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)) 374(g)(11)) is amended—amended by striking “October 1, 2017” and inserting “October 1, 2022”.

removed “(v) 180-day exclusivity period for competitive generic therapies

removed “(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.

removed “(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).

removed “(III) Definitions—In this clause and subparagraph (D)(iv):

removed “(aa) The term “competitive generic therapy” means a drug—

removed “(AA) that is designated as a competitive generic therapy under section 506H; and

removed “(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.

removed “(bb) The term “first approved applicant” means any applicant that has submitted an application that—

removed “(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;

removed “(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

removed “(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).”

removed “(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.”

changed Subparagraph (A) Subsection (e)(4) of section 524(a)(4) 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360n(a)(4)) 381(e)(4)) is amended—

added “(E)

added “(i)

added “(I) If the Secretary denies a request for certification under subparagraph (A)(ii) with respect to a device manufactured in an establishment (foreign or domestic) registered under section 510, 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.

added “(II) If the denial of a request as described in subclause (I) is based on 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 is based on the facility being out of compliance with part 820 of title 21, Code of Federal Regulations, the Secretary shall provide a substantive summary of the specific grounds for noncompliance identified by the Secretary.

added “(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 as described in subclause (I) with respect to a device based solely 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.

added “(ii)

added “(I) The Secretary shall provide a process for a person who is denied a certification as described in clause (i)(I) to request a review that conforms to the standards of section 517A(b).

added “(II) Notwithstanding any previous review conducted pursuant to subclause (I), a person who has been denied a certification as described in clause (i)(I) may at any time request a review in order to present new information relating to actions taken by such person to address the reasons identified by the Secretary for the denial of certification, including evidence that corrective actions are being or have been implemented to address grounds for noncompliance identified by the Secretary.

added “(III) Not later than 1 year after the date of enactment of the FDA Reauthorization Act of 2017, the Secretary shall issue guidance providing for a process to carry out this subparagraph. Not later than 1 year after the close of the comment period for such guidance, the Secretary shall issue final guidance.

added “(iii)

added “(I) Subject to subclause (II), this subparagraph applies to requests for certification on behalf of any device establishment registered under section 510, whether the establishment is located inside or outside of the United States, and regardless of whether such devices are to be exported from the United States.

added “(II) If an establishment described in subclause (I) is not located within the United States and does not demonstrate that the devices manufactured, prepared, propagated, compounded, or processed at such establishment are to be exported from the United States, this subparagraph shall apply only if—

added “(aa) the establishment has been inspected by the Secretary within 3 years of the date of the request; or

added “(bb) the establishment participates in an audit program in which the United States participates or the United States recognizes, an audit under such program has been conducted, and the findings of such audit are provided to the Secretary within 3 years of the date of the request.”

removed “(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

removed “(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.”

added Section 704(g) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 374) is amended by adding at the end the following:

added “(15)

added “(A) Notwithstanding any other provision of this subsection, the Secretary may recognize auditing organizations that are recognized by organizations established by governments to facilitate international harmonization for purposes of conducting inspections of—

added “(i) establishments that manufacture, prepare, propagate, compound, or process devices (other than types of devices licensed under section 351 of the Public Health Service Act), as required under section 510(h); or

added “(ii) establishments required to register pursuant to section 510(i).

added “(B) Nothing in this paragraph affects—

added “(i) the authority of the Secretary to inspect any device establishment pursuant to this Act; or

added “(ii) the authority of the Secretary to determine the official classification of an inspection.”

changed Section 520 505(j) of the Federal Food, Drug, and Cosmetic Act (42 (21 U.S.C. 360j), as amended by section 613, 355(j)) is further amended by adding at the end the following:

changed “(q) Diagnostic imaging devices intended for use with contrast agents“(11)

changed “(1) The Secretary may, subject “(A) Subject to subparagraph (B), the succeeding provisions Secretary shall prioritize the review of, and act within 8 months 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 date 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 the submission of, an applicable medical imaging device, or may grant a request original abbreviated new drug application 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 review under this subsection that is not—for a drug—

changed “(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 “(i) for which there are not adversely affect the safety more than 3 approved drug products listed under paragraph (7) and effectiveness of the contrast agent when used with the device;for which there are no blocking patents and exclusivities; or

changed “(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 “(ii) 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 has been included on the device;list under section 506E.

changed “(C) in a patient population that is different from those “(B) To qualify for priority review under this paragraph, not later than 60 days prior to the submission of an application described in subparagraph (A) or that the approved labeling Secretary may prioritize pursuant to subparagraph (D), the applicant shall provide complete, accurate information regarding facilities involved in manufacturing processes and testing of the contrast agent, except drug that is the Secretary may approve such subject of the application, make such substantial equivalence determination, including facilities in corresponding Type II active pharmaceutical ingredients drug master files referenced in an application and sites or grant such request if organizations involved in bioequivalence and clinical studies used to support the application, to enable the Secretary determines to make a determination regarding whether an inspection of a facility is necessary. Such information shall include the relevant (as determined by the Secretary) sections of such differences in patient population exist but do not adversely affect application, which shall be unchanged relative to the safety and effectiveness date of the contrast agent when submission of such application, except to the extent that a change is made to such information to exclude a facility that was not used with to generate data to meet any application requirements for such submission and that is not the device; oronly facility intended to conduct one or more unit operations in commercial production. Information provided by an applicant under this subparagraph shall not be considered the submission of an application under this subsection.

changed “(D) in an imaging modality (such as an ultrasound, “(C) The Secretary may expedite an x-ray, diagnostic radiopharmaceutical-based technologies, fluorescent imaging technology, inspection or magnetic resonance) reinspection under section 704 of an establishment that is different from those proposes to manufacture a drug described in the approved labeling of the contrast agent.subparagraph (A).

changed “(2) The agency center charged with premarket review of devices “(D) Nothing in this paragraph shall have primary jurisdiction with respect to prevent the Secretary from prioritizing the review of an application, notification, or request described in paragraph (1). In conducting such review, such agency center may—other applications as the Secretary determines appropriate.

changed “(A) consult with “(12) The Secretary shall publish on the agency center charged with internet website of the premarket review Food and Drug Administration, and update at least once every 6 months, a list of all drugs or biological products; andapproved under subsection (c) for which all patents and periods of exclusivity under this Act have expired and for which no application has been approved under this subsection.”

removed “(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.

removed “(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.

removed “(4) For purposes of this subsection and section 505(y)—

removed “(A) the term “applicable medical imaging device” means a device intended to be used in conjunction with a contrast agent (or class of contrast agents) for an imaging use that is not described in the approved labeling of such contrast agent (or the approved labeling of any contrast agent in the same class as such contrast agent); and

removed “(B) the term “contrast agent” means a drug that is approved under section 505 or licensed under section 351 of the Public Health Service Act, is intended for use in conjunction with an applicable medical imaging device, and—

removed “(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

removed “(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.”

changed Section 505 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) 355), as amended by section 801, is further amended by adding at the end the following:

changed “(y) Contrast agents intended for use with applicable medical imaging devices“(13) Upon the request of an applicant regarding one or more specified pending applications under this subsection, the Secretary shall, as appropriate, provide review status updates indicating the categorical status of the applications by each relevant review discipline.”

removed “(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).

removed “(2) In reviewing a supplement submitted under this subsection, the agency center charged with the premarket review of drugs may—

removed “(A) consult with the center charged with the premarket review of devices; and

removed “(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.

removed “(3) For purposes of this subsection—

removed “(A) the term “new indication” means a use of a contrast agent that is described in the approved labeling of an applicable medical imaging device described in section 520(q), but that is not described in the approved labeling of the contrast agent; and

removed “(B) the term “applicable medical imaging device” and “contrast agent” have the meanings given such terms in section 520(q).”

changed Section 566(f) Not later than March 1 of each year, the Secretary of Health and Human Services shall post on the internet website of the Food and Drug Administration information related to inspections of facilities necessary for approval of a drug under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–5(f)) is amended by striking “2013 through 2017” and inserting “2018 through 2022”.355), approval of a device under section 515 of such Act (21 U.S.C. 360e), or clearance of a device under section 510(k) of such Act (21 U.S.C. 360(k)) that were conducted during the previous calendar year. Such information shall include the following: