[House Report 117-348]
[From the U.S. Government Publishing Office]


117th Congress    }                                    {     Report
                        HOUSE OF REPRESENTATIVES
 2d Session       }                                    {     117-348
_______________________________________________________________________

.                                    
                    
                    
                    FOOD AND DRUG AMENDMENTS OF 2022

                               ----------                              

                              R E P O R T

                                 of the

                    COMMITTEE ON ENERGY AND COMMERCE

                              to accompany

                               H.R. 7667


		[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


  June 7, 2022.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed
              
              
              
              
              
              
 
                    FOOD AND DRUG AMENDMENTS OF 2022












117th Congress    } 				        {  Report
 	                HOUSE OF REPRESENTATIVES                 
 2d Session       }                                     {  117-348
_______________________________________________________________________

                                     


 

                    FOOD AND DRUG AMENDMENTS OF 2022

                               __________

                              R E P O R T

                                 of the

                    COMMITTEE ON ENERGY AND COMMERCE

                              to accompany

                               H.R. 7667


	        [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


  June 7, 2022.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed
              
              
                                __________              
                                
              
              
              	     U.S. GOVERNMENT PUBLISHING OFFICE
              
29-006			     WASHINGTON : 2022              
              
              


















117th Congress    } 				        {  Report
 	                HOUSE OF REPRESENTATIVES                 
 2d Session       }                                     {  117-348

======================================================================



 

                    FOOD AND DRUG AMENDMENTS OF 2022

                                _______
                                

  June 7, 2022.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

 Mr. Pallone, from the Committee on Energy and Commerce, submitted the 
                               following

                              R E P O R T

                        [To accompany H.R. 7667]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 7667) 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, having 
considered the same, reports favorably thereon with an 
amendment and recommends that the bill as amended do pass.

                                CONTENTS

                                                                   Page
  I. Purpose and Summary.............................................49
 II. Background and Need for the Legislation.........................49
III. Committee Hearings..............................................67
 IV. Committee Consideration.........................................68
  V. Committee Votes.................................................68
 VI. Oversight Findings..............................................72
VII. New Budget Authority, Entitlement Authority, and Tax Expenditure72
VIII.Federal Mandates Statement......................................72

 IX. Statement of General Performance Goals and Objectives...........72
  X. Duplication of Federal Programs.................................72
 XI. Committee Cost Estimate.........................................72
XII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits.....72
XIII.Advisory Committee Statement....................................73

XIV. Applicability to Legislative Branch.............................73
 XV. Section-by-Section Analysis of the Legislation..................73
XVI. Changes in Existing Law Made by the Bill, as Reported...........86

    The amendment is as follows:
  Strike all after the enacting clause and insert the 
following:

SECTION 1. SHORT TITLE.

  This Act may be cited as the ``Food and Drug Amendments of 2022''.

SEC. 2. TABLE OF CONTENTS.

  The table of contents of 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. Definitions.
Sec. 103. Authority to assess and use drug fees.
Sec. 104. Reauthorization; reporting requirements.
Sec. 105. Sunset dates.
Sec. 106. Effective date.
Sec. 107. Savings clause.

                   TITLE II--FEES RELATING TO DEVICES

Sec. 201. Short title; finding.
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 third-party review program.
Sec. 207. Sunset dates.
Sec. 208. Effective date.
Sec. 209. Savings clause.

               TITLE III--FEES RELATING TO GENERIC DRUGS

Sec. 301. Short title; finding.
Sec. 302. Authority to assess and use human generic drug fees.
Sec. 303. Reauthorization; reporting requirements.
Sec. 304. Sunset dates.
Sec. 305. Effective date.
Sec. 306. 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--IMPROVING DIVERSITY IN CLINICAL STUDIES

Sec. 501. Diversity action plans for clinical studies.
Sec. 502. Evaluation of the need for FDA authority to mandate 
postapproval studies or postmarket surveillance due to insufficient 
demographic subgroup data.
Sec. 503. Public workshops to enhance clinical study diversity.
Sec. 504. Annual summary report on progress to increase diversity in 
clinical studies.
Sec. 505. Public meeting on clinical study flexibilities initiated in 
response to COVID-19 pandemic.
Sec. 506. Decentralized clinical studies.

                   TITLE VI--GENERIC DRUG COMPETITION

Sec. 601. Increasing transparency in generic drug applications.
Sec. 602. Enhancing access to affordable medicines.

    TITLE VII--RESEARCH, DEVELOPMENT, AND SUPPLY CHAIN IMPROVEMENTS

                         Subtitle A--In General

Sec. 701. Animal testing alternatives.
Sec. 702. Emerging technology program.
Sec. 703. Improving the treatment of rare diseases and conditions.
Sec. 704. Antifungal research and development.
Sec. 705. Advancing qualified infectious disease product innovation.
Sec. 706. Advanced manufacturing technologies designation pilot 
program.
Sec. 707. Public workshop on cell therapies.
Sec. 708. Reauthorization of best pharmaceuticals for children.
Sec. 709. Reauthorization for humanitarian device exemption and 
demonstration grants for improving pediatric availability.
Sec. 710. Reauthorization of provision related to exclusivity of 
certain drugs containing single enantiomers.
Sec. 711. Reauthorization of the critical path public-private 
partnership program.
Sec. 712. Reauthorization of orphan drug grants.
Sec. 713. Research into pediatric uses of drugs; additional authorities 
of Food and Drug Administration regarding molecularly targeted cancer 
drugs.

                        Subtitle B--Inspections

Sec. 721. Factory inspection.
Sec. 722. Uses of certain evidence.
Sec. 723. Improving FDA inspections.
Sec. 724. GAO report on inspections of foreign establishments 
manufacturing drugs.
Sec. 725. Unannounced foreign facility inspections pilot program.
Sec. 726. Reauthorization of inspection program.
Sec. 727. Enhancing intra-agency coordination and public health 
assessment with regard to compliance activities.
Sec. 728. Reporting of mutual recognition agreements for inspections 
and review activities.
Sec. 729. Enhancing transparency of drug facility inspection timelines.

      TITLE VIII--TRANSPARENCY, PROGRAM INTEGRITY, AND REGULATORY 
                              IMPROVEMENTS

Sec. 801. Prompt reports of marketing status by holders of approved 
applications for biological products.
Sec. 802. Encouraging blood donation.
Sec. 803. Regulation of certain products as drugs.
Sec. 804. Postapproval studies and program integrity for accelerated 
approval drugs.
Sec. 805. Facilitating the use of real world evidence.
Sec. 806. Dual Submission for Certain Devices.
Sec. 807. Medical Devices Advisory Committee meetings.
Sec. 808. Ensuring cybersecurity of medical devices.
Sec. 809. Public docket on proposed changes to third-party vendors.
Sec. 810. Facilitating exchange of product information prior to 
approval.
Sec. 811. Bans of devices for one or more intended uses.
Sec. 812. Clarifying application of exclusive approval, certification, 
or licensure for drugs designated for rare diseases or conditions.
Sec. 813. GAO report on third-party review.
Sec. 814. Reporting on pending generic drug applications and priority 
review applications.
Sec. 815. FDA Workforce Improvements.

                    TITLE I--FEES RELATING TO DRUGS

SEC. 101. SHORT TITLE; FINDING.

  (a) Short Title.--This title may be cited as the ``Prescription Drug 
User Fee Amendments of 2022''.
  (b) Finding.--The Congress finds that the fees authorized by the 
amendments made by 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 (21 U.S.C. 379g 
et seq.), 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.

SEC. 102. DEFINITIONS.

  (a) Human Drug Application.--Section 735(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379g(1)) is amended by striking ``an 
allergenic extract product, or'' and inserting ``does not include an 
application with respect to an allergenic extract product licensed 
before October 1, 2022, does not include an application with respect to 
a standardized allergenic extract product submitted pursuant to a 
notification to the applicant from the Secretary regarding the 
existence of a potency test that measures the allergenic activity of an 
allergenic extract product licensed by the applicant before October 1, 
2022, does not include an application with respect to''.
  (b) Prescription Drug Product.--Section 735(3) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379g(3)) is amended--
          (1) by redesignating subparagraphs (A), (B), and (C) as 
        clauses (i), (ii), and (iii), respectively;
          (2) by striking ``(3) The term'' and inserting ``(3)(A) The 
        term'';
          (3) by striking ``Such term does not include whole blood'' 
        and inserting the following:
          ``(B) Such term does not include whole blood'';
          (4) by striking ``an allergenic extract product,'' and 
        inserting ``an allergenic extract product licensed before 
        October 1, 2022, a standardized allergenic extract product 
        submitted pursuant to a notification to the applicant from the 
        Secretary regarding the existence of a potency test that 
        measures the allergenic activity of an allergenic extract 
        product licensed by the applicant before October 1, 2022,'' ; 
        and
          (5) by adding at the end the following:
                  ``(C)(i) If a written request to place a product in 
                the discontinued section of either of the lists 
                referenced in subparagraph (A)(iii) is submitted to the 
                Secretary on behalf of an applicant, and the request 
                identifies the date the product is withdrawn from sale, 
                then for purposes of assessing the prescription drug 
                program fee under section 736(a)(2), the Secretary 
                shall consider such product to have been included in 
                the discontinued section on the later of--
                          ``(I) the date such request was received; or
                          ``(II) if the product will be withdrawn from 
                        sale on a future date, such future date when 
                        the product is withdrawn from sale.
                  ``(ii) For purposes of this subparagraph, a product 
                shall be considered withdrawn from sale once the 
                applicant has ceased its own distribution of the 
                product, whether or not the applicant has ordered 
                recall of all previously distributed lots of the 
                product, except that a routine, temporary interruption 
                in supply shall not render a product withdrawn from 
                sale.''.
  (c) Skin-Test Diagnostic Product.--Section 735 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379g) is amended by adding at the end 
the following:
          ``(12) The term `skin-test diagnostic product'--
                  ``(A) means a product--
                          ``(i) for prick, scratch, intradermal, or 
                        subcutaneous administration;
                          ``(ii) expected to produce a limited, local 
                        reaction at the site of administration (if 
                        positive), rather than a systemic effect;
                          ``(iii) not intended to be a preventive or 
                        therapeutic intervention; and
                          ``(iv) intended to detect an immediate- or 
                        delayed-type skin hypersensitivity reaction to 
                        aid in the diagnosis of--
                                  ``(I) an allergy to an antimicrobial 
                                agent;
                                  ``(II) an allergy that is not to an 
                                antimicrobial agent, if the diagnostic 
                                product was authorized for marketing 
                                prior to October 1, 2022; or
                                  ``(III) infection with fungal or 
                                mycobacterial pathogens; and
                  ``(B) includes positive and negative controls 
                required to interpret the results of a product 
                described in subparagraph (A).''.

SEC. 103. AUTHORITY TO ASSESS AND USE DRUG FEES.

  (a) Types of Fees.--
          (1) Human drug application fee.--Section 736(a) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(a)) is 
        amended--
                  (A) in the matter preceding paragraph (1), by 
                striking ``fiscal year 2018'' and inserting ``fiscal 
                year 2023'';
                  (B) in paragraph (1)(A), by striking ``(c)(5)'' each 
                place it appears and inserting ``(c)(6)'';
                  (C) in paragraph (1)(C), by inserting ``prior to 
                approval'' after ``or was withdrawn''; and
                  (D) in paragraph (1), by adding at the end the 
                following:
                  ``(H) Exception for skin-test diagnostic products.--A 
                human drug application for a skin-test diagnostic 
                product shall not be subject to a fee under 
                subparagraph (A).''.
          (2) Prescription drug program fee.--Section 736(a)(2) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(a)(2)) is 
        amended--
                  (A) in subparagraph (A)--
                          (i) by striking ``Except as provided in 
                        subparagraphs (B) and (C)'' and inserting the 
                        following:
                          ``(i) Fee.--Except as provided in 
                        subparagraphs (B) and (C)'';
                          (ii) by striking ``subsection (c)(5)'' and 
                        inserting ``subsection (c)(6)''; and
                          (iii) by adding at the end the following:
                          ``(ii) Special rule.--If a drug product that 
                        is identified in a human drug application 
                        approved as of October 1 of a fiscal year is 
                        not a prescription drug product as of that date 
                        because the drug product is in the discontinued 
                        section of a list referenced in section 
                        735(3)(A)(iii), and on any subsequent day 
                        during such fiscal year the drug product is a 
                        prescription drug product, then except as 
                        provided in subparagraphs (B) and (C), each 
                        person who is named as the applicant in a human 
                        drug application with respect to such product, 
                        and who, after September 1, 1992, had pending 
                        before the Secretary a human drug application 
                        or supplement with respect to such product, 
                        shall pay the annual prescription drug program 
                        fee established for a fiscal year under 
                        subsection (c)(6) for such prescription drug 
                        product. Such fee shall be due on the last 
                        business day of such fiscal year and shall be 
                        paid only once for each such product for a 
                        fiscal year in which the fee is payable.''; and
                  (B) by amending subparagraph (B) to read as follows:
                  ``(B) Exception for certain prescription drug 
                products.--A prescription drug program fee shall not be 
                assessed for a prescription drug product under 
                subparagraph (A) if such product is--
                          ``(i) a large volume parenteral product (a 
                        sterile aqueous drug product packaged in a 
                        single-dose container with a volume greater 
                        than or equal to 100 mL, not including powders 
                        for reconstitution or pharmacy bulk packages) 
                        identified on the list compiled under section 
                        505(j)(7);
                          ``(ii) pharmaceutically equivalent (as 
                        defined in section 314.3 of title 21, Code of 
                        Federal Regulations (or any successor 
                        regulation)) to another product on the list of 
                        products compiled under section 505(j)(7) (not 
                        including the discontinued section of such 
                        list); or
                          ``(iii) a skin-test diagnostic product.''.
  (b) Fee Revenue Amounts.--
          (1) In general.--Paragraph (1) of section 736(b) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(b)) is 
        amended to read as follows:
          ``(1) In general.--For each of the fiscal years 2023 through 
        2027, fees under subsection (a) shall, except as provided in 
        subsections (c), (d), (f), and (g), be established to generate 
        a total revenue amount under such subsection that is equal to 
        the sum of--
                  ``(A) the annual base revenue for the fiscal year (as 
                determined under paragraph (3));
                  ``(B) the dollar amount equal to the inflation 
                adjustment for the fiscal year (as determined under 
                subsection (c)(1));
                  ``(C) the dollar amount equal to the strategic hiring 
                and retention adjustment for the fiscal year (as 
                determined under subsection (c)(2));
                  ``(D) the dollar amount equal to the capacity 
                planning adjustment for the fiscal year (as determined 
                under subsection (c)(3));
                  ``(E) the dollar amount equal to the operating 
                reserve adjustment for the fiscal year, if applicable 
                (as determined under subsection (c)(4));
                  ``(F) the dollar amount equal to the additional 
                direct cost adjustment for the fiscal year (as 
                determined under subsection (c)(5)); and
                  ``(G) additional dollar amounts for each fiscal year 
                as follows:
                          ``(i) $65,773,693 for fiscal year 2023.
                          ``(ii) $25,097,671 for fiscal year 2024.
                          ``(iii) $14,154,169 for fiscal year 2025.
                          ``(iv) $4,864,860 for fiscal year 2026.
                          ``(v) $1,314,620 for fiscal year 2027.''.
          (2) Annual base revenue.--Paragraph (3) of section 736(b) of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(b)) is 
        amended to read as follows:
          ``(3) Annual base revenue.--For purposes of paragraph (1), 
        the dollar amount of the annual base revenue for a fiscal year 
        shall be--
                  ``(A) for fiscal year 2023, $1,151,522,958; and
                  ``(B) for fiscal years 2024 through 2027, the dollar 
                amount of the total revenue amount established under 
                paragraph (1) for the previous fiscal year, not 
                including any adjustments made under subsection (c)(4) 
                or (c)(5).''.
  (c) Adjustments; Annual Fee Setting.--
          (1) Inflation adjustment.--Section 736(c)(1)(B)(ii) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        379h(c)(1)(B)(ii)) is amended by striking ``Washington-
        Baltimore, DC-MD-VA-WV'' and inserting ``Washington-Arlington-
        Alexandria, DC-VA-MD-WV''.
          (2) Strategic hiring and retention adjustment.--Section 
        736(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        379h(c)) is amended--
                  (A) by redesignating paragraphs (2) through (6) as 
                paragraphs (3) through (7), respectively; and
                  (B) by inserting after paragraph (1) the following:
          ``(2) Strategic hiring and retention adjustment.--For each 
        fiscal year, after the annual base revenue established in 
        subsection (b)(1)(A) is adjusted for inflation in accordance 
        with paragraph (1), the Secretary shall further increase the 
        fee revenue and fees by the following amounts:
                  ``(A) For fiscal year 2023, $9,000,000.
                  ``(B) For each of fiscal years 2024 through 2027, 
                $4,000,000.''.
          (3) Capacity planning adjustment.--Paragraph (3), as 
        redesignated, of section 736(c) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 379h(c)) is amended to read as follows:
          ``(3) Capacity planning adjustment.--
                  ``(A) In general.--For each fiscal year, after the 
                annual base revenue established in subsection (b)(1)(A) 
                is adjusted in accordance with paragraphs (1) and (2), 
                such revenue shall be adjusted further for such fiscal 
                year, in accordance with this paragraph, to reflect 
                changes in the resource capacity needs of the Secretary 
                for the process for the review of human drug 
                applications.
                  ``(B) Methodology.--For purposes of this paragraph, 
                the Secretary shall employ the capacity planning 
                methodology utilized by the Secretary in setting fees 
                for fiscal year 2021, as described in the notice titled 
                `Prescription Drug User Fee Rates for Fiscal Year 2021' 
                published in the Federal Register on August 3, 2020 (85 
                Fed. Reg. 46651). The workload categories used in 
                applying such methodology in forecasting shall include 
                only the activities described in that notice and, as 
                feasible, additional activities that are also directly 
                related to the direct review of applications and 
                supplements, including additional formal meeting types, 
                the direct review of postmarketing commitments and 
                requirements, the direct review of risk evaluation and 
                mitigation strategies, and the direct review of annual 
                reports for approved prescription drug products. 
                Subject to the exceptions in the preceding sentence, 
                the Secretary shall not include as workload categories 
                in applying such methodology in forecasting any non-
                core review activities, including those activities that 
                the Secretary referenced for potential future use in 
                such notice but did not utilize in setting fees for 
                fiscal year 2021.
                  ``(C) Limitation.--Under no circumstances shall an 
                adjustment under this paragraph result in fee revenue 
                for a fiscal year that is less than the sum of the 
                amounts under subsections (b)(1)(A) (the annual base 
                revenue for the fiscal year), (b)(1)(B) (the dollar 
                amount of the inflation adjustment for the fiscal 
                year), and (b)(1)(C) (the dollar amount of the 
                strategic hiring and retention adjustment for the 
                fiscal year).
                  ``(D) Publication in federal register.--The Secretary 
                shall publish in the Federal Register notice under 
                paragraph (6) of the fee revenue and fees resulting 
                from the adjustment and the methodologies under this 
                paragraph.''.
          (4) Operating reserve adjustment.--Paragraph (4), as 
        redesignated, of section 736(c) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 379h(c)) is amended--
                  (A) by amending subparagraph (A) to read as follows:
                  ``(A) Increase.--For fiscal year 2023 and subsequent 
                fiscal years, the Secretary shall, in addition to 
                adjustments under paragraphs (1), (2), and (3), further 
                increase the fee revenue and fees if such an adjustment 
                is necessary to provide for operating reserves of 
                carryover user fees for the process for the review of 
                human drug applications for each fiscal year in at 
                least the following amounts:
                          ``(i) For fiscal year 2023, at least 8 weeks 
                        of operating reserves.
                          ``(ii) For fiscal year 2024, at least 9 weeks 
                        of operating reserves.
                          ``(iii) For fiscal year 2025 and subsequent 
                        fiscal years, at least 10 weeks of operating 
                        reserves.''; and
                  (B) in subparagraph (C), by striking ``paragraph 
                (5)'' and inserting ``paragraph (6)''.
          (5) Additional direct cost adjustment.--Paragraph (5), as 
        redesignated, of section 736(c) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 379h(c)) is amended to read as follows:
          ``(5) Additional direct cost adjustment.--
                  ``(A) Increase.--The Secretary shall, in addition to 
                adjustments under paragraphs (1), (2), (3), and (4), 
                further increase the fee revenue and fees--
                          ``(i) for fiscal year 2023, by $44,386,150; 
                        and
                          ``(ii) for each of fiscal years 2024 through 
                        2027, by the amount set forth in clauses (i) 
                        through (iv) of subparagraph (B), as 
                        applicable, multiplied by the Consumer Price 
                        Index for urban consumers (Washington-
                        Arlington-Alexandria, DC-VA-MD-WV; Not 
                        Seasonally Adjusted; All Items; Annual Index) 
                        for the most recent year of available data, 
                        divided by such Index for 2021.
                  ``(B) Applicable amounts.--The amounts referred to in 
                subparagraph (A)(ii) are the following:
                          ``(i) For fiscal year 2024, $60,967,993.
                          ``(ii) For fiscal year 2025, $35,799,314.
                          ``(iii) For fiscal year 2026, $35,799, 314.
                          ``(iv) For fiscal year 2027, $35,799,314.''.
          (6) Annual fee setting.--Paragraph (6), as redesignated, of 
        section 736(c) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 379h(c)) is amended by striking ``September 30, 2017'' 
        and inserting ``September 30, 2022''.
  (d) Crediting and Availability of Fees.--Section 736(g)(3) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)(3)) is amended 
by striking ``fiscal years 2018 through 2022'' and inserting ``fiscal 
years 2023 through 2027''.
  (e) Written Requests for Waivers, Reductions, Exemptions, and 
Returns; Disputes Concerning Fees.--Section 736(i) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379h(i)) is amended to read as 
follows:
  ``(i) Written Requests for Waivers, Reductions, Exemptions, and 
Returns; Disputes Concerning Fees.--To qualify for consideration for a 
waiver or reduction under subsection (d), an exemption under subsection 
(k), or the return of any fee paid under this section, including if the 
fee is claimed to have been paid in error, a person shall--
          ``(1) not later than 180 days after such fee is due, submit 
        to the Secretary a written request justifying such waiver, 
        reduction, exemption, or return; and
          ``(2) include in the request any legal authorities under 
        which the request is made.''.
  (f) Orphan Drugs.--Section 736(k) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379h(k)) is amended--
          (1) in paragraph (1)(B), by striking ``during the previous 
        year'' and inserting ``as determined under paragraph (2)''; and
          (2) by amending paragraph (2) to read as follows:
          ``(2) Evidence of qualification.--An exemption under 
        paragraph (1) applies with respect to a drug only if the 
        applicant involved submits a certification that the applicant's 
        gross annual revenues did not exceed $50,000,000 for the last 
        calendar year ending prior to the fiscal year for which the 
        exemption is requested. Such certification shall be supported 
        by--
                  ``(A) tax returns submitted to the United States 
                Internal Revenue Service; or
                  ``(B) as necessary, other appropriate financial 
                information.''.

SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS.

  Section 736B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379h-2) is amended--
          (1) in subsection (a)(1), by striking ``Beginning with fiscal 
        year 2018, not'' and inserting ``Not'';
          (2) by striking ``Prescription Drug User Fee Amendments of 
        2017'' each place it appears and inserting ``Prescription Drug 
        User Fee Amendments of 2022'';
          (3) in subsection (a)(3)(A), by striking ``Not later than 30 
        calendar days after the end of the second quarter of fiscal 
        year 2018, and not later than 30 calendar days after the end of 
        each quarter of each fiscal year thereafter'' and inserting 
        ``Not later than 30 calendar days after the end of each quarter 
        of each fiscal year for which fees are collected under this 
        part'';
          (4) in subsection (a)(3)(B), by adding at the end the 
        following:
                          ``(v) For fiscal years 2023 and 2024, of the 
                        meeting requests from sponsors for which the 
                        Secretary has determined that a face-to-face 
                        meeting is appropriate, the number of face-to-
                        face meetings requested by sponsors to be 
                        conducted in person (in such manner as the 
                        Secretary shall prescribe on the internet 
                        website of the Food and Drug Administration), 
                        and the number of such in-person meetings 
                        granted by the Secretary.'';
          (5) in subsection (a)(4), by striking ``Beginning with fiscal 
        year 2020, the'' and inserting ``The'';
          (6) in subsection (b), by striking ``Beginning with fiscal 
        year 2018, not'' and inserting ``Not'';
          (7) in subsection (c), by striking ``Beginning with fiscal 
        year 2018, for'' and inserting ``For''; and
          (8) in subsection (f)--
                  (A) in paragraph (1), in the matter preceding 
                subparagraph (A), by striking ``fiscal year 2022'' and 
                inserting ``fiscal year 2027''; and
                  (B) in paragraph (5), by striking ``January 15, 
                2022'' and inserting ``January 15, 2027''.

SEC. 105. SUNSET DATES.

  (a) Authorization.--Sections 735 and 736 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379g; 379h) shall cease to be effective 
October 1, 2027.
  (b) Reporting Requirements.--Section 736B of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379h-2) shall cease to be effective January 
31, 2028.
  (c) Previous Sunset Provision.--Effective October 1, 2022, 
subsections (a) and (b) of section 104 of the FDA Reauthorization Act 
of 2017 (Public Law 115-52) are repealed.

SEC. 106. EFFECTIVE DATE.

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

SEC. 107. 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 
(21 U.S.C. 379g et seq.), as in effect on the day before the date of 
the enactment of this title, shall continue to be in effect with 
respect to human drug applications and supplements (as defined in such 
part as of such day) that on or after October 1, 2017, but before 
October 1, 2022, were accepted by the Food and Drug Administration for 
filing with respect to assessing and collecting any fee required by 
such part for a fiscal year prior to fiscal year 2023.

                   TITLE II--FEES RELATING TO DEVICES

SEC. 201. SHORT TITLE; FINDING.

  (a) Short Title.--This title may be cited as the ``Medical Device 
User Fee Amendments of 2022''.
  (b) Finding.--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 (21 U.S.C. 379i et seq.), 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.

SEC. 202. DEFINITIONS.

  Section 737 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379i) is amended--
          (1) in paragraph (9)--
                  (A) in the matter preceding subparagraph (A), by 
                striking ``and premarket notification submissions'' and 
                inserting ``premarket notification submissions, and de 
                novo classification requests'';
                  (B) in subparagraph (D), by striking ``and 
                submissions'' and inserting ``submissions, and 
                requests'';
                  (C) in subparagraph (F), by striking ``and premarket 
                notification submissions'' and inserting ``premarket 
                notification submissions, and de novo classification 
                requests'';
                  (D) in each of subparagraphs (G) and (H), by striking 
                ``or submissions'' and inserting ``submissions, or 
                requests''; and
                  (E) in subparagraph (K), by striking ``or premarket 
                notification submissions'' and inserting ``premarket 
                notification submissions, or de novo classification 
                requests''; and
          (2) in paragraph (11), by striking ``2016'' and inserting 
        ``2021''.

SEC. 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)) is amended--
          (1) in paragraph (1), by striking ``fiscal year 2018'' and 
        inserting ``fiscal year 2023''; and
          (2) in paragraph (2)--
                  (A) in subparagraph (A)--
                          (i) in the matter preceding clause (i), by 
                        striking ``October 1, 2017'' and inserting 
                        ``October 1, 2022'';
                          (ii) in clause (iii), by striking ``75 
                        percent'' and inserting ``80 percent''; and
                          (iii) in clause (viii), by striking ``3.4 
                        percent'' and inserting ``4.5 percent'';
                  (B) in subparagraph (B)(iii), by striking ``or 
                premarket notification submission'' and inserting 
                ``premarket notification submission, or de novo 
                classification request''; and
                  (C) in subparagraph (C), by striking ``or periodic 
                reporting concerning a class III device'' and inserting 
                ``periodic reporting concerning a class III device, 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)) is amended--
          (1) in paragraph (1), by striking ``2018 through 2022'' and 
        inserting ``2023 through 2027'';
          (2) by amending paragraph (2) to read as follows:
          ``(2) Base fee amounts specified.--For purposes of paragraph 
        (1), the base fee amounts specified in this paragraph are as 
        follows:

 
----------------------------------------------------------------------------------------------------------------
                                                             Fiscal     Fiscal     Fiscal     Fiscal     Fiscal
                        ``Fee Type                         Year 2023  Year 2024  Year 2025  Year 2026  Year 2027
----------------------------------------------------------------------------------------------------------------
Premarket Application....................................   $425,000   $435,000   $445,000   $455,000   $470,000
Establishment Registration...............................     $6,250     $6,875     $7,100     $7,575  $8,465'';
                                                                                                             and
----------------------------------------------------------------------------------------------------------------


        ''; and  (3) by amending paragraph (3) to read as follows:
          ``(3) Total revenue amounts specified.--For purposes of 
        paragraph (1), the total revenue amounts specified in this 
        paragraph are as follows:
                  ``(A) $312,606,000 for fiscal year 2023.
                  ``(B) $335,750,000 for fiscal year 2024.
                  ``(C) $350,746,400 for fiscal year 2025.
                  ``(D) $366,486,300 for fiscal year 2026.
                  ``(E) $418,343,000 for fiscal year 2027.''.
  (c) Annual Fee Setting; Adjustments.--Section 738(c) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j(c)) is amended--
          (1) in paragraph (1), by striking ``2017'' and inserting 
        ``2022'';
          (2) in paragraph (2)--
                  (A) in subparagraph (A), by striking ``2018'' and 
                inserting ``2023'';
                  (B) in subparagraph (B)--
                          (i) in the matter preceding clause (i), by 
                        striking ``fiscal year 2018'' and inserting 
                        ``fiscal year 2023''; and
                          (ii) in clause (ii), by striking ``fiscal 
                        year 2016'' and inserting ``fiscal year 2022'';
                  (C) in subparagraph (C), by striking ``Washington-
                Baltimore, DC-MD-VA-WV'' and inserting ``Washington-
                Arlington-Alexandria, DC-VA-MD-WV''; and
                  (D) in subparagraph (D), in the matter preceding 
                clause (i), by striking ``fiscal years 2018 through 
                2022'' and inserting ``fiscal years 2023 through 
                2027'';
          (3) in paragraph (3), by striking ``2018 through 2022'' and 
        inserting ``2023 through 2027'';
          (4) by redesignating paragraphs (4) and (5) as paragraphs (7) 
        and (8), respectively; and
          (5) by inserting after paragraph (3) the following:
          ``(4) Performance improvement adjustment.--
                  ``(A) In general.--For each of fiscal years 2025 
                through 2027, after the adjustments under paragraphs 
                (2) and (3), the base establishment registration fee 
                amounts for such fiscal year shall be increased to 
                reflect changes in the resource needs of the Secretary 
                due to improved review performance goals for the 
                process for the review of device applications 
                identified in the letters described in section 201(b) 
                of the Medical Device User Fee Amendments of 2022, as 
                the Secretary determines necessary to achieve an 
                increase in total fee collections for such fiscal year 
                equal to the following amounts:
                          ``(i) For fiscal year 2025, the product of--
                                  ``(I) the amount determined under 
                                subparagraph (B)(i)(I); and
                                  ``(II) the applicable inflation 
                                adjustment under paragraph (2)(B) for 
                                such fiscal year.
                          ``(ii) For fiscal year 2026, the product of--
                                  ``(I) the sum of the amounts 
                                determined under subparagraphs 
                                (B)(i)(II), (B)(ii)(I), and 
                                (B)(iii)(I); and
                                  ``(II) the applicable inflation 
                                adjustment under paragraph (2)(B) for 
                                such fiscal year.
                          ``(iii) For fiscal year 2027, the product 
                        of--
                                  ``(I) the sum of the amounts 
                                determined under subparagraphs 
                                (B)(i)(III), (B)(ii)(II), and 
                                (B)(iii)(II); and
                                  ``(II) the applicable inflation 
                                adjustment under paragraph (2)(B) for 
                                such fiscal year.
                  ``(B) Amounts.--
                          ``(i) Pre-submission amount.--For purposes of 
                        subparagraph (A), with respect to the pre-
                        submission written feedback goal, the amounts 
                        determined under this subparagraph are as 
                        follows:
                                  ``(I) For fiscal year 2025, 
                                $15,396,600 if such goal for fiscal 
                                year 2023 is met.
                                  ``(II) For fiscal year 2026:
                                          ``(aa) $15,396,600 if such 
                                        goal for fiscal year 2023 is 
                                        met and such goal for fiscal 
                                        year 2024 is not met.
                                          ``(bb) $36,792,200 if such 
                                        goal for fiscal year 2024 is 
                                        met.
                                  ``(III) For fiscal year 2027:
                                          ``(aa) $15,396,600 if such 
                                        goal for fiscal year 2023 is 
                                        met and such goal for each of 
                                        fiscal years 2024 and 2025 is 
                                        not met.
                                          ``(bb) $36,792,200 if such 
                                        goal for fiscal year 2024 is 
                                        met and such goal for fiscal 
                                        year 2025 is not met.
                                          ``(cc) $40,572,600 if such 
                                        goal for fiscal year 2025 is 
                                        met.
                          ``(ii) De novo classification amount.--For 
                        purposes of subparagraph (A), with respect to 
                        the de novo decision goal, the amounts 
                        determined under this subparagraph are as 
                        follows:
                                  ``(I) For fiscal year 2026, 
                                $6,323,500 if such goal for fiscal year 
                                2023 is met.
                                  ``(II) For fiscal year 2027:
                                          ``(aa) $6,323,500 if such 
                                        goal for fiscal year 2023 is 
                                        met and such goal for fiscal 
                                        year 2024 is not met.
                                          ``(bb) $11,765,400 if such 
                                        goal for fiscal year 2024 is 
                                        met.
                          ``(iii) Premarket notification and premarket 
                        approval amount.--For purposes of subparagraph 
                        (A), with respect to the 510(k) decision goal, 
                        510(k) shared outcome total time to decision 
                        goal, PMA decision goal, and PMA shared outcome 
                        total time to decision goal, the amounts 
                        determined under this subparagraph are as 
                        follows:
                                  ``(I) For fiscal year 2026, 
                                $1,020,000 if the four goals for fiscal 
                                year 2023 are met.
                                  ``(II) For fiscal year 2027:
                                          ``(aa) $1,020,000 if the four 
                                        goals for fiscal year 2023 are 
                                        met and one or more of the four 
                                        goals for fiscal year 2024 are 
                                        not met.
                                          ``(bb) $3,906,000 if the four 
                                        goals for fiscal year 2024 are 
                                        met.
                  ``(C) Performance calculation.--For purposes of this 
                paragraph, performance of the goals listed in 
                subparagraph (D) shall be determined as specified in 
                the letters described in section 201(b) of the Medical 
                Device User Fee Amendments of 2022 and based on data 
                available as of the following dates:
                          ``(i) The performance of the pre-submission 
                        written feedback goal shall be based on data 
                        available as of--
                                  ``(I) for fiscal year 2023, March 31, 
                                2024;
                                  ``(II) for fiscal year 2024, March 
                                31, 2025; and
                                  ``(III) for fiscal year 2025, March 
                                31, 2026.
                          ``(ii) The performance of the de novo 
                        decision goal, 510(k) decision goal, 510(k) 
                        shared outcome total time to decision goal, PMA 
                        decision goal, and PMA shared outcome total 
                        time to decision goal shall be based on data 
                        available as of--
                                  ``(I) for fiscal year 2023, March 31, 
                                2025; and
                                  ``(II) for fiscal year 2024, March 
                                31, 2026.
                  ``(D) Goals defined.--For purposes of this paragraph, 
                the terms `pre-submission written feedback goal', `de 
                novo decision goal', `510(k) decision goal', `510(k) 
                shared outcome total time to decision goal', `PMA 
                decision goal', and `PMA shared outcome total time to 
                decision goal' refer to the goals identified by the 
                same names in the letters described in section 201(b) 
                of the Medical Device User Fee Amendments of 2022.
          ``(5) Hiring adjustment.--
                  ``(A) In general.--For each of fiscal years 2025 
                through 2027, after the adjustments under paragraphs 
                (2), (3), and (4), if applicable, if the number of 
                hires to support the process for the review of device 
                applications falls below the thresholds specified in 
                subparagraph (B) for the applicable fiscal years, the 
                base establishment registration fee amounts shall be 
                decreased as the Secretary determines necessary to 
                achieve a reduction in total fee collections equal to 
                the hiring adjustment amount under subparagraph (C).
                  ``(B) Thresholds.--The thresholds specified in this 
                subparagraph are as follows:
                          ``(i) For fiscal year 2025, the threshold is 
                        123 hires for fiscal year 2023.
                          ``(ii) For fiscal year 2026, the threshold is 
                        38 hires for fiscal year 2024.
                          ``(iii) For fiscal year 2027, the threshold 
                        is--
                                  ``(I) 22 hires for fiscal year 2025 
                                if the base establishment registration 
                                fees are not increased by the amount 
                                determined under paragraph (4)(A)(i); 
                                or
                                  ``(II) 75 hires for fiscal year 2025 
                                if such fees are so increased.
                  ``(C) Hiring adjustment amount.--The hiring 
                adjustment amount for fiscal year 2025 and each 
                subsequent fiscal year is the product of--
                          ``(i) the number of hires by which the hiring 
                        goal specified in subparagraph (D) for the 
                        fiscal year before the prior fiscal year was 
                        not met;
                          ``(ii) $72,877; and
                          ``(iii) the applicable inflation adjustment 
                        under paragraph (2)(B) for the fiscal year for 
                        which the hiring goal was not met.
                  ``(D) Hiring goals.--The hiring goals for each of 
                fiscal years 2023 through 2025 are as follows:
                          ``(i) For fiscal year 2023, 144 hires.
                          ``(ii) For fiscal year 2024, 42 hires.
                          ``(iii) For fiscal year 2025:
                                  ``(I) 24 hires if the base 
                                establishment registration fees are not 
                                increased by the amount determined 
                                under paragraph (4)(A)(i).
                                  ``(II) 83 hires if the base 
                                establishment registration fees are 
                                increased by the amount determined 
                                under paragraph (4)(A)(i).
                  ``(E) Number of hires.--For purposes of this 
                paragraph, the number of hires shall be determined by 
                the Secretary as set forth in the letters described in 
                section 201(b) of the Medical Device User Fee 
                Amendments of 2022.
          ``(6) Operating reserve adjustment.--
                  ``(A) In general.--For each of fiscal years 2023 
                through 2027, after the adjustments under paragraphs 
                (2), (3), (4), and (5), if applicable, if the Secretary 
                has operating reserves of carryover user fees for the 
                process for the review of device applications in excess 
                of the designated amount in subparagraph (B), the 
                Secretary shall decrease the base establishment 
                registration fee amounts to provide for not more than 
                such designated amount of operating reserves.
                  ``(B) Designated amount.--Subject to subparagraph 
                (C), for each fiscal year, the designated amount in 
                this subparagraph is equal to the sum of--
                          ``(i) 13 weeks of operating reserves of 
                        carryover user fees; and
                          ``(ii) 1 month of operating reserves 
                        maintained pursuant to paragraph (8).
                  ``(C) Excluded amount.--For the period of fiscal 
                years 2023 through 2026, a total amount equal to 
                $118,000,000 shall not be considered part of the 
                designated amount under subparagraph (B) and shall not 
                be subject to the decrease under subparagraph (A).''.
  (d) Small Businesses.--Section 738 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j) is amended in each of subsections 
(d)(2)(B)(iii) and (e)(2)(B)(iii) by inserting ``, if extant,'' after 
``national taxing authority''.
  (e) Conditions.--Section 738(g) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j(g)) is amended--
          (1) in paragraph (1)(A), by striking ``$320,825,000'' and 
        inserting ``$398,566,000''; and
          (2) in paragraph (2), by inserting ``de novo classification 
        requests,'' after ``class III device,''.
  (f) Crediting and Availability of Fees.--Section 738(h)(3) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(h)(3)) is amended 
to read as follows:
          ``(3) Authorization of appropriations.--
                  ``(A) In general.--For each of fiscal years 2023 
                through 2027, there is authorized to be appropriated 
                for fees under this section an amount equal to the 
                revenue amount determined under subparagraph (B), less 
                the amount of reductions determined under subparagraph 
                (C).
                  ``(B) Revenue amount.--For purposes of this 
                paragraph, the revenue amount for each fiscal year is 
                the sum of--
                          ``(i) the total revenue amount under 
                        subsection (b)(3) for the fiscal year, as 
                        adjusted under paragraphs (2) and (3) of 
                        subsection (c); and
                          ``(ii) the performance improvement adjustment 
                        amount for the fiscal year under subsection 
                        (c)(4), if applicable.
                  ``(C) Reductions.--For purposes of this paragraph, 
                the amount of reductions for each fiscal year is the 
                sum of--
                          ``(i) the hiring adjustment amount for the 
                        fiscal year under subsection (c)(5), if 
                        applicable; and
                          ``(ii) the operating reserve adjustment 
                        amount for the fiscal year under subsection 
                        (c)(6), if applicable.''.

SEC. 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)) is amended--
          (1) by striking ``fiscal year 2018'' each place it appears 
        and inserting ``fiscal year 2023'';
          (2) by striking ``Medical Device User Fee Amendments of 
        2017'' each place it appears and inserting ``Medical Device 
        User Fee Amendments of 2022'';
          (3) in paragraph (1)--
                  (A) in subparagraph (A), by redesignating the second 
                clause (iv) (relating to analysis) as clause (v); and
                  (B) in subparagraph (A)(iv), by striking ``fiscal 
                year 2020'' and inserting ``fiscal year 2023''; and
          (4) in paragraph (4), by striking ``2018 through 2022'' and 
        inserting ``2023 through 2027''.
  (b) Reauthorization.--Section 738A(b) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j-1(b)) is amended--
          (1) in paragraph (1), by striking ``2022'' and inserting 
        ``2027''; and
          (2) in paragraph (5), by striking ``2022'' and inserting 
        ``2027''.

SEC. 205. CONFORMITY ASSESSMENT PILOT PROGRAM.

  Section 514(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360d(d)) is amended to read as follows:
  ``(d) Accreditation Scheme for Conformity Assessment.--
          ``(1) In general.--The Secretary shall establish a program 
        under which--
                  ``(A) testing laboratories meeting criteria specified 
                in guidance by the Secretary may be accredited by 
                accreditation bodies meeting criteria specified in 
                guidance by the Secretary, to conduct testing to 
                support the assessment of the conformity of a device to 
                certain standards recognized under this section; and
                  ``(B) subject to paragraph (2), results from tests 
                conducted to support the assessment of conformity of 
                devices as described in subparagraph (A) conducted by 
                testing laboratories accredited pursuant to this 
                subsection shall be accepted by the Secretary for 
                purposes of demonstrating such conformity unless the 
                Secretary finds that certain results of such tests 
                should not be so accepted.
          ``(2) Secretarial review of accredited laboratory results.--
        The Secretary may--
                  ``(A) review the results of tests conducted by 
                testing laboratories accredited pursuant to this 
                subsection, including by conducting periodic audits of 
                such results or of the processes of accredited bodies 
                or testing laboratories;
                  ``(B) following such review, take additional measures 
                under this Act, as the Secretary determines 
                appropriate, such as--
                          ``(i) suspension or withdrawal of 
                        accreditation of a testing laboratory or 
                        recognition of an accreditation body under 
                        paragraph (1)(A); or
                          ``(ii) requesting additional information with 
                        respect to a device; and
                  ``(C) if the Secretary becomes aware of information 
                materially bearing on the safety or effectiveness of a 
                device for which an assessment of conformity was 
                supported by testing conducted by a testing laboratory 
                accredited under this subsection, take such additional 
                measures under this Act, as the Secretary determines 
                appropriate, such as--
                          ``(i) suspension or withdrawal of 
                        accreditation of a testing laboratory or 
                        recognition of an accreditation body under 
                        paragraph (1)(A); or
                          ``(ii) requesting additional information with 
                        regard to such device.
          ``(3) Implementation and reporting.--
                  ``(A) Pilot program transition.--After September 30, 
                2023, the pilot program previously initiated under this 
                subsection, as in effect prior to the date of enactment 
                of the Medical Device User Fee Amendments of 2022, 
                shall be considered to be completed, and the Secretary 
                may continue operating a program consistent with this 
                subsection.
                  ``(B) 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.''.

SEC. 206. REAUTHORIZATION OF THIRD-PARTY REVIEW PROGRAM.

  Section 523(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360m(c)) is amended by striking ``2022'' and inserting ``2027''.

SEC. 207. SUNSET DATES.

  (a) Authorization.--Sections 737 and 738 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379i; 379j) shall cease to be effective 
October 1, 2027.
  (b) Reporting Requirements.--Section 738A (21 U.S.C. 379j- 1) of the 
Federal Food, Drug, and Cosmetic Act (regarding reauthorization and 
reporting requirements) shall cease to be effective January 31, 2028.
  (c) Previous Sunset Provisions.--Effective October 1, 2022, 
subsections (a) and (b) of section 210 of the FDA Reauthorization Act 
of 2017 (Public Law 115-52) are repealed.

SEC. 208. EFFECTIVE DATE.

  The amendments made by this title shall take effect on October 1, 
2022, or the date of the enactment of this Act, whichever is later, 
except that fees under part 3 of subchapter C of chapter VII of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.) shall be 
assessed for all submissions listed in section 738(a)(2)(A) of such Act 
received on or after October 1, 2022, regardless of the date of the 
enactment of this Act.

SEC. 209. 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 et seq.), as in effect on the day before the date of 
the enactment of this title, shall continue to be in effect with 
respect to the submissions listed in section 738(a)(2)(A) of such Act 
(as defined in such part as of such day) that on or after October 1, 
2017, but before October 1, 2022, were received by the Food and Drug 
Administration with respect to assessing and collecting any fee 
required by such part for a fiscal year prior to fiscal year 2023.

               TITLE III--FEES RELATING TO GENERIC DRUGS

SEC. 301. SHORT TITLE; FINDING.

  (a) Short Title.--This title may be cited as the ``Generic Drug User 
Fee Amendments of 2022''.
  (b) Finding.--The Congress finds that the fees authorized by the 
amendments made by 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 (21 U.S.C. 379j-41 et seq.), 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.

SEC. 302. 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)) is amended--
          (1) in the matter preceding paragraph (1), by striking 
        ``fiscal year 2018'' and inserting ``fiscal year 2023'';
          (2) in paragraph (2)(C), by striking ``2018 through 2022'' 
        and inserting ``2023 through 2027'';
          (3) in paragraph (3)(B), by striking ``2018 through 2022'' 
        and inserting ``2023 through 2027'';
          (4) in paragraph (4)(D), by striking ``2018 through 2022'' 
        and inserting ``2023 through 2027''; and
          (5) in paragraph (5)(D), by striking ``2018 through 2022'' 
        and inserting ``2023 through 2027''.
  (b) Fee Revenue Amounts.--Section 744B(b) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j-42(b)) is amended--
          (1) in paragraph (1)--
                  (A) in subparagraph (A)--
                          (i) in the heading, by striking ``2018'' and 
                        inserting ``2023'';
                          (ii) by striking ``2018'' and inserting 
                        ``2023''; and
                          (iii) by striking ``$493,600,000'' and 
                        inserting ``$582,500,000''; and
                  (B) by amending subparagraph (B) to read as follows:
                  ``(B) Fiscal years 2024 through 2027.--
                          ``(i) In general.--For each of the fiscal 
                        years 2024 through 2027, fees under paragraphs 
                        (2) through (5) of subsection (a) shall be 
                        established to generate a total estimated 
                        revenue amount under such subsection that is 
                        equal to the base revenue amount for the fiscal 
                        year under clause (ii), as adjusted pursuant to 
                        subsection (c).
                          ``(ii) Base revenue amount.--The base revenue 
                        amount for a fiscal year referred to in clause 
                        (i) is equal to the total revenue amount 
                        established under this paragraph for the 
                        previous fiscal year, not including any 
                        adjustments made for such previous fiscal year 
                        under subsection (c)(3).''; and
          (2) in paragraph (2)--
                  (A) in subparagraph (C), by striking ``one-third the 
                amount'' and inserting ``twenty-four percent'';
                  (B) in subparagraph (D), by striking ``Seven 
                percent'' and inserting ``Six percent''; and
                  (C) in subparagraph (E)(i), by striking ``Thirty-five 
                percent'' and inserting ``Thirty-six percent''.
  (c) Adjustments.--Section 744B(c) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j-42(c)) is amended--
          (1) in paragraph (1)--
                  (A) in the matter preceding subparagraph (A)--
                          (i) by striking ``2019'' and inserting 
                        ``2024''; and
                          (ii) by striking ``to equal the product of 
                        the total revenues established in such notice 
                        for the prior fiscal year multiplied'' and 
                        inserting ``to equal the base revenue amount 
                        for the fiscal year (as specified in subsection 
                        (b)(1)(B)) multiplied''; and
                  (B) in subparagraph (C), by striking ``Washington-
                Baltimore, DC-MD-VA-WV'' and inserting ``Washington-
                Arlington-Alexandria, DC-VA-MD-WV''; and
          (2) by striking paragraph (2) and inserting the following:
          ``(2) Capacity planning adjustment.--
                  ``(A) In general.--Beginning with fiscal year 2024, 
                the Secretary shall, in addition to the adjustment 
                under paragraph (1), further increase the fee revenue 
                and fees under this section for a fiscal year, in 
                accordance with this paragraph, to reflect changes in 
                the resource capacity needs of the Secretary for human 
                generic drug activities.
                  ``(B) Capacity planning methodology.--The Secretary 
                shall establish a capacity planning methodology for 
                purposes of this paragraph, which shall--
                          ``(i) be derived from the methodology and 
                        recommendations made in the report titled 
                        `Independent Evaluation of the GDUFA Resource 
                        Capacity Planning Adjustment Methodology: 
                        Evaluation and Recommendations' announced in 
                        the Federal Register on August 3, 2020;
                          ``(ii) incorporate approaches and attributes 
                        determined appropriate by the Secretary, 
                        including approaches and attributes made in 
                        such report, except that in incorporating such 
                        approaches and attributes the workload 
                        categories used in forecasting resources shall 
                        only be the workload categories specified in 
                        section VIII.B.2.e. of the letters described in 
                        section 301(b) of the Generic Drug User Fee 
                        Amendments of 2022; and
                          ``(iii) be effective beginning with fiscal 
                        year 2024.
                  ``(C) Limitations.--
                          ``(i) In general.--Under no circumstances 
                        shall an adjustment under this paragraph result 
                        in fee revenue for a fiscal year that is less 
                        than the sum of the amounts under subsection 
                        (b)(1)(B)(ii) (the base revenue amount for the 
                        fiscal year) and paragraph (1) (the dollar 
                        amount of the inflation adjustment for the 
                        fiscal year).
                          ``(ii) Percentage limitation.--An adjustment 
                        under this paragraph shall not exceed three 
                        percent of the sum described in clause (i) for 
                        the fiscal year, except that such limitation 
                        shall be four percent if--
                                  ``(I) for purposes of a fiscal year 
                                2024 adjustment, the Secretary 
                                determines that during the period from 
                                April 1, 2021, through March 31, 2023--
                                          ``(aa) the total number of 
                                        abbreviated new drug 
                                        applications submitted was 
                                        greater than or equal to 2,000; 
                                        or
                                          ``(bb) thirty-five percent or 
                                        more of abbreviated new drug 
                                        applications submitted related 
                                        to complex products (as that 
                                        term is defined in section XI 
                                        of the letters described in 
                                        section 301(b) of the Generic 
                                        Drug User Fee Amendments of 
                                        2022);
                                  ``(II) for purposes of a fiscal year 
                                2025 adjustment, the Secretary 
                                determines that during the period from 
                                April 1, 2022, through March 31, 2024--
                                          ``(aa) the total number of 
                                        abbreviated new drug 
                                        applications submitted was 
                                        greater than or equal to 2,300; 
                                        or
                                          ``(bb) thirty-five percent or 
                                        more of abbreviated new drug 
                                        applications submitted related 
                                        to complex products (as so 
                                        defined);
                                  ``(III) for purposes of a fiscal year 
                                2026 adjustment, the Secretary 
                                determines that during the period from 
                                April 1, 2023, through March 31, 2025--
                                          ``(aa) the total number of 
                                        abbreviated new drug 
                                        applications submitted was 
                                        greater than or equal to 2,300; 
                                        or
                                          ``(bb) thirty-five percent or 
                                        more of abbreviated new drug 
                                        applications submitted related 
                                        to complex products (as so 
                                        defined); and
                                  ``(IV) for purposes of a fiscal year 
                                2027 adjustment, the Secretary 
                                determines that during the period from 
                                April 1, 2024, through March 31, 2026--
                                          ``(aa) the total number of 
                                        abbreviated new drug 
                                        applications submitted was 
                                        greater than or equal to 2,300; 
                                        or
                                          ``(bb) thirty-five percent or 
                                        more of abbreviated new drug 
                                        applications submitted related 
                                        to complex products (as so 
                                        defined).
                  ``(D) Publication in federal register.--The Secretary 
                shall publish in the Federal Register notice referred 
                to in subsection (a) the fee revenue and fees resulting 
                from the adjustment and the methodology under this 
                paragraph.
          ``(3) Operating reserve adjustment.--
                  ``(A) In general.--For fiscal year 2024 and each 
                subsequent fiscal year, the Secretary may, in addition 
                to adjustments under paragraphs (1) and (2), further 
                increase the fee revenue and fees under this section 
                for such fiscal year if such an adjustment is necessary 
                to provide operating reserves of carryover user fees 
                for human generic drug activities for not more than the 
                number of weeks specified in subparagraph (B) with 
                respect to that fiscal year.
                  ``(B) Number of weeks.--The number of weeks specified 
                in this subparagraph is--
                          ``(i) 8 weeks for fiscal year 2024;
                          ``(ii) 9 weeks for fiscal year 2025; and
                          ``(iii) 10 weeks for each of fiscal year 2026 
                        and 2027.
                  ``(C) Decrease.--If the Secretary has carryover 
                balances for human generic drug activities in excess of 
                12 weeks of the operating reserves referred to in 
                subparagraph (A), the Secretary shall decrease the fee 
                revenue and fees referred to in such subparagraph to 
                provide for not more than 12 weeks of such operating 
                reserves.
                  ``(D) Rationale for adjustment.--If an adjustment 
                under this paragraph is made, the rationale for the 
                amount of the increase or decrease (as applicable) in 
                fee revenue and fees shall be contained in the annual 
                Federal Register notice under subsection (a) publishing 
                the fee revenue and fees for the fiscal year 
                involved.''.
  (d) Annual Fee Setting.--Section 744B(d)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j-42(d)(1)) is amended--
          (1) in the paragraph heading, by striking ``2018 through 
        2022'' and inserting ``2023 through 2027''; and
          (2) by striking ``more than 60 days before the first day of 
        each of fiscal years 2018 through 2022'' and inserting ``later 
        than 60 days before the first day of each of fiscal years 2023 
        through 2027''.
  (e) Crediting and Availability of Fees.--Section 744B(i)(3) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(i)(3)) is 
amended by striking ``fiscal years 2018 through 2022'' and inserting 
``fiscal years 2023 through 2027''.
  (f) Effect of Failure to Pay Fees.--The heading of paragraph (3) of 
section 744B(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j-42(g)) is amended by striking ``and prior approval supplement 
fee''.

SEC. 303. REAUTHORIZATION; REPORTING REQUIREMENTS.

  Section 744C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j-43) is amended--
          (1) in subsection (a)(1), by striking ``Beginning with fiscal 
        year 2018, not'' and inserting ``Not'';
          (2) by striking ``Generic Drug User Fee Amendments of 2017'' 
        each place it appears and inserting ``Generic Drug User Fee 
        Amendments of 2022'';
          (3) in subsection (a)(2), by striking ``Not later than 30 
        calendar days after the end of the second quarter of fiscal 
        year 2018, and not later than 30 calendar days after the end of 
        each quarter of each fiscal year thereafter'' and inserting 
        ``Not later than 30 calendar days after the end of each quarter 
        of each fiscal year for which fees are collected under this 
        part'';
          (4) in subsection (a)(3), by striking ``Beginning with fiscal 
        year 2020, the'' and inserting ``The'';
          (5) in subsection (b), by striking ``Beginning with fiscal 
        year 2018, not'' and inserting ``Not'';
          (6) in subsection (c), by striking ``Beginning with fiscal 
        year 2018, for'' and inserting ``For''; and
          (7) in subsection (f)--
                  (A) in paragraph (1), in the matter preceding 
                subparagraph (A), by striking ``fiscal year 2022'' and 
                inserting ``fiscal year 2027''; and
                  (B) in paragraph (5), by striking ``January 15, 
                2022'' and inserting ``January 15, 2027''.

SEC. 304. SUNSET DATES.

  (a) Authorization.--Sections 744A and 744B of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j-41; 379j-42) shall cease to be 
effective October 1, 2027.
  (b) Reporting Requirements.--Section 744C of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j-43) shall cease to be effective 
January 31, 2028.
  (c) Previous Sunset Provision.--Effective October 1, 2022, 
subsections (a) and (b) of section 305 of the FDA Reauthorization Act 
of 2017 (Public Law 115-52) are repealed.

SEC. 305. EFFECTIVE DATE.

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

SEC. 306. 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 
(21 U.S.C. 379j-41 et seq.), as in effect on the day before the date of 
the enactment of this title, shall continue to be in effect with 
respect to abbreviated new drug applications (as defined in such part 
as of such day) that were received by the Food and Drug Administration 
within the meaning of section 505(j)(5)(A) of such Act (21 U.S.C. 
355(j)(5)(A)), prior approval supplements that were submitted, and drug 
master files for Type II active pharmaceutical ingredients that were 
first referenced on or after October 1, 2017, but before October 1, 
2022, with respect to assessing and collecting any fee required by such 
part for a fiscal year prior to fiscal year 2023.

       TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

SEC. 401. SHORT TITLE; FINDING.

  (a) Short Title.--This title may be cited as the ``Biosimilar User 
Fee Amendments of 2022''.
  (b) Finding.--The Congress finds that the fees authorized by the 
amendments made by 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 (21 U.S.C. 379j-51 et seq.), 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.

SEC. 402. DEFINITIONS.

  (a) Adjustment Factor.--Section 744G(1) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j-51(1)) is amended to read as follows:
          ``(1) The term `adjustment factor' applicable to a fiscal 
        year is the Consumer Price Index for urban consumers 
        (Washington-Arlington-Alexandria, DC-VA-MD-WV; Not Seasonally 
        Adjusted; All items; Annual Index) for September of the 
        preceding fiscal year divided by such Index for September 
        2011.''.
  (b) Biosimilar Biological Product Application.--Section 
744G(4)(B)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j-51(4)(B)(iii)) is amended--
          (1) by striking subclause (II) (relating to an allergenic 
        extract product); and
          (2) by redesignating subclauses (III) and (IV) as subclauses 
        (II) and (III), respectively.

SEC. 403. AUTHORITY TO ASSESS AND USE BIOSIMILAR FEES.

  (a) Types of Fees.--
          (1) In general.--The matter preceding paragraph (1) in 
        section 744H(a) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 379j-52(a)) is amended by striking ``fiscal year 2018'' 
        and inserting ``fiscal year 2023''.
          (2) Initial biosimilar biological product development fee.--
        Clauses (iv)(I) and (v)(II) of section 744H(a)(1)(A) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
        52(a)(1)(A)) are each amended by striking ``5 days'' and 
        inserting ``7 days''.
          (3) Annual biosimilar biological product development fee.--
        Section 744H(a)(1)(B) of the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 379j-52(a)(1)(B)) is amended--
                  (A) in clause (i), by inserting before the period at 
                the end the following: ``, except where such product 
                (including, where applicable, ownership of the relevant 
                investigational new drug application) is transferred to 
                a licensee, assignee, or successor of such person, and 
                written notice of such transfer is provided to the 
                Secretary, in which case such licensee, assignee, or 
                successor shall pay the annual biosimilar biological 
                product development fee'';
                  (B) in clause (iii)--
                          (i) in subclause (I), by striking ``or'' at 
                        the end;
                          (ii) in subclause (II), by striking the 
                        period at the end and inserting ``; or''; and
                          (iii) by adding at the end the following:
                                  ``(III) been administratively removed 
                                from the biosimilar biological product 
                                development program for the product 
                                under subparagraph (E)(v).''; and
                  (C) in clause (iv), by striking ``is accepted for 
                filing on or after October 1 of such fiscal year'' and 
                inserting ``is subsequently accepted for filing''.
          (4) Reactivation fee.--Section 744H(a)(1)(D) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52(a)(1)(D)) is 
        amended to read as follows:
                  ``(D) Reactivation fee.--
                          ``(i) In general.--A person that has 
                        discontinued participation in the biosimilar 
                        biological product development program for a 
                        product under subparagraph (C), or who has been 
                        administratively removed from the biosimilar 
                        biological product development program for a 
                        product under subparagraph (E)(v), shall, if 
                        the person seeks to resume participation in 
                        such program, pay all annual biosimilar 
                        biological product development fees previously 
                        assessed for such product and still owed and a 
                        fee (referred to in this section as 
                        `reactivation fee') by the earlier of the 
                        following:
                                  ``(I) Not later than 7 days after the 
                                Secretary grants a request by such 
                                person for a biosimilar biological 
                                product development meeting for the 
                                product (after the date on which such 
                                participation was discontinued or the 
                                date of administrative removal, as 
                                applicable).
                                  ``(II) Upon the date of submission 
                                (after the date on which such 
                                participation was discontinued or the 
                                date of administrative removal, as 
                                applicable) by such person of an 
                                investigational new drug application 
                                describing an investigation that the 
                                Secretary determines is intended to 
                                support a biosimilar biological product 
                                application for that product.
                          ``(ii) Application of annual fee.--A person 
                        that pays a reactivation fee for a product 
                        shall pay for such product, beginning in the 
                        next fiscal year, the annual biosimilar 
                        biological product development fee under 
                        subparagraph (B), except where such product 
                        (including, where applicable, ownership of the 
                        relevant investigational new drug application) 
                        is transferred to a licensee, assignee, or 
                        successor of such person, and written notice of 
                        such transfer is provided to the Secretary, in 
                        which case such licensee, assignee, or 
                        successor shall pay the annual biosimilar 
                        biological product development fee.''.
          (5) Effect of failure to pay fees.--Section 744H(a)(1)(E) of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
        52(a)(1)(E)) is amended by adding at the end the following:
                          ``(v) Administrative removal from the 
                        biosimilar biological product development 
                        program.--If a person has failed to pay an 
                        annual biosimilar biological product 
                        development fee for a product as required under 
                        subparagraph (B) for a period of two 
                        consecutive fiscal years, the Secretary may 
                        administratively remove such person from the 
                        biosimilar biological product development 
                        program for the product. At least 30 days prior 
                        to administratively removing a person from the 
                        biosimilar biological product development 
                        program for a product under this clause, the 
                        Secretary shall provide written notice to such 
                        person of the intended administrative 
                        removal.''.
          (6) Biosimilar biological product application fee.--Section 
        744H(a)(2)(D) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 379j-52(a)(2)(D)) is amended by inserting after ``or was 
        withdrawn'' the following: ``prior to approval''.
          (7) Biosimilar biological product program fee.--Section 
        744H(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 379j-52(a)(3)) is amended--
                  (A) in subparagraph (A)--
                          (i) in clause (i), by striking ``and'' at the 
                        end;
                          (ii) by redesignating clause (ii) as clause 
                        (iii); and
                          (iii) by inserting after clause (i) the 
                        following:
                          ``(ii) may be dispensed only under 
                        prescription pursuant to section 503(b); and''; 
                        and
                  (B) by adding at the end the following:
                  ``(E) Movement to discontinued list.--
                          ``(i) Date of inclusion.--If a written 
                        request to place a product on the list 
                        referenced in subparagraph (A) of discontinued 
                        biosimilar biological products is submitted to 
                        the Secretary on behalf of an applicant, and 
                        the request identifies the date the product is 
                        withdrawn from sale, then for purposes of 
                        assessing the biosimilar biological product 
                        program fee, the Secretary shall consider such 
                        product to have been included on such list on 
                        the later of--
                                  ``(I) the date such request was 
                                received; or
                                  ``(II) if the product will be 
                                withdrawn from sale on a future date, 
                                such future date when the product is 
                                withdrawn from sale.
                          ``(ii) Treatment as withdrawn from sale.--For 
                        purposes of clause (i), a product shall be 
                        considered withdrawn from sale once the 
                        applicant has ceased its own distribution of 
                        the product, whether or not the applicant has 
                        ordered recall of all previously distributed 
                        lots of the product, except that a routine, 
                        temporary interruption in supply shall not 
                        render a product withdrawn from sale.
                          ``(iii) Special rule.--If a biosimilar 
                        biological product that is identified in a 
                        biosimilar biological product application 
                        approved as of October 1 of a fiscal year 
                        appears, as of October 1 of such fiscal year, 
                        on the list referenced in subparagraph (A) of 
                        discontinued biosimilar biological products, 
                        and on any subsequent day during such fiscal 
                        year the biosimilar biological product does not 
                        appear on such list, then except as provided in 
                        subparagraph (D), each person who is named as 
                        the applicant in a biosimilar biological 
                        product application with respect to such 
                        product shall pay the annual biosimilar 
                        biological product program fee established for 
                        a fiscal year under subsection (c)(5) for such 
                        biosimilar biological product. Notwithstanding 
                        subparagraph (B), such fee shall be due on the 
                        last business day of such fiscal year and shall 
                        be paid only once for each such product for 
                        each fiscal year.''.
          (8) Biosimilar biological product fee.--Section 744H(a) of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52(a)) 
        is amended by striking paragraph (4).
  (c) Fee Revenue Amounts.--Subsection (b) of section 744H of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52) is amended--
          (1) by striking paragraph (1);
          (2) by redesignating paragraphs (2) through (4) as paragraphs 
        (1) through (3), respectively;
          (3) by amending paragraph (1) (as so redesignated) to read as 
        follows:
          ``(1) In general.--For each of the fiscal years 2023 through 
        2027, fees under subsection (a) shall, except as provided in 
        subsection (c), be established to generate a total revenue 
        amount equal to the sum of--
                  ``(A) the annual base revenue for the fiscal year (as 
                determined under paragraph (3));
                  ``(B) the dollar amount equal to the inflation 
                adjustment for the fiscal year (as determined under 
                subsection (c)(1));
                  ``(C) the dollar amount equal to the strategic hiring 
                and retention adjustment (as determined under 
                subsection (c)(2));
                  ``(D) the dollar amount equal to the capacity 
                planning adjustment for the fiscal year (as determined 
                under subsection (c)(3));
                  ``(E) the dollar amount equal to the operating 
                reserve adjustment for the fiscal year, if applicable 
                (as determined under subsection (c)(4));
                  ``(F) for fiscal year 2023 an additional amount of 
                $4,428,886; and
                  ``(G) for fiscal year 2024 an additional amount of 
                $320,569.'';
          (4) in paragraph (2) (as so redesignated)--
                  (A) in the paragraph heading, by striking ``; 
                limitations on fee amounts'';
                  (B) by striking subparagraph (B); and
                  (C) by redesignating subparagraphs (C) and (D) as 
                subparagraphs (B) and (C), respectively; and
          (5) by amending paragraph (3) (as so redesignated) to read as 
        follows:
          ``(3) Annual base revenue.--For purposes of paragraph (1), 
        the dollar amount of the annual base revenue for a fiscal year 
        shall be--
                  ``(A) for fiscal year 2023, $43,376,922; and
                  ``(B) for fiscal years 2024 through 2027, the dollar 
                amount of the total revenue amount established under 
                paragraph (1) for the previous fiscal year, excluding 
                any adjustments to such revenue amount under subsection 
                (c)(4).''.
  (d) Adjustments; Annual Fee Setting.--Section 744H(c) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52(c)) is amended--
          (1) in paragraph (1)--
                  (A) in subparagraph (A)--
                          (i) in the matter preceding clause (i), by 
                        striking ``subsection (b)(2)(B)'' and inserting 
                        ``subsection (b)(1)(B)''; and
                          (ii) in clause (i), by striking ``subsection 
                        (b)'' and inserting ``subsection (b)(1)(A)''; 
                        and
                  (B) in subparagraph (B)(ii), by striking 
                ``Washington-Baltimore, DC-MD-VA-WV'' and inserting 
                ``Washington-Arlington-Alexandria, DC-VA-MD-WV'';
          (2) by striking paragraphs (2) through (4) and inserting the 
        following:
          ``(2) Strategic hiring and retention adjustment.--For each 
        fiscal year, after the annual base revenue under subsection 
        (b)(1)(A) is adjusted for inflation in accordance with 
        paragraph (1), the Secretary shall further increase the fee 
        revenue and fees by $150,000.
          ``(3) Capacity planning adjustment.--
                  ``(A) In general.--For each fiscal year, the 
                Secretary shall, in addition to the adjustments under 
                paragraphs (1) and (2), further adjust the fee revenue 
                and fees under this section for a fiscal year to 
                reflect changes in the resource capacity needs of the 
                Secretary for the process for the review of biosimilar 
                biological product applications.
                  ``(B) Methodology.--For purposes of this paragraph, 
                the Secretary shall employ the capacity planning 
                methodology utilized by the Secretary in setting fees 
                for fiscal year 2021, as described in the notice titled 
                `Biosimilar User Fee Rates for Fiscal Year 2021' 
                published in the Federal Register on August 4, 2020 (85 
                Fed. Reg. 47220). The workload categories used in 
                applying such methodology in forecasting shall include 
                only the activities described in that notice and, as 
                feasible, additional activities that are also directly 
                related to the direct review of biosimilar biological 
                product applications and supplements, including 
                additional formal meeting types, the direct review of 
                postmarketing commitments and requirements, the direct 
                review of risk evaluation and mitigation strategies, 
                and the direct review of annual reports for approved 
                biosimilar biological products. Subject to the 
                exceptions in the preceding sentence, the Secretary 
                shall not include as workload categories in applying 
                such methodology in forecasting any non-core review 
                activities, including those activities that the 
                Secretary referenced for potential future use in such 
                notice but did not utilize in setting fees for fiscal 
                year 2021.
                  ``(C) Limitations.--Under no circumstances shall an 
                adjustment under this paragraph result in fee revenue 
                for a fiscal year that is less than the sum of the 
                amounts under subsections (b)(1)(A) (the annual base 
                revenue for the fiscal year), (b)(1)(B) (the dollar 
                amount of the inflation adjustment for the fiscal 
                year), and (b)(1)(C) (the dollar amount of the 
                strategic hiring and retention adjustment).
                  ``(D) Publication in federal register.--The Secretary 
                shall publish in the Federal Register notice under 
                paragraph (5) the fee revenue and fees resulting from 
                the adjustment and the methodologies under this 
                paragraph.
          ``(4) Operating reserve adjustment.--
                  ``(A) Increase.--For fiscal year 2023 and subsequent 
                fiscal years, the Secretary shall, in addition to 
                adjustments under paragraphs (1), (2), and (3), further 
                increase the fee revenue and fees if such an adjustment 
                is necessary to provide for at least 10 weeks of 
                operating reserves of carryover user fees for the 
                process for the review of biosimilar biological product 
                applications.
                  ``(B) Decrease.--
                          ``(i) Fiscal year 2023.--For fiscal year 
                        2023, if the Secretary has carryover balances 
                        for such process in excess of 33 weeks of such 
                        operating reserves, the Secretary shall 
                        decrease such fee revenue and fees to provide 
                        for not more than 33 weeks of such operating 
                        reserves.
                          ``(ii) Fiscal year 2024.--For fiscal year 
                        2024, if the Secretary has carryover balances 
                        for such process in excess of 27 weeks of such 
                        operating reserves, the Secretary shall 
                        decrease such fee revenue and fees to provide 
                        for not more than 27 weeks of such operating 
                        reserves.
                          ``(iii) Fiscal year 2025 and subsequent 
                        fiscal years.--For fiscal year 2025 and 
                        subsequent fiscal years, if the Secretary has 
                        carryover balances for such process in excess 
                        of 21 weeks of such operating reserves, the 
                        Secretary shall decrease such fee revenue and 
                        fees to provide for not more than 21 weeks of 
                        such operating reserves.
                  ``(C) Federal register notice.--If an adjustment 
                under subparagraph (A) or (B) is made, the rationale 
                for the amount of the increase or decrease in fee 
                revenue and fees shall be contained in the annual 
                Federal Register notice under paragraph (5)(B) 
                establishing fee revenue and fees for the fiscal year 
                involved.''; and
          (3) in paragraph (5), in the matter preceding subparagraph 
        (A), by striking ``2018'' and inserting ``2023''.
  (e) Crediting and Availability of Fees.--Subsection (f)(3) of section 
744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
52(f)(3)) is amended by striking ``2018 through 2022'' and inserting 
``2023 through 2027''.
  (f) Written Requests for Waivers and Returns; Disputes Concerning 
Fees.--Section 744H(h) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379j-52(h)) is amended to read as follows:
  ``(h) Written Requests for Waivers and Returns; Disputes Concerning 
Fees.--To qualify for consideration for a waiver under subsection (d), 
or for the return of any fee paid under this section, including if the 
fee is claimed to have been paid in error, a person shall submit to the 
Secretary a written request justifying such waiver or return and, 
except as otherwise specified in this section, such written request 
shall be submitted to the Secretary not later than 180 days after such 
fee is due. A request submitted under this paragraph shall include any 
legal authorities under which the request is made.''.

SEC. 404. REAUTHORIZATION; REPORTING REQUIREMENTS.

  Section 744I of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j-53) is amended--
          (1) in subsection (a)(1), by striking ``Beginning with fiscal 
        year 2018, not'' and inserting ``Not'';
          (2) by striking ``Biosimilar User Fee Amendments of 2017'' 
        each place it appears and inserting ``Biosimilar User Fee 
        Amendments of 2022'';
          (3) in subsection (a)(2), by striking ``Beginning with fiscal 
        year 2018, the'' and inserting ``The'';
          (4) in subsection (a)(3)(A), by striking ``Not later than 30 
        calendar days after the end of the second quarter of fiscal 
        year 2018, and not later than 30 calendar days after the end of 
        each quarter of each fiscal year thereafter'' and inserting 
        ``Not later than 30 calendar days after the end of each quarter 
        of each fiscal year for which fees are collected under this 
        part'';
          (5) in subsection (b), by striking ``Not later than 120 days 
        after the end of fiscal year 2018 and each subsequent fiscal 
        year for which fees are collected under this part'' and 
        inserting ``Not later than 120 days after the end of each 
        fiscal year for which fees are collected under this part'';
          (6) in subsection (c), by striking ``Beginning with fiscal 
        year 2018, and for'' and inserting ``For''; and
          (7) in subsection (f)--
                  (A) in paragraph (1), in the matter preceding 
                subparagraph (A), by striking ``fiscal year 2022'' and 
                inserting ``fiscal year 2027''; and
                  (B) in paragraph (3), by striking ``January 15, 
                2022'' and inserting ``January 15, 2027''.

SEC. 405. SUNSET DATES.

  (a) Authorization.--Sections 744G and 744H of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j-51, 379j-52) shall cease to be 
effective October 1, 2027.
  (b) Reporting Requirements.--Section 744I of the Federal Food, Drug, 
and Cosmetic Act shall cease to be effective January 31, 2028.
  (c) Previous Sunset Provision.--Effective October 1, 2022, 
subsections (a) and (b) of section 405 of the FDA Reauthorization Act 
of 2017 (Public Law 115-52) are repealed.

SEC. 406. EFFECTIVE DATE.

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

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

            TITLE V--IMPROVING DIVERSITY IN CLINICAL STUDIES

SEC. 501. DIVERSITY ACTION PLANS FOR CLINICAL STUDIES.

  (a) Drugs.--Section 505(i) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355(i)) is amended by adding at the end the following:
  ``(5)(A) In order for a new drug that is being studied in a phase 3 
study, as defined in section 312.21(c) of title 21, Code of Federal 
Regulations (or successor regulations), or other pivotal study (other 
than bioavailability or bioequivalence studies), to be exempt pursuant 
to this subsection, the sponsor of a clinical investigation of such new 
drug shall submit to the Secretary a diversity action plan.
  ``(B) Such diversity action plan shall include--
          ``(i) the sponsor's goals for enrollment in such clinical 
        study;
          ``(ii) the sponsor's rationale for such goals; and
          ``(iii) an explanation of how the sponsor intends to meet 
        such goals.
  ``(C) The sponsor shall submit such diversity action plan in the form 
and manner specified in the guidance required by section 524B as soon 
as practicable but no later than when the sponsor seeks feedback 
regarding such a phase 3 study or other pivotal study of the drug.
  ``(D) The Secretary may waive the requirement in subparagraph (A) if 
the Secretary determines that a waiver is necessary based on what is 
known about the prevalence of the disease in terms of the patient 
population that may use the new drug.
  ``(E) No diversity action plan shall be required for a submission 
described in section 561.''.
  (b) Devices.--Section 520(g) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360j(g)) is amended by adding at the end the following:
  ``(9)(A)(i) In order for a device in a clinical study for which 
submission of an application for an investigational device exemption is 
required to be exempt under this subsection, the sponsor of such study 
shall submit to the Secretary in such application a diversity action 
plan in the form and manner specified in the guidance required by 
section 524B.
  ``(ii) In order for a device in a clinical study for which submission 
of an application for an investigational device exemption is not 
required, except for a device being studied as described in section 
812.2(c) of title 21, Code of Federal Regulations (or successor 
regulations), to be exempt under this subsection, the sponsor of such 
study shall develop and implement a diversity action plan. Such 
diversity action plan shall be submitted to the Secretary in any 
premarket notification under section 510(k), request for classification 
under section 513(f)(2), or application for premarket approval under 
section 515 for such device.
  ``(B) A diversity action plan under clause (i) or (ii) of 
subparagraph (A) shall include--
          ``(i) the sponsor's goals for enrollment in the clinical 
        study;
          ``(ii) the sponsor's rationale for such goals; and
          ``(iii) an explanation of how the sponsor intends to meet 
        such goals.
  ``(C) The Secretary may waive the requirement in subparagraph (A) or 
(B) if the Secretary determines that a waiver is necessary based on 
what is known about the prevalence of the disease in terms of the 
patient population that may use the device.
  ``(D) No diversity action plan shall be required for a submission 
described in section 561.''.
  (c) Guidance.--Subchapter A of chapter V of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by adding at the 
end the following:

``SEC. 524B. GUIDANCE ON DIVERSITY ACTION PLANS FOR CLINICAL STUDIES.

  ``(a) In General.--The Secretary shall issue guidance relating to--
          ``(1) the format and content of the diversity action plans 
        required by sections 505(i)(5) and 520(g)(9) pertaining to the 
        sponsor's goals for clinical study enrollment, disaggregated by 
        age group, sex, race, geographic location, socioeconomic 
        status, and ethnicity, including with respect to--
                  ``(A) the rationale for the sponsor's enrollment 
                goals, which may include--
                          ``(i) the estimated prevalence or incidence 
                        in the United States of the disease or 
                        condition for which the drug or device is being 
                        developed or investigated, if such estimated 
                        prevalence or incidence is known or can be 
                        determined based on available data;
                          ``(ii) what is known about the disease or 
                        condition for which the drug or device is being 
                        developed or investigated;
                          ``(iii) any relevant pharmacokinetic or 
                        pharmacogenomic data;
                          ``(iv) what is known about the patient 
                        population for such disease or condition, 
                        including, to the extent data is available--
                                  ``(I) demographic information, 
                                including age group, sex, race, 
                                geographic location, socioeconomic 
                                status, and ethnicity;
                                  ``(II) non-demographic factors, 
                                including co-morbidities affecting the 
                                patient population; and
                                  ``(III) potential barriers to 
                                enrolling diverse participants, such as 
                                patient population size, geographic 
                                location, and socioeconomic status; and
                          ``(v) any other data or information relevant 
                        to selecting appropriate enrollment goals, 
                        disaggregated by demographic subgroup, such as 
                        the inclusion of pregnant and lactating women;
                  ``(B) an explanation for how the sponsor intends to 
                meet such goals, including demographic-specific 
                outreach and enrollment strategies, study-site 
                selection, clinical study inclusion and exclusion 
                practices, and any diversity training for study 
                personnel; and
                  ``(C) procedures for the public posting of key 
                information from the diversity action plan that would 
                be useful to patients and providers on the sponsor's 
                website, as appropriate; and
          ``(2) how sponsors should include in regular reports to the 
        Secretary--
                  ``(A) the sponsor's progress in meeting the goals 
                referred to in paragraph (1)(A); and
                  ``(B) if the sponsor does not expect to meet such 
                goals--
                          ``(i) any updates needed to be made to a 
                        diversity action plan referred to in paragraph 
                        (1) to help meet such goals; and
                          ``(ii) the sponsor's reasons for why the 
                        sponsor does not expect to meet such goals.
  ``(b) Issuance.--The Secretary shall--
          ``(1) not later than 12 months after the date of enactment of 
        this section, issue new draft guidance or update existing draft 
        guidance described in subsection (a); and
          ``(2) not later than 9 months after closing the comment 
        period on such draft guidance, finalize such guidance.''.
  (d) Applicability.--Sections 505(i)(5) and 520(g)(9) of the Federal 
Food, Drug, and Cosmetic Act, as added by subsections (a) and (b) of 
this section, apply only with respect to clinical investigations with 
respect to which enrollment commences after the date that is 180 days 
after the publication of final guidance under section 524B(b)(2) of the 
Federal Food, Drug, and Cosmetic Act, as added by subsection (c).

SEC. 502. EVALUATION OF THE NEED FOR FDA AUTHORITY TO MANDATE 
                    POSTAPPROVAL STUDIES OR POSTMARKET SURVEILLANCE DUE 
                    TO INSUFFICIENT DEMOGRAPHIC SUBGROUP DATA.

  (a) In General.--Not later than 2 years after the date of publication 
of final guidance pursuant to section 524B(b)(2) of the Federal Food, 
Drug, and Cosmetic Act, as added by section 501(c) of this Act, the 
Secretary of Health and Human Services shall commence an evaluation to 
assess whether additions or changes to statutes or regulations are 
warranted to ensure that sponsors conduct post-approval studies or 
postmarket surveillance where--
          (1) premarket studies collected insufficient data for 
        underrepresented subgroups according to the goals specified in 
        the diversity action plans of such sponsors; and
          (2) the Secretary has requested additional studies be 
        conducted.
  (b) Determination and Reporting.--Not later than 180 days after the 
commencement of the evaluation under subsection (a), the Secretary of 
Health and Human Services shall submit a report to the Congress on the 
outcome of such evaluation, including any recommendations related to 
additional needed authorities.

SEC. 503. PUBLIC WORKSHOPS TO ENHANCE CLINICAL STUDY DIVERSITY.

  (a) In General.--Not later than one year after the date of enactment 
of this Act, the Secretary of Health and Human Services, in 
consultation with drug sponsors, medical device manufacturers, 
patients, and other stakeholders, shall convene one or more public 
workshops to solicit input from stakeholders on increasing the 
enrollment of historically underrepresented populations in clinical 
studies and encouraging clinical study participation that reflects the 
prevalence of the disease or condition among demographic subgroups, 
where appropriate, and other topics, including--
          (1) how and when to collect and present the prevalence or 
        incidence data on a disease or condition by demographic 
        subgroup, including possible sources for such data and 
        methodologies for assessing such data;
          (2) considerations for the dissemination, after approval, of 
        information to the public on clinical study enrollment 
        demographic data;
          (3) the establishment of goals for enrollment in clinical 
        trials, including the relevance of the estimated prevalence or 
        incidence, as applicable, in the United States of the disease 
        or condition for which the drug or device is being developed; 
        and
          (4) approaches to support inclusion of underrepresented 
        populations and to encourage clinical study participation that 
        reflects the population expected to use the drug or device 
        under study, including with respect to--
                  (A) the establishment of inclusion and exclusion 
                criteria for certain subgroups, such as pregnant and 
                lactating women and individuals with disabilities, 
                including intellectual or developmental disabilities or 
                mental illness;
                  (B) considerations regarding informed consent with 
                respect to individuals with intellectual or 
                developmental disabilities or mental illness, including 
                ethical and scientific considerations;
                  (C) the appropriate use of decentralized trials or 
                digital health tools;
                  (D) clinical endpoints;
                  (E) biomarker selection; and
                  (F) studying analysis.
  (b) Public Docket.--The Secretary of Health and Human Services shall 
establish a public comment period to receive written comments related 
to the topics addressed during each public workshop convened under this 
section. The public comment period shall remain open for 60 days 
following the date on which each public workshop is convened.
  (c) Report.--Not later than 180 days after the close of the public 
comment period for each public workshop convened under this section, 
the Secretary of Health and Human Services shall make available on the 
public website of the Food and Drug Administration a report on the 
topics discussed at such workshop. The report shall include a summary 
of, and response to, recommendations raised in such workshop.

SEC. 504. ANNUAL SUMMARY REPORT ON PROGRESS TO INCREASE DIVERSITY IN 
                    CLINICAL STUDIES.

  (a) In General.--Beginning not later than 2 years after the date of 
enactment of this Act, and each year thereafter, the Secretary of 
Health and Human Services shall submit to the Congress, and publish on 
the public website of the Food and Drug Administration, a report that--
          (1) summarizes, in aggregate, the diversity action plans 
        received pursuant to section 505(i)(5) or 520(g)(9) of the 
        Federal Food, Drug, and Cosmetic Act, as added by subsection 
        (a) or (b) of section 501 of this Act; and
          (2) contains information on--
                  (A) for drugs, biological products, and devices 
                approved, licensed, cleared, or classified under 
                section 505, 515, 510(k), or 513(f)(2) of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 355; 360e; 
                360(k); and 360(f)(2)), or section 351(a) of the Public 
                Health Service Act (42 U.S.C. 262(a)), whether the 
                clinical studies conducted with respect to such 
                applications met the demographic subgroup enrollment 
                goals from the diversity action plan submitted for such 
                applications;
                  (B) the reasons provided for why enrollment goals 
                from submitted diversity action plans were not met; and
                  (C) any postmarket studies of a drug or device in a 
                demographic subgroup or subgroups required or 
                recommended by the Secretary based on inadequate 
                premarket clinical study diversity or based on other 
                reasons where a premarket study lacked adequate 
                diversity, including the status and completion date of 
                any such study.
  (b) Confidentiality.--Nothing in this section shall be construed as 
authorizing the Secretary of Health and Human Services to disclose any 
information that is a trade secret or confidential information subject 
to section 552(b)(4) of title 5, United States Code, or section 1905 of 
title 18, United States Code.

SEC. 505. PUBLIC MEETING ON CLINICAL STUDY FLEXIBILITIES INITIATED IN 
                    RESPONSE TO COVID-19 PANDEMIC.

  (a) In General.--Not later than 180 days after the date on which the 
COVID-19 emergency period ends, the Secretary of Health and Human 
Services shall convene a public meeting to discuss the recommendations 
provided by the Food and Drug Administration during the COVID-19 
emergency period to mitigate disruption of clinical studies, including 
recommendations detailed in the guidance entitled ``Conduct of Clinical 
Trials of Medical Products During the COVID-19 Public Health Emergency, 
Guidance for Industry, Investigators, and Institutional Review 
Boards'', as updated on August 8, 2021, and by any subsequent updates 
to such guidance. The Secretary of Health and Human Services shall 
invite to such meeting representatives from the pharmaceutical and 
medical device industries who sponsored clinical studies during the 
COVID-19 emergency period and organizations representing patients.
  (b) Topics.--Not later than 90 days after the date on which the 
public meeting under subsection (a) is convened, the Secretary of 
Health and Human Services shall make available on the public website of 
the Food and Drug Administration a report on the topics discussed at 
such meeting. Such topics shall include discussion of--
          (1) the actions drug sponsors took to utilize such 
        recommendations and the frequency at which such recommendations 
        were employed;
          (2) the characteristics of the sponsors, studies, and patient 
        populations impacted by such recommendations;
          (3) a consideration of how recommendations intended to 
        mitigate disruption of clinical studies during the COVID-19 
        emergency period, including any recommendations to consider 
        decentralized clinical studies when appropriate, may have 
        affected access to clinical studies for certain patient 
        populations, especially unrepresented racial and ethnic 
        minorities; and
          (4) recommendations for incorporating certain clinical study 
        disruption mitigation recommendations into current or 
        additional guidance to improve clinical study access and 
        enrollment of diverse patient populations.
  (c) COVID-19 Emergency Period Defined.--In this section, the term 
``COVID-19 emergency period'' has the meaning given the term 
``emergency period'' in section 1135(g)(1)(B) of the Social Security 
Act (42 U.S.C. 1320b-5(g)(1)(B)).

SEC. 506. DECENTRALIZED CLINICAL STUDIES.

  (a) Guidance.--The Secretary of Health and Human Services shall--
          (1) not later than 12 months after the date of enactment of 
        this Act, issue draft guidance that addresses considerations 
        for decentralized clinical studies, including considerations 
        regarding the engagement, enrollment, and retention of a 
        meaningfully diverse clinical population, with respect to race, 
        ethnicity, age, sex, and geographic location, when appropriate; 
        and
          (2) not later than 1 year after closing the comment period on 
        such draft guidance, finalize such guidance.
  (b) Content of Guidance.--The guidance under subsection (a) shall 
address the following:
          (1) Recommendations for how digital health technology or 
        other remote assessment options, such as telehealth, could 
        support decentralized clinical studies, including guidance on 
        considerations for selecting technological platforms and 
        mediums, data collection and use, data integrity and security, 
        and communication to study participants through digital 
        technology.
          (2) Recommendations for subject recruitment and retention, 
        including considerations for sponsors to minimize or reduce 
        burdens for clinical study participants through the use of 
        digital health technology, telehealth, local health care 
        providers and laboratories, or other means.
          (3) Recommendations with respect to the evaluation of data 
        collected within a decentralized clinical study setting.
  (c) Definition.--In this section, the term ``decentralized clinical 
study'' means a clinical study in which some or all of the study-
related activities occur at a location separate from the investigator's 
location.

                   TITLE VI--GENERIC DRUG COMPETITION

SEC. 601. INCREASING TRANSPARENCY IN GENERIC DRUG APPLICATIONS.

  (a) In General.--Section 505(j)(3) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(j)(3)) is amended by adding at the end the 
following:
  ``(H)(i) Upon request (in controlled correspondence or otherwise) by 
a person that has submitted or intends to submit an abbreviated 
application for a new drug under this subsection for which the 
Secretary has specified in regulation, including under section 
314.94(a)(9), title 21, Code of Federal Regulations (or a successor 
regulation), or recommended in applicable guidance, certain qualitative 
or quantitative criteria with respect to an inactive ingredient, or on 
the Secretary's own initiative during the review of such abbreviated 
application, the Secretary shall inform the person whether such new 
drug is qualitatively and quantitatively the same as the listed drug.
  ``(ii) Notwithstanding section 301(j), if the Secretary determines 
that such new drug is not qualitatively or quantitatively the same as 
the listed drug, the Secretary shall identify and disclose to the 
person--
          ``(I) the ingredient or ingredients that cause the new drug 
        not to be qualitatively or quantitatively the same as the 
        listed drug; and
          ``(II) for any ingredient for which there is an identified 
        quantitative deviation, the amount of such deviation.
  ``(iii) If the Secretary determines that such new drug is 
qualitatively and quantitatively the same as the listed drug, the 
Secretary shall not change or rescind such determination after the 
submission of an abbreviated application for such new drug under this 
subsection unless--
          ``(I) the formulation of the listed drug has been changed and 
        the Secretary has determined that the prior listed drug 
        formulation was withdrawn for reasons of safety or 
        effectiveness; or
          ``(II) the Secretary makes a written determination that the 
        prior determination must be changed because an error has been 
        identified.
  ``(iv) If the Secretary makes a written determination described in 
clause (iii)(II), the Secretary shall provide notice and a copy of the 
written determination to the person making the request under clause 
(i).
  ``(v) The disclosures required by this subparagraph are disclosures 
authorized by law including for purposes of section 1905 of title 18, 
United States Code.''.
  (b) Guidance.--
          (1) In general.--Not later than 1 year after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services shall issue draft guidance, or update guidance, 
        describing how the Secretary will determine whether a new drug 
        is qualitatively and quantitatively the same as the listed drug 
        (as such terms are used in section 505(j)(3)(H) of the Federal 
        Food, Drug, and Cosmetic Act, as added by subsection (a)), 
        including with respect to assessing pH adjusters.
          (2) Process.--In issuing guidance as required by paragraph 
        (1), the Secretary of Health and Human Services shall--
                  (A) publish draft guidance;
                  (B) provide a period of at least 60 days for comment 
                on the draft guidance; and
                  (C) after considering any comments received, and not 
                later than one year after the close of the comment 
                period on the draft guidance, publish final guidance.
  (c) Applicability.--Section 505(j)(3)(H) of the Federal Food, Drug, 
and Cosmetic Act, as added by subsection (a), applies beginning on the 
date of enactment of this Act, irrespective of the date on which the 
guidance required by subsection (b) is finalized.

SEC. 602. ENHANCING ACCESS TO AFFORDABLE MEDICINES.

  Section 505(j)(10)(A) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(j)(10)(A)) is amended by striking clauses (i) through (iii) 
and inserting the following:
          ``(i) a revision to the labeling of the listed drug has been 
        approved by the Secretary within 90 days of when the 
        application is otherwise eligible for approval under this 
        subsection;
          ``(ii) the sponsor of the application agrees to submit 
        revised labeling for the drug that is the subject of the 
        application not later than 60 days after approval under this 
        subsection of the application;
          ``(iii) the labeling revision described under clause (i) does 
        not include a change to the `Warnings' section of the labeling; 
        and''.

    TITLE VII--RESEARCH, DEVELOPMENT, AND SUPPLY CHAIN IMPROVEMENTS

                         Subtitle A--In General

SEC. 701. ANIMAL TESTING ALTERNATIVES.

  Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355) is amended--
          (1) in subsection (b)(5)(B)(i)(II), by striking ``animal'' 
        and inserting ``nonclinical tests'';
          (2) in subsection (i)--
                  (A) in paragraph (1)(A), by striking ``preclinical 
                tests (including tests on animals)'' and inserting 
                ``nonclinical tests''; and
                  (B) in paragraph (2)(B), by striking ``animal'' and 
                inserting ``nonclinical tests''; and
          (3) after subsection (y), by inserting the following:
  ``(z) Nonclinical Test Defined.--For purposes of this section, the 
term `nonclinical test' means a test conducted in vitro, in silico, or 
in chemico, or a nonhuman in vivo test, that occurs before or during 
the clinical trial phase of the investigation of the safety and 
effectiveness of a drug. Such test may include the following:
          ``(1) Cell-based assays.
          ``(2) Organ chips and microphysiological systems.
          ``(3) Computer modeling.
          ``(4) Other nonhuman or human biology-based test methods.
          ``(5) Animal tests.''.

SEC. 702. EMERGING TECHNOLOGY PROGRAM.

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

``SEC. 566A. EMERGING TECHNOLOGY PROGRAM.

  ``(a) Program Establishment.--
          ``(1) In general.--The Secretary shall establish a program to 
        support the adoption of, and improve the development of, 
        innovative approaches to drug product design and manufacturing.
          ``(2) Actions.--In carrying out the program under paragraph 
        (1), the Secretary may--
                  ``(A) facilitate and increase communication between 
                public and private entities, consortia, and individuals 
                with respect to innovative drug product design and 
                manufacturing;
                  ``(B) solicit information regarding, and conduct or 
                support research on, innovative approaches to drug 
                product design and manufacturing;
                  ``(C) convene meetings with representatives of 
                industry, academia, other Federal agencies, 
                international agencies, and other interested persons, 
                as appropriate;
                  ``(D) convene working groups to support drug product 
                design and manufacturing research and development;
                  ``(E) support education and training for regulatory 
                staff and scientists related to innovative approaches 
                to drug product design and manufacturing;
                  ``(F) advance regulatory science related to the 
                development and review of innovative approaches to drug 
                product design and manufacturing;
                  ``(G) convene or participate in working groups to 
                support the harmonization of international regulatory 
                requirements related to innovative approaches to drug 
                product design and manufacturing; and
                  ``(H) award grants or contracts to carry out or 
                support the program under paragraph (1).
          ``(3) Grants and contracts.--To seek a grant or contract 
        under this section, an entity shall submit an application--
                  ``(A) in such form and manner as the Secretary may 
                require; and
                  ``(B) containing such information as the Secretary 
                may require, including a description of--
                          ``(i) how the entity will conduct the 
                        activities to be supported through the grant or 
                        contract; and
                          ``(ii) how such activities will further 
                        research and development related to, or 
                        adoption of, innovative approaches to drug 
                        product design and manufacturing.
  ``(b) Guidance.--The Secretary shall--
          ``(1) issue or update guidance to help facilitate the 
        adoption of, and advance the development of, innovative 
        approaches to drug product design and manufacturing; and
          ``(2) include in such guidance descriptions of--
                  ``(A) any regulatory requirements related to the 
                development or review of technologies related to 
                innovative approaches to drug product design and 
                manufacturing, including updates and improvements to 
                such technologies after product approval; and
                  ``(B) data that can be used to demonstrate the 
                identity, safety, purity, and potency of drugs 
                manufactured using such technologies.
  ``(c) Report to Congress.--Not later than 4 years after the date of 
enactment of this section, the Secretary shall submit to the Committee 
on Energy and Commerce of the House of Representatives and the 
Committee on Health, Education, Labor, and Pensions of the Senate a 
report containing--
          ``(1) an annual accounting of the allocation of funds made 
        available to carry out this section;
          ``(2) a description of how Food and Drug Administration staff 
        were utilized to carry out this section and, as applicable, any 
        challenges or limitations related to staffing;
          ``(3) the number of public meetings held or participated in 
        by the Food and Drug Administration pursuant to this section, 
        including meetings convened as part of a working group 
        described in subparagraph (D) or (G) of subsection (a)(2), and 
        the topics of each such meeting; and
          ``(4) the number of drug products approved or licensed, after 
        the date of enactment of this section, using an innovative 
        approach to drug product design and manufacturing.
  ``(d) Authorization of Appropriations.--To carry out this section, 
there is authorized to be appropriated $20,000,000 for each fiscal year 
2023 through 2027.''.

SEC. 703. IMPROVING THE TREATMENT OF RARE DISEASES AND CONDITIONS.

  (a) Report on Orphan Drug Program.--
          (1) In general.--Not later than September 30, 2026, 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 
        summarizing the activities of the Food and Drug Administration 
        related to designating drugs under section 526 of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 360bb) for a rare 
        disease or condition and approving such drugs under section 505 
        of such Act (21 U.S.C. 355) or licensing such drugs under 
        section 351 of the Public Health Service Act (42 U.S.C. 262), 
        including--
                  (A) the number of applications for such drugs under 
                section 505 of the Federal Food, Drug, and Cosmetic Act 
                (21 U.S.C. 355) or section 351 of the Public Health 
                Service Act (42 U.S.C. 262) received by the Food and 
                Drug Administration, the number of such applications 
                accepted and rejected for filing, and the number of 
                such applications pending, approved, and disapproved by 
                the Food and Drug Administration;
                  (B) a description of trends in drug approvals for 
                rare diseases and conditions across review divisions at 
                the Food and Drug Administration;
                  (C) the extent to which the Food and Drug 
                Administration is consulting with external experts 
                pursuant to section 569(a)(2) of the Federal Food, 
                Drug, and Cosmetic Act (21 U.S.C. 360bbb-8(a)(2)) on 
                topics pertaining to drugs for a rare disease or 
                condition, including how and when any such consultation 
                is occurring; and
                  (D) the Food and Drug Administration's efforts to 
                promote best practices in the development of novel 
                treatments for rare diseases, including--
                          (i) reviewer training on rare disease-related 
                        policies, methods, and tools; and
                          (ii) new regulatory science and coordinated 
                        support for patient and stakeholder engagement.
          (2) Public availability.--The Secretary shall make the report 
        under paragraph (1) available to the public, including by 
        posting the report on the website of the Food and Drug 
        Administration.
          (3) Information disclosure.--Nothing in this subsection shall 
        be construed to authorize the disclosure of information that is 
        prohibited from disclosure under section 1905 of title 18, 
        United States Code, or subject to withholding under paragraph 
        (4) of section 552(b) of title 5, United States Code (commonly 
        referred to as the ``Freedom of Information Act'').
  (b) Study on European Union Safety and Efficacy Reviews of Drugs for 
Rare Diseases and Conditions.--
          (1) In general.--The Secretary of Health and Human Services 
        shall enter into a contract with an appropriate entity to 
        conduct a study on processes for evaluating the safety and 
        efficacy of drugs for rare diseases or conditions in the United 
        States and the European Union, including--
                  (A) flexibilities, authorities, or mechanisms 
                available to regulators in the United States and the 
                European Union specific to rare diseases or conditions;
                  (B) the consideration and use of supplemental data 
                submitted during review processes in the United States 
                and the European Union, including data associated with 
                open label extension studies and expanded access 
                programs specific to rare diseases or conditions;
                  (C) an assessment of collaborative efforts between 
                United States and European Union regulators related 
                to--
                          (i) product development programs under 
                        review;
                          (ii) policies under development recently 
                        issued; and
                          (iii) scientific information related to 
                        product development or regulation; and
                  (D) recommendations for how Congress can support 
                collaborative efforts described in subparagraph (C).
          (2) Consultation.--The contract under paragraph (1) shall 
        provide for consultation with relevant stakeholders, 
        including--
                  (A) representatives from the Food and Drug 
                Administration and the European Medicines Agency;
                  (B) rare disease or condition patients; and
                  (C) patient groups that--
                          (i) represent rare disease or condition 
                        patients; and
                          (ii) have international patient outreach.
          (3) Report.--The contract under paragraph (1) shall provide 
        for, not later than 2 years after the date of entering into 
        such contract--
                  (A) the completion of the study under paragraph (1); 
                and
                  (B) the submission of a report on the results of such 
                study to the Committee on Energy and Commerce of the 
                House of Representatives and the Committee on Health, 
                Education, Labor, and Pensions of the Senate.
          (4) Public availability.--The contract under paragraph (1) 
        shall provide for the appropriate entity referred to in 
        paragraph (1) to make the report under paragraph (3) available 
        to the public, including by posting the report on the website 
        of the appropriate entity.
  (c) Public Meeting.--
          (1) In general.--Not later than December 31, 2023, the 
        Secretary of Health and Human Services, acting through the 
        Commissioner of Food and Drugs, shall convene one or more 
        public meetings to solicit input from stakeholders regarding 
        the approaches described in paragraph (2).
          (2) Approaches.--The public meeting or meetings under 
        paragraph (1) shall address approaches to increasing and 
        improving engagement with rare disease or condition patients, 
        groups representing such patients, rare disease or condition 
        experts, and experts on small population studies, in order to 
        improve the understanding with respect to rare diseases or 
        conditions of--
                  (A) patient burden;
                  (B) treatment options; and
                  (C) side effects of treatments, including--
                          (i) comparing the side effects of treatments; 
                        and
                          (ii) understanding the risks of side effects 
                        relative to the health status of the patient 
                        and the progression of the disease or 
                        condition.
          (3) Public docket.--The Secretary of Health and Human 
        Services shall establish a public docket to receive written 
        comments related to the approaches addressed during each public 
        meeting under paragraph (1). Such public docket shall remain 
        open for 60 days following the date of each such public 
        meeting.
          (4) Reports.--Not later than 180 days after each public 
        meeting under paragraph (1), the Commissioner of Food and Drugs 
        shall develop and publish on the website of the Food and Drug 
        Administration a report on--
                  (A) the approaches discussed at the public meeting; 
                and
                  (B) any related recommendations.
  (d) Consultation on the Science of Small Population Studies.--Section 
569(a)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb-8(a)(2)) is amended by adding at the end the following:
                  ``(C) Small population studies.--The external experts 
                on the list maintained pursuant to subparagraph (A) may 
                include experts on the science of small population 
                studies.''.
  (e) Study on Sufficiency and Use of FDA Mechanisms for Incorporating 
the Patient and Clinician Perspective in FDA Processes Related to 
Applications Concerning Drugs for Rare Diseases or Conditions.--
          (1) In general.--The Comptroller General of the United States 
        shall conduct a study on the use of Food and Drug 
        Administration mechanisms and tools to ensure that patient and 
        physician perspectives are considered and incorporated 
        throughout the processes of the Food and Drug Administration--
                  (A) for approving or licensing under section 505 of 
                the Federal Food, Drug, or Cosmetic Act (21 U.S.C. 355) 
                or section 351 of the Public Health Service Act (42 
                U.S.C. 262) a drug designated as a drug for a rare 
                disease or condition under section 526 of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 360bb); and
                  (B) in making any determination related to such a 
                drug's approval, including assessment of the drug's--
                          (i) safety or effectiveness; or
                          (ii) postapproval safety monitoring.
          (2) Topics.--The study under paragraph (1) shall--
                  (A) identify and compare the processes that the Food 
                and Drug Administration has formally put in place and 
                utilized to gather external expertise (including 
                patients, patient groups, and physicians) related to 
                applications for rare diseases or conditions;
                  (B) examine tools or mechanisms to improve efforts 
                and initiatives of the Food and Drug Administration to 
                collect and consider such external expertise with 
                respect to applications for rare diseases or conditions 
                throughout the application review and approval or 
                licensure processes, including within internal benefit-
                risk assessments, advisory committee processes, and 
                postapproval safety monitoring; and
                  (C) examine processes or alternatives to address or 
                resolve conflicts of interest that impede the Food and 
                Drug Administration in gaining external expert input on 
                rare diseases or conditions with a limited set of 
                clinical and research experts.
          (3) Report.--Not later than 2 years after the date of 
        enactment of this Act, the Comptroller General of the United 
        States shall--
                  (A) complete the study under paragraph (1);
                  (B) submit a report on the results of such study to 
                the Congress; and
                  (C) include in such report recommendations, if 
                appropriate, for changes to the processes and 
                authorities of the Food and Drug Administration to 
                improve the collection and consideration of external 
                expert opinions of patients, patient groups, and 
                physicians with expertise in rare diseases or 
                conditions.
  (f) Definition.--In this section, the term ``rare disease or 
condition'' has the meaning given such term in section 526(a)(2) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb(a)(2)).

SEC. 704. ANTIFUNGAL RESEARCH AND DEVELOPMENT.

  (a) Draft Guidance.--Not later than 3 years after the date of the 
enactment of this Act, the Secretary of Health and Human Services, 
acting through the Commissioner of Food and Drugs, shall issue draft 
guidance for industry for the purposes of assisting entities seeking 
approval under section 505 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355) or licensure under section 351 of the Public Health 
Service Act (42 U.S.C. 262) of antifungal therapies designed to treat 
coccidioidomycosis (commonly known as Valley Fever).
  (b) Final Guidance.--Not later than 18 months after the close of the 
public comment period on the draft guidance issued pursuant to 
subsection (a), the Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs, shall finalize the draft 
guidance.
  (c) Workshop.--To assist entities developing preventive vaccines for 
fungal infections and coccidioidomycosis, the Secretary of Health and 
Human Services shall hold a public workshop.

SEC. 705. ADVANCING QUALIFIED INFECTIOUS DISEASE PRODUCT INNOVATION.

  (a) In General.--Section 505E of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355f) is amended--
          (1) in subsection (c)--
                  (A) in paragraph (2), by striking ``or'' at the end;
                  (B) in paragraph (3), by striking the period at the 
                end and inserting ``; or''; and
                  (C) by adding at the end the following:
          ``(4) an application pursuant to section 351(a) of the Public 
        Health Service Act.'';
          (2) in subsection (d)(1), by inserting ``of this Act or 
        section 351(a) of the Public Health Service Act'' after 
        ``section 505(b)''; and
          (3) by amending subsection (g) to read as follows:
  ``(g) Qualified Infectious Disease Product.--The term `qualified 
infectious disease product' means a drug, including an antibacterial or 
antifungal drug or a biological product, for human use that--
          ``(1) acts directly on bacteria or fungi or on substances 
        produced by such bacteria or fungi; and
          ``(2) is intended to treat a serious or life-threatening 
        infection, including such an infection caused by--
                  ``(A) an antibacterial or antifungal resistant 
                pathogen, including novel or emerging infectious 
                pathogens; or
                  ``(B) qualifying pathogens listed by the Secretary 
                under subsection (f).''.
  (b) Priority Review.--Section 524A(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360n-1(a)) is amended by inserting ``of this 
Act or section 351(a) of the Public Health Service Act that requires 
clinical data (other than bioavailability studies) to demonstrate 
safety or effectiveness'' before the period at the end.

SEC. 706. ADVANCED MANUFACTURING TECHNOLOGIES DESIGNATION PILOT 
                    PROGRAM.

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

``SEC. 506K. ADVANCED MANUFACTURING TECHNOLOGIES DESIGNATION PILOT 
                    PROGRAM.

  ``(a) In General.--Not later than 1 year after the date of enactment 
of this section, the Secretary shall initiate a pilot program under 
which persons may request designation of an advanced manufacturing 
technology as described in subsection (b).
  ``(b) Designation Process.--The Secretary shall establish a process 
for the designation under this section of methods of manufacturing 
drugs, including biological products, and active pharmaceutical 
ingredients of such drugs, as advanced manufacturing technologies. A 
method of manufacturing, or a combination of manufacturing methods, is 
eligible for designation as an advanced manufacturing technology if 
such method or combination of methods incorporates a novel technology, 
or uses an established technique or technology in a novel way, that 
will substantially improve the manufacturing process for a drug and 
maintain equivalent or provide superior drug quality, including by--
          ``(1) reducing development time for a drug using the 
        designated manufacturing method; or
          ``(2) increasing or maintaining the supply of--
                  ``(A) a drug that is described in section 506C(a) and 
                is intended to treat a serious or life-threatening 
                condition; or
                  ``(B) a drug that is on the drug shortage list under 
                section 506E.
  ``(c) Evaluation and Designation of an Advanced Manufacturing 
Technology.--
          ``(1) Submission.--A person who requests designation of a 
        method of manufacturing as an advanced manufacturing technology 
        under this section shall submit to the Secretary data or 
        information demonstrating that the method of manufacturing 
        meets the criteria described in subsection (b) in a particular 
        context of use. The Secretary may facilitate the development 
        and review of such data or information by--
                  ``(A) providing timely advice to, and interactive 
                communication with, such person regarding the 
                development of the method of manufacturing; and
                  ``(B) involving senior managers and experienced staff 
                of the Food and Drug Administration, as appropriate, in 
                a collaborative, cross-disciplinary review of the 
                method of manufacturing, as applicable.
          ``(2) Evaluation and designation.--Not later than 180 
        calendar days after the receipt of a request under paragraph 
        (1), the Secretary shall determine whether to designate such 
        method of manufacturing as an advanced manufacturing 
        technology, in a particular context of use, based on the data 
        and information submitted under paragraph (1) and the criteria 
        described in subsection (b).
  ``(d) Review of Advanced Manufacturing Technologies.--If the 
Secretary designates a method of manufacturing as an advanced 
manufacturing technology, the Secretary shall--
          ``(1) expedite the development and review of an application 
        submitted under section 505 of this Act or section 351 of the 
        Public Health Service Act, including supplemental applications, 
        for drugs that are manufactured using a designated advanced 
        manufacturing technology and could help mitigate or prevent a 
        shortage or substantially improve manufacturing processes for a 
        drug and maintain equivalent or provide superior drug quality, 
        as described in subsection (b); and
          ``(2) allow the holder of an advanced technology designation, 
        or a person authorized by the advanced manufacturing technology 
        designation holder, to reference or rely upon, in an 
        application submitted under section 505 of this Act or section 
        351 of the Public Health Service Act, including a supplemental 
        application, data and information about the designated advanced 
        manufacturing technology for use in manufacturing drugs in the 
        same context of use for which the designation was granted.
  ``(e) Implementation and Evaluation of Advanced Manufacturing 
Technologies Pilot.--
          ``(1) Public meeting.--The Secretary shall publish in the 
        Federal Register a notice of a public meeting, to be held not 
        later than 180 days after the date of enactment of this 
        section, to discuss and obtain input and recommendations from 
        relevant stakeholders regarding--
                  ``(A) the goals and scope of the pilot program, and a 
                suitable framework, procedures, and requirements for 
                such program; and
                  ``(B) ways in which the Food and Drug Administration 
                will support the use of advanced manufacturing 
                technologies and other innovative manufacturing 
                approaches for drugs.
          ``(2) Pilot program guidance.--
                  ``(A) In general.--The Secretary shall--
                          ``(i) not later than 180 days after the 
                        public meeting under paragraph (1), issue draft 
                        guidance regarding the goals and implementation 
                        of the pilot program under this section; and
                          ``(ii) not later than 2 years after the date 
                        of enactment of this section, issue final 
                        guidance regarding the implementation of such 
                        program.
                  ``(B) Content.--The guidance described in 
                subparagraph (A) shall address--
                          ``(i) the process by which a person may 
                        request a designation under subsection (b);
                          ``(ii) the data and information that a person 
                        requesting such a designation is required to 
                        submit under subsection (c), and how the 
                        Secretary intends to evaluate such submissions;
                          ``(iii) the process to expedite the 
                        development and review of applications under 
                        subsection (d); and
                          ``(iv) the criteria described in subsection 
                        (b) for eligibility for such a designation.
          ``(3) Report.--Not later than 3 years after the date of 
        enactment of this section and annually thereafter, the 
        Secretary shall publish on the website of the Food and Drug 
        Administration and submit to the Committee on Health, 
        Education, Labor, and Pensions of the Senate and the Committee 
        on Energy and Commerce of the House of Representatives a report 
        containing a description and evaluation of the pilot program 
        being conducted under this section, including the types of 
        innovative manufacturing approaches supported under the 
        program. Such report shall include the following:
                  ``(A) The number of persons that have requested 
                designations and that have been granted designations.
                  ``(B) The number of methods of manufacturing that 
                have been the subject of designation requests and that 
                have been granted designations.
                  ``(C) The average number of calendar days for 
                completion of evaluations under subsection (c)(2).
                  ``(D) An analysis of the factors in data submissions 
                that are relevant to determinations to designate and 
                not to designate after evaluation under subsection 
                (c)(2).
                  ``(E) The number of applications received under 
                section 505 of this Act or section 351 of the Public 
                Health Service Act, including supplemental 
                applications, that have included an advanced 
                manufacturing technology designated under this section, 
                and the number of such applications approved.
  ``(f) Sunset.--The Secretary--
          ``(1) may not consider any requests for designation submitted 
        under subsection (c) after October 1, 2029; and
          ``(2) may continue all activities under this section with 
        respect to advanced manufacturing technologies that were 
        designated pursuant to subsection (d) prior to such date, if 
        the Secretary determines such activities are in the interest of 
        the public health.''.

SEC. 707. PUBLIC WORKSHOP ON CELL THERAPIES.

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

SEC. 708. REAUTHORIZATION OF BEST PHARMACEUTICALS FOR CHILDREN.

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

SEC. 709. REAUTHORIZATION FOR HUMANITARIAN DEVICE EXEMPTION AND 
                    DEMONSTRATION GRANTS FOR IMPROVING PEDIATRIC 
                    AVAILABILITY.

  (a) Humanitarian Device Exemption.--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 ``2022'' and inserting ``2027''.
  (b) Pediatric Medical Device Safety and Improvement Act.--Section 
305(e) of the Pediatric Medical Device Safety and Improvement Act of 
2007 (Public Law 110-85) is amended by striking ``2018 through 2022'' 
and inserting ``2023 through 2027''.

SEC. 710. REAUTHORIZATION OF PROVISION RELATED 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)) is amended by striking ``2022'' and inserting 
``2027''.

SEC. 711. REAUTHORIZATION OF THE CRITICAL PATH PUBLIC-PRIVATE 
                    PARTNERSHIP PROGRAM.

  Section 566(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb-5(f)) is amended by striking ``$6,000,000 for each of fiscal 
years 2018 through 2022'' and inserting ``$10,000,000 for each of 
fiscal years 2023 through 2027''.

SEC. 712. REAUTHORIZATION OF ORPHAN DRUG GRANTS.

  Section 5 of the Orphan Drug Act (21 U.S.C. 360ee) is amended--
          (1) in subsection (a)--
                  (A) by striking ``and (3)'' and inserting ``(3)''; 
                and
                  (B) by inserting before the period at the end the 
                following: ``, and (4) developing regulatory science 
                pertaining to the chemistry, manufacturing, and 
                controls of individualized medical products to treat 
                individuals with rare diseases or conditions''; and
          (2) in subsection (c), by striking ``2018 through 2022'' and 
        inserting ``2023 through 2027''.

SEC. 713. RESEARCH INTO PEDIATRIC USES OF DRUGS; ADDITIONAL AUTHORITIES 
                    OF FOOD AND DRUG ADMINISTRATION REGARDING 
                    MOLECULARLY TARGETED CANCER DRUGS.

  (a) In General.--
          (1) Additional active ingredient for application drug; 
        limitation regarding novel-combination application drug.--
        Section 505B(a)(3) of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 355c(a)(3)) is amended--
                  (A) by redesignating subparagraphs (B) and (C) as 
                subparagraphs (C) and (D), respectively; and
                  (B) by striking subparagraph (A) and inserting the 
                following:
                  ``(A) In general.--For purposes of paragraph (1)(B), 
                the investigation described in this paragraph is (as 
                determined by the Secretary) a molecularly targeted 
                pediatric cancer investigation of--
                          ``(i) the drug or biological product for 
                        which the application referred to in such 
                        paragraph is submitted; or
                          ``(ii) such drug or biological product in 
                        combination with--
                                  ``(I) an active ingredient of a drug 
                                or biological product--
                                          ``(aa) for which an approved 
                                        application under section 
                                        505(j) under this Act or under 
                                        section 351(k) of the Public 
                                        Health Service Act is in 
                                        effect; and
                                          ``(bb) that is determined by 
                                        the Secretary to be the 
                                        standard of care for treating a 
                                        pediatric cancer; or
                                  ``(II) an active ingredient of a drug 
                                or biological product--
                                          ``(aa) for which an approved 
                                        application under section 
                                        505(b) of this Act or section 
                                        351(a) of the Public Health 
                                        Service Act to treat an adult 
                                        cancer is in effect and is held 
                                        by the same person submitting 
                                        the application under paragraph 
                                        (1)(B); and
                                          ``(bb) that is directed at a 
                                        molecular target that the 
                                        Secretary determines to be 
                                        substantially relevant to the 
                                        growth or progression of a 
                                        pediatric cancer.
                  ``(B) Additional requirements.--
                          ``(i) Design of investigation.--A molecularly 
                        targeted pediatric cancer investigation 
                        referred to in subparagraph (A) shall be 
                        designed to yield clinically meaningful 
                        pediatric study data that is 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.
                          ``(ii) Limitation.--An investigation 
                        described in subparagraph (A)(ii) may be 
                        required only if the drug or biological product 
                        for which the application referred to in 
                        paragraph (1)(B) contains either--
                                  ``(I) a single new active ingredient; 
                                or
                                  ``(II) more than one active 
                                ingredient, if an application for the 
                                combination of active ingredients has 
                                not previously been approved but each 
                                active ingredient has been previously 
                                approved to treat an adult cancer.
                          ``(iii) Results of already-completed 
                        preclinical studies of application drug.--The 
                        Secretary may require that reports on an 
                        investigation required pursuant to paragraph 
                        (1)(B) include the results of all preclinical 
                        studies on which the decision to conduct such 
                        investigation was based.
                          ``(iv) Rule of construction regarding 
                        inactive ingredients.--With respect to a 
                        combination of active ingredients referred to 
                        in subparagraph (A)(ii), such subparagraph 
                        shall not be construed as addressing the use of 
                        inactive ingredients with such combination.''.
          (2) Determination of applicable requirements.--Section 
        505B(e)(1) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355c(e)(1)) is amended by adding at the end the 
        following: ``The Secretary shall determine whether subparagraph 
        (A) or (B) of subsection (a)(1) shall apply with respect to an 
        application before the date on which the applicant is required 
        to submit the initial pediatric study plan under paragraph 
        (2)(A).''.
          (3) Clarifying applicability.--Section 505B(a)(1) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(a)(1)) is 
        amended by adding at the end the following:
                  ``(C) Rule of construction.--No application that is 
                subject to the requirements of subparagraph (B) shall 
                be subject to the requirements of subparagraph (A), and 
                no application (or supplement to an application) that 
                is subject to the requirements of subparagraph (A) 
                shall be subject to the requirements of subparagraph 
                (B).''.
          (4) Conforming amendments.--Section 505B(a) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 355c(a)) is amended--
                  (A) in paragraph (3)(C), as redesignated by paragraph 
                (1)(A) of this subsection, by striking ``investigations 
                described in this paragraph'' and inserting 
                ``investigations referred to in subparagraph (A)''; and
                  (B) in paragraph (3)(D), as redesignated by paragraph 
                (1)(A) of this subsection, by striking ``the 
                assessments under paragraph (2)(B)'' and inserting 
                ``the assessments required under paragraph (1)(A)''.
  (b) Guidance.--The Secretary shall--
          (1) not later than 6 months after the date of enactment of 
        this Act, issue draft guidance on the implementation of the 
        requirements in subsection (a); and
          (2) not later than 12 months after closing the comment period 
        on such draft guidance, finalize such guidance.
  (c) Applicability.--The amendments made by this section apply with 
respect to any application under section 505(i) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(i)) and any application under 
section 351(a) of the Public Health Service Act (42 U.S.C. 262), that 
is submitted on or after the date that is 3 years after the date of 
enactment of this Act.
  (d) Reports to Congress.--
          (1) Secretary of health and human services.--Not later than 2 
        years after the date of enactment of this Act, the Secretary of 
        Health and Human Services shall submit to the Committee on 
        Energy and Commerce of the House of Representatives and the 
        Committee on Health, Education, Labor, and Pensions of the 
        Senate a report on the Secretary's efforts, in coordination 
        with industry, to ensure implementation of the amendments made 
        by subsection (a).
          (2) GAO study and report.--
                  (A) Study.--Not later than 2 years after the date of 
                enactment of this Act, the Comptroller General of the 
                United States shall conduct a study of the 
                effectiveness of requiring assessments and 
                investigations described in section 505B of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C.355c), as 
                amended by subsection (a), in the development of drugs 
                and biological products for pediatric cancer 
                indications.
                  (B) Findings.--Not later than 4 years after the date 
                of enactment of this Act, the Comptroller General 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 the findings of the study conducted under 
                subparagraph (A).

                        Subtitle B--Inspections

SEC. 721. FACTORY INSPECTION.

  (a) In General.--Section 704(a)(1) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 374(a)(1)) is amended by striking ``restricted 
devices'' each place it appears and inserting ``devices''.
  (b) Records or Other Information.--
          (1) Establishments.--Section 704(a)(4)(A) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)(4)(A)) is 
        amended--
                  (A) by striking ``an establishment that is engaged in 
                the manufacture, preparation, propagation, compounding, 
                or processing of a drug'' and inserting ``an 
                establishment that is engaged in the manufacture, 
                preparation, propagation, compounding, or processing of 
                a drug or device, or that is subject to inspection 
                under paragraph (5)(C),''; and
                  (B) by inserting after ``a sufficient description of 
                the records requested'' the following: ``and a 
                rationale for requesting such records or other 
                information in advance of, or in lieu of, an 
                inspection''.
          (2) Guidance.--
                  (A) In general.--The Secretary of Health and Human 
                Services shall issue or update guidance describing--
                          (i) circumstances in which the Secretary 
                        intends to issue requests for records or other 
                        information in advance of, or in lieu of, an 
                        inspection under section 704(a)(4) of the 
                        Federal Food, Drug, and Cosmetic Act, as 
                        amended by paragraph (1);
                          (ii) processes for responding to such 
                        requests electronically or in physical form; 
                        and
                          (iii) factors the Secretary intends to 
                        consider in evaluating whether such records and 
                        other information are provided within a 
                        reasonable timeframe, within reasonable limits, 
                        and in a reasonable manner, accounting for 
                        resource and other limitations that may exist, 
                        including for small businesses.
                  (B) Timing.--The Secretary of Health and Human 
                Services shall--
                          (i) not later than 1 year after the date of 
                        enactment of this Act, issue draft guidance 
                        under subparagraph (A); and
                          (ii) not later than 1 year after the close of 
                        the comment period for such draft guidance, 
                        issue final guidance under subparagraph (A).
  (c) Bioresearch Monitoring Inspections.--
          (1) In general.--Section 704(a) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 374(a)) is amended by adding at the 
        end the following:
          ``(5) Bioresearch monitoring inspections.--
                  ``(A) In general.--The Secretary may, to ensure the 
                accuracy and reliability of studies and records or 
                other information described in subparagraph (B) and to 
                assess compliance with applicable requirements under 
                this Act or the Public Health Service Act, enter sites 
                and facilities specified in subparagraph (C) in order 
                to inspect such records or other information.
                  ``(B) Information subject to inspection.--An 
                inspection under this paragraph shall extend to all 
                records and other information related to the studies 
                and submissions described in subparagraph (E), 
                including records and information related to the 
                conduct, results, and analyses of, and the protection 
                of human and animal trial participants participating 
                in, such studies.
                  ``(C) Sites and facilities subject to inspection.--
                          ``(i) Sites and facilities described.--The 
                        sites and facilities subject to inspection by 
                        the Secretary under this paragraph are those 
                        owned or operated by a person described in 
                        clause (ii) and which are (or were) utilized by 
                        such person in connection with--
                                  ``(I) developing an application or 
                                other submission to the Secretary under 
                                this Act or the Public Health Service 
                                Act related to marketing authorization 
                                for a product described in paragraph 
                                (1);
                                  ``(II) preparing, conducting, or 
                                analyzing the results of a study 
                                described in subparagraph (E); or
                                  ``(III) holding any records or other 
                                information described in subparagraph 
                                (B).
                          ``(ii) Persons described.--A person described 
                        in this clause is--
                                  ``(I) the sponsor of an application 
                                or submission specified in subparagraph 
                                (E);
                                  ``(II) a person engaged in any 
                                activity described in clause (i) on 
                                behalf of such a sponsor, through a 
                                contract, grant, or other business 
                                arrangement with such sponsor;
                                  ``(III) an institutional review 
                                board, or other individual or entity, 
                                engaged by contract, grant, or other 
                                business arrangement with a nonsponsor 
                                in preparing, collecting, or analyzing 
                                records or other information described 
                                in subparagraph (B); or
                                  ``(IV) any person not otherwise 
                                described in this clause that conducts, 
                                or has conducted, a study described in 
                                subparagraph (E) yielding records or 
                                other information described in 
                                subparagraph (B).
                  ``(D) Conditions of inspection.--
                          ``(i) Access to information subject to 
                        inspection.--Subject to clause (ii), an entity 
                        that owns or operates any site or facility 
                        subject to inspection under this paragraph 
                        shall provide the Secretary with access to 
                        records and other information described in 
                        subparagraph (B) that is held by or under the 
                        control of such entity, including--
                                  ``(I) permitting the Secretary to 
                                record or copy such information for 
                                purposes of this paragraph;
                                  ``(II) providing the Secretary with 
                                access to any electronic information 
                                system utilized by such entity to hold, 
                                process, analyze, or transfer any 
                                records or other information described 
                                in subparagraph (B); and
                                  ``(III) permitting the Secretary to 
                                inspect the facilities, equipment, 
                                written procedures, processes, and 
                                conditions through which records or 
                                other information described in 
                                subparagraph (B) is or was generated, 
                                held, processed, analyzed, or 
                                transferred.
                          ``(ii) No effect on applicability of 
                        provisions for protection of proprietary 
                        information or trade secrets.--Nothing in 
                        clause (i) shall negate, supersede, or 
                        otherwise affect the applicability of 
                        provisions, under this or any other Act, 
                        preventing or limiting the disclosure of 
                        confidential commercial information or other 
                        information considered proprietary or trade 
                        secret.
                          ``(iii) Reasonableness of inspections.--An 
                        inspection under this paragraph shall be 
                        conducted at reasonable times and within 
                        reasonable limits and in a reasonable manner.
                  ``(E) Studies and submissions described.--The studies 
                and submissions described in this subparagraph are each 
                of the following:
                          ``(i) Clinical and nonclinical studies 
                        submitted to the Secretary in support of, or 
                        otherwise related to, applications and other 
                        submissions to the Secretary under this Act or 
                        the Public Health Service Act for marketing 
                        authorization of a product described in 
                        paragraph (1).
                          ``(ii) Postmarket safety activities conducted 
                        under this Act or the Public Health Service 
                        Act.
                          ``(iii) Any other clinical investigation of--
                                  ``(I) a drug subject to section 505 
                                or 512 of this Act or section 351 of 
                                the Public Health Service Act; or
                                  ``(II) a device subject to section 
                                520(g).
                          ``(iv) Any other submissions made under this 
                        Act or the Public Health Service Act with 
                        respect to which the Secretary determines an 
                        inspection under this paragraph is warranted in 
                        the interest of public health.
                  ``(F) Clarification.--This paragraph clarifies the 
                authority of the Secretary to conduct inspections of 
                the type described in this paragraph and shall not be 
                construed as a basis for inferring that, prior to the 
                date of enactment of this paragraph, the Secretary 
                lacked the authority to conduct such inspections, 
                including under this Act or the Public Health Service 
                Act.''.
          (2) Review of processes and practices; guidance for 
        industry.--
                  (A) In general.--The Secretary of Health and Human 
                Services shall--
                          (i) review processes and practices in effect 
                        as of the date of enactment of this Act 
                        applicable to inspections of foreign and 
                        domestic sites and facilities described in 
                        subparagraph (C)(i) of section 704(a)(5) of the 
                        Federal Food, Drug, and Cosmetic Act, as added 
                        by paragraph (1); and
                          (ii) evaluate whether any updates are needed 
                        to facilitate the consistency of such processes 
                        and practices.
                  (B) Guidance.--
                          (i) In general.--The Secretary of Health and 
                        Human Services shall issue guidance describing 
                        the processes and practices applicable to 
                        inspections of sites and facilities described 
                        in subparagraph (C)(i) of section 704(a)(5) of 
                        the Federal Food, Drug, and Cosmetic Act, as 
                        added by paragraph (1), including with respect 
                        to the types of records and information 
                        required to be provided, best practices for 
                        communication between the Food and Drug 
                        Administration and industry in advance of or 
                        during an inspection or request for records or 
                        other information, and other inspections-
                        related conduct, to the extent not specified in 
                        existing publicly available Food and Drug 
                        Administration guides and manuals for such 
                        inspections.
                          (ii) Timing.--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 under clause (i); 
                                and
                                  (II) not later than 1 year after the 
                                close of the public comment period for 
                                such draft guidance, issue final 
                                guidance under clause (i).

SEC. 722. USES OF CERTAIN EVIDENCE.

  Section 703 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
373) is amended by adding at the end the following:
  ``(c) Applicability.--The limitations on the Secretary's use of 
evidence obtained under this section, or any evidence which is directly 
or indirectly derived from such evidence, in a criminal prosecution of 
the person from whom such evidence was obtained shall not apply to 
evidence, including records or other information, obtained under 
authorities other than this section, unless such limitations are 
specifically incorporated by reference in such other authorities.''.

SEC. 723. IMPROVING FDA INSPECTIONS.

  (a) Risk Factors for Establishments.--Section 510(h)(4) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(h)(4)) is amended--
          (1) by redesignating subparagraph (F) as subparagraph (G); 
        and
          (2) by inserting after subparagraph (E) the following:
                  ``(F) The compliance history of establishments in the 
                country or region in which the establishment is located 
                that are subject to regulation under this Act, 
                including the history of violations related to products 
                exported from such country or region that are subject 
                to such regulation.''.
  (b) Use of Records.--Section 704(a)(4) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 374(a)(4)) is amended--
          (1) by redesignating subparagraph (C) as subparagraph (D); 
        and
          (2) by inserting after subparagraph (B) the following:
  ``(C) The Secretary may rely on any records or other information that 
the Secretary may inspect under this section to satisfy requirements 
that may pertain to a preapproval or risk-based surveillance 
inspection, or to resolve deficiencies identified during such 
inspections, if applicable and appropriate.''.
  (c) Recognition of Foreign Government Inspections.--Section 809 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384e) is amended--
          (1) in subsection (a)(1), by inserting ``preapproval or'' 
        before ``risk-based inspections''; and
          (2) by adding at the end the following:
  ``(c) Periodic Review.--
          ``(1) In general.--Beginning not later than 1 year after the 
        date of the enactment of the Food and Drug Amendments of 2022, 
        the Secretary shall periodically assess whether additional 
        arrangements and agreements with a foreign government or an 
        agency of a foreign government, as allowed under this section, 
        are appropriate.
          ``(2) Reports to congress.--Beginning not later than 4 years 
        after the date of the enactment of the Food and Drug Amendments 
        of 2022, and every 4 years thereafter, the Secretary shall 
        submit to the Committee on Energy and Commerce of the House of 
        Representatives and the Committee on Health, Education, Labor, 
        and Pensions of the Senate a report describing the findings and 
        conclusions of each review conducted under paragraph (1).''.

SEC. 724. GAO REPORT ON INSPECTIONS OF FOREIGN ESTABLISHMENTS 
                    MANUFACTURING DRUGS.

  (a) In General.--Not later than 18 months after the date of the 
enactment of this Act, the Comptroller General of the United States 
shall submit to the Committee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Education, Labor, and 
Pensions of the Senate a report on inspections conducted by--
          (1) the Secretary of Health and Human Services (in this 
        section referred to as the ``Secretary'') of foreign 
        establishments pursuant to subsections (h) and (i) of section 
        510 and section 704 of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 360; 374); or
          (2) a foreign government or an agency of a foreign government 
        pursuant to section 809 of such Act (21 U.S.C. 384e).
  (b) Contents.--The report conducted under subsection (a) shall 
include--
          (1) what alternative tools, including remote inspections or 
        remote evaluations, other countries are utilizing to facilitate 
        inspections of foreign establishments;
          (2) how frequently trusted foreign regulators conduct 
        inspections of foreign facilities that could be useful to the 
        Food and Drug Administration to review in lieu of its own 
        inspections;
          (3) how frequently and under what circumstances, including 
        for what types of inspections, the Secretary utilizes existing 
        agreements or arrangements under section 809 of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 384e) and whether the 
        use of such agreements could be appropriately expanded;
          (4) whether the Secretary has accepted reports of inspections 
        of facilities in China and India conducted by entities with 
        which they have entered into such an agreement or arrangement;
          (5) what additional foreign governments or agencies of 
        foreign governments the Secretary has considered entering into 
        a mutual recognition agreement with and, if applicable, reasons 
        why the Secretary declined to enter into a mutual recognition 
        agreement with such foreign governments or agencies;
          (6) what tools, if any, the Secretary used to facilitate 
        inspections of domestic facilities that could also be 
        effectively utilized to appropriately inspect foreign 
        facilities;
          (7) what steps the Secretary has taken to identify and 
        evaluate tools and strategies the Secretary may use to continue 
        oversight with respect to inspections when in-person 
        inspections are disrupted;
          (8) how the Secretary is considering incorporating 
        alternative tools into the inspection activities conducted 
        pursuant to the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        301 et seq.); and
          (9) what steps the Secretary has taken to identify and 
        evaluate how the Secretary may use alternative tools to address 
        workforce shortages to carry out such inspection activities.

SEC. 725. UNANNOUNCED FOREIGN FACILITY INSPECTIONS PILOT PROGRAM.

  (a) In General.--The Secretary of Health and Human Services (referred 
to in this section as the ``Secretary'') shall conduct a pilot program 
under which the Secretary increases the conduct of unannounced 
surveillance inspections of foreign human drug establishments and 
evaluates the differences between such inspections of domestic and 
foreign human drug establishments, including the impact of announcing 
inspections to persons who own or operate foreign human drug 
establishments in advance of an inspection. Such pilot program shall 
evaluate--
          (1) differences in the number and type of violations of 
        section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 351(a)(2)(B)) identified as a result of 
        unannounced and announced inspections of foreign human drug 
        establishments and any other significant differences between 
        each type of inspection;
          (2) costs and benefits associated with conducting announced 
        and unannounced inspections of foreign human drug 
        establishments;
          (3) barriers to conducting unannounced inspections of foreign 
        human drug establishments and any challenges to achieving 
        parity between domestic and foreign human drug establishment 
        inspections; and
          (4) approaches for mitigating any negative effects of 
        conducting announced inspections of foreign human drug 
        establishments.
  (b) Pilot Program Scope.--The inspections evaluated under the pilot 
program under this section shall be routine surveillance inspections 
and shall not include inspections conducted as part of the Secretary's 
evaluation of a request for approval to market a drug submitted under 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the 
Public Health Service Act (42 U.S.C. 201 et seq.).
  (c) Pilot Program Initiation.--The Secretary shall initiate the pilot 
program under this section not later than 180 days after the date of 
enactment of this Act.
  (d) Report.--The Secretary shall, not later than 180 days following 
the completion of the pilot program under this section, make available 
on the website of the Food and Drug Administration a final report on 
the pilot program under this section, including--
          (1) findings and any associated recommendations with respect 
        to the evaluation under subsection (a), including any 
        recommendations to address identified barriers to conducting 
        unannounced inspections of foreign human drug establishments;
          (2) findings and any associated recommendations regarding how 
        the Secretary may achieve parity between domestic and foreign 
        human drug inspections; and
          (3) the number of unannounced inspections during the pilot 
        program that would not be unannounced under existing practices.

SEC. 726. REAUTHORIZATION OF INSPECTION PROGRAM.

  Section 704(g)(11) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 374(g)(11)) is amended by striking ``2022'' and inserting 
``2027''.

SEC. 727. ENHANCING INTRA-AGENCY COORDINATION AND PUBLIC HEALTH 
                    ASSESSMENT WITH REGARD TO COMPLIANCE ACTIVITIES.

  (a) Coordination.--Section 506D of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 356d) is amended by adding at the end the 
following:
  ``(g) Coordination.--The Secretary shall ensure timely and effective 
internal coordination and alignment among the field investigators of 
the Food and Drug Administration and the staff of the Center for Drug 
Evaluation and Research's Office of Compliance and Drug Shortage 
Program regarding--
          ``(1) the reviews of reports shared pursuant to section 
        704(b)(2); and
          ``(2) any feedback or corrective or preventive actions in 
        response to such reports.''.
  (b) Reporting.--
          (1) In general.--Section 506C-1(a)(2) of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 356c-1(a)(2)) is amended to 
        read as follows:
          ``(2)(A) describes the communication between the field 
        investigators of the Food and Drug Administration and the staff 
        of the Center for Drug Evaluation and Research's Office of 
        Compliance and Drug Shortage Program, including the Food and 
        Drug Administration's procedures for enabling and ensuring such 
        communication;
          ``(B) provides the number of reports described in section 
        704(b)(2) that were required to be sent to the appropriate 
        offices of the Food and Drug Administration and the number of 
        such reports that were sent; and
          ``(C) describes the coordination and alignment activities 
        undertaken pursuant to section 506D(g);''.
          (2) Applicability.--The amendment made by paragraph (1) shall 
        apply with respect to reports submitted on or after March 31, 
        2023.

SEC. 728. REPORTING OF MUTUAL RECOGNITION AGREEMENTS FOR INSPECTIONS 
                    AND REVIEW ACTIVITIES.

  (a) In General.--Not later than December 31, 2022, and annually 
thereafter, the Secretary of Health and Human Services (referred to in 
this section as the ``Secretary'') shall publish a report on the public 
website of the Food and Drug Administration on the utilization of 
agreements entered into pursuant to section 809 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 384e) or otherwise entered into by 
the Secretary in the previous fiscal year to recognize inspections 
between drug regulatory authorities across countries and international 
regions with analogous review criteria to the Food and Drug 
Administration, such as the Pharmaceutical Inspection Co-Operation 
Scheme, the Mutual Recognition Agreement with the European Union, and 
the Australia-Canada-Singapore-Switzerland-United Kingdom Consortium.
  (b) Content.--The report under subsection (a) shall include each of 
the following:
          (1) The total number of establishments that are registered 
        under section 510(i) of the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 360(i)), and the number of such establishments 
        in each region of interest.
          (2)  The total number of inspections conducted at 
        establishments described in paragraph (1), disaggregated by 
        inspections conducted--
                  (A) pursuant to an agreement or other recognition 
                described in subsection (a); and
                  (B) by employees or contractors of the Food and Drug 
                Administration.
          (3) Of the inspections described in paragraph (2), the total 
        number of inspections in each region of interest.
          (4) Of the inspections in each region of interest reported 
        pursuant to paragraph (3), the number of inspections in each 
        FDA inspection category.
          (5) Of the number of inspections reported under each of 
        paragraphs (3) and (4)--
                  (A) the number of inspections which have been 
                conducted pursuant to an agreement or other recognition 
                described in subsection (a); and
                  (B) the number of inspections which have been 
                conducted by employees or contractors of the Food and 
                Drug Administration.
  (c) Definitions.--In this section:
          (1) FDA inspection category.--The term ``FDA inspection 
        category'' means the following inspection categories:
                  (A) Inspections to support approvals of changes to 
                the manufacturing process of drugs approved under 
                section 505 of the Federal Food, Drug, and Cosmetic Act 
                (21 U.S.C. 355) or section 351 of the Public Health 
                Service Act (42 U.S.C. 262).
                  (B) Surveillance inspections.
                  (C) For-cause inspections.
          (2) Region of interest.--The term ``region of interest'' 
        means China, India, the European Union, and any other 
        geographic region as the Secretary determines appropriate.

SEC. 729. ENHANCING TRANSPARENCY OF DRUG FACILITY INSPECTION TIMELINES.

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

``SEC. 902. ANNUAL REPORT ON INSPECTIONS.

  ``Not later than 120 days after the end of each fiscal year, the 
Secretary of Health and Human Services shall post on the public website 
of the Food and Drug Administration information related to inspections 
of facilities necessary for approval of a drug under subsection (c) or 
(j) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355), approval of a device under section 515 of such Act (21 
U.S.C. 360e), or clearance of a device under section 510(k) of such Act 
(21 U.S.C. 360(k)) that were conducted during the previous fiscal year. 
Such information shall include the following:
          ``(1) The median time following a request from staff of the 
        Food and Drug Administration reviewing an application or report 
        to the beginning of the inspection, including--
                  ``(A) the median time for drugs described in section 
                505(j)(11)(A)(i) of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 355(j)(11)(A)(i));
                  ``(B) the median time for drugs described in section 
                506C(a) of such Act (21 U.S.C. 356c(a)) only; and
                  ``(C) the median time for drugs on the drug shortage 
                list in effect under section 506E of such Act (21 
                U.S.C. 356e).
          ``(2) The median time from the issuance of a report pursuant 
        to section 704(b) of such Act (21 U.S.C. 374(b)) to the sending 
        of a warning letter, issuance of an import alert, or holding of 
        a regulatory meeting for inspections for which the Secretary 
        concluded that regulatory or enforcement action was indicated, 
        including the median time for each category of drugs listed in 
        subparagraphs (A) through (C) of paragraph (1).
          ``(3) The median time from the sending of a warning letter, 
        issuance of an import alert, or holding of a regulatory meeting 
        to resolution of the actions indicated to address the 
        conditions or practices observed during an inspection.
          ``(4) The number of facilities that failed to implement 
        adequate corrective or preventive actions following a report 
        pursuant to such section 704(b), resulting in a withhold 
        recommendation, including the number of such times for each 
        category of drugs listed in subparagraphs (A) through (C) of 
        paragraph (1).''.

      TITLE VIII--TRANSPARENCY, PROGRAM INTEGRITY, AND REGULATORY 
                              IMPROVEMENTS

SEC. 801. PROMPT REPORTS OF MARKETING STATUS BY HOLDERS OF APPROVED 
                    APPLICATIONS FOR BIOLOGICAL PRODUCTS.

  (a) In General.--Section 506I of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 356i) is amended--
          (1) in subsection (a)--
                  (A) in the matter preceding paragraph (1), by 
                striking ``The holder of an application approved under 
                subsection (c) or (j) of section 505'' and inserting 
                ``The holder of an application approved under 
                subsection (c) or (j) of section 505 of this Act or 
                subsection (a) or (k) of section 351 of the Public 
                Health Service Act'';
                  (B) in paragraph (2), by striking ``established 
                name'' and inserting ``established name (for biological 
                products, by proper name)''; and
                  (C) in paragraph (3), by striking ``or abbreviated 
                application number'' and inserting ``, abbreviated 
                application number, or biologics license application 
                number''; and
          (2) in subsection (b)--
                  (A) in the matter preceding paragraph (1), by 
                striking ``The holder of an application approved under 
                subsection (c) or (j)'' and inserting ``The holder of 
                an application approved under subsection (c) or (j) of 
                section 505 of this Act or subsection (a) or (k) of 
                section 351 of the Public Health Service Act'';
                  (B) in paragraph (1), by striking ``established 
                name'' and inserting ``established name (for biological 
                products, by proper name)''; and
                  (C) in paragraph (2), by striking ``or abbreviated 
                application number'' and inserting ``, abbreviated 
                application number, or biologics license application 
                number''.
  (b) Additional One-Time Report.--Subsection (c) of section 506I of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356i) is amended to 
read as follows:
  ``(c) Additional One-Time Report.--Within 180 days of the date of 
enactment of the Food and Drug Amendments of 2022, all holders of 
applications approved under subsection (a) or (k) of section 351 of the 
Public Health Service Act shall review the information in the list 
published under section 351(k)(9)(A) and shall submit a written notice 
to the Secretary--
          ``(1) stating that all of the application holder's biological 
        products in the list published under section 351(k)(9)(A) that 
        are not listed as discontinued are available for sale; or
          ``(2) including the information required pursuant to 
        subsection (a) or (b), as applicable, for each of the 
        application holder's biological products that are in the list 
        published under section 351(k)(9)(A) and not listed as 
        discontinued, but have been discontinued from sale or never 
        have been available for sale.''.
  (c) Purple Book.--Section 506I of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 356i) is amended--
          (1) by striking subsection (d) and inserting the following:
  ``(d) Failure To Meet Requirements.--If a holder of an approved 
application fails to submit the information required under subsection 
(a), (b), or (c), the Secretary may--
          ``(1) move the application holder's drugs from the active 
        section of the list published under section 505(j)(7)(A) to the 
        discontinued section of the list, except that the Secretary 
        shall remove from the list in accordance with section 
        505(j)(7)(C) drugs the Secretary determines have been withdrawn 
        from sale for reasons of safety or effectiveness; and
          ``(2) identify the application holder's biological products 
        as discontinued in the list published under section 
        351(k)(9)(A) of the Public Health Service Act, except that the 
        Secretary shall remove from the list in accordance with section 
        351(k)(9)(B) of such Act biological products for which the 
        license has been revoked or suspended for reasons of safety, 
        purity, or potency.''; and
          (2) in subsection (e)--
                  (A) by inserting after the first sentence the 
                following: ``The Secretary shall update the list 
                published under section 351(k)(9)(A) of the Public 
                Health Service Act based on information provided under 
                subsections (a), (b), and (c) by identifying as 
                discontinued biological products that are not available 
                for sale, except that biological products for which the 
                license has been revoked or suspended for safety, 
                purity, or potency reasons shall be removed from the 
                list in accordance with section 351(k)(9)(B) of the 
                Public Health Service Act.'';
                  (B) by striking ``monthly updates to the list'' and 
                inserting ``monthly updates to the lists referred to in 
                the preceding sentences''; and
                  (C) by striking ``and shall update the list based 
                on'' and inserting ``and shall update such lists based 
                on''.
  (d) Technical Corrections.--Section 506I(e) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 356i(e)) is amended--
          (1) by striking ``subsection 505(j)(7)(A)'' and inserting 
        ``section 505(j)(7)(A)''; and
          (2) by striking ``subsection 505(j)(7)(C)'' and inserting 
        ``section 505(j)(7)(C)''.

SEC. 802. ENCOURAGING BLOOD DONATION.

  (a) Streamlining Patient and Blood Donor Input.--Section 3003 of the 
21st Century Cures Act (21 U.S.C. 360bbb-8c note) is amended to read as 
follows:

``SEC. 3003. STREAMLINING PATIENT AND BLOOD DONOR INPUT.

  ``Chapter 35 of title 44, United States Code, shall not apply to the 
collection of information to which a response is voluntary, to 
solicit--
          ``(1) the views and perspectives of patients under section 
        569C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        360bbb-8c) (as amended by section 3001) or section 3002; or
          ``(2) information from blood donors or potential blood donors 
        to support the development of recommendations by the Secretary 
        of Health and Human Services acting through the Commissioner of 
        Food and Drugs concerning blood donation.''.
  (b) Clerical Amendment.--The table of contents in section 1(b) of the 
21st Century Cures Act is amended by striking the item relating to 
section 3003 and inserting the following:

``Sec. 3003. Streamlining patient and blood donor input.''.

SEC. 803. REGULATION OF CERTAIN PRODUCTS AS DRUGS.

  Section 503 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
353) is amended by adding at the end the following:
  ``(h)(1) Any contrast agent, radioactive drug, or OTC monograph drug 
shall be deemed to be a drug under section 201(g) and not a device 
under section 201(h).
  ``(2) For purposes of this subsection:
          ``(A) The term `contrast agent' means an article that is 
        intended for use in conjunction with a medical imaging device, 
        and--
                  ``(i) is a diagnostic radiopharmaceutical, as defined 
                in sections 315.2 and 601.31 of title 21, Code of 
                Federal Regulations (or any successor regulations); or
                  ``(ii) is a diagnostic agent that improves the 
                visualization of structure or function within the body 
                by increasing the relative difference in signal 
                intensity within the target tissue, structure, or 
                fluid.
          ``(B) The term `radioactive drug' has the meaning given such 
        term in section 310.3(n) of title 21, Code of Federal 
        Regulations (or any successor regulations), except that such 
        term does not include--
                  ``(i) an implant or article similar to an implant;
                  ``(ii) an article that applies radiation from outside 
                of the body; or
                  ``(iii) the radiation source of an article described 
                in clause (i) or (ii).
          ``(C) The term `OTC monograph drug' has the meaning given 
        such term in section 744L.
  ``(3) Nothing in this subsection shall be construed as allowing for 
the classification of a product as a drug (as defined in section 
201(g)) if such product--
          ``(A) is not described in paragraph (1); and
          ``(B) meets the definition of a device under section 201(h),
unless another provision of this Act otherwise indicates a different 
classification.''.

SEC. 804. POSTAPPROVAL STUDIES AND PROGRAM INTEGRITY FOR ACCELERATED 
                    APPROVAL DRUGS.

  (a) In General.--Section 506(c) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 356(c)) is amended--
          (1) by striking paragraph (2) and inserting the following:
          ``(2) Limitation.--
                  ``(A) In general.--Approval of a product under this 
                subsection may be subject to 1 or both of the following 
                requirements:
                          ``(i) That the sponsor conduct an appropriate 
                        postapproval study or studies (which may be 
                        augmented or supported by real world evidence) 
                        to verify and describe the predicted effect on 
                        irreversible morbidity or mortality or other 
                        clinical benefit.
                          ``(ii) That the sponsor submit copies of all 
                        promotional materials related to the product 
                        during the preapproval review period and, 
                        following approval and for such period 
                        thereafter as the Secretary determines to be 
                        appropriate, at least 30 days prior to 
                        dissemination of the materials.
                  ``(B) Studies not required.--If the Secretary does 
                not require that the sponsor of a product approved 
                under accelerated approval conduct a postapproval study 
                under this paragraph, the Secretary shall publish on 
                the website of the Food and Drug Administration the 
                rationale for why such study is not appropriate or 
                necessary.
                  ``(C) Postapproval study conditions.--Not later than 
                the time of approval of a product under accelerated 
                approval, the Secretary shall specify the conditions 
                for a postapproval study or studies required to be 
                conducted under this paragraph with respect to such 
                product, which may include enrollment targets, the 
                study protocol, and milestones, including the target 
                date of study completion.
                  ``(D) Studies begun before approval.--The Secretary 
                may require such study or studies to be underway prior 
                to approval.''; and
          (2) by striking paragraph (3) and inserting the following:
          ``(3) Expedited withdrawal of approval.--
                  ``(A) In general.--The Secretary may withdraw 
                approval of a product approved under accelerated 
                approval using expedited procedures described in 
                subparagraph (B), if--
                          ``(i) the sponsor fails to conduct any 
                        required postapproval study of the product with 
                        due diligence, including with respect to 
                        conditions specified by the Secretary under 
                        paragraph (2)(C);
                          ``(ii) a study required to verify and 
                        describe the predicted effect on irreversible 
                        morbidity or mortality or other clinical 
                        benefit of the product fails to verify and 
                        describe such effect or benefit;
                          ``(iii) other evidence demonstrates that the 
                        product is not shown to be safe or effective 
                        under the conditions of use; or
                          ``(iv) the sponsor disseminates false or 
                        misleading promotional materials with respect 
                        to the product.
                  ``(B) Expedited procedures described.--Expedited 
                procedures described in this subparagraph shall consist 
                of, prior to the withdrawal of accelerated approval--
                          ``(i) providing the sponsor with--
                                  ``(I) due notice;
                                  ``(II) an explanation for the 
                                proposed withdrawal;
                                  ``(III) an opportunity for a meeting 
                                with the Commissioner of Food and Drugs 
                                or the Commissioner's designee; and
                                  ``(IV) an opportunity for written 
                                appeal to--
                                          ``(aa) the Commissioner of 
                                        Food and Drugs; or
                                          ``(bb) a designee of the 
                                        Commissioner who has not 
                                        participated in the proposed 
                                        withdrawal of approval (other 
                                        than a meeting pursuant to 
                                        subclause (III)) and is not a 
                                        subordinate of an individual 
                                        (other than the Commissioner) 
                                        who participated in such 
                                        proposed withdrawal;
                          ``(ii) providing an opportunity for public 
                        comment on the notice proposing to withdraw 
                        approval;
                          ``(iii) the publication of a summary of the 
                        public comments received, and the Secretary's 
                        response to such comments, on the website of 
                        the Food and Drug Administration; and
                          ``(iv) convening and consulting an advisory 
                        committee on issues related to the proposed 
                        withdrawal, if requested by the sponsor and if 
                        no such advisory committee has previously 
                        advised the Secretary on such issues with 
                        respect to the withdrawal of the product prior 
                        to the sponsor's request.
          ``(4) Labeling.--
                  ``(A) In general.--Subject to subparagraph (B), the 
                labeling for a product approved under accelerated 
                approval shall include--
                          ``(i) a statement indicating that the product 
                        was approved under accelerated approval;
                          ``(ii) a statement indicating that continued 
                        approval of the product is subject to 
                        postmarketing studies to verify clinical 
                        benefit;
                          ``(iii) identification of the surrogate or 
                        intermediate endpoint or endpoints that 
                        supported approval and any known limitations of 
                        such surrogate or intermediate endpoint or 
                        endpoints in determining clinical benefit; and
                          ``(iv) a succinct description of the product 
                        and any uncertainty about anticipated clinical 
                        benefit and a discussion of available evidence 
                        with respect to such clinical benefit.
                  ``(B) Applicability.--The labeling requirements of 
                subparagraph (A) shall apply only to products approved 
                under accelerated approval for which the predicted 
                effect on irreversible morbidity or mortality or other 
                clinical benefit has not been verified.
                  ``(C) Rule of construction.--With respect to any 
                application pending before the Secretary on the date of 
                enactment of the Food and Drug Amendments of 2022, the 
                Secretary shall allow any applicable changes to the 
                product labeling required to comply with subparagraph 
                (A) to be made by supplement after the approval of such 
                application.
          ``(5) Reporting.--Not later than September 30, 2025, the 
        Secretary shall submit to the Committee on Energy and Commerce 
        of the House of Representatives and the Committee on Health, 
        Education, Labor, and Pensions of the Senate a report 
        describing circumstances in which the Secretary considered real 
        world evidence submitted to support postapproval studies 
        required under this subsection that were completed after the 
        date of enactment of the Food and Drug Amendments of 2022.''.
  (b) Reports of Postmarketing Studies.--Section 506B(a) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 356b(a)) is amended--
          (1) by redesignating paragraph (2) as paragraph (3); and
          (2) by inserting after paragraph (1) the following:
          ``(2) Accelerated approval.--Notwithstanding paragraph (1), a 
        sponsor of a drug approved under accelerated approval shall 
        submit to the Secretary a report of the progress of any study 
        required under section 506(c), including progress toward 
        enrollment targets, milestones, and other information as 
        required by the Secretary, not later than 180 days after the 
        approval of such drug and not less frequently than every 180 
        days thereafter, until the study is completed or terminated.''.
  (c) Guidance.--
          (1) In general.--The Secretary of Health and Human Services 
        shall issue guidance describing--
                  (A) how sponsor questions related to the 
                identification of novel surrogate or intermediate 
                clinical endpoints may be addressed in early-stage 
                development meetings with the Food and Drug 
                Administration;
                  (B) the use of novel clinical trial designs that may 
                be used to conduct appropriate postapproval studies as 
                may be required under section 506(c)(2)(A) of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                356(c)(2)(A)), as amended by subsection (a); and
                  (C) the expedited procedures described in section 
                506(c)(3)(B) of the Federal Food, Drug, and Cosmetic 
                Act (21 U.S.C. 356(c)(3)(B)).
          (2) Final guidance.--The Secretary shall issue--
                  (A) draft guidance under paragraph (1) not later than 
                18 months after the date of enactment of this Act; and
                  (B) final guidance not later than 1 year after the 
                close of the public comment period on such draft 
                guidance.
  (d) Rare Disease Endpoint Advancement Pilot.--
          (1) In general.--The Secretary of Health and Human Services 
        shall establish a pilot program under which the Secretary will 
        establish procedures to provide increased interaction with 
        sponsors of rare disease drug development programs for purposes 
        of advancing the development of efficacy endpoints, including 
        surrogate and intermediate endpoints, for drugs intended to 
        treat rare diseases, including through--
                  (A) determining eligibility of participants for such 
                a program; and
                  (B) developing and implementing a process for 
                applying to, and participating in, such a program.
          (2) Public workshops.--The Secretary shall conduct up to 3 
        public workshops, which shall be completed not later than 
        September 30, 2026, to discuss topics relevant to the 
        development of endpoints for rare diseases, which may include 
        discussions about--
                  (A) novel endpoints developed through the pilot 
                program established under this subsection; and
                  (B) as appropriate, the use of real world evidence 
                and real world data to support the validation of 
                efficacy endpoints, including surrogate and 
                intermediate endpoints, for rare diseases.
          (3) Report.--Not later than September 30, 2027, the Secretary 
        shall submit to the Committee on Energy and Commerce of the 
        House of Representatives and the Committee on Health, 
        Education, Labor, and Pensions of the Senate a report 
        describing the outcomes of the pilot program established under 
        this subsection.
          (4) Guidance.--Not later than September 30, 2027, the 
        Secretary shall issue guidance describing best practices and 
        strategies for development of efficacy endpoints, including 
        surrogate and intermediate endpoints, for rare diseases.
          (5) Sunset.--The Secretary may not accept any new application 
        or request to participate in the program established by this 
        subsection on or after October 1, 2027.

SEC. 805. FACILITATING THE USE OF REAL WORLD EVIDENCE.

  (a) Guidance.--Not later than 1 year after the date of the enactment 
of this Act, the Secretary of Health and Human Services shall issue, or 
revise existing, guidance on considerations for the use of real world 
data and real world evidence to support regulatory decisionmaking, as 
follows:
          (1) With respect to drugs, such guidance shall address--
                  (A) the use of such data and evidence to support the 
                approval of a drug application under section 505 of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or 
                a biological product application under section 351 of 
                the Public Health Service Act (42 U.S.C. 262), or to 
                support an investigational use exemption under section 
                505(i) of the Federal Food, Drug, and Cosmetic Act or 
                section 351(a)(3) of the Public Health Service Act; and
                  (B) the use of such data and evidence obtained as a 
                result of the use of drugs authorized for emergency use 
                under section 564 of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 360bbb-3) in such applications, 
                submissions, or requests; and
                  (C) standards and methodologies which may be used for 
                collection and analysis of real world evidence included 
                in such applications, submissions, or requests, as 
                appropriate.
          (2) With respect to devices, such guidance shall address--
                  (A) the use of such data and evidence to support the 
                approval, clearance, or classification of a device 
                pursuant to an application or submission submitted 
                under section 510(k), 513(f)(2), or 515 of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 360(k), 
                360c(f)(2), 360e), or to support an investigational use 
                exemption under section 520(g) of such Act (21 U.S.C. 
                360j(g));
                  (B) the use of such data and evidence obtained as a 
                result of the use of devices authorized for emergency 
                use under section 564 of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 360bbb-3), in such 
                applications, submissions, or requests; and
                  (C) standards and methodologies which may be used for 
                collection and analysis of real world evidence included 
                in such applications, submissions, or requests, as 
                appropriate.
  (b) Report to Congress.--Not later than 2 years after the termination 
of the public health emergency determination by the Secretary of Health 
and Human Services under section 564 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360bbb-3) on February 4, 2020, with respect to 
the Coronavirus Disease 2019 (COVID-19), the Secretary shall submit a 
report to the Committee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Education, Labor, and 
Pensions of the Senate on--
          (1) the number of applications, submissions, or requests 
        submitted for clearance or approval under section 505, 510(k), 
        513(f)(2), or 515 of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 355, 360(k), 360c(f)(2), 360e) or section 351 of the 
        Public Health Service Act, for which an authorization under 
        section 564 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 360bbb-3) was previously granted;
          (2) of the number of applications so submitted, the number of 
        such applications--
                  (A) for which real world evidence was submitted and 
                used to support a regulatory decision; and
                  (B) for which real world evidence was submitted and 
                determined to be insufficient to support a regulatory 
                decision; and
          (3) a summary explanation of why, in the case of applications 
        described in paragraph (2)(B), real world evidence could not be 
        used to support regulatory decisions.
  (c) Information Disclosure.--Nothing in this section shall be 
construed to authorize the disclosure of information that is prohibited 
from disclosure under section 1905 of title 18, United States Code, or 
subject to withholding under subsection (b)(4) of section 552 of title 
5, United States Code (commonly referred to as the ``Freedom of 
Information Act'').

SEC. 806. DUAL SUBMISSION FOR CERTAIN DEVICES.

  Section 513 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360c) is amended by adding at the end the following:
  ``(k) For a device authorized for emergency use under section 564 for 
which, in accordance with section 564(m), the Secretary has deemed a 
laboratory examination or procedure associated with such device to be 
in the category of examinations and procedures described in section 
353(d)(3) of the Public Health Service Act, the sponsor of such device 
may, when submitting a request for classification under section 
513(f)(2), submit a single submission containing--
          ``(1) the information needed for such a request; and
          ``(2) sufficient information to enable the Secretary to 
        determine whether such laboratory examination or procedure 
        satisfies the criteria to be categorized under section 
        353(d)(3) of the Public Health Service Act.''.

SEC. 807. MEDICAL DEVICES ADVISORY COMMITTEE MEETINGS.

  (a) In General.--The Secretary shall convene one or more panels of 
the Medical Devices Advisory Committee not less than once per year for 
the purpose of providing advice to the Secretary on topics related to 
medical devices used in pandemic preparedness and response, including 
topics related to in vitro diagnostics.
  (b) Required Panel Member.--A panel convened under subsection (a) 
shall include at least 1 population health-specific representative.
  (c) Sunset.--This section shall cease to be effective on October 1, 
2027.

SEC. 808. ENSURING CYBERSECURITY OF MEDICAL DEVICES.

  (a) In General.--Subchapter A of chapter V of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 351 et seq.), as amended by section 501, is 
further amended by adding at the end the following:

``SEC. 524C. ENSURING CYBERSECURITY OF DEVICES.

  ``(a) In General.--For purposes of ensuring cybersecurity throughout 
the lifecycle of a cyber device, any person who submits a premarket 
submission for the cyber device shall include such information as the 
Secretary may require to ensure that the cyber device meets such 
cybersecurity requirements as the Secretary determines to be 
appropriate to demonstrate a reasonable assurance of safety and 
effectiveness, including at a minimum the cybersecurity requirements 
under subsection (b).
  ``(b) Cybersecurity Requirements.--At a minimum, the manufacturer of 
a cyber device shall meet the following cybersecurity requirements:
          ``(1) The manufacturer shall have a plan to appropriately 
        monitor, identify, and address in a reasonable time postmarket 
        cybersecurity vulnerabilities and exploits, including 
        coordinated vulnerability disclosure and procedures.
          ``(2) The manufacturer shall design, develop, and maintain 
        processes and procedures to ensure the device and related 
        systems are cybersecure, and shall make available updates and 
        patches to the cyber device and related systems throughout the 
        lifecycle of the cyber device to address--
                  ``(A) on a reasonably justified regular cycle, known 
                unacceptable vulnerabilities; and
                  ``(B) as soon as possible out of cycle, critical 
                vulnerabilities that could cause uncontrolled risks.
          ``(3) The manufacturer shall provide in the labeling of the 
        cyber device a software bill of materials, including 
        commercial, open-source, and off-the-shelf software components.
          ``(4) The manufacturer shall comply with such other 
        requirements as the Secretary may require to demonstrate 
        reasonable assurance of the safety and effectiveness of the 
        device for purposes of cybersecurity, which the Secretary may 
        require by an order published in the Federal Register.
  ``(c) Substantial Equivalence.--In making a determination of 
substantial equivalence under section 513(i) for a cyber device, the 
Secretary may--
          ``(1) find that cybersecurity information for the cyber 
        device described in the relevant premarket submission in the 
        cyber device's use environment is inadequate; and
          ``(2) issue a nonsubstantial equivalence determination based 
        on this finding.
  ``(d) Definition.--In this section:
          ``(1) Cyber device.--The term `cyber device' means a device 
        that--
                  ``(A) includes software, including software as or in 
                a device;
                  ``(B) has the ability to connect to the internet; or
                  ``(C) contains any such technological characteristics 
                that could be vulnerable to cybersecurity threats.
          ``(2) Lifecycle of the cyber device.--The term `lifecycle of 
        the cyber device' includes the postmarket lifecycle of the 
        cyber device.
          ``(3) Premarket submission.--The term `premarket submission' 
        means any submission under section 510(k), 513, 515(c), 515(f), 
        or 520(m).
  ``(e) Exemption.--The Secretary may identify devices or types of 
devices that are exempt from meeting the cybersecurity requirements 
established by this section and regulations promulgated pursuant to 
this section. The Secretary shall publish in the Federal Register, and 
update, as appropriate, a list of the devices and types of devices so 
identified by the Secretary.''.
  (b) Prohibited Act.--Section 301(q) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331(q)) is amended by adding at the end the 
following:
  ``(3) The failure to comply with any requirement under section 524C 
(relating to ensuring device cybersecurity).''.
  (c) Adulteration.--Section 501 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 351) is amended by inserting after paragraph 
(j) the following:
  ``(k) If it is a device subject to the requirements set forth in 
section 524C (relating to ensuring device cybersecurity) and fails to 
comply with any requirement under that section.''.
  (d) Misbranding.--Section 502(t) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 352(t)) is amended--
          (1) by striking ``or (3)'' and inserting ``(3)''; and
          (2) by inserting before the period at the end the following: 
        ``, or (4) to furnish a software bill of materials as required 
        under section 524C (relating to ensuring device 
        cybersecurity)''.

SEC. 809. PUBLIC DOCKET ON PROPOSED CHANGES TO THIRD-PARTY VENDORS.

  (a) In General.--
          (1) Opening public docket.--Not later than 90 days after the 
        date of enactment of this Act, the Secretary of Health and 
        Human Services shall open a single public docket to solicit 
        comments on factors that generally should be considered by the 
        Secretary when reviewing requests from sponsors of drugs 
        subject to risk evaluation and mitigation strategies to change 
        third-party vendors engaged by sponsors to aid in 
        implementation and management of the strategies.
          (2) Factors.--Such factors include the potential effects of 
        changes in third-party vendors on--
                  (A) patient access; and
                  (B) prescribing and administration of the drugs by 
                health care providers.
          (3) Closing public docket.--The Secretary of Health and Human 
        Services may close such public docket not earlier than 90 days 
        after such docket is opened.
          (4) No delay.--Nothing in this section shall delay agency 
        action on any modification to a risk evaluation and mitigation 
        strategy.
  (b) GAO Report.--Not later than December 31, 2026, the Comptroller 
General of the United States shall submit to the Committee on Energy 
and Commerce of the House of Representatives and the Committee on 
Health, Education, Labor, and Pensions of the Senate a report on--
          (1) the number of changes in third-party vendors (engaged by 
        sponsors to aid implementation and management of risk 
        evaluation and mitigation strategies) for an approved risk 
        evaluation and mitigation strategy the Secretary of Health and 
        Human Services has approved under section 505-1(h) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1(h));
          (2) any issues affecting patient access to the drug that is 
        subject to the strategy or considerations with respect to the 
        administration or prescribing of such drug by health care 
        providers that arose as a result of such modifications; and
          (3) how such issues were resolved, as applicable.

SEC. 810. FACILITATING EXCHANGE OF PRODUCT INFORMATION PRIOR TO 
                    APPROVAL.

  (a) In General.--Section 502 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 352) is amended--
          (1) in paragraph (a)--
                  (A) by striking ``drugs for coverage'' and inserting 
                ``drugs or devices for coverage''; and
                  (B) by striking ``drug'' each place it appears and 
                inserting ``drug or device'', respectively;
          (2) in paragraphs (a)(1) and (a)(2)(B), by striking ``under 
        section 505 or under section 351 of the Public Health Service 
        Act'' and inserting ``under section 505, 510(k), 513(f)(2), or 
        515 of this Act or section 351 of the Public Health Service 
        Act'';
          (3) in paragraph (a)(1)--
                  (A) by striking ``under section 505 or under section 
                351(a) of the Public Health Service Act'' and inserting 
                ``under section 505, 510(k), 513(f)(2), or 515 of this 
                Act or section 351 of the Public Health Service Act''; 
                and
                  (B) by striking ``in section 505(a) or in subsections 
                (a) and (k) of section 351 of the Public Health Service 
                Act'' and inserting ``in section 505, 510(k), 
                513(f)(2), or 515 of this Act or section 351 of the 
                Public Health Service Act''; and
          (4) by adding at the end the following:
  ``(gg)(1) Unless its labeling bears adequate directions for use in 
accordance with paragraph (f), except that (in addition to drugs or 
devices that conform with exemptions pursuant to such paragraph) no 
drug or device shall be deemed to be misbranded under such paragraph 
through the provision of product information to a payor, formulary 
committee, or other similar entity with knowledge and expertise in the 
area of health care economic analysis carrying out its responsibilities 
for the selection of drugs or devices for coverage or reimbursement if 
the product information relates to an investigational drug or device or 
investigational use of a drug or device that is approved, cleared, 
granted marketing authorization, or licensed under section 505, 510(k), 
513(f)(2), or 515 of this Act or section 351 of the Public Health 
Service Act (as applicable), provided--
          ``(A) the product information includes--
                  ``(i) a clear statement that the investigational drug 
                or device or investigational use of a drug or device 
                has not been approved, cleared, granted marketing 
                authorization, or licensed under section 505, 510(k), 
                513(f)(2), or 515 of this Act or section 351 of the 
                Public Health Service Act (as applicable) and that the 
                safety and effectiveness of the drug or device or use 
                has not been established;
                  ``(ii) information related to the stage of 
                development of the drug or device involved, such as--
                          ``(I) the status of any study or studies in 
                        which the investigational drug or device or 
                        investigational use is being investigated;
                          ``(II) how the study or studies relate to the 
                        overall plan for the development of the drug or 
                        device; and
                          ``(III) whether an application, premarket 
                        notification, or request for classification for 
                        the investigational drug or device or 
                        investigational use has been submitted to the 
                        Secretary and when such a submission is 
                        planned;
                  ``(iii) in the case of information that includes 
                factual presentations of results from studies, which 
                shall not be selectively presented, a description of--
                          ``(I) all material aspects of study design, 
                        methodology, and results; and
                          ``(II) all material limitations related to 
                        the study design, methodology, and results;
                  ``(iv) where applicable, a prominent statement 
                disclosing the indication or indications for which the 
                Secretary has approved, granted marketing 
                authorization, cleared, or licensed the product 
                pursuant to section 505, 510(k), 513(f)(2), or 515 of 
                this Act or section 351 of the Public Health Service 
                Act, and a copy of the most current required labeling; 
                and
                  ``(v) updated information, if previously communicated 
                information becomes materially outdated as a result of 
                significant changes or as a result of new information 
                regarding the product or its review status; and
          ``(B) the product information does not include--
                  ``(i) information that represents that an unapproved 
                product--
                          ``(I) has been approved, cleared, granted 
                        marketing authorization, or licensed under 
                        section 505, 510(k), 513(f)(2), or 515 of this 
                        Act or section 351 of the Public Health Service 
                        Act (as applicable); or
                          ``(II) has otherwise been determined to be 
                        safe or effective for the purpose or purposes 
                        for which the drug or device is being studied; 
                        or
                  ``(ii) information that represents that an unapproved 
                use of a drug or device that has been so approved, 
                granted marketing authorization, cleared, or licensed--
                          ``(I) is so approved, granted marketing 
                        authorization, cleared, or licensed; or
                          ``(II) that the product is safe or effective 
                        for the use or uses for which the drug or 
                        device is being studied.
  ``(2) For purposes of this paragraph, the term `product information' 
includes--
          ``(A) information describing the drug or device (such as drug 
        class, device description, and features);
          ``(B) information about the indication or indications being 
        investigated;
          ``(C) the anticipated timeline for a possible approval, 
        clearance, marketing authorization, or licensure pursuant to 
        section 505, 510(k), 513, or 515 of this Act or section 351 of 
        the Public Health Service Act;
          ``(D) drug or device pricing information;
          ``(E) patient utilization projections;
          ``(F) product-related programs or services; and
          ``(G) factual presentations of results from studies that do 
        not characterize or make conclusions regarding safety or 
        efficacy.''.
  (b) GAO Study and Report.--Beginning on the date that is 5 years and 
6 months after the date of enactment of this Act, the Comptroller 
General of the United States shall conduct a study on the provision and 
use of information pursuant to section 502(gg) of the Federal Food, 
Drug, and Cosmetic Act, as added by this subsection (a), between 
manufacturers of drugs and devices (as defined in section 201 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)) and entities 
described in such section 502(gg). Such study shall include an analysis 
of the following:
          (1) The types of information communicated between such 
        manufacturers and payors.
          (2) The manner of communication between such manufacturers 
        and payors.
          (3)(A) Whether such manufacturers file an application for 
        approval, marketing authorization, clearance, or licensing of a 
        new drug or device or the new use of a drug or device that is 
        the subject of communication between such manufacturers and 
        payors under section 502(gg) of the Federal Food, Drug, and 
        Cosmetic Act, as added by subsection (a).
          (B) How frequently the Food and Drug Administration approves, 
        grants marketing authorization, clears, or licenses the new 
        drug or device or new use.
          (C) The timeframe between the initial communications 
        permitted under section 502(gg) of the Federal Food, Drug, and 
        Cosmetic Act, as added by subsection (a), regarding an 
        investigational drug or device or investigational use, and the 
        initial marketing of such drug or device.

SEC. 811. BANS OF DEVICES FOR ONE OR MORE INTENDED USES.

  (a) In General.--Section 516(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360f(a)) is amended--
          (1) in paragraph (1), by inserting ``for one or more intended 
        use'' before the semicolon at the end; and
          (2) in the matter following paragraph (2), by inserting ``for 
        any such intended use or uses. A device that is banned for one 
        or more intended uses is not a legally marketed device under 
        section 1006 when intended for such use or uses'' after 
        ``banned device''.
  (b) Specific Devices Deemed Banned.--Section 516 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360f) is further amended by adding at 
the end the following:
  ``(c) Specific Device Banned.--Electrical stimulation devices that 
apply a noxious electrical stimulus to a person's skin intended to 
reduce or cease self-injurious behavior or aggressive behavior are 
deemed to be banned devices, as described in subsection (a).
  ``(d) Reversal by Regulation.--Devices banned under this section are 
banned devices unless or until the Secretary promulgates a regulation 
to make such devices or use of such devices no longer banned based on a 
finding that such devices or use of such devices does not present 
substantial deception or an unreasonable and substantial risk of 
illness or injury, or that such risk can be corrected or eliminated by 
labeling.''.

SEC. 812. CLARIFYING APPLICATION OF EXCLUSIVE APPROVAL, CERTIFICATION, 
                    OR LICENSURE FOR DRUGS DESIGNATED FOR RARE DISEASES 
                    OR CONDITIONS.

  (a) Application of Exclusive Approval, Certification, or Licensure 
for Drugs Designated for Rare Diseases or Conditions.--Section 527 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360cc) is amended--
          (1) in subsection (a), in the matter following paragraph (2), 
        by striking ``same disease or condition'' and inserting ``same 
        approved indication or use within such rare disease or 
        condition'';
          (2) in subsection (b)--
                  (A) in the matter preceding paragraph (1), by 
                striking ``same rare disease or condition'' and 
                inserting ``same indication or use for which the 
                Secretary has approved or licensed such drug''; and
                  (B) in paragraph (1), by striking ``with the disease 
                or condition for which the drug was designated'' and 
                inserting ``for whom the drug is indicated''; and
          (3) in subsection (c), by striking ``same rare disease or 
        condition'' and inserting ``same indication or use''.
  (b) Application of Amendments.--The amendments made by subsection (a) 
shall apply with respect to any drug designated under section 526 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb), regardless 
of the date on which the drug was so designated, and regardless of the 
date on which the drug was approved under section 505 of such Act (21 
U.S.C. 355) or licensed under section 351 of the Public Health Service 
Act (42 U.S.C. 262).

SEC. 813. GAO REPORT ON THIRD-PARTY REVIEW.

  Not later than September 30, 2026, the Comptroller General of the 
United States shall submit to the Committee on Energy and Commerce of 
the House of Representatives and the Committee on Health, Education, 
Labor, and Pensions of the Senate a report on the third-party review 
program described in section 523 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360m). Such report shall include--
          (1) a description of the financial and staffing resources 
        used to carry out such program;
          (2) a description of actions taken by the Secretary pursuant 
        section 523(b)(2)(C) of the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 360m(b)(2)(C)); and
          (3) the results of an audit of the performance of select 
        persons accredited under such program.

SEC. 814. REPORTING ON PENDING GENERIC DRUG APPLICATIONS AND PRIORITY 
                    REVIEW APPLICATIONS.

  Section 807 of the FDA Reauthorization Act of 2017 (Public Law 115-
52) is amended, in the matter preceding paragraph (1), by striking 
``2022'' and inserting ``2027''.

SEC. 815. FDA WORKFORCE IMPROVEMENTS.

  Section 714A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379d-3a) is amended--
          (1) in subsection (a), by striking ``medical products'' and 
        inserting ``products regulated by the Food and Drug 
        Administration''; and
          (2) by striking subsection (d) and inserting the following:
  ``(d) Agency-wide Strategic Workforce Plan.--
          ``(1) In general.--Not later than 1 year after the date of 
        enactment of the Food and Drug Amendments of 2022, the 
        Commissioner of Food and Drugs shall develop and begin 
        implementation of an agency-wide strategic workforce plan at 
        the Food and Drug Administration, which shall include--
                  ``(A) agency-wide human capital goals and strategies;
                  ``(B) performance measures, benchmarks, or other 
                elements to facilitate the monitoring and evaluation of 
                the progress made toward such goals and the 
                effectiveness of such strategies; and
                  ``(C) a process for updating such plan based on 
                timely and relevant information on an ongoing basis.
          ``(2) Report to congress.--Not later than 18 months after the 
        date of enactment of the Food and Drug Amendments of 2022, the 
        Secretary shall submit to the Committee on Energy and Commerce 
        of the House of Representatives and the Committee on Health, 
        Education, Labor, and Pensions of the Senate a report 
        describing the plan under paragraph (1) and the status of its 
        implementation.''.

                         I. Purpose and Summary

    H.R. 7667, the ``Food and Drug Amendments of 2022,'' 
enables Food and Drug Administration (FDA) to continue to 
collect user fees from regulated industry to supplement 
Congressional appropriations for the premarket review and 
regulation of medical products. Specifically, the bill revises 
and reauthorizes provisions of the Prescription Drug User Fee 
Act (PDUFA), the Medical Device User Fee Amendments (MDUFA), 
the Generic Drug User Fee Amendments (GDUFA), and the 
Biosimilars User Fee Act (BsUFA) through 2027. The legislation 
also includes various provisions that will promote clinical 
trial diversity, encourage increased generic drug competition, 
preserve existing incentives for orphan drug development, 
facilitate a more resilient supply chain, and improve the 
review and regulation of medical products and the inspections 
of facilities that manufacture them.

                II. Background and Need for Legislation


A. User Fees

    Since 1992, pursuant to PDUFA, Congress has authorized FDA 
to collect fees from regulated industry to supplement 
Congressional appropriations. Revenues generated from these 
fees have been used on specific activities related to the 
review and regulation of medical products. FDA also commits to 
meeting certain performance goals, such as completing product 
reviews within specified timeframes. FDA's ability to collect 
such fees must be reauthorized every five years following a 
process laid out in statute that involves negotiations between 
the agency and regulated industry and recommendations provided 
to Congress. The reauthorization process allows for input by 
other interested stakeholders, including patient and consumer 
groups, and provides opportunity for broader public comment.
    Based in large part on the positive impact PDUFA had on 
expediting new drug product review times and improving related 
regulatory activities at FDA, Congress authorized FDA to 
collect medical device user fees in 2002 as part of the Medical 
Device User Fee and Modernization Act.\1\ MDUFA user fees were 
reauthorized in 2007, 2012, and 2017, along with PDUFA.
---------------------------------------------------------------------------
    \1\Pub. L. No. 107-250 (2002).
---------------------------------------------------------------------------
    Due to growing concerns from a wide range of stakeholders 
about the time it was taking FDA to review generic drug 
applications and the backlog of such applications pending at 
the agency, Congress passed the Generic Drug User Fee 
Amendments (GDUFA) in 2012 as part of the Food and Drug 
Administration Safety and Innovation Act (FDASIA).\2\ Congress 
reauthorized GDUFA user fees in 2017.
---------------------------------------------------------------------------
    \2\Pub. L. No. 112-114 (2012).
---------------------------------------------------------------------------
    As part of FDASIA, Congress also passed BsUFA in 2012 to 
authorize FDA to collect user fees from biosimilar product 
manufacturers. Congress reauthorized BsUFA in 2017.
    Each of these four user fee programs is due to expire at 
the end of this fiscal year and must be reauthorized if FDA is 
to continue collecting fees to support review programs and 
other functions of the agency. H.R. 7667 would reauthorize all 
four user fee programs through 2027. The Committee also 
considered additional policies that would improve the 
regulation of certain medical products, a number of which are 
also included in the bill.

B. Improvements Across Product Areas

            1. Clinical Study Diversity
    Clinical studies--studies in human subjects--are 
fundamental to assessing whether medical products are safe and 
effective for a particular use and patient population.\3\ FDA 
relies on these studies to assess whether medical products meet 
applicable premarket review standards, which determines whether 
they may be marketed, as well as what uses and patient 
populations they may be approved for, what labeling, including 
warnings and contraindications is required, and whether 
additional post-market studies are warranted, among other 
considerations. These studies also inform physician decisions 
regarding diagnosis and treatment, and providers and patients 
rely on FDA's premarket review and labeling determinations in 
their medical decision-making.
---------------------------------------------------------------------------
    \3\U.S. Food and Drug Administration, Step 3: Clinical Research 
(www.fda.gov/patients/drug-development-process/step-3-clinical-
research) (Jan. 4, 2018).
---------------------------------------------------------------------------
    Neither diseases nor medical products affect everyone the 
same way. Certain demographic groups are at higher risk of 
developing certain illnesses or conditions than others; a 
product that poses little risk or is highly effective in some 
demographic groups may pose serious risks or provide little 
benefit to others.\4\ Non-demographic factors such as co-
morbidities can also affect outcomes. Inclusion of diverse, 
representative populations in clinical studies can enable 
identification of these differences in risk and benefit across 
subgroups before a product comes to market,\5\ which in turn 
can improve both regulatory and medical decision-making. It is 
thus critical that the participants that sponsors and 
investigators enroll in a clinical study are reflective of the 
patient population expected to use the medical product, both as 
a matter of health equity and as a matter of good science and 
medicine.\6\
---------------------------------------------------------------------------
    \4\House Committee on Energy and Commerce, Subcommittee on Health, 
Testimony of Dr. Ruben Mesa, Executive Director, Mays Cancer Center at 
UT Health San Antonio MD Anderson, Hearing on The Future of Medicine: 
Legislation to Encourage Innovation and Improve Oversight, 117th Cong. 
(Mar. 17, 2022) (energycommerce.house.gov/sites/
democrats.energycommerce
.house.gov/files/documents/Witness%20Testimony_Mesa_HE_2022.03.17.pdf).
    \5\Food and Drug Administration, Draft Guidance, Diversity Plans to 
Improve Enrollment of Participants from Underrepresented Racial and 
Ethnic Populations in Clinical Trials (April 2022) (www.fda.gov/
regulatory-information/search-fda-guidance-documents/diversity-plans-
improve-enrollment-participants-underrepresented-racial-and-ethnic-
populations).
    \6\See note 4; National Academies of Sciences, Engineering, and 
Medicine, Improving Representation in Clinical Trials and Research: 
Building Research Equity for Women and Underrepresented Groups (2022) 
(nap.nationalacademies.org/download/26479).
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    At present, clinical studies often lack adequate diversity. 
Individuals from Black or African American, Hispanic/Latino, 
Indigenous and Native American, Asian, Native Hawaiian and 
other Pacific Islander populations and other persons of color 
``are frequently underrepresented in biomedical research 
despite having a disproportionate disease burden for certain 
diseases relative to their proportional representation in the 
general population.''\7\ For example, in an FDA analysis of 
nearly 300,000 people who participated in clinical studies 
between 2015 and 2019, only seven percent identified as African 
American and only 13 percent identified as Hispanic or 
Latino,\8\ despite these groups making up 13.4 percent and 18.5 
percent of the United States population, respectively.\9\ There 
are various reasons for this lack of adequate representation. 
On the sponsor side, there may be challenges to including 
subpopulations where expanding enrollment may require 
additional time or resources.\10\ On the participant side, 
barriers include lack of awareness of open studies, mistrust of 
research, financial and language barriers, and lack of 
diversity among those conducting the studies.\11\
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    \7\See note 4.
    \8\Food and Drug Administration, 2015-2019 Drug Trials Snapshots 
Summary Report (www.fda.gov/media/143592/download).
    \9\Census Bureau, QuickFacts (www.census.gov/quickfacts/fact/table/
US/PST045221) (accessed May 24, 2022).
    \10\See note 6 at 134-35.
    \11\See note 4.
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    Title V of H.R. 7667 addresses both sides of this problem. 
Under section 501, the legislation requires sponsors of phase 3 
or other pivotal studies of drugs and biological products, and 
sponsors of clinical studies of devices, to develop, implement, 
and submit to FDA diversity action plans that include the 
sponsor's goals for study enrollment, a rationale for such 
goals, and an explanation of how these goals will be met. 
Section 501 also requires FDA to update its guidance to address 
sponsor diversity goals, disaggregated by age group, sex, race, 
geographic location, socioeconomic status, and ethnicity, and 
how sponsors will publicly post key information from their 
plans on their website. Building on some of the experience 
gained during the current coronavirus disease 2019 (COVID-19) 
pandemic, the legislation also requires guidance addressing 
decentralized study enrollment, including the engagement, 
enrollment, and retention of a meaningfully diverse study 
population and recommendations for sponsors to reduce burdens 
for participants through digital health technology, telehealth, 
local providers and laboratories, or other means.
    To further advance the goal of robust diverse 
participation, the legislation requires FDA to further study 
and discuss these issues. Section 502 requires FDA to evaluate 
whether there is a need for additional authorities to assure 
that sponsors conduct post-approval studies or postmarket 
surveillance in certain circumstances where premarket studies 
collect insufficient data for underrepresented subgroups. 
Section 503 requires public workshops to discuss how study 
enrollment of historically underrepresented populations may be 
increased and how participation reflective of the prevalence of 
a disease among subgroups may be encouraged, the creation of a 
docket for public comment regarding such information, and the 
publication of an FDA report on such workshops on its website. 
Section 504 requires an annual report from FDA to Congress 
summarizing the diversity action plans received, whether goals 
were met, and the reasons given why any goals were not met. The 
report also must include any postmarket studies required or 
recommended by FDA based on its existing authority and the 
premarket study lacked adequate diversity. Section 505 requires 
a public meeting regarding the clinical study flexibilities 
initiated in response to the COVID-19 pandemic, including how 
such flexibilities, such as those relating to study 
decentralization, may have affected access to studies by 
unrepresented or underrepresented populations, including racial 
and ethnic minorities, and how they may help improve clinical 
study access and diverse enrollment in the future. Finally, 
Section 506 requires FDA to issue guidance recommending how 
digital health technology or other remote assessment options 
could support decentralized clinical studies, as well as 
considerations for sponsors to minimize or reduce burdens for 
clinical study participants, thus encouraging the retention of 
a meaningfully diverse clinical population.
            2. Inspections
    The COVID-19 pandemic and an increasing reliance on drugs 
manufactured overseas has illustrated the need for updates and 
clarification with respect to FDA's inspectional authorities 
for medical products, in particular with respect to certain 
aspects of foreign inspections, bioresearch monitoring 
inspections, and inspections of records both in-person and 
remotely.
    Concerns have been raised in recent years regarding FDA's 
inspections of foreign medical product facilities, including 
with respect to its practice of preannouncing most of these 
inspections. For example, in 2019 the Government Accountability 
Office (GAO) reported:

          FDA investigators identified persistent challenges 
        conducting foreign inspections, raising questions about 
        the equivalence of foreign to domestic inspections. For 
        example, while domestic inspections are almost always 
        unannounced, FDA's practice of preannouncing foreign 
        inspections up to 12 weeks in advance may give 
        manufacturers the opportunity to fix problems [before 
        the investigator arrives]. Investigators from FDA's 
        China and India offices do conduct some unannounced 
        inspections, but they are involved in a small 
        percentage of inspections in these countries (27 
        percent and 10 percent, respectively).\12\
---------------------------------------------------------------------------
    \12\House Committee on Energy and Commerce, Subcommittee on 
Oversight and Investigations, Testimony of Mary Denigan-Macauley, 
Director, U.S. Government Accountability Office, Hearing on Securing 
the U.S. Drug Supply Chain: Oversight of FDA's Foreign Inspection 
Program, Preliminary Findings Indicate Persistent Challenges with FDA 
Foreign Inspections, 116th Cong. (Dec. 10, 2019) (www.gao.gov/assets/
gao-20-262t.pdf).

    On the other hand, FDA investigators reported some benefits 
to preannouncing foreign inspections, including avoiding 
wasting agency resources, better preparation of establishment 
records and staff, and ensuring the safety of investigators in 
the foreign country,\13\ which has become more of a concern 
during the COVID-19 public health emergency. FDA also reported 
a lack of data that would enable it to assess the relative 
merits of unannounced and preannounced inspections.\14\ GAO 
more recently reported that FDA plans to implement two pilot 
programs to help address challenges related to preannounced 
inspections and language barriers, which will include gathering 
data that can be used to evaluate differences between announced 
and unannounced inspections.\15\ However, FDA has not yet 
finalized the design of these pilots due to the COVID-19 
pandemic.\16\
---------------------------------------------------------------------------
    \13\Id.
    \14\Id. 
    \15\Government Accountability Office, GAO-22-103611, Drug Safety: 
FDA Should Take Additional Steps to Improve its Foreign Inspection 
Program (Jan. 2022) (www.gao.gov/assets/gao-22-103611.pdf).
    \16\Id.
---------------------------------------------------------------------------
    H.R. 7667 addresses these issues in several ways. Section 
725 requires FDA to initiate a pilot program within 180 days of 
enactment in which FDA increases the conduct of unannounced 
surveillance inspections of foreign drug establishments, 
evaluates the differences between such inspections of domestic 
and foreign establishments, including the impact of announcing 
inspections, and posts a report of its findings and 
recommendations on the FDA website. Section 721 requires FDA to 
review its processes and practices applicable to bioresearch 
monitoring inspections in the United States and in foreign 
countries, evaluate whether updates are needed to facilitate 
consistency, and issue guidance describing the conduct of such 
inspections. Section 723 provides for FDA consideration of the 
compliance history of other FDA-regulated establishments in the 
country or region in which an establishment is located as a 
factor in establishing a schedule for risk-based inspections 
and requires a periodic assessment of whether additional 
arrangements with foreign governments pertaining to recognition 
of foreign government inspections of foreign establishments are 
appropriate. Currently, FDA has these arrangements in place 
with the European Union and the United Kingdom; however, the 
agency's inspection capabilities may benefit from assessing 
whether additional arrangements with countries with robust 
regulatory systems and drug safety protocols, such as Israel, 
Japan, or others, are appropriate, taking into account public 
health and safety, and any differences with regard to how these 
systems operate. Section 728 requires FDA to annually publish 
on its website a report on the utilization of these and other 
agreements entered into with foreign governments with review 
criteria analogous to those of FDA.
    Building on the lessons learned during the COVID-19 
pandemic, which has made in-person inspections more difficult, 
section 721 clarifies that FDA's authority to inspect records, 
among other things, applies not only to restricted devices but 
to all devices, and that FDA's authority to require records in 
advance or in lieu of an inspection applies not only to drugs 
but devices as well. Section 721 also codifies and clarifies 
FDA authority to inspect clinical study sites, also known as 
bioresearch monitoring inspections, including with respect to 
records. Section 723 clarifies that FDA may rely on any records 
or other information inspected to satisfy requirements that may 
pertain to a preapproval or risk-based surveillance inspection, 
or to resolve deficiencies found in such inspections, if 
applicable and appropriate. Finally, section 727 requires FDA 
to ensure timely and effective internal coordination and 
alignment among field investigators and staff regarding the 
reviews of inspection reports and any feedback or corrective 
actions in response to such reports and requires FDA reporting 
to Congress regarding such coordination and feedback and 
regarding certain drug shortage reports.
            3. Appropriate and Consistent Regulation of Certain 
                    Products as Drugs
    FDA has consistently regulated contrast agents as drugs for 
decades. However, a 2021 decision by the Court of Appeals for 
the District of Columbia Circuit created uncertainty as to 
whether these products, as well as certain therapeutic 
radioactive products and certain products that have been 
regulated under over-the-counter drug monographs, could be 
regulated by FDA as drugs or medical devices.\17\ Devices have 
different standards for premarket review and different 
regulatory requirements from drugs. Without a legislative 
remedy, sponsors of contrast agents and certain other products 
who went through the drug approval process may be unnecessarily 
subject to new regulatory regimes.
---------------------------------------------------------------------------
    \17\Genus Med. Techs., LLC v. FDA, 994 F.3d 631 (D.C. Cir. 2021).
---------------------------------------------------------------------------
    This court-mandated change raises concerns about fairness 
and potential negative consequences for patients. The 
uncertainty and determinations regarding which products may 
transition, the timing and process by which they would 
transition, and how they would be regulated as devices would 
impose additional costs on sponsors and the agency. Section 803 
of H.R. 7667 addresses these concerns by preserving the 
longstanding status quo of regulation of these products as 
drugs, as they have been regulated for decades.
            4. Real World Evidence
    Real-world evidence (RWE) has been playing an increasing 
role in health care and regulatory decision-making in recent 
years, for example with respect to clinical practice 
guidelines, improving clinical study designs, and postmarket 
safety monitoring.\18\ While RWE holds great promise for 
further advancing the study, regulation, and use of medical 
products, further understanding and development of RWE and RWE 
generation practices is needed. At least one example in which 
RWE played a significant role in premarket drug review, for a 
product used in combination with other immunosuppressant drugs 
to prevent organ rejection in lung transplant recipients, 
illustrates this point.\19\ First, while FDA relied on RWE in 
its approval of a new indication for Prograf (tacrolimus), it 
has not yet approved a new molecular entity primarily relying 
on RWE; second, the observed clinical benefit was so large that 
it was highly unlikely that the outcomes could be explained by 
bias; and third, in addition to RWE, the approval was also 
supported by randomized controlled trials of the drug in other 
settings, which provided confirmatory evidence of 
effectiveness, and additional clinical trial evidence from 
research publications, which supported the independent 
contribution of the drug as part of a multidrug regimen.\20\
---------------------------------------------------------------------------
    \18\Food and Drug Administration, Real-World Evidence (www.fda.gov/
science-research/science-and-research-special-topics/real-world-
evidence) (accessed May 24, 2022).
    \19\Food and Drug Administration, FDA Approval Demonstrates the 
Role of Real-World Evidence in Regulatory Decision-Making on Drug 
Effectiveness (Aug. 4, 2021) (www.fda.gov/drugs/news-events-human-
drugs/fda-approval-demonstrates-role-real-world-evidence-regulatory-
decision-making-drug-effectiveness).
    \20\Id.
---------------------------------------------------------------------------
    There is hope that RWE will not only reduce medical product 
development costs, speed patient access, and lower prices, but 
also provide greater confidence in their safety and 
effectiveness. Thus, it is important to advance the 
development, study, and regulatory application of RWE, while 
being careful to recognize that at the present time 
``randomized and other types of clinical trials are still 
generally the most reliable way to assess the potential 
effectiveness of a drug and these trials will remain a critical 
part of the drug development process.''\21\
---------------------------------------------------------------------------
    \21\Id.
---------------------------------------------------------------------------
    Section 805 of H.R. 7667 aims to improve the understanding 
of the potential uses and limitations of RWE in the premarket 
review of medical products by requiring FDA to issue guidance 
addressing the use of RWE, including that obtained through 
COVID-19 emergency use authorizations, to support drug and 
device approvals and clearances. This section also advances 
this goal by requiring FDA to report to Congress regarding the 
number of applications including RWE submitted for products for 
which an emergency use authorization was granted and whether 
such evidence was sufficient to support a regulatory decision. 
Additionally, section 804 clarifies that RWE may augment or 
support appropriate postapproval studies required by FDA, 
including such conditions as the Secretary may require, to 
verify clinical benefit for drugs approved through accelerated 
approval.
            5. Pre-Approval Information Exchange
    Information about a drug or device being studied in 
clinical investigations can be used to inform payors, formulary 
committees, and other entities responsible for the selection of 
drugs or devices for coverage or reimbursement as they plan for 
and make coverage and reimbursement decisions. In its guidance 
on these communications, FDA has explained that the important 
impact these decisions have for many patients renders it 
critical that the information drug and device sponsors provide 
to payors about their products be truthful and not misleading, 
and that appropriate background and context be provided so that 
this sophisticated audience will understand its limitations and 
be able to make informed decisions.\22\
---------------------------------------------------------------------------
    \22\Food and Drug Administration, Drug and Device Manufacturer 
Communications with Payors, Formulary Committees, and Similar Entities, 
Questions and Answers (final guidance) (June 2018) (www.fda.gov/media/
133620/download).
---------------------------------------------------------------------------
    In the interest of facilitating the provision of this 
information to these specific audiences and ensuring its 
accuracy and comprehensiveness, section 810 of H.R. 7667 
essentially codifies FDA's guidance on preapproval information 
exchange.\23\ Section 810 of H.R. 7667 amends section 502 of 
the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 
Sec. 352) to clarify that no drug or device shall be misbranded 
as a result of providing information regarding investigational 
drugs or devices or uses to payors, formulary committees, or 
other similar entities under specified conditions. It requires 
the information to include a clear statement that the drug or 
device discussed has not been approved, and that the safety and 
efficacy of the drug or device has not been established. 
Additional required disclosures to help ensure the information 
is not misleading include information about the studies the 
product is undergoing, whether an application for the drug or 
device has been submitted to FDA, and if not, when such 
submission is planned.
---------------------------------------------------------------------------
    \23\Id.
---------------------------------------------------------------------------
            6. Hiring
    FDA needs to be able to hire and retain a highly-skilled 
workforce with various types of specialized expertise in order 
to successfully carry out its mission to promote the public 
health by promptly and efficiently reviewing clinical research 
and taking appropriate action on the marketing of regulated 
products in a timely manner; and to protect the public health 
by ensuring that foods are safe, wholesome, sanitary, and 
properly labeled; human and veterinary drugs are safe and 
effective; there is reasonable assurance of the safety and 
effectiveness of devices intended for human use; cosmetics are 
safe and properly labeled; and public health and safety are 
protected from electronic product radiation.\24\ As the science 
behind the products FDA regulates becomes more complex and 
specialized, so too must the skills and expertise of its 
staff.\25\
---------------------------------------------------------------------------
    \24\Section 1003(b) of the FFDCA (21 U.S.C. Sec.  393(b)).
    \25\Food and Drug Administration, 21st Century Cures Workforce 
Planning Report to Congress (June 2018) (www.fda.gov/media/114163/
download).
---------------------------------------------------------------------------
    To advance this end with respect to the development, 
review, and regulation of medical products, in 2016 Congress 
provided FDA specific hiring authority in the 21st Century 
Cures Act, which added section 714A to the FFDCA (21 U.S.C. 
Sec. 379d-3a).\26\ This authority has enabled FDA to simplify 
and expedite the hiring process for certain scientific, 
technical, and professional positions and set higher rates of 
pay for these positions to enable it to better compete with the 
private sector in the recruitment and retention of outstanding, 
highly qualified candidates.\27\
---------------------------------------------------------------------------
    \26\Pub. L. No. 114-255 (2016).
    \27\See note 25.
---------------------------------------------------------------------------
    FDA's need for highly skilled employees with specialized 
expertise is not limited to its regulation of human drugs, 
biological products, and devices. The successful regulation of 
food, veterinary medicine, tobacco, cosmetics, and electronic 
products also demands the hiring and retention of such highly 
qualified and trained individuals. Section 815 of H.R. 7667 
accomplishes this goal by extending the hiring and pay 
authority Congress granted to FDA in 2016 to the hiring of 
outstanding candidates for scientific, technical, or 
professional positions across the entire agency. This section 
also provides accountability by requiring FDA to develop and 
implement a strategic workforce plan, as recommended by GAO, 
and report to Congress regarding such implementation.

C. Improvements to Drug Regulation

            1. Accelerated Approval Integrity
    Initiated by FDA through regulation in 1992 in response to 
the HIV/AIDS crisis and codified in section 506(c) of the FFDCA 
(21 U.S.C. Sec. 356(c)) by Congress in 2012, the accelerated 
approval premarket review pathway for new drugs has expedited 
the approvals of hundreds of drugs and biologics in several 
disease areas, most of which have been for oncology and 
hematology indications; as a result, patients with no 
alternative options have had access to life-extending 
treatments for cancer and other serious diseases years earlier 
than they would have had without accelerated approval.\28\ 
Drugs approved via accelerated approval must meet the same 
``safe and effective'' review standard as other drugs, 
including substantial evidence of effectiveness, but rather 
than having to prove clinical benefit in the same way as drugs 
reviewed under the traditional pathway, sponsors of drugs 
reviewed under accelerated approval can demonstrate effect on a 
surrogate or intermediate endpoint reasonably likely to predict 
clinical benefit. This enables shorter studies and earlier 
approvals, but this greater uncertainty regarding benefit to 
patients requires postapproval studies to confirm such benefit. 
If a sponsor fails to conduct such a required study with due 
diligence, such a study fails to verify benefit, or if the drug 
is otherwise not shown to be safe and effective, FDA may 
withdraw approval. If a sponsor fails to complete such a 
postapproval study, this violates section 505(p) of the FFDCA 
(21 U.S.C. Sec. 355(p)) and distribution of the drug in 
interstate commerce is prohibited.
---------------------------------------------------------------------------
    \28\Julia A. Beaver, et al., A 25-Year Experience of US Food and 
Drug Administration Accelerated Approval of Malignant Hematology and 
Oncology Drugs and Biologics: A Review, JAMA Oncology (June 1, 2018); 
Food and Drug Administration, Project Confirm, Promoting the 
transparency of Accelerated Approval for oncology indications 
(www.fda.gov/about-fda/oncology-center-excellence/project-confirm).
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    While many in the patient community, among others, have 
touted the success of this program,\29\ others, including some 
patient and provider groups, have criticized various aspects of 
it, such as the uncertainty of clinical benefit; delays in 
postapproval study initiation, conduct, and completion; 
inadequacy of postapproval study design; inadequacy of 
postapproval study reporting and transparency; inadequacy of 
labeling information for providers and patients; and the fact 
that FDA has not withdrawn approvals for a number of drugs 
where confirmatory studies failed to verify benefit, which some 
argue is due to a cumbersome and time-consuming process.\30\
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    \29\House Committee on Energy and Commerce, Subcommittee on Health, 
Testimony of Jeff Allen, Ph.D., President and CEO, Friends of Cancer 
Research, Hearing on The Future of Medicine: Legislation to Encourage 
Innovation and Improve Oversight, 117th Cong. (March 17, 2022) 
(energycommerce.house.gov/sites/democrats.energycommerce.house.gov/
files/documents/Witness%20Testimony_Allen_HE_2022.03.17.pdf).
    \30\See Bishal Gyawali, M.D., Ph.D., et al., Assessment of the 
Clinical Benefit of Cancer Drugs Receiving Accelerated Approval, JAMA 
Internal Medicine (May 28, 2019) (jamanetwork.com/journals/
jamainternalmedicine/fullarticle/2733561); House Committee on Energy 
and Commerce, Subcommittee on Health, Testimony of Reshma Ramachandran, 
M.D., M.P.P., Yale School of Medicine, Hearing on The Future of 
Medicine: Legislation to Encourage Innovation and Improve Oversight, 
117th Cong. (March 17, 2022) (energycommerce.house.gov/sites/
democrats.energycommerce.house.gov/files/documents/
Witness%20Testimony_Ramachandran_HE_2022.03.17.pdf); National 
Organization for Rare Diseases, FDA's Accelerated Approval Pathway: A 
Rare Disease Perspective (2021) (rarediseases.org/wp-content/uploads/
2021/06/NRD-2182-Policy-Report_Accelerated-Approval_FNL.pdf).
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    Section 804 of H.R. 7667 aims to improve the integrity and 
performance of this valuable pathway by addressing some of 
these concerns. In the interest of enhancing the quality and 
timeliness of postapproval studies, it requires FDA to specify 
the conditions for such studies, which may include enrollment 
targets and the target date for study completion as well as 
other milestones, by the time the drug is approved, requires 
more frequent reporting of postapproval study progress, and 
makes clear that FDA may require postapproval studies to be 
underway at the time of approval and may withdraw approval 
where the conditions it specified at the time of approval are 
not satisfied. It also clarifies that postapproval studies, 
which FDA regulation requires to be adequate, well controlled, 
and carried out with due diligence, may be supported or 
augmented by real world evidence.\31\ To promote accurate 
provider and patient understanding of the limitations of 
accelerated approvals, section 804 requires the labeling of 
drugs approved under this pathway to include certain 
information, such as the uncertainty regarding benefit, the 
endpoints used in premarket studies, and the fact that 
continued approval depends on the ability of a postapproval 
study to verify benefit.
---------------------------------------------------------------------------
    \31\See 21 C.F.R. Sec. 314.510.
---------------------------------------------------------------------------
    H.R. 7667 also ensures FDA can expeditiously withdraw 
approval where a postapproval study fails to verify patient 
benefit or if any of the other grounds for withdrawal apply, 
while still providing the sponsor due process by which to 
challenge a proposed withdrawal. The informal hearing required 
by the current process can be cumbersome and time-consuming, 
requires a meeting of an advisory committee even if the same 
committee previously met to discuss the same issues regarding 
withdrawal of the drug's approval, and enables a drug sponsor 
to continue marketing a drug long after a postapproval study 
fails to verify any benefit to patients.\32\ Section 804 
replaces the requirement for an informal hearing with an 
opportunity for written appeal to the Commissioner of Food and 
Drugs, which should significantly streamline the withdrawal 
process, while allowing sponsors to present the same case 
against withdrawal they may currently present to the 
Commissioner. In the interest of fairness and transparency, 
section 804 also requires FDA to provide an explanation for the 
withdrawal, an opportunity for a meeting with the Commissioner, 
a public comment period and responses to public comments, and 
an advisory committee meeting, if one was not held previously, 
to discuss the issues that have led to the determination that 
the product should be withdrawn.
---------------------------------------------------------------------------
    \32\House Committee on Energy and Commerce, Subcommittee on Health, 
Testimony of Patrizia Cavazzoni, Director, Center for Drug Evaluation 
and Research, U.S. Food and Drug Administration, Hearing on FDA User 
Fee Reauthorization: Ensuring Safe and Effective Drugs and Biologics 
(Feb. 3, 2022).
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            2. Drugs for Rare Diseases, Pediatric Populations, and 
                    Certain Infectious Diseases
    Significant progress has been made in recent decades with 
respect to the treatment of rare diseases, also known as orphan 
products, thanks in part to the Orphan Drug Act of 1983. Before 
the enactment of this law, only 38 orphan products existed; 
between 1983 and 2020, FDA approved 599 orphan products to 
treat rare diseases.\33\ However, there is still a long way to 
go; together rare diseases affect more than 25 million 
Americans, 90 percent of these diseases continue not to have an 
FDA-approved treatment, and numerous obstacles to the 
investment in research and development of these drugs 
remain.\34\
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    \33\National Organization for Rare Disorders, Orphan Drugs in the 
United States: An Examination of Patents and Orphan Drug Exclusivity 
(March 25, 2021) (https://rarediseases.org/wp-content/uploads/2021/03/
NORD-Avalere-Report-2021_FNL-1.pdf).
    \34\Id.; Food and Drug Administration, Remarks by Acting 
Commissioner Woodcock to the 2021 NORD Breakthrough Summit (Oct. 19, 
2021) (www.fda.gov/news-events/speeches-fda-officials/remarks-acting-
commissioner-woodcock-2021-nord-breakthrough-summit-10192021).
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    A recent decision of the 11th Circuit Court of Appeals 
upended FDA's longstanding interpretation of seven-year orphan 
drug exclusivity under section 527 of the FFDCA (21 U.S.C. 
Sec. 360cc).\35\ Under FDA's implementation of section 527, 
orphan drug exclusivity blocks approval of the same drug only 
for the same use or indication that FDA previously approved, 
which may be in a small subgroup affected by the disease. This 
incentivizes companies to continue to study and obtain approval 
for other uses within the designated disease, such as a 
pediatric indication for a drug approved for adults.\36\
---------------------------------------------------------------------------
    \35\Catalyst Pharms., Inc. v. Becerra, 14 F.4th 1299 (11th Cir. 
2021).
    \36\Food and Drug Administration, Overview of Catalyst Pharms., 
Inc. v. Becerra (www.fda.gov/industry/developing-products-rare-
diseases-conditions/fdas-overview-catalyst-pharms-inc-v-becerra) 
(accessed May 24, 2022).
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    As a result of the court's decision, which held that 
exclusivity applies to the entire designated disease regardless 
of the specific indications for which a drug is actually 
approved, sponsors would have incentive to obtain approval for 
the smallest, easiest-to-study subpopulation and block approval 
for any other populations or indications within the rare 
disease for seven years.\37\ Were this interpretation to stand, 
there could be a chilling effect on investment in studying and 
obtaining approval for these drugs in different subpopulations, 
which could be especially harmful to populations that tend to 
be studied later in drug development, such as children, the 
elderly, and patients with co-morbidities. The ruling also 
creates uncertainty regarding existing approvals for a number 
of brand-name and generic drugs and could block approval of 
drugs in late-stage development or for which premarket review 
is pending. This problem will grow over time for the hundreds 
of existing terms of orphan exclusivity that would be subject 
to the broad scope resulting from the Catalyst decision.\38\
---------------------------------------------------------------------------
    \37\Id.
    \38\Id.
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    Section 812 of H.R. 7667 will prevent the potential 
negative consequences of this decision from occurring by 
amending section 527 of the FFDCA (21 U.S.C. Sec. 360cc) to 
clearly provide that orphan exclusivity applies only to the 
specific indication or use approved by FDA under this section, 
not the entire rare disease or condition for which a drug is 
designated, consistent with FDA's long-held interpretation of 
the law.\39\
---------------------------------------------------------------------------
    \39\21 CFR 316.
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    Section 703 of H.R. 7667 further seeks to advance the 
development of drugs for rare diseases by requiring FDA to 
study processes for evaluating drugs for rare diseases in the 
United States and the European Union, convene a public meeting 
to solicit input from stakeholders regarding approaches to 
improving engagement with patients, patient groups, and 
experts, and submit a report to Congress summarizing its 
activities relating to designating, approving, and licensing 
drugs used to treat rare diseases. Section 703 also requires 
GAO to conduct a study on the use of FDA tools to ensure that 
patient and physician perspectives are incorporated throughout 
FDA processes for approving and licensing drugs and making 
determinations related to a drug's approval.
    Section 804 addresses the need for further rare disease 
development by requiring FDA to establish a rare disease 
endpoint advancement pilot program and issue guidance on novel 
surrogate endpoints and trial designs, and section 712 does so 
by reauthorizing orphan drug grants and allowing such grants to 
be used to develop regulatory science pertaining to the 
chemistry, manufacturing, and controls of rare disease drugs.
    Although there has been progress in the treatment of 
pediatric cancer in recent years, particularly with respect to 
the most common malignancy, little improvement has been made in 
the treatment of certain other types of childhood cancer. High 
development costs and the relatively smaller number of 
pediatric patients limit investment in treatments for this 
population; as a result, few cancer drugs have obtained FDA 
approval for pediatric indications and the need for more 
clinical studies in children persists.\40\
---------------------------------------------------------------------------
    \40\Theodore W. Laetsch, et al., Opportunities and Challenges in 
Drug Development for Pediatric Cancers, Cancer Discovery (Mar. 2, 2021) 
(aacrjournals.org/cancerdiscovery/article/11/3/545/3017/Opportunities-
and-Challenges-in-Drug-Development).
---------------------------------------------------------------------------
    The FDA Reauthorization Act of 2017 sought to facilitate 
development of appropriate new therapies for pediatric cancer 
patients by requiring pediatric investigations of certain adult 
cancer drugs with new active ingredients directed at a 
molecular target FDA determines to be substantially relevant to 
the growth or progression of a pediatric cancer, unless FDA 
waives or defers the requirement.\41\ Section 713 of H.R. 7667 
takes this mandate a step further, clarifying that the required 
pediatric investigations may be of the new drug for which 
approval is sought or such drug used in combination with a 
previously-approved drug or biological product that meets 
certain conditions. This section also requires FDA to issue 
guidance and report to Congress on its implementation of this 
section, and a GAO report on its success.
---------------------------------------------------------------------------
    \41\Pub. L. No. 115-52 (2017).
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    As antibiotic resistance continues to rise throughout the 
world and remains one of the biggest threats to public health, 
there continues to be a critical need for new antibiotic and 
antifungal treatments.\42\ The Generating Antibiotic Incentives 
Now (GAIN) provisions of the FDA Safety and Innovation Act of 
2012 promoted the development and approval of such treatments 
for serious or life-threatening infections by allowing a drug 
designated by FDA as a Qualified Infectious Disease Product 
(QIDP) to be eligible for market exclusivity, priority review 
for the first application submitted for approval, and fast-
track designation upon request. Section 705 of H.R. 7667 
broadens QIDP designation to antibiotic and antifungal 
biological products, which renders them eligible for fast-track 
designation and provides for priority review for the first 
application for an innovative biological antifungal or 
antibiotic QIDP that requires clinical data to demonstrate 
safety or effectiveness. This section does not extend QIDP 
exclusivity to biological products.
---------------------------------------------------------------------------
    \42\World Health Organization, Antibiotic Resistance (www.who.int/
news-room/fact-sheets/detail/antibiotic-resistance) (accessed May 24, 
2002).
---------------------------------------------------------------------------
    H.R. 7667 also addresses the specific need for antifungal 
treatments for coccidioidomycosis, commonly known as Valley 
Fever, which is a serious fungal lung infection that afflicts 
about 15,000 patients in the United States each year, mostly in 
Arizona and California.\43\ Section 704 attempts to advance the 
development of antifungal therapies for this illness by 
requiring FDA to issue guidance assisting entities seeking 
approval for such treatments and to hold a public workshop to 
assist entities developing vaccines for fungal infections, 
including Valley Fever.
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    \43\Centers for Disease Control and Prevention, Valley Fever 
Awareness (www.cdc.gov/fungal/features/valley-fever.html) (accessed May 
24, 2022).
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            3. Generic Drug and Biosimilar Competition
    For a generic drug to be approved by FDA, it generally must 
have the same inactive ingredients in the same concentration 
(within a certain range) as the listed drug.\44\ Currently, 
generic drug sponsors often have to engage in trial and error 
before they successfully match the same inactive ingredients in 
the same proportions as the listed drug in order to obtain 
approval.\45\ This is a costly, burdensome, and inefficient 
process for both the agency and these sponsors, and more 
importantly, can delay patient access to cost-saving generic 
drugs.\46\ Section 601 of H.R. 7667 fixes this problem by 
requiring FDA to provide this information to generic sponsors 
of certain drugs upon request, which will avoid this 
unnecessary back-and-forth and enable patients to have access 
to more affordable drugs sooner, which will reduce costs for 
patients and the health system. This section makes clear this 
information is not protected under the Trade Secrets Act.
---------------------------------------------------------------------------
    \44\21 C.F.R. Sec. 314.94(a)(9).
    \45\House Committee on Energy and Commerce, Subcommittee on Health, 
Testimony of David R. Gaugh, RPh, Senior Vice President, Sciences & 
Regulatory Affairs, Association for Accessible Medicines, Hearing on 
The Future of Medicine: Legislation to Encourage Innovation and Improve 
Oversight, 117th Cong. (Mar. 17, 2022) (energycommerce.house.gov/sites/
democrats.energycommerce.house.gov/files/documents/
Witness%20Testimony_Gaugh_HE_2022.03.17.pdf).
    \46\Id.
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    An NDA holder for a listed drug can also attempt to block 
competition from generics by changing the labeling of its drug 
shortly before a generic is approved and prepared to enter the 
market. Because generic drug labeling must generally match that 
of the listed drug, any change in a listed drug's labeling can 
temporarily block a generic drug market entry. Section 
505(j)(10)(A) of the FFDCA (21 U.S.C. Sec. 355(j)(10)(A)) 
addresses this issue by enabling FDA to approve a generic drug 
despite differences between its proposed labeling and that of 
the listed drug, other than differences in the ``Warnings'' 
section, resulting from revisions made to the labeling of the 
listed drug approved by FDA within 60 days of when the generic 
could be approved. Section 602 of H.R. 7667 extends this 
protection to 90 days, which will help cost-saving generic 
drugs get to market sooner in certain circumstances, saving 
patients money.
    Timely, accurate information regarding which drugs are on 
the market, and which are not, can help generic drug 
manufacturers and policymakers identify circumstances where 
generic competition is lacking, which can help spur competition 
and help identify any policy changes that may be appropriate to 
address these circumstances.\47\ This information can also be 
useful to providers, payors, pharmacies, and patients. Congress 
addressed this issue in the FDA Reauthorization Act of 2017, 
which added section 506I to the FFDCA (21 U.S.C. Sec. 356i), 
requiring all drug application holders to report to FDA certain 
information regarding the marketing status of approved drug 
products. Section 801 of H.R. 7667 extends these requirements 
and benefits to biological products, including biosimilars.
---------------------------------------------------------------------------
    \47\Food and Drug Administration, Statement from FDA Commissioner 
Scott Gottlieb, M.D., on the agency's efforts to enhance the utility of 
the Orange Book to foster drug competition (Jan. 30, 2019) 
(www.fda.gov/news-events/press-announcements/statement-fda-
commissioner-scott-gottlieb-md-agencys-efforts-enhance-utility-orange-
book-foster-drug).
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            4. Advanced and Innovative Manufacturing for Drugs
    The COVID-19 public health emergency has exposed gaps in 
the United States manufacturing supply chain and has reinforced 
the need to develop and implement manufacturing technologies 
that improve drug supply chain resilience, reduce time to 
market, or increase manufacturing capacity.\48\ Advanced 
manufacturing, which is a collective term for new medical 
product manufacturing technologies and approaches that can 
improve drug quality, address shortages of medicines, and speed 
time-to-market, is a key component of the overall United States 
strategy to strengthen domestic drug manufacturing and increase 
the domestic supply of quality medical products for 
consumers.\49\ Patients with diseases including cystic 
fibrosis, HIV, breast cancer, leukemia, and asthma are already 
benefitting from medications manufactured in newer, more 
expedient, and more flexible ways.\50\ Innovations in this area 
promise to rapidly scale manufacturing capabilities for 
vaccines and other medical countermeasures to enable faster 
responses in public health emergencies, shorten supply chains 
and increase manufacturing resilience to disruption by creating 
reserve capacity in network of small manufacturing sites, 
accelerate therapy development for rare diseases by improving 
the cost-efficiency of small-scale manufacturing processes, 
speed availability of emerging therapies, and provide new tools 
to address drug shortages and other challenges, including 
pharmaceutical quality.\51\
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    \48\Manufacturing x Digital (MxD) and the International Academy of 
Automation Engineering (IAAE), Analysis of the Advantages of and 
Barriers to Adoption of Smart Manufacturing for Medical Products--Focus 
on Response to Emerging and Pandemic Threats such as SARS-CoV-2, FDA-
funded study (June 30, 2021) (www.fda.gov/media/152569/download).
    \49\Food and Drug Administration, Advanced Manufacturing 
(www.fda.gov/emergency-preparedness-and-response/mcm-issues/advanced-
manufacturing) (accessed May 24, 2022).
    \50\Id.
    \51\Id.; Food and Drug Administration, FDA's Advanced Manufacturing 
Initiatives Helping to Provide Quality Human Drugs for Patients 
(www.fda.gov/news-events/fda-voices/fdas-advanced-manufacturing-
initiatives-helping-provide-quality-human-drugs-patients) (accessed May 
24, 2022).
---------------------------------------------------------------------------
    Section 706 of H.R. 7667 fosters expanded creation and use 
of these methods by requiring FDA to initiate a pilot program 
for the designation of advanced manufacturing technologies. A 
method of manufacturing is eligible for designation if such 
method incorporates a novel technology or novel use of 
technology, will at least maintain equivalent drug quality, and 
will substantially improve the manufacturing process, for 
example by reducing development time or increasing or 
maintaining the supply of certain drugs on the shortage list or 
drugs for serious diseases the manufacture of which has been 
interrupted or discontinued. Designated technologies qualify 
for expedited application development and review and allow the 
holder or their designee to reference or rely upon data and 
information about the designated technology for use in 
manufacturing drugs in the same context of use as the 
designation. This section also encourages advanced 
manufacturing utilization by requiring FDA to hold a public 
meeting, issue guidance, and report to Congress regarding this 
pilot.
    These goals are further advanced through section 702 of 
H.R. 7667, which codifies FDA's Emerging Technologies Program. 
This is a collaborative program wherein industry 
representatives, academics, and others can meet with FDA 
officials to support the adoption and improve the development 
of innovative approaches to drug design and manufacturing. This 
section also authorizes FDA to make grants, provides FDA $20 
million annually to carry out the program, and requires FDA to 
issue guidance regarding such innovative approaches. It also 
requires a report to Congress detailing the effectiveness of 
the program.
            5. Animal Testing
    Animal studies have long been critical to the development 
of safe and effective medical products. For example, scientists 
have relied heavily on animal studies to determine whether a 
drug is toxic before testing it in humans; such studies have 
shown great accuracy in predicting safe doses and determining 
appropriate monitoring for adverse effects.\52\ Conversely, 
although animal testing is still necessary in many situations, 
it is expensive and time-consuming, and does not always predict 
toxic effects in humans.\53\ Some have also raised ethical 
concerns.\54\ Advances in recent years, for example in the use 
of stem cells, engineered tissues, and mathematical modeling, 
have led to the development of alternative testing models that 
promise to improve the predictive ability of pre-clinical 
testing in conjunction with more traditional approaches.\55\ 
While most current alternative methods cannot yet predict 
effects in highly complex interacting systems, they hold the 
potential to reduce and refine animal testing, and potentially 
someday replace it.\56\
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    \52\Food and Drug Administration, Advancing New Alternative 
Methodologies at FDA (Jan. 2021) (www.fda.gov/media/144891/download).
    \53\Id.
    \54\Stephanie Liou, The Ethics of Animal Experimentation, 
Huntington's Outreach Project for Education at Stanford (July 6, 2010) 
(hopes.stanford.edu/animal-research/).
    \55\See note 52.
    \56\Food and Drug Administration, Advancing Alternative Methods at 
FDA (www.fda.gov/science-research/about-science-research-fda/advancing-
alternative-methods-fda) (accessed May 24, 2022).
---------------------------------------------------------------------------
    Recognizing these advances and this potential for expanded 
use of non-animal testing, section 701 of H.R. 7667 amends 
certain provisions of the FFDCA pertaining to drug studies to 
allow for the possible use of non-animal nonclinical testing in 
certain circumstances as appropriate. It broadens the purpose 
of a certain type of FDA-sponsor meeting in situations where 
human efficacy studies are not ethical or feasible to include 
reaching agreement on the design of ``nonclinical tests'' 
intended to support effectiveness, so that non-animal 
nonclinical studies may be included in these meetings. This 
section also broadens references to animal testing in section 
505(i) regarding investigational new drug exemptions to 
``nonclinical tests,'' defined to include cell-based assays, 
organ chips and microphysiological systems, computer modeling, 
other nonhuman or human biology-based test methods, and animal 
tests.
            6. Addressing Third-Party Vendor Issues
    In the wake of recent FDA-approved changes to the risk 
evaluation and mitigation strategies (REMS) programs for 
clozapine and isotretinoin, users have experienced problems 
such as long wait times and difficulties obtaining certain 
authorizations. To attempt to avoid such problems in the 
future, section 809 of H.R. 7667 requires FDA to provide a 
single public comment period regarding patient access and 
provider administration when a proposed modification to an 
approved REMS is reviewed under section 505-1(h) of the FFDCA 
(21 U.S.C. Sec. 355-1). This section makes clear that it shall 
not delay any agency action on any modification to a REMS. It 
also requires a GAO study on how any third-party vendor changes 
have impacted patient access to drugs subject to the modified 
REMS and how those access issues were resolved.
            7. Encouraging Blood Donation
    To facilitate FDA collection of certain information 
pertaining to blood donation and ultimately encourage broad 
donation of blood to assure adequate supply, section 802 
exempts from Paperwork Reduction Act requirements FDA 
information gathering regarding patient perspectives during 
medical product development and solicitation of information 
from blood donors and potential blood donors to inform 
recommendations regarding blood donation.
            8. Cell and Gene Therapy Workshop
    In the interest of advancing the understanding of certain 
human cell-, tissue-, and cellular-based medical products and 
the latest scientific information about such products and 
providing a public forum for discussion of related issues, 
section 707 requires FDA to convene a public workshop on 
generating the scientific data necessary to further facilitate 
development of these products.

D. Improvements for Device Regulation

            1. Cybersecurity
    As cyberattacks generally, and on the health care sector in 
particular, have become more widespread and more sophisticated 
in recent years, medical device cybersecurity is more important 
than ever.\57\ Connected, networked systems that leverage 
wireless technologies provide many advantages in health care 
delivery, but also leave systems more vulnerable to 
cyberattacks. For example, recent ransomware attacks on 
hospitals have rendered medical devices and hospital networks 
inoperable, necessitated moving patients to other hospitals, 
and prevented access to patient records, putting patients at 
risk and imposing substantial financial costs on the health 
care system.\58\ Without adequate cybersecurity across all 
components of larger medical device systems, which can include 
health care facility networks, various individual devices, and 
software update servers, a cybersecurity threat can compromise 
the safety or effectiveness of a device by compromising any 
component in the system.\59\
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    \57\Cybersecurity and Infrastructure Security Agency, Stop 
Ransomware Resources, Sector Risk Management Agencies, Healthcare and 
the Public Sector (www.cisa.gov/stopransomware/healthcare-and-public-
health-sector) (accessed May 24, 2022); Cybersecurity and 
Infrastructure Security Agency, Federal Bureau of Investigation, and 
Department of Health and Human Services, Alert AA20-302A, Ransomware 
Activity Targeting the Healthcare and Public Health Sector (Oct. 28, 
2020) (www.cisa.gov/uscert/ncas/alerts/aa20-302a).
    \58\Id.; Food and Drug Administration, Cybersecurity in Medical 
Devices: Quality System Considerations and Content of Premarket 
Submissions (draft guidance) (April 8, 2022) (www.fda.gov/media/119933/
download).
    \59\Id. 
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    Section 808 of H.R. 7667 imposes crucial requirements that 
will improve the cybersecurity of medical devices and thereby 
improve the cybersecurity of our entire health care system. It 
requires manufacturers of all cyber devices, defined as any 
device that includes software, can connect to the internet, or 
otherwise could be vulnerable to cybersecurity threats, to 
develop processes to ensure their devices are secure, have 
plans to identify and address cybersecurity vulnerabilities, 
and provide a software bill of materials in their labeling so 
that users can more easily identify threats and 
vulnerabilities. This section also provides that this 
information, as well as any other information pertaining to 
cybersecurity that FDA determines to be appropriate to 
demonstrate a reasonable assurance of safety and effectiveness, 
must be submitted in any premarket submissions and authorizes 
FDA to deny 510(k) clearance if cybersecurity information is 
inadequate. To enable enforcement of these requirements, it 
makes failure to comply a prohibited act.
            2. Bans of Devices for Specific Intended Use(s)
    In 2020, FDA, pursuant to section 516 of the FFDCA (21 
U.S.C. Sec. 360f), issued a final rule banning electric shock 
devices intended to aversively condition patients against self-
injurious and aggressive behavior.\60\ In 2021, the Court of 
Appeals for the District of Columbia Circuit, without weighing 
in on the reasons for FDA's decision to ban such devices, 
overturned the ban, finding that banning a device for a 
particular use interferes with the practice of medicine in 
contravention of section 1006 of the FFDCA (21 U.S.C. 
Sec. 396).\61\ This section makes two legislative changes to 
address this court decision: one to clarify FDA's authority to 
ban a device, in appropriate circumstances where the 
longstanding banning standard is met, regardless of whether it 
includes other devices that are technologically similar but 
have different intended uses within the scope of the ban, and 
another to effectuate FDA's ban of this particular device, 
including its particular intended use.
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    \60\ Food and Drug Administration, Banned Devices: Electrical 
Stimulation Devices for Self-Injurious or Aggressive Behavior, 85 Fed. 
Reg. 13312 (Mar. 6, 2020).
    \61\Judge Rotenberg Educ. Ctr., Inc. v. FDA, 3 F.4th 390 (D.C. Cir. 
2021).
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    Since the Medical Device Amendments of 1976, FDA has had 
the authority under section 516 of the FFDCA (21 U.S.C. 
Sec. 360f) to ban medical devices that present an unreasonable 
and substantial risk of illness or injury. For an even longer 
time--since Congress first gave FDA authority over devices in 
the FFDCA of 1938--the regulatory status of a product as a 
``device'' under section 201(h) of the FFDCA (21 U.S.C. 
Sec. 321(h)) has been dependent on its intended use; whereas a 
technology for one use may not be FDA-regulated, the same 
technology for a different use may be a ``device.'' How a 
device is classified, its premarket pathway, labeling, and 
other requirements very much depend on its intended use; a 
device that is safe and effective for one use may be unsafe and 
ineffective for a different use or different population.\62\ 
Section 811 of H.R. 7667 makes clear that the same principle 
applies to FDA's banning authority, so that FDA may ban a 
device intended for one particular use. Without this change, 
FDA would either have to ban a technology for all uses, which 
could prevent patient access to safe and effective devices, or 
not ban a device that presents a substantial and unreasonable 
risk of illness or injury for a certain use or population, 
depriving those individuals of the protection Congress intended 
the banning authority to provide for over 45 years.
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    \62\Sections 513(a)(1), 513(a)(2) and 513(i) of the FFDCA (21 
U.S.C. Sec. Sec. 360c(a)(1), 360c(a)(2), 360c(i)).
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    FDA's ban applied to shock devices intended for use on a 
particularly vulnerable patient population--individuals who 
engage in self-injurious and aggressive behavior, conditions 
that present in individuals with intellectual and developmental 
disabilities, such as Autism spectrum disorder, Down syndrome, 
and Tourette's syndrome.\63\ FDA determined that these devices 
intended for this use present an unreasonable and substantial 
risk of illness or injury based on the serious risks they pose, 
the inadequacy of data to show effectiveness, and the positive 
benefit-risk profiles of behavioral and pharmacological 
alternatives developed in recent decades to treat patients with 
these conditions.\64\
---------------------------------------------------------------------------
    \63\See note 60.
    \64\Id.
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    Specifically, in its final rule imposing the ban, FDA cited 
medical literature that found that the use of these devices 
included risks of physical harms, including pain, skin burns, 
and tissue damage, as well as serious psychological harms, 
including depression, posttraumatic stress disorder (PTSD), 
suicidality, chronic stress, anxiety, fear, panic, and 
substitution of other negative behaviors.\65\ FDA issued the 
final rule after an extensive process spanning nearly a decade 
over two administrations, with multiple opportunities for 
stakeholder input, including an outside expert advisory 
committee meeting in 2014, a proposed rule in 2016, meetings 
with the affected company and other stakeholders, consideration 
of tens of thousands of pages of scientific literature, state 
court proceedings, and over 1,500 comments, which were 
overwhelmingly supportive of the ban.\66\ Section 811 of H.R. 
7667 would reinstitute this ban without the need for additional 
time-consuming and resource-intensive proceedings.
---------------------------------------------------------------------------
    \65\Id.
    \66\Id.
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            3. Public Health Emergency Diagnostic Testing
    One of the lessons learned from the COVID-19 public health 
emergency regards the value that external expertise and 
experience can provide to FDA regarding medical devices that 
are essential during such an emergency, such as personal 
protective equipment and diagnostic tests, including with 
respect to the use of such tests in the detection of an 
emerging threat and its spread across the nation and globe. It 
can be difficult to obtain such expertise in the middle of an 
emergency, given the focus of public health resources on other 
aspects of emergency response. Section 807 of H.R. 7667 aims to 
address this issue by requiring at least one panel of FDA's 
Medical Device Advisory Committee, which shall include at least 
one population-health representative, to meet at least once per 
year to discuss topics related to device use in pandemic 
preparedness and response, including with respect to in vitro 
diagnostics.
    Looking ahead to a post-pandemic world, section 806 of H.R. 
7667 will streamline FDA premarket review and categorization 
under the Clinical Laboratory Improvement Amendments (CLIA) for 
certain diagnostic tests that were granted an emergency use 
authorization during the COVID-19 emergency. More specifically, 
sponsors of such tests that were deemed to be CLIA-waived under 
section 564(m) of the FFDCA (21 U.S.C. Sec. 360bbb-3) as part 
of such authorization that submit requests for de novo 
classification of their test under section 513(f)(2) (21 U.S.C. 
Sec. 360c(f)(2)) of the FFDCA may submit a request for CLIA 
categorization together with their de novo request in a single 
submission.

                        III. Committee Hearings

    For the purposes of section 3(c) of rule XIII of the Rules 
of the House of Representatives, the following hearings were 
used to develop and consider H.R. 7667:
    The Subcommittee on Health held a legislative hearing on 
February 3, 2022, entitled ``FDA User Fee Reauthorization: 
Ensuring Safe and Effective Drugs and Biologics.'' The 
Subcommittee received testimony from the following witnesses:
    Panel I:
           Patrizia Cavazzoni, M.D., Director, Center 
        for Drug Evaluation and Research, Food and Drug 
        Administration; and
           Peter Marks, M.D., Ph.D., Director, Center 
        for Biologics Evaluation and Research, Food and Drug 
        Administration.
    Panel II:
           Cartier Esham, Ph.D., Chief Scientific 
        Officer, Executive Vice President, Emerging Companies, 
        Biotechnology Innovation Organization;
           David Gaugh, Senior Vice President, Sciences 
        and Regulatory Affairs, Association for Accessible 
        Medicines;
           Reshma Ramachandran, M.D., Chair, Doctors 
        for America FDA Task Force, Physician-Fellow, Yale 
        National Clinician Scholars Program, Yale School of 
        Medicine;
           Juliana M. Reed, Executive Director, 
        Biosimilars Forum; and
           Lucy Vereshchagina, Ph.D., Vice President, 
        Science and Regulatory Advocacy. Pharmaceutical 
        Research and Manufacturers of America.
    The Subcommittee on Health held a hearing on March 17, 
2022, entitled ``The Future of Medicine: Legislation to 
Encourage Innovation and Improve Oversight.'' The Subcommittee 
received testimony from the following witnesses:
           Jeff Allen, Ph.D., President and CEO, 
        Friends of Cancer Research;
           Cartier Esham, Ph.D., Chief Scientific 
        Officer, Executive Vice President, Emerging Companies, 
        Biotechnology Innovation Organization;
           David Gaugh, Senior Vice President, Sciences 
        and Regulatory Affairs, Association for Accessible 
        Medicines;
           Ruben Mesa, M.D., Executive Director, Mays 
        Cancer Center, UT Health San Antonio MD Anderson;
           Reshma Ramachandran, M.D., Chair, Doctors 
        for America FDA Task Force, Physician-Fellow, Yale 
        National Clinician Scholars Program, Yale School of 
        Medicine; and
           Lucy Vereshchagina, Ph.D., Vice President, 
        Science and Regulatory Advocacy. Pharmaceutical 
        Research and Manufacturers of America.
    The Subcommittee on Health held a legislative hearing on 
March 30, 2022, entitled ``FDA User Fee Reauthorization: 
Ensuring Safe and Effective Medical Devices.'' The Subcommittee 
received testimony from the following witnesses:
    Panel I:
           Jeff Shuren, M.D., Director, Center for 
        Devices and Radiological Health, Food and Drug 
        Administration.
    Panel II:
           Richard J. Kovacs, M.D., Q.E. and Sally 
        Russell Professor of Medicine, Indiana University 
        School of Medicine, Chief Medical Officer, American 
        College of Cardiology;
           Mark Leahey, President & CEO, Medical Device 
        Manufacturers Association;
           Janet Trunzo, Senior Executive Vice 
        President, Technology and Regulatory Affairs, Advanced 
        Medical Technology Association (AdvaMed); and
           Diane Wurzburger, Executive of Regulatory 
        Affairs, GE Healthcare.

                      IV. Committee Consideration

    H.R. 7667, the ``Food and Drug Amendments of 2022,'' was 
introduced on May 6, 2022, by Representatives Eshoo (D-CA), 
Guthrie (R-KY), Pallone (D-NJ), and Rodgers (R-WA) and referred 
to the Committee on Energy and Commerce. Subsequently, on May 
9, 2022, the bill was referred to the Subcommittee on Health.
    On May 11, 2022, the Subcommittee on Health met in open 
markup session, pursuant to notice, to consider H.R. 7667 and 
five other bills. During consideration of the bill, an 
amendment in the nature of a substitute (AINS) offered by 
Representative Eshoo was agreed to by a voice vote. Upon 
conclusion of consideration of the bill, the Subcommittee on 
Health agreed to report the bill favorably to the full 
Committee, amended, by a roll call vote of 30 yeas to zero 
nays.
    On May 18, 2022, the full Committee met in open markup 
session, pursuant to notice, to consider H.R. 7667 and five 
other bills. An AINS offered by Representative Guthrie was 
agreed to by a voice vote. An amendment to the AINS offered by 
Representative Butterfield (D-NC) was agreed to by a voice 
vote. Upon conclusion of consideration of the bill, the full 
Committee agreed to a motion on final passage offered by 
Representative Pallone, Chairman of the Committee, to order 
H.R. 7667 reported favorably to the House, amended, by a roll 
call vote of 55 yeas to zero nays.

                           V. Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list each record vote 
on the motion to report legislation and amendments thereto. The 
Committee advises that there were two record votes taken on 
H.R. 7667, including a motion by Mr. Pallone ordering H.R. 7667 
favorably reported to the House, amended. The motion on final 
passage of the bill was approved by a record vote of 55 yeas to 
zero nays. The following are the record votes taken during 
Committee consideration, including the names of those members 
voting for and against:


		[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

                         VI. Oversight Findings

    Pursuant to clause 3(c)(1) of rule XIII and clause 2(b)(1) 
of rule X of the Rules of the House of Representatives, the 
oversight findings and recommendations of the Committee are 
reflected in the descriptive portion of the report.

 VII. New Budget Authority, Entitlement Authority, and Tax Expenditures

    Pursuant to 3(c)(2) of rule XIII of the Rules of the House 
of Representatives, the Committee adopts as its own the 
estimate of new budget authority, entitlement authority, or tax 
expenditures or revenues contained in the cost estimate 
prepared by the Director of the Congressional Budget Office 
pursuant to section 402 of the Congressional Budget Act of 
1974.
    The Committee has requested but not received from the 
Director of the Congressional Budget Office a statement as to 
whether this bill contains any new budget authority, spending 
authority, credit authority, or an increase or decrease in 
revenues or tax expenditures.

                    VIII. Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

       IX. Statement of General Performance Goals and Objectives

    Pursuant to clause 3(c)(4) of rule XIII, the general 
performance goal or objective of this legislation is to 
reauthorize important FDA user fee programs and to improve the 
review and regulation of products regulated by FDA.

                   X. Duplication of Federal Programs

    Pursuant to clause 3(c)(5) of rule XIII, no provision of 
H.R. 7667 is known to be duplicative of another Federal 
program, including any program that was included in a report to 
Congress pursuant to section 21 of Public Law 111-139 or the 
most recent Catalog of Federal Domestic Assistance.

                      XI. Committee Cost Estimate

    Pursuant to clause 3(d)(1) of rule XIII, the Committee 
adopts as its own the cost estimate prepared by the Director of 
the Congressional Budget Office pursuant to section 402 of the 
Congressional Budget Act of 1974.

    XII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits

    Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the 
Committee finds that H.R. 7667 contains no earmarks, limited 
tax benefits, or limited tariff benefits.

                   XIII. Advisory Committee Statement

    No advisory committee within the meaning of section 5(b) of 
the Federal Advisory Committee Act was created by this 
legislation.

                XIV. Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

           XV. Section-by-Section Analysis of the Legislation


                    TITLE I--FEES RELATING TO DRUGS

Section 101. Short title; finding

    Section 101 establishes a short title for Title I--the 
``Prescription Drug User Fee Amendments of 2022''--and provides 
that the fees authorized in the title will be dedicated to 
expediting the drug development and review processes, including 
postmarket drug safety activities, as set forth in the 
commitment letter submitted to the Congressional Record.

Sec. 102. Definitions

    Section 102 adds to the definition of human drug 
application certain applications with respect to allergenic 
extract products, adds to the definition of prescription drug 
product certain allergenic extract products, details how 
product withdrawn from sale may be considered discontinued for 
purposes of the prescription drug program fee, and adds a 
definition for skin-test diagnostic products.

Sec. 103. Authority to assess and use drug fees

    Section 103 reauthorizes FDA's prescription drug user fee 
program through 2027, maintains the existing fee structure, and 
increases and adjusts fees, including a new strategic hiring 
and a reserve adjustment. This section also excepts skin-test 
diagnostic products from human drug application fees, provides 
a special rule for products that are no longer discontinued, 
and provides program fee exceptions for certain large volume 
parenteral products, products that are pharmaceutically 
equivalent to certain other products, and skin-test diagnostic 
products.

Sec. 104. Reauthorization; reporting requirements

    Section 104 reauthorizes and updates requirements for FDA 
reporting to Congress and requires reporting regarding certain 
requests for in-person face-to-face meetings in fiscal years 
2023 and 2024.

Sec 105. Sunset dates

    Section 105 sunsets the authority to collect prescription 
drug user fees on October 1, 2027, and sunsets reporting 
requirements on January 31, 2028.

Sec 106. Effective date

    Section 106 clarifies that the effective date of this title 
is October 1, 2022, or the date of enactment, whichever is 
later, except that the fees in FFDCA apply to applications 
received on or after October 1, 2022, regardless of the date of 
enactment.

Sec. 107. Savings clause

    Section 107 clarifies that the prescription drug user fees 
in effect before enactment continue to apply to human drug 
applications and supplements accepted by FDA for filing before 
October 1, 2022.

                   TITLE II--FEES RELATING TO DEVICES

Sec. 201. Short title; finding

    Section 201 establishes a short title for Title II--the 
``Medical Device User Fee Amendments of 2022''--and provides 
that the fees authorized in the title will be dedicated to 
expediting the process for device review and assuring device 
safety and effectiveness, as set forth in the commitment letter 
submitted to the Congressional Record.

Sec. 202. Definitions

    Section 202 amends the definition of ``process for the 
review of device applications'' to include de novo 
classification requests.

Sec. 203. Authority to assess and use device fees

    Section 203 reauthorizes FDA's medical device user fee 
program through 2027, maintains the existing fee structure, and 
increases and adjusts fees, including a new strategic hiring 
adjustment, operating reserve adjustment, and performance 
improvement adjustment that provides for increased fees in 
later years if FDA meets review goal timelines.

Sec. 204. Reauthorization; reporting requirements

    Section 204 reauthorizes and updates requirements for FDA 
reporting to Congress.

Sec. 205. Conformity assessment pilot program

    Section 205 reauthorizes a pilot program for accreditation 
of testing laboratories to assess conformance of a device with 
certain recognized standards and continuation of program after 
completion of pilot.

Sec. 206. Reauthorization of third-party review program

    Section 206 reauthorizes third party 510(k) review of 
certain devices.

Sec. 207. Sunset dates

    Section 209 sunsets the authority to collect medical device 
user fees on October 1, 2027, and sunsets reporting 
requirements on January 31, 2028.

Sec. 208. Effective date

    Section 208 clarifies that the effective date of this title 
is October 1, 2022, or the date of enactment, whichever is 
later, except that the fees in FFDCA apply to submissions 
received on or after October 1, 2022, regardless of the date of 
enactment.

Sec. 209. Savings clause

    Section 207 clarifies that the medical device user fees in 
effect before enactment continue to apply to device submissions 
received by FDA before October 1, 2022.

               TITLE III--FEES RELATING TO GENERIC DRUGS

Sec. 301. Short title; finding

    Section 301 establishes a short title for Title III--the 
``Generic Drug User Fee Amendments of 2022''--and provides that 
the fees authorized in the title will be dedicated to human 
generic drug activities, as set forth in the commitment letter 
submitted to the Congressional Record.

Sec. 302. Authority to assess and use human generic drug fees

    Section 302 reauthorizes FDA's generic drug user fee 
program through 2027, maintains existing fee structure, and 
increases and adjusts fees, including capacity planning and 
operating reserve adjustments.

Sec. 303. Reauthorization; reporting requirements

    Section 303 reauthorizes and updates requirements for FDA 
reporting to Congress.

Sec. 304. Sunset dates

    Section 304 sunsets the authority to collect generic drug 
user fees on October 1, 2027, and sunsets reporting 
requirements on January 31, 2028.

Sec. 305. Effective date

    Section 305 clarifies that the effective date of this title 
is October 1, 2022, or the date of enactment, whichever is 
later, except that the fees in FFDCA apply to applications 
received on or after October 1, 2022, regardless of the date of 
enactment.

Sec. 306. Savings clause

    Section 306 clarifies that the generic drug user fees in 
effect before enactment continue to apply to new drug 
applications and prior approval supplements received by FDA 
before October 1, 2022, and drug master files for Type II 
active pharmaceutical ingredients first referenced before 
October 1, 2022.

       TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

Sec. 401. Short title; finding

    Section 401 establishes a short title for Title IV--the 
``Biosimilar User Fee Amendments of 2022''--and provides that 
the fees authorized in the title will be dedicated to 
expediting the review of biosimilar biological product 
applications, including postmarket drug safety activities, as 
set forth in the commitment letter submitted to the 
Congressional Record.

Sec. 402. Definitions

    Section 402 defines adjustment factor and removes the 
exclusion of allergenic extract product applications from the 
definition of biosimilar biological product application.

Sec. 403. Authority to assess and use biosimilar fees

    Section 403 reauthorizes the biosimilar user fee program 
through 2027, maintains the existing fee structure, and 
increases and adjusts fees, including a strategic hiring and 
retention adjustment. Section 403 also adds provisions 
regarding removal from the biosimilar development program for 
failure to pay fees under certain circumstances, requests for 
movement to the list of discontinued biosimilar biological 
products, and a special rule for products that are no longer 
discontinued.

Sec. 404. Reauthorization; reporting requirements

    Section 404 reauthorizes and updates requirements for FDA 
reporting to Congress.

Sec. 405. Sunset dates

    Section 405 sunsets the authority to collect biosimilar 
user fees on October 1, 2027, and sunsets reporting 
requirements on January 31, 2028.

Sec. 406. Effective date

    Section 406 clarifies that the effective date of this title 
is October 1, 2022, or the date of enactment, whichever is 
later, except that the fees in FFDCA apply to applications 
received on or after October 1, 2022, regardless of the date of 
enactment.

Sec. 407. Savings clause

    Section 407 clarifies that the biosimilar user fees in 
effect before enactment continue to apply to biosimilar 
biological product applications and supplements accepted by FDA 
for filing before October 1, 2022.

            TITLE V--IMPROVING DIVERSITY IN CLINICAL STUDIES

Sec. 501. Diversity action plans for clinical studies

    Section 501 requires sponsors of phase 3 and other pivotal 
studies of new drugs (and biological products that are also 
drugs) and sponsors of studies of devices (including biological 
products that are also devices) except those excepted under 21 
C.F.R. Sec. 812.3(c), to develop and implement a diversity 
action plan. Such plan must include the sponsor's goals for 
enrollment in the clinical studies, the sponsor's rationale for 
such goals, and an explanation for how the sponsor intends to 
meet such goals. FDA may waive this requirement for certain 
drugs and devices based on a determination that submission of a 
diversity action plan is not necessary based on what is known 
about the prevalence of the disease in terms of the patient 
population that may use the drug. Submissions under section 561 
of the FFDCA (21 U.S.C. Sec. 360bbb) are exempt from this 
requirement. This section requires drug sponsors to submit 
their plans to FDA in the form and manner specified in the 
guidance required by this section as soon as practicable but no 
later than when the sponsor seeks feedback from FDA regarding a 
phase 3 study or other pivotal study of the drug.
    The timing and manner of diversity action plan submission 
to FDA for device studies is dependent upon whether submission 
of an application for investigational device exemption (IDE) to 
FDA is required under FDA regulations. FDA regulations, 21 
C.F.R. Sec. 812.20(a), require submission of an IDE application 
for studies of significant risk devices, studies involving 
exceptions from informed consent, and studies for which FDA 
notifies the sponsor an application is required. Under 21 
C.F.R. Sec. 812.2(b), non-significant risk studies are 
considered to have approved IDE applications, without sponsor 
submission of such, as long as the sponsor complies with 
certain abbreviated requirements and FDA does not notify the 
sponsor that IDE application submission is required. Section 
501 of H.R. 7667 provides that device sponsors must submit 
their diversity action plan in their IDE application, if one is 
required; if one is not required, sponsors must submit their 
plans in any premarket notification, application for premarket 
approval, or request for de novo classification the sponsor may 
submit to FDA. Diversity action plans would also be subject to 
inspection by FDA.
    The requirement to submit diversity action plans becomes 
effective six months after publication of the final guidance 
required by this section; sponsors of studies for which 
enrollment has begun after such date must comply. Failure to 
comply prevents a drug or device to which this requirement is 
applicable from being exempt under section 505(i) or 520(g) of 
the FFDCA (21 U.S.C. Sec. Sec. 355(i), 360j(g)) from other 
applicable requirements. For non-significant risk devices, at 
the time the study is being conducted, failure to develop or 
implement a plan as required by this section would prevent the 
device from being exempt under section 520(g) of the FFDCA; at 
the time of any submission for premarket review to FDA, failure 
to submit the diversity action plan to FDA would render the 
device adulterated under section 501(i) of the FFDCA.
    This section also requires FDA to issue new draft guidance 
or update existing draft guidance within 12 months of 
enactment, and to finalize such guidance no later than nine 
months after the close of the comment period. The guidance must 
specify the form and content of diversity action plans 
regarding the sponsor's goals for study enrollment, 
disaggregated into certain demographic categories, including 
with respect to the rationale for enrollment goals, an 
explanation for how the sponsor will meet such goals, and how 
the sponsor will publicly post key information from the plan 
that would be useful to patients and providers on its website.

Sec. 502. Evaluation of the need for FDA authority to mandate 
        postapproval studies or postmarket surveillance due to 
        insufficient demographic subgroup data

    Section 502 requires FDA to evaluate, not later than two 
years after the publication of the final guidance required by 
section 501, whether regulations or additional authorities are 
warranted to ensure that sponsors conduct post-approval studies 
or postmarket surveillance where premarket studies collected 
insufficient data for underrepresented subgroups according to 
the sponsor's goals and FDA has requested additional studies to 
be conducted.

Sec. 503. Public workshops to enhance clinical study diversity

    Section 503 requires FDA, in consultation with drug 
sponsors, medical device manufacturers, patients, and other 
stakeholders, not later than one year after enactment, to 
convene one or more public workshops to solicit input from 
stakeholders on increasing the enrollment of historically 
underrepresented populations in clinical studies.

Sec. 504. Annual summary report on progress to increase diversity in 
        clinical studies

    Section 504 requires FDA, not later than two years after 
the enactment of the Food and Drug Amendments of 2022, and 
annually thereafter, to submit to Congress, and publish on the 
public website of FDA, a report that summarizes the diversity 
action plans received pursuant to section 501 and contains 
information on whether studies for approved and cleared drugs 
and devices met diversity action plan goals, the reasons given 
whenever sponsors failed to meet their goals, and any 
postmarket studies requested or required by FDA where there was 
inadequate premarket study diversity.

Sec. 505. Public meeting on clinical study flexibilities initiated in 
        response to COVID-19 pandemic

    Section 505 requires FDA, not later than 180 days after the 
date on which the COVID-19 public health emergency period ends, 
to convene a public meeting to discuss recommendations provided 
during the COVID-19 public health emergency to mitigate 
disruption of clinical studies. Such meeting shall discuss 
incorporating certain clinical study disruption mitigation 
recommendations into current or additional guidance to improve 
clinical study access and enrollment of diverse patient 
populations.

Sec. 506. Decentralized clinical studies

    Section 506 requires FDA, not later than 12 months after 
the enactment of the Food and Drug Amendments of 2022, to issue 
draft guidance that addresses considerations for decentralized 
clinical studies, including regarding the engagement, 
enrollment, and retention of a meaningfully diverse clinical 
population with respect to race, ethnicity, age, sex, and 
geographic location, when appropriate. FDA is required to 
finalize this guidance no later than one year after the public 
comment period for the draft guidance ends.

                   TITLE VI--GENERIC DRUG COMPETITION

Sec. 601. Increasing transparency in generic drug applications

    Section 601 requires FDA to provide generic drug sponsors, 
upon request, information regarding any qualitative or 
quantitative differences in ingredients between their generic 
drug and the reference listed drug to which they are compared, 
to facilitate generic drug development and review. This section 
makes clear these disclosures are authorized by law, including 
under section 1905 of title 18, United States Code. This 
section also requires FDA to issue guidance explaining how it 
determines whether a generic drug is qualitatively and 
quantitatively the same as the listed drug.

Sec. 602. Enhancing access to affordable medicines

    Section 602 provides that a generic drug is eligible for 
approval notwithstanding differences between its proposed 
labeling and that of the listed drug due to revisions made to 
the labeling of the listed drug approved by FDA within 90 days 
of when the generic application is otherwise eligible for 
approval. This section preserves the provisions requiring that 
the revisions not be to the ``Warnings'' section of the 
labeling, the generic sponsor must submit revised labeling 
within 60 days of approval, and the applicable otherwise meet 
applicable requirements for approval.

    TITLE VII--RESEARCH, DEVELOPMENT, AND SUPPLY CHAIN IMPROVEMENTS

                         SUBTITLE A--IN GENERAL

Sec. 701. Animal testing alternatives

    Section 701 clarifies one of the purposes of a certain type 
of meeting FDA is required to have with sponsors of drug 
studies and applicants for drug approval, upon reasonable 
written request, in situations where human efficacy studies are 
not ethical or feasible. Section 701 broadens the purpose from 
reaching agreement on the design and size of ``animal and any 
associated clinical trials'' intended to support effectiveness 
to reaching agreement on the design and size of ``nonclinical 
tests and any associated clinical trials'' intended to support 
effectiveness, so that non-animal nonclinical studies would be 
included in these meetings in the event that such studies may 
be sufficient to provide substantial evidence of effectiveness 
in these situations. This section also broadens references to 
animal testing in section 505(i) regarding investigational new 
drug exemptions to ``nonclinical tests.'' Section 701 also 
defines ``nonclinical test'' and clarifies that it includes 
cell-based assays, organ chips and microphysiological systems, 
computer modeling, other nonhuman or human biology-based test 
methods, and animal tests.

Sec. 702. Emerging technology program

    Section 702 authorizes the Emerging Technologies Program at 
FDA, a collaborative program wherein industry representatives, 
academics, and others can meet with FDA officials to support 
the adoption and improve the development of innovative 
approaches to drug design and manufacturing. This section 
requires FDA to issue guidance regarding requirements related 
to such approaches and report to Congress regarding allocation 
of funds and staff utilization in this program. It authorizes 
FDA to make grants and authorizes $20 million each year for 
fiscal years 2023 through 2027 to carry out the program.

Sec. 703. Improving the treatment of rare diseases and conditions

    Section 703 requires FDA to submit a report summarizing its 
activities relating to designating, approving, and licensing 
drugs used to treat rare diseases no later than September 30, 
2026. This section also requires FDA to study processes for 
evaluating drugs for rare diseases in the United States and the 
European Union and to convene one or more public meetings to 
solicit input from stakeholders regarding approaches to 
improving engagement with rare disease condition patients, 
patient groups, and experts. Section 703 also requires the 
Government Accountability Office (GAO) to conduct a study on 
the use of FDA tools and mechanisms to ensure that patient and 
physician perspectives are considered and incorporated 
throughout FDA processes for approving and licensing drugs and 
making determinations related to a drug's approval.

Sec. 704. Antifungal research and development

    Section 704 requires the Secretary to issue guidance for 
industry to assist entities seeking approval or licensure for 
antifungal therapies intended to treat coccidioidomycosis, 
commonly known as Valley Fever, and to hold a public workshop 
to assist entities developing preventative vaccines for fungal 
infections and Valley Fever.

Sec. 705. Advancing qualified infectious disease product innovation

    Section 705 allows a biological product to qualify as a 
Qualified Infectious Disease Product (QIDP) under Section 505E 
of the FFDCA (21 U.S.C. Sec. 355f), which renders it eligible 
for fast track designation, and provides for priority review 
for the first application for an innovative biological 
antifungal or antibiotic QIDP that requires clinical data to 
demonstrate safety or effectiveness. This section does not 
extend QIDP exclusivity to biological products.

Sec. 706. Advanced manufacturing technologies designation pilot program

    Section 706 requires FDA to initiate a pilot program for 
designating methods of manufacturing as advanced manufacturing 
technologies. A method of manufacturing is eligible for 
designation if such method both: incorporates a novel 
technology or uses an established technology in a novel way and 
will substantially improve the manufacturing process and 
maintain equivalent or superior drug quality. Designated 
technologies qualify for expedited application development and 
review and allow the holder of such designation, or a person 
authorized by the designation holder, to reference or rely 
upon, in a drug or biologic application, data and information 
about the designated technology for use in manufacturing drugs 
in the same context of use for which FDA granted the 
designation. This section also requires FDA to hold a public 
meeting, issue guidance, and report to Congress regarding this 
pilot, which sunsets on October 1, 2029.

Sec. 707. Public workshop on cell therapies

    Section 707 requires FDA to convene a public workshop on 
best practices on generating scientific data necessary to 
further facilitate development of certain human cell-, tissue-, 
and cellular-based medical products, and the latest scientific 
information about such products.

Sec. 708. Reauthorization of best pharmaceuticals for children

    Section 708 reauthorizes the Best Pharmaceuticals for 
Children Act through 2027, which allows the National Institutes 
of Health to fund studies of off-patent drugs in children.

Sec. 709. Reauthorization for humanitarian device exemption and 
        demonstration grants for improving pediatric availability

    Section 709 reauthorizes through 2027 the exemption, 
subject to certain conditions, from the profit limitation on 
devices granted a humanitarian device exemption under section 
520(m) of the FFDCA (21 U.S.C. Sec. 360j(m)). Such devices, 
which are designed to treat or diagnose a disease or condition 
that affects 8,000 or fewer individuals in the United States, 
are exempt from certain requirements if they meet certain 
criteria. Section 709 also reauthorizes demonstration grants 
for improving development of pediatric medical devices through 
2027.

Sec. 710. Reauthorization of provision related to exclusivity of 
        certain drugs containing single enantiomers

    Section 710 reauthorizes the provision allowing for 
exclusivity for certain single enantiomer drugs under certain 
conditions through 2027.

Sec. 711. Reauthorization of the critical path public-private 
        partnership program

    Section 711 reauthorizes the Critical Path Public-Private 
Partnership at $10 million annually through 2027.

Sec. 712. Reauthorization of orphan drug grants

    Section 712 reauthorizes orphan drug grants through 2027 
and expands uses of such grants to include the development of 
regulatory science pertaining to manufacturing and controls 
related to individualized medical products to treat those with 
rare diseases or conditions.

Sec. 713. Research into pediatric uses of drugs; additional authorities 
        of Food and Drug Administration regarding molecularly targeted 
        cancer drugs

    This section builds on the requirement included in Section 
504 of the FDA Reauthorization Act of 2017 for pediatric 
studies by sponsors of certain adult cancer drugs with new 
active ingredients directed at a molecular target FDA 
determines to be substantially relevant to the growth or 
progression of a pediatric cancer. Such required pediatric 
studies shall be designed to yield clinically meaningful data 
regarding dosing, safety, and preliminary efficacy to inform 
potential pediatric labeling. The section also clarifies that 
the required pediatric study may be of the new drug for which 
approval is sought or such drug used in combination with a 
previously approved drug or biological product that meets 
certain conditions. Additionally, Section 713 requires FDA to 
issue guidance and report to Congress on its implementation of 
this section not later than two years after enactment, and a 
GAO report on its success in the development of drugs and 
biological products for pediatric cancer indications.

                        SUBTITLE B--INSPECTIONS

Sec. 721. Factory inspection

    Section 721 clarifies that the scope of FDA inspectional 
authority extending to all things in a factory, warehouse, 
establishment, or consulting laboratory applies to such places 
that manufacture, process, pack, or hold non-restricted devices 
as well as ones that do so with respect to restricted devices. 
This section also extends the requirement for the provision, to 
FDA, of records requested in advance or in lieu of an 
inspection to persons that own or operate establishments 
engaged in the manufacture, preparation, propagation, 
compounding, or processing of devices. FDA will have to provide 
a rationale for requesting such records and issue guidance 
regarding such requests.
    Section 721 also codifies and clarifies FDA authority to 
inspect clinical study sites, also known as bioresearch 
monitoring inspections. It requires FDA to review its processes 
and practices applicable to such inspections in the United 
States and in foreign countries, evaluate whether updates are 
needed to facilitate consistency, and issue guidance describing 
the conduct of such inspections.

Sec. 722. Uses of certain evidence

    Section 722 clarifies that the limitation on FDA's use of 
certain evidence regarding product movement in interstate 
commerce obtained from carriers and receivers does not apply to 
information obtained under other authorities such as those 
authorizing inspections unless such limitations are 
specifically incorporated.

Sec. 723. Improving FDA inspections

    Section 723 provides for FDA consideration of the 
compliance history of other FDA-regulated establishments in the 
country or region in which an establishment is located as a 
factor in establishing a schedule for risk-based inspections. 
It clarifies that FDA may rely on any records or other 
information inspected to satisfy requirements that may pertain 
to a preapproval or risk-based surveillance inspection, or to 
resolve deficiencies found in such inspections, if applicable 
and appropriate. It provides that FDA may enter into agreements 
with foreign governments to recognize inspections of foreign 
establishments to facilitate preapproval inspections and 
requires a periodic assessment of whether additional 
arrangements with foreign governments are appropriate.

Sec. 724. GAO report on inspections of foreign establishments 
        manufacturing drugs

    Section 724 requires GAO to report on FDA and recognized 
foreign government inspections of foreign establishments 
manufacturing drugs.

Sec. 725. Unannounced foreign facility inspections pilot program

    Section 725 requires FDA to conduct a pilot program in 
which FDA increases the conduct of unannounced surveillance 
inspections of foreign drug establishments, evaluates the 
differences between such inspections of domestic and foreign 
establishments, including the impact of announcing inspections, 
and post a report of its findings and recommendations on the 
FDA website.

Sec. 726. Reauthorization of inspection program

    Section 726 reauthorizes the third-party inspection program 
until October 1, 2027.

Sec. 727. Enhancing intra-agency coordination and public health 
        assessment with regard to compliance activities

    Section 727 amends section 506D of the FFDCA (21 U.S.C. 
Sec. 356d) to require FDA to ensure timely and effective 
internal coordination and alignment among field investigators 
and staff of CDER's Office of Compliance and Drug Shortage 
Program regarding the reviews of inspection reports and any 
feedback or corrective actions in response to such reports. It 
also requires FDA reporting to Congress regarding certain drug 
shortage reports and the internal coordination and alignment 
required by this section.

Sec. 728. Reporting of mutual recognition agreements for inspections 
        and review activities

    Section 728 requires FDA to publish on its website a 
report, no later than the end of calendar year 2022 and 
annually thereafter, on the utilization of agreements entered 
into pursuant to section 809 of the FFDCA (21 U.S.C. Sec. 384e) 
or otherwise entered into to recognize inspections across 
countries and international regions by drug regulatory 
authorities with analogous review criteria to the FDA.

Sec. 729. Enhancing transparency of drug facility inspection timelines

    Section 729 amends the information FDA must annually report 
regarding inspections on its website pursuant to section 902 of 
the FDA Reauthorization Act of 2017, including by adding to 
this information the time between a request from FDA and the 
beginning of an inspection for certain generic drugs, drugs 
subject to discontinuance reporting, and drugs on the shortage 
list.

      TITLE VIII--TRANSPARENCY, PROGRAM INTEGRITY, AND REGULATORY 
                              IMPROVEMENTS

Sec. 801. Prompt reports of marketing status by holders of approved 
        applications for biological products

    Section 801 requires all holders of approved Biologics 
License Applications to submit a one-time notification to FDA 
indicating whether their products listed in the Purple Book are 
still available for sale and to report to FDA on an ongoing 
basis when withdrawing a product from the market.

Sec. 802. Encouraging blood donation

    Section 802 exempts from Paperwork Reduction Act 
requirements FDA information collections to solicit patient 
perspectives during medical product development and to solicit 
information from blood donors and potential blood donors to 
inform recommendations regarding blood donation.

Sec. 803. Regulation of certain products as drugs

    Section 803 deems all contrast agents and products under 
over-the-counter drug monographs, and certain radioactive 
products, to be drugs and not medical devices.

Sec. 804. Postapproval studies and program integrity for accelerated 
        approval drugs

    Section 804 requires FDA to specify conditions for required 
postapproval studies for drugs approved under accelerated 
approval, which may include enrollment targets and milestones, 
including the target date for study completion, by the time the 
drug is approved. This section also authorizes FDA to require 
postapproval studies to be underway at the time of approval for 
such drugs, requires FDA to explain any instances where it does 
not require such studies, and provides that postapproval 
studies may be augmented or supported by real world evidence. 
This section clarifies that existing authority to withdraw 
approvals where sponsors fail to conduct studies with due 
diligence applies with respect to the approval conditions and 
streamlines the procedures for withdrawal of approval. To 
withdraw an accelerated approval, it requires FDA to provide an 
explanation for the withdrawal, an opportunity for written 
appeal, a meeting with the Commissioner or their designee, 
responses to public comment, and, upon request, an advisory 
committee meeting if there was not previously one on the 
withdrawal. Section 804 codifies labeling requirements for 
accelerated approval and requires more frequent reports on 
postapproval study progress. It also requires FDA to report to 
Congress on the use of real world evidence to support 
postapproval studies, issue guidance on novel surrogate 
endpoints and trial designs, and establish a rare disease 
endpoint advancement pilot program.

Sec. 805. Facilitating the use of real world evidence

    Section 805 requires FDA to issue guidance addressing the 
use of real world evidence and real world data, including that 
obtained for drugs and devices authorized for emergency use 
during the COVID-19 public health emergency, to support drug 
and device approvals and clearances. It requires FDA to report 
to Congress regarding the number of applications submitted for 
products for which an emergency use authorization was 
previously granted and, of such applications, how many included 
real world evidence and whether such evidence was sufficient to 
support a regulatory decision.

Sec. 806. Dual submission for certain devices

    Section 806 provides that sponsors of diagnostic tests that 
have been deemed to be CLIA-waived under section 564(m) of the 
FFDCA (21 U.S.C. Sec. 360j(m)) as part of a COVID-19 emergency 
use authorization that submit requests for de novo 
classification of their test under section 513(f)(2) of the 
FFDCA (21 U.S.C. Sec. 360c(f)(2)) may submit such request 
together with sufficient information to enable FDA to determine 
whether the test satisfies the criteria for CLIA categorization 
under section 353(d)(3) of the Public Health Service Act (42 
U.S.C. Sec. 263a(d)(3)) in a single submission.

Sec. 807. Medical devices advisory committee meetings

    Section 807 requires the Medical Device Advisory Committee 
to meet at least once a year through 2027 to provide FDA advice 
on topics related to medical devices in pandemic preparedness 
and response, including issues related to in vitro diagnostics.

Sec. 808. Ensuring cybersecurity of medical devices

    Section 808 requires manufacturers of cyber devices to 
develop processes to ensure their devices are secure, have 
plans to identify and address cybersecurity vulnerabilities, 
provide a software bill of materials in their labeling, and 
submit this information to FDA in any premarket submissions. It 
defines cyber devices as devices that have software, connect to 
the internet, or otherwise could be vulnerable to cybersecurity 
threats. Section 808 authorizes FDA to deny 510(k) clearance if 
cyber security information is inadequate and to exempt types of 
devices from these requirements. It makes failure to comply 
with these requirements a prohibited act.

Sec. 809. Public docket on proposed changes to third-party vendors

    Section 809 requires FDA to provide a public comment period 
regarding patient access and provider administration when a 
proposed modification to an approved risk evaluation and 
mitigation strategy (REMS) is reviewed under section 505-1(h) 
of the FFDCA (21 U.S.C. Sec. 355 1(h)). This section makes 
clear that it shall not delay any agency action on any 
modification to a REMS.

Sec. 810. Facilitating exchange of product information prior to 
        approval

    Section 810 provides that no drug or device shall be 
considered misbranded as a result of the provision of 
information regarding investigational drugs or devices or uses 
to payors, formulary committees, or other similar entities 
under specified conditions. It requires the information to 
include a clear statement that the drug or device it discusses 
has not been approved and that the safety and efficacy of the 
drug or device has not been established. Additional required 
disclosures include information about studies the drug or 
device is undergoing, how the studies relate to the overall 
plan for the development of the drug or device, whether an 
application for the drug or device has been submitted to FDA, 
and if not, when such submission is planned.

Sec. 811. Bans of devices for one or more intended uses

    Section 811 amends section 516 of the FFDCA (21 U.S.C. 
Sec. 360f) to make clear that FDA is authorized to ban a 
medical device intended for a particular use. A ban may apply 
to devices intended for more than one use, but in a situation 
where there are devices with the same or similar technological 
characteristics and different intended uses, FDA may ban one 
and not the other. Section 811 also bans electrical stimulation 
devices intended for self-injurious and aggressive behavior, 
which renders such devices adulterated under section 501(g) of 
the FFDCA (21 U.S.C. Sec. 351(g)).

Sec. 812. Clarifying application of exclusive approval, certification, 
        or licensure for drugs designated for rare disease or 
        conditions

    Section 812 amends section 527 of the FFDCA (21 U.S.C. 
Sec. 360cc) regarding orphan drugs to provide clarity that 
orphan exclusivity applies only to the specific indication or 
use approved by FDA under this section, not the entire rare 
disease or condition for which the drug was designated, 
consistent with FDA's long-held interpretation of the law.

Sec. 813. GAO report on third-party review

    Section 813 requires GAO to report on the program for 
accredited third-party review of 510(k) premarket notifications 
for medical devices.

Sec. 814. Reporting on pending generic drug applications and priority 
        review applications

    Section 814 reauthorizes reporting on certain pending 
generic drug applications and priority review applications 
through 2027.

Sec. 815. FDA workforce improvements

    Section 815 extends the authority Congress granted to FDA 
in the 21st Century Cures Act of 2016 to facilitate the hiring 
and retention of outstanding candidates for scientific, 
technical, or professional positions that support the 
development and regulation of medical products to the hiring of 
candidates for such positions to support the regulation of 
products across the entire agency. This section also requires 
FDA to develop and begin implementation of a strategic 
workforce plan and report to Congress regarding such plan.

       XVI. Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italics, and existing law in which no 
change is proposed is shown in roman):

                  FEDERAL FOOD, DRUG, AND COSMETIC ACT




           *       *       *       *       *       *       *
               CHAPTER III--PROHIBITED ACTS AND PENALTIES


                            prohibited acts

  Sec. 301. The following acts and the causing thereof are 
hereby prohibited:
  (a) The introduction or delivery for introduction into 
interstate commerce of any food, drug, device, tobacco product, 
or cosmetic that is adulterated or misbranded.
  (b) The adulteration or misbranding of any food, drug, 
device, tobacco product, or cosmetic in interstate commerce.
  (c) The receipt in interstate commerce of any food, drug, 
device, tobacco product, or cosmetic that is adulterated or 
misbranded, and the delivery or proffered delivery thereof for 
pay or otherwise.
  (d) The introduction or delivery for introduction into 
interstate commerce of any article in violation of section 404, 
415, 505, or 564.
  (e) The refusal to permit access to or copying of any record 
as required by section 412, 414, 417(j), 416, 504, 564, 703, 
704(a), 760, or 761; or the failure to establish or maintain 
any record, or make any report, required under section 412, 
414(b), 417, 416, 504, 505 (i) or (k), 512(a)(4)(C), 512 (j), 
(l) or (m), 572(i), 515(f), 519, 564, 760, 761, 909, or 920 or 
the refusal to permit access to or verification or copying of 
any such required record; or the violation of any recordkeeping 
requirement under section 204 of the FDA Food Safety 
Modernization Act (except when such violation is committed by a 
farm).
  (f) The refusal to permit entry or inspection as authorized 
by section 704.
  (g) The manufacture within any Territory of any food, drug, 
device, tobacco product, or cosmetic that is adulterated or 
misbranded.
  (h) The giving of a guaranty or undertaking referred to in 
section 303(c)(2), which guaranty or undertaking is false, 
except by a person who relied upon a guaranty or undertaking to 
the same effect signed by, and containing the name and address 
of, the person residing in the United States from whom he 
received in good faith the food, drug, device, tobacco product, 
or cosmetic; or the giving of a guaranty or undertaking 
referred to in section 303(c)(3), which guaranty or undertaking 
is false.
  (i)(1) Forging, counterfeiting, simulating, or falsely 
representing, or without proper authority using any mark, 
stamp, tag, label, or other identification device authorized or 
required by regulations promulgated under the provisions of 
section 404 or 721.
  (2) Making, selling, disposing of, or keeping in possession, 
control, or custody, or concealing any punch, die, plate, 
stone, or other thing designed to print, imprint, or reproduce 
the trademark, trade name, or other identifying mark, imprint, 
or device of another or any likeness of any of the foregoing 
upon any drug or container or labeling thereof so as to render 
such drugs a counterfeit drug.
  (3) The doing of any act which causes a drug to be a 
counterfeit drug, or the sale or dispensing, or the holding for 
sale or dispensing, of a counterfeit drug.
  (j) The using by any person to his own advantage, or 
revealing, other than to the Secretary or officers or employees 
of the Department, or to the courts when relevant in any 
judicial proceeding under this Act, any information acquired 
under authority of section 404, 409, 412, 414, 505, 510, 512, 
513, 514, 515, 516, 518, 519, 520, 571, 572, 573, 704, 708, 
721, 904, 905, 906, 907, 908, 909, or 920(b) concerning any 
method or process which as a trade secret is entitled to 
protection; or the violating of section 408(i)(2) or any 
regulation issued under that section.. This paragraph does not 
authorize the withholding of information from either House of 
Congress or from, to the extent of matter within its 
jurisdiction, any committee or subcommittee of such committee 
or any joint committee of Congress or any subcommittee of such 
joint committee.
  (k) The alteration, mutilation, destruction, obliteration, or 
removal of the whole or any part of the labeling of, or the 
doing of any other act with respect to, a food, drug, device, 
tobacco product, or cosmetic, if such act is done while such 
article is held for sale (whether or not the first sale) after 
shipment in interstate commerce and results in such article 
being adulterated or misbranded.
  (m) The sale or offering for sale of colored oleomargarine or 
colored margarine, or the possession or serving of colored 
oleomargarine or colored margarine in violation of section 
407(b) or 407(c).
  (n) The using, in labeling, advertising or other sales 
promotion of any reference to any report or analysis furnished 
in compliance with section 704.
  (o) In the case of a prescription drug distributed or offered 
for sale in interstate commerce, the failure of the 
manufacturer, packer, or distributor thereof to maintain for 
transmittal, or to transmit, to any practitioner licensed by 
applicable State law to administer such drug who makes written 
request for information as to such drug, true and correct 
copies of all printed matter which is required to be included 
in any package in which that drug is distributed or sold, or 
such other printed matter as is approved by the Secretary. 
Nothing in this paragraph shall be construed to exempt any 
person from any labeling requirement imposed by or under other 
provisions of this Act.
  (p) The failure to register in accordance with section 510 or 
905, the failure to provide any information required by section 
510(j), 510(k), 905(i), or 905(j), or the failure to provide a 
notice required by section 510(j)(2) or 905(i)(3).
  (q)(1) The failure or refusal--
          (A) to comply with any requirement prescribed under 
        section 518, 520(g), 903(b), 907, 908, or 915;
          (B) to furnish any notification or other material or 
        information required by or under section 519, 520(g), 
        904, 909, or 920; or
          (C) to comply with a requirement under section 522 or 
        913.
  (2) With respect to any device or tobacco product, the 
submission of any report that is required by or under this Act 
that is false or misleading in any material respect.
  (3) The failure to comply with any requirement under section 
524C (relating to ensuring device cybersecurity).
  (r) The movement of a device, drug, or tobacco product in 
violation of an order under section 304(g) or the removal or 
alteration of any mark or label required by the order to 
identify the device, drug, or tobacco product as detained.
  (s) The failure to provide the notice required by section 
412(c) or 412(e), the failure to make the reports required by 
section 412(f)(1)(B), the failure to retain the records 
required by section 412(b)(4), or the failure to meet the 
requirements prescribed under section 412(f)(3).
  (t) The importation of a drug in violation of section 
801(d)(1), the sale, purchase, or trade of a drug or drug 
sample or the offer to sell, purchase, or trade a drug or drug 
sample in violation of section 503(c), the sale, purchase, or 
trade of a coupon, the offer to sell, purchase, or trade such a 
coupon, or the counterfeiting of such a coupon in violation of 
section 503(c)(2), the distribution of a drug sample in 
violation of section 503(d) or the failure to otherwise comply 
with the requirements of section 503(d), the distribution of 
drugs in violation of section 503(e), failure to comply with 
the requirements under section 582, the failure to comply with 
the requirements under section 584, as applicable, or the 
failure to otherwise comply with the requirements of section 
503(e).
  (u) The failure to comply with any requirements of the 
provisions of, or any regulations or orders of the Secretary, 
under section 512(a)(4)(A), 512(a)(4)(D), or 512(a)(5).
  (v) The introduction or delivery for introduction into 
interstate commerce of a dietary supplement that is unsafe 
under section 413.
  (w) The making of a knowingly false statement in any 
statement, certificate of analysis, record, or report required 
or requested under section 801(d)(3); the failure to submit a 
certificate of analysis as required under such section; the 
failure to maintain records or to submit records or reports as 
required by such section; the release into interstate commerce 
of any article or portion thereof imported into the United 
States under such section or any finished product made from 
such article or portion, except for export in accordance with 
section 801(e) or 802, or with section 351(h) of the Public 
Health Service Act; or the failure to so export or to destroy 
such an article or portions thereof, or such a finished 
product.
  (x) The falsification of a declaration of conformity 
submitted under section 514(c) or the failure or refusal to 
provide data or information requested by the Secretary under 
paragraph (3) of such section.
  (y) In the case of a drug, device, or food--
          (1) the submission of a report or recommendation by a 
        person accredited under section 523 that is false or 
        misleading in any material respect;
          (2) the disclosure by a person accredited under 
        section 523 of confidential commercial information or 
        any trade secret without the express written consent of 
        the person who submitted such information or secret to 
        such person; or
          (3) the receipt by a person accredited under section 
        523 of a bribe in any form or the doing of any corrupt 
        act by such person associated with a responsibility 
        delegated to such person under this Act.
  (z) The dissemination of information in violation of section 
551.
  (aa) The importation of a prescription drug in violation of 
section 804, the falsification of any record required to be 
maintained or provided to the Secretary under such section, or 
any other violation of regulations under such section.
  (bb) The transfer of an article of food in violation of an 
order under section 304(h), or the removal or alteration of any 
mark or label required by the order to identify the article as 
detained.
  (cc) The importing or offering for import into the United 
States of an article of food or a drug by, with the assistance 
of, or at the direction of, a person debarred from such 
activity under section 306(b)(3).
  (dd) The failure to register in accordance with section 415.
  (ee) The importing or offering for import into the United 
States of an article of food in violation of the requirements 
under section 801(m).
  (ff) The importing or offering for import into the United 
States of a drug or device with respect to which there is a 
failure to comply with a request of the Secretary to submit to 
the Secretary a statement under section 801(o).
  (gg) The knowing failure to comply with paragraph (7)(E) of 
section 704(g); the knowing inclusion by a person accredited 
under paragraph (2) of such section of false information in an 
inspection report under paragraph (7)(A) of such section; or 
the knowing failure of such a person to include material facts 
in such a report.
  (hh) The failure by a shipper, carrier by motor vehicle or 
rail vehicle, receiver, or any other person engaged in the 
transportation of food to comply with the sanitary 
transportation practices prescribed by the Secretary under 
section 416.
  (ii) The falsification of a report of a serious adverse event 
submitted to a responsible person (as defined under section 760 
or 761) or the falsification of a serious adverse event report 
(as defined under section 760 or 761) submitted to the 
Secretary.
  (jj)(1) The failure to submit the certification required by 
section 402(j)(5)(B) of the Public Health Service Act, or 
knowingly submitting a false certification under such section.
  (2) The failure to submit clinical trial information required 
under subsection (j) of section 402 of the Public Health 
Service Act.
  (3) The submission of clinical trial information under 
subsection (j) of section 402 of the Public Health Service Act 
that is false or misleading in any particular under paragraph 
(5)(D) of such subsection (j).
  (kk) The dissemination of a television advertisement without 
complying with section 503B.
  (ll) The introduction or delivery for introduction into 
interstate commerce of any food to which has been added a drug 
approved under section 505, a biological product licensed under 
section 351 of the Public Health Service Act, or a drug or a 
biological product for which substantial clinical 
investigations have been instituted and for which the existence 
of such investigations has been made public, unless--
          (1) such drug or such biological product was marketed 
        in food before any approval of the drug under section 
        505, before licensure of the biological product under 
        such section 351, and before any substantial clinical 
        investigations involving the drug or the biological 
        product have been instituted;
          (2) the Secretary, in the Secretary's discretion, has 
        issued a regulation, after notice and comment, 
        approving the use of such drug or such biological 
        product in the food;
          (3) the use of the drug or the biological product in 
        the food is to enhance the safety of the food to which 
        the drug or the biological product is added or applied 
        and not to have independent biological or therapeutic 
        effects on humans, and the use is in conformity with--
                  (A) a regulation issued under section 409 
                prescribing conditions of safe use in food;
                  (B) a regulation listing or affirming 
                conditions under which the use of the drug or 
                the biological product in food is generally 
                recognized as safe;
                  (C) the conditions of use identified in a 
                notification to the Secretary of a claim of 
                exemption from the premarket approval 
                requirements for food additives based on the 
                notifier's determination that the use of the 
                drug or the biological product in food is 
                generally recognized as safe, provided that the 
                Secretary has not questioned the general 
                recognition of safety determination in a letter 
                to the notifier;
                  (D) a food contact substance notification 
                that is effective under section 409(h); or
                  (E) such drug or biological product had been 
                marketed for smoking cessation prior to the 
                date of the enactment of the Food and Drug 
                Administration Amendments Act of 2007; or
          (4) the drug is a new animal drug whose use is not 
        unsafe under section 512.
  (mm) The failure to submit a report or provide a notification 
required under section 417(d).
  (nn) The falsification of a report or notification required 
under section 417(d).
  (oo) The sale of tobacco products in violation of a no-
tobacco-sale order issued under section 303(f).
  (pp) The introduction or delivery for introduction into 
interstate commerce of a tobacco product in violation of 
section 911.
  (qq)(1) Forging, counterfeiting, simulating, or falsely 
representing, or without proper authority using any mark, stamp 
(including tax stamp), tag, label, or other identification 
device upon any tobacco product or container or labeling 
thereof so as to render such tobacco product a counterfeit 
tobacco product.
  (2) Making, selling, disposing of, or keeping in possession, 
control, or custody, or concealing any punch, die, plate, 
stone, or other item that is designed to print, imprint, or 
reproduce the trademark, trade name, or other identifying mark, 
imprint, or device of another or any likeness of any of the 
foregoing upon any tobacco product or container or labeling 
thereof so as to render such tobacco product a counterfeit 
tobacco product.
  (3) The doing of any act that causes a tobacco product to be 
a counterfeit tobacco product, or the sale or dispensing, or 
the holding for sale or dispensing, of a counterfeit tobacco 
product.
  (rr) The charitable distribution of tobacco products.
  (ss) The failure of a manufacturer or distributor to notify 
the Attorney General and the Secretary of the Treasury of their 
knowledge of tobacco products used in illicit trade.
  (tt) Making any express or implied statement or 
representation directed to consumers with respect to a tobacco 
product, in a label or labeling or through the media or 
advertising, that either conveys, or misleads or would mislead 
consumers into believing, that--
          (1) the product is approved by the Food and Drug 
        Administration;
          (2) the Food and Drug Administration deems the 
        product to be safe for use by consumers;
          (3) the product is endorsed by the Food and Drug 
        Administration for use by consumers; or
          (4) the product is safe or less harmful by virtue 
        of--
                  (A) its regulation or inspection by the Food 
                and Drug Administration; or
                  (B) its compliance with regulatory 
                requirements set by the Food and Drug 
                Administration;
        including any such statement or representation 
        rendering the product misbranded under section 903.
                  
  (uu) The operation of a facility that manufactures, 
processes, packs, or holds food for sale in the United States 
if the owner, operator, or agent in charge of such facility is 
not in compliance with section 418.
  (vv) The failure to comply with the requirements under 
section 419.
  (ww) The failure to comply with section 420.
  (xx) The refusal or failure to follow an order under section 
423.
  (yy) The knowing and willful failure to comply with the 
notification requirement under section 417(h).
  (zz) The importation or offering for importation of a food if 
the importer (as defined in section 805) does not have in place 
a foreign supplier verification program in compliance with such 
section 805.
  (aaa) The failure to register in accordance with section 
801(s).
  (bbb) The failure to notify the Secretary in violation of 
section 568.
  (ccc)(1) The resale of a compounded drug that is labeled 
``not for resale'' in accordance with section 503B.
  (2) With respect to a drug to be compounded pursuant to 
section 503A or 503B, the intentional falsification of a 
prescription, as applicable.
  (3) The failure to report drugs or adverse events by an 
entity that is registered in accordance with subsection (b) of 
section 503B.
  (ddd)(1) The manufacture or the introduction or delivery for 
introduction into interstate commerce of a rinse-off cosmetic 
that contains intentionally-added plastic microbeads.
  (2) In this paragraph--
          (A) the term ``plastic microbead'' means any solid 
        plastic particle that is less than five millimeters in 
        size and is intended to be used to exfoliate or cleanse 
        the human body or any part thereof; and
          (B) the term ``rinse-off cosmetic'' includes 
        toothpaste.
  (eee) The failure to comply with any order issued under 
section 569D.

           *       *       *       *       *       *       *


                      CHAPTER V--DRUGS AND DEVICES


                    Subchapter A--Drugs and Devices


                     adulterated drugs and devices

  Sec. 501. A drug or device shall be deemed to be 
adulterated--
  (a)(1) If it consists in whole or in part of any filthy, 
putrid, or decomposed substance; or (2)(A) if it has been 
prepared, packed, or held under insanitary conditions whereby 
it may have been contaminated with filth, or whereby it may 
have been rendered injurious to health; or (B) if it is a drug 
and the methods used in, or the facilities or controls used 
for, its manufacture, processing, packing, or holding do not 
conform to or are not operated or administered in conformity 
with current good manufacturing practice to assure that such 
drug meets the requirements of this Act as to safety and has 
the identity and strength, and meets the quality and purity 
characteristics, which it purports or is represented to 
possess; or (C) if it is a compounded positron emission 
tomography drug and the methods used in, or the facilities and 
controls used for, its compounding, processing, packing, or 
holding do not conform to or are not operated or administered 
in conformity with the positron emission tomography compounding 
standards and the official monographs of the United States 
Pharmacopoeia to assure that such drug meets the requirements 
of this Act as to safety and has the identity and strength, and 
meets the quality and purity characteristics, that it purports 
or is represented to possess; or (3) if its container is 
composed, in whole or in part, of any poisonous or deleterious 
substance which may render the contents injurious to health; or 
(4) if (A) it bears or contains, for purposes of coloring only, 
a color additive which is unsafe within the meaning of section 
721(a), or (B) it is a color additive the intended use of which 
in or on drugs or devices is for purposes of coloring only and 
is unsafe within the meaning of section 721(a); or (5) if it is 
a new animal drug which is unsafe within the meaning of section 
512; or (6) if it is an animal feed bearing or containing a new 
animal drug, and such animal feed is unsafe within the meaning 
of section 512.
  (b) If it purports to be or is represented as a drug the name 
of which is recognized in an official compendium, and its 
strength differs from, or its quality or purity falls below, 
the standards set forth in such compendium. Such determination 
as to strength, quality, or purity shall be made in accordance 
with the tests or methods of assay set forth in such 
compendium, except that whenever tests or methods of assay have 
not been prescribed in such compendium, or such tests or 
methods of assay as are prescribed are, in the judgment of the 
Secretary, insufficient for the making of such determination, 
the Secretary shall bring such fact to the attention of the 
appropriate body charged with the revision of such compendium, 
and if such body fails within a reasonable time to prescribe 
tests or methods of assay which, in the judgment of the 
Secretary, are sufficient for purposes of this paragraph, then 
the Secretary shall promulgate regulations prescribing 
appropriate tests or methods of assay in accordance with which 
such determination as to strength, quality, or purity shall be 
made. No drug defined in an official compendium shall be deemed 
to be adulterated under this paragraph because it differs from 
the standard of strength, quality, or purity therefor set forth 
in such compendium, if its difference in strength, quality, or 
purity from such standards is plainly stated on its label. 
Whenever a drug is recognized in both the United States 
Pharmacopeia and the Homeopathic Pharmacopeia of the United 
States it shall be subject to the requirements of the United 
States Pharmacopeia unless it is labeled and offered for sale 
as a homeopathic drug, in which case it shall be subject to the 
provisions of the Homeopathic Pharmacopeia of the United States 
and not to those of the United States Pharmacopeia.
  (c) If it is not subject to the provisions of paragraph (b) 
of this section and its strength differs from, or its purity or 
quality falls below, that which it purports or is represented 
to possess.
  (d) If it is a drug and any substance has been (1) mixed or 
packed therewith so as to reduce its quality or strength or (2) 
substituted wholly or in part therefor.
  (e)(1) If it is, or purports to be or is represented as, a 
device which is subject to a performance standard established 
under section 514, unless such device is in all respects in 
conformity with such standard.
  (2) If it is declared to be, purports to be, or is 
represented as, a device that is in conformity with any 
standard recognized under section 514(c) unless such device is 
in all respects in conformity with such standard.
  (f)(1) If it is a class III device--
          (A)(i) which is required by an order issued under 
        subsection (b) of section 515 to have an approval under 
        such section of an application for premarket approval 
        and which is not exempt from section 515 under section 
        520(g), and
          (ii)(I) for which an application for premarket 
        approval or a notice of completion of a product 
        development protocol was not filed with the Secretary 
        within the ninety-day period beginning on the date of 
        the issuance of such order, or
          (II) for which such an application was filed and 
        approval of the application has been denied, suspended, 
        or withdrawn, or such a notice was filed and has been 
        declared not completed or the approval of the device 
        under the protocol has been withdrawn;
          (B)(i) which was classified under section 513(f) into 
        class III, which under section 515(a) is required to 
        have in effect an approved application for premarket 
        approval, and which is not exempt from section 515 
        under section 520(g), and
          (ii) which has an application which has been 
        suspended or is otherwise not in effect; or
          (C) which was classified under section 520(l) into 
        class III, which under such section is required to have 
        in effect an approved application under section 515, 
        and which has an application which has been suspended 
        or is otherwise not in effect.
  (2)(A) In the case of a device classified under section 
513(f) into class III and intended solely for investigational 
use, paragraph (1)(B) shall not apply with respect to such 
device during the period ending on the ninetieth day after the 
date of the promulgation of the regulations prescribing the 
procedures and conditions required by section 520(g)(2).
  (B) In the case of a device subject to an order issued under 
subsection (b) of section 515, paragraph (1) shall not apply 
with respect to such device during the period ending--
          (i) on the last day of the thirtieth calendar month 
        beginning after the month in which the classification 
        of the device in class III became effective under 
        section 513, or
          (ii) on the ninetieth day after the date of the 
        issuance of such order,
whichever occurs later.
  (3) In the case of a device with respect to which a 
regulation was promulgated under section 515(b) prior to the 
date of enactment of the Food and Drug Administration Safety 
and Innovation Act, a reference in this subsection to an order 
issued under section 515(b) shall be deemed to include such 
regulation.
  (g) If it is a banned device.
  (h) If it is a device and the methods used in, or the 
facilities or controls used for, its manufacture, packing, 
storage, or installation are not in conformity with applicable 
requirements under section 520(f)(1) or an applicable condition 
prescribed by an order under section 520(f)(2).
  (i) If it is a device for which an exemption has been granted 
under section 520(g) for investigational use and the person who 
was granted such exemption or any investigator who uses such 
device under such exemption fails to comply with a requirement 
prescribed by or under such section.
  (j) If it is a drug or device and it has been manufactured, 
processed, packed, or held in any factory, warehouse, or 
establishment and the owner, operator, or agent of such 
factory, warehouse, or establishment delays, denies, or limits 
an inspection, or refuses to permit entry or inspection.
For purposes of paragraph (a)(2)(B), the term ``current good 
manufacturing practice'' includes the implementation of 
oversight and controls over the manufacture of drugs to ensure 
quality, including managing the risk of and establishing the 
safety of raw materials, materials used in the manufacturing of 
drugs, and finished drug products.
  (k) If it is a device subject to the requirements set forth 
in section 524C (relating to ensuring device cybersecurity) and 
fails to comply with any requirement under that section.

                      misbranded drugs and devices

  Sec. 502. A drug or device shall be deemed to be misbranded--
  (a)(1) If its labeling is false or misleading in any 
particular. Health care economic information provided to a 
payor, formulary committee, or other similar entity with 
knowledge and expertise in the area of health care economic 
analysis, carrying out its responsibilities for the selection 
of [drugs for coverage] drugs or devices for coverage or 
reimbursement, shall not be considered to be false or 
misleading under this paragraph if the health care economic 
information relates to an indication approved [under section 
505 or under section 351(a) of the Public Health Service Act] 
under section 505, 510(k), 513(f)(2), or 515 of this Act or 
section 351 of the Public Health Service Act for such [drug] 
drug or device, is based on competent and reliable scientific 
evidence, and includes, where applicable, a conspicuous and 
prominent statement describing any material differences between 
the health care economic information and the labeling approved 
for the [drug] drug or device [under section 505 or under 
section 351 of the Public Health Service Act] under section 
505, 510(k), 513(f)(2), or 515 of this Act or section 351 of 
the Public Health Service Act. The requirements set forth [in 
section 505(a) or in subsections (a) and (k) of section 351 of 
the Public Health Service Act] in section 505, 510(k), 
513(f)(2), or 515 of this Act or section 351 of the Public 
Health Service Act shall not apply to health care economic 
information provided to such a payor, committee, or entity in 
accordance with this paragraph. Information that is relevant to 
the substantiation of the health care economic information 
presented pursuant to this paragraph shall be made available to 
the Secretary upon request.
  (2)(A) For purposes of this paragraph, the term ``health care 
economic information'' means any analysis (including the 
clinical data, inputs, clinical or other assumptions, methods, 
results, and other components underlying or comprising the 
analysis) that identifies, measures, or describes the economic 
consequences, which may be based on the separate or aggregated 
clinical consequences of the represented health outcomes, of 
the use of a [drug] drug or device. Such analysis may be 
comparative to the use of another [drug] drug or device, to 
another health care intervention, or to no intervention.
  (B) Such term does not include any analysis that relates only 
to an indication that is not approved [under section 505 or 
under section 351 of the Public Health Service Act] under 
section 505, 510(k), 513(f)(2), or 515 of this Act or section 
351 of the Public Health Service Act for such [drug] drug or 
device.
  (b) If in a package form unless it bears a label containing 
(1) the name and place of business of the manufacturer, packer, 
or distributor; and (2) an accurate statement of the quantity 
of the contents in terms of weight, measure, or numerical 
count: Provided, That under clause (2) of this paragraph 
reasonable variations shall be permitted, and exemptions as to 
small packages shall be established, by regulations prescribed 
by the Secretary.
  (c) If any word, statement, or other information required by 
or under authority of this Act to appear on the label or 
labeling is not prominently placed thereon with such 
conspicuousness (as compared with other words, statements, 
designs, or devices, in the labeling) and in such terms as to 
render it likely to be read and understood by the ordinary 
individual under customary conditions of purchase and use.
  (e)(1)(A) If it is a drug, unless its label bears, to the 
exclusion of any other nonproprietary name (except the 
applicable systematic chemical name or the chemical formula)--
          (i) the established name (as defined in subparagraph 
        (3)) of the drug, if there is such a name;
          (ii) the established name and quantity or, if 
        determined to be appropriate by the Secretary, the 
        proportion of each active ingredient, including the 
        quantity, kind, and proportion of any alcohol, and also 
        including whether active or not the established name 
        and quantity or if determined to be appropriate by the 
        Secretary, the proportion of any bromides, ether, 
        chloroform, acetanilide, acetophenetidin, amidopyrine, 
        antipyrine, atropine, hyoscine, hyoscyamine, arsenic, 
        digitalis, digitalis glucosides, mercury, ouabain, 
        strophanthin, strychnine, thyroid, or any derivative or 
        preparation of any such substances, contained therein, 
        except that the requirement for stating the quantity of 
        the active ingredients, other than the quantity of 
        those specifically named in this subclause, shall not 
        apply to nonprescription drugs not intended for human 
        use; and
          (iii) the established name of each inactive 
        ingredient listed in alphabetical order on the outside 
        container of the retail package and, if determined to 
        be appropriate by the Secretary, on the immediate 
        container, as prescribed in regulation promulgated by 
        the Secretary, except that nothing in this subclause 
        shall be deemed to require that any trade secret be 
        divulged, and except that the requirements of this 
        subclause with respect to alphabetical order shall 
        apply only to nonprescription drugs that are not also 
        cosmetics and that this subclause shall not apply to 
        nonprescription drugs not intended for human use.
  (B) For any prescription drug the established name of such 
drug or ingredient, as the case may be, on such label (and on 
any labeling on which a name for such drug or ingredient is 
used) shall be printed prominently and in type at least half as 
large as that used thereon for any proprietary name or 
designation for such drug or ingredient, except that to the 
extent that compliance with the requirements of subclause (ii) 
or (iii) of clause (A) or this clause is impracticable, 
exemptions shall be established by regulations promulgated by 
the Secretary.
  (2) If it is a device and it has an established name, unless 
its label bears, to the exclusion of any other nonproprietary 
name, its established name (as defined in subparagraph (4)) 
prominently printed in type at least half as large as that used 
thereon for any proprietary name or designation for such 
device, except that to the extent compliance with the 
requirements of this subparagraph is impracticable, exemptions 
shall be established by regulations promulgated by the 
Secretary.
  (3) As used in subparagraph (1), the term ``established 
name'', with respect to a drug or ingredient thereof, means (A) 
the applicable official name designated pursuant to section 
508, or (B) if there is no such name and such drug, or such 
ingredient, is an article recognized in an official compendium, 
then the official title thereof in such compendium, or (C) if 
neither clause (A) nor clause (B) of this subparagraph applies, 
then the common or usual name, if any, of such drug or of such 
ingredient, except that where clause (B) of this subparagraph 
applies to an article recognized in the United States 
Pharmacopeia and in the Homeopathic Pharmacopeia under 
different official titles, the official title used in the 
United States Pharmacopeia shall apply unless it is labeled and 
offered for sale as a homeopathic drug, in which case the 
official title used in the Homeopathic Pharmacopeia shall 
apply.
  (4) As used in subparagraph (2), the term ``established 
name'' with respect to a device means (A) the applicable 
official name of the device designated pursuant to section 508, 
(B) if there is no such name and such device is an article 
recognized in an official compendium, then the official title 
thereof in such compendium, or (C) if neither clause (A) nor 
clause (B) of this subparagraph applies, then any common or 
usual name of such device.
  (f) Unless its labeling bears (1) adequate directions for 
use; and (2) such adequate warnings against use in those 
pathological conditions or by children where its use may be 
dangerous to health, or against unsafe dosage or methods or 
duration of administration or application, in such manner and 
form, as are necessary for the protection of users, except that 
where any requirement of clause (1) of this paragraph, as 
applied to any drug or device, is not necessary for the 
protection of the public health, the Secretary shall promulgate 
regulations exempting such drug or device from such 
requirement. Required labeling for prescription devices 
intended for use in health care facilities or by a health care 
professional and required labeling for in vitro diagnostic 
devices intended for use by health care professionals or in 
blood establishments may be made available solely by electronic 
means, provided that the labeling complies with all applicable 
requirements of law, and that the manufacturer affords such 
users the opportunity to request the labeling in paper form, 
and after such request, promptly provides the requested 
information without additional cost.
  (g) If it purports to be a drug the name of which is 
recognized in an official compendium, unless it is packaged and 
labeled as prescribed therein. The method of packing may be 
modified with the consent of the Secretary. Whenever a drug is 
recognized in both the United States Pharmacopeia and the 
Homeopathic Pharmacopeia of the United States, it shall be 
subject to the requirements of the United States Pharmacopeia 
with respect to packaging, and labeling unless it is labeled 
and offered for sale as a homeopathic drug, in which case it 
shall be subject to the provisions of the Homeopathic 
Pharmacopeia of the United States, and not to those of the 
United States Pharmacopeia, except that in the event of 
inconsistency between the requirements of this paragraph and 
those of paragraph (e) as to the name by which the drug or its 
ingredients shall be designated, the requirements of paragraph 
(e) shall prevail.
  (h) If it has been found by the Secretary to be a drug liable 
to deterioration, unless it is packaged in such form and 
manner, and its label bears a statement of such precautions, as 
the Secretary shall by regulations require as necessary for the 
protection of the public health. No such regulation shall be 
established for any drug recognized in an official compendium 
until the Secretary shall have informed the appropriate body 
charged with the revision of such compendium of the need for 
such packaging or labeling requirements and such body shall 
have failed within a reasonable time to prescribe such 
requirements.
  (i)(1) If it is a drug and its container is so made, formed, 
or filled as to be misleading; or (2) if it is an imitation of 
another drug; or (3) if it is offered for sale under the name 
of another drug.
  (j) If it is dangerous to health when used in the dosage or 
manner; or with the frequency or duration prescribed, 
recommended, or suggested in the labeling thereof.
  (m) If it is a color additive the intended use of which is 
for the purpose of coloring only, unless its packaging and 
labeling are in conformity with such packaging and labeling 
requirements applicable to such color additive, as may be 
contained in regulations issued under section 721.
  (n) In the case of any prescription drug distributed or 
offered for sale in any State, unless the manufacturer, packer, 
or distributor thereof includes in all advertisements and other 
descriptive printed matter issued or caused to be issued by the 
manufacturer, packer, or distributor with respect to that drug 
a true statement of (1) the established name as defined in 
section 502(e), printed prominently and in type at least half 
as large as that used for any trade or brand name thereof, (2) 
the formula showing quantitatively each ingredient of such drug 
to the extent required for labels under section 502(e), and (3) 
such other information in brief summary relating to side 
effects, contraindications, and effectiveness as shall be 
required in regulations which shall be issued by the Secretary 
in accordance with section 701(a), and in the case of published 
direct-to-consumer advertisements the following statement 
printed in conspicuous text: ``You are encouraged to report 
negative side effects of prescription drugs to the FDA. Visit 
www.fda.gov/medwatch, or call 1-800-FDA-1088.'', except that 
(A) except in extraordinary circumstances, no regulation issued 
under this paragraph shall require prior approval by the 
Secretary of the content of any advertisement, and (B) no 
advertisement of a prescription drug, published after the 
effective date of regulations issued under this paragraph 
applicable to advertisements of prescription drugs, shall, with 
respect to the matters specified in this paragraph or covered 
by such regulations, be subject to the provisions of sections 
12 through 17 of the Federal Trade Commission Act, as amended 
(15 U.S.C. 52-57). This paragraph (n) shall not be applicable 
to any printed matter which the Secretary determines to be 
labeling as defined in section 201(m) of this Act. Nothing in 
the Convention on Psychotropic Substances, signed at Vienna, 
Austria, on February 21, 1971, shall be construed to prevent 
drug price communications to consumers. In the case of an 
advertisement for a drug subject to section 503(b)(1) presented 
directly to consumers in television or radio format and stating 
the name of the drug and its conditions of use, the major 
statement relating to side effects and contraindications shall 
be presented in a clear, conspicuous, and neutral manner.
  (o) If it was manufactured, prepared, propagated, compounded, 
or processed in an establishment not duly registered under 
section 510, if it is a drug and was imported or offered for 
import by a commercial importer of drugs not duly registered 
under section 801(s), if it was not included in a list required 
by section 510(j), if a notice or other information respecting 
it was not provided as required by such section or section 
510(k), or if it does not bear such symbols from the uniform 
system for identification of devices prescribed under section 
510(e) as the Secretary by regulation requires.
  (p) If it is a drug and its packaging or labeling is in 
violation of an applicable regulation issued pursuant to 
section 3 or 4 of the Poison Prevention Packaging Act of 1970.
  (q) In the case of any restricted device distributed or 
offered for sale in any State, if (1) its advertising is false 
or misleading in any particular, or (2) it is sold, 
distributed, or used in violation of regulations prescribed 
under section 520(e).
  (r) In the case of any restricted device distributed or 
offered for sale in any State, unless the manufacturer, packer, 
or distributor thereof includes in all advertisements and other 
descriptive printed matter issued or caused to be issued by the 
manufacturer, packer, or distributor with respect to that 
device (1) a true statement of the device's established name as 
defined in section 502(e), printed prominently and in type at 
least half as large as that used for any trade or brand name 
thereof, and (2) a brief statement of the intended uses of the 
device and relevant warnings, precautions, side effects, and 
contraindications and, in the case of specific devices made 
subject to a finding by the Secretary after notice and 
opportunity for comment that such action is necessary to 
protect the public health, a full description of the components 
of such device or the formula showing quantitatively each 
ingredient of such device to the extent required in regulations 
which shall be issued by the Secretary after an opportunity for 
a hearing. Except in extraordinary circumstances, no regulation 
issued under this paragraph shall require prior approval by the 
Secretary of the content of any advertisement and no 
advertisement of a restricted device, published after the 
effective date of this paragraph shall, with respect to the 
matters specified in this paragraph or covered by regulations 
issued hereunder, be subject to the provisions of sections 12 
through 15 of the Federal Trade Commission Act (15 U.S.C. 52-
55). This paragraph shall not be applicable to any printed 
matter which the Secretary determines to be labeling as defined 
in section 201(m).
  (s) If it is a device subject to a performance standard 
established under section 514, unless it bears such labeling as 
may be prescribed in such performance standard.
  (t) If it is a device and there was a failure or refusal (1) 
to comply with any requirement prescribed under section 518 
respecting the device, (2) to furnish any material or 
information required by or under section 519 respecting the 
device, [or (3)] (3) to comply with a requirement under section 
522, or (4) to furnish a software bill of materials as required 
under section 524C (relating to ensuring device cybersecurity).
  (u)(1) Subject to paragraph (2), if it is a reprocessed 
single-use device, unless it, or an attachment thereto, 
prominently and conspicuously bears the name of the 
manufacturer of the reprocessed device, a generally recognized 
abbreviation of such name, or a unique and generally recognized 
symbol identifying such manufacturer.
  (2) If the original device or an attachment thereto does not 
prominently and conspicuously bear the name of the manufacturer 
of the original device, a generally recognized abbreviation of 
such name, or a unique and generally recognized symbol 
identifying such manufacturer, a reprocessed device may satisfy 
the requirements of paragraph (1) through the use of a 
detachable label on the packaging that identifies the 
manufacturer and is intended to be affixed to the medical 
record of a patient.
  (v) If it is a reprocessed single-use device, unless all 
labeling of the device prominently and conspicuously bears the 
statement ``Reprocessed device for single use. Reprocessed by 
__.'' The name of the manufacturer of the reprocessed device 
shall be placed in the space identifying the person responsible 
for reprocessing.
  (w) If it is a new animal drug--
          (1) that is conditionally approved under section 571 
        and its labeling does not conform with the approved 
        application or section 571(f), or that is not 
        conditionally approved under section 571 and its label 
        bears the statement set forth in section 571(f)(1)(A);
          (2) that is indexed under section 572 and its 
        labeling does not conform with the index listing under 
        section 572(e) or 572(h), or that has not been indexed 
        under section 572 and its label bears the statement set 
        forth in section 572(h); or
          (3) for which an application has been approved under 
        section 512 and the labeling of such drug does not 
        include the application number in the format: 
        ``Approved by FDA under (A)NADA # xxx-xxx'', except 
        that this subparagraph shall not apply to 
        representative labeling required under section 
        514.1(b)(3)(v)(b) of title 21, Code of Federal 
        Regulations (or any successor regulation) for animal 
        feed bearing or containing a new animal drug.
  (x) If it is a nonprescription drug (as defined in section 
760) that is marketed in the United States, unless the label of 
such drug includes a domestic address or domestic phone number 
through which the responsible person (as described in section 
760) may receive a report of a serious adverse event (as 
defined in section 760) with such drug.
  (y) If it is a drug subject to an approved risk evaluation 
and mitigation strategy pursuant to section 505(p) and the 
responsible person (as such term is used in section 505-1) 
fails to comply with a requirement of such strategy provided 
for under subsection (d), (e), or (f) of section 505-1.
  (z) If it is a drug, and the responsible person (as such term 
is used in section 505(o)) is in violation of a requirement 
established under paragraph (3) (relating to postmarket studies 
and clinical trials) or paragraph (4) (relating to labeling) of 
section 505(o) with respect to such drug.
  (aa) If it is a drug, or an active pharmaceutical ingredient, 
and it was manufactured, prepared, propagated, compounded, or 
processed in a facility for which fees have not been paid as 
required by section 744B(a)(4) or for which identifying 
information required by section 744B(f) has not been submitted, 
or it contains an active pharmaceutical ingredient that was 
manufactured, prepared, propagated, compounded, or processed in 
such a facility.
  (bb) If the advertising or promotion of a compounded drug is 
false or misleading in any particular.
  (cc) If it is a drug and it fails to bear the product 
identifier as required by section 582.
  (dd) If it is an antimicrobial drug, as defined in section 
511A(f), and its labeling fails to conform with the 
requirements under section 511A(d).
  (ee) If it is a nonprescription drug that is subject to 
section 505G, is not the subject of an application approved 
under section 505, and does not comply with the requirements 
under section 505G.
  (ff) If it is a drug and it was manufactured, prepared, 
propagated, compounded, or processed in a facility for which 
fees have not been paid as required by section 744M.
  (gg)(1) Unless its labeling bears adequate directions for use 
in accordance with paragraph (f), except that (in addition to 
drugs or devices that conform with exemptions pursuant to such 
paragraph) no drug or device shall be deemed to be misbranded 
under such paragraph through the provision of product 
information to a payor, formulary committee, or other similar 
entity with knowledge and expertise in the area of health care 
economic analysis carrying out its responsibilities for the 
selection of drugs or devices for coverage or reimbursement if 
the product information relates to an investigational drug or 
device or investigational use of a drug or device that is 
approved, cleared, granted marketing authorization, or licensed 
under section 505, 510(k), 513(f)(2), or 515 of this Act or 
section 351 of the Public Health Service Act (as applicable), 
provided--
          (A) the product information includes--
                  (i) a clear statement that the 
                investigational drug or device or 
                investigational use of a drug or device has not 
                been approved, cleared, granted marketing 
                authorization, or licensed under section 505, 
                510(k), 513(f)(2), or 515 of this Act or 
                section 351 of the Public Health Service Act 
                (as applicable) and that the safety and 
                effectiveness of the drug or device or use has 
                not been established;
                  (ii) information related to the stage of 
                development of the drug or device involved, 
                such as--
                          (I) the status of any study or 
                        studies in which the investigational 
                        drug or device or investigational use 
                        is being investigated;
                          (II) how the study or studies relate 
                        to the overall plan for the development 
                        of the drug or device; and
                          (III) whether an application, 
                        premarket notification, or request for 
                        classification for the investigational 
                        drug or device or investigational use 
                        has been submitted to the Secretary and 
                        when such a submission is planned;
                  (iii) in the case of information that 
                includes factual presentations of results from 
                studies, which shall not be selectively 
                presented, a description of--
                          (I) all material aspects of study 
                        design, methodology, and results; and
                          (II) all material limitations related 
                        to the study design, methodology, and 
                        results;
                  (iv) where applicable, a prominent statement 
                disclosing the indication or indications for 
                which the Secretary has approved, granted 
                marketing authorization, cleared, or licensed 
                the product pursuant to section 505, 510(k), 
                513(f)(2), or 515 of this Act or section 351 of 
                the Public Health Service Act, and a copy of 
                the most current required labeling; and
                  (v) updated information, if previously 
                communicated information becomes materially 
                outdated as a result of significant changes or 
                as a result of new information regarding the 
                product or its review status; and
          (B) the product information does not include--
                  (i) information that represents that an 
                unapproved product--
                          (I) has been approved, cleared, 
                        granted marketing authorization, or 
                        licensed under section 505, 510(k), 
                        513(f)(2), or 515 of this Act or 
                        section 351 of the Public Health 
                        Service Act (as applicable); or
                          (II) has otherwise been determined to 
                        be safe or effective for the purpose or 
                        purposes for which the drug or device 
                        is being studied; or
                  (ii) information that represents that an 
                unapproved use of a drug or device that has 
                been so approved, granted marketing 
                authorization, cleared, or licensed--
                          (I) is so approved, granted marketing 
                        authorization, cleared, or licensed; or
                          (II) that the product is safe or 
                        effective for the use or uses for which 
                        the drug or device is being studied.
  (2) For purposes of this paragraph, the term ``product 
information'' includes--
          (A) information describing the drug or device (such 
        as drug class, device description, and features);
          (B) information about the indication or indications 
        being investigated;
          (C) the anticipated timeline for a possible approval, 
        clearance, marketing authorization, or licensure 
        pursuant to section 505, 510(k), 513, or 515 of this 
        Act or section 351 of the Public Health Service Act;
          (D) drug or device pricing information;
          (E) patient utilization projections;
          (F) product-related programs or services; and
          (G) factual presentations of results from studies 
        that do not characterize or make conclusions regarding 
        safety or efficacy.

exemptions and consideration for certain drugs, devices, and biological 
                                products

  Sec. 503. (a) The Secretary is hereby directed to promulgate 
regulations exempting from any labeling or packaging 
requirement of this Act drugs and devices which are, in 
accordance with the practice of the trade, to be processed, 
labeled, or repacked in substantial quantities at 
establishments other than those where originally processed or 
packed, on condition that such drugs and devices are not 
adulterated or misbranded, under the provisions of this Act 
upon removal from such processing, labeling, or repacking 
establishment.
  (b)(1) A drug intended for use by man which--
          (A) because of its toxicity or other potentiality for 
        harmful effect, or the method of its use, or the 
        collateral measures necessary to its use, is not safe 
        for use except under the supervision of a practitioner 
        licensed by law to administer such drug; or
          (B) is limited by an approved application under 
        section 505 to use under the professional supervision 
        of a practitioner licensed by law to administer such 
        drug;
shall be dispensed only (i) upon a written prescription of a 
practitioner licensed by law to administer such drug, or (ii) 
upon an oral prescription of such practitioner which is reduced 
promptly to writing and filed by the pharmacist, or (iii) by 
refilling any such written or oral prescription if such 
refilling is authorized by the prescriber either in the 
original prescription or by oral order which is reduced 
promptly to writing and filed by the pharmacist. The act of 
dispensing a drug contrary to the provisions of this paragraph 
shall be deemed to be an act which results in the drug being 
misbranded while held for sale.
  (2) Any drug dispensed by filling or refilling a written or 
oral prescription of a practitioner licensed by law to 
administer such drug shall be exempt from the requirements of 
section 502, except paragraphs (a), (i) (2) and (3), (k), and 
(l), and the packaging requirements of paragraphs (g), (h), and 
(p), if the drug bears a label containing the name and address 
of the dispenser, the serial number and date of the 
prescription or of its filling, the name of the prescriber, 
and, if stated in the prescription, the name of the patient, 
and the directions for use and cautionary statements, if any, 
contained in such prescription. This exemption shall not apply 
to any drug dispensed in the course of the conduct of a 
business of dispensing drugs pursuant to diagnosis by mail, or 
to a drug dispensed in violation of paragraph (1) of this 
subsection.
  (3) The Secretary may by regulation remove drugs subject to 
section 505 from the requirements of paragraph (1) of this 
subsection when such requirements are not necessary for the 
protection of the public health.
  (4)(A) A drug that is subject to paragraph (1) shall be 
deemed to be misbranded if at any time prior to dispensing the 
label of the drug fails to bear, at a minimum, the symbol ``Rx 
only''.
  (B) A drug to which paragraph (1) does not apply shall be 
deemed to be misbranded if at any time prior to dispensing the 
label of the drug bears the symbol described in subparagraph 
(A).
  (5) Nothing in this subsection shall be construed to relieve 
any person from any requirement prescribed by or under 
authority of law with respect to drugs now included or which 
may hereafter be included within the classifications stated in 
section 3220 of the Internal Revenue Code (26 U.S.C. 3220), or 
to marihuana as defined in section 3238(b) of the Internal 
Revenue Code (26 U.S.C. 3238(b)).
  (c)(1) No person may sell, purchase, or trade or offer to 
sell, purchase, or trade any drug sample. For purposes of this 
paragraph and subsection (d), the term ``drug sample'' means a 
unit of a drug, subject to subsection (b), which is not 
intended to be sold and is intended to promote the sale of the 
drug. Nothing in this paragraph shall subject an officer or 
executive of a drug manufacturer or distributor to criminal 
liability solely because of a sale, purchase, trade, or offer 
to sell, purchase, or trade in violation of this paragraph by 
other employees of the manufacturer or distributor.
  (2) No person may sell, purchase, or trade, offer to sell, 
purchase, or trade, or counterfeit any coupon. For purposes of 
this paragraph, the term ``coupon'' means a form which may be 
redeemed, at no cost or at a reduced cost, for a drug which is 
prescribed in accordance with subsection (b).
  (3)(A) No person may sell, purchase, or trade, or offer to 
sell, purchase, or trade, any drug--
          (i) which is subject to subsection (b), and
          (ii)(I) which was purchased by a public or private 
        hospital or other health care entity, or
          (II) which was donated or supplied at a reduced price 
        to a charitable organization described in section 
        501(c)(3) of the Internal Revenue Code of 1954.
  (B) Subparagraph (A) does not apply to--
          (i) the purchase or other acquisition by a hospital 
        or other health care entity which is a member of a 
        group purchasing organization of a drug for its own use 
        from the group purchasing organization or from other 
        hospitals or health care entities which are members of 
        such organization,
          (ii) the sale, purchase, or trade of a drug or an 
        offer to sell, purchase, or trade a drug by an 
        organization described in subparagraph (A)(ii)(II) to a 
        nonprofit affiliate of the organization to the extent 
        otherwise permitted by law,
          (iii) a sale, purchase, or trade of a drug or an 
        offer to sell, purchase, or trade a drug among 
        hospitals or other health care entities which are under 
        common control,
          (iv) a sale, purchase, or trade of a drug or an offer 
        to sell, purchase, or trade a drug for emergency 
        medical reasons, or
          (v) a sale, purchase, or trade of a drug, an offer to 
        sell, purchase, or trade a drug, or the dispensing of a 
        drug pursuant to a prescription executed in accordance 
        with subsection (b).
For purposes of this paragraph, the term ``entity'' does not 
include a wholesale distributor of drugs or a retail pharmacy 
licensed under State law and the term ``emergency medical 
reasons'' includes transfers of a drug between health care 
entities or from a health care entity to a retail pharmacy 
undertaken to alleviate temporary shortages of the drug arising 
from delays in or interruptions of regular distribution 
schedules.
  (d)(1) Except as provided in paragraphs (2) and (3), no 
person may distribute any drug sample. For purposes of this 
subsection, the term ``distribute'' does not include the 
providing of a drug sample to a patient by a--
          (A) practitioner licensed to prescribe such drug,
          (B) health care professional acting at the direction 
        and under the supervision of such a practitioner, or
          (C) pharmacy of a hospital or of another health care 
        entity that is acting at the direction of such a 
        practitioner and that received such sample pursuant to 
        paragraph (2) or (3).
  (2)(A) The manufacturer or authorized distributor of record 
of a drug subject to subsection (b) may, in accordance with 
this paragraph, distribute drug samples by mail or common 
carrier to practitioners licensed to prescribe such drugs or, 
at the request of a licensed practitioner, to pharmacies of 
hospitals or other health care entities. Such a distribution of 
drug samples may only be made--
          (i) in response to a written request for drug samples 
        made on a form which meets the requirements of 
        subparagraph (B), and
          (ii) under a system which requires the recipient of 
        the drug sample to execute a written receipt for the 
        drug sample upon its delivery and the return of the 
        receipt to the manufacturer or authorized distributor 
        of record.
  (B) A written request for a drug sample required by 
subparagraph (A)(i) shall contain--
          (i) the name, address, professional designation, and 
        signature of the practitioner making the request,
          (ii) the identity of the drug sample requested and 
        the quantity requested,
          (iii) the name of the manufacturer of the drug sample 
        requested, and
          (iv) the date of the request.
  (C) Each drug manufacturer or authorized distributor of 
record which makes distributions by mail or common carrier 
under this paragraph shall maintain, for a period of 3 years, 
the request forms submitted for such distributions and the 
receipts submitted for such distributions and shall maintain a 
record of distributions of drug samples which identifies the 
drugs distributed and the recipients of the distributions. 
Forms, receipts, and records required to be maintained under 
this subparagraph shall be made available by the drug 
manufacturer or authorized distributor of record to Federal and 
State officials engaged in the regulation of drugs and in the 
enforcement of laws applicable to drugs.
  (3) The manufacturer or authorized distributor of record of a 
drug subject to subsection (b) may, by means other than mail or 
common carrier, distribute drug samples only if the 
manufacturer or authorized distributor of record makes the 
distributions in accordance with subparagraph (A) and carries 
out the activities described in subparagraphs (B) through (F) 
as follows:
          (A) Drug samples may only be distributed--
                  (i) to practitioners licensed to prescribe 
                such drugs if they make a written request for 
                the drug samples, or
                  (ii) at the written request of such a 
                licensed practitioner, to pharmacies of 
                hospitals or other health care entities.
        A written request for drug samples shall be made on a 
        form which contains the practitioner's name, address, 
        and professional designation, the identity of the drug 
        sample requested, the quantity of drug samples 
        requested, the name of the manufacturer or authorized 
        distributor of record of the drug sample, the date of 
        the request and signature of the practitioner making 
        the request.
          (B) Drug manufacturers or authorized distributors of 
        record shall store drug samples under conditions that 
        will maintain their stability, integrity, and 
        effectiveness and will assure that the drug samples 
        will be free of contamination, deterioration, and 
        adulteration.
          (C) Drug manufacturers or authorized distributors of 
        record shall conduct, at least annually, a complete and 
        accurate inventory of all drug samples in the 
        possession of representatives of the manufacturer or 
        authorized distributor of record. Drug manufacturers or 
        authorized distributors of record shall maintain lists 
        of the names and address of each of their 
        representatives who distribute drug samples and of the 
        sites where drug samples are stored. Drug manufacturers 
        or authorized distributors of record shall maintain 
        records for at least 3 years of all drug samples 
        distributed, destroyed, or returned to the manufacturer 
        or authorized distributor of record, of all inventories 
        maintained under this subparagraph, of all thefts or 
        significant losses of drug samples, and of all requests 
        made under subparagraph (A) for drug samples. Records 
        and lists maintained under this subparagraph shall be 
        made available by the drug manufacturer or authorized 
        distributor of record to the Secretary upon request.
          (D) Drug manufacturers or authorized distributors of 
        record shall notify the Secretary of any significant 
        loss of drug samples and any known theft of drug 
        samples.
          (E) Drug manufacturers or authorized distributors of 
        record shall report to the Secretary any conviction of 
        their representatives for violations of subsection 
        (c)(1) or a State law because of the sale, purchase, or 
        trade of a drug sample or the offer to sell, purchase, 
        or trade a drug sample.
          (F) Drug manufacturers or authorized distributors of 
        record shall provide to the Secretary the name and 
        telephone number of the individual responsible for 
        responding to a request for information respecting drug 
        samples.
          (4) In this subsection, the term ``authorized 
        distributors of record'' means those distributors with 
        whom a manufacturer has established an ongoing 
        relationship to distribute such manufacturer's 
        products.
  (e)
          (1) Requirement.--Subject to section 583:
                  (A) In general.--No person may engage in 
                wholesale distribution of a drug subject to 
                subsection (b)(1) in any State unless such 
                person--
                          (i)(I) is licensed by the State from 
                        which the drug is distributed; or
                          (II) if the State from which the drug 
                        is distributed has not established a 
                        licensure requirement, is licensed by 
                        the Secretary; and
                          (ii) if the drug is distributed 
                        interstate, is licensed by the State 
                        into which the drug is distributed if 
                        the State into which the drug is 
                        distributed requires the licensure of a 
                        person that distributes drugs into the 
                        State.
                  (B) Standards.--Each Federal and State 
                license described in subparagraph (A) shall 
                meet the standards, terms, and conditions 
                established by the Secretary under section 583.
          (2) Reporting and database.--
                  (A) Reporting.--Beginning January 1, 2015, 
                any person who owns or operates an 
                establishment that engages in wholesale 
                distribution shall--
                          (i) report to the Secretary, on an 
                        annual basis pursuant to a schedule 
                        determined by the Secretary--
                                  (I) each State by which the 
                                person is licensed and the 
                                appropriate identification 
                                number of each such license; 
                                and
                                  (II) the name, address, and 
                                contact information of each 
                                facility at which, and all 
                                trade names under which, the 
                                person conducts business; and
                          (ii) report to the Secretary within a 
                        reasonable period of time and in a 
                        reasonable manner, as determined by the 
                        Secretary, any significant disciplinary 
                        actions, such as the revocation or 
                        suspension of a wholesale distributor 
                        license, taken by a State or the 
                        Federal Government during the reporting 
                        period against the wholesale 
                        distributor.
                  (B) Database.--Not later than January 1, 
                2015, the Secretary shall establish a database 
                of authorized wholesale distributors. Such 
                database shall--
                          (i) identify each authorized 
                        wholesale distributor by name, contact 
                        information, and each State where such 
                        wholesale distributor is appropriately 
                        licensed to engage in wholesale 
                        distribution;
                          (ii) be available to the public on 
                        the Internet Web site of the Food and 
                        Drug Administration; and
                          (iii) be regularly updated on a 
                        schedule determined by the Secretary.
                  (C) Coordination.--The Secretary shall 
                establish a format and procedure for 
                appropriate State officials to access the 
                information provided pursuant to subparagraph 
                (A) in a prompt and secure manner.
                  (D) Confidentiality.--Nothing in this 
                paragraph shall be construed as authorizing the 
                Secretary to disclose any information that is a 
                trade secret or confidential information 
                subject to section 552(b)(4) of title 5, United 
                States Code, or section 1905 of title 18, 
                United States Code.
          (3) Costs.--
                  (A) Authorized fees of secretary.--If a State 
                does not establish a licensing program for 
                persons engaged in the wholesale distribution 
                of a drug subject to subsection (b), the 
                Secretary shall license a person engaged in 
                wholesale distribution located in such State 
                and may collect a reasonable fee in such amount 
                necessary to reimburse the Secretary for costs 
                associated with establishing and administering 
                the licensure program and conducting periodic 
                inspections under this section. The Secretary 
                shall adjust fee rates as needed on an annual 
                basis to generate only the amount of revenue 
                needed to perform this service. Fees authorized 
                under this paragraph shall be collected and 
                available for obligation only to the extent and 
                in the amount provided in advance in 
                appropriations Acts. Such fees are authorized 
                to remain available until expended. Such sums 
                as may be necessary may be transferred from the 
                Food and Drug Administration salaries and 
                expenses appropriation account without fiscal 
                year limitation to such appropriation account 
                for salaries and expenses with such fiscal year 
                limitation.
                  (B) State licensing fees.--Nothing in this 
                Act shall prohibit States from collecting fees 
                from wholesale distributors in connection with 
                State licensing of such distributors.
          (4) For the purposes of this subsection and 
        subsection (d), the term ``wholesale distribution'' 
        means the distribution of a drug subject to subsection 
        (b) to a person other than a consumer or patient, or 
        receipt of a drug subject to subsection (b) by a person 
        other than the consumer or patient, but does not 
        include--
                  (A) intracompany distribution of any drug 
                between members of an affiliate or within a 
                manufacturer;
                  (B) the distribution of a drug, or an offer 
                to distribute a drug among hospitals or other 
                health care entities which are under common 
                control;
                  (C) the distribution of a drug or an offer to 
                distribute a drug for emergency medical 
                reasons, including a public health emergency 
                declaration pursuant to section 319 of the 
                Public Health Service Act, except that, for 
                purposes of this paragraph, a drug shortage not 
                caused by a public health emergency shall not 
                constitute an emergency medical reason;
                  (D) the dispensing of a drug pursuant to a 
                prescription executed in accordance with 
                subsection (b)(1);
                  (E) the distribution of minimal quantities of 
                drug by a licensed retail pharmacy to a 
                licensed practitioner for office use;
                  (F) the distribution of a drug or an offer to 
                distribute a drug by a charitable organization 
                to a nonprofit affiliate of the organization to 
                the extent otherwise permitted by law;
                  (G) the purchase or other acquisition by a 
                dispenser, hospital, or other health care 
                entity of a drug for use by such dispenser, 
                hospital, or other health care entity;
                  (H) the distribution of a drug by the 
                manufacturer of such drug;
                  (I) the receipt or transfer of a drug by an 
                authorized third-party logistics provider 
                provided that such third-party logistics 
                provider does not take ownership of the drug;
                  (J) a common carrier that transports a drug, 
                provided that the common carrier does not take 
                ownership of the drug;
                  (K) the distribution of a drug, or an offer 
                to distribute a drug by an authorized 
                repackager that has taken ownership or 
                possession of the drug and repacks it in 
                accordance with section 582(e);
                  (L) salable drug returns when conducted by a 
                dispenser;
                  (M) the distribution of a collection of 
                finished medical devices, which may include a 
                product or biological product, assembled in kit 
                form strictly for the convenience of the 
                purchaser or user (referred to in this 
                subparagraph as a ``medical convenience kit'') 
                if--
                          (i) the medical convenience kit is 
                        assembled in an establishment that is 
                        registered with the Food and Drug 
                        Administration as a device manufacturer 
                        in accordance with section 510(b)(2);
                          (ii) the medical convenience kit does 
                        not contain a controlled substance that 
                        appears in a schedule contained in the 
                        Comprehensive Drug Abuse Prevention and 
                        Control Act of 1970;
                          (iii) in the case of a medical 
                        convenience kit that includes a 
                        product, the person that manufacturers 
                        the kit--
                                  (I) purchased such product 
                                directly from the 
                                pharmaceutical manufacturer or 
                                from a wholesale distributor 
                                that purchased the product 
                                directly from the 
                                pharmaceutical manufacturer; 
                                and
                                  (II) does not alter the 
                                primary container or label of 
                                the product as purchased from 
                                the manufacturer or wholesale 
                                distributor; and
                          (iv) in the case of a medical 
                        convenience kit that includes a 
                        product, the product is--
                                  (I) an intravenous solution 
                                intended for the replenishment 
                                of fluids and electrolytes;
                                  (II) a product intended to 
                                maintain the equilibrium of 
                                water and minerals in the body;
                                  (III) a product intended for 
                                irrigation or reconstitution;
                                  (IV) an anesthetic;
                                  (V) an anticoagulant;
                                  (VI) a vasopressor; or
                                  (VII) a sympathomimetic;
                  (N) the distribution of an intravenous drug 
                that, by its formulation, is intended for the 
                replenishment of fluids and electrolytes (such 
                as sodium, chloride, and potassium) or calories 
                (such as dextrose and amino acids);
                  (O) the distribution of an intravenous drug 
                used to maintain the equilibrium of water and 
                minerals in the body, such as dialysis 
                solutions;
                  (P) the distribution of a drug that is 
                intended for irrigation, or sterile water, 
                whether intended for such purposes or for 
                injection;
                  (Q) the distribution of medical gas, as 
                defined in section 575;
                  (R) facilitating the distribution of a 
                product by providing solely administrative 
                services, including processing of orders and 
                payments; or
                  (S) the transfer of a product by a hospital 
                or other health care entity, or by a wholesale 
                distributor or manufacturer operating at the 
                direction of the hospital or other health care 
                entity, to a repackager described in section 
                581(16)(B) and registered under section 510 for 
                the purpose of repackaging the drug for use by 
                that hospital, or other health care entity and 
                other health care entities that are under 
                common control, if ownership of the drug 
                remains with the hospital or other health care 
                entity at all times.
          (5) Third-party logistics providers.--Notwithstanding 
        paragraphs (1) through (4), each entity that meets the 
        definition of a third-party logistics provider under 
        section 581(22) shall obtain a license as a third-party 
        logistics provider as described in section 584(a) and 
        is not required to obtain a license as a wholesale 
        distributor if the entity never assumes an ownership 
        interest in the product it handles.
          (6) Affiliate.--For purposes of this subsection, the 
        term ``affiliate'' means a business entity that has a 
        relationship with a second business entity if, directly 
        or indirectly--
                  (A) one business entity controls, or has the 
                power to control, the other business entity; or
                  (B) a third party controls, or has the power 
                to control, both of the business entities.
  (f)(1)(A) A drug intended for use by animals other than man, 
other than a veterinary feed directive drug intended for use in 
animal feed or an animal feed bearing or containing a 
veterinary feed directive drug, which--
          (i) because of its toxicity or other potentiality for 
        harmful effect, or the method of its use, or the 
        collateral measures necessary for its use, is not safe 
        for animal use except under the professional 
        supervision of a licensed veterinarian, or
          (ii) is limited by an approved application under 
        subsection (b) of section 512, a conditionally-approved 
        application under section 571, or an index listing 
        under section 572 to use under the professional 
        supervision of a licensed veterinarian,
shall be dispensed only by or upon the lawful written or oral 
order of a licensed veterinarian in the course of the 
veterinarian's professional practice.
  (B) For purposes of subparagraph (A), an order is lawful if 
the order--
          (i) is a prescription or other order authorized by 
        law,
          (ii) is, if an oral order, promptly reduced to 
        writing by the person lawfully filling the order, and 
        filed by that person, and
          (iii) is refilled only if authorized in the original 
        order or in a subsequent oral order promptly reduced to 
        writing by the person lawfully filling the order, and 
        filed by that person.
  (C) The act of dispensing a drug contrary to the provisions 
of this paragraph shall be deemed to be an act which results in 
the drug being misbranded while held for sale.
  (2) Any drug when dispensed in accordance with paragraph (1) 
of this subsection--
          (A) Shall be exempt from the requirements of section 
        502, except subsections (a), (g), (h), (i)(2), (i)(3), 
        and (p) of such section, and
          (B) shall be exempt from the packaging requirements 
        of subsections (g), (h), and (p) of such section, if--
                  (i) when dispensed by a licensed 
                veterinarian, the drug bears a label containing 
                the name and address of the practitioner and 
                any directions for use and cautionary 
                statements specified by the practitioner, or
                  (ii) when dispensed by filling the lawful 
                order of a licensed veterinarian, the drug 
                bears a label containing the name and address 
                of the dispenser, the serial number and date of 
                the order or of its filing, the name of the 
                licensed veterinarian, and the directions for 
                use and cautionary statements, if any, 
                contained in such order.
The preceding sentence shall not apply to any drug dispensed in 
the course of the conduct of a business of dispensing drugs 
pursuant to diagnosis by mail.
  (3) The Secretary may by regulation exempt drugs for animals 
other than man subject to section 512, 571, or 572 from the 
requirements of paragraph (1) when such requirements are not 
necessary for the protection of the public health.
  (4) A drug which is subject to paragraph (1) shall be deemed 
to be misbranded if at any time prior to dispensing its label 
fails to bear the statement ``Caution: Federal law restricts 
this drug to use by or on the order of a licensed 
veterinarian.''. A drug to which paragraph (1) does not apply 
shall be deemed to be misbranded if at any time prior to 
dispensing its label bears the statement specified in the 
preceding sentence.
  (g)(1)(A) The Secretary shall, in accordance with this 
subsection, assign a primary agency center to regulate products 
that constitute a combination of a drug, device, or biological 
product.
  (B) The Secretary shall conduct the premarket review of any 
combination product under a single application, whenever 
appropriate.
  (C) For purposes of this subsection, the term ``primary mode 
of action'' means the single mode of action of a combination 
product expected to make the greatest contribution to the 
overall intended therapeutic effects of the combination 
product.
  (D) The Secretary shall determine the primary mode of action 
of the combination product. If the Secretary determines that 
the primary mode of action is that of--
          (i) a drug (other than a biological product), the 
        agency center charged with premarket review of drugs 
        shall have primary jurisdiction;
          (ii) a device, the agency center charged with 
        premarket review of devices shall have primary 
        jurisdiction; or
          (iii) a biological product, the agency center charged 
        with premarket review of biological products shall have 
        primary jurisdiction.
  (E) In determining the primary mode of action of a 
combination product, the Secretary shall not determine that the 
primary mode of action is that of a drug or biological product 
solely because the combination product has any chemical action 
within or on the human body.
  (F) If a sponsor of a combination product disagrees with the 
determination under subparagraph (D)--
          (i) such sponsor may request, and the Secretary shall 
        provide, a substantive rationale to such sponsor that 
        references scientific evidence provided by the sponsor 
        and any other scientific evidence relied upon by the 
        Secretary to support such determination; and
          (ii)(I) the sponsor of the combination product may 
        propose one or more studies (which may be nonclinical, 
        clinical, or both) to establish the relevance, if any, 
        of the chemical action in achieving the primary mode of 
        action of such product;
          (II) if the sponsor proposes any such studies, the 
        Secretary and the sponsor of such product shall 
        collaborate and seek to reach agreement, within a 
        reasonable time of such proposal, not to exceed 90 
        calendar days, on the design of such studies; and
          (III) if an agreement is reached under subclause (II) 
        and the sponsor conducts one or more of such studies, 
        the Secretary shall consider the data resulting from 
        any such study when reevaluating the determination of 
        the primary mode of action of such product, and unless 
        and until such reevaluation has occurred and the 
        Secretary issues a new determination, the determination 
        of the Secretary under subparagraph (D) shall remain in 
        effect.
  (2)(A)(i) To establish clarity and certainty for the sponsor, 
the sponsor of a combination product may request a meeting on 
such combination product. If the Secretary concludes that a 
determination of the primary mode of action pursuant to 
paragraph (1)(D) is necessary, the sponsor may request such 
meeting only after the Secretary makes such determination. If 
the sponsor submits a written meeting request, the Secretary 
shall, not later than 75 calendar days after receiving such 
request, meet with the sponsor of such combination product.
  (ii) A meeting under clause (i) may--
          (I) address the standards and requirements for market 
        approval or clearance of the combination product;
          (II) address other issues relevant to such 
        combination product, such as requirements related to 
        postmarket modification of such combination product and 
        good manufacturing practices applicable to such 
        combination product; and
          (III) identify elements under subclauses (I) and (II) 
        that may be more appropriate for discussion and 
        agreement with the Secretary at a later date given that 
        scientific or other information is not available, or 
        agreement is otherwise not feasible regarding such 
        elements, at the time a request for such meeting is 
        made.
  (iii) Any agreement under this subparagraph shall be in 
writing and made part of the administrative record by the 
Secretary.
  (iv) Any such agreement shall remain in effect, except--
          (I) upon the written agreement of the Secretary and 
        the sponsor or applicant; or
          (II) pursuant to a decision by the director of the 
        reviewing division of the primary agency center, or a 
        person more senior than such director, in consultation 
        with consulting centers and the Office, as appropriate, 
        that an issue essential to determining whether the 
        standard for market clearance or other applicable 
        standard under this Act or the Public Health Service 
        Act applicable to the combination product has been 
        identified since the agreement was reached, or that 
        deviating from the agreement is otherwise justifiable 
        based on scientific evidence, for public health 
        reasons.
  (3) For purposes of conducting the premarket review of a 
combination product that contains an approved constituent part 
described in paragraph (4), the Secretary may require that the 
sponsor of such combination product submit to the Secretary 
only data or information that the Secretary determines is 
necessary to meet the standard for clearance or approval, as 
applicable, under this Act or the Public Health Service Act, 
including any incremental risks and benefits posed by such 
combination product, using a risk-based approach and taking 
into account any prior finding of safety and effectiveness or 
substantial equivalence for the approved constituent part 
relied upon by the applicant in accordance with paragraph (5).
  (4) For purposes of paragraph (3), an approved constituent 
part is--
          (A) a drug constituent part of a combination product 
        being reviewed in a single application or request under 
        section 515, 510(k), or 513(f)(2) (submitted in 
        accordance with paragraph (5)), that is an approved 
        drug, provided such application or request complies 
        with paragraph (5);
          (B) a device constituent part approved under section 
        515 that is referenced by the sponsor and that is 
        available for use by the Secretary under section 
        520(h)(4); or
          (C) any constituent part that was previously 
        approved, cleared, or classified under section 505, 
        510(k), 513(f)(2), or 515 of this Act for which the 
        sponsor has a right of reference or any constituent 
        part that is a nonprescription drug, as defined in 
        section 760(a)(2).
  (5)(A) If an application is submitted under section 515 or 
510(k) or a request is submitted under section 513(f)(2), 
consistent with any determination made under paragraph (1)(D), 
for a combination product containing as a constituent part an 
approved drug--
          (i) the application or request shall include the 
        certification or statement described in section 
        505(b)(2); and
          (ii) the applicant or requester shall provide notice 
        as described in section 505(b)(3).
  (B) For purposes of this paragraph and paragraph (4), the 
term ``approved drug'' means an active ingredient--
          (i) that was in an application previously approved 
        under section 505(c);
          (ii) where such application is relied upon by the 
        applicant submitting the application or request 
        described in subparagraph (A);
          (iii) for which full reports of investigations that 
        have been made to show whether such drug is safe for 
        use and whether such drug is effective in use were not 
        conducted by or for the applicant submitting the 
        application or request described in subparagraph (A); 
        and
          (iv) for which the applicant submitting the 
        application or request described in subparagraph (A) 
        has not obtained a right of reference or use from the 
        person by or for whom the investigations described in 
        clause (iii) were conducted.
  (C) The following provisions shall apply with respect to an 
application or request described in subparagraph (A) to the 
same extent and in the same manner as if such application or 
request were an application described in section 505(b)(2) that 
referenced the approved drug:
          (i) Subparagraphs (A), (B), (C), and (D) of section 
        505(c)(3).
          (ii) Clauses (ii), (iii), and (iv) of section 
        505(c)(3)(E).
          (iii) Subsections (b) and (c) of section 505A.
          (iv) Section 505E(a).
          (v) Section 527(a).
  (D) Notwithstanding any other provision of this subsection, 
an application or request for classification for a combination 
product described in subparagraph (A) shall be considered an 
application submitted under section 505(b)(2) for purposes of 
section 271(e)(2)(A) of title 35, United States Code.
  (6) Nothing in this subsection shall be construed as 
prohibiting a sponsor from submitting separate applications for 
the constituent parts of a combination product, unless the 
Secretary determines that a single application is necessary.
  (7) Nothing in this subsection shall prevent the Secretary 
from using any agency resources of the Food and Drug 
Administration necessary to ensure adequate review of the 
safety, effectiveness, or substantial equivalence of an 
article.
  (8)(A) Not later than 60 days after the date of the enactment 
of this paragraph, the Secretary shall establish within the 
Office of the Commissioner of Food and Drugs an office to 
ensure the prompt assignment of combination products to agency 
centers, the timely and effective premarket review of such 
products, and consistent and appropriate postmarket regulation 
of like products subject to the same statutory requirements to 
the extent permitted by law. Additionally, the office shall, in 
determining whether a product is to be designated a combination 
product, consult with the component within the Office of the 
Commissioner of Food and Drugs that is responsible for such 
determinations. Such office (referred to in this paragraph as 
the ``Office'') shall have appropriate scientific and medical 
expertise, and shall be headed by a director.
  (B) In carrying out this subsection, the Office shall, for 
each combination product, promptly assign an agency center with 
primary jurisdiction in accordance with paragraph (1) for the 
premarket review of such product.
  (C)(i) In carrying out this subsection, the Office shall help 
to ensure timely and effective premarket review that involves 
more than one agency center by coordinating such reviews, 
overseeing the timeliness of such reviews, and overseeing the 
alignment of feedback regarding such reviews.
  (ii) In order to ensure the timeliness and alignment of the 
premarket review of a combination product, the agency center 
with primary jurisdiction for the product, and the consulting 
agency center, shall be responsible to the Office with respect 
to the timeliness and alignment of the premarket review.
  (iii) The Office shall ensure that, with respect to a 
combination product, a designated person or persons in the 
primary agency center is the primary point or points of contact 
for the sponsor of such combination product. The Office shall 
also coordinate communications to and from any consulting 
center involved in such premarket review, if requested by such 
primary agency center or any such consulting center. Agency 
communications and commitments, to the extent consistent with 
other provisions of law and the requirements of all affected 
agency centers, from the primary agency center shall be 
considered as communication from the Secretary on behalf of all 
agency centers involved in the review.
  (iv) The Office shall, with respect to the premarket review 
of a combination product--
          (I) ensure that any meeting between the Secretary and 
        the sponsor of such product is attended by each agency 
        center involved in the review, as appropriate;
          (II) ensure that each consulting agency center has 
        completed its premarket review and provided the results 
        of such review to the primary agency center in a timely 
        manner; and
          (III) ensure that each consulting center follows the 
        guidance described in clause (vi) and advises, as 
        appropriate, on other relevant regulations, guidances, 
        and policies.
  (v) In seeking agency action with respect to a combination 
product, the sponsor of such product--
          (I) shall identify the product as a combination 
        product; and
          (II) may request in writing the participation of 
        representatives of the Office in meetings related to 
        such combination product, or to have the Office 
        otherwise engage on such regulatory matters concerning 
        the combination product.
  (vi) Not later than 4 years after the date of enactment of 
the 21st Century Cures Act, and after a public comment period 
of not less than 60 calendar days, the Secretary shall issue a 
final guidance that describes--
          (I) the structured process for managing pre-
        submission interactions with sponsors developing 
        combination products;
          (II) the best practices for ensuring that the 
        feedback in such pre-submission interactions represents 
        the Agency's best advice based on the information 
        provided during such pre-submission interactions;
          (III) the information that is required to be 
        submitted with a meeting request under paragraph (2), 
        how such meetings relate to other types of meetings in 
        the Food and Drug Administration, and the form and 
        content of any agreement reached through a meeting 
        under such paragraph (2);
  (D) In carrying out this subsection, the Office shall ensure 
the consistency and appropriateness of postmarket regulation of 
like products subject to the same statutory requirements to the 
extent permitted by law.
  (E)(i) Any dispute regarding the timeliness of the premarket 
review of a combination product may be presented to the Office 
for resolution, unless the dispute is clearly premature.
  (ii) During the review process, any dispute regarding the 
substance of the premarket review may be presented to the 
Commissioner of Food and Drugs after first being considered by 
the agency center with primary jurisdiction of the premarket 
review, under the scientific dispute resolution procedures for 
such center. The Commissioner of Food and Drugs shall consult 
with the Director of the Office in resolving the substantive 
dispute.
  (F) The Secretary, acting through the Office, shall review 
each agreement, guidance, or practice of the Secretary that is 
specific to the assignment of combination products to agency 
centers and shall determine whether the agreement, guidance, or 
practice is consistent with the requirements of this 
subsection. In carrying out such review, the Secretary shall 
consult with stakeholders and the directors of the agency 
centers. After such consultation, the Secretary shall determine 
whether to continue in effect, modify, revise, or eliminate 
such agreement, guidance, or practice, and shall publish in the 
Federal Register a notice of the availability of such modified 
or revised agreement, guidance or practice. Nothing in this 
paragraph shall be construed as preventing the Secretary from 
following each agreement, guidance, or practice until 
continued, modified, revised, or eliminated.
  (G) Not later than one year after the date of the enactment 
of this paragraph (except with respect to clause (iv), 
beginning not later than one year after the date of the 
enactment of the 21st Century Cures Act) and annually 
thereafter, the Secretary shall report to the appropriate 
committees of Congress on the activities and impact of the 
Office. The report shall include provisions--
          (i) describing the numbers and types of combination 
        products under review and the timeliness in days of 
        such assignments, reviews, and dispute resolutions;
          (ii) identifying the number of premarket reviews of 
        such products that involved a consulting agency center;
          (iii) describing improvements in the consistency of 
        postmarket regulation of combination products; and
          (iv) identifying the percentage of combination 
        products for which a dispute resolution, with respect 
        to premarket review, was requested by the combination 
        product's sponsor.
  (H) Nothing in this paragraph shall be construed to limit the 
regulatory authority of any agency center.
  (9) As used in this subsection:
          (A) The term ``agency center'' means a center or 
        alternative organizational component of the Food and 
        Drug Administration.
          (B) The term ``biological product'' has the meaning 
        given the term in section 351(i) of the Public Health 
        Service Act (42 U.S.C. 262(i)).
          (C) The term ``market clearance'' includes--
                  (i) approval of an application under section 
                505, 507, 515, or 520(g);
                  (ii) a finding of substantial equivalence 
                under this subchapter;
                  (iii) approval of a biologics license 
                application under subsection (a) of section 351 
                of the Public Health Service Act (42 U.S.C. 
                262); and
                  (iv) de novo classification under section 
                513(a)(1).
          (D) The terms ``premarket review'' and ``reviews'' 
        include all activities of the Food and Drug 
        Administration conducted prior to approval or clearance 
        of an application, notification, or request for 
        classification submitted under section 505, 510(k), 
        513(f)(2), 515, or 520 of this Act or under section 351 
        of the Public Health Service Act, including with 
        respect to investigational use of the product.
  (h)(1) Any contrast agent, radioactive drug, or OTC monograph 
drug shall be deemed to be a drug under section 201(g) and not 
a device under section 201(h).
  (2) For purposes of this subsection:
          (A) The term ``contrast agent'' means an article that 
        is intended for use in conjunction with a medical 
        imaging device, and--
                  (i) is a diagnostic radiopharmaceutical, as 
                defined in sections 315.2 and 601.31 of title 
                21, Code of Federal Regulations (or any 
                successor regulations); or
                  (ii) is a diagnostic agent that improves the 
                visualization of structure or function within 
                the body by increasing the relative difference 
                in signal intensity within the target tissue, 
                structure, or fluid.
          (B) The term `radioactive drug' has the meaning given 
        such term in section 310.3(n) of title 21, Code of 
        Federal Regulations (or any successor regulations), 
        except that such term does not include--
                  (i) an implant or article similar to an 
                implant;
                  (ii) an article that applies radiation from 
                outside of the body; or
                  (iii) the radiation source of an article 
                described in clause (i) or (ii).
          (C) The term `OTC monograph drug' has the meaning 
        given such term in section 744L.
  (3) Nothing in this subsection shall be construed as allowing 
for the classification of a product as a drug (as defined in 
section 201(g)) if such product--
          (A) is not described in paragraph (1); and
          (B) meets the definition of a device under section 
        201(h),
unless another provision of this Act otherwise indicates a 
different classification.

           *       *       *       *       *       *       *


                               new drugs

  Sec. 505. (a) No person shall introduce or deliver for 
introduction into interstate commerce any new drug, unless an 
approval of an application filed pursuant to subsection (b) or 
(j) is effective with respect to such drug.
  (b)
  (b)(1)(A) Any person may file with the Secretary an 
application with respect to any drug subject to the provisions 
of subsection (a). Such persons shall submit to the Secretary 
as part of the application--
          (i) full reports of investigations which have been 
        made to show whether such drug is safe for use and 
        whether such drug is effective in use;
          (ii) a full list of the articles used as components 
        of such drug;
          (iii) a full statement of the composition of such 
        drug;
          (iv) a full description of the methods used in, and 
        the facilities and controls used for, the manufacture, 
        processing, and packing of such drug;
          (v) such samples of such drug and of the articles 
        used as components thereof as the Secretary may 
        require;
          (vi) specimens of the labeling proposed to be used 
        for such drug;
          (vii) any assessments required under section 505B; 
        and
          (viii) the patent number and expiration date of each 
        patent for which a claim of patent infringement could 
        reasonably be asserted if a person not licensed by the 
        owner of the patent engaged in the manufacture, use, or 
        sale of the drug, and that--
                  (I) claims the drug for which the applicant 
                submitted the application and is a drug 
                substance (active ingredient) patent or a drug 
                product (formulation or composition) patent; or
                  (II) claims a method of using such drug for 
                which approval is sought or has been granted in 
                the application.
  (B) If an application is filed under this subsection for a 
drug, and a patent of the type described in subparagraph 
(A)(viii) is issued after the filing date but before approval 
of the application, the applicant shall amend the application 
to include the patent number and expiration date.
  (2) An application submitted under paragraph (1) for a drug 
for which the investigations described in clause (A) of such 
paragraph and relied upon by the applicant for approval of the 
application were not conducted by or for the applicant and for 
which the applicant has not obtained a right of reference or 
use from the person by or for whom the investigations were 
conducted shall also include--
          (A) a certification, in the opinion of the applicant 
        and to the best of his knowledge, with respect to each 
        patent which claims the drug for which such 
        investigations were conducted or which claims a use for 
        such drug for which the applicant is seeking approval 
        under this subsection and for which information is 
        required to be filed under paragraph (1) or subsection 
        (c)--
                  (i) that such patent information has not been 
                filed,
                  (ii) that such patent has expired,
                  (iii) of the date on which such patent will 
                expire, or
                  (iv) that such patent is invalid or will not 
                be infringed by the manufacture, use, or sale 
                of the new drug for which the application is 
                submitted; and
          (B) if with respect to the drug for which 
        investigations described in paragraph (1)(A) were 
        conducted information was filed under paragraph (1) or 
        subsection (c) for a method of use patent which does 
        not claim a use for which the applicant is seeking 
        approval under this subsection, a statement that the 
        method of use patent does not claim such a use.
  (3) Notice of opinion that patent is invalid or will not be 
infringed.--
          (A) Agreement to give notice.--An applicant that 
        makes a certification described in paragraph (2)(A)(iv) 
        shall include in the application a statement that the 
        applicant will give notice as required by this 
        paragraph.
          (B) Timing of notice.--An applicant that makes a 
        certification described in paragraph (2)(A)(iv) shall 
        give notice as required under this paragraph--
                  (i) if the certification is in the 
                application, not later than 20 days after the 
                date of the postmark on the notice with which 
                the Secretary informs the applicant that the 
                application has been filed; or
                  (ii) if the certification is in an amendment 
                or supplement to the application, at the time 
                at which the applicant submits the amendment or 
                supplement, regardless of whether the applicant 
                has already given notice with respect to 
                another such certification contained in the 
                application or in an amendment or supplement to 
                the application.
          (C) Recipients of notice.--An applicant required 
        under this paragraph to give notice shall give notice 
        to--
                  (i) each owner of the patent that is the 
                subject of the certification (or a 
                representative of the owner designated to 
                receive such a notice); and
                  (ii) the holder of the approved application 
                under this subsection for the drug that is 
                claimed by the patent or a use of which is 
                claimed by the patent (or a representative of 
                the holder designated to receive such a 
                notice).
          (D) Contents of notice.--A notice required under this 
        paragraph shall--
                  (i) state that an application that contains 
                data from bioavailability or bioequivalence 
                studies has been submitted under this 
                subsection for the drug with respect to which 
                the certification is made to obtain approval to 
                engage in the commercial manufacture, use, or 
                sale of the drug before the expiration of the 
                patent referred to in the certification; and
                  (ii) include a detailed statement of the 
                factual and legal basis of the opinion of the 
                applicant that the patent is invalid or will 
                not be infringed.
  (4)(A) An applicant may not amend or supplement an 
application referred to in paragraph (2) to seek approval of a 
drug that is a different drug than the drug identified in the 
application as submitted to the Secretary.
  (B) With respect to the drug for which such an application is 
submitted, nothing in this subsection or subsection (c)(3) 
prohibits an applicant from amending or supplementing the 
application to seek approval of a different strength.
  (5)(A) The Secretary shall issue guidance for the individuals 
who review applications submitted under paragraph (1) or under 
section 351 of the Public Health Service Act, which shall 
relate to promptness in conducting the review, technical 
excellence, lack of bias and conflict of interest, and 
knowledge of regulatory and scientific standards, and which 
shall apply equally to all individuals who review such 
applications.
  (B) The Secretary shall meet with a sponsor of an 
investigation or an applicant for approval for a drug under 
this subsection or section 351 of the Public Health Service Act 
if the sponsor or applicant makes a reasonable written request 
for a meeting for the purpose of reaching agreement on the 
design and size--
          (i)(I) of clinical trials intended to form the 
        primary basis of an effectiveness claim; or
          (II) in the case where human efficacy studies are not 
        ethical or feasible, of [animal] nonclinical tests and 
        any associated clinical trials which, in combination, 
        are intended to form the primary basis of an 
        effectiveness claim; or
          (ii) with respect to an application for approval of a 
        biological product under section 351(k) of the Public 
        Health Service Act, of any necessary clinical study or 
        studies.
The sponsor or applicant shall provide information necessary 
for discussion and agreement on the design and size of the 
clinical trials. Minutes of any such meeting shall be prepared 
by the Secretary and made available to the sponsor or applicant 
upon request.
  (C) Any agreement regarding the parameters of the design and 
size of clinical trials of a new drug under this paragraph that 
is reached between the Secretary and a sponsor or applicant 
shall be reduced to writing and made part of the administrative 
record by the Secretary. Such agreement shall not be changed 
after the testing begins, except--
          (i) with the written agreement of the sponsor or 
        applicant; or
          (ii) pursuant to a decision, made in accordance with 
        subparagraph (D) by the director of the reviewing 
        division, that a substantial scientific issue essential 
        to determining the safety or effectiveness of the drug 
        has been identified after the testing has begun.
  (D) A decision under subparagraph (C)(ii) by the director 
shall be in writing and the Secretary shall provide to the 
sponsor or applicant an opportunity for a meeting at which the 
director and the sponsor or applicant will be present and at 
which the director will document the scientific issue involved.
  (E) The written decisions of the reviewing division shall be 
binding upon, and may not directly or indirectly be changed by, 
the field or compliance division personnel unless such field or 
compliance division personnel demonstrate to the reviewing 
division why such decision should be modified.
  (F) No action by the reviewing division may be delayed 
because of the unavailability of information from or action by 
field personnel unless the reviewing division determines that a 
delay is necessary to assure the marketing of a safe and 
effective drug.
  (G) For purposes of this paragraph, the reviewing division is 
the division responsible for the review of an application for 
approval of a drug under this subsection or section 351 of the 
Public Health Service Act (including all scientific and medical 
matters, chemistry, manufacturing, and controls).
          (6) An application submitted under this subsection 
        shall be accompanied by the certification required 
        under section 402(j)(5)(B) of the Public Health Service 
        Act. Such certification shall not be considered an 
        element of such application.
  (c)(1) Within one hundred and eighty days after the filing of 
an application under subsection (b), or such additional period 
as may be agreed upon by the Secretary and the applicant, the 
Secretary shall either--
          (A) approve the application if he then finds that 
        none of the grounds for denying approval specified in 
        subsection (d) applies, or
          (B) give the applicant notice of an opportunity for a 
        hearing before the Secretary under subsection (d) on 
        the question whether such application is approvable. If 
        the applicant elects to accept the opportunity for 
        hearing by written request within thirty days after 
        such notice, such hearing shall commence not more than 
        ninety days after the expiration of such thirty days 
        unless the Secretary and the applicant otherwise agree. 
        Any such hearing shall thereafter be conducted on an 
        expedited basis and the Secretary's order thereon shall 
        be issued within ninety days after the date fixed by 
        the Secretary for filing final briefs.
  (2) Not later than 30 days after the date of approval of an 
application submitted under subsection (b), the holder of the 
approved application shall file with the Secretary the patent 
number and the expiration date of any patent described in 
subsection (b)(1)(A)(viii), except that a patent that is 
identified as claiming a method of using such drug shall be 
filed only if the patent claims a method of use approved in the 
application. If a patent described in subsection 
(b)(1)(A)(viii) is issued after the date of approval of an 
application submitted under subsection (b), the holder of the 
approved application shall, not later than 30 days after the 
date of issuance of the patent, file the patent number and the 
expiration date of the patent, except that a patent that claims 
a method of using such drug shall be filed only if approval for 
such use has been granted in the application. If the patent 
information described in subsection (b) could not be filed with 
the submission of an application under subsection (b) because 
the application was filed before the patent information was 
required under subsection (b) or a patent was issued after the 
application was approved under such subsection, the holder of 
an approved application shall file with the Secretary, the 
patent number and the expiration date of any patent described 
in subsection (b)(1)(A)(viii). If the holder of an approved 
application could not file patent information under subsection 
(b) because it was not required at the time the application was 
approved, the holder shall file such information under this 
subsection not later than thirty days after the date of the 
enactment of this sentence, and if the holder of an approved 
application could not file patent information under subsection 
(b) because no patent of the type for which information is 
required to be submitted in subsection (b)(1)(A)(viii) had been 
issued when an application was filed or approved, the holder 
shall file such information under this subsection not later 
than thirty days after the date the patent involved is issued. 
Upon the submission of patent information under this 
subsection, the Secretary shall publish it. Patent 
informationthat is not the type of patent information 
requiredby subsection (b)(1)(A)(viii) shall not be submitted 
underthis paragraph.
  (3) The approval of an application filed under subsection (b) 
which contains a certification required by paragraph (2) of 
such subsection shall be made effective on the last applicable 
date determined by applying the following to each certification 
made under subsection (b)(2)(A):
          (A) If the applicant only made a certification 
        described in clause (i) or (ii) of subsection (b)(2)(A) 
        or in both such clauses, the approval may be made 
        effective immediately.
          (B) If the applicant made a certification described 
        in clause (iii) of subsection (b)(2)(A), the approval 
        may be made effective on the date certified under 
        clause (iii).
          (C) If the applicant made a certification described 
        in clause (iv) of subsection (b)(2)(A), the approval 
        shall be made effective immediately unless, before the 
        expiration of 45 days after the date on which the 
        notice described in subsection (b)(3) is received, an 
        action is brought for infringement of the patent that 
        is the subject of the certification and for which 
        information was submitted to the Secretary under 
        paragraph (2) or subsection (b)(1) before the date on 
        which the application (excluding an amendment or 
        supplement to the application) was submitted. If such 
        an action is brought before the expiration of such 
        days, the approval may be made effective upon the 
        expiration of the thirty-month period beginning on the 
        date of the receipt of the notice provided under 
        subsection (b)(3) or such shorter or longer period as 
        the court may order because either party to the action 
        failed to reasonably cooperate in expediting the 
        action, except that--
                  (i) if before the expiration of such period 
                the district court decides that the patent is 
                invalid or not infringed (including any 
                substantive determination that there is no 
                cause of action for patent infringement or 
                invalidity), the approval shall be made 
                effective on--
                          (I) the date on which the court 
                        enters judgment reflecting the 
                        decision; or
                          (II) the date of a settlement order 
                        or consent decree signed and entered by 
                        the court stating that the patent that 
                        is the subject of the certification is 
                        invalid or not infringed;
                  (ii) if before the expiration of such period 
                the district court decides that the patent has 
                been infringed--
                          (I) if the judgment of the district 
                        court is appealed, the approval shall 
                        be made effective on--
                                  (aa) the date on which the 
                                court of appeals decides that 
                                the patent is invalid or not 
                                infringed (including any 
                                substantive determination that 
                                there is no cause of action for 
                                patent infringement or 
                                invalidity); or
                                  (bb) the date of a settlement 
                                order or consent decree signed 
                                and entered by the court of 
                                appeals stating that the patent 
                                that is the subject of the 
                                certification is invalid or not 
                                infringed; or
                          (II) if the judgment of the district 
                        court is not appealed or is affirmed, 
                        the approval shall be made effective on 
                        the date specified by the district 
                        court in a court order under section 
                        271(e)(4)(A) of title 35, United States 
                        Code;
                  (iii) if before the expiration of such period 
                the court grants a preliminary injunction 
                prohibiting the applicant from engaging in the 
                commercial manufacture or sale of the drug 
                until the court decides the issues of patent 
                validity and infringement and if the court 
                decides that such patent is invalid or not 
                infringed, the approval shall be made effective 
                as provided in clause (i); or
                  (iv) if before the expiration of such period 
                the court grants a preliminary injunction 
                prohibiting the applicant from engaging in the 
                commercial manufacture or sale of the drug 
                until the court decides the issues of patent 
                validity and infringement and if the court 
                decides that such patent has been infringed, 
                the approval shall be made effective as 
                provided in clause (ii).
        In such an action, each of the parties shall reasonably 
        cooperate in expediting the action.
          (D) Civil action to obtain patent certainty.--
                  (i) Declaratory judgment absent infringement 
                action.--
                          (I) In general.--No action may be 
                        brought under section 2201 of title 28, 
                        United States Code, by an applicant 
                        referred to in subsection (b)(2) for a 
                        declaratory judgment with respect to a 
                        patent which is the subject of the 
                        certification referred to in 
                        subparagraph (C) unless--
                                  (aa) the 45-day period 
                                referred to in such 
                                subparagraph has expired;
                                  (bb) neither the owner of 
                                such patent nor the holder of 
                                the approved application under 
                                subsection (b) for the drug 
                                that is claimed by the patent 
                                or a use of which is claimed by 
                                the patent brought a civil 
                                action against the applicant 
                                for infringement of the patent 
                                before the expiration of such 
                                period; and
                                  (cc) in any case in which the 
                                notice provided under paragraph 
                                (2)(B) relates to 
                                noninfringement, the notice was 
                                accompanied by a document 
                                described in subclause (III).
                          (II) Filing of civil action.--If the 
                        conditions described in items (aa), 
                        (bb), and as applicable, (cc) of 
                        subclause (I) have been met, the 
                        applicant referred to in such subclause 
                        may, in accordance with section 2201 of 
                        title 28, United States Code, bring a 
                        civil action under such section against 
                        the owner or holder referred to in such 
                        subclause (but not against any owner or 
                        holder that has brought such a civil 
                        action against the applicant, unless 
                        that civil action was dismissed without 
                        prejudice) for a declaratory judgment 
                        that the patent is invalid or will not 
                        be infringed by the drug for which the 
                        applicant seeks approval, except that 
                        such civil action may be brought for a 
                        declaratory judgment that the patent 
                        will not be infringed only in a case in 
                        which the condition described in 
                        subclause (I)(cc) is applicable. A 
                        civil action referred to in this 
                        subclause shall be brought in the 
                        judicial district where the defendant 
                        has its principal place of business or 
                        a regular and established place of 
                        business.
                          (III) Offer of confidential access to 
                        application.--For purposes of subclause 
                        (I)(cc), the document described in this 
                        subclause is a document providing an 
                        offer of confidential access to the 
                        application that is in the custody of 
                        the applicant referred to in subsection 
                        (b)(2) for the purpose of determining 
                        whether an action referred to in 
                        subparagraph (C) should be brought. The 
                        document providing the offer of 
                        confidential access shall contain such 
                        restrictions as to persons entitled to 
                        access, and on the use and disposition 
                        of any information accessed, as would 
                        apply had a protective order been 
                        entered for the purpose of protecting 
                        trade secrets and other confidential 
                        business information. A request for 
                        access to an application under an offer 
                        of confidential access shall be 
                        considered acceptance of the offer of 
                        confidential access with the 
                        restrictions as to persons entitled to 
                        access, and on the use and disposition 
                        of any information accessed, contained 
                        in the offer of confidential access, 
                        and those restrictions and other terms 
                        of the offer of confidential access 
                        shall be considered terms of an 
                        enforceable contract. Any person 
                        provided an offer of confidential 
                        access shall review the application for 
                        the sole and limited purpose of 
                        evaluating possible infringement of the 
                        patent that is the subject of the 
                        certification under subsection 
                        (b)(2)(A)(iv) and for no other purpose, 
                        and may not disclose information of no 
                        relevance to any issue of patent 
                        infringement to any person other than a 
                        person provided an offer of 
                        confidential access. Further, the 
                        application may be redacted by the 
                        applicant to remove any information of 
                        no relevance to any issue of patent 
                        infringement.
                  (ii) Counterclaim to infringement action.--
                          (I) In general.--If an owner of the 
                        patent or the holder of the approved 
                        application under subsection (b) for 
                        the drug that is claimed by the patent 
                        or a use of which is claimed by the 
                        patent brings a patent infringement 
                        action against the applicant, the 
                        applicant may assert a counterclaim 
                        seeking an order requiring the holder 
                        to correct or delete the patent 
                        information submitted by the holder 
                        under subsection (b) or this subsection 
                        on the ground that the patent does not 
                        claim either--
                                  (aa) the drug for which the 
                                application was approved; or
                                  (bb) an approved method of 
                                using the drug.
                          (II) No independent cause of 
                        action.--Subclause (I) does not 
                        authorize the assertion of a claim 
                        described in subclause (I) in any civil 
                        action or proceeding other than a 
                        counterclaim described in subclause 
                        (I).
                  (iii) No damages.--An applicant shall not be 
                entitled to damages in a civil action under 
                clause (i) or a counterclaim under clause (ii).
          (E)
          (ii) If an application submitted under subsection (b) 
        for a drug, no active moiety (as defined by the 
        Secretary in section 314.3 of title 21, Code of Federal 
        Regulations (or any successor regulations)) of which 
        has been approved in any other application under 
        subsection (b), is approved after the date of the 
        enactment of this clause, no application which refers 
        to the drug for which the subsection (b) application 
        was submitted and for which the investigations 
        described in subsection (b)(1)(A)(i) and relied upon by 
        the applicant for approval of the application were not 
        conducted by or for the applicant and for which the 
        applicant has not obtained a right of reference or use 
        from the person by or for whom the investigations were 
        conducted may be submitted under subsection (b) before 
        the expiration of five years from the date of the 
        approval of the application under subsection (b), 
        except that such an application may be submitted under 
        subsection (b) after the expiration of four years from 
        the date of the approval of the subsection (b) 
        application if it contains a certification of patent 
        invalidity or noninfringement described in clause (iv) 
        of subsection (b)(2)(A). The approval of such an 
        application shall be made effective in accordance with 
        this paragraph except that, if an action for patent 
        infringement is commenced during the one-year period 
        beginning forty-eight months after the date of the 
        approval of the subsection (b) application, the thirty-
        month period referred to in subparagraph (C) shall be 
        extended by such amount of time (if any) which is 
        required for seven and one-half years to have elapsed 
        from the date of approval of the subsection (b) 
        application.
          (iii) If an application submitted under subsection 
        (b) for a drug, which includes an active moiety (as 
        defined by the Secretary in section 314.3 of title 21, 
        Code of Federal Regulations (or any successor 
        regulations)) that has been approved in another 
        application approved under subsection (b), is approved 
        after the date of the enactment of this clause and if 
        such application contains reports of new clinical 
        investigations (other than bioavailability studies) 
        essential to the approval of the application and 
        conducted or sponsored by the applicant, the Secretary 
        may not make the approval of an application submitted 
        under subsection (b) for the conditions of approval of 
        such drug in the approved subsection (b) application 
        effective before the expiration of three years from the 
        date of the approval of the application under 
        subsection (b) if the investigations described in 
        subsection (b)(1)(A)(i) and relied upon by the 
        applicant for approval of the application were not 
        conducted by or for the applicant and if the applicant 
        has not obtained a right of reference or use from the 
        person by or for whom the investigations were 
        conducted.
          (iv) If a supplement to an application approved under 
        subsection (b) is approved after the date of enactment 
        of this clause and the supplement contains reports of 
        new clinical investigations (other than bioavailabilty 
        studies) essential to the approval of the supplement 
        and conducted or sponsored by the person submitting the 
        supplement, the Secretary may not make the approval of 
        an application submitted under subsection (b) for a 
        change approved in the supplement effective before the 
        expiration of three years from the date of the approval 
        of the supplement under subsection (b) if the 
        investigations described in subsection (b)(1)(A)(i) and 
        relied upon by the applicant for approval of the 
        application were not conducted by or for the applicant 
        and if the applicant has not obtained a right of 
        reference or use from the person by or for whom the 
        investigations were conducted.
          (v) If an application (or supplement to an 
        application) submitted under subsection (b) for a drug, 
        which includes anactive moiety (as defined by the 
        Secretary in section 314.3 of title 21, Code of Federal 
        Regulations (or any successor regulations)) that has 
        been approved in another application under subsection 
        (b), was approved during the period beginning January 
        1, 1982, and ending on the date of the enactment of 
        this clause, the Secretary may not make the approval of 
        an application submitted under this subsection and for 
        which the investigations described in subsection 
        (b)(1)(A)(i) and relied upon by the applicant for 
        approval of the application were not conducted by or 
        for the applicant and for which the applicant has not 
        obtained a right of reference or use from the person by 
        or for whom the investigations were conducted and which 
        refers to the drug for which the subsection (b) 
        application was submitted effective before the 
        expiration of two years from the date of enactment of 
        this clause.
  (4) A drug manufactured in a pilot or other small facility 
may be used to demonstrate the safety and effectiveness of the 
drug and to obtain approval for the drug prior to manufacture 
of the drug in a larger facility, unless the Secretary makes a 
determination that a full scale production facility is 
necessary to ensure the safety or effectiveness of the drug.
  (5)(A) The Secretary may rely upon qualified data summaries 
to support the approval of a supplemental application, with 
respect to a qualified indication for a drug, submitted under 
subsection (b), if such supplemental application complies with 
subparagraph (B).
  (B) A supplemental application is eligible for review as 
described in subparagraph (A) only if--
          (i) there is existing data available and acceptable 
        to the Secretary demonstrating the safety of the drug; 
        and
          (ii) all data used to develop the qualified data 
        summaries are submitted to the Secretary as part of the 
        supplemental application.
  (C) The Secretary shall post on the Internet website of the 
Food and Drug Administration and update annually--
          (i) the number of applications reviewed solely under 
        subparagraph (A) or section 351(a)(2)(E) of the Public 
        Health Service Act;
          (ii) the average time for completion of review under 
        subparagraph (A) or section 351(a)(2)(E) of the Public 
        Health Service Act;
          (iii) the average time for review of supplemental 
        applications where the Secretary did not use review 
        flexibility under subparagraph (A) or section 
        351(a)(2)(E) of the Public Health Service Act; and
          (iv) the number of applications reviewed under 
        subparagraph (A) or section 351(a)(2)(E) of the Public 
        Health Service Act for which the Secretary made use of 
        full data sets in addition to the qualified data 
        summary.
  (D) In this paragraph--
          (i) the term ``qualified indication'' means an 
        indication for a drug that the Secretary determines to 
        be appropriate for summary level review under this 
        paragraph; and
          (ii) the term ``qualified data summary'' means a 
        summary of clinical data that demonstrates the safety 
        and effectiveness of a drug with respect to a qualified 
        indication.
  (d) If the Secretary finds, after due notice to the applicant 
in accordance with subsection (c) and giving him an opportunity 
for a hearing, in accordance with said subsection, that (1) the 
investigations, reports of which are required to be submitted 
to the Secretary pursuant to subsection (b), do not include 
adequate tests by all methods reasonably applicable to show 
whether or not such drug is safe for use under the conditions 
prescribed, recommended, or suggested in the proposed labeling 
thereof; (2) the results of such tests show that such drug is 
unsafe for use under such conditions or do not show that such 
drug is safe for use under such conditions; (3) the methods 
used in, and the facilities and controls used for, the 
manufacture, processing, and packing of such drug are 
inadequate to preserve its identity, strength, quality, and 
purity; (4) upon the basis of the information submitted to him 
as part of the application, or upon the basis of any other 
information before him with respect to such drug, he has 
insufficient information to determine whether such drug is safe 
for use under such conditions; or (5) evaluated on the basis of 
the information submitted to him as part of the application and 
any other information before him with respect to such drug, 
there is a lack of substantial evidence that the drug will have 
the effect it purports or is represented to have under the 
conditions of use prescribed, recommended, or suggested in the 
proposed labeling thereof; or (6) the application failed to 
contain the patent information prescribed by subsection (b); or 
(7) based on a fair evaluation of all material facts, such 
labeling is false or misleading in any particular; he shall 
issue an order refusing to approve the application. If, after 
such notice and opportunity for hearing, the Secretary finds 
that clauses (1) through (6) do not apply, he shall issue an 
order approving the application. As used in this subsection and 
subsection (e), the term ``substantial evidence'' means 
evidence consisting of adequate and well-controlled 
investigations, including clinical investigations, by experts 
qualified by scientific training and experience to evaluate the 
effectiveness of the drug involved, on the basis of which it 
could fairly and responsibly be concluded by such experts that 
the drug will have the effect it purports or is represented to 
have under the conditions of use prescribed, recommended, or 
suggested in the labeling or proposed labeling thereof. If the 
Secretary determines, based on relevant science, that data from 
one adequate and well-controlled clinical investigation and 
confirmatory evidence (obtained prior to or after such 
investigation) are sufficient to establish effectiveness, the 
Secretary may consider such data and evidence to constitute 
substantial evidence for purposes of the preceding sentence. 
The Secretary shall implement a structured risk-benefit 
assessment framework in the new drug approval process to 
facilitate the balanced consideration of benefits and risks, a 
consistent and systematic approach to the discussion and 
regulatory decisionmaking, and the communication of the 
benefits and risks of new drugs. Nothing in the preceding 
sentence shall alter the criteria for evaluating an application 
for marketing approval of a drug.
  (e) The Secretary shall, after due notice and opportunity for 
hearing to the applicant, withdraw approval of an application 
with respect to any drug under this section if the Secretary 
finds (1) that clinical or other experience, tests, or other 
scientific data show that such drug is unsafe for use under the 
conditions of use upon the basis of which the application was 
approved; (2) that new evidence of clinical experience, not 
contained in such application or not available to the Secretary 
until after such application was approved, or tests by new 
methods, or tests by methods not deemed reasonably applicable 
when such application was approved, evaluated together with the 
evidence available to the Secretary when the application was 
approved, shows that such drug is not shown to be safe for use 
under the conditions of use upon the basis of which the 
application was approved; or (3) on the basis of new 
information before him with respect to such drug, evaluated 
together with the evidence available to him when the 
application was approved, that there is a lack of substantial 
evidence that the drug will have the effect it purports or is 
represented to have under the conditions of use prescribed, 
recommended, or suggested in the labeling thereof; or (4) the 
patent information prescribed by subsection (c) was not filed 
within thirty days after the receipt of written notice from the 
Secretary specifying the failure to file such information; or 
(5) that the application contains any untrue statement of a 
material fact: Provided, That if the Secretary (or in his 
absence the officer acting as Secretary) finds that there is an 
imminent hazard to the public health, he may suspend the 
approval of such application immediately, and give the 
applicant prompt notice of his action and afford the applicant 
the opportunity for an expedited hearing under this subsection; 
but the authority conferred by this proviso to suspend the 
approval of an application shall not be delegated. The 
Secretary may also, after due notice and opportunity for 
hearing to the applicant, withdraw the approval of an 
application submitted under subsection (b) or (j) with respect 
to any drug under this section if the Secretary finds (1) that 
the applicant has failed to establish a system for maintaining 
required records, or has repeatedly or deliberately failed to 
maintain such records or to make required reports, in 
accordance with a regulation or order under subsection (k) or 
to comply with the notice requirements of section 510(k)(2), or 
the applicant has refused to permit access to, or copying or 
verification of, such records as required by paragraph (2) of 
such subsection; or (2) that on the basis of new information 
before him, evaluated together with the evidence before him 
when the application was approved, the methods used in, or the 
facilities and controls used for, the manufacture, processing, 
and packing of such drug are inadequate to assure and preserve 
its identity, strength, quality, and purity and were not made 
adequate within a reasonable time after receipt of written 
notice from the Secretary specifying the matter complained of; 
or (3) that on the basis of new information before him, 
evaluated together with the evidence before him when the 
application was approved, the labeling of such drug, based on a 
fair evaluation of all material facts, is false or misleading 
in any particular and was not corrected within a reasonable 
time after receipt of written notice from the Secretary 
specifying the matter complained of. Any order under this 
subsection shall state the findings upon which it is based. The 
Secretary may withdraw the approval of an application submitted 
under this section, or suspend the approval of such an 
application, as provided under this subsection, without first 
ordering the applicant to submit an assessment of the approved 
risk evaluation and mitigation strategy for the drug under 
section 505-1(g)(2)(D).
  (f) Whenever the Secretary finds that the facts so require, 
he shall revoke any previous order under subsection (d) or (e) 
refusing, withdrawing, or suspending approval of an application 
and shall approve such application or reinstate such approval, 
as may be appropriate.
  (g) Orders of the Secretary issued under this section shall 
be served (1) in person by any officer or employee of the 
Department designated by the Secretary or (2) by mailing the 
order by registered mail or by certified mail addressed to the 
applicant or respondent at his last-known address in the 
records of the Secretary.
  (h) An appeal may be taken by the applicant from an order of 
the Secretary refusing or withdrawing approval of an 
application under this section. Such appeal shall be taken by 
filing in the United States court of appeals for the circuit 
wherein such applicant resides or has his principal place of 
business, or in the United States Court of Appeals for the 
District of Columbia Circuit, within sixty days after the entry 
of such order, a written petition praying that the order of the 
Secretary be set aside. A copy of such petition shall be 
forthwith transmitted by the clerk of the court to the 
Secretary, or any officer designated by him for that purpose, 
and thereupon the Secretary shall certify and file in the court 
the record upon which the order complained of was entered, as 
provided in section 2112 of title 28, United States Code. Upon 
the filing of such petition such court shall have exclusive 
jurisdiction to affirm or set aside such order, except that 
until the filing of the record the Secretary may modify or set 
aside his order. No objection to the order of the Secretary 
shall be considered by the court unless such objection shall 
have been urged before the Secretary or unless there were 
reasonable grounds for failure so to do. The finding of the 
Secretary as to the facts, if supported by substantial 
evidence, shall be conclusive. If any person shall apply to the 
court for leave to adduce additional evidence, and shall show 
to the satisfaction of the court that such additional evidence 
is material and that there were reasonable grounds for failure 
to adduce such evidence in the proceeding before the Secretary, 
the court may order such additional evidence to be taken before 
the Secretary and to be adduced upon the hearing in such manner 
and upon such terms and conditions as to the court may seem 
proper. The Secretary may modify his findings as to the facts 
by reason of the additional evidence so taken, and he shall 
file with the court such modified findings which, if supported 
by substantial evidence, shall be conclusive, and his 
recommendation, if any, for the setting aside of the original 
order. The judgment of the court affirming or setting aside any 
such order of the Secretary shall be final, subject to review 
by the Supreme Court of the United States upon certiorari or 
certification as provided in section 1254 of title 28 of the 
United States Code. The commencement of proceedings under this 
subsection shall not, unless specifically ordered by the court 
to the contrary, operate as a stay of the Secretary's order.
  (i)(1) The Secretary shall promulgate regulations for 
exempting from the operation of the foregoing subsections of 
this section drugs intended solely for investigational use by 
experts qualified by scientific training and experience to 
investigate the safety and effectiveness of drugs. Such 
regulations may, within the discretion of the Secretary, among 
other conditions relating to the protection of the public 
health, provide for conditioning such exemption upon--
          (A) the submission to the Secretary, before any 
        clinical testing of a new drug is undertaken, of 
        reports, by the manufacturer or the sponsor of the 
        investigation of such drug, or [preclinical tests 
        (including tests on animals)] nonclinical tests of such 
        drug adequate to justify the proposed clinical testing;
          (B) the manufacturer or the sponsor of the 
        investigation of a new drug proposed to be distributed 
        to investigators for clinical testing obtaining a 
        signed agreement from each of such investigators that 
        patients to whom the drug is administered will be under 
        his personal supervision, or under the supervision of 
        investigators responsible to him, and that he will not 
        supply such drug to any other investigator, or to 
        clinics, for administration to human beings;
          (C) the establishment and maintenance of such 
        records, and the making of such reports to the 
        Secretary, by the manufacturer or the sponsor of the 
        investigation of such drug, of data (including but not 
        limited to analytical reports by investigators) 
        obtained as the result of such investigational use of 
        such drug, as the Secretary finds will enable him to 
        evaluate the safety and effectiveness of such drug in 
        the event of the filing of an application pursuant to 
        subsection (b); and
                  (D) the submission to the Secretary by the 
                manufacturer or the sponsor of the 
                investigation of a new drug of a statement of 
                intent regarding whether the manufacturer or 
                sponsor has plans for assessing pediatric 
                safety and efficacy.
  (2) Subject to paragraph (3), a clinical investigation of a 
new drug may begin 30 days after the Secretary has received 
from the manufacturer or sponsor of the investigation a 
submission containing such information about the drug and the 
clinical investigation, including--
          (A) information on design of the investigation and 
        adequate reports of basic information, certified by the 
        applicant to be accurate reports, necessary to assess 
        the safety of the drug for use in clinical 
        investigation; and
          (B) adequate information on the chemistry and 
        manufacturing of the drug, controls available for the 
        drug, and primary data tabulations from [animal] 
        nonclinical tests or human studies.
  (3)(A) At any time, the Secretary may prohibit the sponsor of 
an investigation from conducting the investigation (referred to 
in this paragraph as a ``clinical hold'') if the Secretary 
makes a determination described in subparagraph (B). The 
Secretary shall specify the basis for the clinical hold, 
including the specific information available to the Secretary 
which served as the basis for such clinical hold, and confirm 
such determination in writing.
  (B) For purposes of subparagraph (A), a determination 
described in this subparagraph with respect to a clinical hold 
is that--
          (i) the drug involved represents an unreasonable risk 
        to the safety of the persons who are the subjects of 
        the clinical investigation, taking into account the 
        qualifications of the clinical investigators, 
        information about the drug, the design of the clinical 
        investigation, the condition for which the drug is to 
        be investigated, and the health status of the subjects 
        involved; or
          (ii) the clinical hold should be issued for such 
        other reasons as the Secretary may by regulation 
        establish (including reasons established by regulation 
        before the date of the enactment of the Food and Drug 
        Administration Modernization Act of 1997).
  (C) Any written request to the Secretary from the sponsor of 
an investigation that a clinical hold be removed shall receive 
a decision, in writing and specifying the reasons therefor, 
within 30 days after receipt of such request. Any such request 
shall include sufficient information to support the removal of 
such clinical hold.
  (4) Regulations under paragraph (1) shall provide that such 
exemption shall be conditioned upon the manufacturer, or the 
sponsor of the investigation, requiring that experts using such 
drugs for investigational purposes certify to such manufacturer 
or sponsor that they will inform any human beings to whom such 
drugs, or any controls used in connection therewith, are being 
administered, or their representatives, that such drugs are 
being used for investigational purposes and will obtain the 
consent of such human beings or their representatives, except 
where it is not feasible, it is contrary to the best interests 
of such human beings, or the proposed clinical testing poses no 
more than minimal risk to such human beings and includes 
appropriate safeguards as prescribed to protect the rights, 
safety, and welfare of such human beings. Nothing in this 
subsection shall be construed to require any clinical 
investigator to submit directly to the Secretary reports on the 
investigational use of drugs. The Secretary shall update such 
regulations to require inclusion in the informed consent 
documents and process a statement that clinical trial 
information for such clinical investigation has been or will be 
submitted for inclusion in the registry data bank pursuant to 
subsection (j) of section 402 of the Public Health Service Act.
  (5)(A) In order for a new drug that is being studied in a 
phase 3 study, as defined in section 312.21(c) of title 21, 
Code of Federal Regulations (or successor regulations), or 
other pivotal study (other than bioavailability or 
bioequivalence studies), to be exempt pursuant to this 
subsection, the sponsor of a clinical investigation of such new 
drug shall submit to the Secretary a diversity action plan.
  (B) Such diversity action plan shall include--
          (i) the sponsor's goals for enrollment in such 
        clinical study;
          (ii) the sponsor's rationale for such goals; and
          (iii) an explanation of how the sponsor intends to 
        meet such goals.
  (C) The sponsor shall submit such diversity action plan in 
the form and manner specified in the guidance required by 
section 524B as soon as practicable but no later than when the 
sponsor seeks feedback regarding such a phase 3 study or other 
pivotal study of the drug.
  (D) The Secretary may waive the requirement in subparagraph 
(A) if the Secretary determines that a waiver is necessary 
based on what is known about the prevalence of the disease in 
terms of the patient population that may use the new drug.
  (E) No diversity action plan shall be required for a 
submission described in section 561.
  (j)(1) Any person may file with the Secretary an abbreviated 
application for the approval of a new drug.
  (2)(A) An abbreviated application for a new drug shall 
contain--
          (i) information to show that the conditions of use 
        prescribed, recommended, or suggested in the labeling 
        proposed for the new drug have been previously approved 
        for a drug listed under paragraph (7) (hereinafter in 
        this subsection referred to as a ``listed drug'');
          (ii)(I) if the listed drug referred to in clause (i) 
        has only one active ingredient, information to show 
        that the active ingredient of the new drug is the same 
        as that of the listed drug;
          (II) if the listed drug referred to in clause (i) has 
        more than one active ingredient, information to show 
        that the active ingredients of the new drug are the 
        same as those of the listed drug, or
          (III) if the listed drug referred to in clause (i) 
        has more than one active ingredient and if one of the 
        active ingredients of the new drug is different and the 
        application is filed pursuant to the approval of a 
        petition filed under subparagraph (C), information to 
        show that the other active ingredients of the new drug 
        are the same as the active ingredients of the listed 
        drug, information to show that the different active 
        ingredient is an active ingredient of a listed drug or 
        of a drug which does not meet the requirements of 
        section 201(p), and such other information respecting 
        the different active ingredient with respect to which 
        the petition was filed as the Secretary may require;
          (iii) information to show that the route of 
        administration, the dosage form, and the strength of 
        the new drug are the same as those of the listed drug 
        referred to in clause (i) or, if the route of 
        administration, the dosage form, or the strength of the 
        new drug is different and the application is filed 
        pursuant to the approval of a petition filed under 
        subparagraph (C), such information respecting the route 
        of administration, dosage form, or strength with 
        respect to which the petition was filed as the 
        Secretary may require;
          (iv) information to show that the new drug is 
        bioequivalent to the listed drug referred to in clause 
        (i), except that if the application is filed pursuant 
        to the approval of a petition filed under subparagraph 
        (C), information to show that the active ingredients of 
        the new drug are of the same pharmacological or 
        therapeutic class as those of the listed drug referred 
        to in clause (i) and the new drug can be expected to 
        have the same therapeutic effect as the listed drug 
        when administered to patients for a condition of use 
        referred to in clause (i);
          (v) information to show that the labeling proposed 
        for the new drug is the same as the labeling approved 
        for the listed drug referred to in clause (i) except 
        for changes required because of differences approved 
        under a petition filed under subparagraph (C) or 
        because the new drug and the listed drug are produced 
        or distributed by different manufacturers;
          (vi) the items specified in clauses (ii) through (vi) 
        of subsection (b)(1)(A);
          (vii) a certification, in the opinion of the 
        applicant and to the best of his knowledge, with 
        respect to each patent which claims the listed drug 
        referred to in clause (i) or which claims a use for 
        such listed drug for which the applicant is seeking 
        approval under this subsection and for which 
        information is required to be filed under subsection 
        (b) or (c)--
                  (I) that such patent information has not been 
                filed,
                  (II) that such patent has expired,
                  (III) of the date on which such patent will 
                expire, or
                  (IV) that such patent is invalid or will not 
                be infringed by the manufacture, use, or sale 
                of the new drug for which the application is 
                submitted; and
          (viii) if with respect to the listed drug referred to 
        in clause (i) information was filed under subsection 
        (b) or (c) for a method of use patent which does not 
        claim a use for which the applicant is seeking approval 
        under this subsection, a statement that the method of 
        use patent does not claim such a use.
The Secretary may not require that an abbreviated application 
contain information in addition to that required by clauses (i) 
through (viii).
  (B) Notice of opinion that patent is invalid or will not be 
infringed.--
          (i) Agreement to give notice.--An applicant that 
        makes a certification described in subparagraph 
        (A)(vii)(IV) shall include in the application a 
        statement that the applicant will give notice as 
        required by this subparagraph.
          (ii) Timing of notice.--An applicant that makes a 
        certification described in subparagraph (A)(vii)(IV) 
        shall give notice as required under this subparagraph--
                  (I) if the certification is in the 
                application, not later than 20 days after the 
                date of the postmark on the notice with which 
                the Secretary informs the applicant that the 
                application has been filed; or
                  (II) if the certification is in an amendment 
                or supplement to the application, at the time 
                at which the applicant submits the amendment or 
                supplement, regardless of whether the applicant 
                has already given notice with respect to 
                another such certification contained in the 
                application or in an amendment or supplement to 
                the application.
          (iii) Recipients of notice.--An applicant required 
        under this subparagraph to give notice shall give 
        notice to--
                  (I) each owner of the patent that is the 
                subject of the certification (or a 
                representative of the owner designated to 
                receive such a notice); and
                  (II) the holder of the approved application 
                under subsection (b) for the drug that is 
                claimed by the patent or a use of which is 
                claimed by the patent (or a representative of 
                the holder designated to receive such a 
                notice).
          (iv) Contents of notice.--A notice required under 
        this subparagraph shall--
                  (I) state that an application that contains 
                data from bioavailability or bioequivalence 
                studies has been submitted under this 
                subsection for the drug with respect to which 
                the certification is made to obtain approval to 
                engage in the commercial manufacture, use, or 
                sale of the drug before the expiration of the 
                patent referred to in the certification; and
                  (II) include a detailed statement of the 
                factual and legal basis of the opinion of the 
                applicant that the patent is invalid or will 
                not be infringed.
  (C) If a person wants to submit an abbreviated application 
for a new drug which has a different active ingredient or whose 
route of administration, dosage form, or strength differ from 
that of a listed drug, such person shall submit a petition to 
the Secretary seeking permission to file such an application. 
The Secretary shall approve or disapprove a petition submitted 
under this subparagraph within ninety days of the date the 
petition is submitted. The Secretary shall approve such a 
petition unless the Secretary finds--
          (i) that investigations must be conducted to show the 
        safety and effectiveness of the drug or of any of its 
        active ingredients, the route of administration, the 
        dosage form, or strength which differ from the listed 
        drug; or
          (ii) that any drug with a different active ingredient 
        may not be adequately evaluated for approval as safe 
        and effective on the basis of the information required 
        to be submitted in an abbreviated application.
  (D)(i) An applicant may not amend or supplement an 
application to seek approval of a drug referring to a different 
listed drug from the listed drug identified in the application 
as submitted to the Secretary.
  (ii) With respect to the drug for which an application is 
submitted, nothing in this subsection prohibits an applicant 
from amending or supplementing the application to seek approval 
of a different strength.
  (iii) Within 60 days after the date of the enactment of the 
Medicare Prescription Drug, Improvement, and Modernization Act 
of 2003, the Secretary shall issue guidance defining the term 
``listed drug'' for purposes of this subparagraph.
  (3)(A) The Secretary shall issue guidance for the individuals 
who review applications submitted under paragraph (1), which 
shall relate to promptness in conducting the review, technical 
excellence, lack of bias and conflict of interest, and 
knowledge of regulatory and scientific standards, and which 
shall apply equally to all individuals who review such 
applications.
  (B) The Secretary shall meet with a sponsor of an 
investigation or an applicant for approval for a drug under 
this subsection if the sponsor or applicant makes a reasonable 
written request for a meeting for the purpose of reaching 
agreement on the design and size of bioavailability and 
bioequivalence studies needed for approval of such application. 
The sponsor or applicant shall provide information necessary 
for discussion and agreement on the design and size of such 
studies. Minutes of any such meeting shall be prepared by the 
Secretary and made available to the sponsor or applicant.
  (C) Any agreement regarding the parameters of design and size 
of bioavailability and bioequivalence studies of a drug under 
this paragraph that is reached between the Secretary and a 
sponsor or applicant shall be reduced to writing and made part 
of the administrative record by the Secretary. Such agreement 
shall not be changed after the testing begins, except--
          (i) with the written agreement of the sponsor or 
        applicant; or
          (ii) pursuant to a decision, made in accordance with 
        subparagraph (D) by the director of the reviewing 
        division, that a substantial scientific issue essential 
        to determining the safety or effectiveness of the drug 
        has been identified after the testing has begun.
  (D) A decision under subparagraph (C)(ii) by the director 
shall be in writing and the Secretary shall provide to the 
sponsor or applicant an opportunity for a meeting at which the 
director and the sponsor or applicant will be present and at 
which the director will document the scientific issue involved.
  (E) The written decisions of the reviewing division shall be 
binding upon, and may not directly or indirectly be changed by, 
the field or compliance office personnel unless such field or 
compliance office personnel demonstrate to the reviewing 
division why such decision should be modified.
  (F) No action by the reviewing division may be delayed 
because of the unavailability of information from or action by 
field personnel unless the reviewing division determines that a 
delay is necessary to assure the marketing of a safe and 
effective drug.
  (G) For purposes of this paragraph, the reviewing division is 
the division responsible for the review of an application for 
approval of a drug under this subsection (including scientific 
matters, chemistry, manufacturing, and controls).
  (H)(i) Upon request (in controlled correspondence or 
otherwise) by a person that has submitted or intends to submit 
an abbreviated application for a new drug under this subsection 
for which the Secretary has specified in regulation, including 
under section 314.94(a)(9), title 21, Code of Federal 
Regulations (or a successor regulation), or recommended in 
applicable guidance, certain qualitative or quantitative 
criteria with respect to an inactive ingredient, or on the 
Secretary's own initiative during the review of such 
abbreviated application, the Secretary shall inform the person 
whether such new drug is qualitatively and quantitatively the 
same as the listed drug.
  (ii) Notwithstanding section 301(j), if the Secretary 
determines that such new drug is not qualitatively or 
quantitatively the same as the listed drug, the Secretary shall 
identify and disclose to the person--
          (I) the ingredient or ingredients that cause the new 
        drug not to be qualitatively or quantitatively the same 
        as the listed drug; and
          (II) for any ingredient for which there is an 
        identified quantitative deviation, the amount of such 
        deviation.
  (iii) If the Secretary determines that such new drug is 
qualitatively and quantitatively the same as the listed drug, 
the Secretary shall not change or rescind such determination 
after the submission of an abbreviated application for such new 
drug under this subsection unless--
          (I) the formulation of the listed drug has been 
        changed and the Secretary has determined that the prior 
        listed drug formulation was withdrawn for reasons of 
        safety or effectiveness; or
          (II) the Secretary makes a written determination that 
        the prior determination must be changed because an 
        error has been identified.
  (iv) If the Secretary makes a written determination described 
in clause (iii)(II), the Secretary shall provide notice and a 
copy of the written determination to the person making the 
request under clause (i).
  (v) The disclosures required by this subparagraph are 
disclosures authorized by law including for purposes of section 
1905 of title 18, United States Code.
  (4) Subject to paragraph (5), the Secretary shall approve an 
application for a drug unless the Secretary finds--
          (A) the methods used in, or the facilities and 
        controls used for, the manufacture, processing, and 
        packing of the drug are inadequate to assure and 
        preserve its identity, strength, quality, and purity;
          (B) information submitted with the application is 
        insufficient show that each of the proposed conditions 
        of use have been previously approved for the listed 
        drug referred to in the application;
          (C)(i) if the listed drug has only one active 
        ingredient, information submitted with the application 
        is insufficient to show that the active ingredient is 
        the same as that of the listed drug;
          (ii) if the listed drug has more than one active 
        ingredient, information submitted with the application 
        is insufficient to show that the active ingredients are 
        the same as the active ingredients of the listed drug, 
        or
          (iii) if the listed drug has more than one active 
        ingredient and if the application is for a drug which 
        has an active ingredient different from the listed 
        drug, information submitted with the application is 
        insufficient to show--
                  (I) that the other active ingredients are the 
                same as the active ingredients of the listed 
                drug, or
                  (II) that the different active ingredient is 
                an active ingredient of a listed drug or a drug 
                which does not meet the requirements of section 
                201(p),
        or no petition to file an application for the drug with 
        the different ingredient was approved under paragraph 
        (2)(C);
          (D)(i) if the application is for a drug whose route 
        of administration, dosage form, or strength of the drug 
        is the same as the route of administration, dosage 
        form, or strength of the listed drug referred to in the 
        application, information submitted in the application 
        is insufficient to show that the route of 
        administration, dosage form, or strength is the same as 
        that of the listed drug, or
          (ii) if the application is for a drug whose route of 
        administration, dosage form, or strength of the drug is 
        different from that of the listed drug referred to in 
        the application, no petition to file an application for 
        the drug with the different route of administration, 
        dosage form, or strength was approved under paragraph 
        (2)(C);
          (E) if the application was filed pursuant to the 
        approval of a petition under paragraph (2)(C), the 
        application did not contain the information required by 
        the Secretary respecting the active ingredient, route 
        of administration, dosage form, or strength which is 
        not the same;
          (F) information submitted in the application is 
        insufficient to show that the drug is bioequivalent to 
        the listed drug referred to in the application or, if 
        the application was filed pursuant to a petition 
        approved under paragraph (2)(C), information submitted 
        in the application is insufficient to show that the 
        active ingredients of the new drug are of the same 
        pharmacological or therapeutic class as those of the 
        listed drug referred to in paragraph (2)(A)(i) and that 
        the new drug can be expected to have the same 
        therapeutic effect as the listed drug when administered 
        to patients for a condition of use referred to in such 
        paragraph;
          (G) information submitted in the application is 
        insufficient to show that the labeling proposed for the 
        drug is the same as the labeling approved for the 
        listed drug referred to in the application except for 
        changes required because of differences approved under 
        a petition filed under paragraph (2)(C) or because the 
        drug and the listed drug are produced or distributed by 
        different manufacturers;
          (H) information submitted in the application or any 
        other information available to the Secretary shows that 
        (i) the inactive ingredients of the drug are unsafe for 
        use under the conditions prescribed, recommended, or 
        suggested in the labeling proposed for the drug, or 
        (ii) the composition of the drug is unsafe under such 
        conditions because of the type or quantity of inactive 
        ingredients included or the manner in which the 
        inactive ingredients are included;
          (I) the approval under subsection (c) of the listed 
        drug referred to in the application under this 
        subsection has been withdrawn or suspended for grounds 
        described in the first sentence of subsection (e), the 
        Secretary has published a notice of opportunity for 
        hearing to withdraw approval of the listed drug under 
        subsection (c) for grounds described in the first 
        sentence of subsection (e), the approval under this 
        subsection of the listed drug referred to in the 
        application under this subsection has been withdrawn or 
        suspended under paragraph (6), or the Secretary has 
        determined that the listed drug has been withdrawn from 
        sale for safety or effectiveness reasons;
          (J) the application does not meet any other 
        requirement of paragraph (2)(A); or
          (K) the application contains an untrue statement of 
        material fact.
  (5)(A) Within one hundred and eighty days of the initial 
receipt of an application under paragraph (2) or within such 
additional period as may be agreed upon by the Secretary and 
the applicant, the Secretary shall approve or disapprove the 
application.
  (B) The approval of an application submitted under paragraph 
(2) shall be made effective on the last applicable date 
determined by applying the following to each certification made 
under paragraph (2)(A)(vii):
          (i) If the applicant only made a certification 
        described in subclause (I) or (II) of paragraph 
        (2)(A)(vii) or in both such subclauses, the approval 
        may be made effective immediately.
          (ii) If the applicant made a certification described 
        in subclause (III) of paragraph (2)(A)(vii), the 
        approval may be made effective on the date certified 
        under subclause (III).
          (iii) If the applicant made a certification described 
        in subclause (IV) of paragraph (2)(A)(vii), the 
        approval shall be made effective immediately unless, 
        before the expiration of 45 days after the date on 
        which the notice described in paragraph (2)(B) is 
        received, an action is brought for infringement of the 
        patent that is the subject of the certification and for 
        which information was submitted to the Secretary under 
        subsection (b)(1) or (c)(2) before the date on which 
        the application (excluding an amendment or supplement 
        to the application), which the Secretary later 
        determines to be substantially complete, was submitted. 
        If such an action is brought before the expiration of 
        such days, the approval shall be made effective upon 
        the expiration of the thirty-month period beginning on 
        the date of the receipt of the notice provided under 
        paragraph (2)(B)(i) or such shorter or longer period as 
        the court may order because either party to the action 
        failed to reasonably cooperate in expediting the 
        action, except that--
                  (I) if before the expiration of such period 
                the district court decides that the patent is 
                invalid or not infringed (including any 
                substantive determination that there is no 
                cause of action for patent infringement or 
                invalidity), the approval shall be made 
                effective on--
                          (aa) the date on which the court 
                        enters judgment reflecting the 
                        decision; or
                          (bb) the date of a settlement order 
                        or consent decree signed and entered by 
                        the court stating that the patent that 
                        is the subject of the certification is 
                        invalid or not infringed;
                  (II) if before the expiration of such period 
                the district court decides that the patent has 
                been infringed--
                          (aa) if the judgment of the district 
                        court is appealed, the approval shall 
                        be made effective on--
                                  (AA) the date on which the 
                                court of appeals decides that 
                                the patent is invalid or not 
                                infringed (including any 
                                substantive determination that 
                                there is no cause of action for 
                                patent infringement or 
                                invalidity); or
                                  (BB) the date of a settlement 
                                order or consent decree signed 
                                and entered by the court of 
                                appeals stating that the patent 
                                that is the subject of the 
                                certification is invalid or not 
                                infringed; or
                          (bb) if the judgment of the district 
                        court is not appealed or is affirmed, 
                        the approval shall be made effective on 
                        the date specified by the district 
                        court in a court order under section 
                        271(e)(4)(A) of title 35, United States 
                        Code;
                  (III) if before the expiration of such period 
                the court grants a preliminary injunction 
                prohibiting the applicant from engaging in the 
                commercial manufacture or sale of the drug 
                until the court decides the issues of patent 
                validity and infringement and if the court 
                decides that such patent is invalid or not 
                infringed, the approval shall be made effective 
                as provided in subclause (I); or
                  (IV) if before the expiration of such period 
                the court grants a preliminary injunction 
                prohibiting the applicant from engaging in the 
                commercial manufacture or sale of the drug 
                until the court decides the issues of patent 
                validity and infringement and if the court 
                decides that such patent has been infringed, 
                the approval shall be made effective as 
                provided in subclause (II).
        In such an action, each of the parties shall reasonably 
        cooperate in expediting the action.
          (iv)  180-day exclusivity period.--
                  (I) Effectiveness of application.--Subject to 
                subparagraph (D), if the application contains a 
                certification described in paragraph 
                (2)(A)(vii)(IV) and is for a drug for which a 
                first applicant has submitted an application 
                containing such a certification, the 
                application shall be made effective on the date 
                that is 180 days after the date of the first 
                commercial marketing of the drug (including the 
                commercial marketing of the listed drug) by any 
                first applicant.
                  (II) Definitions.--In this paragraph:
                          (aa)  180-day exclusivity period.--
                        The term ``180-day exclusivity period'' 
                        means the 180-day period ending on the 
                        day before the date on which an 
                        application submitted by an applicant 
                        other than a first applicant could 
                        become effective under this clause.
                          (bb) First applicant.--As used in 
                        this subsection, the term ``first 
                        applicant'' means an applicant that, on 
                        the first day on which a substantially 
                        complete application containing a 
                        certification described in paragraph 
                        (2)(A)(vii)(IV) is submitted for 
                        approval of a drug, submits a 
                        substantially complete application that 
                        contains and lawfully maintains a 
                        certification described in paragraph 
                        (2)(A)(vii)(IV) for the drug.
                          (cc) Substantially complete 
                        application.--As used in this 
                        subsection, the term ``substantially 
                        complete application'' means an 
                        application under this subsection that 
                        on its face is sufficiently complete to 
                        permit a substantive review and 
                        contains all the information required 
                        by paragraph (2)(A).
                          (dd) Tentative approval.--
                                  (AA) In general.--The term 
                                ``tentative approval'' means 
                                notification to an applicant by 
                                the Secretary that an 
                                application under this 
                                subsection meets the 
                                requirements of paragraph 
                                (2)(A), but cannot receive 
                                effective approval because the 
                                application does not meet the 
                                requirements of this 
                                subparagraph, there is a period 
                                of exclusivity for the listed 
                                drug under subparagraph (F) or 
                                section 505A, or there is a 7-
                                year period of exclusivity for 
                                the listed drug under section 
                                527.
                                  (BB) Limitation.--A drug that 
                                is granted tentative approval 
                                by the Secretary is not an 
                                approved drug and shall not 
                                have an effective approval 
                                until the Secretary issues an 
                                approval after any necessary 
                                additional review of the 
                                application.
          (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'' means a drug--
                                  (AA) that is designated as a 
                                competitive generic therapy 
                                under section 506H; and
                                  (BB) for which there are no 
                                unexpired patents or 
                                exclusivities on the list of 
                                products described in section 
                                505(j)(7)(A) at the time of 
                                submission.
                          (bb) The term ``first approved 
                        applicant'' means any applicant that 
                        has submitted an application that--
                                  (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).
          (C) Civil action to obtain patent certainty.--
                  (i) Declaratory judgment absent infringement 
                action.--
                          (I) In general.--No action may be 
                        brought under section 2201 of title 28, 
                        United States Code, by an applicant 
                        under paragraph (2) for a declaratory 
                        judgment with respect to a patent which 
                        is the subject of the certification 
                        referred to in subparagraph (B)(iii) 
                        unless--
                                  (aa) the 45-day period 
                                referred to in such 
                                subparagraph has expired;
                                  (bb) neither the owner of 
                                such patent nor the holder of 
                                the approved application under 
                                subsection (b) for the drug 
                                that is claimed by the patent 
                                or a use of which is claimed by 
                                the patent brought a civil 
                                action against the applicant 
                                for infringement of the patent 
                                before the expiration of such 
                                period; and
                                  (cc) in any case in which the 
                                notice provided under paragraph 
                                (2)(B) relates to 
                                noninfringement, the notice was 
                                accompanied by a document 
                                described in subclause (III).
                          (II) Filing of civil action.--If the 
                        conditions described in items (aa), 
                        (bb), and as applicable, (cc) of 
                        subclause (I) have been met, the 
                        applicant referred to in such subclause 
                        may, in accordance with section 2201 of 
                        title 28, United States Code, bring a 
                        civil action under such section against 
                        the owner or holder referred to in such 
                        subclause (but not against any owner or 
                        holder that has brought such a civil 
                        action against the applicant, unless 
                        that civil action was dismissed without 
                        prejudice) for a declaratory judgment 
                        that the patent is invalid or will not 
                        be infringed by the drug for which the 
                        applicant seeks approval, except that 
                        such civil action may be brought for a 
                        declaratory judgment that the patent 
                        will not be infringed only in a case in 
                        which the condition described in 
                        subclause (I)(cc) is applicable. A 
                        civil action referred to in this 
                        subclause shall be brought in the 
                        judicial district where the defendant 
                        has its principal place of business or 
                        a regular and established place of 
                        business.
                          (III) Offer of confidential access to 
                        application.--For purposes of subclause 
                        (I)(cc), the document described in this 
                        subclause is a document providing an 
                        offer of confidential access to the 
                        application that is in the custody of 
                        the applicant under paragraph (2) for 
                        the purpose of determining whether an 
                        action referred to in subparagraph 
                        (B)(iii) should be brought. The 
                        document providing the offer of 
                        confidential access shall contain such 
                        restrictions as to persons entitled to 
                        access, and on the use and disposition 
                        of any information accessed, as would 
                        apply had a protective order been 
                        entered for the purpose of protecting 
                        trade secrets and other confidential 
                        business information. A request for 
                        access to an application under an offer 
                        of confidential access shall be 
                        considered acceptance of the offer of 
                        confidential access with the 
                        restrictions as to persons entitled to 
                        access, and on the use and disposition 
                        of any information accessed, contained 
                        in the offer of confidential access, 
                        and those restrictions and other terms 
                        of the offer of confidential access 
                        shall be considered terms of an 
                        enforceable contract. Any person 
                        provided an offer of confidential 
                        access shall review the application for 
                        the sole and limited purpose of 
                        evaluating possible infringement of the 
                        patent that is the subject of the 
                        certification under paragraph 
                        (2)(A)(vii)(IV) and for no other 
                        purpose, and may not disclose 
                        information of no relevance to any 
                        issue of patent infringement to any 
                        person other than a person provided an 
                        offer of confidential access. Further, 
                        the application may be redacted by the 
                        applicant to remove any information of 
                        no relevance to any issue of patent 
                        infringement.
                  (ii) Counterclaim to infringement action.--
                          (I) In general.--If an owner of the 
                        patent or the holder of the approved 
                        application under subsection (b) for 
                        the drug that is claimed by the patent 
                        or a use of which is claimed by the 
                        patent brings a patent infringement 
                        action against the applicant, the 
                        applicant may assert a counterclaim 
                        seeking an order requiring the holder 
                        to correct or delete the patent 
                        information submitted by the holder 
                        under subsection (b) or (c) on the 
                        ground that the patent does not claim 
                        either--
                                  (aa) the drug for which the 
                                application was approved; or
                                  (bb) an approved method of 
                                using the drug.
                          (II) No independent cause of 
                        action.--Subclause (I) does not 
                        authorize the assertion of a claim 
                        described in subclause (I) in any civil 
                        action or proceeding other than a 
                        counterclaim described in subclause 
                        (I).
                  (iii) No damages.--An applicant shall not be 
                entitled to damages in a civil action under 
                clause (i) or a counterclaim under clause (ii).
          (D) Forfeiture of 180-day exclusivity period.--
                  (i) Definition of forfeiture event.--In this 
                subparagraph, the term ``forfeiture event'', 
                with respect to an application under this 
                subsection, means the occurrence of any of the 
                following:
                          (I) Failure to market.--The first 
                        applicant fails to market the drug by 
                        the later of--
                                  (aa) the earlier of the date 
                                that is--
                                          (AA) 75 days after 
                                        the date on which the 
                                        approval of the 
                                        application of the 
                                        first applicant is made 
                                        effective under 
                                        subparagraph (B)(iii); 
                                        or
                                          (BB) 30 months after 
                                        the date of submission 
                                        of the application of 
                                        the first applicant; or
                                  (bb) with respect to the 
                                first applicant or any other 
                                applicant (which other 
                                applicant has received 
                                tentative approval), the date 
                                that is 75 days after the date 
                                as of which, as to each of the 
                                patents with respect to which 
                                the first applicant submitted 
                                and lawfully maintained a 
                                certification qualifying the 
                                first applicant for the 180-day 
                                exclusivity period under 
                                subparagraph (B)(iv), at least 
                                1 of the following has 
                                occurred:
                                          (AA) In an 
                                        infringement action 
                                        brought against that 
                                        applicant with respect 
                                        to the patent or in a 
                                        declaratory judgment 
                                        action brought by that 
                                        applicant with respect 
                                        to the patent, a court 
                                        enters a final decision 
                                        from which no appeal 
                                        (other than a petition 
                                        to the Supreme Court 
                                        for a writ of 
                                        certiorari) has been or 
                                        can be taken that the 
                                        patent is invalid or 
                                        not infringed.
                                          (BB) In an 
                                        infringement action or 
                                        a declaratory judgment 
                                        action described in 
                                        subitem (AA), a court 
                                        signs a settlement 
                                        order or consent decree 
                                        that enters a final 
                                        judgment that includes 
                                        a finding that the 
                                        patent is invalid or 
                                        not infringed.
                                          (CC) The patent 
                                        information submitted 
                                        under subsection (b) or 
                                        (c) is withdrawn by the 
                                        holder of the 
                                        application approved 
                                        under subsection (b).
                          (II) Withdrawal of application.--The 
                        first applicant withdraws the 
                        application or the Secretary considers 
                        the application to have been withdrawn 
                        as a result of a determination by the 
                        Secretary that the application does not 
                        meet the requirements for approval 
                        under paragraph (4).
                          (III) Amendment of certification.--
                        The first applicant amends or withdraws 
                        the certification for all of the 
                        patents with respect to which that 
                        applicant submitted a certification 
                        qualifying the applicant for the 180-
                        day exclusivity period.
                          (IV) Failure to obtain tentative 
                        approval.--The first applicant fails to 
                        obtain tentative approval of the 
                        application within 30 months after the 
                        date on which the application is filed, 
                        unless the failure is caused by a 
                        change in or a review of the 
                        requirements for approval of the 
                        application imposed after the date on 
                        which the application is filed.
                          (V) Agreement with another applicant, 
                        the listed drug application holder, or 
                        a patent owner.--The first applicant 
                        enters into an agreement with another 
                        applicant under this subsection for the 
                        drug, the holder of the application for 
                        the listed drug, or an owner of the 
                        patent that is the subject of the 
                        certification under paragraph 
                        (2)(A)(vii)(IV), the Federal Trade 
                        Commission or the Attorney General 
                        files a complaint, and there is a final 
                        decision of the Federal Trade 
                        Commission or the court with regard to 
                        the complaint from which no appeal 
                        (other than a petition to the Supreme 
                        Court for a writ of certiorari) has 
                        been or can be taken that the agreement 
                        has violated the antitrust laws (as 
                        defined in section 1 of the Clayton Act 
                        (15 U.S.C. 12), except that the term 
                        includes section 5 of the Federal Trade 
                        Commission Act (15 U.S.C. 45) to the 
                        extent that that section applies to 
                        unfair methods of competition).
                          (VI) Expiration of all patents.--All 
                        of the patents as to which the 
                        applicant submitted a certification 
                        qualifying it for the 180-day 
                        exclusivity period have expired.
                  (ii) Forfeiture.--The 180-day exclusivity 
                period described in subparagraph (B)(iv) shall 
                be forfeited by a first applicant if a 
                forfeiture event occurs with respect to that 
                first applicant.
                  (iii) Subsequent applicant.--If all first 
                applicants forfeit the 180-day exclusivity 
                period under clause (ii)--
                          (I) approval of any application 
                        containing a certification described in 
                        paragraph (2)(A)(vii)(IV) shall be made 
                        effective in accordance with 
                        subparagraph (B)(iii); and
                          (II) no applicant shall be eligible 
                        for a 180-day exclusivity period.
                  (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.
  (E) If the Secretary decides to disapprove an application, 
the Secretary shall give the applicant notice of an opportunity 
for a hearing before the Secretary on the question of whether 
such application is approvable. If the applicant elects to 
accept the opportunity for hearing by written request within 
thirty days after such notice, such hearing shall commence not 
more than ninety days after the expiration of such thirty days 
unless the Secretary and the applicant otherwise agree. Any 
such hearing shall thereafter be conducted on an expedited 
basis and the Secretary's order thereon shall be issued within 
ninety days after the date fixed by the Secretary for filing 
final briefs.
  (F)
  (ii) If an application submitted under subsection (b) for a 
drug, no active moiety (as defined by the Secretary in section 
314.3 of title 21, Code of Federal Regulations (or any 
successor regulations)) of which has been approved in any other 
application under subsection (b), is approved after the date of 
the enactment of this subsection, no application may be 
submitted under this subsection which refers to the drug for 
which the subsection (b) application was submitted before the 
expiration of five years from the date of the approval of the 
application under subsection (b), except that such an 
application may be submitted under this subsection after the 
expiration of four years from the date of the approval of the 
subsection (b) application if it contains a certification of 
patent invalidity or noninfringement described in subclause 
(IV) of paragraph (2)(A)(vii). The approval of such an 
application shall be made effective in accordance with 
subparagraph (B) except that, if an action for patent 
infringement is commenced during the one-year period beginning 
forty-eight months after the date of the approval of the 
subsection (b) application, the thirty-month period referred to 
in subparagraph (B)(iii) shall be extended by such amount of 
time (if any) which is required for seven and one-half years to 
have elapsed from the date of approval of the subsection (b) 
application.
  (iii) If an application submitted under subsection (b) for a 
drug, which includes an active moiety (as defined by the 
Secretary in section 314.3 of title 21, Code of Federal 
Regulations (or any successor regulations)) that has been 
approved in another application approved under subsection (b), 
is approved after the date of enactment of this subsection and 
if such application contains reports of new clinical 
investigations (other than bioavailability studies) essential 
to the approval of the application and conducted or sponsored 
by the applicant, the Secretary may not make the approval of an 
application submitted under this subsection for the conditions 
of approval of such drug in the subsection (b) application 
effective before the expiration of three years from the date of 
the approval of the application under subsection (b) for such 
drug.
  (iv) If a supplement to an application approved under 
subsection (b) is approved after the date of enactment of this 
subsection and the supplement contains reports of new clinical 
investigations (other than bioavailability studies) essential 
to the approval of the supplement and conducted or sponsored by 
the person submitting the supplement, the Secretary may not 
make the approval of an application submitted under this 
subsection for a change approved in the supplement effective 
before the expiration of three years from the date of the 
approval of the supplement under subsection (b).
  (v) If an application (or supplement to an application) 
submitted under subsection (b) for a drug, which includes an 
active moiety (as defined by the Secretary in section 314.3 of 
title 21, Code of Federal Regulations (or any successor 
regulations)) that has been approved in another application 
under subsection (b), was approved during the period beginning 
January 1, 1982, and ending on the date of the enactment of 
this subsection, the Secretary may not make the approval of an 
application submitted under this subsection which refers to the 
drug for which the subsection (b) application was submitted or 
which refers to a change approved in a supplement to the 
subsection (b) application effective before the expiration of 
two years from the date of enactment of this subsection.
  (6) If a drug approved under this subsection refers in its 
approved application to a drug the approval of which was 
withdrawn or suspended for grounds described in the first 
sentence of subsection (e) or was withdrawn or suspended under 
this paragraph or which, as determined by the Secretary, has 
been withdrawn from sale for safety or effectiveness reasons, 
the approval of the drug under this subsection shall be 
withdrawn or suspended--
          (A) for the same period as the withdrawal or 
        suspension under subsection (e) or this paragraph, or
          (B) if the listed drug has been withdrawn from sale, 
        for the period of withdrawal from sale or, if earlier, 
        the period ending on the date the Secretary determines 
        that the withdrawal from sale is not for safety or 
        effectiveness reasons.
  (7)(A)(i) Within sixty days of the date of the enactment of 
this subsection, the Secretary shall publish and make available 
to the public--
          (I) a list in alphabetical order of the official and 
        proprietary name of each drug which has been approved 
        for safety and effectiveness under subsection (c) 
        before the date of the enactment of this subsection;
          (II) the date of approval if the drug is approved 
        after 1981 and the number of the application which was 
        approved; and
          (III) whether in vitro or in vivo bioequivalence 
        studies, or both such studies, are required for 
        applications filed under this subsection which will 
        refer to the drug published.
  (ii) Every thirty days after the publication of the first 
list under clause (i) the Secretary shall revise the list to 
include each drug which has been approved for safety and 
effectiveness under subsection (c) or approved under this 
subsection during the thirty-day period.
  (iii) When patent information submitted under subsection (c) 
respecting a drug included on the list is to be published by 
the Secretary, the Secretary shall, in revisions made under 
clause (ii), include such information for such drug.
  (iv) For each drug included on the list, the Secretary shall 
specify any exclusivity period that is applicable, for which 
the Secretary has determined the expiration date, and for which 
such period has not yet expired, under--
          (I) clause (ii), (iii), or (iv) of subsection 
        (c)(3)(E);
          (II) clause (iv) or (v) of paragraph (5)(B);
          (III) clause (ii), (iii), or (iv) of paragraph 
        (5)(F);
          (IV) section 505A;
          (V) section 505E;
          (VI) section 527(a); or
          (VII) subsection (u).
  (B) A drug approved for safety and effectiveness under 
subsection (c) or approved under this subsection shall, for 
purposes of this subsection, be considered to have been 
published under subparagraph (A) on the date of its approval or 
the date of enactment, whichever is later.
  (C) If the approval of a drug was withdrawn or suspended for 
grounds described in the first sentence of subsection (e) or 
was withdrawn or suspended under paragraph (6) or if the 
Secretary determines that a drug has been withdrawn from sale 
for safety or effectiveness reasons, it may not be published in 
the list under subparagraph (A) or, if the withdrawal or 
suspension occurred after its publication in such list, it 
shall be immediately removed from such list--
          (i) for the same period as the withdrawal or 
        suspension under subsection (e) or paragraph (6), or
          (ii) if the listed drug has been withdrawn from sale, 
        for the period of withdrawal from sale or, if earlier, 
        the period ending on the date the Secretary determines 
        that the withdrawal from sale is not for safety or 
        effectiveness reasons.
A notice of the removal shall be published in the Federal 
Register.
  (D) In the case of a listed drug for which the list under 
subparagraph (A)(i) includes a patent for such drug, and any 
claim of the patent has been cancelled or invalidated pursuant 
to a final decision issued by the Patent Trial and Appeal Board 
of the United States Patent and Trademark Office or by a court, 
from which no appeal has been, or can be, taken, if the holder 
of the applicable application approved under subsection (c) 
determines that a patent for such drug, or any patent 
information for such drug, no longer meets the listing 
requirements under this section--
          (i) the holder of such approved application shall 
        notify the Secretary, in writing, within 14 days of 
        such decision of such cancellation or invalidation and 
        request that such patent or patent information, as 
        applicable, be amended or withdrawn in accordance with 
        the decision issued by the Patent Trial and Appeal 
        Board or a court;
          (ii) the holder of such approved application shall 
        include in any notification under clause (i) 
        information related to such patent cancellation or 
        invalidation decision and submit such information, 
        including a copy of such decision, to the Secretary; 
        and
          (iii) the Secretary shall, in response to a 
        notification under clause (i), amend or remove patent 
        or patent information in accordance with the relevant 
        decision from the Patent Trial and Appeals Board or 
        court, as applicable, except that the Secretary shall 
        not remove from the list any patent or patent 
        information before the expiration of any 180-day 
        exclusivity period under paragraph (5)(B)(iv) that 
        relies on a certification described in paragraph 
        (2)(A)(vii)(IV).
  (8) For purposes of this subsection:
          (A)(i) The term ``bioavailability'' means the rate 
        and extent to which the active ingredient or 
        therapeutic ingredient is absorbed from a drug and 
        becomes available at the site of drug action.
          (ii) For a drug that is not intended to be absorbed 
        into the bloodstream, the Secretary may assess 
        bioavailability by scientifically valid measurements 
        intended to reflect the rate and extent to which the 
        active ingredient or therapeutic ingredient becomes 
        available at the site of drug action.
          (B) A drug shall be considered to be bioequivalent to 
        a listed drug if--
                  (i) the rate and extent of absorption of the 
                drug do not show a significant difference from 
                the rate and extent of absorption of the listed 
                drug when administered at the same molar dose 
                of the therapeutic ingredient under similar 
                experimental conditions in either a single dose 
                or multiple doses; or
                  (ii) the extent of absorption of the drug 
                does not show a significant difference from the 
                extent of absorption of the listed drug when 
                administered at the same molar dose of the 
                therapeutic ingredient under similar 
                experimental conditions in either a single dose 
                or multiple doses and the difference from the 
                listed drug in the rate of absorption of the 
                drug is intentional, is reflected in its 
                proposed labeling, is not essential to the 
                attainment of effective body drug 
                concentrations on chronic use, and is 
                considered medically insignificant for the 
                drug.
          (C) For a drug that is not intended to be absorbed 
        into the bloodstream, the Secretary may establish 
        alternative, scientifically valid methods to show 
        bioequivalence if the alternative methods are expected 
        to detect a significant difference between the drug and 
        the listed drug in safety and therapeutic effect.
  (9) The Secretary shall, with respect to each application 
submitted under this subsection, maintain a record of--
          (A) the name of the applicant,
          (B) the name of the drug covered by the application,
          (C) the name of each person to whom the review of the 
        chemistry of the application was assigned and the date 
        of such assignment, and
          (D) the name of each person to whom the 
        bioequivalence review for such application was assigned 
        and the date of such assignment.
The information the Secretary is required to maintain under 
this paragraph with respect to an application submitted under 
this subsection shall be made available to the public after the 
approval of such application.
  (10)(A) If the proposed labeling of a drug that is the 
subject of an application under this subsection differs from 
the listed drug due to a labeling revision described under 
clause (i), the drug that is the subject of such application 
shall, notwithstanding any other provision of this Act, be 
eligible for approval and shall not be considered misbranded 
under section 502 if--
          [(i) the application is otherwise eligible for 
        approval under this subsection but for expiration of 
        patent, an exclusivity period, or of a delay in 
        approval described in paragraph (5)(B)(iii), and a 
        revision to the labeling of the listed drug has been 
        approved by the Secretary within 60 days of such 
        expiration;
          [(ii) the labeling revision described under clause 
        (i) does not include a change to the ``Warnings'' 
        section of the labeling;
          [(iii) the sponsor of the application under this 
        subsection agrees to submit revised labeling of the 
        drug that is the subject of such application not later 
        than 60 days after the notification of any changes to 
        such labeling required by the Secretary; and]
          (i) a revision to the labeling of the listed drug has 
        been approved by the Secretary within 90 days of when 
        the application is otherwise eligible for approval 
        under this subsection;
          (ii) the sponsor of the application agrees to submit 
        revised labeling for the drug that is the subject of 
        the application not later than 60 days after approval 
        under this subsection of the application;
          (iii) the labeling revision described under clause 
        (i) does not include a change to the ``Warnings'' 
        section of the labeling; and
          (iv) such application otherwise meets the applicable 
        requirements for approval under this subsection.
  (B) If, after a labeling revision described in subparagraph 
(A)(i), the Secretary determines that the continued presence in 
interstate commerce of the labeling of the listed drug (as in 
effect before the revision described in subparagraph (A)(i)) 
adversely impacts the safe use of the drug, no application 
under this subsection shall be eligible for approval with such 
labeling.
  (11)(A) Subject to subparagraph (B), the Secretary shall 
prioritize the review of, and act within 8 months of the date 
of the submission of, an original abbreviated new drug 
application submitted for review under this subsection that is 
for a drug--
          (i) for which there are not more than 3 approved drug 
        products listed under paragraph (7) and for which there 
        are no blocking patents and exclusivities; or
          (ii) that has been included on the list under section 
        506E.
  (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 Secretary may 
prioritize pursuant to subparagraph (D), the applicant shall 
provide complete, accurate information regarding facilities 
involved in manufacturing processes and testing of the drug 
that is the subject of the application, including facilities in 
corresponding Type II active pharmaceutical ingredients drug 
master files referenced in an application and sites or 
organizations involved in bioequivalence and clinical studies 
used to support the application, to enable the Secretary 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 
application, which shall be unchanged relative to the date of 
the submission of such application, except to the extent that a 
change is made to such information to exclude a facility that 
was not used to generate data to meet any application 
requirements for such submission and that is not the only 
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.
  (C) The Secretary may expedite an inspection or reinspection 
under section 704 of an establishment that proposes to 
manufacture a drug described in subparagraph (A).
  (D) Nothing in this paragraph shall prevent the Secretary 
from prioritizing the review of other applications as the 
Secretary determines appropriate.
  (12) The Secretary shall publish on the internet website of 
the Food and Drug Administration, and update at least once 
every 6 months, a list of all drugs approved 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.
  (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.
  (k)(1) In the case of any drug for which an approval of an 
application filed under subsection (b) or (j) is in effect, the 
applicant shall establish and maintain such records, and make 
such reports to the Secretary, of data relating to clinical 
experience and other data or information, received or otherwise 
obtained by such applicant with respect to such drug, as the 
Secretary may by general regulation, or by order with respect 
to such application, prescribe on the basis of a finding that 
such records and reports are necessary in order to enable the 
Secretary to determine, or facilitate a determination, whether 
there is or may be ground for invoking subsection (e) of this 
section. Regulations and orders issued under this subsection 
and under subsection (i) shall have due regard for the 
professional ethics of the medical profession and the interests 
of patients and shall provide, where the Secretary deems it to 
be appropriate, for the examination, upon request, by the 
persons to whom such regulations or orders are applicable, of 
similar information received or otherwise obtained by the 
Secretary.
  (2) Every person required under this section to maintain 
records, and every person in charge or custody thereof, shall, 
upon request of an officer or employee designated by the 
Secretary, permit such officer or employee at all reasonable 
times to have access to and copy and verify such records.
          (3) Active postmarket risk identification.--
                  (A) Definition.--In this paragraph, the term 
                ``data'' refers to information with respect to 
                a drug approved under this section or under 
                section 351 of the Public Health Service Act, 
                including claims data, patient survey data, 
                standardized analytic files that allow for the 
                pooling and analysis of data from disparate 
                data environments, and any other data deemed 
                appropriate by the Secretary.
                  (B) Development of postmarket risk 
                identification and analysis methods.--The 
                Secretary shall, not later than 2 years after 
                the date of the enactment of the Food and Drug 
                Administration Amendments Act of 2007, in 
                collaboration with public, academic, and 
                private entities--
                          (i) develop methods to obtain access 
                        to disparate data sources including the 
                        data sources specified in subparagraph 
                        (C);
                          (ii) develop validated methods for 
                        the establishment of a postmarket risk 
                        identification and analysis system to 
                        link and analyze safety data from 
                        multiple sources, with the goals of 
                        including, in aggregate--
                                  (I) at least 25,000,000 
                                patients by July 1, 2010; and
                                  (II) at least 100,000,000 
                                patients by July 1, 2012; and
                          (iii) convene a committee of experts, 
                        including individuals who are 
                        recognized in the field of protecting 
                        data privacy and security, to make 
                        recommendations to the Secretary on the 
                        development of tools and methods for 
                        the ethical and scientific uses for, 
                        and communication of, postmarketing 
                        data specified under subparagraph (C), 
                        including recommendations on the 
                        development of effective research 
                        methods for the study of drug safety 
                        questions.
                  (C) Establishment of the postmarket risk 
                identification and analysis system.--
                          (i) In general.--The Secretary shall, 
                        not later than 1 year after the 
                        development of the risk identification 
                        and analysis methods under subparagraph 
                        (B), establish and maintain 
                        procedures--
                                  (I) for risk identification 
                                and analysis based on 
                                electronic health data, in 
                                compliance with the regulations 
                                promulgated under section 
                                264(c) of the Health Insurance 
                                Portability and Accountability 
                                Act of 1996, and in a manner 
                                that does not disclose 
                                individually identifiable 
                                health information in violation 
                                of paragraph (4)(B);
                                  (II) for the reporting (in a 
                                standardized form) of data on 
                                all serious adverse drug 
                                experiences (as defined in 
                                section 505-1(b)) submitted to 
                                the Secretary under paragraph 
                                (1), and those adverse events 
                                submitted by patients, 
                                providers, and drug sponsors, 
                                when appropriate;
                                  (III) to provide for active 
                                adverse event surveillance 
                                using the following data 
                                sources, as available:
                                          (aa) Federal health-
                                        related electronic data 
                                        (such as data from the 
                                        Medicare program and 
                                        the health systems of 
                                        the Department of 
                                        Veterans Affairs);
                                          (bb) private sector 
                                        health-related 
                                        electronic data (such 
                                        as pharmaceutical 
                                        purchase data and 
                                        health insurance claims 
                                        data); and
                                          (cc) other data as 
                                        the Secretary deems 
                                        necessary to create a 
                                        robust system to 
                                        identify adverse events 
                                        and potential drug 
                                        safety signals;
                                  (IV) to identify certain 
                                trends and patterns with 
                                respect to data accessed by the 
                                system;
                                  (V) to provide regular 
                                reports to the Secretary 
                                concerning adverse event 
                                trends, adverse event patterns, 
                                incidence and prevalence of 
                                adverse events, and other 
                                information the Secretary 
                                determines appropriate, which 
                                may include data on comparative 
                                national adverse event trends; 
                                and
                                  (VI) to enable the program to 
                                export data in a form 
                                appropriate for further 
                                aggregation, statistical 
                                analysis, and reporting.
                          (ii) Timeliness of reporting.--The 
                        procedures established under clause (i) 
                        shall ensure that such data are 
                        accessed, analyzed, and reported in a 
                        timely, routine, and systematic manner, 
                        taking into consideration the need for 
                        data completeness, coding, cleansing, 
                        and standardized analysis and 
                        transmission.
                          (iii) Private sector resources.--To 
                        ensure the establishment of the active 
                        postmarket risk identification and 
                        analysis system under this subsection 
                        not later than 1 year after the 
                        development of the risk identification 
                        and analysis methods under subparagraph 
                        (B), as required under clause (i), the 
                        Secretary may, on a temporary or 
                        permanent basis, implement systems or 
                        products developed by private entities.
                          (iv) Complementary approaches.--To 
                        the extent the active postmarket risk 
                        identification and analysis system 
                        under this subsection is not sufficient 
                        to gather data and information relevant 
                        to a priority drug safety question, the 
                        Secretary shall develop, support, and 
                        participate in complementary approaches 
                        to gather and analyze such data and 
                        information, including--
                                  (I) approaches that are 
                                complementary with respect to 
                                assessing the safety of use of 
                                a drug in domestic populations 
                                not included, or 
                                underrepresented, in the trials 
                                used to approve the drug (such 
                                as older people, people with 
                                comorbidities, pregnant women, 
                                or children); and
                                  (II) existing approaches such 
                                as the Vaccine Adverse Event 
                                Reporting System and the 
                                Vaccine Safety Datalink or 
                                successor databases.
                          (v) Authority for contracts.--The 
                        Secretary may enter into contracts with 
                        public and private entities to fulfill 
                        the requirements of this subparagraph.
          (4) Advanced analysis of drug safety data.--
                  (A) Purpose.--The Secretary shall establish 
                collaborations with public, academic, and 
                private entities, which may include the Centers 
                for Education and Research on Therapeutics 
                under section 912 of the Public Health Service 
                Act, to provide for advanced analysis of drug 
                safety data described in paragraph (3)(C) and 
                other information that is publicly available or 
                is provided by the Secretary, in order to--
                          (i) improve the quality and 
                        efficiency of postmarket drug safety 
                        risk-benefit analysis;
                          (ii) provide the Secretary with 
                        routine access to outside expertise to 
                        study advanced drug safety questions; 
                        and
                          (iii) enhance the ability of the 
                        Secretary to make timely assessments 
                        based on drug safety data.
                  (B) Privacy.--Such analysis shall not 
                disclose individually identifiable health 
                information when presenting such drug safety 
                signals and trends or when responding to 
                inquiries regarding such drug safety signals 
                and trends.
                  (C) Public process for priority questions.--
                At least biannually, the Secretary shall seek 
                recommendations from the Drug Safety and Risk 
                Management Advisory Committee (or any successor 
                committee) and from other advisory committees, 
                as appropriate, to the Food and Drug 
                Administration on--
                          (i) priority drug safety questions; 
                        and
                          (ii) mechanisms for answering such 
                        questions, including through--
                                  (I) active risk 
                                identification under paragraph 
                                (3); and
                                  (II) when such risk 
                                identification is not 
                                sufficient, postapproval 
                                studies and clinical trials 
                                under subsection (o)(3).
                  (D) Procedures for the development of drug 
                safety collaborations.--
                          (i) In general.--Not later than 180 
                        days after the date of the 
                        establishment of the active postmarket 
                        risk identification and analysis system 
                        under this subsection, the Secretary 
                        shall establish and implement 
                        procedures under which the Secretary 
                        may routinely contract with one or more 
                        qualified entities to--
                                  (I) classify, analyze, or 
                                aggregate data described in 
                                paragraph (3)(C) and 
                                information that is publicly 
                                available or is provided by the 
                                Secretary;
                                  (II) allow for prompt 
                                investigation of priority drug 
                                safety questions, including--
                                          (aa) unresolved 
                                        safety questions for 
                                        drugs or classes of 
                                        drugs; and
                                          (bb) for a newly-
                                        approved drugs, safety 
                                        signals from clinical 
                                        trials used to approve 
                                        the drug and other 
                                        preapproval trials; 
                                        rare, serious drug side 
                                        effects; and the safety 
                                        of use in domestic 
                                        populations not 
                                        included, or 
                                        underrepresented, in 
                                        the trials used to 
                                        approve the drug (such 
                                        as older people, people 
                                        with comorbidities, 
                                        pregnant women, or 
                                        children);
                                  (III) perform advanced 
                                research and analysis on 
                                identified drug safety risks;
                                  (IV) focus postapproval 
                                studies and clinical trials 
                                under subsection (o)(3) more 
                                effectively on cases for which 
                                reports under paragraph (1) and 
                                other safety signal detection 
                                is not sufficient to resolve 
                                whether there is an elevated 
                                risk of a serious adverse event 
                                associated with the use of a 
                                drug; and
                                  (V) carry out other 
                                activities as the Secretary 
                                deems necessary to carry out 
                                the purposes of this paragraph.
                          (ii) Request for specific 
                        methodology.--The procedures described 
                        in clause (i) shall permit the 
                        Secretary to request that a specific 
                        methodology be used by the qualified 
                        entity. The qualified entity shall work 
                        with the Secretary to finalize the 
                        methodology to be used.
                  (E) Use of analyses.--The Secretary shall 
                provide the analyses described in this 
                paragraph, including the methods and results of 
                such analyses, about a drug to the sponsor or 
                sponsors of such drug.
                  (F) Qualified entities.--
                          (i) In general.--The Secretary shall 
                        enter into contracts with a sufficient 
                        number of qualified entities to develop 
                        and provide information to the 
                        Secretary in a timely manner.
                          (ii) Qualification.--The Secretary 
                        shall enter into a contract with an 
                        entity under clause (i) only if the 
                        Secretary determines that the entity 
                        has a significant presence in the 
                        United States and has one or more of 
                        the following qualifications:
                                  (I) The research, 
                                statistical, epidemiologic, or 
                                clinical capability and 
                                expertise to conduct and 
                                complete the activities under 
                                this paragraph, including the 
                                capability and expertise to 
                                provide the Secretary de-
                                identified data consistent with 
                                the requirements of this 
                                subsection.
                                  (II) An information 
                                technology infrastructure in 
                                place to support electronic 
                                data and operational standards 
                                to provide security for such 
                                data.
                                  (III) Experience with, and 
                                expertise on, the development 
                                of drug safety and 
                                effectiveness research using 
                                electronic population data.
                                  (IV) An understanding of drug 
                                development or risk/benefit 
                                balancing in a clinical 
                                setting.
                                  (V) Other expertise which the 
                                Secretary deems necessary to 
                                fulfill the activities under 
                                this paragraph.
                  (G) Contract requirements.--Each contract 
                with a qualified entity under subparagraph 
                (F)(i) shall contain the following 
                requirements:
                          (i) Ensuring privacy.--The qualified 
                        entity shall ensure that the entity 
                        will not use data under this subsection 
                        in a manner that--
                                  (I) violates the regulations 
                                promulgated under section 
                                264(c) of the Health Insurance 
                                Portability and Accountability 
                                Act of 1996;
                                  (II) violates sections 552 or 
                                552a of title 5, United States 
                                Code, with regard to the 
                                privacy of individually-
                                identifiable beneficiary health 
                                information; or
                                  (III) discloses individually 
                                identifiable health information 
                                when presenting drug safety 
                                signals and trends or when 
                                responding to inquiries 
                                regarding drug safety signals 
                                and trends.
                        Nothing in this clause prohibits lawful 
                        disclosure for other purposes.
                          (ii) Component of another 
                        organization.--If a qualified entity is 
                        a component of another organization--
                                  (I) the qualified entity 
                                shall establish appropriate 
                                security measures to maintain 
                                the confidentiality and privacy 
                                of such data; and
                                  (II) the entity shall not 
                                make an unauthorized disclosure 
                                of such data to the other 
                                components of the organization 
                                in breach of such 
                                confidentiality and privacy 
                                requirement.
                          (iii) Termination or nonrenewal.--If 
                        a contract with a qualified entity 
                        under this subparagraph is terminated 
                        or not renewed, the following 
                        requirements shall apply:
                                  (I) Confidentiality and 
                                privacy protections.--The 
                                entity shall continue to comply 
                                with the confidentiality and 
                                privacy requirements under this 
                                paragraph with respect to all 
                                data disclosed to the entity.
                                  (II) Disposition of data.--
                                The entity shall return any 
                                data disclosed to such entity 
                                under this subsection to which 
                                it would not otherwise have 
                                access or, if returning the 
                                data is not practicable, 
                                destroy the data.
                  (H) Competitive procedures.--The Secretary 
                shall use competitive procedures (as defined in 
                section 4(5) of the Federal Procurement Policy 
                Act) to enter into contracts under subparagraph 
                (G).
                  (I) Review of contract in the event of a 
                merger or acquisition.--The Secretary shall 
                review the contract with a qualified entity 
                under this paragraph in the event of a merger 
                or acquisition of the entity in order to ensure 
                that the requirements under this paragraph will 
                continue to be met.
                  (J) Coordination.--In carrying out this 
                paragraph, the Secretary shall provide for 
                appropriate communications to the public, 
                scientific, public health, and medical 
                communities, and other key stakeholders, and to 
                the extent practicable shall coordinate with 
                the activities of private entities, 
                professional associations, or other entities 
                that may have sources of drug safety data.
          (5) The Secretary shall--
                  (A) conduct regular screenings of the Adverse 
                Event Reporting System database and post a 
                quarterly report on the Adverse Event Reporting 
                System Web site of any new safety information 
                or potential signal of a serious risk 
                identified by Adverse Event Reporting System 
                within the last quarter; and
                  (B) on an annual basis, review the entire 
                backlog of postmarket safety commitments to 
                determine which commitments require revision or 
                should be eliminated, report to the Congress on 
                these determinations, and assign start dates 
                and estimated completion dates for such 
                commitments; and
          (C) make available on the Internet website of the 
        Food and Drug Administration--
                  (i) guidelines, developed with input from 
                experts qualified by scientific training and 
                experience to evaluate the safety and 
                effectiveness of drugs, that detail best 
                practices for drug safety surveillance using 
                the Adverse Event Reporting System; and
                  (ii) criteria for public posting of adverse 
                event signals.
  (l)(1) Safety and effectiveness data and information which 
has been submitted in an application under subsection (b) for a 
drug and which has not previously been disclosed to the public 
shall be made available to the public, upon request, unless 
extraordinary circumstances are shown--
          (A) if no work is being or will be undertaken to have 
        the application approved,
          (B) if the Secretary has determined that the 
        application is not approvable and all legal appeals 
        have been exhausted,
          (C) if approval of the application under subsection 
        (c) is withdrawn and all legal appeals have been 
        exhausted,
          (D) if the Secretary has determined that such drug is 
        not a new drug, or
          (E) upon the effective date of the approval of the 
        first application under subsection (j) which refers to 
        such drug or upon the date upon which the approval of 
        an application under subsection (j) which refers to 
        such drug could be made effective if such an 
        application had been submitted.
  (2) Action Package for Approval.--
          (A) Action package.--The Secretary shall publish the 
        action package for approval of an application under 
        subsection (b) or section 351 of the Public Health 
        Service Act on the Internet Web site of the Food and 
        Drug Administration--
                  (i) not later than 30 days after the date of 
                approval of such applications--
                          (I) for a drug, no active moiety (as 
                        defined by the Secretary in section 
                        314.3 of title 21, Code of Federal 
                        Regulations (or any successor 
                        regulations)) of which has been 
                        approved in any other application under 
                        this section; or
                          (II) for a biological product, no 
                        active ingredient of which has been 
                        approved in any other application under 
                        section 351 of the Public Health 
                        Service Act; and
                  (ii) not later than 30 days after the third 
                request for such action package for approval 
                received under section 552 of title 5, United 
                States Code, for any other drug or biological 
                product.
          (B) Immediate publication of summary review.--
        Notwithstanding subparagraph (A), the Secretary shall 
        publish, on the Internet Web site of the Food and Drug 
        Administration, the materials described in subparagraph 
        (C)(iv) not later than 48 hours after the date of 
        approval of the drug, except where such materials 
        require redaction by the Secretary.
          (C) Contents.--An action package for approval of an 
        application under subparagraph (A) shall be dated and 
        shall include the following:
                  (i) Documents generated by the Food and Drug 
                Administration related to review of the 
                application.
                  (ii) Documents pertaining to the format and 
                content of the application generated during 
                drug development.
                  (iii) Labeling submitted by the applicant.
                  (iv) A summary review that documents 
                conclusions from all reviewing disciplines 
                about the drug, noting any critical issues and 
                disagreements with the applicant and within the 
                review team and how they were resolved, 
                recommendations for action, and an explanation 
                of any nonconcurrence with review conclusions.
                  (v) The Division Director and Office 
                Director's decision document which includes--
                          (I) a brief statement of concurrence 
                        with the summary review;
                          (II) a separate review or addendum to 
                        the review if disagreeing with the 
                        summary review; and
                          (III) a separate review or addendum 
                        to the review to add further analysis.
                  (vi) Identification by name of each officer 
                or employee of the Food and Drug Administration 
                who--
                          (I) participated in the decision to 
                        approve the application; and
                          (II) consents to have his or her name 
                        included in the package.
          (D) Review.--A scientific review of an application is 
        considered the work of the reviewer and shall not be 
        altered by management or the reviewer once final.
          (E) Confidential information.--This paragraph does 
        not authorize the disclosure of any trade secret, 
        confidential commercial or financial information, or 
        other matter listed in section 552(b) of title 5, 
        United States Code.
  (m) For purposes of this section, the term ``patent'' means a 
patent issued by the United States Patent and Trademark Office.
  (n)(1) For the purpose of providing expert scientific advice 
and recommendations to the Secretary regarding a clinical 
investigation of a drug or the approval for marketing of a drug 
under section 505 or section 351 of the Public Health Service 
Act, the Secretary shall establish panels of experts or use 
panels of experts established before the date of enactment of 
the Food and Drug Administration Modernization Act of 1997, or 
both.
  (2) The Secretary may delegate the appointment and oversight 
authority granted under section 1004 to a director of a center 
or successor entity within the Food and Drug Administration.
  (3) The Secretary shall make appointments to each panel 
established under paragraph (1) so that each panel shall 
consist of--
          (A) members who are qualified by training and 
        experience to evaluate the safety and effectiveness of 
        the drugs to be referred to the panel and who, to the 
        extent feasible, possess skill and experience in the 
        development, manufacture, or utilization of such drugs;
          (B) members with diverse expertise in such fields as 
        clinical and administrative medicine, pharmacy, 
        pharmacology, pharmacoeconomics, biological and 
        physical sciences, and other related professions;
          (C) a representative of consumer interests, and a 
        representative of interests of the drug manufacturing 
        industry not directly affected by the matter to be 
        brought before the panel; and
          (D) two or more members who are specialists or have 
        other expertise in the particular disease or condition 
        for which the drug under review is proposed to be 
        indicated.
Scientific, trade, and consumer organizations shall be afforded 
an opportunity to nominate individuals for appointment to the 
panels. No individual who is in the regular full-time employ of 
the United States and engaged in the administration of this Act 
may be a voting member of any panel. The Secretary shall 
designate one of the members of each panel to serve as chairman 
thereof.
  (4) The Secretary shall, as appropriate, provide education 
and training to each new panel member before such member 
participates in a panel's activities, including education 
regarding requirements under this Act and related regulations 
of the Secretary, and the administrative processes and 
procedures related to panel meetings.
  (5) Panel members (other than officers or employees of the 
United States), while attending meetings or conferences of a 
panel or otherwise engaged in its business, shall be entitled 
to receive compensation for each day so engaged, including 
traveltime, at rates to be fixed by the Secretary, but not to 
exceed the daily equivalent of the rate in effect for positions 
classified above grade GS-15 of the General Schedule. While 
serving away from their homes or regular places of business, 
panel members may be allowed travel expenses (including per 
diem in lieu of subsistence) as authorized by section 5703 of 
title 5, United States Code, for persons in the Government 
service employed intermittently.
  (6) The Secretary shall ensure that scientific advisory 
panels meet regularly and at appropriate intervals so that any 
matter to be reviewed by such a panel can be presented to the 
panel not more than 60 days after the matter is ready for such 
review. Meetings of the panel may be held using electronic 
communication to convene the meetings.
  (7) Within 90 days after a scientific advisory panel makes 
recommendations on any matter under its review, the Food and 
Drug Administration official responsible for the matter shall 
review the conclusions and recommendations of the panel, and 
notify the affected persons of the final decision on the 
matter, or of the reasons that no such decision has been 
reached. Each such final decision shall be documented including 
the rationale for the decision.
  (o) Postmarket Studies and Clinical Trials; Labeling.--
          (1) In general.--A responsible person may not 
        introduce or deliver for introduction into interstate 
        commerce the new drug involved if the person is in 
        violation of a requirement established under paragraph 
        (3) or (4) with respect to the drug.
          (2) Definitions.--For purposes of this subsection:
                  (A) Responsible person.--The term 
                ``responsible person'' means a person who--
                          (i) has submitted to the Secretary a 
                        covered application that is pending; or
                          (ii) is the holder of an approved 
                        covered application.
                  (B) Covered application.--The term ``covered 
                application'' means--
                          (i) an application under subsection 
                        (b) for a drug that is subject to 
                        section 503(b); and
                          (ii) an application under section 351 
                        of the Public Health Service Act.
                  (C) New safety information; serious risk.--
                The terms ``new safety information'', ``serious 
                risk'', and ``signal of a serious risk'' have 
                the meanings given such terms in section 505-
                1(b).
          (3) Studies and clinical trials.--
                  (A) In general.--For any or all of the 
                purposes specified in subparagraph (B), the 
                Secretary may, subject to subparagraph (D), 
                require a responsible person for a drug to 
                conduct a postapproval study or studies of the 
                drug, or a postapproval clinical trial or 
                trials of the drug, on the basis of scientific 
                data deemed appropriate by the Secretary, 
                including information regarding chemically-
                related or pharmacologically-related drugs.
                  (B) Purposes of study or clinical trial.--The 
                purposes referred to in this subparagraph with 
                respect to a postapproval study or postapproval 
                clinical trial are the following:
                          (i) To assess a known serious risk 
                        related to the use of the drug 
                        involved.
                          (ii) To assess signals of serious 
                        risk related to the use of the drug.
                          (iii) To identify an unexpected 
                        serious risk when available data 
                        indicates the potential for a serious 
                        risk.
                  (C) Establishment of requirement after 
                approval of covered application.--The Secretary 
                may require a postapproval study or studies or 
                postapproval clinical trial or trials for a 
                drug for which an approved covered application 
                is in effect as of the date on which the 
                Secretary seeks to establish such requirement 
                only if the Secretary becomes aware of new 
                safety information.
                  (D) Determination by secretary.--
                          (i) Postapproval studies.--The 
                        Secretary may not require the 
                        responsible person to conduct a study 
                        under this paragraph, unless the 
                        Secretary makes a determination that 
                        the reports under subsection (k)(1) and 
                        the active postmarket risk 
                        identification and analysis system as 
                        available under subsection (k)(3) will 
                        not be sufficient to meet the purposes 
                        set forth in subparagraph (B).
                          (ii) Postapproval clinical trials.--
                        The Secretary may not require the 
                        responsible person to conduct a 
                        clinical trial under this paragraph, 
                        unless the Secretary makes a 
                        determination that a postapproval study 
                        or studies will not be sufficient to 
                        meet the purposes set forth in 
                        subparagraph (B).
                  (E) Notification; timetables; periodic 
                reports.--
                          (i) Notification.--The Secretary 
                        shall notify the responsible person 
                        regarding a requirement under this 
                        paragraph to conduct a postapproval 
                        study or clinical trial by the target 
                        dates for communication of feedback 
                        from the review team to the responsible 
                        person regarding proposed labeling and 
                        postmarketing study commitments as set 
                        forth in the letters described in 
                        section 101(c) of the Food and Drug 
                        Administration Amendments Act of 2007.
                          (ii) Timetable; periodic reports.--
                        For each study or clinical trial 
                        required to be conducted under this 
                        paragraph, the Secretary shall require 
                        that the responsible person submit a 
                        timetable for completion of the study 
                        or clinical trial. With respect to each 
                        study required to be conducted under 
                        this paragraph or otherwise undertaken 
                        by the responsible person to 
                        investigate a safety issue, the 
                        Secretary shall require the responsible 
                        person to periodically report to the 
                        Secretary on the status of such study 
                        including whether any difficulties in 
                        completing the study have been 
                        encountered. With respect to each 
                        clinical trial required to be conducted 
                        under this paragraph or otherwise 
                        undertaken by the responsible person to 
                        investigate a safety issue, the 
                        Secretary shall require the responsible 
                        person to periodically report to the 
                        Secretary on the status of such 
                        clinical trial including whether 
                        enrollment has begun, the number of 
                        participants enrolled, the expected 
                        completion date, whether any 
                        difficulties completing the clinical 
                        trial have been encountered, and 
                        registration information with respect 
                        to the requirements under section 
                        402(j) of the Public Health Service 
                        Act. If the responsible person fails to 
                        comply with such timetable or violates 
                        any other requirement of this 
                        subparagraph, the responsible person 
                        shall be considered in violation of 
                        this subsection, unless the responsible 
                        person demonstrates good cause for such 
                        noncompliance or such other violation. 
                        The Secretary shall determine what 
                        constitutes good cause under the 
                        preceding sentence.
                  (F) Dispute resolution.--The responsible 
                person may appeal a requirement to conduct a 
                study or clinical trial under this paragraph 
                using dispute resolution procedures established 
                by the Secretary in regulation and guidance.
          (4) Safety labeling changes requested by secretary.--
                  (A) New safety or new effectiveness 
                information.--If the Secretary becomes aware of 
                new information, including any new safety 
                information or information related to reduced 
                effectiveness, that the Secretary determines 
                should be included in the labeling of the drug, 
                the Secretary shall promptly notify the 
                responsible person or, if the same drug 
                approved under section 505(b) is not currently 
                marketed, the holder of an approved application 
                under 505(j).
                  (B) Response to notification.--Following 
                notification pursuant to subparagraph (A), the 
                responsible person or the holder of the 
                approved application under section 505(j) shall 
                within 30 days--
                          (i) submit a supplement proposing 
                        changes to the approved labeling to 
                        reflect the new safety information, 
                        including changes to boxed warnings, 
                        contraindications, warnings, 
                        precautions, or adverse reactions, or 
                        new effectiveness information; or
                          (ii) notify the Secretary that the 
                        responsible person or the holder of the 
                        approved application under section 
                        505(j) does not believe a labeling 
                        change is warranted and submit a 
                        statement detailing the reasons why 
                        such a change is not warranted.
                  (C) Review.--Upon receipt of such supplement, 
                the Secretary shall promptly review and act 
                upon such supplement. If the Secretary 
                disagrees with the proposed changes in the 
                supplement or with the statement setting forth 
                the reasons why no labeling change is 
                necessary, the Secretary shall initiate 
                discussions to reach agreement on whether the 
                labeling for the drug should be modified to 
                reflect the new safety or new effectiveness 
                information, and if so, the contents of such 
                labeling changes.
                  (D) Discussions.--Such discussions shall not 
                extend for more than 30 days after the response 
                to the notification under subparagraph (B), 
                unless the Secretary determines an extension of 
                such discussion period is warranted.
                  (E) Order.--Within 15 days of the conclusion 
                of the discussions under subparagraph (D), the 
                Secretary may issue an order directing the 
                responsible person or the holder of the 
                approved application under section 505(j) to 
                make such a labeling change as the Secretary 
                deems appropriate to address the new safety or 
                new effectiveness information. Within 15 days 
                of such an order, the responsible person or the 
                holder of the approved application under 
                section 505(j) shall submit a supplement 
                containing the labeling change.
                  (F) Dispute resolution.--Within 5 days of 
                receiving an order under subparagraph (E), the 
                responsible person or the holder of the 
                approved application under section 505(j) may 
                appeal using dispute resolution procedures 
                established by the Secretary in regulation and 
                guidance.
                  (G) Violation.--If the responsible person or 
                the holder of the approved application under 
                section 505(j) has not submitted a supplement 
                within 15 days of the date of such order under 
                subparagraph (E), and there is no appeal or 
                dispute resolution proceeding pending, the 
                responsible person or holder shall be 
                considered to be in violation of this 
                subsection. If at the conclusion of any dispute 
                resolution procedures the Secretary determines 
                that a supplement must be submitted and such a 
                supplement is not submitted within 15 days of 
                the date of that determination, the responsible 
                person or holder shall be in violation of this 
                subsection.
                  (H) Public health threat.--Notwithstanding 
                subparagraphs (A) through (F), if the Secretary 
                concludes that such a labeling change is 
                necessary to protect the public health, the 
                Secretary may accelerate the timelines in such 
                subparagraphs.
                  (I) Rule of construction.--This paragraph 
                shall not be construed to affect the 
                responsibility of the responsible person or the 
                holder of the approved application under 
                section 505(j) to maintain its label in 
                accordance with existing requirements, 
                including subpart B of part 201 and sections 
                314.70 and 601.12 of title 21, Code of Federal 
                Regulations (or any successor regulations).
          (5) Non-delegation.--Determinations by the Secretary 
        under this subsection for a drug shall be made by 
        individuals at or above the level of individuals 
        empowered to approve a drug (such as division directors 
        within the Center for Drug Evaluation and Research).
  (p) Risk Evaluation and Mitigation Strategy.--
          (1) In general.--A person may not introduce or 
        deliver for introduction into interstate commerce a new 
        drug if--
                  (A)(i) the application for such drug is 
                approved under subsection (b) or (j) and is 
                subject to section 503(b); or
                  (ii) the application for such drug is 
                approved under section 351 of the Public Health 
                Service Act; and
                  (B) a risk evaluation and mitigation strategy 
                is required under section 505-1 with respect to 
                the drug and the person fails to maintain 
                compliance with the requirements of the 
                approved strategy or with other requirements 
                under section 505-1, including requirements 
                regarding assessments of approved strategies.
          (2) Certain postmarket studies.--The failure to 
        conduct a postmarket study under section 506, subpart H 
        of part 314, or subpart E of part 601 of title 21, Code 
        of Federal Regulations (or any successor regulations), 
        is deemed to be a violation of paragraph (1).
  (q) Petitions and Civil Actions Regarding Approval of Certain 
Applications.--
          (1) In general.--
                  (A) Determination.--The Secretary shall not 
                delay approval of a pending application 
                submitted under subsection (b)(2) or (j) of 
                this section or section 351(k) of the Public 
                Health Service Act because of any request to 
                take any form of action relating to the 
                application, either before or during 
                consideration of the request, unless--
                          (i) the request is in writing and is 
                        a petition submitted to the Secretary 
                        pursuant to section 10.30 or 10.35 of 
                        title 21, Code of Federal Regulations 
                        (or any successor regulations); and
                          (ii) the Secretary determines, upon 
                        reviewing the petition, that a delay is 
                        necessary to protect the public health.
                Consideration of the petition shall be separate 
                and apart from review and approval of any 
                application.
                  (B) Notification.--If the Secretary 
                determines under subparagraph (A) that a delay 
                is necessary with respect to an application, 
                the Secretary shall provide to the applicant, 
                not later than 30 days after making such 
                determination, the following information:
                          (i) Notification of the fact that a 
                        determination under subparagraph (A) 
                        has been made.
                          (ii) If applicable, any clarification 
                        or additional data that the applicant 
                        should submit to the docket on the 
                        petition to allow the Secretary to 
                        review the petition promptly.
                          (iii) A brief summary of the specific 
                        substantive issues raised in the 
                        petition which form the basis of the 
                        determination.
                  (C) Format.--The information described in 
                subparagraph (B) shall be conveyed via either, 
                at the discretion of the Secretary--
                          (i) a document; or
                          (ii) a meeting with the applicant 
                        involved.
                  (D) Public disclosure.--Any information 
                conveyed by the Secretary under subparagraph 
                (C) shall be considered part of the application 
                and shall be subject to the disclosure 
                requirements applicable to information in such 
                application.
                  (E) Denial based on intent to delay.--If the 
                Secretary determines that a petition or a 
                supplement to the petition was submitted with 
                the primary purpose of delaying the approval of 
                an application and the petition does not on its 
                face raise valid scientific or regulatory 
                issues, the Secretary may deny the petition at 
                any point based on such determination. The 
                Secretary may issue guidance to describe the 
                factors that will be used to determine under 
                this subparagraph whether a petition is 
                submitted with the primary purpose of delaying 
                the approval of an application.
                  (F) Final agency action.--The Secretary shall 
                take final agency action on a petition not 
                later than 150 days after the date on which the 
                petition is submitted. The Secretary shall not 
                extend such period for any reason, including--
                          (i) any determination made under 
                        subparagraph (A);
                          (ii) the submission of comments 
                        relating to the petition or 
                        supplemental information supplied by 
                        the petitioner; or
                          (iii) the consent of the petitioner.
                  (G) Extension of 30-month period.--If the 
                filing of an application resulted in first-
                applicant status under subsection 
                (j)(5)(D)(i)(IV) and approval of the 
                application was delayed because of a petition, 
                the 30-month period under such subsection is 
                deemed to be extended by a period of time equal 
                to the period beginning on the date on which 
                the Secretary received the petition and ending 
                on the date of final agency action on the 
                petition (inclusive of such beginning and 
                ending dates), without regard to whether the 
                Secretary grants, in whole or in part, or 
                denies, in whole or in part, the petition.
                  (H) Certification.--The Secretary shall not 
                consider a petition for review unless the party 
                submitting such petition does so in written 
                form and the subject document is signed and 
                contains the following certification: ``I 
                certify that, to my best knowledge and belief: 
                (a) this petition includes all information and 
                views upon which the petition relies; (b) this 
                petition includes representative data and/or 
                information known to the petitioner which are 
                unfavorable to the petition; and (c) I have 
                taken reasonable steps to ensure that any 
                representative data and/or information which 
                are unfavorable to the petition were disclosed 
                to me. I further certify that the information 
                upon which I have based the action requested 
                herein first became known to the party on whose 
                behalf this petition is submitted on or about 
                the following date: __________. If I received 
                or expect to receive payments, including cash 
                and other forms of consideration, to file this 
                information or its contents, I received or 
                expect to receive those payments from the 
                following persons or organizations: 
                _____________. I verify under penalty of 
                perjury that the foregoing is true and correct 
                as of the date of the submission of this 
                petition.'', with the date on which such 
                information first became known to such party 
                and the names of such persons or organizations 
                inserted in the first and second blank space, 
                respectively.
                  (I) Verification.--The Secretary shall not 
                accept for review any supplemental information 
                or comments on a petition unless the party 
                submitting such information or comments does so 
                in written form and the subject document is 
                signed and contains the following verification: 
                ``I certify that, to my best knowledge and 
                belief: (a) I have not intentionally delayed 
                submission of this document or its contents; 
                and (b) the information upon which I have based 
                the action requested herein first became known 
                to me on or about __________. If I received or 
                expect to receive payments, including cash and 
                other forms of consideration, to file this 
                information or its contents, I received or 
                expect to receive those payments from the 
                following persons or organizations: _____. I 
                verify under penalty of perjury that the 
                foregoing is true and correct as of the date of 
                the submission of this petition.'', with the 
                date on which such information first became 
                known to the party and the names of such 
                persons or organizations inserted in the first 
                and second blank space, respectively.
          (2) Exhaustion of administrative remedies.--
                  (A) Final agency action within 150 days.--The 
                Secretary shall be considered to have taken 
                final agency action on a petition if--
                          (i) during the 150-day period 
                        referred to in paragraph (1)(F), the 
                        Secretary makes a final decision within 
                        the meaning of section 10.45(d) of 
                        title 21, Code of Federal Regulations 
                        (or any successor regulation); or
                          (ii) such period expires without the 
                        Secretary having made such a final 
                        decision.
                  (B) Dismissal of certain civil actions.--If a 
                civil action is filed against the Secretary 
                with respect to any issue raised in the 
                petition before the Secretary has taken final 
                agency action on the petition within the 
                meaning of subparagraph (A), the court shall 
                dismiss without prejudice the action for 
                failure to exhaust administrative remedies.
                  (C) Administrative record.--For purposes of 
                judicial review related to the approval of an 
                application for which a petition under 
                paragraph (1) was submitted, the administrative 
                record regarding any issue raised by the 
                petition shall include--
                          (i) the petition filed under 
                        paragraph (1) and any supplements and 
                        comments thereto;
                          (ii) the Secretary's response to such 
                        petition, if issued; and
                          (iii) other information, as 
                        designated by the Secretary, related to 
                        the Secretary's determinations 
                        regarding the issues raised in such 
                        petition, as long as the information 
                        was considered by the agency no later 
                        than the date of final agency action as 
                        defined under subparagraph (2)(A), and 
                        regardless of whether the Secretary 
                        responded to the petition at or before 
                        the approval of the application at 
                        issue in the petition.
          (3) Annual report on delays in approvals per 
        petitions.--The Secretary shall annually submit to the 
        Congress a report that specifies--
                  (A) the number of applications that were 
                approved during the preceding 12-month period;
                  (B) the number of such applications whose 
                effective dates were delayed by petitions 
                referred to in paragraph (1) during such 
                period;
                  (C) the number of days by which such 
                applications were so delayed; and
                  (D) the number of such petitions that were 
                submitted during such period.
          (4) Exceptions.--
                  (A) This subsection does not apply to--
                          (i) a petition that relates solely to 
                        the timing of the approval of an 
                        application pursuant to subsection 
                        (j)(5)(B)(iv); or
                          (ii) a petition that is made by the 
                        sponsor of an application and that 
                        seeks only to have the Secretary take 
                        or refrain from taking any form of 
                        action with respect to that 
                        application.
                  (B) Paragraph (2) does not apply to a 
                petition addressing issues concerning an 
                application submitted pursuant to section 
                351(k) of the Public Health Service Act.
          (5) Definitions.--
                  (A) Application.--For purposes of this 
                subsection, the term ``application'' means an 
                application submitted under subsection (b)(2) 
                or (j) of this section or section 351(k) of the 
                Public Health Service Act.
                  (B) Petition.--For purposes of this 
                subsection, other than paragraph (1)(A)(i), the 
                term ``petition'' means a request described in 
                paragraph (1)(A)(i).
  (r) Postmarket Drug Safety Information for Patients and 
Providers.--
          (1) Establishment.--Not later than 1 year after the 
        date of the enactment of the Food and Drug 
        Administration Amendments Act of 2007, the Secretary 
        shall improve the transparency of information about 
        drugs and allow patients and health care providers 
        better access to information about drugs by developing 
        and maintaining an Internet Web site that--
                  (A) provides links to drug safety information 
                listed in paragraph (2) for prescription drugs 
                that are approved under this section or 
                licensed under section 351 of the Public Health 
                Service Act; and
                  (B) improves communication of drug safety 
                information to patients and providers.
          (2) Internet web site.--The Secretary shall carry out 
        paragraph (1) by--
                  (A) developing and maintaining an accessible, 
                consolidated Internet Web site with easily 
                searchable drug safety information, including 
                the information found on United States 
                Government Internet Web sites, such as the 
                United States National Library of Medicine's 
                Daily Med and Medline Plus Web sites, in 
                addition to other such Web sites maintained by 
                the Secretary;
                  (B) ensuring that the information provided on 
                the Internet Web site is comprehensive and 
                includes, when available and appropriate--
                          (i) patient labeling and patient 
                        packaging inserts;
                          (ii) a link to a list of each drug, 
                        whether approved under this section or 
                        licensed under such section 351, for 
                        which a Medication Guide, as provided 
                        for under part 208 of title 21, Code of 
                        Federal Regulations (or any successor 
                        regulations), is required;
                          (iii) a link to the registry and 
                        results data bank provided for under 
                        subsections (i) and (j) of section 402 
                        of the Public Health Service Act;
                          (iv) the most recent safety 
                        information and alerts issued by the 
                        Food and Drug Administration for drugs 
                        approved by the Secretary under this 
                        section, such as product recalls, 
                        warning letters, and import alerts;
                          (v) publicly available information 
                        about implemented RiskMAPs and risk 
                        evaluation and mitigation strategies 
                        under subsection (o);
                          (vi) guidance documents and 
                        regulations related to drug safety; and
                          (vii) other material determined 
                        appropriate by the Secretary;
                  (C) providing access to summaries of the 
                assessed and aggregated data collected from the 
                active surveillance infrastructure under 
                subsection (k)(3) to provide information of 
                known and serious side-effects for drugs 
                approved under this section or licensed under 
                such section 351;
                  (D) preparing and making publicly available 
                on the Internet website established under 
                paragraph (1) best practices for drug safety 
                surveillance activities for drugs approved 
                under this section or section 351 of the Public 
                Health Service Act;
                  (E) enabling patients, providers, and drug 
                sponsors to submit adverse event reports 
                through the Internet Web site;
                  (F) providing educational materials for 
                patients and providers about the appropriate 
                means of disposing of expired, damaged, or 
                unusable medications; and
                  (G) supporting initiatives that the Secretary 
                determines to be useful to fulfill the purposes 
                of the Internet Web site.
          (3) Posting of drug labeling.--The Secretary shall 
        post on the Internet Web site established under 
        paragraph (1) the approved professional labeling and 
        any required patient labeling of a drug approved under 
        this section or licensed under such section 351 not 
        later than 21 days after the date the drug is approved 
        or licensed, including in a supplemental application 
        with respect to a labeling change.
          (4) Private sector resources.--To ensure development 
        of the Internet Web site by the date described in 
        paragraph (1), the Secretary may, on a temporary or 
        permanent basis, implement systems or products 
        developed by private entities.
          (5) Authority for contracts.--The Secretary may enter 
        into contracts with public and private entities to 
        fulfill the requirements of this subsection.
          (6) Review.--The Advisory Committee on Risk 
        Communication under section 567 shall, on a regular 
        basis, perform a comprehensive review and evaluation of 
        the types of risk communication information provided on 
        the Internet Web site established under paragraph (1) 
        and, through other means, shall identify, clarify, and 
        define the purposes and types of information available 
        to facilitate the efficient flow of information to 
        patients and providers, and shall recommend ways for 
        the Food and Drug Administration to work with outside 
        entities to help facilitate the dispensing of risk 
        communication information to patients and providers.
  (s) Referral to Advisory Committee.--The Secretary shall--
          (1) refer a drug or biological product to a Food and 
        Drug Administration advisory committee for review at a 
        meeting of such advisory committee prior to the 
        approval of such drug or biological if it is--
                  (A) a drug, no active moiety (as defined by 
                the Secretary in section 314.3 of title 21, 
                Code of Federal Regulations (or any successor 
                regulations)) of which has been approved in any 
                other application under this section; or
                  (B) a biological product, no active 
                ingredient of which has been approved in any 
                other application under section 351 of the 
                Public Health Service Act; or
          (2) if the Secretary does not refer a drug or 
        biological product described in paragraph (1) to a Food 
        and Drug Administration advisory committee prior to 
        such approval, provide in the action letter on the 
        application for the drug or biological product a 
        summary of the reasons why the Secretary did not refer 
        the drug or biological product to an advisory committee 
        prior to approval.
  (t) Database for Authorized Generic Drugs.--
          (1) In general.--
                  (A) Publication.--The Commissioner shall--
                          (i) not later than 9 months after the 
                        date of the enactment of the Food and 
                        Drug Administration Amendments Act of 
                        2007, publish a complete list on the 
                        Internet Web site of the Food and Drug 
                        Administration of all authorized 
                        generic drugs (including drug trade 
                        name, brand company manufacturer, and 
                        the date the authorized generic drug 
                        entered the market); and
                          (ii) update the list quarterly to 
                        include each authorized generic drug 
                        included in an annual report submitted 
                        to the Secretary by the sponsor of a 
                        listed drug during the preceding 3-
                        month period.
                  (B) Notification.--The Commissioner shall 
                notify relevant Federal agencies, including the 
                Centers for Medicare & Medicaid Services and 
                the Federal Trade Commission, when the 
                Commissioner first publishes the information 
                described in subparagraph (A) that the 
                information has been published and that the 
                information will be updated quarterly.
          (2) Inclusion.--The Commissioner shall include in the 
        list described in paragraph (1) each authorized generic 
        drug included in an annual report submitted to the 
        Secretary by the sponsor of a listed drug after January 
        1, 1999.
          (3) Authorized generic drug.--In this section, the 
        term ``authorized generic drug'' means a listed drug 
        (as that term is used in subsection (j)) that--
                  (A) has been approved under subsection (c); 
                and
                  (B) is marketed, sold, or distributed 
                directly or indirectly to retail class of trade 
                under a different labeling, packaging (other 
                than repackaging as the listed drug in blister 
                packs, unit doses, or similar packaging for use 
                in institutions), product code, labeler code, 
                trade name, or trade mark than the listed drug.
  (u) Certain Drugs Containing Single Enantiomers.--
          (1) In general.--For purposes of subsections 
        (c)(3)(E)(ii) and (j)(5)(F)(ii), if an application is 
        submitted under subsection (b) for a non-racemic drug 
        containing as an active moiety (as defined by the 
        Secretary in section 314.3 of title 21, Code of Federal 
        Regulations (or any successor regulations)) a single 
        enantiomer that is contained in a racemic drug approved 
        in another application under subsection (b), the 
        applicant may, in the application for such non-racemic 
        drug, elect to have the single enantiomer not be 
        considered the same active moiety as that contained in 
        the approved racemic drug, if--
                  (A)(i) the single enantiomer has not been 
                previously approved except in the approved 
                racemic drug; and
                  (ii) the application submitted under 
                subsection (b) for such non-racemic drug--
                          (I) includes full reports of new 
                        clinical investigations (other than 
                        bioavailability studies)--
                                  (aa) necessary for the 
                                approval of the application 
                                under subsections (c) and (d); 
                                and
                                  (bb) conducted or sponsored 
                                by the applicant; and
                          (II) does not rely on any clinical 
                        investigations that are part of an 
                        application submitted under subsection 
                        (b) for approval of the approved 
                        racemic drug; and
                  (B) the application submitted under 
                subsection (b) for such non-racemic drug is not 
                submitted for approval of a condition of use--
                          (i) in a therapeutic category in 
                        which the approved racemic drug has 
                        been approved; or
                          (ii) for which any other enantiomer 
                        of the racemic drug has been approved.
          (2) Limitation.--
                  (A) No approval in certain therapeutic 
                categories.--Until the date that is 10 years 
                after the date of approval of a non-racemic 
                drug described in paragraph (1) and with 
                respect to which the applicant has made the 
                election provided for by such paragraph, the 
                Secretary shall not approve such non-racemic 
                drug for any condition of use in the 
                therapeutic category in which the racemic drug 
                has been approved.
                  (B) Labeling.--If applicable, the labeling of 
                a non-racemic drug described in paragraph (1) 
                and with respect to which the applicant has 
                made the election provided for by such 
                paragraph shall include a statement that the 
                non-racemic drug is not approved, and has not 
                been shown to be safe and effective, for any 
                condition of use of the racemic drug.
          (3) Definition.--
                  (A) In general.--For purposes of this 
                subsection, the term ``therapeutic category'' 
                means a therapeutic category identified in the 
                list developed by the United States 
                Pharmacopeia pursuant to section 1860D-
                4(b)(3)(C)(ii) of the Social Security Act and 
                as in effect on the date of the enactment of 
                this subsection.
                  (B) Publication by secretary.--The Secretary 
                shall publish the list described in 
                subparagraph (A) and may amend such list by 
                regulation.
          (4) Availability.--The election referred to in 
        paragraph (1) may be made only in an application that 
        is submitted to the Secretary after the date of the 
        enactment of this subsection and before October 1, 
        [2022] 2027.
  (v) Antibiotic Drugs Submitted Before November 21, 1997.--
          (1) Antibiotic drugs approved before november 21, 
        1997.--
                  (A) In general.--Notwithstanding any 
                provision of the Food and Drug Administration 
                Modernization Act of 1997 or any other 
                provision of law, a sponsor of a drug that is 
                the subject of an application described in 
                subparagraph (B)(i) shall be eligible for, with 
                respect to the drug, the 3-year exclusivity 
                period referred to under clauses (iii) and (iv) 
                of subsection (c)(3)(E) and under clauses (iii) 
                and (iv) of subsection (j)(5)(F), subject to 
                the requirements of such clauses, as 
                applicable.
                  (B) Application; antibiotic drug described.--
                          (i) Application.--An application 
                        described in this clause is an 
                        application for marketing submitted 
                        under this section after the date of 
                        the enactment of this subsection in 
                        which the drug that is the subject of 
                        the application contains an antibiotic 
                        drug described in clause (ii).
                          (ii) Antibiotic drug.--An antibiotic 
                        drug described in this clause is an 
                        antibiotic drug that was the subject of 
                        an application approved by the 
                        Secretary under section 507 of this Act 
                        (as in effect before November 21, 
                        1997).
          (2) Antibiotic drugs submitted before november 21, 
        1997, but not approved.--
                  (A) In general.--Notwithstanding any 
                provision of the Food and Drug Administration 
                Modernization Act of 1997 or any other 
                provision of law, a sponsor of a drug that is 
                the subject of an application described in 
                subparagraph (B)(i) may elect to be eligible 
                for, with respect to the drug--
                          (i)(I) the 3-year exclusivity period 
                        referred to under clauses (iii) and 
                        (iv) of subsection (c)(3)(E) and under 
                        clauses (iii) and (iv) of subsection 
                        (j)(5)(F), subject to the requirements 
                        of such clauses, as applicable; and
                          (II) the 5-year exclusivity period 
                        referred to under clause (ii) of 
                        subsection (c)(3)(E) and under clause 
                        (ii) of subsection (j)(5)(F), subject 
                        to the requirements of such clauses, as 
                        applicable; or
                          (ii) a patent term extension under 
                        section 156 of title 35, United States 
                        Code, subject to the requirements of 
                        such section.
                  (B) Application; antibiotic drug described.--
                          (i) Application.--An application 
                        described in this clause is an 
                        application for marketing submitted 
                        under this section after the date of 
                        the enactment of this subsection in 
                        which the drug that is the subject of 
                        the application contains an antibiotic 
                        drug described in clause (ii).
                          (ii) Antibiotic drug.--An antibiotic 
                        drug described in this clause is an 
                        antibiotic drug that was the subject of 
                        1 or more applications received by the 
                        Secretary under section 507 of this Act 
                        (as in effect before November 21, 
                        1997), none of which was approved by 
                        the Secretary under such section.
          (3) Limitations.--
                  (A) Exclusivities and extensions.--Paragraphs 
                (1)(A) and (2)(A) shall not be construed to 
                entitle a drug that is the subject of an 
                approved application described in subparagraphs 
                (1)(B)(i) or (2)(B)(i), as applicable, to any 
                market exclusivities or patent extensions other 
                than those exclusivities or extensions 
                described in paragraph (1)(A) or (2)(A).
                  (B) Conditions of use.--Paragraphs (1)(A) and 
                (2)(A)(i) shall not apply to any condition of 
                use for which the drug referred to in 
                subparagraph (1)(B)(i) or (2)(B)(i), as 
                applicable, was approved before the date of the 
                enactment of this subsection.
          (4) Application of certain provisions.--
        Notwithstanding section 125, or any other provision, of 
        the Food and Drug Administration Modernization Act of 
        1997, or any other provision of law, and subject to the 
        limitations in paragraphs (1), (2), and (3), the 
        provisions of the Drug Price Competition and Patent 
        Term Restoration Act of 1984 shall apply to any drug 
        subject to paragraph (1) or any drug with respect to 
        which an election is made under paragraph (2)(A).
  (w) Deadline for Determination on Certain Petitions.--The 
Secretary shall issue a final, substantive determination on a 
petition submitted pursuant to subsection (b) of section 
314.161 of title 21, Code of Federal Regulations (or any 
successor regulations), no later than 270 days after the date 
the petition is submitted.
  (x) Date of Approval in the Case of Recommended Controls 
Under the CSA.--
          (1) In general.--In the case of an application under 
        subsection (b) with respect to a drug for which the 
        Secretary provides notice to the sponsor that the 
        Secretary intends to issue a scientific and medical 
        evaluation and recommend controls under the Controlled 
        Substances Act, approval of such application shall not 
        take effect until the interim final rule controlling 
        the drug is issued in accordance with section 201(j) of 
        the Controlled Substances Act.
          (2) Date of approval.--For purposes of this section, 
        with respect to an application described in paragraph 
        (1), the term ``date of approval'' shall mean the later 
        of--
                  (A) the date an application under subsection 
                (b) is approved under subsection (c); or
                  (B) the date of issuance of the interim final 
                rule controlling the drug.
  (y) Contrast Agents Intended for Use With Applicable Medical 
Imaging Devices.--
          (1) In general.--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 a new 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(p)(1).
          (2) Review of supplement.--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) Definitions.--For purposes of this subsection--
                  (A) the term ``new use'' means a use of a 
                contrast agent that is described in the 
                approved labeling of an applicable medical 
                imaging device described in section 520(p), but 
                that is not described in the approved labeling 
                of the contrast agent; and
                  (B) the terms ``applicable medical imaging 
                device'' and ``contrast agent'' have the 
                meanings given such terms in section 520(p).
  (z) Nonclinical Test Defined.--For purposes of this section, 
the term ``nonclinical test'' means a test conducted in vitro, 
in silico, or in chemico, or a nonhuman in vivo test, that 
occurs before or during the clinical trial phase of the 
investigation of the safety and effectiveness of a drug. Such 
test may include the following:
          (1) Cell-based assays.
          (2) Organ chips and microphysiological systems.
          (3) Computer modeling.
          (4) Other nonhuman or human biology-based test 
        methods.
          (5) Animal tests.

           *       *       *       *       *       *       *


SEC. 505B. RESEARCH INTO PEDIATRIC USES FOR DRUGS AND BIOLOGICAL 
                    PRODUCTS.

  (a) New Drugs and Biological Products.--
          (1) In general.--
                  (A) General requirements.--Except with 
                respect to an application for which 
                subparagraph (B) applies, a person that 
                submits, on or after the date of the enactment 
                of the Pediatric Research Equity Act of 2007, 
                an application (or supplement to an 
                application) for a drug--
                          (i) under section 505 for a new 
                        active ingredient, new indication, new 
                        dosage form, new dosing regimen, or new 
                        route of administration; or
                          (ii) under section 351 of the Public 
                        Health Service Act (42 U.S.C. 262) for 
                        a new active ingredient, new 
                        indication, new dosage form, new dosing 
                        regimen, or new route of 
                        administration,
                shall submit with the application the 
                assessments described in paragraph (2).
                  (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--
                          (i) intended for the treatment of an 
                        adult cancer; and
                          (ii) directed at a molecular target 
                        that the Secretary determines to be 
                        substantially relevant to the growth or 
                        progression of a pediatric cancer.
                  (C) Rule of construction.--No application 
                that is subject to the requirements of 
                subparagraph (B) shall be subject to the 
                requirements of subparagraph (A), and no 
                application (or supplement to an application) 
                that is subject to the requirements of 
                subparagraph (A) shall be subject to the 
                requirements of subparagraph (B).
          (2) Assessments.--
                  (A) In general.--The assessments referred to 
                in paragraph (1)(A) shall contain data, 
                gathered using appropriate formulations for 
                each age group for which the assessment is 
                required, that are adequate--
                          (i) to assess the safety and 
                        effectiveness of the drug or the 
                        biological product for the claimed 
                        indications in all relevant pediatric 
                        subpopulations; and
                          (ii) to support dosing and 
                        administration for each pediatric 
                        subpopulation for which the drug or the 
                        biological product is safe and 
                        effective.
                  (B) Similar course of disease or similar 
                effect of drug or biological product.--
                          (i) In general.--If the course of the 
                        disease and the effects of the drug are 
                        sufficiently similar in adults and 
                        pediatric patients, the Secretary may 
                        conclude that pediatric effectiveness 
                        can be extrapolated from adequate and 
                        well-controlled studies in adults, 
                        usually supplemented with other 
                        information obtained in pediatric 
                        patients, such as pharmacokinetic 
                        studies.
                          (ii) Extrapolation between age 
                        groups.--A study may not be needed in 
                        each pediatric age group if data from 
                        one age group can be extrapolated to 
                        another age group.
                          (iii) Information on extrapolation.--
                        A brief documentation of the scientific 
                        data supporting the conclusion under 
                        clauses (i) and (ii) shall be included 
                        in any pertinent reviews for the 
                        application under section 505 of this 
                        Act or section 351 of the Public Health 
                        Service Act (42 U.S.C. 262).
          (3) Molecularly targeted pediatric cancer 
        investigation.--
                  [(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.]
                  (A) In general.--For purposes of paragraph 
                (1)(B), the investigation described in this 
                paragraph is (as determined by the Secretary) a 
                molecularly targeted pediatric cancer 
                investigation of--
                          (i) the drug or biological product 
                        for which the application referred to 
                        in such paragraph is submitted; or
                          (ii) such drug or biological product 
                        in combination with--
                                  (I) an active ingredient of a 
                                drug or biological product--
                                          (aa) for which an 
                                        approved application 
                                        under section 505(j) 
                                        under this Act or under 
                                        section 351(k) of the 
                                        Public Health Service 
                                        Act is in effect; and
                                          (bb) that is 
                                        determined by the 
                                        Secretary to be the 
                                        standard of care for 
                                        treating a pediatric 
                                        cancer; or
                                  (II) an active ingredient of 
                                a drug or biological product--
                                          (aa) for which an 
                                        approved application 
                                        under section 505(b) of 
                                        this Act or section 
                                        351(a) of the Public 
                                        Health Service Act to 
                                        treat an adult cancer 
                                        is in effect and is 
                                        held by the same person 
                                        submitting the 
                                        application under 
                                        paragraph (1)(B); and
                                          (bb) that is directed 
                                        at a molecular target 
                                        that the Secretary 
                                        determines to be 
                                        substantially relevant 
                                        to the growth or 
                                        progression of a 
                                        pediatric cancer.
                  (B) Additional requirements.--
                          (i) Design of investigation.--A 
                        molecularly targeted pediatric cancer 
                        investigation referred to in 
                        subparagraph (A) shall be designed to 
                        yield clinically meaningful pediatric 
                        study data that is 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.
                          (ii) Limitation.--An investigation 
                        described in subparagraph (A)(ii) may 
                        be required only if the drug or 
                        biological product for which the 
                        application referred to in paragraph 
                        (1)(B) contains either--
                                  (I) a single new active 
                                ingredient; or
                                  (II) more than one active 
                                ingredient, if an application 
                                for the combination of active 
                                ingredients has not previously 
                                been approved but each active 
                                ingredient has been previously 
                                approved to treat an adult 
                                cancer.
                          (iii) Results of already-completed 
                        preclinical studies of application 
                        drug.--The Secretary may require that 
                        reports on an investigation required 
                        pursuant to paragraph (1)(B) include 
                        the results of all preclinical studies 
                        on which the decision to conduct such 
                        investigation was based.
                          (iv) Rule of construction regarding 
                        inactive ingredients.--With respect to 
                        a combination of active ingredients 
                        referred to in subparagraph (A)(ii), 
                        such subparagraph shall not be 
                        construed as addressing the use of 
                        inactive ingredients with such 
                        combination.
                  [(B)] (C) Extrapolation of data.--Paragraph 
                (2)(B) shall apply to [investigations described 
                in this paragraph] investigations referred to 
                in subparagraph (A) to the same extent and in 
                the same manner as paragraph (2)(B) applies 
                with respect to the assessments required under 
                paragraph (1)(A).
                  [(C)] (D) 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)] the assessments required under 
                paragraph (1)(A).
          (4) Deferral.--
                  (A) In general.--On the initiative of the 
                Secretary or at the request of the applicant, 
                the Secretary may defer submission of some or 
                all assessments required under paragraph (1)(A) 
                or reports on the investigation required under 
                paragraph (1)(B) until a specified date after 
                approval of the drug or issuance of the license 
                for a biological product if--
                          (i) the Secretary finds that--
                                  (I) the drug or biological 
                                product is ready for approval 
                                for use in adults before 
                                pediatric studies are complete;
                                  (II) pediatric studies should 
                                be delayed until additional 
                                safety or effectiveness data 
                                have been collected; or
                                  (III) there is another 
                                appropriate reason for 
                                deferral; and
                          (ii) the applicant submits to the 
                        Secretary--
                                  (I) certification of the 
                                grounds for deferring the 
                                assessments or reports on the 
                                investigation;
                                  (II) a pediatric study plan 
                                as described in subsection (e);
                                  (III) evidence that the 
                                studies are being conducted or 
                                will be conducted with due 
                                diligence and at the earliest 
                                possible time; and
                                  (IV) a timeline for the 
                                completion of such studies.
                  (B) Deferral extension.--
                          (i) In general.--On the initiative of 
                        the Secretary or at the request of the 
                        applicant, the Secretary may grant an 
                        extension of a deferral approved under 
                        subparagraph (A) for submission of some 
                        or all assessments required under 
                        paragraph (1)(A) or reports on the 
                        investigation required under paragraph 
                        (1)(B) if--
                                  (I) the Secretary determines 
                                that the conditions described 
                                in subclause (II) or (III) of 
                                subparagraph (A)(i) continue to 
                                be met; and
                                  (II) the applicant submits a 
                                new timeline under subparagraph 
                                (A)(ii)(IV) and any significant 
                                updates to the information 
                                required under subparagraph 
                                (A)(ii).
                          (ii) Timing and information.--If the 
                        deferral extension under this 
                        subparagraph is requested by the 
                        applicant, the applicant shall submit 
                        the deferral extension request 
                        containing the information described in 
                        this subparagraph not less than 90 days 
                        prior to the date that the deferral 
                        would expire. The Secretary shall 
                        respond to such request not later than 
                        45 days after the receipt of such 
                        letter. If the Secretary grants such an 
                        extension, the specified date shall be 
                        the extended date. The sponsor of the 
                        required assessment under paragraph 
                        (1)(A) or reports on the investigation 
                        under paragraph (1)(B) shall not be 
                        issued a letter described in subsection 
                        (d) unless the specified or extended 
                        date of submission for such required 
                        studies has passed or if the request 
                        for an extension is pending. For a 
                        deferral that has expired prior to the 
                        date of enactment of the Food and Drug 
                        Administration Safety and Innovation 
                        Act or that will expire prior to 270 
                        days after the date of enactment of 
                        such Act, a deferral extension shall be 
                        requested by an applicant not later 
                        than 180 days after the date of 
                        enactment of such Act. The Secretary 
                        shall respond to any such request as 
                        soon as practicable, but not later than 
                        1 year after the date of enactment of 
                        such Act. Nothing in this clause shall 
                        prevent the Secretary from updating the 
                        status of a study or studies publicly 
                        if components of such study or studies 
                        are late or delayed.
                  (C) Annual review.--
                          (i) In general.--On an annual basis 
                        following the approval of a deferral 
                        under subparagraph (A), the applicant 
                        shall submit to the Secretary the 
                        following information:
                                  (I) Information detailing the 
                                progress made in conducting 
                                pediatric studies.
                                  (II) If no progress has been 
                                made in conducting such 
                                studies, evidence and 
                                documentation that such studies 
                                will be conducted with due 
                                diligence and at the earliest 
                                possible time.
                                  (III) Projected completion 
                                date for pediatric studies.
                                  (IV) The reason or reasons 
                                why a deferral or deferral 
                                extension continues to be 
                                necessary.
                          (ii) Public availability.--Not later 
                        than 90 days after the submission to 
                        the Secretary of the information 
                        submitted through the annual review 
                        under clause (i), the Secretary shall 
                        make available to the public in an 
                        easily accessible manner, including 
                        through the Internet Web site of the 
                        Food and Drug Administration--
                                  (I) such information;
                                  (II) the name of the 
                                applicant for the product 
                                subject to the assessment or 
                                investigation;
                                  (III) the date on which the 
                                product was approved; and
                                  (IV) the date of each 
                                deferral or deferral extension 
                                under this paragraph for the 
                                product.
          (5) Waivers.--
                  (A) Full waiver.--On the initiative of the 
                Secretary or at the request of an applicant, 
                the Secretary shall grant a full waiver, as 
                appropriate, of the requirement to submit 
                assessments or reports on the investigation for 
                a drug or biological product under this 
                subsection if the applicant certifies and the 
                Secretary finds that--
                          (i) necessary studies are impossible 
                        or highly impracticable (because, for 
                        example, the number of patients is so 
                        small or the patients are 
                        geographically dispersed);
                          (ii) there is evidence strongly 
                        suggesting that the drug or biological 
                        product would be ineffective or unsafe 
                        in all pediatric age groups; or
                          (iii) the drug or biological 
                        product--
                                  (I) does not represent a 
                                meaningful therapeutic benefit 
                                over existing therapies for 
                                pediatric patients; and
                                  (II) is not likely to be used 
                                in a substantial number of 
                                pediatric patients.
                  (B) Partial waiver.--On the initiative of the 
                Secretary or at the request of an applicant, 
                the Secretary shall grant a partial waiver, as 
                appropriate, of the requirement to submit 
                assessments or reports on the investigation for 
                a drug or biological product under this 
                subsection with respect to a specific pediatric 
                age group if the applicant certifies and the 
                Secretary finds that--
                          (i) necessary studies are impossible 
                        or highly impracticable (because, for 
                        example, the number of patients in that 
                        age group is so small or patients in 
                        that age group are geographically 
                        dispersed);
                          (ii) there is evidence strongly 
                        suggesting that the drug or biological 
                        product would be ineffective or unsafe 
                        in that age group;
                          (iii) the drug or biological 
                        product--
                                  (I) does not represent a 
                                meaningful therapeutic benefit 
                                over existing therapies for 
                                pediatric patients in that age 
                                group; and
                                  (II) is not likely to be used 
                                by a substantial number of 
                                pediatric patients in that age 
                                group; or
                          (iv) the applicant can demonstrate 
                        that reasonable attempts to produce a 
                        pediatric formulation necessary for 
                        that age group have failed.
                  (C) Pediatric formulation not possible.--If a 
                partial waiver is granted on the ground that it 
                is not possible to develop a pediatric 
                formulation, the waiver shall cover only the 
                pediatric groups requiring that formulation. An 
                applicant seeking such a partial waiver shall 
                submit to the Secretary documentation detailing 
                why a pediatric formulation cannot be developed 
                and, if the waiver is granted, the applicant's 
                submission shall promptly be made available to 
                the public in an easily accessible manner, 
                including through posting on the Web site of 
                the Food and Drug Administration.
                  (D) Labeling requirement.--If the Secretary 
                grants a full or partial waiver because there 
                is evidence that a drug or biological product 
                would be ineffective or unsafe in pediatric 
                populations, the information shall be included 
                in the labeling for the drug or biological 
                product.
  (b) Marketed Drugs and Biological Products.--
          (1) In general.--The Secretary may (by order in the 
        form of a letter) require the sponsor or holder of an 
        approved application for a drug under section 505 or 
        the holder of a license for a biological product under 
        section 351 of the Public Health Service Act to submit 
        by a specified date the assessments described in 
        subsection (a)(2), if the Secretary finds that--
                  (A)(i) the drug or biological product is used 
                for a substantial number of pediatric patients 
                for the labeled indications; and
                  (ii) adequate pediatric labeling could confer 
                a benefit on pediatric patients;
                  (B) there is reason to believe that the drug 
                or biological product would represent a 
                meaningful therapeutic benefit over existing 
                therapies for pediatric patients for 1 or more 
                of the claimed indications; or
                  (C) the absence of adequate pediatric 
                labeling could pose a risk to pediatric 
                patients.
          (2) Waivers.--
                  (A) Full waiver.--At the request of an 
                applicant, the Secretary shall grant a full 
                waiver, as appropriate, of the requirement to 
                submit assessments under this subsection if the 
                applicant certifies and the Secretary finds 
                that--
                          (i) necessary studies are impossible 
                        or highly impracticable (because, for 
                        example, the number of patients in that 
                        age group is so small or patients in 
                        that age group are geographically 
                        dispersed); or
                          (ii) there is evidence strongly 
                        suggesting that the drug or biological 
                        product would be ineffective or unsafe 
                        in all pediatric age groups.
                  (B) Partial waiver.--At the request of an 
                applicant, the Secretary shall grant a partial 
                waiver, as appropriate, of the requirement to 
                submit assessments under this subsection with 
                respect to a specific pediatric age group if 
                the applicant certifies and the Secretary finds 
                that--
                          (i) necessary studies are impossible 
                        or highly impracticable (because, for 
                        example, the number of patients in that 
                        age group is so small or patients in 
                        that age group are geographically 
                        dispersed);
                          (ii) there is evidence strongly 
                        suggesting that the drug or biological 
                        product would be ineffective or unsafe 
                        in that age group;
                          (iii)(I) the drug or biological 
                        product--
                                  (aa) does not represent a 
                                meaningful therapeutic benefit 
                                over existing therapies for 
                                pediatric patients in that age 
                                group; and
                                  (bb) is not likely to be used 
                                in a substantial number of 
                                pediatric patients in that age 
                                group; and
                          (II) the absence of adequate labeling 
                        could not pose significant risks to 
                        pediatric patients; or
                          (iv) the applicant can demonstrate 
                        that reasonable attempts to produce a 
                        pediatric formulation necessary for 
                        that age group have failed.
                  (C) Pediatric formulation not possible.--If a 
                waiver is granted on the ground that it is not 
                possible to develop a pediatric formulation, 
                the waiver shall cover only the pediatric 
                groups requiring that formulation. An applicant 
                seeking either a full or partial waiver shall 
                submit to the Secretary documentation detailing 
                why a pediatric formulation cannot be developed 
                and, if the waiver is granted, the applicant's 
                submission shall promptly be made available to 
                the public in an easily accessible manner, 
                including through posting on the Web site of 
                the Food and Drug Administration.
                  (D) Labeling requirement.--If the Secretary 
                grants a full or partial waiver because there 
                is evidence that a drug or biological product 
                would be ineffective or unsafe in pediatric 
                populations, the information shall be included 
                in the labeling for the drug or biological 
                product.
          (3) Effect of subsection.--Nothing in this subsection 
        alters or amends section 301(j) of this Act or section 
        552 of title 5 or section 1905 of title 18, United 
        States Code.
  (c) Meaningful Therapeutic Benefit.--For the purposes of 
paragraph (4)(A)(iii)(I) and (4)(B)(iii)(I) of subsection (a) 
and paragraphs (1)(B) and (2)(B)(iii)(I)(aa) of subsection (b), 
a drug or biological product shall be considered to represent a 
meaningful therapeutic benefit over existing therapies if the 
Secretary determines that--
          (1) if approved, the drug or biological product could 
        represent an improvement in the treatment, diagnosis, 
        or prevention of a disease, compared with marketed 
        products adequately labeled for that use in the 
        relevant pediatric population; or
          (2) the drug or biological product is in a class of 
        products or for an indication for which there is a need 
        for additional options.
  (d) Submission of Assessments And Reports on the 
Investigation.--If a person fails to submit a required 
assessment described in subsection (a)(2) or the investigation 
described in subsection (a)(3), fails to meet the applicable 
requirements in subsection (a)(4), or fails to submit a request 
for approval of a pediatric formulation described in subsection 
(a) or (b), in accordance with applicable provisions of 
subsections (a) and (b), the following shall apply:
          (1) Beginning 270 days after the date of enactment of 
        the Food and Drug Administration Safety and Innovation 
        Act, the Secretary shall issue a non-compliance letter 
        to such person informing them of such failure to submit 
        or meet the requirements of the applicable subsection. 
        Such letter shall require the person to respond in 
        writing within 45 calendar days of issuance of such 
        letter. Such response may include the person's request 
        for a deferral extension if applicable. Such letter and 
        the person's written response to such letter shall be 
        made publicly available on the Internet Web site of the 
        Food and Drug Administration 60 calendar days after 
        issuance, with redactions for any trade secrets and 
        confidential commercial information. If the Secretary 
        determines that the letter was issued in error, the 
        requirements of this paragraph shall not apply. The 
        Secretary shall inform the Pediatric Advisory Committee 
        of letters issued under this paragraph and responses to 
        such letters.
          (2) The drug or biological product that is the 
        subject of an assessment described in subsection (a)(2) 
        or the investigation described in subsection (a)(3), 
        applicable requirements in subsection (a)(4), or 
        request for approval of a pediatric formulation, may be 
        considered misbranded solely because of that failure 
        and subject to relevant enforcement action (except that 
        the drug or biological product shall not be subject to 
        action under section 303), but such failure shall not 
        be the basis for a proceeding--
                  (A) to withdraw approval for a drug under 
                section 505(e); or
                  (B) to revoke the license for a biological 
                product under section 351 of the Public Health 
                Service Act.
  (e) Pediatric Study Plans.--
          (1) In general.--An applicant subject to subsection 
        (a) shall submit to the Secretary an initial pediatric 
        study plan prior to the submission of the assessments 
        described under subsection (a)(2) or the investigation 
        described in subsection (a)(3). The Secretary shall 
        determine whether subparagraph (A) or (B) of subsection 
        (a)(1) shall apply with respect to an application 
        before the date on which the applicant is required to 
        submit the initial pediatric study plan under paragraph 
        (2)(A).
          (2) Timing; content; meetings.--
                  (A) Timing.--An applicant shall submit the 
                initial pediatric study plan under paragraph 
                (1)--
                          (i) before the date on which the 
                        applicant submits the assessments under 
                        subsection (a)(2) or the investigation 
                        described in subsection (a)(3); and
                          (ii) not later than--
                                  (I) 60 calendar days after 
                                the date of the end-of-Phase 2 
                                meeting (as such term is used 
                                in section 312.47 of title 21, 
                                Code of Federal Regulations, or 
                                successor regulations); or
                                  (II) such other time as may 
                                be agreed upon between the 
                                Secretary and the applicant.
                Nothing in this section shall preclude the 
                Secretary from accepting the submission of an 
                initial pediatric study plan earlier than the 
                date otherwise applicable under this 
                subparagraph.
                  (B) Content of initial pediatric study 
                plan.--The initial pediatric study plan shall 
                include--
                          (i) an outline of the pediatric study 
                        or studies that the applicant plans to 
                        conduct (including, to the extent 
                        practicable study objectives and 
                        design, age groups, relevant endpoints, 
                        and statistical approach);
                          (ii) any request for a deferral, 
                        partial waiver, or waiver under this 
                        section, if applicable, along with any 
                        supporting information; and
                          (iii) other information specified in 
                        the regulations promulgated under 
                        paragraph (7).
                  (C) Meetings.--The Secretary--
                          (i) shall meet with the applicant--
                                  (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;
                                  (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
                                  (III) to discuss the bases 
                                for the deferral under 
                                subsection (a)(4) or a full or 
                                partial waiver under subsection 
                                (a)(5);
                          (ii) may determine that a written 
                        response to the initial pediatric study 
                        plan is sufficient to communicate 
                        comments on the initial pediatric study 
                        plan, and that no meeting under clause 
                        (i)(II) is necessary; and
                          (iii) if the Secretary determines 
                        that no meeting under clause (i)(II) is 
                        necessary, shall so notify the 
                        applicant and provide written comments 
                        of the Secretary as soon as 
                        practicable, but not later than 90 
                        calendar days after the receipt of the 
                        initial pediatric study plan.
          (3) Agreed initial pediatric study plan.--Not later 
        than 90 calendar days following the meeting under 
        paragraph (2)(C)(i)(II) or the receipt of a written 
        response from the Secretary under paragraph 
        (2)(C)(iii), the applicant shall document agreement on 
        the initial pediatric study plan in a submission to the 
        Secretary marked ``Agreed Initial Pediatric Study 
        Plan'', and the Secretary shall confirm such agreement 
        to the applicant in writing not later than 30 calendar 
        days of receipt of such agreed initial pediatric study 
        plan.
          (4) Deferral and waiver.--If the agreed initial 
        pediatric study plan contains a request from the 
        applicant for a deferral, partial waiver, or waiver 
        under this section, the written confirmation under 
        paragraph (3) shall include a recommendation from the 
        Secretary as to whether such request meets the 
        standards under paragraphs (3) or (4) of subsection 
        (a).
          (5) Amendments to the agreed initial pediatric study 
        plan.--At the initiative of the Secretary or the 
        applicant, the agreed initial pediatric study plan may 
        be amended at any time. The requirements of paragraph 
        (2)(C) shall apply to any such proposed amendment in 
        the same manner and to the same extent as such 
        requirements apply to an initial pediatric study plan 
        under paragraph (1). The requirements of paragraphs (3) 
        and (4) shall apply to any agreement resulting from 
        such proposed amendment in the same manner and to the 
        same extent as such requirements apply to an agreed 
        initial pediatric study plan.
          (6) Internal committee.--The Secretary shall consult 
        the internal committee under section 505C on the review 
        of the initial pediatric study plan, agreed initial 
        pediatric study plan, and any significant amendments to 
        such plans.
          (7) Required rulemaking.--Not later than 1 year after 
        the date of enactment of the Food and Drug 
        Administration Safety and Innovation Act, the Secretary 
        shall promulgate proposed regulations and issue 
        guidance to implement the provisions of this 
        subsection.
  (f) Review of Pediatric Study Plans,Assessments, Deferrals, 
Deferral Extensions, and Waivers.--
          (1) Review.--Beginning not later than 30 days after 
        the date of the enactment of the Pediatric Research 
        Equity Act of 2007, the Secretary shall utilize the 
        internal committee established under section 505C to 
        provide consultation to reviewing divisions on initial 
        pediatric study plans, agreed initial pediatric study 
        plans, and any significant amendments to such plans, 
        and assessments prior to approval of an application or 
        supplement for which a pediatric assessment is required 
        under this section and all deferral, deferral 
        extension, and waiver requests granted pursuant to this 
        section.
          (2) Activity by committee.--The committee referred to 
        in paragraph (1) may operate using appropriate members 
        of such committee and need not convene all members of 
        the committee.
          (3) Documentation of committee action.--For each drug 
        or biological product, the committee referred to in 
        paragraph (1) shall document, for each activity 
        described in paragraph (4) or (5), which members of the 
        committee participated in such activity.
          (4) Review of pediatric study plans, assessments, 
        deferrals, deferral extensions, and waivers.--
        Consultation on initial pediatric study plans, agreed 
        initial pediatric study plans, and assessments by the 
        committee referred to in paragraph (1) pursuant to this 
        section shall occur prior to approval of an application 
        or supplement for which a pediatric assessment is 
        required under this section. The committee shall review 
        all requests for deferrals, deferral extensions, and 
        waivers from the requirement to submit a pediatric 
        assessment granted under this section and shall provide 
        recommendations as needed to reviewing divisions, 
        including with respect to whether such a supplement, 
        when submitted, shall be considered for priority 
        review.
          (5) Retrospective review of pediatric assessments, 
        deferrals, and waivers.--Not later than 1 year after 
        the date of the enactment of the Pediatric Research 
        Equity Act of 2007, the committee referred to in 
        paragraph (1) shall conduct a retrospective review and 
        analysis of a representative sample of assessments 
        submitted and deferrals and waivers approved under this 
        section since the enactment of the Pediatric Research 
        Equity Act of 2003. Such review shall include an 
        analysis of the quality and consistency of pediatric 
        information in pediatric assessments and the 
        appropriateness of waivers and deferrals granted. Based 
        on such review, the Secretary shall issue 
        recommendations to the review divisions for 
        improvements and initiate guidance to industry related 
        to the scope of pediatric studies required under this 
        section.
          (6) Tracking of assessments and labeling changes.--
        The Secretary, in consultation with the committee 
        referred to in paragraph (1), shall track and make 
        available to the public in an easily accessible manner, 
        including through posting on the Web site of the Food 
        and Drug Administration--
                  (A) the number of assessments conducted under 
                this section;
                  (B) the specific drugs and biological 
                products and their uses assessed under this 
                section;
                  (C) the types of assessments conducted under 
                this section, including trial design, the 
                number of pediatric patients studied, and the 
                number of centers and countries involved;
                  (D) aggregated on an annual basis--
                          (i) the total number of deferrals and 
                        deferral extensions requested and 
                        granted under this section and, if 
                        granted, the reasons for each such 
                        deferral or deferral extension;
                          (ii) the timeline for completion of 
                        the assessments;
                          (iii) the number of assessments 
                        completed and pending; and
                          (iv) the number of postmarket non-
                        compliance letters issued pursuant to 
                        subsection (d), and the recipients of 
                        such letters;
                  (E) the number of waivers requested and 
                granted under this section and, if granted, the 
                reasons for the waivers;
                  (F) the number of pediatric formulations 
                developed and the number of pediatric 
                formulations not developed and the reasons any 
                such formulation was not developed;
                  (G) the labeling changes made as a result of 
                assessments conducted under this section;
                  (H) an annual summary of labeling changes 
                made as a result of assessments conducted under 
                this section for distribution pursuant to 
                subsection (h)(2);
                  (I) an annual summary of information 
                submitted pursuant to subsection (a)(3)(B); and
                  (J) the number of times the committee 
                referred to in paragraph (1) made a 
                recommendation to the Secretary under paragraph 
                (4) regarding priority review, the number of 
                times the Secretary followed or did not follow 
                such a recommendation, and, if not followed, 
                the reasons why such a recommendation was not 
                followed.
  (g) Labeling Changes.--
          (1) Dispute resolution.--
                  (A) Request for labeling change and failure 
                to agree.--If, on or after the date of the 
                enactment of the Pediatric Research Equity Act 
                of 2007, the Commissioner determines that a 
                sponsor and the Commissioner have been unable 
                to reach agreement on appropriate changes to 
                the labeling for the drug that is the subject 
                of the application or supplement, not later 
                than 180 days after the date of the submission 
                of the application or supplement that receives 
                a priority review or 330 days after the date of 
                the submission of an application or supplement 
                that receives a standard review--
                          (i) the Commissioner shall request 
                        that the sponsor of the application 
                        make any labeling change that the 
                        Commissioner determines to be 
                        appropriate; and
                          (ii) if the sponsor does not agree 
                        within 30 days after the Commissioner's 
                        request to make a labeling change 
                        requested by the Commissioner, the 
                        Commissioner shall refer the matter to 
                        the Pediatric Advisory Committee.
                  (B) Action by the pediatric advisory 
                committee.--Not later than 90 days after 
                receiving a referral under subparagraph 
                (A)(ii), the Pediatric Advisory Committee 
                shall--
                          (i) review the pediatric study 
                        reports; and
                          (ii) make a recommendation to the 
                        Commissioner concerning appropriate 
                        labeling changes, if any.
                  (C) Consideration of recommendations.--The 
                Commissioner shall consider the recommendations 
                of the Pediatric Advisory Committee and, if 
                appropriate, not later than 30 days after 
                receiving the recommendation, make a request to 
                the sponsor of the application or supplement to 
                make any labeling changes that the Commissioner 
                determines to be appropriate.
                  (D) Misbranding.--If the sponsor of the 
                application or supplement, within 30 days after 
                receiving a request under subparagraph (C), 
                does not agree to make a labeling change 
                requested by the Commissioner, the Commissioner 
                may deem the drug that is the subject of the 
                application or supplement to be misbranded.
                  (E) No effect on authority.--Nothing in this 
                subsection limits the authority of the United 
                States to bring an enforcement action under 
                this Act when a drug lacks appropriate 
                pediatric labeling. Neither course of action 
                (the Pediatric Advisory Committee process or an 
                enforcement action referred to in the preceding 
                sentence) shall preclude, delay, or serve as 
                the basis to stay the other course of action.
          (2) Other labeling changes.--If, on or after the date 
        of the enactment of the Pediatric Research Equity Act 
        of 2007, the Secretary makes a determination that a 
        pediatric assessment conducted under this section does 
        or does not demonstrate that the drug that is the 
        subject of such assessment is safe and effective in 
        pediatric populations or subpopulations, including 
        whether such assessment results are inconclusive, the 
        Secretary shall order the labeling of such product to 
        include information about the results of the assessment 
        and a statement of the Secretary's determination.
  (h) Dissemination of Pediatric Information.--
          (1) In general.--Not later than 210 days after the 
        date of submission of an application (or supplement to 
        an application) that contains a pediatric assessment 
        under this section, if the application (or supplement) 
        receives a priority review, or not later than 330 days 
        after the date of submission of an application (or 
        supplement to an application) that contains a pediatric 
        assessment under this section, if the application (or 
        supplement) receives a standard review, the Secretary 
        shall make available to the public in an easily 
        accessible manner the medical, statistical, and 
        clinical pharmacology reviews of such pediatric 
        assessments, and shall post such assessments on the Web 
        site of the Food and Drug Administration.
          (2) Dissemination of information regarding labeling 
        changes.--Beginning on the date of the enactment of the 
        Pediatric Research Equity Act of 2007, the Secretary 
        shall require that the sponsors of the assessments that 
        result in labeling changes that are reflected in the 
        annual summary developed pursuant to subsection 
        (f)(6)(H) distribute such information to physicians and 
        other health care providers.
          (3) Effect of subsection.--Nothing in this subsection 
        shall alter or amend section 301(j) of this Act or 
        section 552 of title 5 or section 1905 of title 18, 
        United States Code.
  (i) Adverse Event Reporting.--
          (1) Reporting in first 18-month period.--Beginning on 
        the date of the enactment of the Pediatric Research 
        Equity Act of 2007, during the 18-month period 
        beginning on the date a labeling change is made 
        pursuant to subsection (g), the Secretary shall ensure 
        that all adverse event reports that have been received 
        for such drug (regardless of when such report was 
        received) are referred to the Office of Pediatric 
        Therapeutics. In considering such reports, the Director 
        of such Office shall provide for the review of such 
        reports by the Pediatric Advisory Committee, including 
        obtaining any recommendations of such committee 
        regarding whether the Secretary should take action 
        under this Act in response to such reports.
          (2) Reporting in subsequent periods.--Following the 
        18-month period described in paragraph (1), the 
        Secretary shall, as appropriate, refer to the Office of 
        Pediatric Therapeutics all pediatric adverse event 
        reports for a drug for which a pediatric study was 
        conducted under this section. In considering such 
        reports, the Director of such Office may provide for 
        the review of such reports by the Pediatric Advisory 
        Committee, including obtaining any recommendation of 
        such Committee regarding whether the Secretary should 
        take action in response to such reports.
          (3) Preservation of authority.--Nothing in this 
        subsection shall prohibit the Office of Pediatric 
        Therapeutics from providing for the review of adverse 
        event reports by the Pediatric Advisory Committee prior 
        to the 18-month period referred to in paragraph (1), if 
        such review is necessary to ensure safe use of a drug 
        in a pediatric population.
          (4) Effect.--The requirements of this subsection 
        shall supplement, not supplant, other review of such 
        adverse event reports by the Secretary.
  (j) Scope of Authority.--Nothing in this section provides to 
the Secretary any authority to require a pediatric assessment 
of any drug or biological product, or any assessment regarding 
other populations or uses of a drug or biological product, 
other than the pediatric assessments described in this section.
  (k) Relation to Orphan Drugs.--
          (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.
          (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).
  (l) New Active Ingredient.--
          (1) Non-interchangeable biosimilar biological 
        product.--A biological product that is biosimilar to a 
        reference product under section 351 of the Public 
        Health Service Act, and that the Secretary has not 
        determined to meet the standards described in 
        subsection (k)(4) of such section for 
        interchangeability with the reference product, shall be 
        considered to have a new active ingredient under this 
        section.
          (2) Interchangeable biosimilar biological product.--A 
        biological product that is interchangeable with a 
        reference product under section 351 of the Public 
        Health Service Act shall not be considered to have a 
        new active ingredient under this section.
  (m) List of Primary Molecular Targets.--
          (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--
                  (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
                  (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.
          (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).
          (3) Rule of construction.--Nothing in paragraph (1) 
        shall be construed--
                  (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
                  (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.

           *       *       *       *       *       *       *


SEC. 505E. EXTENSION OF EXCLUSIVITY PERIOD FOR NEW QUALIFIED INFECTIOUS 
                    DISEASE PRODUCTS.

  (a) Extension.--If the Secretary approves an application 
pursuant to section 505 for a drug that has been designated as 
a qualified infectious disease product under subsection (d), 
the 4- and 5-year periods described in subsections 
(c)(3)(E)(ii) and (j)(5)(F)(ii) of section 505, the 3-year 
periods described in clauses (iii) and (iv) of subsection 
(c)(3)(E) and clauses (iii) and (iv) of subsection (j)(5)(F) of 
section 505, or the 7-year period described in section 527, as 
applicable, shall be extended by 5 years.
  (b) Relation to Pediatric Exclusivity.--Any extension under 
subsection (a) of a period shall be in addition to any 
extension of the period under section 505A with respect to the 
drug.
  (c) Limitations.--Subsection (a) does not apply to the 
approval of--
          (1) a supplement to an application under section 
        505(b) for any qualified infectious disease product for 
        which an extension described in subsection (a) is in 
        effect or has expired;
          (2) a subsequent application filed with respect to a 
        product approved under section 505 for a change that 
        results in a new indication, route of administration, 
        dosing schedule, dosage form, delivery system, delivery 
        device, or strength; [or]
          (3) a product that does not meet the definition of a 
        qualified infectious disease product under subsection 
        (g) based upon its approved uses[.]; or
          (4) an application pursuant to section 351(a) of the 
        Public Health Service Act.
  (d) Designation.--
          (1) In general.--The manufacturer or sponsor of a 
        drug may request the Secretary to designate a drug as a 
        qualified infectious disease product at any time before 
        the submission of an application under section 505(b) 
        of this Act or section 351(a) of the Public Health 
        Service Act for such drug. The Secretary shall, not 
        later than 60 days after the submission of such a 
        request, determine whether the drug is a qualified 
        infectious disease product.
          (2) Limitation.--Except as provided in paragraph (3), 
        a designation under this subsection shall not be 
        withdrawn for any reason, including modifications to 
        the list of qualifying pathogens under subsection 
        (f)(2)(C).
          (3) Revocation of designation.--The Secretary may 
        revoke a designation of a drug as a qualified 
        infectious disease product if the Secretary finds that 
        the request for such designation contained an untrue 
        statement of material fact.
  (e) Regulations.--
          (1) In general.--Not later than 2 years after the 
        date of enactment of the Food and Drug Administration 
        Safety and Innovation Act, the Secretary shall adopt 
        final regulations implementing this section, including 
        developing the list of qualifying pathogens described 
        in subsection (f).
          (2) Procedure.--In promulgating a regulation 
        implementing this section, the Secretary shall--
                  (A) issue a notice of proposed rulemaking 
                that includes the proposed regulation;
                  (B) provide a period of not less than 60 days 
                for comments on the proposed regulation; and
                  (C) publish the final regulation not less 
                than 30 days before the effective date of the 
                regulation.
          (3) Restrictions.--Notwithstanding any other 
        provision of law, the Secretary shall promulgate 
        regulations implementing this section only as described 
        in paragraph (2), except that the Secretary may issue 
        interim guidance for sponsors seeking designation under 
        subsection (d) prior to the promulgation of such 
        regulations.
          (4) Designation prior to regulations.--The Secretary 
        shall designate drugs as qualified infectious disease 
        products under subsection (d) prior to the promulgation 
        of regulations under this subsection, if such drugs 
        meet the definition of a qualified infectious disease 
        product described in subsection (g).
  (f) Qualifying Pathogen.--
          (1) Definition.--In this section, the term 
        ``qualifying pathogen'' means a pathogen identified and 
        listed by the Secretary under paragraph (2) that has 
        the potential to pose a serious threat to public 
        health, such as--
                  (A) resistant gram positive pathogens, 
                including methicillin-resistant Staphylococcus 
                aureus, vancomycin-resistant Staphylococcus 
                aureus, and vancomycin-resistant enterococcus;
                  (B) multi-drug resistant gram negative 
                bacteria, including Acinetobacter, Klebsiella, 
                Pseudomonas, and E. coli species;
                  (C) multi-drug resistant tuberculosis; and
                  (D) Clostridium difficile.
          (2) List of qualifying pathogens.--
                  (A) In general.--The Secretary shall 
                establish and maintain a list of qualifying 
                pathogens, and shall make public the 
                methodology for developing such list.
                  (B) Considerations.--In establishing and 
                maintaining the list of pathogens described 
                under this section, the Secretary shall--
                          (i) consider--
                                  (I) the impact on the public 
                                health due to drug-resistant 
                                organisms in humans;
                                  (II) the rate of growth of 
                                drug-resistant organisms in 
                                humans;
                                  (III) the increase in 
                                resistance rates in humans; and
                                  (IV) the morbidity and 
                                mortality in humans; and
                          (ii) consult with experts in 
                        infectious diseases and antibiotic 
                        resistance, including the Centers for 
                        Disease Control and Prevention, the 
                        Food and Drug Administration, medical 
                        professionals, and the clinical 
                        research community.
                  (C) Review.--Every 5 years, or more often as 
                needed, the Secretary shall review, provide 
                modifications to, and publish the list of 
                qualifying pathogens under subparagraph (A) and 
                shall by regulation revise the list as 
                necessary, in accordance with subsection (e).
  [(g) Qualified Infectious Disease Product.--The term 
``qualified infectious disease product'' means an antibacterial 
or antifungal drug for human use intended to treat serious or 
life-threatening infections, including those caused by--
          [(1) an antibacterial or antifungal resistant 
        pathogen, including novel or emerging infectious 
        pathogens; or
          [(2) qualifying pathogens listed by the Secretary 
        under subsection (f).]
  (g) Qualified Infectious Disease Product.--The term 
``qualified infectious disease product'' means a drug, 
including an antibacterial or antifungal drug or a biological 
product, for human use that--
          (1) acts directly on bacteria or fungi or on 
        substances produced by such bacteria or fungi; and
          (2) is intended to treat a serious or life-
        threatening infection, including such an infection 
        caused by--
                  (A) an antibacterial or antifungal resistant 
                pathogen, including novel or emerging 
                infectious pathogens; or
                  (B) qualifying pathogens listed by the 
                Secretary under subsection (f).

           *       *       *       *       *       *       *


SEC. 506. EXPEDITED APPROVAL OF DRUGS FOR SERIOUS OR LIFE-THREATENING 
                    DISEASES OR CONDITIONS.

  (a) Designation of a Drug as a Breakthrough Therapy.--
          (1) In general.--The Secretary shall, at the request 
        of the sponsor of a drug, expedite the development and 
        review of such drug if the drug is intended, alone or 
        in combination with 1 or more other drugs, to treat a 
        serious or life-threatening disease or condition and 
        preliminary clinical evidence indicates that the drug 
        may demonstrate substantial improvement over existing 
        therapies on 1 or more clinically significant 
        endpoints, such as substantial treatment effects 
        observed early in clinical development. (In this 
        section, such a drug is referred to as a ``breakthrough 
        therapy''.)
          (2) Request for designation.--The sponsor of a drug 
        may request the Secretary to designate the drug as a 
        breakthrough therapy. A request for the designation may 
        be made concurrently with, or at any time after, the 
        submission of an application for the investigation of 
        the drug under section 505(i) or section 351(a)(3) of 
        the Public Health Service Act.
          (3) Designation.--
                  (A) In general.--Not later than 60 calendar 
                days after the receipt of a request under 
                paragraph (2), the Secretary shall determine 
                whether the drug that is the subject of the 
                request meets the criteria described in 
                paragraph (1). If the Secretary finds that the 
                drug meets the criteria, the Secretary shall 
                designate the drug as a breakthrough therapy 
                and shall take such actions as are appropriate 
                to expedite the development and review of the 
                application for approval of such drug.
                  (B) Actions.--The actions to expedite the 
                development and review of an application under 
                subparagraph (A) may include, as appropriate--
                          (i) holding meetings with the sponsor 
                        and the review team throughout the 
                        development of the drug;
                          (ii) providing timely advice to, and 
                        interactive communication with, the 
                        sponsor regarding the development of 
                        the drug to ensure that the development 
                        program to gather the nonclinical and 
                        clinical data necessary for approval is 
                        as efficient as practicable;
                          (iii) involving senior managers and 
                        experienced review staff, as 
                        appropriate, in a collaborative, cross-
                        disciplinary review;
                          (iv) assigning a cross-disciplinary 
                        project lead for the Food and Drug 
                        Administration review team to 
                        facilitate an efficient review of the 
                        development program and to serve as a 
                        scientific liaison between the review 
                        team and the sponsor; and
                          (v) taking steps to ensure that the 
                        design of the clinical trials is as 
                        efficient as practicable, when 
                        scientifically appropriate, such as by 
                        minimizing the number of patients 
                        exposed to a potentially less 
                        efficacious treatment.
  (b) Designation of Drug as Fast Track Product.--
          (1) In general.--The Secretary shall, at the request 
        of the sponsor of a new drug, facilitate the 
        development and expedite the review of such drug if it 
        is intended, whether alone or in combination with one 
        or more other drugs, for the treatment of a serious or 
        life-threatening disease or condition, and it 
        demonstrates the potential to address unmet medical 
        needs for such a disease or condition, or if the 
        Secretary designates the drug as a qualified infectious 
        disease product under section 505E(d). (In this 
        section, such a drug is referred to as a ``fast track 
        product''.)
          (2) Request for designation.--The sponsor of a new 
        drug may request the Secretary to designate the drug as 
        a fast track product. A request for the designation may 
        be made concurrently with, or at any time after, 
        submission of an application for the investigation of 
        the drug under section 505(i) or section 351(a)(3) of 
        the Public Health Service Act.
          (3) Designation.--Within 60 calendar days after the 
        receipt of a request under paragraph (2), the Secretary 
        shall determine whether the drug that is the subject of 
        the request meets the criteria described in paragraph 
        (1). If the Secretary finds that the drug meets the 
        criteria, the Secretary shall designate the drug as a 
        fast track product and shall take such actions as are 
        appropriate to expedite the development and review of 
        the application for approval of such product.
  (c) Accelerated Approval of a Drug for a Serious or Life-
Threatening Disease or Condition, Including a Fast Track 
Product.--
          (1) In general.--
                  (A) Accelerated approval.--The Secretary may 
                approve an application for approval of a 
                product for a serious or life-threatening 
                disease or condition, including a fast track 
                product, under section 505(c) or section 351(a) 
                of the Public Health Service Act upon a 
                determination that the product has an effect on 
                a surrogate endpoint that is reasonably likely 
                to predict clinical benefit, or on a clinical 
                endpoint that can be measured earlier than 
                irreversible morbidity or mortality, that is 
                reasonably likely to predict an effect on 
                irreversible morbidity or mortality or other 
                clinical benefit, taking into account the 
                severity, rarity, or prevalence of the 
                condition and the availability or lack of 
                alternative treatments. The approval described 
                in the preceding sentence is referred to in 
                this section as ``accelerated approval''.
                  (B) Evidence.--The evidence to support that 
                an endpoint is reasonably likely to predict 
                clinical benefit under subparagraph (A) may 
                include epidemiological, pathophysiological, 
                therapeutic, pharmacologic, or other evidence 
                developed using biomarkers, for example, or 
                other scientific methods or tools.
          [(2) Limitation.--Approval of a product under this 
        subsection may be subject to 1 or both of the following 
        requirements:
                  [(A) That the sponsor conduct appropriate 
                postapproval studies to verify and describe the 
                predicted effect on irreversible morbidity or 
                mortality or other clinical benefit.
                  [(B) That the sponsor submit copies of all 
                promotional materials related to the product 
                during the preapproval review period and, 
                following approval and for such period 
                thereafter as the Secretary determines to be 
                appropriate, at least 30 days prior to 
                dissemination of the materials.
          [(3) Expedited withdrawal of approval.--The Secretary 
        may withdraw approval of a product approved under 
        accelerated approval using expedited procedures (as 
        prescribed by the Secretary in regulations which shall 
        include an opportunity for an informal hearing) if--
                  [(A) the sponsor fails to conduct any 
                required postapproval study of the drug with 
                due diligence;
                  [(B) a study required to verify and describe 
                the predicted effect on irreversible morbidity 
                or mortality or other clinical benefit of the 
                product fails to verify and describe such 
                effect or benefit;
                  [(C) other evidence demonstrates that the 
                product is not safe or effective under the 
                conditions of use; or
                  [(D) the sponsor disseminates false or 
                misleading promotional materials with respect 
                to the product.]
          (2) Limitation.--
                  (A) In general.--Approval of a product under 
                this subsection may be subject to 1 or both of 
                the following requirements:
                          (i) That the sponsor conduct an 
                        appropriate postapproval study or 
                        studies (which may be augmented or 
                        supported by real world evidence) to 
                        verify and describe the predicted 
                        effect on irreversible morbidity or 
                        mortality or other clinical benefit.
                          (ii) That the sponsor submit copies 
                        of all promotional materials related to 
                        the product during the preapproval 
                        review period and, following approval 
                        and for such period thereafter as the 
                        Secretary determines to be appropriate, 
                        at least 30 days prior to dissemination 
                        of the materials.
                  (B) Studies not required.--If the Secretary 
                does not require that the sponsor of a product 
                approved under accelerated approval conduct a 
                postapproval study under this paragraph, the 
                Secretary shall publish on the website of the 
                Food and Drug Administration the rationale for 
                why such study is not appropriate or necessary.
                  (C) Postapproval study conditions.--Not later 
                than the time of approval of a product under 
                accelerated approval, the Secretary shall 
                specify the conditions for a postapproval study 
                or studies required to be conducted under this 
                paragraph with respect to such product, which 
                may include enrollment targets, the study 
                protocol, and milestones, including the target 
                date of study completion.
                  (D) Studies begun before approval.--The 
                Secretary may require such study or studies to 
                be underway prior to approval.
          (3) Expedited withdrawal of approval.--
                  (A) In general.--The Secretary may withdraw 
                approval of a product approved under 
                accelerated approval using expedited procedures 
                described in subparagraph (B), if--
                          (i) the sponsor fails to conduct any 
                        required postapproval study of the 
                        product with due diligence, including 
                        with respect to conditions specified by 
                        the Secretary under paragraph (2)(C);
                          (ii) a study required to verify and 
                        describe the predicted effect on 
                        irreversible morbidity or mortality or 
                        other clinical benefit of the product 
                        fails to verify and describe such 
                        effect or benefit;
                          (iii) other evidence demonstrates 
                        that the product is not shown to be 
                        safe or effective under the conditions 
                        of use; or
                          (iv) the sponsor disseminates false 
                        or misleading promotional materials 
                        with respect to the product.
                  (B) Expedited procedures described.--
                Expedited procedures described in this 
                subparagraph shall consist of, prior to the 
                withdrawal of accelerated approval--
                          (i) providing the sponsor with--
                                  (I) due notice;
                                  (II) an explanation for the 
                                proposed withdrawal;
                                  (III) an opportunity for a 
                                meeting with the Commissioner 
                                of Food and Drugs or the 
                                Commissioner's designee; and
                                  (IV) an opportunity for 
                                written appeal to--
                                          (aa) the Commissioner 
                                        of Food and Drugs; or
                                          (bb) a designee of 
                                        the Commissioner who 
                                        has not participated in 
                                        the proposed withdrawal 
                                        of approval (other than 
                                        a meeting pursuant to 
                                        subclause (III)) and is 
                                        not a subordinate of an 
                                        individual (other than 
                                        the Commissioner) who 
                                        participated in such 
                                        proposed withdrawal;
                          (ii) providing an opportunity for 
                        public comment on the notice proposing 
                        to withdraw approval;
                          (iii) the publication of a summary of 
                        the public comments received, and the 
                        Secretary's response to such comments, 
                        on the website of the Food and Drug 
                        Administration; and
                          (iv) convening and consulting an 
                        advisory committee on issues related to 
                        the proposed withdrawal, if requested 
                        by the sponsor and if no such advisory 
                        committee has previously advised the 
                        Secretary on such issues with respect 
                        to the withdrawal of the product prior 
                        to the sponsor's request.
          (4) Labeling.--
                  (A) In general.--Subject to subparagraph (B), 
                the labeling for a product approved under 
                accelerated approval shall include--
                          (i) a statement indicating that the 
                        product was approved under accelerated 
                        approval;
                          (ii) a statement indicating that 
                        continued approval of the product is 
                        subject to postmarketing studies to 
                        verify clinical benefit;
                          (iii) identification of the surrogate 
                        or intermediate endpoint or endpoints 
                        that supported approval and any known 
                        limitations of such surrogate or 
                        intermediate endpoint or endpoints in 
                        determining clinical benefit; and
                          (iv) a succinct description of the 
                        product and any uncertainty about 
                        anticipated clinical benefit and a 
                        discussion of available evidence with 
                        respect to such clinical benefit.
                  (B) Applicability.--The labeling requirements 
                of subparagraph (A) shall apply only to 
                products approved under accelerated approval 
                for which the predicted effect on irreversible 
                morbidity or mortality or other clinical 
                benefit has not been verified.
                  (C) Rule of construction.--With respect to 
                any application pending before the Secretary on 
                the date of enactment of the Food and Drug 
                Amendments of 2022, the Secretary shall allow 
                any applicable changes to the product labeling 
                required to comply with subparagraph (A) to be 
                made by supplement after the approval of such 
                application.
          (5) Reporting.--Not later than September 30, 2025, 
        the Secretary shall submit to the Committee on Energy 
        and Commerce of the House of Representatives and the 
        Committee on Health, Education, Labor, and Pensions of 
        the Senate a report describing circumstances in which 
        the Secretary considered real world evidence submitted 
        to support postapproval studies required under this 
        subsection that were completed after the date of 
        enactment of the Food and Drug Amendments of 2022.
  (d) Review of Incomplete Applications for Approval of a Fast 
Track Product.--
          (1) In general.--If the Secretary determines, after 
        preliminary evaluation of clinical data submitted by 
        the sponsor, that a fast track product may be 
        effective, the Secretary shall evaluate for filing, and 
        may commence review of portions of, an application for 
        the approval of the product before the sponsor submits 
        a complete application. The Secretary shall commence 
        such review only if the applicant--
                  (A) provides a schedule for submission of 
                information necessary to make the application 
                complete; and
                  (B) pays any fee that may be required under 
                section 736.
          (2) Exception.--Any time period for review of human 
        drug applications that has been agreed to by the 
        Secretary and that has been set forth in goals 
        identified in letters of the Secretary (relating to the 
        use of fees collected under section 736 to expedite the 
        drug development process and the review of human drug 
        applications) shall not apply to an application 
        submitted under paragraph (1) until the date on which 
        the application is complete.
  (e) Construction.--
          (1) Purpose.--The amendments made by the Food and 
        Drug Administration Safety and Innovation Act and the 
        21st Century Cures Act to this section are intended to 
        encourage the Secretary to utilize innovative and 
        flexible approaches to the assessment of products under 
        accelerated approval for treatments for patients with 
        serious or life-threatening diseases or conditions and 
        unmet medical needs.
          (2) Construction.--Nothing in this section shall be 
        construed to alter the standards of evidence under 
        subsection (c) or (d) of section 505 (including the 
        substantial evidence standard in section 505(d)) of 
        this Act or under section 351(a) of the Public Health 
        Service Act. Such sections and standards of evidence 
        apply to the review and approval of products under this 
        section, including whether a product is safe and 
        effective. Nothing in this section alters the ability 
        of the Secretary to rely on evidence that does not come 
        from adequate and well-controlled investigations for 
        the purpose of determining whether an endpoint is 
        reasonably likely to predict clinical benefit as 
        described in subsection (b)(1)(B).
  (f) Awareness Efforts.--The Secretary shall--
          (1) develop and disseminate to physicians, patient 
        organizations, pharmaceutical and biotechnology 
        companies, and other appropriate persons a description 
        of the provisions of this section applicable to 
        breakthrough therapies, accelerated approval, and and 
        fast track products; and
          (2) establish a program to encourage the development 
        of surrogate and clinical endpoints, including 
        biomarkers, and other scientific methods and tools that 
        can assist the Secretary in determining whether the 
        evidence submitted in an application is reasonably 
        likely to predict clinical benefit for serious or life-
        threatening conditions for which significant unmet 
        medical needs exist.
  (g) Regenerative Advanced Therapy.--
          (1) In general.--The Secretary, at the request of the 
        sponsor of a drug, shall facilitate an efficient 
        development program for, and expedite review of, such 
        drug if the drug qualifies as a regenerative advanced 
        therapy under the criteria described in paragraph (2).
          (2) Criteria.--A drug is eligible for designation as 
        a regenerative advanced therapy under this subsection 
        if--
                  (A) the drug is a regenerative medicine 
                therapy (as defined in paragraph (8));
                  (B) the drug is intended to treat, modify, 
                reverse, or cure a serious or life-threatening 
                disease or condition; and
                  (C) preliminary clinical evidence indicates 
                that the drug has the potential to address 
                unmet medical needs for such a disease or 
                condition.
          (3) Request for designation.--The sponsor of a drug 
        may request the Secretary to designate the drug as a 
        regenerative advanced therapy concurrently with, or at 
        any time after, submission of an application for the 
        investigation of the drug under section 505(i) of this 
        Act or section 351(a)(3) of the Public Health Service 
        Act.
          (4) Designation.--Not later than 60 calendar days 
        after the receipt of a request under paragraph (3), the 
        Secretary shall determine whether the drug that is the 
        subject of the request meets the criteria described in 
        paragraph (2). If the Secretary determines that the 
        drug meets the criteria, the Secretary shall designate 
        the drug as a regenerative advanced therapy and shall 
        take such actions as are appropriate under paragraph 
        (1). If the Secretary determines that a drug does not 
        meet the criteria for such designation, the Secretary 
        shall include with the determination a written 
        description of the rationale for such determination.
          (5) Actions.--The sponsor of a regenerative advanced 
        therapy shall be eligible for the actions to expedite 
        development and review of such therapy under subsection 
        (a)(3)(B), including early interactions to discuss any 
        potential surrogate or intermediate endpoint to be used 
        to support the accelerated approval of an application 
        for the product under subsection (c).
          (6) Access to expedited approval pathways.--An 
        application for a regenerative advanced therapy under 
        section 505(b)(1) of this Act or section 351(a) of the 
        Public Health Service Act may be--
                  (A) eligible for priority review, as 
                described in the Manual of Policies and 
                Procedures of the Food and Drug Administration 
                and goals identified in the letters described 
                in section 101(b) of the Prescription Drug User 
                Fee Amendments of 2012; and
                  (B) eligible for accelerated approval under 
                subsection (c), as agreed upon pursuant to 
                subsection (a)(3)(B), through, as appropriate--
                          (i) surrogate or intermediate 
                        endpoints reasonably likely to predict 
                        long-term clinical benefit; or
                          (ii) reliance upon data obtained from 
                        a meaningful number of sites, including 
                        through expansion to additional sites, 
                        as appropriate.
          (7) Postapproval requirements.--The sponsor of a 
        regenerative advanced therapy that is granted 
        accelerated approval and is subject to the postapproval 
        requirements under subsection (c) may, as appropriate, 
        fulfill such requirements, as the Secretary may 
        require, through--
                  (A) the submission of clinical evidence, 
                clinical studies, patient registries, or other 
                sources of real world evidence, such as 
                electronic health records;
                  (B) the collection of larger confirmatory 
                data sets, as agreed upon pursuant to 
                subsection (a)(3)(B); or
                  (C) postapproval monitoring of all patients 
                treated with such therapy prior to approval of 
                the therapy.
          (8) Definition.--For purposes of this section, the 
        term ``regenerative medicine therapy'' includes cell 
        therapy, therapeutic tissue engineering products, human 
        cell and tissue products, and combination products 
        using any such therapies or products, except for those 
        regulated solely under section 361 of the Public Health 
        Service Act and part 1271 of title 21, Code of Federal 
        Regulations.
  (h) Limited Population Pathway for Antibacterial and 
Antifungal Drugs.--
          (1) In general.--The Secretary may approve an 
        antibacterial or antifungal drug, alone or in 
        combination with one or more other drugs, as a limited 
        population drug pursuant to this subsection only if--
                  (A) the drug is intended to treat a serious 
                or life-threatening infection in a limited 
                population of patients with unmet needs;
                  (B) the standards for approval under section 
                505(c) and (d), or the standards for licensure 
                under section 351 of the Public Health Service 
                Act, as applicable, are met; and
                  (C) the Secretary receives a written request 
                from the sponsor to approve the drug as a 
                limited population drug pursuant to this 
                subsection.
          (2) Benefit-risk consideration.--The Secretary's 
        determination of safety and effectiveness of an 
        antibacterial or antifungal drug shall reflect the 
        benefit-risk profile of such drug in the intended 
        limited population, taking into account the severity, 
        rarity, or prevalence of the infection the drug is 
        intended to treat and the availability or lack of 
        alternative treatment in such limited population. Such 
        drug may be approved under this subsection 
        notwithstanding a lack of evidence to fully establish a 
        favorable benefit-risk profile in a population that is 
        broader than the intended limited population.
          (3) Additional requirements.--A drug approved under 
        this subsection shall be subject to the following 
        requirements, in addition to any other applicable 
        requirements of this Act:
                  (A) Labeling.--To indicate that the safety 
                and effectiveness of a drug approved under this 
                subsection has been demonstrated only with 
                respect to a limited population--
                          (i) all labeling and advertising of 
                        an antibacterial or antifungal drug 
                        approved under this subsection shall 
                        contain the statement ``Limited 
                        Population'' in a prominent manner and 
                        adjacent to, and not more prominent 
                        than--
                                  (I) the proprietary name of 
                                such drug, if any; or
                                  (II) if there is no 
                                proprietary name, the 
                                established name of the drug, 
                                if any, as defined in section 
                                503(e)(3), or, in the case of a 
                                drug that is a biological 
                                product, the proper name, as 
                                defined by regulation; and
                          (ii) the prescribing information for 
                        the drug required by section 201.57 of 
                        title 21, Code of Federal Regulations 
                        (or any successor regulation) shall 
                        also include the following statement: 
                        ``This drug is indicated for use in a 
                        limited and specific population of 
                        patients.''.
                  (B) Promotional material.--The sponsor of an 
                antibacterial or antifungal drug subject to 
                this subsection shall submit to the Secretary 
                copies of all promotional materials related to 
                such drug at least 30 calendar days prior to 
                dissemination of the materials.
          (4) Other programs.--A sponsor of a drug that seeks 
        approval of a drug under this subsection may also seek 
        designation or approval, as applicable, of such drug 
        under other applicable sections or subsections of this 
        Act or the Public Health Service Act.
          (5) Guidance.--Not later than 18 months after the 
        date of enactment of the 21st Century Cures Act, the 
        Secretary shall issue draft guidance describing 
        criteria, processes, and other general considerations 
        for demonstrating the safety and effectiveness of 
        limited population antibacterial and antifungal drugs. 
        The Secretary shall publish final guidance within 18 
        months of the close of the public comment period on 
        such draft guidance. The Secretary may approve 
        antibacterial and antifungal drugs under this 
        subsection prior to issuing guidance under this 
        paragraph.
          (6) Advice.--The Secretary shall provide prompt 
        advice to the sponsor of a drug for which the sponsor 
        seeks approval under this subsection to enable the 
        sponsor to plan a development program to obtain the 
        necessary data for such approval, and to conduct any 
        additional studies that would be required to gain 
        approval of such drug for use in a broader population.
          (7) Termination of limitations.--If, after approval 
        of a drug under this subsection, the Secretary approves 
        a broader indication for such drug under section 505(b) 
        or section 351(a) of the Public Health Service Act, the 
        Secretary may remove any postmarketing conditions, 
        including requirements with respect to labeling and 
        review of promotional materials under paragraph (3), 
        applicable to the approval of the drug under this 
        subsection.
          (8) Rules of construction.--Nothing in this 
        subsection shall be construed to alter the authority of 
        the Secretary to approve drugs pursuant to this Act or 
        section 351 of the Public Health Service Act, including 
        the standards of evidence and applicable conditions for 
        approval under such Acts, the standards of approval of 
        a drug under such Acts, or to alter the authority of 
        the Secretary to monitor drugs pursuant to such Acts.
          (9) Reporting and accountability.--
                  (A) Biennial reporting.--The Secretary shall 
                report to Congress not less often than once 
                every 2 years on the number of requests for 
                approval, and the number of approvals, of an 
                antibacterial or antifungal drug under this 
                subsection.
                  (B) GAO report.--Not later than December 
                2021, the Comptroller General of the United 
                States shall submit to the Committee on Energy 
                and Commerce of the House of Representatives 
                and the Committee on Health, Education, Labor 
                and Pensions of the Senate a report on the 
                coordination of activities required under 
                section 319E of the Public Health Service Act. 
                Such report shall include a review of such 
                activities, and the extent to which the use of 
                the pathway established under this subsection 
                has streamlined premarket approval for 
                antibacterial or antifungal drugs for limited 
                populations, if such pathway has functioned as 
                intended, if such pathway has helped provide 
                for safe and effective treatment for patients, 
                if such premarket approval would be appropriate 
                for other categories of drugs, and if the 
                authorities under this subsection have affected 
                antibacterial or antifungal resistance.

           *       *       *       *       *       *       *


SEC. 506B. REPORTS OF POSTMARKETING STUDIES.

  (a) Submission.--
          (1) In general.--A sponsor of a drug that has entered 
        into an agreement with the Secretary to conduct a 
        postmarketing study of a drug shall submit to the 
        Secretary, within 1 year after the approval of such 
        drug and annually thereafter until the study is 
        completed or terminated, a report of the progress of 
        the study or the reasons for the failure of the sponsor 
        to conduct the study. The report shall be submitted in 
        such form as is prescribed by the Secretary in 
        regulations issued by the Secretary.
          (2) Accelerated approval.--Notwithstanding paragraph 
        (1), a sponsor of a drug approved under accelerated 
        approval shall submit to the Secretary a report of the 
        progress of any study required under section 506(c), 
        including progress toward enrollment targets, 
        milestones, and other information as required by the 
        Secretary, not later than 180 days after the approval 
        of such drug and not less frequently than every 180 
        days thereafter, until the study is completed or 
        terminated.
          [(2)] (3) Agreements prior to effective date.--Any 
        agreement entered into between the Secretary and a 
        sponsor of a drug, prior to the date of enactment of 
        the Food and Drug Administration Modernization Act of 
        1997, to conduct a postmarketing study of a drug shall 
        be subject to the requirements of paragraph (1). An 
        initial report for such an agreement shall be submitted 
        within 6 months after the date of the issuance of the 
        regulations under paragraph (1).
  (b) Consideration of Information as Public Information.--Any 
information pertaining to a report described in subsection (a) 
shall be considered to be public information to the extent that 
the information is necessary--
          (1) to identify the sponsor; and
          (2) to establish the status of a study described in 
        subsection (a) and the reasons, if any, for any failure 
        to carry out the study.
  (c) Status of Studies and Reports.--The Secretary shall 
annually develop and publish in the Federal Register a report 
that provides information on the status of the postmarketing 
studies--
          (1) that sponsors have entered into agreements to 
        conduct; and
          (2) for which reports have been submitted under 
        subsection (a)(1).
  (d) Disclosure.--If a sponsor fails to complete an agreed 
upon study required by this section by its original or 
otherwise negotiated deadline, the Secretary shall publish a 
statement on the Internet site of the Food and Drug 
Administration stating that the study was not completed and, if 
the reasons for such failure to complete the study were not 
satisfactory to the Secretary, a statement that such reasons 
were not satisfactory to the Secretary.
  (e) Notification.--With respect to studies of the type 
required under section 506(c)(2)(A) or under section 314.510 or 
601.41 of title 21, Code of Federal Regulations, as each of 
such sections was in effect on the day before the effective 
date of this subsection, the Secretary may require that a 
sponsor who, for reasons not satisfactory to the Secretary, 
fails to complete by its deadline a study under any of such 
sections of such type for a drug or biological product 
(including such a study conducted after such effective date) 
notify practitioners who prescribe such drug or biological 
product of the failure to complete such study and the questions 
of clinical benefit, and, where appropriate, questions of 
safety, that remain unanswered as a result of the failure to 
complete such study. Nothing in this subsection shall be 
construed as altering the requirements of the types of studies 
required under section 506(c)(2)(A) or under section 314.510 or 
601.41 of title 21, Code of Federal Regulations, as so in 
effect, or as prohibiting the Secretary from modifying such 
sections of title 21 of such Code to provide for studies in 
addition to those of such type.

           *       *       *       *       *       *       *


SEC. 506C-1. ANNUAL REPORTING ON DRUG SHORTAGES.

  (a) Annual Reports to Congress.--Not later than March 31 of 
each calendar year, 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, with respect to the preceding calendar year, 
on drug shortages that--
          (1) specifies the number of manufacturers that 
        submitted a notification to the Secretary under section 
        506C(a) during such calendar year;
          [(2) describes the communication between the field 
        investigators of the Food and Drug Administration and 
        the staff of the Center for Drug Evaluation and 
        Research's Office of Compliance and Drug Shortage 
        Program, including the Food and Drug Administration's 
        procedures for enabling and ensuring such 
        communication;]
          (2)(A) describes the communication between the field 
        investigators of the Food and Drug Administration and 
        the staff of the Center for Drug Evaluation and 
        Research's Office of Compliance and Drug Shortage 
        Program, including the Food and Drug Administration's 
        procedures for enabling and ensuring such 
        communication;
          (B) provides the number of reports described in 
        section 704(b)(2) that were required to be sent to the 
        appropriate offices of the Food and Drug Administration 
        and the number of such reports that were sent; and
          (C) describes the coordination and alignment 
        activities undertaken pursuant to section 506D(g);
          (3)(A) lists the major actions taken by the Secretary 
        to prevent or mitigate the drug shortages described in 
        paragraph (7);
          (B) in the list under subparagraph (A), includes--
                  (i) the number of applications and 
                supplements for which the Secretary expedited 
                review under section 506C(g)(1) during such 
                calendar year; and
                  (ii) the number of establishment inspections 
                or reinspections that the Secretary expedited 
                under section 506C(g)(2) during such calendar 
                year;
          (4) describes the coordination between the Food and 
        Drug Administration and the Drug Enforcement 
        Administration on efforts to prevent or alleviate drug 
        shortages;
          (5) identifies the number of and describes the 
        instances in which the Food and Drug Administration 
        exercised regulatory flexibility and discretion to 
        prevent or alleviate a drug shortage;
          (6) lists the names of manufacturers that were issued 
        letters under section 506C(f); and
          (7) specifies the number of drug shortages occurring 
        during such calendar year, as identified by the 
        Secretary.
  (b) Trend Analysis.--The Secretary is authorized to retain a 
third party to conduct a study, if the Secretary believes such 
a study would help clarify the causes, trends, or solutions 
related to drug shortages.
  (c) Definition.--In this section, the term ``drug shortage'' 
or ``shortage'' has the meaning given such term in section 
506C.

SEC. 506D. COORDINATION; TASK FORCE AND STRATEGIC PLAN.

  (a) Task Force and Strategic Plan.--
          (1) In general.--
                  (A) Task force.--As soon as practicable after 
                the date of enactment of the Food and Drug 
                Administration Safety and Innovation Act, the 
                Secretary shall establish a task force to 
                develop and implement a strategic plan for 
                enhancing the Secretary's response to 
                preventing and mitigating drug shortages.
                  (B) Strategic plan.--The strategic plan 
                described in subparagraph (A) shall include--
                          (i) plans for enhanced interagency 
                        and intra-agency coordination, 
                        communication, and decisionmaking;
                          (ii) plans for ensuring that drug 
                        shortages are considered when the 
                        Secretary initiates a regulatory action 
                        that could precipitate a drug shortage 
                        or exacerbate an existing drug 
                        shortage;
                          (iii) plans for effective 
                        communication with outside 
                        stakeholders, including who the 
                        Secretary should alert about potential 
                        or actual drug shortages, how the 
                        communication should occur, and what 
                        types of information should be shared;
                          (iv) plans for considering the impact 
                        of drug shortages on research and 
                        clinical trials; and
                          (v) an examination of whether to 
                        establish a ``qualified manufacturing 
                        partner program'', as described in 
                        subparagraph (C).
                  (C) Description of program.--In conducting 
                the examination of a ``qualified manufacturing 
                partner program'' under subparagraph (B)(v), 
                the Secretary--
                          (i) shall take into account that--
                                  (I) a ``qualified 
                                manufacturer'', for purposes of 
                                such program, would need to 
                                have the capability and 
                                capacity to supply products 
                                determined or anticipated to be 
                                in shortage; and
                                  (II) in examining the 
                                capability and capacity to 
                                supply products in shortage, 
                                the ``qualified manufacturer'' 
                                could have a site that 
                                manufactures a drug listed 
                                under section 506E or have the 
                                capacity to produce drugs in 
                                response to a shortage within a 
                                rapid timeframe; and
                          (ii) shall examine whether incentives 
                        are necessary to encourage the 
                        participation of ``qualified 
                        manufacturers'' in such a program.
                  (D) Consultation.--In carrying out this 
                paragraph, the task force shall ensure 
                consultation with the appropriate offices 
                within the Food and Drug Administration, 
                including the Office of the Commissioner, the 
                Center for Drug Evaluation and Research, the 
                Office of Regulatory Affairs, and employees 
                within the Department of Health and Human 
                Services with expertise regarding drug 
                shortages. The Secretary shall engage external 
                stakeholders and experts as appropriate.
          (2) Timing.--Not later than 1 year after the date of 
        enactment of the Food and Drug Administration Safety 
        and Innovation Act, the task force shall--
                  (A) publish the strategic plan described in 
                paragraph (1); and
                  (B) submit such plan to Congress.
  (b) Communication.--The Secretary shall ensure that, prior to 
any enforcement action or issuance of a warning letter that the 
Secretary determines could reasonably be anticipated to lead to 
a meaningful disruption in the supply in the United States of a 
drug described under section 506C(a), there is communication 
with the appropriate office of the Food and Drug Administration 
with expertise regarding drug shortages regarding whether the 
action or letter could cause, or exacerbate, a shortage of the 
drug.
  (c) Action.--If the Secretary determines, after the 
communication described in subsection (b), that an enforcement 
action or a warning letter could reasonably cause or exacerbate 
a shortage of a drug described under section 506C(a), then the 
Secretary shall evaluate the risks associated with the impact 
of such shortage upon patients and those risks associated with 
the violation involved before taking such action or issuing 
such letter, unless there is imminent risk of serious adverse 
health consequences or death to humans.
  (d) Reporting by Other Entities.--The Secretary shall 
identify or establish a mechanism by which health care 
providers and other third-party organizations may report to the 
Secretary evidence of a drug shortage.
  (e) Review and Construction.--No determination, finding, 
action, or omission of the Secretary under this section shall--
          (1) be subject to judicial review; or
          (2) be construed to establish a defense to an 
        enforcement action by the Secretary.
  (f) Sunset.--Subsections (a), (b), (c), and (e) shall cease 
to be effective on the date that is 5 years after the date of 
enactment of the Food and Drug Administration Safety and 
Innovation Act.
  (g) Coordination.--The Secretary shall ensure timely and 
effective internal coordination and alignment among the field 
investigators of the Food and Drug Administration and the staff 
of the Center for Drug Evaluation and Research's Office of 
Compliance and Drug Shortage Program regarding--
          (1) the reviews of reports shared pursuant to section 
        704(b)(2); and
          (2) any feedback or corrective or preventive actions 
        in response to such reports.

           *       *       *       *       *       *       *


SEC. 506I. PROMPT REPORTS OF MARKETING STATUS.

  (a) Notification of Withdrawal.--[The holder of an 
application approved under subsection (c) or (j) of section 
505] The holder of an application approved under subsection (c) 
or (j) of section 505 of this Act or subsection (a) or (k) of 
section 351 of the Public Health Service Act shall notify the 
Secretary in writing 180 days prior to withdrawing the approved 
drug from sale, or if 180 days is not practicable as soon as 
practicable but not later than the date of withdrawal. The 
holder shall include with such notice the--
          (1) National Drug Code;
          (2) identity of the drug by [established name] 
        established name (for biological products, by proper 
        name) and by proprietary name, if any;
          (3) new drug application number [or abbreviated 
        application number], abbreviated application number, or 
        biologics license application number;
          (4) strength of the drug;
          (5) date on which the drug is expected to no longer 
        be available for sale; and
          (6) reason for withdrawal of the drug.
  (b) Notification of Drug Not Available for Sale.--[The holder 
of an application approved under subsection (c) or (j)] The 
holder of an application approved under subsection (c) or (j) 
of section 505 of this Act or subsection (a) or (k) of section 
351 of the Public Health Service Act shall notify the Secretary 
in writing within 180 calendar days of the date of approval of 
the drug if the drug will not be available for sale within 180 
calendar days of such date of approval. The holder shall 
include with such notice the--
          (1) identity of the drug by [established name] 
        established name (for biological products, by proper 
        name) and by proprietary name, if any;
          (2) new drug application number [or abbreviated 
        application number], abbreviated application number, or 
        biologics license application number;
          (3) strength of the drug;
          (4) date on which the drug will be available for 
        sale, if known; and
          (5) reason for not marketing the drug after approval.
  [(c) Additional One-time Report.--Within 180 days of the date 
of enactment of this section, all holders of applications 
approved under subsection (c) or (j) of section 505 shall 
review the information in the list published under subsection 
505(j)(7)(A) and shall notify the Secretary in writing that--
          [(1) all of the application holder's drugs in the 
        active section of the list published under subsection 
        505(j)(7)(A) are available for sale; or
          [(2) one or more of the application holder's drugs in 
        the active section of the list published under 
        subsection 505(j)(7)(A) have been withdrawn from sale 
        or have never been available for sale, and include with 
        such notice the information required pursuant to 
        subsection (a) or (b), as applicable.
  [(d) Failure to Meet Requirements.--If a holder of an 
approved application fails to submit the information required 
under subsection (a), (b), or (c), the Secretary may move the 
application holder's drugs from the active section of the list 
published under subsection 505(j)(7)(A) to the discontinued 
section of the list, except that the Secretary shall remove 
from the list in accordance with subsection 505(j)(7)(C) drugs 
the Secretary determines have been withdrawn from sale for 
reasons of safety of effectiveness.]
  (c) Additional One-Time Report.--Within 180 days of the date 
of enactment of the Food and Drug Amendments of 2022, all 
holders of applications approved under subsection (a) or (k) of 
section 351 of the Public Health Service Act shall review the 
information in the list published under section 351(k)(9)(A) 
and shall submit a written notice to the Secretary--
          (1) stating that all of the application holder's 
        biological products in the list published under section 
        351(k)(9)(A) that are not listed as discontinued are 
        available for sale; or
          (2) including the information required pursuant to 
        subsection (a) or (b), as applicable, for each of the 
        application holder's biological products that are in 
        the list published under section 351(k)(9)(A) and not 
        listed as discontinued, but have been discontinued from 
        sale or never have been available for sale.
  (d) Failure To Meet Requirements.--If a holder of an approved 
application fails to submit the information required under 
subsection (a), (b), or (c), the Secretary may--
          (1) move the application holder's drugs from the 
        active section of the list published under section 
        505(j)(7)(A) to the discontinued section of the list, 
        except that the Secretary shall remove from the list in 
        accordance with section 505(j)(7)(C) drugs the 
        Secretary determines have been withdrawn from sale for 
        reasons of safety or effectiveness; and
          (2) identify the application holder's biological 
        products as discontinued in the list published under 
        section 351(k)(9)(A) of the Public Health Service Act, 
        except that the Secretary shall remove from the list in 
        accordance with section 351(k)(9)(B) of such Act 
        biological products for which the license has been 
        revoked or suspended for reasons of safety, purity, or 
        potency.
  (e) Updates.--The Secretary shall update the list published 
under [subsection 505(j)(7)(A)] section 505(j)(7)(A) based on 
the information provided under subsections (a), (b), and (c) by 
moving drugs that are not available for sale from the active 
section to the discontinued section of the list, except that 
drugs the Secretary determines have been withdrawn from sale 
for reasons of safety or effectiveness shall be removed from 
the list in accordance with [subsection 505(j)(7)(C)] section 
505(j)(7)(C). The Secretary shall update the list published 
under section 351(k)(9)(A) of the Public Health Service Act 
based on information provided under subsections (a), (b), and 
(c) by identifying as discontinued biological products that are 
not available for sale, except that biological products for 
which the license has been revoked or suspended for safety, 
purity, or potency reasons shall be removed from the list in 
accordance with section 351(k)(9)(B) of the Public Health 
Service Act. The Secretary shall make [monthly updates to the 
list] monthly updates to the lists referred to in the preceding 
sentences based on the information provided pursuant to 
subsections (a) and (b), [and shall update the list based on] 
and shall update such lists based on the information provided 
under subsection (c) as soon as practicable.
  (f) Limitation on Use of Notices.--Any notice submitted under 
this section shall not be made public by the Secretary and 
shall be used solely for the purpose of the updates described 
in subsection (e).

           *       *       *       *       *       *       *


SEC. 506K. ADVANCED MANUFACTURING TECHNOLOGIES DESIGNATION PILOT 
                    PROGRAM.

  (a) In General.--Not later than 1 year after the date of 
enactment of this section, the Secretary shall initiate a pilot 
program under which persons may request designation of an 
advanced manufacturing technology as described in subsection 
(b).
  (b) Designation Process.--The Secretary shall establish a 
process for the designation under this section of methods of 
manufacturing drugs, including biological products, and active 
pharmaceutical ingredients of such drugs, as advanced 
manufacturing technologies. A method of manufacturing, or a 
combination of manufacturing methods, is eligible for 
designation as an advanced manufacturing technology if such 
method or combination of methods incorporates a novel 
technology, or uses an established technique or technology in a 
novel way, that will substantially improve the manufacturing 
process for a drug and maintain equivalent or provide superior 
drug quality, including by--
          (1) reducing development time for a drug using the 
        designated manufacturing method; or
          (2) increasing or maintaining the supply of--
                  (A) a drug that is described in section 
                506C(a) and is intended to treat a serious or 
                life-threatening condition; or
                  (B) a drug that is on the drug shortage list 
                under section 506E.
  (c) Evaluation and Designation of an Advanced Manufacturing 
Technology.--
          (1) Submission.--A person who requests designation of 
        a method of manufacturing as an advanced manufacturing 
        technology under this section shall submit to the 
        Secretary data or information demonstrating that the 
        method of manufacturing meets the criteria described in 
        subsection (b) in a particular context of use. The 
        Secretary may facilitate the development and review of 
        such data or information by--
                  (A) providing timely advice to, and 
                interactive communication with, such person 
                regarding the development of the method of 
                manufacturing; and
                  (B) involving senior managers and experienced 
                staff of the Food and Drug Administration, as 
                appropriate, in a collaborative, cross-
                disciplinary review of the method of 
                manufacturing, as applicable.
          (2) Evaluation and designation.--Not later than 180 
        calendar days after the receipt of a request under 
        paragraph (1), the Secretary shall determine whether to 
        designate such method of manufacturing as an advanced 
        manufacturing technology, in a particular context of 
        use, based on the data and information submitted under 
        paragraph (1) and the criteria described in subsection 
        (b).
  (d) Review of Advanced Manufacturing Technologies.--If the 
Secretary designates a method of manufacturing as an advanced 
manufacturing technology, the Secretary shall--
          (1) expedite the development and review of an 
        application submitted under section 505 of this Act or 
        section 351 of the Public Health Service Act, including 
        supplemental applications, for drugs that are 
        manufactured using a designated advanced manufacturing 
        technology and could help mitigate or prevent a 
        shortage or substantially improve manufacturing 
        processes for a drug and maintain equivalent or provide 
        superior drug quality, as described in subsection (b); 
        and
          (2) allow the holder of an advanced technology 
        designation, or a person authorized by the advanced 
        manufacturing technology designation holder, to 
        reference or rely upon, in an application submitted 
        under section 505 of this Act or section 351 of the 
        Public Health Service Act, including a supplemental 
        application, data and information about the designated 
        advanced manufacturing technology for use in 
        manufacturing drugs in the same context of use for 
        which the designation was granted.
  (e) Implementation and Evaluation of Advanced Manufacturing 
Technologies Pilot.--
          (1) Public meeting.--The Secretary shall publish in 
        the Federal Register a notice of a public meeting, to 
        be held not later than 180 days after the date of 
        enactment of this section, to discuss and obtain input 
        and recommendations from relevant stakeholders 
        regarding--
                  (A) the goals and scope of the pilot program, 
                and a suitable framework, procedures, and 
                requirements for such program; and
                  (B) ways in which the Food and Drug 
                Administration will support the use of advanced 
                manufacturing technologies and other innovative 
                manufacturing approaches for drugs.
          (2) Pilot program guidance.--
                  (A) In general.--The Secretary shall--
                          (i) not later than 180 days after the 
                        public meeting under paragraph (1), 
                        issue draft guidance regarding the 
                        goals and implementation of the pilot 
                        program under this section; and
                          (ii) not later than 2 years after the 
                        date of enactment of this section, 
                        issue final guidance regarding the 
                        implementation of such program.
                  (B) Content.--The guidance described in 
                subparagraph (A) shall address--
                          (i) the process by which a person may 
                        request a designation under subsection 
                        (b);
                          (ii) the data and information that a 
                        person requesting such a designation is 
                        required to submit under subsection 
                        (c), and how the Secretary intends to 
                        evaluate such submissions;
                          (iii) the process to expedite the 
                        development and review of applications 
                        under subsection (d); and
                          (iv) the criteria described in 
                        subsection (b) for eligibility for such 
                        a designation.
          (3) Report.--Not later than 3 years after the date of 
        enactment of this section and annually thereafter, the 
        Secretary shall publish on the website of the Food and 
        Drug Administration and submit to the Committee on 
        Health, Education, Labor, and Pensions of the Senate 
        and the Committee on Energy and Commerce of the House 
        of Representatives a report containing a description 
        and evaluation of the pilot program being conducted 
        under this section, including the types of innovative 
        manufacturing approaches supported under the program. 
        Such report shall include the following:
                  (A) The number of persons that have requested 
                designations and that have been granted 
                designations.
                  (B) The number of methods of manufacturing 
                that have been the subject of designation 
                requests and that have been granted 
                designations.
                  (C) The average number of calendar days for 
                completion of evaluations under subsection 
                (c)(2).
                  (D) An analysis of the factors in data 
                submissions that are relevant to determinations 
                to designate and not to designate after 
                evaluation under subsection (c)(2).
                  (E) The number of applications received under 
                section 505 of this Act or section 351 of the 
                Public Health Service Act, including 
                supplemental applications, that have included 
                an advanced manufacturing technology designated 
                under this section, and the number of such 
                applications approved.
  (f) Sunset.--The Secretary--
          (1) may not consider any requests for designation 
        submitted under subsection (c) after October 1, 2029; 
        and
          (2) may continue all activities under this section 
        with respect to advanced manufacturing technologies 
        that were designated pursuant to subsection (d) prior 
        to such date, if the Secretary determines such 
        activities are in the interest of the public health.

           *       *       *       *       *       *       *

  Sec. 510. (a) As used in this section--
          (1) the term ``manufacture, preparation, propagation, 
        compounding, or processing'' shall include repackaging 
        or otherwise changing the container, wrapper, or 
        labeling of any drug package or device package in 
        furtherance of the distribution of the drug or device 
        from the original place of manufacture to the person 
        who makes final delivery or sale to the ultimate 
        consumer or user; and
          (2) the term ``name'' shall include in the case of a 
        partnership the name of each partner and, in the case 
        of a corporation, the name of each corporate officer 
        and director, and the State of incorporation.
  (b)(1) During the period beginning on October 1 and ending on 
December 31 of each year, every person who owns or operates any 
establishment in any State engaged in the manufacture, 
preparation, propagation, compounding, or processing of a drug 
or drugs shall register with the Secretary the name of such 
person, places of business of such person, all such 
establishments, the unique facility identifier of each such 
establishment, and a point of contact e-mail address.
  (2) During the period beginning on October 1 and ending on 
December 31 of each year, every person who owns or operates any 
establishment in any State engaged in the manufacture, 
preparation, propagation, compounding, or processing of a 
device or devices shall register with the Secretary his name, 
places of business, and all such establishments.
  (3) The Secretary shall specify the unique facility 
identifier system that shall be used by registrants under 
paragraph (1). The requirement to include a unique facility 
identifier in a registration under paragraph (1) shall not 
apply until the date that the identifier system is specified by 
the Secretary under the preceding sentence.
  (c) Every person upon first engaging in the manufacture, 
preparation, propagation, compounding, or processing of a drug 
or drugs or a device or devices in any establishment which he 
owns or operates in any State shall immediately register with 
the Secretary--
          (1) with respect to drugs, the information described 
        under subsection (b)(1); and
          (2) with respect to devices, the information 
        described under subsection (b)(2)..
  (d) Every person duly registered in accordance with the 
foregoing subsections of this section shall immediately 
register with the Secretary any additional establishment which 
he owns or operates in any State and in which he begins the 
manufacture, preparation, propagation, compounding, or 
processing of a drug or drugs or a device or devices.
  (e) The Secretary may assign a registration number to any 
person or any establishment registered in accordance with this 
section. The Secretary may also assign a listing number to each 
drug or class of drugs listed under subsection (j). Any number 
assigned pursuant to the preceding sentence shall be the same 
as that assigned pursuant to the National Drug Code. The 
Secretary may by regulation prescribe a uniform system for the 
identification of devices intended for human use and may 
require that persons who are required to list such devices 
pursuant to subsection (j) shall list such devices in 
accordance with such system.
  (f) The Secretary shall make available for inspection, to any 
person so requesting, any registration filed pursuant to this 
section; except that any list submitted pursuant to paragraph 
(3) of subsection (j) and the information accompanying any list 
or notice filed under paragraph (1) or (2) of that subsection 
shall be exempt from such inspection unless the Secretary finds 
that such an exemption would be inconsistent with protection of 
the public health.
  (g) The foregoing subsections of this section shall not apply 
to--
          (1) pharmacies which maintain establishments in 
        conformance with any applicable local laws regulating 
        the practice of pharmacy and medicine and which are 
        regularly engaged in dispensing prescription drugs or 
        devices, upon prescriptions of practitioners licensed 
        to administer such drugs or devices to patients under 
        the care of such practitioners in the course of their 
        professional practice, and which do not manufacture, 
        prepare, propagate, compound, or process drugs or 
        devices for sale other than in the regular course of 
        their business of dispensing or selling drugs or 
        devices at retail;
          (2) practitioners licensed by law to prescribe or 
        administer drugs or devices and who manufacture, 
        prepare, propagate, compound, or process drugs or 
        devices solely for use in the course of their 
        professional practice;
          (3) persons who manufacture, prepare, propagate, 
        compound, or process drugs or devices solely for use in 
        research, teaching, or chemical analysis and not for 
        sale;
          (4) any distributor who acts as a wholesale 
        distributor of devices, and who does not manufacture, 
        repackage, process, or relabel a device; or
          (5) such other classes of persons as the Secretary 
        may by regulation exempt from the application of this 
        section upon a finding that registration by such 
        classes of persons in accordance with this section is 
        not necessary for the protection of the public health.
In this subsection, the term ``wholesale distributor'' means 
any person (other than the manufacturer or the initial 
importer) who distributes a device from the original place of 
manufacture to the person who makes the final delivery or sale 
of the device to the ultimate consumer or user.
  (h) Inspections.--
          (1) In general.--Every establishment that is required 
        to be registered with the Secretary under this section 
        shall be subject to inspection pursuant to section 704.
          (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'') in accordance with a 
                risk-based schedule established by the 
                Secretary.
                  (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 the United 
                        States recognizes for purposes of 
                        inspecting device establishments.
          (3) Risk-based schedule for drugs.--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, preparation, propagation, 
        compounding, or processing of a drug or drugs (referred 
        to in this subsection as ``drug establishments'') in 
        accordance with a risk-based schedule established by 
        the Secretary.
          (4) Risk factors.--In establishing a risk-based 
        schedule under paragraph (2) or (3), the Secretary 
        shall inspect establishments according to the known 
        safety risks of such establishments, which shall be 
        based on the following factors:
                  (A) The compliance history of the 
                establishment.
                  (B) The record, history, and nature of 
                recalls linked to the establishment.
                  (C) The inherent risk of the drug or device 
                manufactured, prepared, propagated, compounded, 
                or processed at the establishment.
                  (D) The inspection frequency and history of 
                the establishment, including whether the 
                establishment has been inspected pursuant to 
                section 704 within the last 4 years.
                  (E) Whether the establishment has been 
                inspected by a foreign government or an agency 
                of a foreign government recognized under 
                section 809.
                  (F) The compliance history of establishments 
                in the country or region in which the 
                establishment is located that are subject to 
                regulation under this Act, including the 
                history of violations related to products 
                exported from such country or region that are 
                subject to such regulation.
                  [(F)] (G) Any other criteria deemed necessary 
                and appropriate by the Secretary for purposes 
                of allocating inspection resources.
          (5) Effect of status.--In determining the risk 
        associated with an establishment for purposes of 
        establishing a risk-based schedule under paragraph (3), 
        the Secretary shall not consider whether the drugs 
        manufactured, prepared, propagated, compounded, or 
        processed by such establishment are drugs described in 
        section 503(b).
          (6) Annual report on inspections of establishments.--
        Beginning in 2014, not later than May 1 of each year, 
        the Secretary shall make available on the Internet Web 
        site of the Food and Drug Administration a report 
        regarding--
                  (A)(i) the number of domestic and foreign 
                establishments registered pursuant to this 
                section in the previous calendar year; and
                  (ii) the number of such domestic 
                establishments and the number of such foreign 
                establishments that the Secretary inspected in 
                the previous calendar year;
                  (B) with respect to establishments that 
                manufacture, prepare, propagate, compound, or 
                process an active ingredient of a drug or a 
                finished drug product, the number of each such 
                type of establishment; and
                  (C) the percentage of the budget of the Food 
                and Drug Administration used to fund the 
                inspections described under subparagraph (A).
  (i)(1) Every person who owns or operates any establishment 
within any foreign country engaged in the manufacture, 
preparation, propagation, compounding, or processing of a drug 
or device that is imported or offered for import into the 
United States shall, through electronic means in accordance 
with the criteria of the Secretary--
          (A) upon first engaging in any such activity, 
        immediately submit a registration to the Secretary that 
        includes--
                  (i) with respect to drugs, the name and place 
                of business of such person, all such 
                establishments, the unique facility identifier 
                of each such establishment, a point of contact 
                e-mail address, the name of the United States 
                agent of each such establishment, the name of 
                each importer of such drug in the United States 
                that is known to the establishment, and the 
                name of each person who imports or offers for 
                import such drug to the United States for 
                purposes of importation; and
                  (ii) with respect to devices, the name and 
                place of business of the establishment, the 
                name of the United States agent for the 
                establishment, the name of each importer of 
                such device in the United States that is known 
                to the establishment, and the name of each 
                person who imports or offers for import such 
                device to the United States for purposes of 
                importation; and
          (B) each establishment subject to the requirements of 
        subparagraph (A) shall thereafter register with the 
        Secretary during the period beginning on October 1 and 
        ending on December 31 of each year.
  (2) The establishment shall also provide the information 
required by subsection (j).
  (3) The Secretary is authorized to enter into cooperative 
arrangements with officials of foreign countries to ensure that 
adequate and effective means are available for purposes of 
determining, from time to time, whether drugs or devices 
manufactured, prepared, propagated, compounded, or processed by 
an establishment described in paragraph (1), if imported or 
offered for import into the United States, shall be refused 
admission on any of the grounds set forth in section 801(a).
  (4) The Secretary shall specify the unique facility 
identifier system that shall be used by registrants under 
paragraph (1) with respect to drugs. The requirement to include 
a unique facility identifier in a registration under paragraph 
(1) with respect to drugs shall not apply until the date that 
the identifier system is specified by the Secretary under the 
preceding sentence.
  (j)(1) Every person who registers with the Secretary under 
subsection (b), (c), (d), or (i) shall, at the time of 
registration under any such subsection, file with the Secretary 
a list of all drugs and a list of all devices and a brief 
statement of the basis for believing that each device included 
in the list is a device rather than a drug (with each drug and 
device in each list listed by its established name (as defined 
in section 502(e)) and by any proprietary name) which are being 
manufactured, prepared, propagated, compounded, or processed by 
him for commercial distribution and which he has not included 
in any list of drugs or devices filed by him with the Secretary 
under this paragraph or paragraph (2) before such time of 
registration. Such list shall be prepared in such form and 
manner as the Secretary may prescribe and shall be accompanied 
by--
          (A) in the case of a drug contained in the applicable 
        list and subject to section 505 or 512, or a device 
        intended for human use contained in the applicable list 
        with respect to which a performance standard has been 
        established under section 514 or which is subject to 
        section 515, a reference to the authority for the 
        marketing of such drug or device and a copy of all 
        labeling for such drug or device;
          (B) in the case of any other drug or device contained 
        in an applicable list--
                  (i) which drug is subject to section 
                503(b)(1), or which device is a restricted 
                device, a copy of all labeling for such drug or 
                device, a representative sampling of 
                advertisements for such drug or device, and, 
                upon request made by the Secretary for good 
                cause, a copy of all advertisements for a 
                particular drug product or device, or
                  (ii) which drug is not subject to section 
                503(b)(1) or which device is not a restricted 
                device, the label and package insert for such 
                drug or device and a representative sampling of 
                any other labeling for such drug or device;
          (C) in the case of any drug contained in an 
        applicable list which is described in subparagraph (B), 
        a quantitative listing of its active ingredient or 
        ingredients, except that with respect to a particular 
        drug product the Secretary may require the submission 
        of a quantitative listing of all ingredients if he 
        finds that such submission is necessary to carry out 
        the purposes of this Act;
          (D) if the registrant filing a list has determined 
        that a particular drug product or device contained in 
        such list is not subject to section 505 or 512, or the 
        particular device contained in such list is not subject 
        to a performance standard established under section 514 
        or to section 515 or is not a restricted device, a 
        brief statement of the basis upon which the registrant 
        made such determination if the Secretary requests such 
        a statement with respect to that particular drug 
        product or device; and
          (E) in the case of a drug contained in the applicable 
        list, the name and place of business of each 
        manufacturer of an excipient of the listed drug with 
        which the person listing the drug conducts business, 
        including all establishments used in the production of 
        such excipient, the unique facility identifier of each 
        such establishment, and a point of contact e-mail 
        address for each such excipient manufacturer.
  (2) Each person who registers with the Secretary under this 
section shall report to the Secretary, with regard to drugs 
once during the month of June of each year and once during the 
month of December of each year, and with regard to devices once 
each year during the period beginning on October 1 and ending 
on December 31, the following information:
          (A) A list of each drug or device introduced by the 
        registrant for commercial distribution which has not 
        been included in any list previously filed by him with 
        the Secretary under this subparagraph or paragraph (1) 
        of this subsection. A list under this subparagraph 
        shall list a drug or device by its established name (as 
        defined in section 502(e)) and by any proprietary name 
        it may have and shall be accompanied by the other 
        information required by paragraph (1).
          (B) If since the date the registrant last made a 
        report under this paragraph (or if he has not made a 
        report under this paragraph, since the effective date 
        of this subsection) he has discontinued the 
        manufacture, preparation, propagation, compounding, or 
        processing for commercial distribution of a drug or 
        device included in a list filed by him under 
        subparagraph (A) or paragraph (1); notice of such 
        discontinuance, the date of such discontinuance, and 
        the identity (by established name (as defined in 
        section 502(e)) and by any proprietary name) of such 
        drug or device.
          (C) If since the date the registrant reported 
        pursuant to subparagraph (B) a notice of discontinuance 
        he has resumed the manufacture, preparation, 
        propagation, compounding, or processing for commercial 
        distribution of the drug or device with respect to 
        which such notice of discontinuance was reported; 
        notice of such resumption, the date of such resumption, 
        the identity of such drug or device (by established 
        name (as defined in section 502(e)) and by any 
        proprietary name), and the other information required 
        by paragraph (1), unless the registrant has previously 
        reported such resumption to the Secretary pursuant to 
        this subparagraph.
          (D) Any material change in any information previously 
        submitted pursuant to this paragraph or paragraph (1).
          (3)(A) Each person who registers with the Secretary 
        under this section with regard to a drug shall report 
        annually to the Secretary on the amount of each drug 
        listed under paragraph (1) that was manufactured, 
        prepared, propagated, compounded, or processed by such 
        person for commercial distribution. Such information 
        may be required to be submitted in an electronic format 
        as determined by the Secretary. The Secretary may 
        require that information required to be reported under 
        this paragraph be submitted at the time a public health 
        emergency is declared by the Secretary under section 
        319 of the Public Health Service Act.
          (B) By order of the Secretary, certain biological 
        products or categories of biological products regulated 
        under section 351 of the Public Health Service Act may 
        be exempt from some or all of the reporting 
        requirements under subparagraph (A), if the Secretary 
        determines that applying such reporting requirements to 
        such biological products or categories of biological 
        products is not necessary to protect the public health.
  (4) The Secretary may also require each registrant under this 
section to submit a list of each drug product which (A) the 
registrant is manufacturing, preparing, propagating, 
compounding, or processing for commercial distribution, and (B) 
contains a particular ingredient. The Secretary may not require 
the submission of such a list unless he has made a finding that 
the submission of such a list is necessary to carry out the 
purposes of this Act.
  (5) The Secretary shall require persons subject to this 
subsection to use, for purposes of this subsection, the unique 
facility identifier systems specified under subsections (b)(3) 
and (i)(4) with respect to drugs. Such requirement shall not 
apply until the date that the identifier system under 
subsection (b)(3) or (i)(4), as applicable, is specified by the 
Secretary.
  (k) Each person who is required to register under this 
section and who proposes to begin the introduction or delivery 
for introduction into interstate commerce for commercial 
distribution of a device intended for human use shall, at least 
ninety days before making such introduction or delivery, report 
to the Secretary or person who is accredited under section 
523(a) (in such form and manner as the Secretary shall by 
regulation prescribe)--
          (1) the class in which the device is classified under 
        section 513 or if such person determines that the 
        device is not classified under such section, a 
        statement of that determination and the basis for such 
        person's determination that the device is or is not so 
        classified, and
          (2) action taken by such person to comply with 
        requirements under section 514 or 515 which are 
        applicable to the device.
A notification submitted under this subsection that contains 
clinical trial data for an applicable device clinical trial (as 
defined in section 402(j)(1) of the Public Health Service Act) 
shall be accompanied by the certification required under 
section 402(j)(5)(B) of such Act. Such certification shall not 
be considered an element of such notification.
  (l)(1) A report under subsection (k) is not required for a 
device intended for human use that is exempted from the 
requirements of this subsection under subsection (m) or is 
within a type that has been classified into class I under 
section 513. The exception established in the preceding 
sentence does not apply to any class I device that is intended 
for a use which is of substantial importance in preventing 
impairment of human health, or to any class I device that 
presents a potential unreasonable risk of illness or injury.
  (2) Not later than 120 calendar days after the date of 
enactment of the 21st Century Cures Act and at least once every 
5 years thereafter, as the Secretary determines appropriate, 
the Secretary shall identify, through publication in the 
Federal Register, any type of class I device that the Secretary 
determines no longer requires a report under subsection (k) to 
provide reasonable assurance of safety and effectiveness. Upon 
such publication--
          (A) each type of class I device so identified shall 
        be exempt from the requirement for a report under 
        subsection (k); and
          (B) the classification regulation applicable to each 
        such type of device shall be deemed amended to 
        incorporate such exemption.
  (m)(1) The Secretary shall--
          (A) not later than 90 days after the date of 
        enactment of the 21st Century Cures Act and at least 
        once every 5 years thereafter, as the Secretary 
        determines appropriate--
                  (i) publish in the Federal Register a notice 
                that contains a list of each type of class II 
                device that the Secretary determines no longer 
                requires a report under subsection (k) to 
                provide reasonable assurance of safety and 
                effectiveness; and
                  (ii) provide for a period of not less than 60 
                calendar days for public comment beginning on 
                the date of the publication of such notice; and
          (B) not later than 210 calendar days after the date 
        of enactment of the 21st Century Cures Act, publish in 
        the Federal Register a list representing the 
        Secretary's final determination with respect to the 
        devices contained in the list published under 
        subparagraph (A).
  (2) Beginning on the date that is 1 calendar day after the 
date of publication of the final list under paragraph (1)(B), 
the Secretary may exempt a class II device from the requirement 
to submit a report under subsection (k), upon the Secretary's 
own initiative or a petition of an interested person, if the 
Secretary determines that such report is not necessary to 
assure the safety and effectiveness of the device. The 
Secretary shall publish in the Federal Register notice of the 
intent of the Secretary to exempt the device, or of the 
petition, and provide a 60-calendar-day period for public 
comment. Within 120 days after the issuance of the notice in 
the Federal Register, the Secretary shall publish an order in 
the Federal Register that sets forth the final determination of 
the Secretary regarding the exemption of the device that was 
the subject of the notice. If the Secretary fails to respond to 
a petition within 180 days of receiving it, the petition shall 
be deemed to be granted.
  (3) Upon the publication of the final list under paragraph 
(1)(B)--
          (A) each type of class II device so listed shall be 
        exempt from the requirement for a report under 
        subsection (k); and
          (B) the classification regulation applicable to each 
        such type of device shall be deemed amended to 
        incorporate such exemption.
  (n)(1) The Secretary shall review the report required in 
subsection (k) and make a determination under section 513(f)(1) 
not later than 90 days after receiving the report.
          (2)(A) Not later than 18 months after the date of 
        enactment of this paragraph, 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 regarding 
        when a premarket notification under subsection (k) 
        should be submitted for a modification or change to a 
        legally marketed device. The report shall include the 
        Secretary's interpretation of the following terms: 
        ``could significantly affect the safety or 
        effectiveness of the device'', ``a significant change 
        or modification in design, material, chemical 
        composition, energy source, or manufacturing process'', 
        and ``major change or modification in the intended use 
        of the device''. The report also shall discuss possible 
        processes for industry to use to determine whether a 
        new submission under subsection (k) is required and 
        shall analyze how to leverage existing quality system 
        requirements to reduce premarket burden, facilitate 
        continual device improvement, and provide reasonable 
        assurance of safety and effectiveness of modified 
        devices. In developing such report, the Secretary shall 
        consider the input of interested stakeholders.
          (B) The Secretary shall withdraw the Food and Drug 
        Administration draft guidance entitled ``Guidance for 
        Industry and FDA Staff--510(k) Device Modifications: 
        Deciding When to Submit a 510(k) for a Change to an 
        Existing Device'', dated July 27, 2011, and shall not 
        use this draft guidance as part of, or for the basis 
        of, any premarket review or any compliance or 
        enforcement decisions or actions. The Secretary shall 
        not issue--
                  (i) any draft guidance or proposed regulation 
                that addresses when to submit a premarket 
                notification submission for changes and 
                modifications made to a manufacturer's 
                previously cleared device before the receipt by 
                the Committee on Energy and Commerce of the 
                House of Representatives and the Committee on 
                Health, Education, Labor, and Pensions of the 
                Senate of the report required in subparagraph 
                (A); and
                  (ii) any final guidance or regulation on that 
                topic for one year after date of receipt of 
                such report by the Committee on Energy and 
                Commerce of the House of Representatives and 
                the Committee on Health, Education, Labor, and 
                Pensions of the Senate.
          (C) The Food and Drug Administration guidance 
        entitled ``Deciding When to Submit a 510(k) for a 
        Change to an Existing Device'', dated January 10, 1997, 
        shall be in effect until the subsequent issuance of 
        guidance or promulgation, if appropriate, of a 
        regulation described in subparagraph (B), and the 
        Secretary shall interpret such guidance in a manner 
        that is consistent with the manner in which the 
        Secretary has interpreted such guidance since 1997.
  (o)(1) With respect to reprocessed single-use devices for 
which reports are required under subsection (k):
          (A) The Secretary shall identify such devices or 
        types of devices for which reports under such 
        subsection must, in order to ensure that the device is 
        substantially equivalent to a predicate device, include 
        validation data, the types of which shall be specified 
        by the Secretary, regarding cleaning and sterilization, 
        and functional performance demonstrating that the 
        single-use device will remain substantially equivalent 
        to its predicate device after the maximum number of 
        times the device is reprocessed as intended by the 
        person submitting the premarket notification. Within 
        six months after enactment of this subsection, the 
        Secretary shall publish in the Federal Register a list 
        of the types so identified, and shall revise the list 
        as appropriate. Reports under subsection (k) for 
        devices or types of devices within a type included on 
        the list are, upon publication of the list, required to 
        include such validation data.
          (B) In the case of each report under subsection (k) 
        that was submitted to the Secretary before the 
        publication of the initial list under subparagraph (A), 
        or any revision thereof, and was for a device or type 
        of device included on such list, the person who 
        submitted the report under subsection (k) shall submit 
        validation data as described in subparagraph (A) to the 
        Secretary not later than nine months after the 
        publication of the list. During such nine-month period, 
        the Secretary may not take any action under this Act 
        against such device solely on the basis that the 
        validation data for the device have not been submitted 
        to the Secretary. After the submission of the 
        validation data to the Secretary, the Secretary may not 
        determine that the device is misbranded under section 
        502(o) or adulterated under section 501(f)(1)(B), or 
        take action against the device under section 301(p) for 
        failure to provide any information required by 
        subsection (k) until (i) the review is terminated by 
        withdrawal of the submission of the report under 
        subsection (k); (ii) the Secretary finds the data to be 
        acceptable and issues a letter; or (iii) the Secretary 
        determines that the device is not substantially 
        equivalent to a predicate device. Upon a determination 
        that a device is not substantially equivalent to a 
        predicate device, or if such submission is withdrawn, 
        the device can no longer be legally marketed.
          (C) In the case of a report under subsection (k) for 
        a device identified under subparagraph (A) that is of a 
        type for which the Secretary has not previously 
        received a report under such subsection, the Secretary 
        may, in advance of revising the list under subparagraph 
        (A) to include such type, require that the report 
        include the validation data specified in subparagraph 
        (A).
          (D) Section 502(o) applies with respect to the 
        failure of a report under subsection (k) to include 
        validation data required under subparagraph (A).
  (2) With respect to critical or semi-critical reprocessed 
single-use devices that, under subsection (l) or (m), are 
exempt from the requirement of submitting reports under 
subsection (k):
          (A) The Secretary shall identify such devices or 
        types of devices for which such exemptions should be 
        terminated in order to provide a reasonable assurance 
        of the safety and effectiveness of the devices. The 
        Secretary shall publish in the Federal Register a list 
        of the devices or types of devices so identified, and 
        shall revise the list as appropriate. The exemption for 
        each device or type included on the list is terminated 
        upon the publication of the list. For each report under 
        subsection (k) submitted pursuant to this subparagraph 
        the Secretary shall require the validation data 
        described in paragraph (1)(A).
          (B) For each device or type of device included on the 
        list under subparagraph (A), a report under subsection 
        (k) shall be submitted to the Secretary not later than 
        15 months after the publication of the initial list, or 
        a revision of the list, whichever terminates the 
        exemption for the device. During such 15-month period, 
        the Secretary may not take any action under this Act 
        against such device solely on the basis that such 
        report has not been submitted to the Secretary. After 
        the submission of the report to the Secretary the 
        Secretary may not determine that the device is 
        misbranded under section 502(o) or adulterated under 
        section 501(f)(1)(B), or take action against the device 
        under section 301(p) for failure to provide any 
        information required by subsection (k) until (i) the 
        review is terminated by withdrawal of the submission; 
        (ii) the Secretary determines by order that the device 
        is substantially equivalent to a predicate device; or 
        (iii) the Secretary determines by order that the device 
        is not substantially equivalent to a predicate device. 
        Upon a determination that a device is not substantially 
        equivalent to a predicate device, the device can no 
        longer be legally marketed.
          (C) In the case of semi-critical devices, the initial 
        list under subparagraph (A) shall be published not 
        later than 18 months after the effective date of this 
        subsection. In the case of critical devices, the 
        initial list under such subparagraph shall be published 
        not later than six months after such effective date.
          (D) Section 502(o) applies with respect to the 
        failure to submit a report under subsection (k) that is 
        required pursuant to subparagraph (A), including a 
        failure of the report to include validation data 
        required in such subparagraph.
          (E) The termination under subparagraph (A) of an 
        exemption under subsection (l) or (m) for a critical or 
        semi-critical reprocessed single-use device does not 
        terminate the exemption under subsection (l) or (m) for 
        the original device.
  (p) Electronic Registration and Listing.--
          (1) In general.--Registrations and listings under 
        this section (including the submission of updated 
        information) shall be submitted to the Secretary by 
        electronic means unless the Secretary grants a request 
        for waiver of such requirement because use of 
        electronic means is not reasonable for the person 
        requesting such waiver.
          (2) Electronic database.--Not later than 2 years 
        after the Secretary specifies a unique facility 
        identifier system under subsections (b) and (i), the 
        Secretary shall maintain an electronic database, which 
        shall not be subject to inspection under subsection 
        (f), populated with the information submitted as 
        described under paragraph (1) that--
                  (A) enables personnel of the Food and Drug 
                Administration to search the database by any 
                field of information submitted in a 
                registration described under paragraph (1), or 
                combination of such fields; and
                  (B) uses the unique facility identifier 
                system to link with other relevant databases 
                within the Food and Drug Administration, 
                including the database for submission of 
                information under section 801(r).
          (3) Risk-based information and coordination.--The 
        Secretary shall ensure the accuracy and coordination of 
        relevant Food and Drug Administration databases in 
        order to identify and inform risk-based inspections 
        under section 510(h).
  (q) Reusable Medical Devices.--
          (1) In general.--Not later than 180 days after the 
        date of enactment of the 21st Century Cures Act, the 
        Secretary shall identify and publish a list of reusable 
        device types for which reports under subsection (k) are 
        required to include--
                  (A) instructions for use, which have been 
                validated in a manner specified by the 
                Secretary; and
                  (B) validation data, the types of which shall 
                be specified by the Secretary;
        regarding cleaning, disinfection, and sterilization, 
        and for which a substantial equivalence determination 
        may be based.
          (2) Revision of list.--The Secretary shall revise the 
        list under paragraph (2), as the Secretary determines 
        appropriate, with notice in the Federal Register.
          (3) Content of reports.--Reports under subsection (k) 
        that are submitted after the publication of the list 
        described in paragraph (1), for devices or types of 
        devices included on such list, shall include such 
        instructions for use and validation data.

           *       *       *       *       *       *       *


            classification of devices intended for human use


                             Device Classes

  Sec. 513. (a)(1) There are established the following classes 
of devices intended for human use:
          (A) Class I, General Controls.--
                  (i) A device for which the controls 
                authorized by or under section 501, 502, 510, 
                516, 518, 519, or 520 or any combination of 
                such sections are sufficient to provide 
                reasonable assurance of the safety and 
                effectiveness of the device.
                  (ii) A device for which insufficient 
                information exists to determine that the 
                controls referred to in clause (i) are 
                sufficient to provide reasonable assurance of 
                the safety and effectiveness of the device or 
                to establish special controls to provide such 
                assurance, but because it--
                          (I) is not purported or represented 
                        to be for a use in supporting or 
                        sustaining human life or for a use 
                        which is of substantial importance in 
                        preventing impairment of human health, 
                        and
                          (II) does not present a potential 
                        unreasonable risk of illness or injury,
                is to be regulated by the controls referred to 
                in clause (i).
          (B) Class ii, special controls.--A device which 
        cannot be classified as a class I device because the 
        general controls by themselves are insufficient to 
        provide reasonable assurance of the safety and 
        effectiveness of the device, and for which there is 
        sufficient information to establish special controls to 
        provide such assurance, including the promulgation of 
        performance standards, postmarket surveillance, patient 
        registries, development and dissemination of guidelines 
        (including guidelines for the submission of clinical 
        data in premarket notification submissions in 
        accordance with section 510(k)), recommendations, and 
        other appropriate actions as the Secretary deems 
        necessary to provide such assurance. For a device that 
        is purported or represented to be for a use in 
        supporting or sustaining human life, the Secretary 
        shall examine and identify the special controls, if 
        any, that are necessary to provide adequate assurance 
        of safety and effectiveness and describe how such 
        controls provide such assurance.
          (C) Class III, Premarket Approval.--A device which 
        because--
                  (i) it (I) cannot be classified as a class I 
                device because insufficient information exists 
                to determine that the application of general 
                controls are sufficient to provide reasonable 
                assurance of the safety and effectiveness of 
                the device, and (II) cannot be classified as a 
                class II device because insufficient 
                information exists to determine that the 
                special controls described in subparagraph (B) 
                would provide reasonable assurance of its 
                safety and effectiveness, and
                  (ii)(I) is purported or represented to be for 
                a use in supporting or sustaining human life or 
                for a use which is of substantial importance in 
                preventing impairment of human health, or
                  (II) presents a potential unreasonable risk 
                of illness or injury,
        is to be subject, in accordance with section 515, to 
        premarket approval to provide reasonable assurance of 
        its safety and effectiveness.
If there is not sufficient information to establish a 
performance standard for a device to provide reasonable 
assurance of its safety and effectiveness, the Secretary may 
conduct such activities as may be necessary to develop or 
obtain such information.
  (2) For purposes of this section and sections 514 and 515, 
the safety and effectiveness of a device are to be determined--
          (A) with respect to the persons for whose use the 
        device is represented or intended,
          (B) with respect to the conditions of use prescribed, 
        recommended, or suggested in the labeling of the 
        device, and
          (C) weighing any probable benefit to health from the 
        use of the device against any probable risk of injury 
        or illness from such use.
  (3)(A) Except as authorized by subparagraph (B), the 
effectiveness of a device is, for purposes of this section and 
sections 514 and 515, to be determined, in accordance with 
regulations promulgated by the Secretary, on the basis of well-
controlled investigations, including 1 or more clinical 
investigations where appropriate, by experts qualified by 
training and experience to evaluate the effectiveness of the 
device, from which investigations it can fairly and responsibly 
be concluded by qualified experts that the device will have the 
effect it purports or is represented to have under the 
conditions of use prescribed, recommended, or suggested in the 
labeling of the device.
  (B) If the Secretary determines that there exists valid 
scientific evidence (other than evidence derived from 
investigations described in subparagraph (A))--
          (i) which is sufficient to determine the 
        effectiveness of a device, and
          (ii) from which it can fairly and responsibly be 
        concluded by qualified experts that the device will 
        have the effect it purports or is represented to have 
        under the conditions of use prescribed, recommended, or 
        suggested in the labeling of the device,
then, for purposes of this section and sections 514 and 515, 
the Secretary may authorize the effectiveness of the device to 
be determined on the basis of such evidence.
  (C) In making a determination of a reasonable assurance of 
the effectiveness of a device for which an application under 
section 515 has been submitted, the Secretary shall consider 
whether the extent of data that otherwise would be required for 
approval of the application with respect to effectiveness can 
be reduced through reliance on postmarket controls.
  (D)(i) The Secretary, upon the written request of any person 
intending to submit an application under section 515, shall 
meet with such person to determine the type of valid scientific 
evidence (within the meaning of subparagraphs (A) and (B)) that 
will be necessary to demonstrate for purposes of approval of an 
application the effectiveness of a device for the conditions of 
use proposed by such person. The written request shall include 
a detailed description of the device, a detailed description of 
the proposed conditions of use of the device, a proposed plan 
for determining whether there is a reasonable assurance of 
effectiveness, and, if available, information regarding the 
expected performance from the device. Within 30 days after such 
meeting, the Secretary shall specify in writing the type of 
valid scientific evidence that will provide a reasonable 
assurance that a device is effective under the conditions of 
use proposed by such person.
  (ii) Any clinical data, including one or more well-controlled 
investigations, specified in writing by the Secretary for 
demonstrating a reasonable assurance of device effectiveness 
shall be specified as result of a determination by the 
Secretary that such data are necessary to establish device 
effectiveness. The Secretary shall consider, in consultation 
with the applicant, the least burdensome appropriate means of 
evaluating device effectiveness that would have a reasonable 
likelihood of resulting in approval.
  (iii) For purposes of clause (ii), the term ``necessary'' 
means the minimum required information that would support a 
determination by the Secretary that an application provides 
reasonable assurance of the effectiveness of the device.
  (iv) Nothing in this subparagraph shall alter the criteria 
for evaluating an application for premarket approval of a 
device.
  (v) The determination of the Secretary with respect to the 
specification of valid scientific evidence under clauses (i) 
and (ii) shall be binding upon the Secretary, unless such 
determination by the Secretary could be contrary to the public 
health.

                 Classification; Classification Panels

  (b)(1) For purposes of--
          (A) determining which devices intended for human use 
        should be subject to the requirements of general 
        controls, performance standards, or premarket approval, 
        and
          (B) providing notice to the manufacturers and 
        importers of such devices to enable them to prepare for 
        the application of such requirements to devices 
        manufactured or imported by them,
the Secretary shall classify all such devices (other than 
devices classified by subsection (f)) into the classes 
established by subsection (a). For the purpose of securing 
recommendations with respect to the classification of devices, 
the Secretary shall establish panels of experts or use panels 
of experts established before the date of the enactment of this 
section, or both. Section 14 of the Federal Advisory Committee 
Act shall not apply to the duration of a panel established 
under this paragraph.
  (2) The Secretary shall appoint to each panel established 
under paragraph (1) persons who are qualified by training and 
experience to evaluate the safety and effectiveness of the 
devices to be referred to the panel and who, to the extent 
feasible, possess skill in the use of, or experience in the 
development, manufacture, or utilization of, such devices. The 
Secretary shall make appointments to each panel so that each 
panel shall consist of members with adequately diversified 
expertise in such fields as clinical and administrative 
medicine, engineering, biological and physical sciences, and 
other related professions. In addition, each panel shall 
include as nonvoting members a representative of consumer 
interests and a representative of interests of the device 
manufacturing industry. Scientific, trade, and consumer 
organizations shall be afforded an opportunity to nominate 
individuals for appointment to the panels. No individual who is 
in the regular full-time employ of the United States and 
engaged in the administration of this Act may be a member of 
any panel. The Secretary shall designate one of the members of 
each panel to serve as chairman thereof.
  (3) Panel members (other than officers or employees of the 
United States), while attending meetings or conferences of a 
panel or otherwise engaged in its business, shall be entitled 
to receive compensation at rates to be fixed by the Secretary, 
but not at rates exceeding the daily equivalent of the rate in 
effect for grade GS-18 of the General Schedule, for each day so 
engaged, including traveltime; and while so serving away from 
their homes or regular places of business each member may be 
allowed travel expenses (including per diem in lieu of 
subsistence) as authorized by section 5703 of title 5, United 
States Code, for persons in the Government service employed 
intermittently.
  (4) The Secretary shall furnish each panel with adequate 
clerical and other necessary assistance.
  (5)(A) Classification panels covering each type of device 
shall be scheduled to meet at such times as may be appropriate 
for the Secretary to meet applicable statutory deadlines.
  (B) When a device is specifically the subject of review by a 
classification panel, the Secretary shall--
          (i) ensure that adequate expertise is represented on 
        the classification panel to assess--
                  (I) the disease or condition which the device 
                is intended to cure, treat, mitigate, prevent, 
                or diagnose; and
                  (II) the technology of the device; and
          (ii) provide an opportunity for the person whose 
        device is specifically the subject of panel review to 
        provide recommendations on the expertise needed among 
        the voting members of the panel.
  (C) For purposes of subparagraph (B)(i), the term ``adequate 
expertise'' means that the membership of the classification 
panel includes--
          (i) two or more voting members, with a specialty or 
        other expertise clinically relevant to the device under 
        review; and
          (ii) at least one voting member who is knowledgeable 
        about the technology of the device.
  (D) The Secretary shall provide an annual opportunity for 
patients, representatives of patients, and sponsors of medical 
devices that may be specifically the subject of a review by a 
classification panel to provide recommendations for individuals 
with appropriate expertise to fill voting member positions on 
classification panels.
  (6)(A) Any person whose device is specifically the subject of 
review by a classification panel shall have--
          (i) the same access to data and information submitted 
        to a classification panel (except for data and 
        information that are not available for public 
        disclosure under section 552 of title 5, United States 
        Code) as the Secretary;
          (ii) the opportunity to submit, for review by a 
        classification panel, information that is based on the 
        data or information provided in the application 
        submitted under section 515 by the person, which 
        information shall be submitted to the Secretary for 
        prompt transmittal to the classification panel; and
          (iii) the same opportunity as the Secretary to 
        participate in meetings of the panel, including, 
        subject to the discretion of the panel chairperson, by 
        designating a representative who will be provided a 
        time during the panel meeting to address the panel for 
        the purpose of correcting misstatements of fact or 
        providing clarifying information, and permitting the 
        person or representative to call on experts within the 
        person's organization to address such specific issues 
        in the time provided.
  (B)(i) Any meeting of a classification panel with respect to 
the review of a device shall--
          (I) provide adequate time for initial presentations 
        by the person whose device is specifically the subject 
        of such review and by the Secretary; and
          (II) encourage free and open participation by all 
        interested persons.
  (ii) Following the initial presentations described in clause 
(i), the panel may--
          (I) pose questions to a designated representative 
        described in subparagraph (A)(iii); and
          (II) consider the responses to such questions in the 
        panel's review of the device.
  (7) After receiving from a classification panel the 
conclusions and recommendations of the panel on a matter that 
the panel has reviewed, the Secretary shall review the 
conclusions and recommendations, shall make a final decision on 
the matter in accordance with section 515(d)(2), and shall 
notify the affected persons of the decision in writing and, if 
the decision differs from the conclusions and recommendations 
of the panel, shall include the reasons for the difference.
  (8) A classification panel under this subsection shall not be 
subject to the annual chartering and annual report requirements 
of the Federal Advisory Committee Act.

            Classification Panel Organization and Operation

  (c)(1) The Secretary shall organize the panels according to 
the various fields of clinical medicine and fundamental 
sciences in which devices intended for human use are used. The 
Secretary shall refer a device to be classified under this 
section to an appropriate panel established or authorized to be 
used under subsection (b) for its review and for its 
recommendation respecting the classification of the device. The 
Secretary shall by regulation prescribe the procedure to be 
followed by the panels in making their reviews and 
recommendations. In making their reviews of devices, the 
panels, to the maximum extent practicable, shall provide an 
opportunity for interested persons to submit data and views on 
the classification of the devices.
  (2)(A) Upon completion of a panel's review of a device 
referred to it under paragraph (1), the panel shall, subject to 
subparagraphs (B) and (C), submit to the Secretary its 
recommendation for the classification of the device. Any such 
recommendation shall (i) contain (I) a summary of the reasons 
for the recommendation, (II) a summary of the data upon which 
the recommendation is based, and (III) an identification of the 
risks to health (if any) presented by the device with respect 
to which the recommendation is made, and (ii) to the extent 
practicable, include a recommendation for the assignment of a 
priority for the application of the requirements of section 514 
or 515 to a device recommended to be classified in class II or 
class III.
  (B) A recommendation of a panel for the classification of a 
device in class I shall include a recommendation as to whether 
the device should be exempted from the requirements of section 
510, 519, or 520(f).
  (C) In the case of a device which has been referred under 
paragraph (1) to a panel, and which--
          (i) is intended to be implanted in the human body or 
        is purported or represented to be for a use in 
        supporting or sustaining human life, and
          (ii)(I) has been introduced or delivered for 
        introduction into interstate commerce for commercial 
        distribution before the date of enactment of this 
        section, or
          (II) is within a type of device which was so 
        introduced or delivered before such date and is 
        substantially equivalent to another device within that 
        type,
such panel shall recommend to the Secretary that the device be 
classified in class III unless the panel determines that 
classification of the device in such class is not necessary to 
provide reasonable assurance of its safety and effectiveness. 
If a panel does not recommend that such a device be classified 
in class III, it shall in its recommendation to the Secretary 
for the classification of the device set forth the reasons for 
not recommending classification of the device in such class.
  (3) The panels shall submit to the Secretary within one year 
of the date funds are first appropriated for the implementation 
of this section their recommendations respecting all devices of 
a type introduced or delivered for introduction into interstate 
commerce for commercial distribution before the date of the 
enactment of this section.

                             Classification

  (d)(1) Upon receipt of a recommendation from a panel 
respecting a device, the Secretary shall publish in the Federal 
Register the panel's recommendation and a proposed regulation 
classifying such device and shall provide interested persons an 
opportunity to submit comments on such recommendation and the 
proposed regulation. After reviewing such comments, the 
Secretary shall, subject to paragraph (2), by regulation 
classify such device.
  (2)(A) A regulation under paragraph (1) classifying a device 
in class I shall prescribe which, if any, of the requirements 
of section 510, 519 or 520(f) shall not apply to the device. A 
regulation which makes a requirement of section 510, 519, or 
520(f) inapplicable to a device shall be accompanied by a 
statement of the reasons of the Secretary for making such 
requirement inapplicable.
  (B) A device described in subsection (c)(2)(C) shall be 
classified in class III unless the Secretary determines that 
classification of the device in such class is not necessary to 
provide reasonable assurance of its safety and effectiveness. A 
proposed regulation under paragraph (1) classifying such a 
device in a class other than class III shall be accompanied by 
a full statement of the reasons of the Secretary (and 
supporting documentation and data) for not classifying such 
device in such class and an identification of the risks to 
health (if any) presented by such device.
  (3) In the case of devices classified in class II and devices 
classified under this subsection in class III and described in 
section 515(b)(1) the Secretary may establish priorities which, 
in his discretion, shall be used in applying sections 514 and 
515, as appropriate, to such devices.

                         Classification Changes

  (e)(1)(A)(i) Based on new information respecting a device, 
the Secretary may, upon the initiative of the Secretary or upon 
petition of an interested person, change the classification of 
such device, and revoke, on account of the change in 
classification, any regulation or requirement in effect under 
section 514 or 515 with respect to such device, by 
administrative order published in the Federal Register 
following publication of a proposed reclassification order in 
the Federal Register, a meeting of a device classification 
panel described in subsection (b), and consideration of 
comments to a public docket, notwithstanding subchapter II of 
chapter 5 of title 5, United States Code. The proposed 
reclassification order published in the Federal Register shall 
set forth the proposed reclassification, and a substantive 
summary of the valid scientific evidence concerning the 
proposed reclassification, including--
          (I) the public health benefit of the use of the 
        device, and the nature and, if known, incidence of the 
        risk of the device;
          (II) in the case of a reclassification from class II 
        to class III, why general controls pursuant to 
        subsection (a)(1)(A) and special controls pursuant to 
        subsection (a)(1)(B) together are not sufficient to 
        provide a reasonable assurance of safety and 
        effectiveness for such device; and
          (III) in the case of reclassification from class III 
        to class II, why general controls pursuant to 
        subsection (a)(1)(A) and special controls pursuant to 
        subsection (a)(1)(B) together are sufficient to provide 
        a reasonable assurance of safety and effectiveness for 
        such device.
  (ii) An order under this subsection changing the 
classification of a device from class III to class II may 
provide that such classification shall not take effect until 
the effective date of a performance standard established under 
section 514 for such device.
  (B) Authority to issue such administrative order shall not be 
delegated below the Director of the Center for Devices and 
Radiological Health, acting in consultation with the 
Commissioner.
  (2) By an order issued under paragraph (1), the Secretary may 
change the classification of a device from class III--
          (A) to class II if the Secretary determines that 
        special controls would provide reasonable assurance of 
        the safety and effectiveness of the device and that 
        general controls would not provide reasonable assurance 
        of the safety and effectiveness of the device, or
          (B) to class I if the Secretary determines that 
        general controls would provide reasonable assurance of 
        the safety and effectiveness of the device.

     Initial Classification and Reclassification of Certain Devices

  (f)(1) Any device intended for human use which was not 
introduced or delivered for introduction into interstate 
commerce for commercial distribution before the date of the 
enactment of this section is classified in class III unless--
          (A) the device--
                  (i) is within a type of device (I) which was 
                introduced or delivered for introduction into 
                interstate commerce for commercial distribution 
                before such date and which is to be classified 
                pursuant to subsection (b), or (II) which was 
                not so introduced or delivered before such date 
                and has been classified in class I or II, and
                  (ii) is substantially equivalent to another 
                device within such type;
          (B) the Secretary in response to a petition submitted 
        under paragraph (3) has classified such device in class 
        I or II; or
          (C) the device is classified pursuant to a request 
        submitted under paragraph (2).
A device classified in class III under this paragraph shall be 
classified in that class until the effective date of an order 
of the Secretary under paragraph (2) or (3) classifying the 
device in class I or II.
  (2)(A)(i) Any person who submits a report under section 
510(k) for a type of device that has not been previously 
classified under this Act, and that is classified into class 
III under paragraph (1), may request, after receiving written 
notice of such a classification, the Secretary to classify the 
device.
  (ii) In lieu of submitting a report under section 510(k) and 
submitting a request for classification under clause (i) for a 
device, if a person determines there is no legally marketed 
device upon which to base a determination of substantial 
equivalence (as defined in subsection (i)), a person may submit 
a request under this clause for the Secretary to classify the 
device.
  (iii) Upon receipt of a request under clause (i) or (ii), the 
Secretary shall classify the device subject to the request 
under the criteria set forth in subparagraphs (A) through (C) 
of subsection (a)(1) within 120 days.
  (iv) Notwithstanding clause (iii), the Secretary may decline 
to undertake a classification request submitted under clause 
(ii) if the Secretary identifies a legally marketed device that 
could provide a reasonable basis for review of substantial 
equivalence under paragraph (1), or when the Secretary 
determines that the device submitted is not of low to moderate 
risk or that general controls would be inadequate to control 
the risks and special controls to mitigate the risks cannot be 
developed.
  (v) The person submitting the request for classification 
under this subparagraph may recommend to the Secretary a 
classification for the device and shall, if recommending 
classification in class II, include in the request an initial 
draft proposal for applicable special controls, as described in 
subsection (a)(1)(B), that are necessary, in conjunction with 
general controls, to provide reasonable assurance of safety and 
effectiveness and a description of how the special controls 
provide such assurance. Any such request shall describe the 
device and provide detailed information and reasons for the 
recommended classification.
  (B)(i) The Secretary shall by written order classify the 
device involved. Such classification shall be the initial 
classification of the device for purposes of paragraph (1) and 
any device classified under this paragraph shall be a predicate 
device for determining substantial equivalence under paragraph 
(1).
  (ii) A device that remains in class III under this 
subparagraph shall be deemed to be adulterated within the 
meaning of section 501(f)(1)(B) until approved under section 
515 or exempted from such approval under section 520(g).
  (C) Within 30 days after the issuance of an order classifying 
a device under this paragraph, the Secretary shall publish a 
notice in the Federal Register announcing such classification.
  (3)(A) The Secretary may initiate the reclassification of a 
device classified into class III under paragraph (1) of this 
subsection or the manufacturer or importer of a device 
classified under paragraph (1) may petition the Secretary (in 
such form and manner as he shall prescribe) for the issuance of 
an order classifying the device in class I or class II. Within 
thirty days of the filing of such a petition, the Secretary 
shall notify the petitioner of any deficiencies in the petition 
which prevent the Secretary from making a decision on the 
petition.
  (B)(i) Upon determining that a petition does not contain any 
deficiency which prevents the Secretary from making a decision 
on the petition, the Secretary may for good cause shown refer 
the petition to an appropriate panel established or authorized 
to be used under subsection (b). A panel to which such a 
petition has been referred shall not later than ninety days 
after the referral of the petition make a recommendation to the 
Secretary respecting approval or denial of the petition. Any 
such recommendation shall contain (I) a summary of the reasons 
for the recommendation, (II) a summary of the data upon which 
the recommendation is based, and (III) an identification of the 
risks to health (if any) presented by the device with respect 
to which the petition was filed. In the case of a petition for 
a device which is intended to be implanted in the human body or 
which is purported or represented to be for a use in supporting 
or sustaining human life, the panel shall recommend that the 
petition be denied unless the panel determines that the 
classification in class III of the device is not necessary to 
provide reasonable assurance of its safety and effectiveness. 
If the panel recommends that such petition be approved, it 
shall in its recommendation to the Secretary set forth its 
reasons for such recommendation.
  (ii) The requirements of paragraphs (1) and (2) of subsection 
(c) (relating to opportunities for submission of data and views 
and recommendations respecting priorities and exemptions from 
sections 510, 519, and 520(f)) shall apply with respect to 
consideration by panels of petitions submitted under 
subparagraph (A).
  (C)(i) Within ninety days from the date the Secretary 
receives the recommendation of a panel respecting a petition 
(but not later than 210 days after the filing of such petition) 
the Secretary shall by order deny or approve the petition. If 
the Secretary approves the petition, the Secretary shall order 
the classification of the device into class I or class II in 
accordance with the criteria prescribed by subsection (a)(1)(A) 
or (a)(1)(B). In the case of a petition for a device which is 
intended to be implanted in the human body or which is 
purported or represented to be for a use in supporting or 
sustaining human life, the Secretary shall deny the petition 
unless the Secretary determines that the classification in 
class III of the device is not necessary to provide reasonable 
assurance of its safety and effectiveness. An order approving 
such petition shall be accompanied by a full statement of the 
reasons of the Secretary (and supporting documentation and 
data) for approving the petition and an identification of the 
risks to health (if any) presented by the device to which such 
order applies.
  (ii) The requirements of paragraphs (1) and (2)(A) of 
subsection (d) (relating to publication of recommendations, 
opportunity for submission of comments, and exemption from 
sections 510, 519, and 520(f)) shall apply with respect to 
action by the Secretary on petitions submitted under 
subparagraph (A).
  (4) If a manufacturer reports to the Secretary under section 
510(k) that a device is substantially equivalent to another 
device--
          (A) which the Secretary has classified as a class III 
        device under subsection (b),
          (B) which was introduced or delivered for 
        introduction into interstate commerce for commercial 
        distribution before December 1, 1990, and
          (C) for which no final regulation requiring premarket 
        approval has been promulgated under section 515(b),
the manufacturer shall certify to the Secretary that the 
manufacturer has conducted a reasonable search of all 
information known or otherwise available to the manufacturer 
respecting such other device and has included in the report 
under section 510(k) a summary of and a citation to all adverse 
safety and effectiveness data respecting such other device and 
respecting the device for which the section 510(k) report is 
being made and which has not been submitted to the Secretary 
under section 519. The Secretary may require the manufacturer 
to submit the adverse safety and effectiveness data described 
in the report.
  (5) The Secretary may not withhold a determination of the 
initial classification of a device under paragraph (1) because 
of a failure to comply with any provision of this Act unrelated 
to a substantial equivalence decision, including a finding that 
the facility in which the device is manufactured is not in 
compliance with good manufacturing requirements as set forth in 
regulations of the Secretary under section 520(f) (other than a 
finding that there is a substantial likelihood that the failure 
to comply with such regulations will potentially present a 
serious risk to human health).
  (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 paragraph shall preclude 
the Secretary's authority to initiate the classification of an 
accessory through regulation or written order, as appropriate.
  (C)(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.
  (D) 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, the following shall 
apply:
          (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 determines appropriate, 
        pursuant to this paragraph, the Secretary shall publish 
        in the Federal Register a notice proposing a list of 
        such accessories that the Secretary determines may be 
        suitable for a distinct classification in class I and 
        the proposed regulations for such classifications. In 
        developing such list, the Secretary shall consider 
        recommendations from sponsors of device submissions and 
        other stakeholders for accessories to be included on 
        such list. 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), 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 85 calendar days after 
        receiving such request by issuing a written order 
        classifying the accessory or denying 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.
  (E) 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.

                              Information

  (g) Within sixty days of the receipt of a written request of 
any person for information respecting the class in which a 
device has been classified or the requirements applicable to a 
device under this Act, the Secretary shall provide such person 
a written statement of the classification (if any) of such 
device and the requirements of this Act applicable to the 
device.

                              Definitions

  (h) For purposes of this section and sections 501, 510, 514, 
515, 516, 519, and 520--
          (1) a reference to ``general controls'' is a 
        reference to the controls authorized by or under 
        sections 501, 502, 510, 516, 518, 519, and 520,
          (2) a reference to ``class I,''``class II,'' or 
        ``class III'' is a reference to a class of medical 
        devices described in subparagraph (A), (B), or (C) of 
        subsection (a)(1), and
          (3) a reference to a ``panel under section 513'' is a 
        reference to a panel established or authorized to be 
        used under this section.

                        Substantial Equivalence

  (i)(1)(A) For purposes of determinations of substantial 
equivalence under subsection (f) and section 520(l), the term 
``substantially equivalent'' or ``substantial equivalence'' 
means, with respect to a device being compared to a predicate 
device, that the device has the same intended use as the 
predicate device and that the Secretary by order has found that 
the device--
          (i) has the same technological characteristics as the 
        predicate device, or
          (ii)(I) has different technological characteristics 
        and the information submitted that the device is 
        substantially equivalent to the predicate device 
        contains information, including appropriate clinical or 
        scientific data if deemed necessary by the Secretary or 
        a person accredited under section 523, that 
        demonstrates that the device is as safe and effective 
        as a legally marketed device, and (II) does not raise 
        different questions of safety and effectiveness than 
        the predicate device.
  (B) For purposes of subparagraph (A), the term ``different 
technological characteristics'' means, with respect to a device 
being compared to a predicate device, that there is a 
significant change in the materials, design, energy source, or 
other features of the device from those of the predicate 
device.
  (C) To facilitate reviews of reports submitted to the 
Secretary under section 510(k), the Secretary shall consider 
the extent to which reliance on postmarket controls may 
expedite the classification of devices under subsection (f)(1) 
of this section.
  (D)(i) Whenever the Secretary requests information to 
demonstrate that devices with differing technological 
characteristics are substantially equivalent, the Secretary 
shall only request information that is necessary to making 
substantial equivalence determinations. In making such request, 
the Secretary shall consider the least burdensome means of 
demonstrating substantial equivalence and request information 
accordingly.
  (ii) For purposes of clause (i), the term ``necessary'' means 
the minimum required information that would support a 
determination of substantial equivalence between a new device 
and a predicate device.
  (iii) Nothing in this subparagraph shall alter the standard 
for determining substantial equivalence between a new device 
and a predicate device.
  (E)(i) Any determination by the Secretary of the intended use 
of a device shall be based upon the proposed labeling submitted 
in a report for the device under section 510(k). However, when 
determining that a device can be found substantially equivalent 
to a legally marketed device, the director of the 
organizational unit responsible for regulating devices (in this 
subparagraph referred to as the ``Director'') may require a 
statement in labeling that provides appropriate information 
regarding a use of the device not identified in the proposed 
labeling if, after providing an opportunity for consultation 
with the person who submitted such report, the Director 
determines and states in writing--
          (I) that there is a reasonable likelihood that the 
        device will be used for an intended use not identified 
        in the proposed labeling for the device; and
          (II) that such use could cause harm.
  (ii) Such determination shall--
          (I) be provided to the person who submitted the 
        report within 10 days from the date of the notification 
        of the Director's concerns regarding the proposed 
        labeling;
          (II) specify the limitations on the use of the device 
        not included in the proposed labeling; and
          (III) find the device substantially equivalent if the 
        requirements of subparagraph (A) are met and if the 
        labeling for such device conforms to the limitations 
        specified in subclause (II).
  (iii) The responsibilities of the Director under this 
subparagraph may not be delegated.
  (F) Not later than 270 days after the date of the enactment 
of the Food and Drug Administration Modernization Act of 1997, 
the Secretary shall issue guidance specifying the general 
principles that the Secretary will consider in determining when 
a specific intended use of a device is not reasonably included 
within a general use of such device for purposes of a 
determination of substantial equivalence under subsection (f) 
or section 520(l).
  (2) A device may not be found to be substantially equivalent 
to a predicate device that has been removed from the market at 
the initiative of the Secretary or that has been determined to 
be misbranded or adulterated by a judicial order.
  (3)(A) As part of a submission under section 510(k) 
respecting a device, the person required to file a premarket 
notification under such section shall provide an adequate 
summary of any information respecting safety and effectiveness 
or state that such information will be made available upon 
request by any person.
  (B) Any summary under subparagraph (A) respecting a device 
shall contain detailed information regarding data concerning 
adverse health effects and shall be made available to the 
public by the Secretary within 30 days of the issuance of a 
determination that such device is substantially equivalent to 
another device.
  (j) Training and Oversight of Least Burdensome 
Requirements.--
          (1) The Secretary shall--
                  (A) ensure that each employee of the Food and 
                Drug Administration who is involved in the 
                review of premarket submissions, including 
                supervisors, receives training regarding the 
                meaning and implementation of the least 
                burdensome requirements under subsections 
                (a)(3)(D) and (i)(1)(D) of this section and 
                section 515(c)(5); and
                  (B) periodically assess the implementation of 
                the least burdensome requirements, including 
                the employee training under subparagraph (A), 
                to ensure that the least burdensome 
                requirements are fully and consistently 
                applied.
          (2) Not later than 18 months after the date of 
        enactment of the 21st Century Cures Act, the ombudsman 
        for any organizational unit of the Food and Drug 
        Administration responsible for the premarket review of 
        devices shall--
                  (A) conduct an audit of the training 
                described in paragraph (1)(A), including the 
                effectiveness of such training in implementing 
                the least burdensome requirements;
                  (B) include in such audit interviews of 
                persons who are representatives of the device 
                industry regarding their experiences in the 
                device premarket review process, including with 
                respect to the application of least burdensome 
                concepts to premarket review and 
                decisionmaking;
                  (C) include in such audit a list of the 
                measurement tools the Secretary uses to assess 
                the implementation of the least burdensome 
                requirements, including under paragraph (1)(B) 
                and section 517A(a)(3), and may also provide 
                feedback on the effectiveness of such tools in 
                the implementation of the least burdensome 
                requirements;
                  (D) summarize the findings of such audit in a 
                final audit report; and
                  (E) within 30 calendar days of completion of 
                such final audit report, make such final audit 
                report available--
                          (i) to the Committee on Health, 
                        Education, Labor, and Pensions of the 
                        Senate and the Committee on Energy and 
                        Commerce of the House of 
                        Representatives; and
                          (ii) on the Internet website of the 
                        Food and Drug Administration.
  (k) For a device authorized for emergency use under section 
564 for which, in accordance with section 564(m), the Secretary 
has deemed a laboratory examination or procedure associated 
with such device to be in the category of examinations and 
procedures described in section 353(d)(3) of the Public Health 
Service Act, the sponsor of such device may, when submitting a 
request for classification under section 513(f)(2), submit a 
single submission containing--
          (1) the information needed for such a request; and
          (2) sufficient information to enable the Secretary to 
        determine whether such laboratory examination or 
        procedure satisfies the criteria to be categorized 
        under section 353(d)(3) of the Public Health Service 
        Act.

                         performance standards


                        Provisions of Standards

  Sec. 514. (a)(1) The special controls required by section 
513(a)(1)(B) shall include performance standards for a class II 
device if the Secretary determines that a performance standard 
is necessary to provide reasonable assurance of the safety and 
effectiveness of the device. A class III device may also be 
considered a class II device for purposes of establishing a 
standard for the device under subsection (b) if the device has 
been reclassified as a class II device under an administrative 
order under section 513(e) (or a regulation promulgated under 
such section prior to the date of enactment of the Food and 
Drug Administration Safety and Innovation Act) but such order 
(or regulation) provides that the reclassification is not to 
take effect until the effective date of such a standard for the 
device.
  (2) A performance standard established under subsection (b) 
for a device--
          (A) shall include provisions to provide reasonable 
        assurance of its safe and effective performance;
          (B) shall, where necessary to provide reasonable 
        assurance of its safe and effective performance, 
        include--
                  (i) provisions respecting the construction, 
                components, ingredients, and properties of the 
                device and its compatibility with power systems 
                and connections to such systems,
                  (ii) provisions for the testing (on a sample 
                basis or, if necessary, on an individual basis) 
                of the device or, if it is determined that no 
                other more practicable means are available to 
                the Secretary to assure the conformity of the 
                device to the standard, provisions for the 
                testing (on a sample basis or, if necessary, on 
                an individual basis) by the Secretary or by 
                another person at the direction of the 
                Secretary,
                  (iii) provisions for the measurement of the 
                performance characteristics of the device,
                  (iv) provisions requiring that the results of 
                each or of certain of the tests of the device 
                required to be made under clause (ii) show that 
                the device is in conformity with the portions 
                of the standard for which the test or tests 
                were required, and
                  (v) a provision requiring that the sale and 
                distribution of the device be restricted but 
                only to the extent that the sale and 
                distribution of a device may be restricted 
                under a regulation under section 520(e); and
          (C) shall, where appropriate, require the use and 
        prescribe the form and content of labeling for the 
        proper installation, maintenance, operation, and use of 
        the device.
  (3) The Secretary shall provide for periodic evaluation of 
performance standards established under subsection (b) to 
determine if such standards should be changed to reflect new 
medical, scientific, or other technological data.
  (4) In carrying out his duties under this subsection and 
subsection (b), the Secretary shall, to the maximum extent 
practicable--
          (A) use personnel, facilities, and other technical 
        support available in other Federal agencies,
          (B) consult with other Federal agencies concerned 
        with standard-setting and other nationally or 
        internationally recognized standard-setting entities, 
        and
          (C) invite appropriate participation, through joint 
        or other conferences, workshops, or other means, by 
        informed persons representative of scientific, 
        professional, industry, or consumer organizations who 
        in his judgment can make a significant contribution.

                      Establishment of a Standard

  (b)(1)(A) The Secretary shall publish in the Federal Register 
a notice of proposed rulemaking for the establishment, 
amendment, or revocation of any performance standard for a 
device.
  (B) A notice of proposed rulemaking for the establishment or 
amendment of a performance standard for a device shall--
          (i) set forth a finding with supporting justification 
        that the performance standard is appropriate and 
        necessary to provide reasonable assurance of the safety 
        and effectiveness of the device,
          (ii) set forth proposed findings with respect to the 
        risk of illness or injury that the performance standard 
        is intended to reduce or eliminate,
          (iii) invite interested persons to submit to the 
        Secretary, within 30 days of the publication of the 
        notice, requests for changes in the classification of 
        the device pursuant to section 513(e) based on new 
        information relevant to the classification, and
          (iv) invite interested persons to submit an existing 
        performance standard for the device, including a draft 
        or proposed performance standard, for consideration by 
        the Secretary.
  (C) A notice of proposed rulemaking for the revocation of a 
performance standard shall set forth a finding with supporting 
justification that the performance standard is no longer 
necessary to provide reasonable assurance of the safety and 
effectiveness of a device.
  (D) The Secretary shall provide for a comment period of not 
less than 60 days.
  (2) If, after publication of a notice in accordance with 
paragraph (1), the Secretary receives a request for a change in 
the classification of the device, the Secretary shall, within 
60 days of the publication of the notice, after consultation 
with the appropriate panel under section 513, either deny the 
request or give notice of an intent to initiate such change 
under section 513(e).
  (3)(A) After the expiration of the period for comment on a 
notice of proposed rulemaking published under paragraph (1) 
respecting a performance standard and after consideration of 
such comments and any report from an advisory committee under 
paragraph (5), the Secretary shall (i) promulgate a regulation 
establishing a performance standard and publish in the Federal 
Register findings on the matters referred to in paragraph (1), 
or (ii) publish a notice terminating the proceeding for the 
development of the standard together with the reasons for such 
termination. If a notice of termination is published, the 
Secretary shall (unless such notice is issued because the 
device is a banned device under section 516) initiate a 
proceeding under section 513(e) to reclassify the device 
subject to the proceeding terminated by such notice.
  (B) A regulation establishing a performance standard shall 
set forth the date or dates upon which the standard shall take 
effect, but no such regulation may take effect before one year 
after the date of its publication unless (i) the Secretary 
determines that an earlier effective date is necessary for the 
protection of the public health and safety, or (ii) such 
standard has been established for a device which, effective 
upon the effective date of the standard, has been reclassified 
from class III to class II. Such date or dates shall be 
established so as to minimize, consistent with the public 
health and safety, economic loss to, and disruption or 
dislocation of, domestic and international trade.
  (4)(A) The Secretary, upon his own initiative or upon 
petition of an interested person may by regulation, promulgated 
in accordance with the requirements of paragraphs (1), (2), and 
(3)(B) of this subsection, amend or revoke a performance 
standard.
  (B) The Secretary may declare a proposed amendment of a 
performance standard to be effective on and after its 
publication in the Federal Register and until the effective 
date of any final action taken on such amendment if he 
determines that making it so effective is in the public 
interest. A proposed amendment of a performance standard made 
so effective under the preceding sentence may not prohibit, 
during the period in which it is so effective, the introduction 
or delivery for introduction into interstate commerce of a 
device which conforms to such standard without the change or 
changes provided by such proposed amendment.
  (5)(A) The Secretary--
          (i) may on his own initiative refer a proposed 
        regulation for the establishment, amendment, or 
        revocation of a performance standard, or
          (ii) shall, upon the request of an interested person 
        which demonstrates good cause for referral and which is 
        made before the expiration of the period for submission 
        of comments on such proposed regulation refer such 
        proposed regulation,
to an advisory committee of experts, established pursuant to 
subparagraph (B) for a report and recommendation with respect 
to any matter involved in the proposed regulation which 
requires the exercise of scientific judgment. If a proposed 
regulation is referred under this subparagraph to an advisory 
committee, the Secretary shall provide the advisory committee 
with the data and information on which such proposed regulation 
is based. The advisory committee shall, within sixty days of 
the referral of a proposed regulation and after independent 
study of the data and information furnished to it by the 
Secretary and other data and information before it, submit to 
the Secretary a report and recommendation respecting such 
regulation, together with all underlying data and information 
and a statement of the reason or basis for the recommendation. 
A copy of such report and recommendation shall be made public 
by the Secretary.
  (B) The Secretary shall establish advisory committees (which 
may not be panels under section 513) to receive referrals under 
subparagraph (A). The Secretary shall appoint as members of any 
such advisory committee persons qualified in the subject matter 
to be referred to the committee and of appropriately 
diversified professional background, except that the Secretary 
may not appoint to such a committee any individual who is in 
the regular full-time employ of the United States and engaged 
in the administration of this Act. Each such committee shall 
include as nonvoting members a representative of consumer 
interests and a representative of interests of the device 
manufacturing industry. Members of an advisory committee who 
are not officers or employees of the United States, while 
attending conferences or meetings of their committee or 
otherwise serving at the request of the Secretary, shall be 
entitled to receive compensation at rates to be fixed by the 
Secretary, which rates may not exceed the daily equivalent of 
the rate in effect for grade GS-18 of the General Schedule, for 
each day (including traveltime) they are so engaged; and while 
so serving away from their homes or regular places of business 
each member may be allowed travel expenses, including per diem 
in lieu of subsistence, as authorized by section 5703 of title 
5 of the United States Code for persons in the Government 
service employed intermittently. The Secretary shall designate 
one of the members of each advisory committee to serve as 
chairman thereof. The Secretary shall furnish each advisory 
committee with clerical and other assistance, and shall by 
regulation prescribe the procedures to be followed by each such 
committee in acting on referrals made under subparagraph (A).

                       Recognition of a Standard

  (c)(1)(A) In addition to establishing a performance standard 
under this section, the Secretary shall, by publication in the 
Federal Register (or, with respect to a susceptibility test 
interpretive criteria standard under section 511A, by posting 
on the Interpretive Criteria Website in accordance with such 
section), recognize all or part of an appropriate standard 
established by a nationally or internationally recognized 
standard development organization for which a person may submit 
a declaration of conformity in order to meet a premarket 
submission requirement or other requirement under this Act to 
which such standard is applicable.
  (B) If a person elects to use a standard recognized by the 
Secretary under subparagraph (A) to meet the requirements 
described in such subparagraph, the person shall provide a 
declaration of conformity to the Secretary that certifies that 
the device is in conformity with such standard. A person may 
elect to use data, or information, other than data required by 
a standard recognized under subparagraph (A) to meet any 
requirement regarding devices under this Act.
  (C)(i) Any person may submit a request for recognition under 
subparagraph (A) of all or part of an appropriate standard 
established by a nationally or internationally recognized 
standard organization.
  (ii) Not later than 60 calendar days after the Secretary 
receives such a request, the Secretary shall--
          (I) make a determination to recognize all, part, or 
        none of the standard that is the subject of the 
        request; and
          (II) issue to the person who submitted such request a 
        response in writing that states the Secretary's 
        rationale for that determination, including the 
        scientific, technical, regulatory, or other basis for 
        such determination.
  (iii) The Secretary shall make a response issued under clause 
(ii)(II) publicly available, in such a manner as the Secretary 
determines appropriate.
  (iv) The Secretary shall take such actions as may be 
necessary to implement all or part of a standard recognized 
under clause (ii)(I), in accordance with subparagraph (A).
  (D) The Secretary shall make publicly available, in such 
manner as the Secretary determines appropriate, the rationale 
for recognition under subparagraph (A) of all, part, or none of 
a standard, including the scientific, technical, regulatory, or 
other basis for the decision regarding such recognition.
  (2) The Secretary may withdraw such recognition of a standard 
through publication of a notice in the Federal Register if the 
Secretary determines that the standard is no longer appropriate 
for meeting a requirement regarding devices under this Act.
  (3)(A) Subject to subparagraph (B), the Secretary shall 
accept a declaration of conformity that a device is in 
conformity with a standard recognized under paragraph (1) 
unless the Secretary finds--
          (i) that the data or information submitted to support 
        such declaration does not demonstrate that the device 
        is in conformity with the standard identified in the 
        declaration of conformity; or
          (ii) that the standard identified in the declaration 
        of conformity is not applicable to the particular 
        device under review.
  (B) The Secretary may request, at any time, the data or 
information relied on by the person to make a declaration of 
conformity with respect to a standard recognized under 
paragraph (1).
  (C) A person making a declaration of conformity with respect 
to a standard recognized under paragraph (1) shall maintain the 
data and information demonstrating conformity of the device to 
the standard for a period of two years after the date of the 
classification or approval of the device by the Secretary or a 
period equal to the expected design life of the device, 
whichever is longer.
  (4) The Secretary shall provide to all employees of the Food 
and Drug Administration who review premarket submissions for 
devices periodic training on the concept and use of recognized 
standards for purposes of meeting a premarket submission 
requirement or other applicable requirement under this Act, 
including standards relevant to an employee's area of device 
review.
  [(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 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.]
  (d) Accreditation Scheme for Conformity Assessment.--
          (1) In general.--The Secretary shall establish a 
        program under which--
                  (A) testing laboratories meeting criteria 
                specified in guidance by the Secretary may be 
                accredited by accreditation bodies meeting 
                criteria specified in guidance by the 
                Secretary, to conduct testing to support the 
                assessment of the conformity of a device to 
                certain standards recognized under this 
                section; and
                  (B) subject to paragraph (2), results from 
                tests conducted to support the assessment of 
                conformity of devices as described in 
                subparagraph (A) conducted by testing 
                laboratories accredited pursuant to this 
                subsection shall be accepted by the Secretary 
                for purposes of demonstrating such conformity 
                unless the Secretary finds that certain results 
                of such tests should not be so accepted.
          (2) Secretarial review of accredited laboratory 
        results.--The Secretary may--
                  (A) review the results of tests conducted by 
                testing laboratories accredited pursuant to 
                this subsection, including by conducting 
                periodic audits of such results or of the 
                processes of accredited bodies or testing 
                laboratories;
                  (B) following such review, take additional 
                measures under this Act, as the Secretary 
                determines appropriate, such as--
                          (i) suspension or withdrawal of 
                        accreditation of a testing laboratory 
                        or recognition of an accreditation body 
                        under paragraph (1)(A); or
                          (ii) requesting additional 
                        information with respect to a device; 
                        and
                  (C) if the Secretary becomes aware of 
                information materially bearing on the safety or 
                effectiveness of a device for which an 
                assessment of conformity was supported by 
                testing conducted by a testing laboratory 
                accredited under this subsection, take such 
                additional measures under this Act, as the 
                Secretary determines appropriate, such as--
                          (i) suspension or withdrawal of 
                        accreditation of a testing laboratory 
                        or recognition of an accreditation body 
                        under paragraph (1)(A); or
                          (ii) requesting additional 
                        information with regard to such device.
          (3) Implementation and reporting.--
                  (A) Pilot program transition.--After 
                September 30, 2023, the pilot program 
                previously initiated under this subsection, as 
                in effect prior to the date of enactment of the 
                Medical Device User Fee Amendments of 2022, 
                shall be considered to be completed, and the 
                Secretary may continue operating a program 
                consistent with this subsection.
                  (B) 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.

           *       *       *       *       *       *       *


                             banned devices


                              General Rule

  Sec. 516. (a) Whenever the Secretary finds, on the basis of 
all available data and information, that--
          (1) a device intended for human use presents 
        substantial deception or an unreasonable and 
        substantial risk of illness or injury for one or more 
        intended use; and
          (2) in the case of substantial deception or an 
        unreasonable and substantial risk of illness or injury 
        which the Secretary determined could be corrected or 
        eliminated by labeling or change in labeling and with 
        respect to which the Secretary provided written notice 
        to the manufacturer specifying the deception or risk of 
        illness or injury, the labeling or change in labeling 
        to correct the deception or eliminate or reduce such 
        risk, and the period within which such labeling or 
        change in labeling was to be done, such labeling or 
        change in labeling was not done within such period;
he may initiate a proceeding to promulgate a regulation to make 
such device a banned device for any such intended use or uses. 
A device that is banned for one or more intended uses is not a 
legally marketed device under section 1006 when intended for 
such use or uses.

                         Special Effective Date

  (b) The Secretary may declare a proposed regulation under 
subsection (a) to be effective upon its publication in the 
Federal Register and until the effective date of any final 
action taken respecting such regulation if (1) he determines, 
on the basis of all available data and information, that the 
deception or risk of illness or injury associated with the use 
of the device which is subject to the regulation presents an 
unreasonable, direct, and substantial danger to the health of 
individuals, and (2) before the date of the publication of such 
regulation, the Secretary notifies the manufacturer of such 
device that such regulation is to be made so effective. If the 
Secretary makes a proposed regulation so effective, he shall, 
as expeditiously as possible, give interested persons prompt 
notice of his action under this subsection, provide reasonable 
opportunity for an informal hearing on the proposed regulation, 
and either affirm, modify, or revoke such proposed regulation.
  (c) Specific Device Banned.--Electrical stimulation devices 
that apply a noxious electrical stimulus to a person's skin 
intended to reduce or cease self-injurious behavior or 
aggressive behavior are deemed to be banned devices, as 
described in subsection (a).
  (d) Reversal by Regulation.--Devices banned under this 
section are banned devices unless or until the Secretary 
promulgates a regulation to make such devices or use of such 
devices no longer banned based on a finding that such devices 
or use of such devices does not present substantial deception 
or an unreasonable and substantial risk of illness or injury, 
or that such risk can be corrected or eliminated by labeling.

           *       *       *       *       *       *       *


general provisions respecting control of devices intended for human use


                              General Rule

  Sec. 520. (a) Any requirement authorized by or under section 
501, 502, 510, or 519 applicable to a device intended for human 
use shall apply to such device until the applicability of the 
requirement to the device has been changed by action taken 
under section 513, 514, or 515 or under subsection (g) of this 
section, and any requirement established by or under section 
501, 502, 510, or 519 which is inconsistent with a requirement 
imposed on such device under section 514 or 515 or under 
subsection (g) of this section shall not apply to such device.
  (b) Custom Devices.--
          (1) In general.--The requirements of sections 514 and 
        515 shall not apply to a device that--
                  (A) is created or modified in order to comply 
                with the order of an individual physician or 
                dentist (or any other specially qualified 
                person designated under regulations promulgated 
                by the Secretary after an opportunity for an 
                oral hearing);
                  (B) in order to comply with an order 
                described in subparagraph (A), necessarily 
                deviates from an otherwise applicable 
                performance standard under section 514 or 
                requirement under section 515;
                  (C) is not generally available in the United 
                States in finished form through labeling or 
                advertising by the manufacturer, importer, or 
                distributor for commercial distribution;
                  (D) is designed to treat a unique pathology 
                or physiological condition that no other device 
                is domestically available to treat;
                  (E)(i) is intended to meet the special needs 
                of such physician or dentist (or other 
                specially qualified person so designated) in 
                the course of the professional practice of such 
                physician or dentist (or other specially 
                qualified person so designated); or
                  (ii) is intended for use by an individual 
                patient named in such order of such physician 
                or dentist (or other specially qualified person 
                so designated);
                  (F) is assembled from components or 
                manufactured and finished on a case-by-case 
                basis to accommodate the unique needs of 
                individuals described in clause (i) or (ii) of 
                subparagraph (E); and
                  (G) may have common, standardized design 
                characteristics, chemical and material 
                compositions, and manufacturing processes as 
                commercially distributed devices.
          (2) Limitations.--Paragraph (1) shall apply to a 
        device only if--
                  (A) such device is for the purpose of 
                treating a sufficiently rare condition, such 
                that conducting clinical investigations on such 
                device would be impractical;
                  (B) production of such device under paragraph 
                (1) is limited to no more than 5 units per year 
                of a particular device type, provided that such 
                replication otherwise complies with this 
                section; and
                  (C) the manufacturer of such device notifies 
                the Secretary on an annual basis, in a manner 
                prescribed by the Secretary, of the manufacture 
                of such device.
          (3) Guidance.--Not later than 2 years after the date 
        of enactment of this section, the Secretary shall issue 
        final guidance on replication of multiple devices 
        described in paragraph (2)(B).

                             Trade Secrets

  (c) Any information reported to or otherwise obtained by the 
Secretary or his representative under section 513, 514, 515, 
516, 518, 519, or 704 or under subsection (f) or (g) of this 
section which is exempt from disclosure pursuant to subsection 
(a) of section 552 of title 5, United States Code, by reason of 
subsection (b)(4) of such section shall be considered 
confidential and shall not be disclosed and may not be used by 
the Secretary as the basis for the reclassification of a device 
from class III to class II or class I or as the basis for the 
establishment or amendment of a performance standard under 
section 514 for a device reclassified from class III to class 
II, except (1) in accordance with subsection (h), and (2) that 
such information may be disclosed to other officers or 
employees concerned with carrying out this Act or when relevant 
in any proceeding under this Act (other than section 513 or 514 
thereof).

                          Notices and Findings

  (d) Each notice of proposed rulemaking under section 513, 
514, 515, 516, 518, or 519, or under this section, any other 
notice which is published in the Federal Register with respect 
to any other action taken under any such section and which 
states the reasons for such action, and each publication of 
findings required to be made in connection with rulemaking 
under any such section shall set forth--
          (1) the manner in which interested persons may 
        examine data and other information on which the notice 
        or findings is based, and
          (2) the period within which interested persons may 
        present their comments on the notice or findings 
        (including the need therefor) orally or in writing, 
        which period shall be at least sixty days but may not 
        exceed ninety days unless the time is extended by the 
        Secretary by a notice published in the Federal Register 
        stating good cause therefor.

                           Restricted Devices

  (e)(1) The Secretary may by regulation require that a device 
be restricted to sale, distribution, or use--
          (A) only upon the written or oral authorization of a 
        practitioner licensed by law to administer or use such 
        device, or
          (B) upon such other conditions as the Secretary may 
        prescribe in such regulation,
if, because of its potentiality for harmful effect or the 
collateral measures necessary to its use, the Secretary 
determines that there cannot otherwise be reasonable assurance 
of its safety and effectiveness. No condition prescribed under 
subparagraph (B) may restrict the use of a device to persons 
with specific training or experience in its use or to persons 
for use in certain facilities unless the Secretary determines 
that such a restriction is required for the safe and effective 
use of the device. No such condition may exclude a person from 
using a device solely because the person does not have the 
training or experience to make him eligible for certification 
by a certifying board recognized by the American Board of 
Medical Specialties or has not been certified by such a Board. 
A device subject to a regulation under this subsection is a 
restricted device.
  (2) The label of a restricted device shall bear such 
appropriate statements of the restrictions required by a 
regulation under paragraph (1) as the Secretary may in such 
regulation prescribe.

                Good Manufacturing Practice Requirements

  (f)(1)(A) The Secretary may, in accordance with subparagraph 
(B), prescribe regulations requiring that the methods used in, 
and the facilities and controls used for, the manufacture, pre-
production design validation (including a process to assess the 
performance of a device but not including an evaluation of the 
safety or effectiveness of a device), packing, storage, and 
installation of a device conform to current good manufacturing 
practice, as prescribed in such regulations, to assure that the 
device will be safe and effective and otherwise in compliance 
with this Act.
  (B) Before the Secretary may promulgate any regulation under 
subparagraph (A) he shall--
          (i) afford the advisory committee established under 
        paragraph (3) an opportunity to submit recommendations 
        to him with respect to the regulation proposed to be 
        promulgated;
          (ii) afford opportunity for an oral hearing; and
          (iii) ensure that such regulation conforms, to the 
        extent practicable, with internationally recognized 
        standards defining quality systems, or parts of the 
        standards, for medical devices.
The Secretary shall provide the advisory committee a reasonable 
time to make its recommendation with respect to proposed 
regulations under subparagraph (A).
  (2)(A) Any person subject to any requirement prescribed by 
regulations under paragraph (1) may petition the Secretary for 
an exemption or variance from such requirement. Such a petition 
shall be submitted to the Secretary in such form and manner as 
he shall prescribe and shall--
          (i) in the case of a petition for an exemption from a 
        requirement, set forth the basis for the petitioner's 
        determination that compliance with the requirement is 
        not required to assure that the device will be safe and 
        effective and otherwise in compliance with this Act,
          (ii) in the case of a petition for a variance from a 
        requirement, set forth the methods proposed to be used 
        in, and the facilities and controls proposed to be used 
        for, the manufacture, packing, storage, and 
        installation of the device in lieu of the methods, 
        facilities, and controls prescribed by the requirement, 
        and
          (iii) contain such other information as the Secretary 
        shall prescribe.
  (B) The Secretary may refer to the advisory committee 
established under paragraph (3) any petition submitted under 
subparagraph (A). The advisory committee shall report its 
recommendations to the Secretary with respect to a petition 
referred to it within sixty days of the date of the petition's 
referral. Within sixty days after--
          (i) the date the petition was submitted to the 
        Secretary under subparagraph (A), or
          (ii) if the petition was referred to an advisory 
        committee, the expiration of the sixty-day period 
        beginning on the date the petition was referred to the 
        advisory committee,
whichever occurs later, the Secretary shall by order either 
deny the petition or approve it.
  (C) The Secretary may approve--
          (i) a petition for an exemption for a device from a 
        requirement if he determines that compliance with such 
        requirement is not required to assure that the device 
        will be safe and effective and otherwise in compliance 
        with this Act, and
          (ii) a petition for a variance for a device from a 
        requirement if he determines that the methods to be 
        used in, and the facilities and controls to be used 
        for, the manufacture, packing, storage, and 
        installation of the device in lieu of the methods, 
        controls, and facilities prescribed by the requirement 
        are sufficient to assure that the device will be safe 
        and effective and otherwise in compliance with this 
        Act.
An order of the Secretary approving a petition for a variance 
shall prescribe such conditions respecting the methods used in, 
and the facilities and controls used for, the manufacture, 
packing, storage, and installation of the device to be granted 
the variance under the petition as may be necessary to assure 
that the device will be safe and effective and otherwise in 
compliance with this Act.
  (D) After the issuance of an order under subparagraph (B) 
respecting a petition, the petitioner shall have an opportunity 
for an informal hearing on such order.
  (3) The Secretary shall establish an advisory committee for 
the purpose of advising and making recommendations to him with 
respect to regulations proposed to be promulgated under 
paragraph (1)(A) and the approval or disapproval of petitions 
submitted under paragraph (2). The advisory committee shall be 
composed of nine members as follows:
          (A) Three of the members shall be appointed from 
        persons who are officers or employees of any State or 
        local government or of the Federal Government.
          (B) Two of the members shall be appointed from 
        persons who are representative of interests of the 
        device manufacturing industry; two of the members shall 
        be appointed from persons who are representative of the 
        interests of physicians and other health professionals; 
        and two of the members shall be representative of the 
        interests of the general public.
Members of the advisory committee who are not officers or 
employees of the United States, while attending conferences or 
meetings of the committee or otherwise engaged in its business, 
shall be entitled to receive compensation at rates to be fixed 
by the Secretary, which rates may not exceed the daily 
equivalent of the rate in effect for grade GS-18 of the General 
Schedule, for each day (including traveltime) they are so 
engaged; and while so serving away from their homes or regular 
places of business each member may be allowed travel expenses, 
including per diem in lieu of subsistence, as authorized by 
section 5703 of title 5 of the United States Code for persons 
in the Government service employed intermittently. The 
Secretary shall designate one of the members of the advisory 
committee to serve as its chairman. The Secretary shall furnish 
the advisory committee with clerical and other assistance. 
Section 14 of the Federal Advisory Committee Act shall not 
apply with respect to the duration of the advisory committee 
established under this paragraph.

             Exemption for Devices for Investigational Use

  (g)(1) It is the purpose of this subsection to encourage to 
the extent consistent with the protection of the public health 
and safety and with ethical standards, the discovery and 
development of useful devices intended for human use and to 
that end to maintain optimum freedom for scientific 
investigators in their pursuit of that purpose.
  (2)(A) The Secretary shall, within the one hundred and 
twenty-day period beginning on the date of the enactment of 
this section, by regulation prescribe procedures and conditions 
under which devices intended for human use may upon application 
be granted an exemption from the requirements of section 502, 
510, 514, 515, 516, 519, or 721 or subsection (e) or (f) of 
this section or from any combination of such requirements to 
permit the investigational use of such devices by experts 
qualified by scientific training and experience to investigate 
the safety and effectiveness of such devices.
  (B) The conditions prescribed pursuant to subparagraph (A) 
shall include the following:
          (i) A requirement that an application be submitted to 
        the Secretary before an exemption may be granted and 
        that the application be submitted in such form and 
        manner as the Secretary shall specify.
          (ii) A requirement that the person applying for an 
        exemption for a device assure the establishment and 
        maintenance of such records, and the making of such 
        reports to the Secretary of safety or effectiveness 
        data obtained as a result of the investigational use of 
        the device during the exemption, as the Secretary 
        determines will enable him to assure compliance with 
        such conditions, review the progress of the 
        investigation, and evaluate the safety and 
        effectiveness of the device.
          (iii) Such other requirements as the Secretary may 
        determine to be necessary for the protection of the 
        public health and safety.
  (C) Procedures and conditions prescribed pursuant to 
subparagraph (A) for an exemption may appropriately vary 
depending on (i) the scope and duration of clinical testing to 
be conducted under such exemption, (ii) the number of human 
subjects that are to be involved in such testing, (iii) the 
need to permit changes to be made in the device subject to the 
exemption during testing conducted in accordance with a 
clinical testing plan required under paragraph (3)(A), and (iv) 
whether the clinical testing of such device is for the purpose 
of developing data to obtain approval for the commercial 
distribution of such device.
  (3) Procedures and conditions prescribed pursuant to 
paragraph (2)(A) shall require, as a condition to the exemption 
of any device to be the subject of testing involving human 
subjects, that the person applying for the exemption--
          (A) submit a plan for any proposed clinical testing 
        of the device and a report of prior investigations of 
        the device (including, where appropriate, tests on 
        animals) adequate to justify the proposed clinical 
        testing--
                  (i) to the institutional review committee 
                established in accordance with regulations of 
                the Secretary to supervise clinical testing of 
                devices in the facilities where the proposed 
                clinical testing is to be conducted, or
                  (ii) to the Secretary, if--
                          (I) no such committee exists, or
                          (II) the Secretary finds that the 
                        process of review by such committee is 
                        inadequate (whether or not the plan for 
                        such testing has been approved by such 
                        committee),
        for review for adequacy to justify the commencement of 
        such testing; and, unless the plan and report are 
        submitted to the Secretary, submit to the Secretary a 
        summary of the plan and a report of prior 
        investigations of the device (including, where 
        appropriate, tests on animals);
          (B) promptly notify the Secretary (under such 
        circumstances and in such manner as the Secretary 
        prescribes) of approval by an institutional review 
        committee of any clinical testing plan submitted to it 
        in accordance with subparagraph (A);
          (C) in the case of a device to be distributed to 
        investigators for testing, obtain signed agreements 
        from each of such investigators that any testing of the 
        device involving human subjects will be under such 
        investigator's supervision and in accordance with 
        subparagraph (D) and submit such agreements to the 
        Secretary; and
          (D) assure that informed consent will be obtained 
        from each human subject (or his representative) of 
        proposed clinical testing involving such device, except 
        where, subject to such conditions as the Secretary may 
        prescribe--
                  (i) the proposed clinical testing poses no 
                more than minimal risk to the human subject and 
                includes appropriate safeguards to protect the 
                rights, safety, and welfare of the human 
                subject; or
                  (ii) the investigator conducting or 
                supervising the proposed clinical testing of 
                the device determines in writing that there 
                exists a life threatening situation involving 
                the human subject of such testing which 
                necessitates the use of such device and it is 
                not feasible to obtain informed consent from 
                the subject and there is not sufficient time to 
                obtain such consent from his representative.
The determination required by subparagraph (D)(ii) shall be 
concurred in by a licensed physician who is not involved in the 
testing of the human subject with respect to which such 
determination is made unless immediate use of the device is 
required to save the life of the human subject of such testing 
and there is not sufficient time to obtain such concurrence.
  (4)(A) An application, submitted in accordance with the 
procedures prescribed by regulations under paragraph (2), for 
an exemption for a device (other than an exemption from section 
516) shall be deemed approved on the thirtieth day after the 
submission of the application to the Secretary unless on or 
before such day the Secretary by order disapproves the 
application and notifies the applicant of the disapproval of 
the application.
  (B) The Secretary may disapprove an application only if he 
finds that the investigation with respect to which the 
application is submitted does not conform to procedures and 
conditions prescribed under regulations under paragraph (2). 
Such a notification shall contain the order of disapproval and 
a complete statement of the reasons for the Secretary's 
disapproval of the application and afford the applicant 
opportunity for an informal hearing on the disapproval order.
  (C) Consistent with paragraph (1), the Secretary shall not 
disapprove an application under this subsection because the 
Secretary determines that--
          (i) the investigation may not support a substantial 
        equivalence or de novo classification determination or 
        approval of the device;
          (ii) the investigation may not meet a requirement, 
        including a data requirement, relating to the approval 
        or clearance of a device; or
          (iii) an additional or different investigation may be 
        necessary to support clearance or approval of the 
        device.
  (5) The Secretary may by order withdraw an exemption granted 
under this subsection for a device if the Secretary determines 
that the conditions applicable to the device under this 
subsection for such exemption are not met. Such an order may be 
issued only after opportunity for an informal hearing, except 
that such an order may be issued before the provision of an 
opportunity for an informal hearing if the Secretary determines 
that the continuation of testing under the exemption with 
respect to which the order is to be issued will result in an 
unreasonable risk to the public health.
  (6)(A) Not later than 1 year after the date of the enactment 
of the Food and Drug Administration Modernization Act of 1997, 
the Secretary shall by regulation establish, with respect to a 
device for which an exemption under this subsection is in 
effect, procedures and conditions that, without requiring an 
additional approval of an application for an exemption or the 
approval of a supplement to such an application, permit--
          (i) developmental changes in the device (including 
        manufacturing changes) that do not constitute a 
        significant change in design or in basic principles of 
        operation and that are made in response to information 
        gathered during the course of an investigation; and
          (ii) changes or modifications to clinical protocols 
        that do not affect--
                  (I) the validity of data or information 
                resulting from the completion of an approved 
                protocol, or the relationship of likely patient 
                risk to benefit relied upon to approve a 
                protocol;
                  (II) the scientific soundness of an 
                investigational plan submitted under paragraph 
                (3)(A); or
                  (III) the rights, safety, or welfare of the 
                human subjects involved in the investigation.
  (B) Regulations under subparagraph (A) shall provide that a 
change or modification described in such subparagraph may be 
made if--
          (i) the sponsor of the investigation determines, on 
        the basis of credible information (as defined by the 
        Secretary) that the applicable conditions under 
        subparagraph (A) are met; and
          (ii) the sponsor submits to the Secretary, not later 
        than 5 days after making the change or modification, a 
        notice of the change or modification.
  (7)(A) In the case of a person intending to investigate the 
safety or effectiveness of a class III device or any 
implantable device, the Secretary shall ensure that the person 
has an opportunity, prior to submitting an application to the 
Secretary or to an institutional review committee, to submit to 
the Secretary, for review, an investigational plan (including a 
clinical protocol). If the applicant submits a written request 
for a meeting with the Secretary regarding such review, the 
Secretary shall, not later than 30 days after receiving the 
request, meet with the applicant for the purpose of reaching 
agreement regarding the investigational plan (including a 
clinical protocol). The written request shall include a 
detailed description of the device, a detailed description of 
the proposed conditions of use of the device, a proposed plan 
(including a clinical protocol) for determining whether there 
is a reasonable assurance of effectiveness, and, if available, 
information regarding the expected performance from the device.
  (B) Any agreement regarding the parameters of an 
investigational plan (including a clinical protocol) that is 
reached between the Secretary and a sponsor or applicant shall 
be reduced to writing and made part of the administrative 
record by the Secretary. Any such agreement shall not be 
changed, except--
          (i) with the written agreement of the sponsor or 
        applicant; or
          (ii) pursuant to a decision, made in accordance with 
        subparagraph (C) by the director of the office in which 
        the device involved is reviewed, that a substantial 
        scientific issue essential to determining the safety or 
        effectiveness of the device involved has been 
        identified.
  (C) A decision under subparagraph (B)(ii) by the director 
shall be in writing, and may be made only after the Secretary 
has provided to the sponsor or applicant an opportunity for a 
meeting at which the director and the sponsor or applicant are 
present and at which the director documents the scientific 
issue involved.
  (8)(A) At any time, the Secretary may prohibit the sponsor of 
an investigation from conducting the investigation (referred to 
in this paragraph as a ``clinical hold'') if the Secretary 
makes a determination described in subparagraph (B). The 
Secretary shall specify the basis for the clinical hold, 
including the specific information available to the Secretary 
which served as the basis for such clinical hold, and confirm 
such determination in writing.
  (B) For purposes of subparagraph (A), a determination 
described in this subparagraph with respect to a clinical hold 
is a determination that--
          (i) the device involved represents an unreasonable 
        risk to the safety of the persons who are the subjects 
        of the clinical investigation, taking into account the 
        qualifications of the clinical investigators, 
        information about the device, the design of the 
        clinical investigation, the condition for which the 
        device is to be investigated, and the health status of 
        the subjects involved; or
          (ii) the clinical hold should be issued for such 
        other reasons as the Secretary may by regulation 
        establish.
  (C) Any written request to the Secretary from the sponsor of 
an investigation that a clinical hold be removed shall receive 
a decision, in writing and specifying the reasons therefor, 
within 30 days after receipt of such request. Any such request 
shall include sufficient information to support the removal of 
such clinical hold.
  (9)(A)(i) In order for a device in a clinical study for which 
submission of an application for an investigational device 
exemption is required to be exempt under this subsection, the 
sponsor of such study shall submit to the Secretary in such 
application a diversity action plan in the form and manner 
specified in the guidance required by section 524B.
  (ii) In order for a device in a clinical study for which 
submission of an application for an investigational device 
exemption is not required, except for a device being studied as 
described in section 812.2(c) of title 21, Code of Federal 
Regulations (or successor regulations), to be exempt under this 
subsection, the sponsor of such study shall develop and 
implement a diversity action plan. Such diversity action plan 
shall be submitted to the Secretary in any premarket 
notification under section 510(k), request for classification 
under section 513(f)(2), or application for premarket approval 
under section 515 for such device.
  (B) A diversity action plan under clause (i) or (ii) of 
subparagraph (A) shall include--
          (i) the sponsor's goals for enrollment in the 
        clinical study;
          (ii) the sponsor's rationale for such goals; and
          (iii) an explanation of how the sponsor intends to 
        meet such goals.
  (C) The Secretary may waive the requirement in subparagraph 
(A) or (B) if the Secretary determines that a waiver is 
necessary based on what is known about the prevalence of the 
disease in terms of the patient population that may use the 
device.
  (D) No diversity action plan shall be required for a 
submission described in section 561.

            Release of Safety and Effectiveness Information

  (h)(1) The Secretary shall promulgate regulations under which 
a detailed summary of information respecting the safety and 
effectiveness of a device which information was submitted to 
the Secretary and which was the basis for--
          (A) an order under section 515(d)(1)(A) approving an 
        application for premarket approval for the device or 
        denying approval of such an application or an order 
        under section 515(e) withdrawing approval of such an 
        application for the device,
          (B) an order under section 515(f)(6)(A) revoking an 
        approved protocol for the device, an order under 
        section 515(f)(6)(B) declaring a protocol for the 
        device completed or not completed, or an order under 
        section 515(f)(7) revoking the approval of the device, 
        or
          (C) an order approving an application under 
        subsection (g) for an exemption for the device from 
        section 516 or an order disapproving, or withdrawing 
        approval of, an application for an exemption under such 
        subsection for the device,
shall be made available to the public upon issuance of the 
order. Summaries of information made available pursuant to this 
paragraph respecting a device shall include information 
respecting any adverse effects on health of the device.
  (2) The Secretary shall promulgate regulations under which 
each advisory committee established under section 515(g)(2)(B) 
shall make available to the public a detailed summary of 
information respecting the safety and effectiveness of a device 
which information was submitted to the advisory committee and 
which was the basis for its recommendation to the Secretary 
made pursuant to section 515(g)(2)(A). A summary of information 
upon which such a recommendation is based shall be made 
available pursuant to this paragraph only after the issuance of 
the order with respect to which the recommendation was made and 
each summary shall include information respecting any adverse 
effect on health of the device subject to such order.
  (3) Except as provided in paragraph (4), any information 
respecting a device which is made available pursuant to 
paragraph (1) or (2) of this subsection (A) may not be used to 
establish the safety or effectiveness of another device for 
purposes of this Act by any person other than the person who 
submitted the information so made available, and (B) shall be 
made available subject to subsection (c) of this section.
  (4)(A) Subject to subparagraph (C), any information contained 
in an application for premarket approval filed with the 
Secretary pursuant to section 515(c) (including information 
from clinical and preclinical tests or studies that demonstrate 
the safety and effectiveness of a device, but excluding 
descriptions of methods of manufacture and product composition 
and other trade secrets) shall be available, 6 years after the 
application has been approved by the Secretary, for use by the 
Secretary in--
          (i) approving another device;
          (ii) determining whether a product development 
        protocol has been completed, under section 515 for 
        another device;
          (iii) establishing a performance standard or special 
        control under this Act; or
          (iv) classifying or reclassifying another device 
        under section 513 and subsection (l)(2).
  (B) The publicly available detailed summaries of information 
respecting the safety and effectiveness of devices required by 
paragraph (1)(A) shall be available for use by the Secretary as 
the evidentiary basis for the agency actions described in 
subparagraph (A).
  (C) No information contained in an application for premarket 
approval filed with the Secretary pursuant to section 515(c) 
may be used to approve or clear any application submitted under 
section 515 or 510(k) or to classify a product under section 
513(f)(2) for a combination product containing as a constituent 
part an approved drug (as defined in section 503(g)(5)(B)) 
unless--
          (i) the application includes the certification or 
        statement referenced in section 503(g)(5)(A);
          (ii) the applicant provides notice as described in 
        section 503(g)(5)(A); and
          (iii) the Secretary's approval of such application is 
        subject to the provisions in section 503(g)(5)(C).

             Proceedings of Advisory Panels and Committees

  (i) Each panel under section 513 and each advisory committee 
established under section 514(b)(5)(B) or 515(g) or under 
subsection (f) of this section shall make and maintain a 
transcript of any proceeding of the panel or committee. Each 
such panel and committee shall delete from any transcript made 
pursuant to this subsection information which under subsection 
(c) of this section is to be considered confidential.

                       Traceability Requirements

  (j) Except as provided in section 519(e), no regulation under 
this Act may impose on a type or class of device requirements 
for the traceability of such type or class of device unless 
such requirements are necessary to assure the protection of the 
public health.

                        Research and Development

  (k) The Secretary may enter into contracts for research, 
testing, and demonstrations respecting devices and may obtain 
devices for research, testing, and demonstration purposes 
without regard to sections 3648 and 3709 of the Revised 
Statutes (31 U.S.C. 529, 41 U.S.C. 5).

      Transitional Provisions for Devices Considered as New Drugs

  (l)(1) Any device intended for human use--
          (A) for which on the date of enactment of the Medical 
        Device Amendments of 1976 (hereinafter in this 
        subsection referred to as the ``enactment date'') an 
        approval of an application submitted under section 
        505(b) was in effect;
          (B) for which such an application was filed on or 
        before the enactment date and with respect to which 
        application no order of approval or refusing to approve 
        had been issued on such date under subsection (c) or 
        (d) of such section;
          (C) for which on the enactment date an exemption 
        under subsection (i) of such section was in effect;
          (D) which is within a type of device described in 
        subparagraph (A), (B), or (C) and is substantially 
        equivalent to another device within that type;
          (E) which the Secretary in a notice published in the 
        Federal Register before the enactment date has declared 
        to be a new drug subject to section 505; or
          (F) with respect to which on the enactment date an 
        action is pending in a United States court under 
        section 302, 303, or 304 for an alleged violation of a 
        provision of section 301 which enforces a requirement 
        of section 505 or for an alleged violation of section 
        505(a),
is classified in class III unless the Secretary in response to 
a petition submitted under paragraph (2) has classified such 
device in class I or II.
  (2) The Secretary may initiate the reclassification of a 
device classified into class III under paragraph (1) of this 
subsection or the manufacturer or importer of a device 
classified under paragraph (1) may petition the Secretary (in 
such form and manner as he shall prescribe) for the issuance of 
an order classifying the device in class I or class II. Within 
thirty days of the filing of such a petition, the Secretary 
shall notify the petitioner of any deficiencies in the petition 
which prevent the Secretary from making a decision on the 
petition. Except as provided in paragraph (3)(D)(ii), within 
one hundred and eighty days after the filing of a petition 
under this paragraph, the Secretary shall, after consultation 
with the appropriate panel under section 513, by order either 
deny the petition or order the classification, in accordance 
with the criteria prescribed by section 513(a)(1)(A) or 
513(a)(1)(B), of the device in class I or class II.
  (3)(A) In the case of a device which is described in 
paragraph (1)(A) and which is in class III--
          (i) such device shall on the enactment date be 
        considered a device with an approved application under 
        section 515, and
          (ii) the requirements applicable to such device 
        before the enactment date under section 505 shall 
        continue to apply to such device until changed by the 
        Secretary as authorized by this Act.
  (B) In the case of a device which is described in paragraph 
(1)(B) and which is in class III, an application for such 
device shall be considered as having been filed under section 
515 on the enactment date. The period in which the Secretary 
shall act on such application in accordance with section 
515(d)(1) shall be one hundred and eighty days from the 
enactment date (or such greater period as the Secretary and the 
applicant may agree upon after the Secretary has made the 
finding required by section 515(d)(1)(B)(i)) less the number of 
days in the period beginning on the date an application for 
such device was filed under section 505 and ending on the 
enactment date. After the expiration of such period such device 
is required, unless exempt under subsection (g), to have in 
effect an approved application under section 515.
  (C) A device which is described in paragraph (1)(C) and which 
is in class III shall be considered a new drug until the 
expiration of the ninety-day period beginning on the date of 
the promulgation of regulations under subsection (g) of this 
section. After the expiration of such period such device is 
required, unless exempt under subsection (g), to have in effect 
an approved application under section 515.
  (D)(i) Except as provided in clauses (ii) and (iii), a device 
which is described in subparagraph (D), (E), or (F) of 
paragraph (1) and which is in class III is required, unless 
exempt under subsection (g) of this section, to have on and 
after sixty days after the enactment date in effect an approved 
application under section 515.
  (ii) If--
          (I) a petition is filed under paragraph (2) for a 
        device described in subparagraph (D), (E), or (F) of 
        paragraph (1), or
          (II) an application for premarket approval is filed 
        under section 515 for such a device,
within the sixty-day period beginning on the enactment date (or 
within such greater period as the Secretary, after making the 
finding required under section 515(d)(1)(B), and the petitioner 
or applicant may agree upon), the Secretary shall act on such 
petition or application in accordance with paragraph (2) or 
section 515 except that the period within which the Secretary 
must act on the petition or application shall be within the one 
hundred and twenty-day period beginning on the date the 
petition or application is filed. If such a petition or 
application is filed within such sixty-day (or greater) period, 
clause (i) of this subparagraph shall not apply to such device 
before the expiration of such one hundred and twenty-day 
period, or if such petition is denied or such application is 
denied approval, before the date of such denial, whichever 
occurs first.
  (iii) In the case of a device which is described in 
subparagraph (E) of paragraph (1), which the Secretary in a 
notice published in the Federal Register after March 31, 1976, 
declared to be a new drug subject to section 505, and which is 
in class III--
          (I) the device shall, after eighteen months after the 
        enactment date, have in effect an approved application 
        under section 515 unless exempt under subsection (g) of 
        this section, and
          (II) the Secretary may, during the period beginning 
        one hundred and eighty days after the enactment date 
        and ending eighteen months after such date, restrict 
        the use of the device to investigational use by experts 
        qualified by scientific training and experience to 
        investigate the safety and effectiveness of such 
        device, and to investigational use in accordance with 
        the requirements applicable under regulations under 
        subsection (g) of this section to investigational use 
        of devices granted an exemption under such subsection.
If the requirements under subsection (g) of this section are 
made applicable to the investigational use of such a device, 
they shall be made applicable in such a manner that the device 
shall be made reasonably available to physicians meeting 
appropriate qualifications prescribed by the Secretary.
  (5)(A) Before December 1, 1991, the Secretary shall by order 
require manufacturers of devices described in paragraph (1), 
which are subject to revision of classification under 
subparagraph (B), to submit to the Secretary a summary of and 
citation to any information known or otherwise available to the 
manufacturers respecting the devices, including adverse safety 
or effectiveness information which has not been submitted under 
section 519. The Secretary may require a manufacturer to submit 
the adverse safety or effectiveness data for which a summary 
and citation were submitted, if such data are available to the 
manufacturer.
  (B) Except as provided in subparagraph (C), after the 
issuance of an order under subparagraph (A) but before December 
1, 1992, the Secretary shall publish a regulation in the 
Federal Register for each device which is classified in class 
III under paragraph (1) revising the classification of the 
device so that the device is classified into class I or class 
II, unless the regulation requires the device to remain in 
class III. In determining whether to revise the classification 
of a device or to require a device to remain in class III, the 
Secretary shall apply the criteria set forth in section 513(a). 
Before the publication of a regulation requiring a device to 
remain in class III or revising its classification, the 
Secretary shall publish a proposed regulation respecting the 
classification of a device under this subparagraph and provide 
an opportunity for the submission of comments on any such 
regulation. No regulation under this subparagraph requiring a 
device to remain in class III or revising its classification 
may take effect before the expiration of 90 days from the date 
of the publication in the Federal Register of the proposed 
regulation.
  (C) The Secretary may by notice published in the Federal 
Register extend the period prescribed by subparagraph (B) for a 
device for an additional period not to exceed 1 year.

                     Humanitarian Device Exemption

  (m)(1) To the extent consistent with the protection of the 
public health and safety and with ethical standards, it is the 
purpose of this subsection to encourage the discovery and use 
of devices intended to benefit patients in the treatment and 
diagnosis of diseases or conditions that affect not more than 
8,000 individuals in the United States.
  (2) The Secretary may grant a request for an exemption from 
the effectiveness requirements of sections 514 and 515 for a 
device for which the Secretary finds that--
          (A) the device is designed to treat or diagnose a 
        disease or condition that affects not more than 8,000 
        individuals in the United States,
          (B) the device would not be available to a person 
        with a disease or condition referred to in subparagraph 
        (A) unless the Secretary grants such an exemption and 
        there is no comparable device, other than under this 
        exemption, available to treat or diagnose such disease 
        or condition, and
          (C) the device will not expose patients to an 
        unreasonable or significant risk of illness or injury 
        and the probable benefit to health from the use of the 
        device outweighs the risk of injury or illness from its 
        use, taking into account the probable risks and 
        benefits of currently available devic or alternative 
        forms of treatment.
The request shall be in the form of an application submitted to 
the Secretary and such application shall include the 
certification required under section 402(j)(5)(B) of the Public 
Health Service Act (which shall not be considered an element of 
such application). Not later than 75 days after the date of the 
receipt of the application, the Secretary shall issue an order 
approving or denying the application.
  (3) Except as provided in paragraph (6), no person granted an 
exemption under paragraph (2) with respect to a device may sell 
the device for an amount that exceeds the costs of research and 
development, fabrication, and distribution of the device.
  (4) Devices granted an exemption under paragraph (2) may only 
be used--
          (A) in facilities in which clinical testing of 
        devices is supervised by an institutional review 
        committee established in accordance with the 
        regulations of the Secretary; and
          (B) if, before the use of a device, an institutional 
        review committee or an appropriate local committee 
        approves the use in the treatment or diagnosis of a 
        disease or condition referred to in paragraph (2)(A), 
        unless a physician determines in an emergency situation 
        that approval from an institutional review committee or 
        an appropriate local committee can not be obtained in 
        time to prevent serious harm or death to a patient.
In a case described in subparagraph (B) in which a physician 
uses a device without an approval from an institutional review 
committee or an appropriate local committee, the physician 
shall, after the use of the device, notify the chairperson of 
the institutional review committee or an appropriate local 
committee of such use. Such notification shall include the 
identification of the patient involved, the date on which the 
device was used, and the reason for the use.
  (5) The Secretary may require a person granted an exemption 
under paragraph (2) to demonstrate continued compliance with 
the requirements of this subsection if the Secretary believes 
such demonstration to be necessary to protect the public 
health, if the Secretary has reason to believe that the 
requirements of paragraph (6) are no longer met, or if the 
Secretary has reason to believe that the criteria for the 
exemption are no longer met. If the person granted an exemption 
under paragraph (2) fails to demonstrate continued compliance 
with the requirements of this subsection, the Secretary may 
suspend or withdraw the exemption from the effectiveness 
requirements of sections 514 and 515 for a humanitarian device 
only after providing notice and an opportunity for an informal 
hearing.
  (6)(A) Except as provided in subparagraph (D), the 
prohibition in paragraph (3) shall not apply with respect to a 
person granted an exemption under paragraph (2) if each of the 
following conditions apply:
          (i) The device with respect to which the exemption is 
        granted--
                  (I) is intended for the treatment or 
                diagnosis of a disease or condition that occurs 
                in pediatric patients or in a pediatric 
                subpopulation, and such device is labeled for 
                use in pediatric patients or in a pediatric 
                subpopulation in which the disease or condition 
                occurs; or
                  (II) is intended for the treatment or 
                diagnosis of a disease or condition that does 
                not occur in pediatric patients or that occurs 
                in pediatric patients in such numbers that the 
                development of the device for such patients is 
                impossible, highly impracticable, or unsafe.
          (ii) During any calendar year, the number of such 
        devices distributed during that year under each 
        exemption granted under this subsection does not exceed 
        the annual distribution number for such device. In this 
        paragraph, the term ``annual distribution number'' 
        means the number of such devices reasonably needed to 
        treat, diagnose, or cure a population of 8,000 
        individuals in the United States. The Secretary shall 
        determine the annual distribution number when the 
        Secretary grants such exemption.
          (iii) Such person immediately notifies the Secretary 
        if the number of such devices distributed during any 
        calendar year exceeds the annual distribution number 
        referred to in clause (ii).
          (iv) The request for such exemption is submitted on 
        or before October 1, [2022] 2027.
  (B) The Secretary may inspect the records relating to the 
number of devices distributed during any calendar year of a 
person granted an exemption under paragraph (2) for which the 
prohibition in paragraph (3) does not apply.
  (C) A person may petition the Secretary to modify the annual 
distribution number determined by the Secretary under 
subparagraph (A)(ii) with respect to a device if additional 
information arises, and the Secretary may modify such annual 
distribution number.
  (D) If a person notifies the Secretary, or the Secretary 
determines through an inspection under subparagraph (B), that 
the number of devices distributed during any calendar year 
exceeds the annual distribution number, as required under 
subparagraph (A)(iii), and modified under subparagraph (C), if 
applicable, then the prohibition in paragraph (3) shall apply 
with respect to such person for such device for any sales of 
such device after such notification.
  (E)(i) In this subsection, the term ``pediatric patients'' 
means patients who are 21 years of age or younger at the time 
of the diagnosis or treatment.
  (ii) In this subsection, the term ``pediatric subpopulation'' 
means 1 of the following populations:
          (I) Neonates.
          (II) Infants.
          (III) Children.
          (IV) Adolescents.
  (7) The Secretary shall refer any report of an adverse event 
regarding a device described in paragraph (6)(A)(i)(I) for 
which the prohibition under paragraph (3) does not apply 
pursuant to paragraph (6)(A) that the Secretary receives to the 
Office of Pediatric Therapeutics, established under section 6 
of the Best Pharmaceuticals for Children Act (Public Law 107-
109). In considering the report, the Director of the Office of 
Pediatric Therapeutics, in consultation with experts in the 
Center for Devices and Radiological Health, shall provide for 
periodic review of the report by the Pediatric Advisory 
Committee, including obtaining any recommendations of such 
committee regarding whether the Secretary should take action 
under this Act in response to the report.
  (8) The Secretary, acting through the Office of Pediatric 
Therapeutics and the Center for Devices and Radiological 
Health, shall provide for an annual review by the Pediatric 
Advisory Committee of all devices described in paragraph 
(6)(A)(i)(I) to ensure that the exemption under paragraph (2) 
remains appropriate for the pediatric populations for which it 
is granted.

                 Regulation of Contact Lens as Devices

  (n)(1) All contact lenses shall be deemed to be devices under 
section 201(h).
  (2) Paragraph (1) shall not be construed as bearing on or 
being relevant to the question of whether any product other 
than a contact lens is a device as defined by section 201(h) or 
a drug as defined by section 201(g).
  (o) Regulation of Medical and Certain Decisions Support 
Software.--
          (1) The term device, as defined in section 201(h), 
        shall not include a software function that is 
        intended--
                  (A) for administrative support of a health 
                care facility, including the processing and 
                maintenance of financial records, claims or 
                billing information, appointment schedules, 
                business analytics, information about patient 
                populations, admissions, practice and inventory 
                management, analysis of historical claims data 
                to predict future utilization or cost-
                effectiveness, determination of health benefit 
                eligibility, population health management, and 
                laboratory workflow;
                  (B) for maintaining or encouraging a healthy 
                lifestyle and is unrelated to the diagnosis, 
                cure, mitigation, prevention, or treatment of a 
                disease or condition;
                  (C) to serve as electronic patient records, 
                including patient-provided information, to the 
                extent that such records are intended to 
                transfer, store, convert formats, or display 
                the equivalent of a paper medical chart, so 
                long as--
                          (i) such records were created, 
                        stored, transferred, or reviewed by 
                        health care professionals, or by 
                        individuals working under supervision 
                        of such professionals;
                          (ii) such records are part of health 
                        information technology that is 
                        certified under section 3001(c)(5) of 
                        the Public Health Service Act; and
                          (iii) such function is not intended 
                        to interpret or analyze patient 
                        records, including medical image data, 
                        for the purpose of the diagnosis, cure, 
                        mitigation, prevention, or treatment of 
                        a disease or condition;
                  (D) for transferring, storing, converting 
                formats, or displaying clinical laboratory test 
                or other device data and results, findings by a 
                health care professional with respect to such 
                data and results, general information about 
                such findings, and general background 
                information about such laboratory test or other 
                device, unless such function is intended to 
                interpret or analyze clinical laboratory test 
                or other device data, results, and findings; or
                  (E) unless the function is intended to 
                acquire, process, or analyze a medical image or 
                a signal from an in vitro diagnostic device or 
                a pattern or signal from a signal acquisition 
                system, for the purpose of--
                          (i) displaying, analyzing, or 
                        printing medical information about a 
                        patient or other medical information 
                        (such as peer-reviewed clinical studies 
                        and clinical practice guidelines);
                          (ii) supporting or providing 
                        recommendations to a health care 
                        professional about prevention, 
                        diagnosis, or treatment of a disease or 
                        condition; and
                          (iii) enabling such health care 
                        professional to independently review 
                        the basis for such recommendations that 
                        such software presents so that it is 
                        not the intent that such health care 
                        professional rely primarily on any of 
                        such recommendations to make a clinical 
                        diagnosis or treatment decision 
                        regarding an individual patient.
          (2) In the case of a product with multiple functions 
        that contains--
                  (A) at least one software function that meets 
                the criteria under paragraph (1) or that 
                otherwise does not meet the definition of 
                device under section 201(h); and
                  (B) at least one function that does not meet 
                the criteria under paragraph (1) and that 
                otherwise meets the definition of a device 
                under section 201(h),
        the Secretary shall not regulate the software function 
        of such product described in subparagraph (A) as a 
        device. Notwithstanding the preceding sentence, when 
        assessing the safety and effectiveness of the device 
        function or functions of such product described in 
        subparagraph (B), the Secretary may assess the impact 
        that the software function or functions described in 
        subparagraph (A) have on such device function or 
        functions.
          (3)(A) Notwithstanding paragraph (1), a software 
        function described in subparagraph (C), (D), or (E) of 
        paragraph (1) shall not be excluded from the definition 
        of device under section 201(h) if--
                  (i) the Secretary makes a finding that use of 
                such software function would be reasonably 
                likely to have serious adverse health 
                consequences; and
                  (ii) the software function has been 
                identified in a final order issued by the 
                Secretary under subparagraph (B).
          (B) Subparagraph (A) shall apply only if the 
        Secretary--
                  (i) publishes a notification and proposed 
                order in the Federal Register;
                  (ii) includes in such notification the 
                Secretary's finding, including the rationale 
                and identification of the evidence on which 
                such finding was based, as described in 
                subparagraph (A)(i); and
                  (iii) provides for a period of not less than 
                30 calendar days for public comment before 
                issuing a final order or withdrawing such 
                proposed order.
          (C) In making a finding under subparagraph (A)(i) 
        with respect to a software function, the Secretary 
        shall consider--
                  (i) the likelihood and severity of patient 
                harm if the software function were to not 
                perform as intended;
                  (ii) the extent to which the software 
                function is intended to support the clinical 
                judgment of a health care professional;
                  (iii) whether there is a reasonable 
                opportunity for a health care professional to 
                review the basis of the information or 
                treatment recommendation provided by the 
                software function; and
                  (iv) the intended user and user environment, 
                such as whether a health care professional will 
                use a software function of a type described in 
                subparagraph (E) of paragraph (1).
          (4) Nothing in this subsection shall be construed as 
        limiting the authority of the Secretary to--
                  (A) exercise enforcement discretion as to any 
                device subject to regulation under this Act;
                  (B) regulate software used in the manufacture 
                and transfusion of blood and blood components 
                to assist in the prevention of disease in 
                humans; or
                  (C) regulate software as a device under this 
                Act if such software meets the criteria under 
                section 513(a)(1)(C).
  (p) Diagnostic Imaging Devices Intended for Use With Contrast 
Agents.--
          (1) In general.--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 such 
        application, notification, or request involves 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 that is different 
                from those described in the approved labeling 
                of the contrast agent.
          (2) Premarket review.--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) Applicable requirements.--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) Definitions.--For purposes of this subsection--
                  (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
                  (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--
                          (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.
  (q) Regulation of Over-the-Counter Hearing Aids.--
          (1) Definition.--
                  (A) In general.--In this subsection, the term 
                ``over-the-counter hearing aid'' means a device 
                that--
                          (i) 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) is intended to be used by adults 
                        age 18 and older to compensate for 
                        perceived mild to moderate hearing 
                        impairment;
                          (iii) 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) may--
                                  (I) use wireless technology; 
                                or
                                  (II) include tests for self-
                                assessment of hearing loss; and
                          (v) 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) Exception.--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 709(b) of the FDA 
        Reauthorization Act of 2017 and shall be exempt from 
        sections 801.420 and 801.421 of title 21, Code of 
        Federal Regulations (or any successor regulations).

           *       *       *       *       *       *       *


SEC. 523. ACCREDITED PERSONS.

  (a) In General.--
          (1) Review and classification of devices.--Not later 
        than 1 year after the date of the enactment of the Food 
        and Drug Administration Modernization Act of 1997, the 
        Secretary shall, subject to paragraph (3), accredit 
        persons for the purpose of reviewing reports submitted 
        under section 510(k) and making recommendations to the 
        Secretary regarding the initial classification of 
        devices under section 513(f)(1).
          (2) Requirements regarding review.--
                  (A) In general.--In making a recommendation 
                to the Secretary under paragraph (1), an 
                accredited person shall notify the Secretary in 
                writing of the reasons for the recommendation.
                  (B) Time period for review.--Not later than 
                30 days after the date on which the Secretary 
                is notified under subparagraph (A) by an 
                accredited person with respect to a 
                recommendation of an initial classification of 
                a device, the Secretary shall make a 
                determination with respect to the initial 
                classification.
                  (C) Special rule.--The Secretary may change 
                the initial classification under section 
                513(f)(1) that is recommended under paragraph 
                (1) by an accredited person, and in such case 
                shall provide to such person, and the person 
                who submitted the report under section 510(k) 
                for the device, a statement explaining in 
                detail the reasons for the change.
          (3) Certain devices.--
                  (A) In general.--An accredited person may not 
                be used to perform a review of--
                          (i) a class III device;
                          (ii) a device classified under 
                        section 513(f)(2) or designated under 
                        section 515C(d);
                          (iii) a device that is intended to be 
                        permanently implantable, life 
                        sustaining, or life supporting, unless 
                        otherwise determined by the Secretary 
                        in accordance with subparagraph 
                        (B)(i)(II) and listed as eligible for 
                        review under subparagraph (B)(iii); or
                          (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
                                  (II) whether the device type, 
                                or subset of such device type, 
                                is permanently implantable, 
                                life sustaining, or life 
                                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.
  (b) Accreditation.--
          (1) Programs.--The Secretary shall provide for such 
        accreditation through programs administered by the Food 
        and Drug Administration, other government agencies, or 
        by other qualified nongovernment organizations.
          (2) Accreditation.--
                  (A) In general.--Not later than 180 days 
                after the date of the enactment of the Food and 
                Drug Administration Modernization Act of 1997, 
                the Secretary shall establish and publish in 
                the Federal Register criteria to accredit or 
                deny accreditation to persons who request to 
                perform the duties specified in subsection (a). 
                The Secretary shall respond to a request for 
                accreditation within 60 days of the receipt of 
                the request. The accreditation of such person 
                shall specify the particular activities under 
                subsection (a) for which such person is 
                accredited.
                  (B) Withdrawal of accreditation.--The 
                Secretary may suspend or withdraw accreditation 
                of any person accredited under this paragraph, 
                after providing notice and an opportunity for 
                an informal hearing, when such person is 
                substantially not in compliance with the 
                requirements of this section or poses a threat 
                to public health or fails to act in a manner 
                that is consistent with the purposes of this 
                section.
                  (C) Performance auditing.--To ensure that 
                persons accredited under this section will 
                continue to meet the standards of 
                accreditation, the Secretary shall--
                          (i) make onsite visits on a periodic 
                        basis to each accredited person to 
                        audit the performance of such person; 
                        and
                          (ii) take such additional measures as 
                        the Secretary determines to be 
                        appropriate.
                  (D) Periodic reaccreditation.--
                          (i) Period.--Subject to suspension or 
                        withdrawal under subparagraph (B), any 
                        accreditation under this section shall 
                        be valid for a period of 3 years after 
                        its issuance.
                          (ii) Response to reaccreditation 
                        request.--Upon the submission of a 
                        request by an accredited person for 
                        reaccreditation under this section, the 
                        Secretary shall approve or deny such 
                        request not later than 60 days after 
                        receipt of the request.
                          (iii) Criteria.--Not later than 120 
                        days after the date of the enactment of 
                        this subparagraph, the Secretary shall 
                        establish and publish in the Federal 
                        Register criteria to reaccredit or deny 
                        reaccreditation to persons under this 
                        section. The reaccreditation of persons 
                        under this section shall specify the 
                        particular activities under subsection 
                        (a), and the devices, for which such 
                        persons are reaccredited.
          (3) Qualifications.--An accredited person shall, at a 
        minimum, meet the following requirements:
                  (A) Such person may not be an employee of the 
                Federal Government.
                  (B) Such person shall be an independent 
                organization which is not owned or controlled 
                by a manufacturer, supplier, or vendor of 
                devices and which has no organizational, 
                material, or financial affiliation with such a 
                manufacturer, supplier, or vendor.
                  (C) Such person shall be a legally 
                constituted entity permitted to conduct the 
                activities for which it seeks accreditation.
                  (D) Such person shall not engage in the 
                design, manufacture, promotion, or sale of 
                devices.
                  (E) The operations of such person shall be in 
                accordance with generally accepted professional 
                and ethical business practices.
                  (F) 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--
                          (i) certify that reported information 
                        accurately reflects data reviewed;
                          (ii) limit work to that for which 
                        competence and capacity are available;
                          (iii) treat information received, 
                        records, reports, and recommendations 
                        as proprietary information;
                          (iv) promptly respond and attempt to 
                        resolve complaints regarding its 
                        activities for which it is accredited; 
                        and
                          (v) protect against the use, in 
                        carrying out subsection (a) with 
                        respect to a device, of any officer or 
                        employee of the person who has a 
                        financial conflict of interest 
                        regarding the device, and annually make 
                        available to the public disclosures of 
                        the extent to which the person, and the 
                        officers and employees of the person, 
                        have maintained compliance with 
                        requirements under this clause relating 
                        to financial conflicts of interest.
          (4) Selection of accredited persons.--The Secretary 
        shall provide each person who chooses to use an 
        accredited person to receive a section 510(k) report a 
        panel of at least two or more accredited persons from 
        which the regulated person may select one for a 
        specific regulatory function.
          (5) Compensation of accredited persons.--Compensation 
        for an accredited person shall be determined by 
        agreement between the accredited person and the person 
        who engages the services of the accredited person, and 
        shall be paid by the person who engages such services.
  (c) Duration.--The authority provided by this section 
terminates October 1, [2022] 2027.

           *       *       *       *       *       *       *


SEC. 524A. PRIORITY REVIEW FOR QUALIFIED INFECTIOUS DISEASE PRODUCTS.

  (a) In General.--If the Secretary designates a drug under 
section 505E(d) as a qualified infectious disease product, then 
the Secretary shall give priority review to the first 
application submitted for approval for such drug under section 
505(b) of this Act or section 351(a) of the Public Health 
Service Act that requires clinical data (other than 
bioavailability studies) to demonstrate safety or 
effectiveness.
  (b) Construction.--Nothing in this section shall prohibit the 
Secretary from giving priority review to a human drug 
application or efficacy supplement submitted for approval under 
section 505(b) that otherwise meets the criteria for the 
Secretary to grant priority review.

SEC. 524B. GUIDANCE ON DIVERSITY ACTION PLANS FOR CLINICAL STUDIES.

  (a) In General.--The Secretary shall issue guidance relating 
to--
          (1) the format and content of the diversity action 
        plans required by sections 505(i)(5) and 520(g)(9) 
        pertaining to the sponsor's goals for clinical study 
        enrollment, disaggregated by age group, sex, race, 
        geographic location, socioeconomic status, and 
        ethnicity, including with respect to--
                  (A) the rationale for the sponsor's 
                enrollment goals, which may include--
                          (i) the estimated prevalence or 
                        incidence in the United States of the 
                        disease or condition for which the drug 
                        or device is being developed or 
                        investigated, if such estimated 
                        prevalence or incidence is known or can 
                        be determined based on available data;
                          (ii) what is known about the disease 
                        or condition for which the drug or 
                        device is being developed or 
                        investigated;
                          (iii) any relevant pharmacokinetic or 
                        pharmacogenomic data;
                          (iv) what is known about the patient 
                        population for such disease or 
                        condition, including, to the extent 
                        data is available--
                                  (I) demographic information, 
                                including age group, sex, race, 
                                geographic location, 
                                socioeconomic status, and 
                                ethnicity;
                                  (II) non-demographic factors, 
                                including co-morbidities 
                                affecting the patient 
                                population; and
                                  (III) potential barriers to 
                                enrolling diverse participants, 
                                such as patient population 
                                size, geographic location, and 
                                socioeconomic status; and
                          (v) any other data or information 
                        relevant to selecting appropriate 
                        enrollment goals, disaggregated by 
                        demographic subgroup, such as the 
                        inclusion of pregnant and lactating 
                        women;
                  (B) an explanation for how the sponsor 
                intends to meet such goals, including 
                demographic-specific outreach and enrollment 
                strategies, study-site selection, clinical 
                study inclusion and exclusion practices, and 
                any diversity training for study personnel; and
                  (C) procedures for the public posting of key 
                information from the diversity action plan that 
                would be useful to patients and providers on 
                the sponsor's website, as appropriate; and
          (2) how sponsors should include in regular reports to 
        the Secretary--
                  (A) the sponsor's progress in meeting the 
                goals referred to in paragraph (1)(A); and
                  (B) if the sponsor does not expect to meet 
                such goals--
                          (i) any updates needed to be made to 
                        a diversity action plan referred to in 
                        paragraph (1) to help meet such goals; 
                        and
                          (ii) the sponsor's reasons for why 
                        the sponsor does not expect to meet 
                        such goals.
  (b) Issuance.--The Secretary shall--
          (1) not later than 12 months after the date of 
        enactment of this section, issue new draft guidance or 
        update existing draft guidance described in subsection 
        (a); and
          (2) not later than 9 months after closing the comment 
        period on such draft guidance, finalize such guidance.

SEC. 524C. ENSURING CYBERSECURITY OF DEVICES.

  (a) In General.--For purposes of ensuring cybersecurity 
throughout the lifecycle of a cyber device, any person who 
submits a premarket submission for the cyber device shall 
include such information as the Secretary may require to ensure 
that the cyber device meets such cybersecurity requirements as 
the Secretary determines to be appropriate to demonstrate a 
reasonable assurance of safety and effectiveness, including at 
a minimum the cybersecurity requirements under subsection (b).
  (b) Cybersecurity Requirements.--At a minimum, the 
manufacturer of a cyber device shall meet the following 
cybersecurity requirements:
          (1) The manufacturer shall have a plan to 
        appropriately monitor, identify, and address in a 
        reasonable time postmarket cybersecurity 
        vulnerabilities and exploits, including coordinated 
        vulnerability disclosure and procedures.
          (2) The manufacturer shall design, develop, and 
        maintain processes and procedures to ensure the device 
        and related systems are cybersecure, and shall make 
        available updates and patches to the cyber device and 
        related systems throughout the lifecycle of the cyber 
        device to address--
                  (A) on a reasonably justified regular cycle, 
                known unacceptable vulnerabilities; and
                  (B) as soon as possible out of cycle, 
                critical vulnerabilities that could cause 
                uncontrolled risks.
          (3) The manufacturer shall provide in the labeling of 
        the cyber device a software bill of materials, 
        including commercial, open-source, and off-the-shelf 
        software components.
          (4) The manufacturer shall comply with such other 
        requirements as the Secretary may require to 
        demonstrate reasonable assurance of the safety and 
        effectiveness of the device for purposes of 
        cybersecurity, which the Secretary may require by an 
        order published in the Federal Register.
  (c) Substantial Equivalence.--In making a determination of 
substantial equivalence under section 513(i) for a cyber 
device, the Secretary may--
          (1) find that cybersecurity information for the cyber 
        device described in the relevant premarket submission 
        in the cyber device's use environment is inadequate; 
        and
          (2) issue a nonsubstantial equivalence determination 
        based on this finding.
  (d) Definition.--In this section:
          (1) Cyber device.--The term ``cyber device'' means a 
        device that--
                  (A) includes software, including software as 
                or in a device;
                  (B) has the ability to connect to the 
                internet; or
                  (C) contains any such technological 
                characteristics that could be vulnerable to 
                cybersecurity threats.
          (2) Lifecycle of the cyber device.--The term 
        ``lifecycle of the cyber device'' includes the 
        postmarket lifecycle of the cyber device.
          (3) Premarket submission.--The term ``premarket 
        submission'' means any submission under section 510(k), 
        513, 515(c), 515(f), or 520(m).
  (e) Exemption.--The Secretary may identify devices or types 
of devices that are exempt from meeting the cybersecurity 
requirements established by this section and regulations 
promulgated pursuant to this section. The Secretary shall 
publish in the Federal Register, and update, as appropriate, a 
list of the devices and types of devices so identified by the 
Secretary.

Subchapter B--Drugs for Rare Diseases or Conditions

           *       *       *       *       *       *       *



          protection for drugs for rare diseases or conditions

  Sec. 527. (a) Except as provided in subsection (b), if the 
Secretary--
          (1) approves an application filed pursuant to section 
        505, or
          (2) issues a license under section 351 of the Public 
        Health Service Act
for a drug designated under section 526 for a rare disease or 
condition, the Secretary may not approve another application 
under section 505 or issue another license under section 351 of 
the Public Health Service Act for the same drug for the [same 
disease or condition] same approved indication or use within 
such rare disease or condition for a person who is not the 
holder of such approved application or of such license until 
the expiration of seven years from the date of the approval of 
the approved application or the issuance of the license. 
Section 505(c)(2) does not apply to the refusal to approve an 
application under the preceding sentence.
  (b) During the 7-year period described in subsection (a) for 
an approved application under section 505 or license under 
section 351 of the Public Health Service Act, the Secretary may 
approve an application or issue a license for a drug that is 
otherwise the same, as determined by the Secretary, as the 
already approved drug for the [same rare disease or condition] 
same indication or use for which the Secretary has approved or 
licensed such drug if--
          (1) the Secretary finds, after providing the holder 
        of exclusive approval or licensure notice and 
        opportunity for the submission of views, that during 
        such period the holder of the exclusive approval or 
        licensure cannot ensure the availability of sufficient 
        quantities of the drug to meet the needs of persons 
        [with the disease or condition for which the drug was 
        designated] for whom the drug is indicated; or
          (2) the holder provides the Secretary in writing the 
        consent of such holder for the approval of other 
        applications or the issuance of other licenses before 
        the expiration of such seven-year period.
  (c) Condition of Clinical Superiority.--
          (1) In general.--If a sponsor of a drug that is 
        designated under section 526 and is otherwise the same, 
        as determined by the Secretary, as an already approved 
        or licensed drug is seeking exclusive approval or 
        exclusive licensure described in subsection (a) for the 
        [same rare disease or condition] same indication or use 
        as the already approved drug, the Secretary shall 
        require such sponsor, as a condition of such exclusive 
        approval or licensure, to demonstrate that such drug is 
        clinically superior to any already approved or licensed 
        drug that is the same drug.
          (2) Definition.--For purposes of paragraph (1), the 
        term ``clinically superior'' with respect to a drug 
        means that the drug provides a significant therapeutic 
        advantage over and above an already approved or 
        licensed drug in terms of greater efficacy, greater 
        safety, or by providing a major contribution to patient 
        care.
          (3) Applicability.--This subsection applies to any 
        drug designated under section 526 for which an 
        application was approved under section 505 of this Act 
        or licensed under section 351 of the Public Health 
        Service Act after the date of enactment of the FDA 
        Reauthorization Act of 2017, regardless of the date on 
        which such drug was designated under section 526.
  (d) Regulations.--The Secretary may promulgate regulations 
for the implementation of subsection (c). Beginning on the date 
of enactment of the FDA Reauthorization Act of 2017, until such 
time as the Secretary promulgates regulations in accordance 
with this subsection, the Secretary may apply any definitions 
set forth in regulations that were promulgated prior to such 
date of enactment, to the extent such definitions are not 
inconsistent with the terms of this section, as amended by such 
Act.
  (e) Demonstration of Clinical Superiority Standard.--To 
assist sponsors in demonstrating clinical superiority as 
described in subsection (c), the Secretary--
          (1) upon the designation of any drug under section 
        526, shall notify the sponsor of such drug in writing 
        of the basis for the designation, including, as 
        applicable, any plausible hypothesis offered by the 
        sponsor and relied upon by the Secretary that the drug 
        is clinically superior to a previously approved drug; 
        and
          (2) upon granting exclusive approval or licensure 
        under subsection (a) on the basis of a demonstration of 
        clinical superiority as described in subsection (c), 
        shall publish a summary of the clinical superiority 
        findings.

           *       *       *       *       *       *       *


Subchapter E--General Provisions Relating to Drugs and Devices

           *       *       *       *       *       *       *



SEC. 566. CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIPS.

  (a) Establishment.--The Secretary, acting through the 
Commissioner of Food and Drugs, may enter into collaborative 
agreements, to be known as Critical Path Public-Private 
Partnerships, with one or more eligible entities to implement 
the Critical Path Initiative of the Food and Drug 
Administration by developing innovative, collaborative projects 
in research, education, and outreach for the purpose of 
fostering medical product innovation, enabling the acceleration 
of medical product development, manufacturing, and 
translational therapeutics, and enhancing medical product 
safety.
  (b) Eligible Entity.--In this section, the term ``eligible 
entity'' means an entity that meets each of the following:
          (1) The entity is--
                  (A) an institution of higher education (as 
                such term is defined in section 101 of the 
                Higher Education Act of 1965) or a consortium 
                of such institutions; or
                  (B) an organization described in section 
                501(c)(3) of the Internal Revenue Code of 1986 
                and exempt from tax under section 501(a) of 
                such Code.
          (2) The entity has experienced personnel and clinical 
        and other technical expertise in the biomedical 
        sciences, which may include graduate training programs 
        in areas relevant to priorities of the Critical Path 
        Initiative.
          (3) The entity demonstrates to the Secretary's 
        satisfaction that the entity is capable of--
                  (A) developing and critically evaluating 
                tools, methods, and processes--
                          (i) to increase efficiency, 
                        predictability, and productivity of 
                        medical product development; and
                          (ii) to more accurately identify the 
                        benefits and risks of new and existing 
                        medical products;
                  (B) establishing partnerships, consortia, and 
                collaborations with health care practitioners 
                and other providers of health care goods or 
                services; pharmacists; pharmacy benefit 
                managers and purchasers; health maintenance 
                organizations and other managed health care 
                organizations; health care insurers; government 
                agencies; patients and consumers; manufacturers 
                of prescription drugs, biological products, 
                diagnostic technologies, and devices; and 
                academic scientists; and
                  (C) securing funding for the projects of a 
                Critical Path Public-Private Partnership from 
                Federal and nonfederal governmental sources, 
                foundations, and private individuals.
  (c) Funding.--The Secretary may not enter into a 
collaborative agreement under subsection (a) unless the 
eligible entity involved provides an assurance that the entity 
will not accept funding for a Critical Path Public-Private 
Partnership project from any organization that manufactures or 
distributes products regulated by the Food and Drug 
Administration unless the entity provides assurances in its 
agreement with the Food and Drug Administration that the 
results of the Critical Path Public-Private Partnership project 
will not be influenced by any source of funding.
  (d) Annual Report.--Not later than 18 months after the date 
of the enactment of this section, and annually thereafter, the 
Secretary, in collaboration with the parties to each Critical 
Path Public-Private Partnership, shall submit a report to the 
Committee on Health, Education, Labor, and Pensions of the 
Senate and the Committee on Energy and Commerce of the House of 
Representatives--
          (1) reviewing the operations and activities of the 
        Partnerships in the previous year; and
          (2) addressing such other issues relating to this 
        section as the Secretary determines to be appropriate.
  (e) Definition.--In this section, the term ``medical 
product'' includes a drug, a biological product as defined in 
section 351 of the Public Health Service Act, a device, and any 
combination of such products.
  (f) Authorization of Appropriations.--To carry out this 
section, there is authorized to be appropriated [$6,000,000 for 
each of fiscal years 2018 through 2022] $10,000,000 for each of 
fiscal years 2023 through 2027.

SEC. 566A. EMERGING TECHNOLOGY PROGRAM.

  (a) Program Establishment.--
          (1) In general.--The Secretary shall establish a 
        program to support the adoption of, and improve the 
        development of, innovative approaches to drug product 
        design and manufacturing.
          (2) Actions.--In carrying out the program under 
        paragraph (1), the Secretary may--
                  (A) facilitate and increase communication 
                between public and private entities, consortia, 
                and individuals with respect to innovative drug 
                product design and manufacturing;
                  (B) solicit information regarding, and 
                conduct or support research on, innovative 
                approaches to drug product design and 
                manufacturing;
                  (C) convene meetings with representatives of 
                industry, academia, other Federal agencies, 
                international agencies, and other interested 
                persons, as appropriate;
                  (D) convene working groups to support drug 
                product design and manufacturing research and 
                development;
                  (E) support education and training for 
                regulatory staff and scientists related to 
                innovative approaches to drug product design 
                and manufacturing;
                  (F) advance regulatory science related to the 
                development and review of innovative approaches 
                to drug product design and manufacturing;
                  (G) convene or participate in working groups 
                to support the harmonization of international 
                regulatory requirements related to innovative 
                approaches to drug product design and 
                manufacturing; and
                  (H) award grants or contracts to carry out or 
                support the program under paragraph (1).
          (3) Grants and contracts.--To seek a grant or 
        contract under this section, an entity shall submit an 
        application--
                  (A) in such form and manner as the Secretary 
                may require; and
                  (B) containing such information as the 
                Secretary may require, including a description 
                of--
                          (i) how the entity will conduct the 
                        activities to be supported through the 
                        grant or contract; and
                          (ii) how such activities will further 
                        research and development related to, or 
                        adoption of, innovative approaches to 
                        drug product design and manufacturing.
  (b) Guidance.--The Secretary shall--
          (1) issue or update guidance to help facilitate the 
        adoption of, and advance the development of, innovative 
        approaches to drug product design and manufacturing; 
        and
          (2) include in such guidance descriptions of--
                  (A) any regulatory requirements related to 
                the development or review of technologies 
                related to innovative approaches to drug 
                product design and manufacturing, including 
                updates and improvements to such technologies 
                after product approval; and
                  (B) data that can be used to demonstrate the 
                identity, safety, purity, and potency of drugs 
                manufactured using such technologies.
  (c) Report to Congress.--Not later than 4 years after the 
date of enactment of this section, the Secretary shall submit 
to the Committee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Education, Labor, 
and Pensions of the Senate a report containing--
          (1) an annual accounting of the allocation of funds 
        made available to carry out this section;
          (2) a description of how Food and Drug Administration 
        staff were utilized to carry out this section and, as 
        applicable, any challenges or limitations related to 
        staffing;
          (3) the number of public meetings held or 
        participated in by the Food and Drug Administration 
        pursuant to this section, including meetings convened 
        as part of a working group described in subparagraph 
        (D) or (G) of subsection (a)(2), and the topics of each 
        such meeting; and
          (4) the number of drug products approved or licensed, 
        after the date of enactment of this section, using an 
        innovative approach to drug product design and 
        manufacturing.
  (d) Authorization of Appropriations.--To carry out this 
section, there is authorized to be appropriated $20,000,000 for 
each fiscal year 2023 through 2027.

           *       *       *       *       *       *       *


SEC. 569. CONSULTATION WITH EXTERNAL EXPERTS ON RARE DISEASES, TARGETED 
                    THERAPIES, AND GENETIC TARGETING OF TREATMENTS.

  (a) In General.--For the purpose of promoting the efficiency 
of and informing the review by the Food and Drug Administration 
of new drugs and biological products for rare diseases and 
drugs and biological products that are genetically targeted, 
the following shall apply:
          (1) Consultation with stakeholders.--Consistent with 
        sections X.C and IX.E.4 of the PDUFA Reauthorization 
        Performance Goals and Procedures Fiscal Years 2013 
        through 2017, as referenced in the letters described in 
        section 101(b) of the Prescription Drug User Fee 
        Amendments of 2012, the Secretary shall ensure that 
        opportunities exist, at a time the Secretary determines 
        appropriate, for consultations with stakeholders on the 
        topics described in subsection (b).
          (2) Consultation with external experts.--
                  (A) In general.--The Secretary shall develop 
                and maintain a list of external experts who, 
                because of their special expertise, are 
                qualified to provide advice on rare disease 
                issues, including topics described in 
                subsection (b). The Secretary may, when 
                appropriate to address a specific regulatory 
                question, consult such external experts on 
                issues related to the review of new drugs and 
                biological products for rare diseases and drugs 
                and biological products that are genetically 
                targeted, including the topics described in 
                subsection (b), when such consultation is 
                necessary because the Secretary lacks the 
                specific scientific, medical, or technical 
                expertise necessary for the performance of the 
                Secretary's regulatory responsibilities and the 
                necessary expertise can be provided by the 
                external experts.
                  (B) External experts.--For purposes of 
                subparagraph (A), external experts are 
                individuals who possess scientific or medical 
                training that the Secretary lacks with respect 
                to one or more rare diseases.
                  (C) Small population studies.--The external 
                experts on the list maintained pursuant to 
                subparagraph (A) may include experts on the 
                science of small population studies.
  (b) Topics for Consultation.--Topics for consultation 
pursuant to this section may include--
          (1) rare diseases;
          (2) the severity of rare diseases;
          (3) the unmet medical need associated with rare 
        diseases;
          (4) the willingness and ability of individuals with a 
        rare disease to participate in clinical trials;
          (5) an assessment of the benefits and risks of 
        therapies to treat rare diseases;
          (6) the general design of clinical trials for rare 
        disease populations and subpopulations; and
          (7) the demographics and the clinical description of 
        patient populations.
  (c) Classification as Special Government Employees.--The 
external experts who are consulted under this section may be 
considered special government employees, as defined under 
section 202 of title 18, United States Code.
  (d) Protection of Confidential Information and Trade 
Secrets.--
          (1) Rule of construction.--Nothing in this section 
        shall be construed to alter the protections offered by 
        laws, regulations, and policies governing disclosure of 
        confidential commercial or trade secret information, 
        and any other information exempt from disclosure 
        pursuant to section 552(b) of title 5, United States 
        Code, as such provisions would be applied to 
        consultation with individuals and organizations prior 
        to the date of enactment of this section.
          (2) Consent required for disclosure.--The Secretary 
        shall not disclose confidential commercial or trade 
        secret information to an expert consulted under this 
        section without the written consent of the sponsor 
        unless the expert is a special government employee (as 
        defined under section 202 of title 18, United States 
        Code) or the disclosure is otherwise authorized by law.
  (e) Other Consultation.--Nothing in this section shall be 
construed to limit the ability of the Secretary to consult with 
individuals and organizations as authorized prior to the date 
of enactment of this section.
  (f) No Right or Obligation.--
          (1) No right to consultation.--Nothing in this 
        section shall be construed to create a legal right for 
        a consultation on any matter or require the Secretary 
        to meet with any particular expert or stakeholder.
          (2) No altering of goals.--Nothing in this section 
        shall be construed to alter agreed upon goals and 
        procedures identified in the letters described in 
        section 101(b) of the Prescription Drug User Fee 
        Amendments of 2012.
          (3) No change to number of review cycles.--Nothing in 
        this section is intended to increase the number of 
        review cycles as in effect before the date of enactment 
        of this section.
  (g) No Delay in Product Review.--
          (1) In general.--Prior to a consultation with an 
        external expert, as described in this section, relating 
        to an investigational new drug application under 
        section 505(i), a new drug application under section 
        505(b), or a biologics license application under 
        section 351 of the Public Health Service Act, the 
        Director of the Center for Drug Evaluation and Research 
        or the Director of the Center for Biologics Evaluation 
        and Research (or appropriate Division Director), as 
        appropriate, shall determine that--
                  (A) such consultation will--
                          (i) facilitate the Secretary's 
                        ability to complete the Secretary's 
                        review; and
                          (ii) address outstanding deficiencies 
                        in the application; or
                  (B) the sponsor authorized such consultation.
          (2) Limitation.--The requirements of this subsection 
        shall apply only in instances where the consultation is 
        undertaken solely under the authority of this section. 
        The requirements of this subsection shall not apply to 
        any consultation initiated under any other authority.

           *       *       *       *       *       *       *


                     CHAPTER VII--GENERAL AUTHORITY


Subchapter A--General Administrative Provisions

           *       *       *       *       *       *       *



SEC. 703. RECORDS.

  (a) In General.--For the purpose of enforcing the provisions 
of this Act, carriers engaged in interstate commerce, and 
persons receiving food, drugs, devices, tobacco products, or 
cosmetics in interstate commerce or holding such articles so 
received, shall, upon the request of an officer or employee 
duly designated by the Secretary, permit such officer or 
employee, at reasonable times, to have access to and to copy 
all records showing the movement in interstate commerce of any 
food, drug, device, tobacco product, or cosmetic, or the 
holding thereof during or after such movement, and the 
quantity, shipper, and consignee thereof; and it shall be 
unlawful for any such carrier or person to fail to permit such 
access to and copying of any such record so requested when such 
request is accompanied by a statement in writing specifying the 
nature or kind of food, drug, device, tobacco product, or 
cosmetic to which such request relates, except that evidence 
obtained under this section, or any evidence which is directly 
or indirectly derived from such evidence, shall not be used in 
a criminal prosecution of the person from whom obtained, and 
except that carriers shall not be subject to the other 
provisions of this Act by reason of their receipt, carriage, 
holding, or delivery of food, drugs, devices, tobacco products, 
or cosmetics in the usual course of business as carriers, 
except as provided in subsection (b).
  (b) Food Transportation Records.--A shipper, carrier by motor 
vehicle or rail vehicle, receiver, or other person subject to 
section 416 shall, on request of an officer or employee 
designated by the Secretary, permit the officer or employee, at 
reasonable times, to have access to and to copy all records 
that the Secretary requires to be kept under section 
416(c)(1)(E).
  (c) Applicability.--The limitations on the Secretary's use of 
evidence obtained under this section, or any evidence which is 
directly or indirectly derived from such evidence, in a 
criminal prosecution of the person from whom such evidence was 
obtained shall not apply to evidence, including records or 
other information, obtained under authorities other than this 
section, unless such limitations are specifically incorporated 
by reference in such other authorities.

                           factory inspection

  Sec. 704. (a)(1) For purposes of enforcement of this Act, 
officers or employees duly designated by the Secretary, upon 
presenting appropriate credentials and a written notice to the 
owner, operator, or agent in charge, are authorized (A) to 
enter, at reasonable times, any factory, warehouse, or 
establishment in which food, drugs, devices, tobacco products, 
or cosmetics are manufactured, processed, packed, or held, for 
introduction into interstate commerce or after such 
introduction, or to enter any vehicle, being used to transport 
or hold such food, drugs, devices, tobacco products, or 
cosmetics in interstate commerce; and (B) to inspect, at 
reasonable times and within reasonable limits and in a 
reasonable manner, such factory, warehouse, establishment, or 
vehicle and all pertinent equipment, finished and unfinished 
materials, containers, and labeling therein. In the case of any 
person (excluding farms and restaurants) who manufactures, 
processes, packs, transports, distributes, holds, or imports 
foods, the inspection shall extend to all records and other 
information described in section 414, when the standard for 
records inspection under paragraph (1) or (2) of section 414(a) 
applies, subject to the limitations established in section 
414(d). In the case of any factory, warehouse, establishment, 
or consulting laboratory in which prescription drugs, 
nonprescription drugs intended for human use, [restricted 
devices] devices, or tobacco products are manufactured, 
processed, packed, or held, inspection shall extend to all 
things therein (including records, files, papers, processes, 
controls, and facilities) bearing on whether prescription 
drugs, nonprescription drugs intended for human use, 
[restricted devices] devices, or tobacco products which are 
adulterated or misbranded within the meaning of this Act, or 
which may not be manufactured, introduced into interstate 
commerce, or sold, or offered for sale by reason of any 
provision of this Act, have been or are being manufactured, 
processed, packed, transported, or held in any such place, or 
otherwise bearing on violation of this Act. No inspection 
authorized by the preceding sentence or by paragraph (3) shall 
extend to financial data, sales data other than shipment data, 
pricing data, personnel data (other than data as to 
qualifications of technical and professional personnel 
performing functions subject to this Act), and research data 
(other than data relating to new drugs, antibiotic drugs, 
devices, and tobacco products and subject to reporting and 
inspection under regulations lawfully issued pursuant to 
section 505 (i) or (k), section 519, section 520(g), or chapter 
IX and data relating to other drugs, devices, or tobacco 
products which in the case of a new drug would be subject to 
reporting or inspection under lawful regulations issued 
pursuant to section 505(j)). A separate notice shall be given 
for each such inspection, but a notice shall not be required 
for each entry made during the period covered by the 
inspection. Each such inspection shall be commenced and 
completed with reasonable promptness.
  (2) The provisions of the third sentence of paragraph (1) 
shall not apply to--
          (A) pharmacies which maintain establishments in 
        conformance with any applicable local laws regulating 
        the practice of pharmacy and medicine and which are 
        regularly engaged in dispensing prescription drugs or 
        devices, upon prescriptions of practitioners licensed 
        to administer such drugs or devices to patients under 
        the care of such practitioners in the course of their 
        professional practice, and which do not, either through 
        a subsidiary or otherwise, manufacture, prepare, 
        propagate, compound, or process drugs or devices for 
        sale other than in the regular course of their business 
        of dispensing or selling drugs or devices at retail;
          (B) practitioners licensed by law to prescribe or 
        administer drugs, or prescribe or use devices, as the 
        case may be, and who manufacture, prepare, propagate, 
        compound, or process drugs, or manufacture or process 
        devices solely for use in the course of their 
        professional practice;
          (C) persons who manufacture, prepare, propagate, 
        compound, or process drugs, or manufacture or process 
        devices solely for use in research, teaching, or 
        chemical analysis and not for sale;
          (D) such other classes of persons as the Secretary 
        may by regulation exempt from the application of this 
        section upon a finding that inspection as applied to 
        such classes of persons in accordance with this section 
        is not necessary for the protection of the public 
        health.
  (3) An officer or employee making an inspection under 
paragraph (1) for purposes of enforcing the requirements of 
section 412 applicable to infant formulas shall be permitted, 
at all reasonable times, to have access to and to copy and 
verify any records--
          (A) bearing on whether the infant formula 
        manufactured or held in the facility inspected meets 
        the requirements of section 412, or
          (B) required to be maintained under section 412.
  (4)(A) Any records or other information that the Secretary 
may inspect under this section from a person that owns or 
operates [an establishment that is engaged in the manufacture, 
preparation, propagation, compounding, or processing of a drug] 
an establishment that is engaged in the manufacture, 
preparation, propagation, compounding, or processing of a drug 
or device, or that is subject to inspection under paragraph 
(5)(C), shall, upon the request of the Secretary, be provided 
to the Secretary by such person, in advance of or in lieu of an 
inspection, within a reasonable timeframe, within reasonable 
limits, and in a reasonable manner, and in either electronic or 
physical form, at the expense of such person. The Secretary's 
request shall include a sufficient description of the records 
requested and a rationale for requesting such records or other 
information in advance of, or in lieu of, an inspection.
  (B) Upon receipt of the records requested under subparagraph 
(A), the Secretary shall provide to the person confirmation of 
receipt.
  (C) The Secretary may rely on any records or other 
information that the Secretary may inspect under this section 
to satisfy requirements that may pertain to a preapproval or 
risk-based surveillance inspection, or to resolve deficiencies 
identified during such inspections, if applicable and 
appropriate.
  [(C)] (D) Nothing in this paragraph supplants the authority 
of the Secretary to conduct inspections otherwise permitted 
under this Act in order to ensure compliance with this Act.
          (5) Bioresearch monitoring inspections.--
                  (A) In general.--The Secretary may, to ensure 
                the accuracy and reliability of studies and 
                records or other information described in 
                subparagraph (B) and to assess compliance with 
                applicable requirements under this Act or the 
                Public Health Service Act, enter sites and 
                facilities specified in subparagraph (C) in 
                order to inspect such records or other 
                information.
                  (B) Information subject to inspection.--An 
                inspection under this paragraph shall extend to 
                all records and other information related to 
                the studies and submissions described in 
                subparagraph (E), including records and 
                information related to the conduct, results, 
                and analyses of, and the protection of human 
                and animal trial participants participating in, 
                such studies.
                  (C) Sites and facilities subject to 
                inspection.--
                          (i) Sites and facilities described.--
                        The sites and facilities subject to 
                        inspection by the Secretary under this 
                        paragraph are those owned or operated 
                        by a person described in clause (ii) 
                        and which are (or were) utilized by 
                        such person in connection with--
                                  (I) developing an application 
                                or other submission to the 
                                Secretary under this Act or the 
                                Public Health Service Act 
                                related to marketing 
                                authorization for a product 
                                described in paragraph (1);
                                  (II) preparing, conducting, 
                                or analyzing the results of a 
                                study described in subparagraph 
                                (E); or
                                  (III) holding any records or 
                                other information described in 
                                subparagraph (B).
                          (ii) Persons described.--A person 
                        described in this clause is--
                                  (I) the sponsor of an 
                                application or submission 
                                specified in subparagraph (E);
                                  (II) a person engaged in any 
                                activity described in clause 
                                (i) on behalf of such a 
                                sponsor, through a contract, 
                                grant, or other business 
                                arrangement with such sponsor;
                                  (III) an institutional review 
                                board, or other individual or 
                                entity, engaged by contract, 
                                grant, or other business 
                                arrangement with a nonsponsor 
                                in preparing, collecting, or 
                                analyzing records or other 
                                information described in 
                                subparagraph (B); or
                                  (IV) any person not otherwise 
                                described in this clause that 
                                conducts, or has conducted, a 
                                study described in subparagraph 
                                (E) yielding records or other 
                                information described in 
                                subparagraph (B).
                  (D) Conditions of inspection.--
                          (i) Access to information subject to 
                        inspection.--Subject to clause (ii), an 
                        entity that owns or operates any site 
                        or facility subject to inspection under 
                        this paragraph shall provide the 
                        Secretary with access to records and 
                        other information described in 
                        subparagraph (B) that is held by or 
                        under the control of such entity, 
                        including--
                                  (I) permitting the Secretary 
                                to record or copy such 
                                information for purposes of 
                                this paragraph;
                                  (II) providing the Secretary 
                                with access to any electronic 
                                information system utilized by 
                                such entity to hold, process, 
                                analyze, or transfer any 
                                records or other information 
                                described in subparagraph (B); 
                                and
                                  (III) permitting the 
                                Secretary to inspect the 
                                facilities, equipment, written 
                                procedures, processes, and 
                                conditions through which 
                                records or other information 
                                described in subparagraph (B) 
                                is or was generated, held, 
                                processed, analyzed, or 
                                transferred.
                          (ii) No effect on applicability of 
                        provisions for protection of 
                        proprietary information or trade 
                        secrets.--Nothing in clause (i) shall 
                        negate, supersede, or otherwise affect 
                        the applicability of provisions, under 
                        this or any other Act, preventing or 
                        limiting the disclosure of confidential 
                        commercial information or other 
                        information considered proprietary or 
                        trade secret.
                          (iii) Reasonableness of 
                        inspections.--An inspection under this 
                        paragraph shall be conducted at 
                        reasonable times and within reasonable 
                        limits and in a reasonable manner.
                  (E) Studies and submissions described.--The 
                studies and submissions described in this 
                subparagraph are each of the following:
                          (i) Clinical and nonclinical studies 
                        submitted to the Secretary in support 
                        of, or otherwise related to, 
                        applications and other submissions to 
                        the Secretary under this Act or the 
                        Public Health Service Act for marketing 
                        authorization of a product described in 
                        paragraph (1).
                          (ii) Postmarket safety activities 
                        conducted under this Act or the Public 
                        Health Service Act.
                          (iii) Any other clinical 
                        investigation of--
                                  (I) a drug subject to section 
                                505 or 512 of this Act or 
                                section 351 of the Public 
                                Health Service Act; or
                                  (II) a device subject to 
                                section 520(g).
                          (iv) Any other submissions made under 
                        this Act or the Public Health Service 
                        Act with respect to which the Secretary 
                        determines an inspection under this 
                        paragraph is warranted in the interest 
                        of public health.
                  (F) Clarification.--This paragraph clarifies 
                the authority of the Secretary to conduct 
                inspections of the type described in this 
                paragraph and shall not be construed as a basis 
                for inferring that, prior to the date of 
                enactment of this paragraph, the Secretary 
                lacked the authority to conduct such 
                inspections, including under this Act or the 
                Public Health Service Act.
  (b)(1) Upon completion of any such inspection of a factory, 
warehouse, consulting laboratory, or other establishment, and 
prior to leaving the premises, the officer or employee making 
the inspection shall give to the owner, operator, or agent in 
charge a report in writing setting forth any conditions or 
practices observed by him which, in his judgment, indicate that 
any food, drug, device, tobacco product, or cosmetic in such 
establishment (A) consists in whole or in part of any filthy, 
putrid, or decomposed substance, or (B) has been prepared, 
packed, or held under insanitary conditions whereby it may have 
become contaminated with filth, or whereby it may have been 
rendered injurious to health. A copy of such report shall be 
sent promptly to the Secretary.
  (2) In carrying out this subsection with respect to any 
establishment manufacturing a drug approved under subsection 
(c) or (j) of section 505 for which a notification has been 
submitted in accordance with section 506C is, or has been in 
the last 5 years, listed on the drug shortage list under 
section 506E, or that is described in section 505(j)(11)(A), a 
copy of the report shall be sent promptly to the appropriate 
offices of the Food and Drug Administration with expertise 
regarding drug shortages.
  (c) If the officer or employee making any such inspection of 
a factory, warehouse, or other establishment has obtained any 
sample in the course of the inspection, upon completion of the 
inspection and prior to leaving the premises he shall give to 
the owner, operator, or agent in charge a receipt describing 
the samples obtained.
  (d) Whenever in the course of any such inspection of a 
factory or other establishment where food is manufactured, 
processed, or packed, the officer or employee making the 
inspection obtains a sample of any such food, and an analysis 
is made of such sample for the purpose of ascertaining whether 
such food consists in whole or in part of any filthy, putrid, 
or decomposed substance, or is otherwise unfit for food, a copy 
of the results of such analysis shall be furnished promptly to 
the owner, operator, or agent in charge.
  (e) Every person required under section 519 or 520(g) to 
maintain records and every person who is in charge or custody 
of such records shall, upon request of an officer or employee 
designated by the Secretary, permit such officer or employee at 
all reasonable times to have access to, and to copy and verify, 
such records.
  (f)(1) An accredited person described in paragraph (3) shall 
maintain records documenting the training qualifications of the 
person and the employees of the person, the procedures used by 
the person for handling confidential information, the 
compensation arrangements made by the person, and the 
procedures used by the person to identify and avoid conflicts 
of interest. Upon the request of an officer or employee 
designated by the Secretary, the person shall permit the 
officer or employee, at all reasonable times, to have access 
to, to copy, and to verify, the records.
  (2) Within 15 days after the receipt of a written request 
from the Secretary to an accredited person described in 
paragraph (3) for copies of records described in paragraph (1), 
the person shall produce the copies of the records at the place 
designated by the Secretary.
  (3) For purposes of paragraphs (1) and (2), an accredited 
person described in this paragraph is a person who--
          (A) is accredited under subsection (g); or
          (B) is accredited under section 523.
  (g)(1) The Secretary shall, subject to the provisions of this 
subsection, accredit persons for the purpose of conducting 
inspections of establishments that manufacture, prepare, 
propagate, compound, or process class II or class III devices, 
which inspections are required under section 510(h) or are 
inspections of such establishments required to register under 
section 510(i). The owner or operator of such an establishment 
that is eligible under paragraph (6) may, from the list 
published under paragraph (4), select an accredited person to 
conduct such inspections.
  (2) The Secretary shall publish in the Federal Register 
criteria to accredit or deny accreditation to persons who 
request to perform the duties specified in paragraph (1). 
Thereafter, the Secretary shall inform those requesting 
accreditation, within 60 days after the receipt of such 
request, whether the request for accreditation is adequate for 
review, and the Secretary shall promptly act on the request for 
accreditation. Any resulting accreditation shall state that 
such person is accredited to conduct inspections at device 
establishments identified in paragraph (1). The accreditation 
of such person shall specify the particular activities under 
this subsection for which such person is accredited.
  (3) An accredited person shall, at a minimum, meet the 
following requirements:
          (A) Such person may not be an employee of the Federal 
        Government.
          (B) Such person shall be an independent organization 
        which is not owned or controlled by a manufacturer, 
        supplier, or vendor of articles regulated under this 
        Act and which has no organizational, material, or 
        financial affiliation (including a consultative 
        affiliation) with such a manufacturer, supplier, or 
        vendor.
          (C) Such person shall be a legally constituted entity 
        permitted to conduct the activities for which it seeks 
        accreditation.
          (D) Such person shall not engage in the design, 
        manufacture, promotion, or sale of articles regulated 
        under this Act.
          (E) The operations of such person shall be in 
        accordance with generally accepted professional and 
        ethical business practices, and such person shall agree 
        in writing that at a minimum the person will--
                  (i) certify that reported information 
                accurately reflects data reviewed, inspection 
                observations made, other matters that relate to 
                or may influence compliance with this Act, and 
                recommendations made during an inspection or at 
                an inspection's closing meeting;
                  (ii) limit work to that for which competence 
                and capacity are available;
                  (iii) treat information received, records, 
                reports, and recommendations as confidential 
                commercial or financial information or trade 
                secret information, except such information may 
                be made available to the Secretary;
                  (iv) promptly respond and attempt to resolve 
                complaints regarding its activities for which 
                it is accredited; and
                  (v) protect against the use, in carrying out 
                paragraph (1), of any officer or employee of 
                the accredited person who has a financial 
                conflict of interest regarding any product 
                regulated under this Act, and annually make 
                available to the public disclosures of the 
                extent to which the accredited person, and the 
                officers and employees of the person, have 
                maintained compliance with requirements under 
                this clause relating to financial conflicts of 
                interest.
          (F) Such person shall notify the Secretary of any 
        withdrawal, suspension, restriction, or expiration of 
        certificate of conformance with the quality systems 
        standard referred to in paragraph (7) for any device 
        establishment that such person inspects under this 
        subsection not later than 30 days after such 
        withdrawal, suspension, restriction, or expiration.
          (G) Such person may conduct audits to establish 
        conformance with the quality systems standard referred 
        to in paragraph (7).
  (4) The Secretary shall publish on the Internet site of the 
Food and Drug Administration a list of persons who are 
accredited under paragraph (2). Such list shall be updated to 
ensure that the identity of each accredited person, and the 
particular activities for which the person is accredited, is 
known to the public. The updating of such list shall be no 
later than one month after the accreditation of a person under 
this subsection or the suspension or withdrawal of 
accreditation, or the modification of the particular activities 
for which the person is accredited.
  (5)(A) To ensure that persons accredited under this 
subsection continue to meet the standards of accreditation, the 
Secretary shall (i) audit the performance of such persons on a 
periodic basis through the review of inspection reports and 
inspections by persons designated by the Secretary to evaluate 
the compliance status of a device establishment and the 
performance of accredited persons, and (ii) take such 
additional measures as the Secretary determines to be 
appropriate.
  (B) The Secretary may withdraw accreditation of any person 
accredited under paragraph (2), after providing notice and an 
opportunity for an informal hearing, when such person is 
substantially not in compliance with the standards of 
accreditation, poses a threat to public health, fails to act in 
a manner that is consistent with the purposes of this 
subsection, or where the Secretary determines that there is a 
financial conflict of interest in the relationship between the 
accredited person and the owner or operator of a device 
establishment that the accredited person has inspected under 
this subsection. The Secretary may suspend the accreditation of 
such person during the pendency of the process under the 
preceding sentence.
  (6)(A) Subject to subparagraphs (B) and (C), a device 
establishment is eligible for inspection by persons accredited 
under paragraph (2) if the following conditions are met:
          (i) The Secretary classified the results of the most 
        recent inspection of the establishment as ``no action 
        indicated'' or ``voluntary action indicated''.
          (ii) With respect to inspections of the establishment 
        to be conducted by an accredited person, the owner or 
        operator of the establishment submits to the Secretary 
        a notice that--
                  (I) provides the date of the last inspection 
                of the establishment by the Secretary and the 
                classification of that inspection;
                  (II) states the intention of the owner or 
                operator to use an accredited person to conduct 
                inspections of the establishment;
                  (III) identifies the particular accredited 
                person the owner or operator intends to select 
                to conduct such inspections; and
                  (IV) includes a certification that, with 
                respect to the devices that are manufactured, 
                prepared, propagated, compounded, or processed 
                in the establishment--
                          (aa) at least 1 of such devices is 
                        marketed in the United States; and
                          (bb) at least 1 of such devices is 
                        marketed, or is intended to be 
                        marketed, in 1 or more foreign 
                        countries, 1 of which countries 
                        certifies, accredits, or otherwise 
                        recognizes the person accredited under 
                        paragraph (2) and identified under 
                        subclause (III) as a person authorized 
                        to conduct inspections of device 
                        establishments.
  (B)(i) Except with respect to the requirement of subparagraph 
(A)(i), a device establishment is deemed to have clearance to 
participate in the program and to use the accredited person 
identified in the notice under subparagraph (A)(ii) for 
inspections of the establishment unless the Secretary, not 
later than 30 days after receiving such notice, issues a 
response that--
          (I) denies clearance to participate as provided under 
        subparagraph (C); or
          (II) makes a request under clause (ii).
  (ii) The Secretary may request from the owner or operator of 
a device establishment in response to the notice under 
subparagraph (A)(ii) with respect to the establishment, or from 
the particular accredited person identified in such notice--
          (I) compliance data for the establishment in 
        accordance with clause (iii)(I); or
          (II) information concerning the relationship between 
        the owner or operator of the establishment and the 
        accredited person identified in such notice in 
        accordance with clause (iii)(II).
The owner or operator of the establishment, or such accredited 
person, as the case may be, shall respond to such a request not 
later than 60 days after receiving such request.
  (iii)(I) The compliance data to be submitted by the owner or 
operator of a device establishment in response to a request 
under clause (ii)(I) are data describing whether the quality 
controls of the establishment have been sufficient for ensuring 
consistent compliance with current good manufacturing practice 
within the meaning of section 501(h) and with other applicable 
provisions of this Act. Such data shall include complete 
reports of inspectional findings regarding good manufacturing 
practice or other quality control audits that, during the 
preceding 2-year period, were conducted at the establishment by 
persons other than the owner or operator of the establishment, 
together with all other compliance data the Secretary deems 
necessary. Data under the preceding sentence shall demonstrate 
to the Secretary whether the establishment has facilitated 
consistent compliance by promptly correcting any compliance 
problems identified in such inspections.
  (II) A request to an accredited person under clause (ii)(II) 
may not seek any information that is not required to be 
maintained by such person in records under subsection (f)(1).
  (iv) A device establishment is deemed to have clearance to 
participate in the program and to use the accredited person 
identified in the notice under subparagraph (A)(ii) for 
inspections of the establishment unless the Secretary, not 
later than 60 days after receiving the information requested 
under clause (ii), issues a response that denies clearance to 
participate as provided under subparagraph (C).
  (C)(i) The Secretary may deny clearance to a device 
establishment if the Secretary has evidence that the 
certification under subparagraph (A)(ii)(IV) is untrue and the 
Secretary provides to the owner or operator of the 
establishment a statement summarizing such evidence.
  (ii) The Secretary may deny clearance to a device 
establishment if the Secretary determines that the 
establishment has failed to demonstrate consistent compliance 
for purposes of subparagraph (B)(iii)(I) and the Secretary 
provides to the owner or operator of the establishment a 
statement of the reasons for such determination.
  (iii)(I) The Secretary may reject the selection of the 
accredited person identified in the notice under subparagraph 
(A)(ii) if the Secretary provides to the owner or operator of 
the establishment a statement of the reasons for such 
rejection. Reasons for the rejection may include that the 
establishment or the accredited person, as the case may be, has 
failed to fully respond to the request, or that the Secretary 
has concerns regarding the relationship between the 
establishment and such accredited person.
  (II) If the Secretary rejects the selection of an accredited 
person by the owner or operator of a device establishment, the 
owner or operator may make an additional selection of an 
accredited person by submitting to the Secretary a notice that 
identifies the additional selection. Clauses (i) and (ii) of 
subparagraph (B), and subclause (I) of this clause, apply to 
the selection of an accredited person through a notice under 
the preceding sentence in the same manner and to the same 
extent as such provisions apply to a selection of an accredited 
person through a notice under subparagraph (A)(ii).
  (iv) In the case of a device establishment that is denied 
clearance under clause (i) or (ii) or with respect to which the 
selection of the accredited person is rejected under clause 
(iii), the Secretary shall designate a person to review the 
statement of reasons, or statement summarizing such evidence, 
as the case may be, of the Secretary under such clause if, 
during the 30-day period beginning on the date on which the 
owner or operator of the establishment receives such statement, 
the owner or operator requests the review. The review shall 
commence not later than 30 days after the owner or operator 
requests the review, unless the Secretary and the owner or 
operator otherwise agree.
  (7)(A) Persons accredited under paragraph (2) to conduct 
inspections shall record in writing their inspection 
observations and shall present the observations to the device 
establishment's designated representative and describe each 
observation. Additionally, such accredited person shall prepare 
an inspection report in a form and manner designated by the 
Secretary to conduct inspections, taking into consideration the 
goals of international harmonization of quality systems 
standards. Any official classification of the inspection shall 
be determined by the Secretary.
  (B) At a minimum, an inspection report under subparagraph (A) 
shall identify the persons responsible for good manufacturing 
practice compliance at the inspected device establishment, the 
dates of the inspection, the scope of the inspection, and shall 
describe in detail each observation identified by the 
accredited person, identify other matters that relate to or may 
influence compliance with this Act, and describe any 
recommendations during the inspection or at the inspection's 
closing meeting.
  (C) An inspection report under subparagraph (A) shall be sent 
to the Secretary and to the designated representative of the 
inspected device establishment at the same time, but under no 
circumstances later than three weeks after the last day of the 
inspection. The report to the Secretary shall be accompanied by 
all written inspection observations previously provided to the 
designated representative of the establishment.
  (D) Any statement or representation made by an employee or 
agent of a device establishment to a person accredited under 
paragraph (2) to conduct inspections shall be subject to 
section 1001 of title 18, United States Code.
  (E) If at any time during an inspection by an accredited 
person the accredited person discovers a condition that could 
cause or contribute to an unreasonable risk to the public 
health, the accredited person shall immediately notify the 
Secretary of the identification of the device establishment 
subject to inspection and such condition.
  (F) For the purpose of setting risk-based inspectional 
priorities, the Secretary shall accept voluntary submissions of 
reports of audits assessing conformance with appropriate 
quality systems standards set by the International Organization 
for Standardization (ISO) and identified by the Secretary in 
public notice. If the owner or operator of an establishment 
elects to submit audit reports under this subparagraph, the 
owner or operator shall submit all such audit reports with 
respect to the establishment during the preceding 2-year 
periods.
  (8) Compensation for an accredited person shall be determined 
by agreement between the accredited person and the person who 
engages the services of the accredited person, and shall be 
paid by the person who engages such services.
  (9) Nothing in this subsection affects the authority of the 
Secretary to inspect any device establishment pursuant to this 
Act.
  (10)(A) For fiscal year 2005 and each subsequent fiscal year, 
no device establishment may be inspected during the fiscal year 
involved by a person accredited under paragraph (2) if--
          (i) of the amounts appropriated for salaries and 
        expenses of the Food and Drug Administration for the 
        preceding fiscal year (referred to in this subparagraph 
        as the ``first prior fiscal year''), the amount 
        obligated by the Secretary for inspections of device 
        establishments by the Secretary was less than the 
        adjusted base amount applicable to such first prior 
        fiscal year; and
          (ii) of the amounts appropriated for salaries and 
        expenses of the Food and Drug Administration for the 
        fiscal year preceding the first prior fiscal year 
        (referred to in this subparagraph as the ``second prior 
        fiscal year''), the amount obligated by the Secretary 
        for inspections of device establishments by the 
        Secretary was less than the adjusted base amount 
        applicable to such second prior fiscal year.
  (B)(i) Subject to clause (ii), the Comptroller General of the 
United States shall determine the amount that was obligated by 
the Secretary for fiscal year 2002 for compliance activities of 
the Food and Drug Administration with respect to devices 
(referred to in this subparagraph as the ``compliance 
budget''), and of such amount, the amount that was obligated 
for inspections by the Secretary of device establishments 
(referred to in this subparagraph as the ``inspection 
budget'').
  (ii) For purposes of determinations under clause (i), the 
Comptroller General shall not include in the compliance budget 
or the inspection budget any amounts obligated for inspections 
of device establishments conducted as part of the process of 
reviewing applications under section 515.
  (iii) Not later than March 31, 2003, the Comptroller General 
shall complete the determinations required in this subparagraph 
and submit to the Secretary and the Congress a report 
describing the findings made through such determinations.
  (C) For purposes of this paragraph:
          (i) The term ``base amount'' means the inspection 
        budget determined under subparagraph (B) for fiscal 
        year 2002.
          (ii) The term ``adjusted base amount'', in the case 
        of applicability to fiscal year 2003, means an amount 
        equal to the base amount increased by 5 percent.
          (iii) The term ``adjusted base amount'', with respect 
        to applicability to fiscal year 2004 or any subsequent 
        fiscal year, means the adjusted base amount applicable 
        to the preceding year increased by 5 percent.
  (11) The authority provided by this subsection terminates on 
October 1, [2022] 2027.
  (12) No later than four years after the enactment of this 
subsection the Comptroller General shall report 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) the number of inspections conducted by accredited 
        persons pursuant to this subsection and the number of 
        inspections conducted by Federal employees pursuant to 
        section 510(h) and of device establishments required to 
        register under section 510(i);
          (B) the number of persons who sought accreditation 
        under this subsection, as well as the number of persons 
        who were accredited under this subsection;
          (C) the reasons why persons who sought accreditation, 
        but were denied accreditation, were denied;
          (D) the number of audits conducted by the Secretary 
        of accredited persons, the quality of inspections 
        conducted by accredited persons, whether accredited 
        persons are meeting their obligations under this Act, 
        and whether the number of audits conducted is 
        sufficient to permit these assessments;
          (E) whether this subsection is achieving the goal of 
        ensuring more information about device establishment 
        compliance is being presented to the Secretary, and 
        whether that information is of a quality consistent 
        with information obtained by the Secretary pursuant to 
        inspections conducted by Federal employees;
          (F) whether this subsection is advancing efforts to 
        allow device establishments to rely upon third-party 
        inspections for purposes of compliance with the laws of 
        foreign governments; and
          (G) whether the Congress should continue, modify, or 
        terminate the program under this subsection.
  (13) The Secretary shall include in the annual report 
required under section 1003(g) the names of all accredited 
persons and the particular activities under this subsection for 
which each such person is accredited and the name of each 
accredited person whose accreditation has been withdrawn during 
the year.
  (14) Notwithstanding any provision of this subsection, this 
subsection does not have any legal effect on any agreement 
described in section 803(b) between the Secretary and a foreign 
country.
  (15)(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--
          (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
          (ii) establishments required to register pursuant to 
        section 510(i).
  (B) Nothing in this paragraph affects--
          (i) the authority of the Secretary to inspect any 
        device establishment pursuant to this Act; or
          (ii) the authority of the Secretary to determine the 
        official classification of an inspection.
  (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 uniform 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; 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 affects the authority of the 
Secretary to conduct inspections otherwise permitted under this 
Act in order to ensure compliance with this Act.

           *       *       *       *       *       *       *


SEC. 714A. HIRING AUTHORITY FOR SCIENTIFIC, TECHNICAL, AND PROFESSIONAL 
                    PERSONNEL.

  (a) In General.--The Secretary may, notwithstanding title 5, 
United States Code, governing appointments in the competitive 
service, appoint outstanding and qualified candidates to 
scientific, technical, or professional positions that support 
the development, review, and regulation of [medical products] 
products regulated by the Food and Drug Administration. Such 
positions shall be within the competitive service.
  (b) Compensation.--
          (1) In general.--Notwithstanding any other provision 
        of law, including any requirement with respect to 
        General Schedule pay rates under subchapter III of 
        chapter 53 of title 5, United States Code, and 
        consistent with the requirements of paragraph (2), the 
        Commissioner of Food and Drugs may determine and set--
                  (A) the annual rate of pay of any individual 
                appointed under subsection (a); and
                  (B) for purposes of retaining qualified 
                employees, the annual rate of pay for any 
                qualified scientific, technical, or 
                professional personnel appointed to a position 
                described in subsection (a) before the date of 
                enactment of the 21st Century Cures Act.
          (2) Limitation.--The annual rate of pay established 
        pursuant to paragraph (1) may not exceed the amount of 
        annual compensation (excluding expenses) specified in 
        section 102 of title 3, United States Code.
          (3) Public availability.--The annual rate of pay 
        provided to an individual in accordance with this 
        section shall be publicly available information.
  (c) Rule of Construction.--The authorities under this section 
shall not be construed to affect the authority provided under 
section 714.
  [(d) Report on Workforce Planning.--
          [(1) In general.--Not later than 18 months after the 
        date of enactment of the 21st Century Cures Act, the 
        Secretary shall submit a report on workforce planning 
        to the Committee on Health, Education, Labor, and 
        Pensions of the Senate and the Committee on Energy and 
        Commerce of the House of Representatives that examines 
        the extent to which the Food and Drug Administration 
        has a critical need for qualified individuals for 
        scientific, technical, or professional positions, 
        including--
                  [(A) an analysis of the workforce needs at 
                the Food and Drug Administration and the 
                Secretary's strategic plan for addressing such 
                needs, including through use of the authority 
                under this section; and
                  [(B) a recruitment and retention plan for 
                hiring qualified scientific, technical, and 
                professional candidates, which may include the 
                use of--
                          [(i) recruitment through 
                        nongovernmental recruitment or 
                        placement agencies;
                          [(ii) recruitment through academic 
                        institutions;
                          [(iii) recruitment or hiring bonuses, 
                        if applicable;
                          [(iv) recruitment using targeted 
                        direct hiring authorities; and
                          [(v) retention of qualified 
                        scientific, technical, and professional 
                        employees using the authority under 
                        this section, or other applicable 
                        authorities of the Secretary.
          [(2) Recommendations.--The report under paragraph (1) 
        may include the recommendations of the Commissioner of 
        Food and Drugs that would help the Food and Drug 
        Administration to better recruit and retain qualified 
        individuals for scientific, technical, or professional 
        positions at the agency.]
  (d) Agency-wide Strategic Workforce Plan.--
          (1) In general.--Not later than 1 year after the date 
        of enactment of the Food and Drug Amendments of 2022, 
        the Commissioner of Food and Drugs shall develop and 
        begin implementation of an agency-wide strategic 
        workforce plan at the Food and Drug Administration, 
        which shall include--
                  (A) agency-wide human capital goals and 
                strategies;
                  (B) performance measures, benchmarks, or 
                other elements to facilitate the monitoring and 
                evaluation of the progress made toward such 
                goals and the effectiveness of such strategies; 
                and
                  (C) a process for updating such plan based on 
                timely and relevant information on an ongoing 
                basis.
          (2) Report to congress.--Not later than 18 months 
        after the date of enactment of the Food and Drug 
        Amendments of 2022, the Secretary shall submit to the 
        Committee on Energy and Commerce of the House of 
        Representatives and the Committee on Health, Education, 
        Labor, and Pensions of the Senate a report describing 
        the plan under paragraph (1) and the status of its 
        implementation.

           *       *       *       *       *       *       *


Subchapter C--Fees

           *       *       *       *       *       *       *



                     PART 2--FEES RELATING TO DRUGS

SEC. 735. DEFINITIONS.

   For purposes of this part:
          (1) The term ``human drug application'' means an 
        application for--
                  (A) approval of a new drug submitted under 
                section 505(b), or
                  (B) licensure of a biological product under 
                subsection (a) of section 351 of the Public 
                Health Service Act.
        Such term does not include a supplement to such an 
        application, does not include an application with 
        respect to whole blood or a blood component for 
        transfusion, does not include an application with 
        respect to a bovine blood product for topical 
        application licensed before September 1, 1992, [an 
        allergenic extract product, or] does not include an 
        application with respect to an allergenic extract 
        product licensed before October 1, 2022, does not 
        include an application with respect to a standardized 
        allergenic extract product submitted pursuant to a 
        notification to the applicant from the Secretary 
        regarding the existence of a potency test that measures 
        the allergenic activity of an allergenic extract 
        product licensed by the applicant before October 1, 
        2022, does not include an application with respect to 
        an in vitro diagnostic biologic product licensed under 
        section 351 of the Public Health Service Act, does not 
        include an application with respect to a large volume 
        parenteral drug product approved before September 1, 
        1992, does not include an application for a licensure 
        of a biological product for further manufacturing use 
        only, and does not include an application or supplement 
        submitted by a State or Federal Government entity for a 
        drug that is not distributed commercially. Such term 
        does include an application for licensure, as described 
        in subparagraph (B), of a large volume biological 
        product intended for single dose injection for 
        intravenous use or infusion.
          (2) The term ``supplement'' means a request to the 
        Secretary to approve a change in a human drug 
        application which has been approved.
          [(3) The term] (3)(A) The term  ``prescription drug 
        product'' means a specific strength or potency of a 
        drug in final dosage form--
                          [(A)] (i) for which a human drug 
                        application has been approved,
                          [(B)] (ii) which may be dispensed 
                        only under prescription pursuant to 
                        section 503(b), and
                          [(C)] (iii) which is on the list of 
                        products described in section 
                        505(j)(7)(A) (not including the 
                        discontinued section of such list) or 
                        is on a list created and maintained by 
                        the Secretary of products approved 
                        under human drug applications under 
                        section 351 of the Public Health 
                        Service Act (not including the 
                        discontinued section of such list).
         [Such term does not include whole blood]
          (B) Such term does not include whole blood  or a 
        blood component for transfusion, does not include a 
        bovine blood product for topical application licensed 
        before September 1, 1992, [an allergenic extract 
        product,] an allergenic extract product licensed before 
        October 1, 2022, a standardized allergenic extract 
        product submitted pursuant to a notification to the 
        applicant from the Secretary regarding the existence of 
        a potency test that measures the allergenic activity of 
        an allergenic extract product licensed by the applicant 
        before October 1, 2022, or an in vitro diagnostic 
        biologic product licensed under section 351 of the 
        Public Health Service Act. Such term does not include a 
        biological product that is licensed for further 
        manufacturing use only, and does not include a drug 
        that is not distributed commercially and is the subject 
        of an application or supplement submitted by a State or 
        Federal Government entity. Such term does include a 
        large volume biological product intended for single 
        dose injection for intravenous use or infusion.
                  (C)(i) If a written request to place a 
                product in the discontinued section of either 
                of the lists referenced in subparagraph 
                (A)(iii) is submitted to the Secretary on 
                behalf of an applicant, and the request 
                identifies the date the product is withdrawn 
                from sale, then for purposes of assessing the 
                prescription drug program fee under section 
                736(a)(2), the Secretary shall consider such 
                product to have been included in the 
                discontinued section on the later of--
                          (I) the date such request was 
                        received; or
                          (II) if the product will be withdrawn 
                        from sale on a future date, such future 
                        date when the product is withdrawn from 
                        sale.
                  (ii) For purposes of this subparagraph, a 
                product shall be considered withdrawn from sale 
                once the applicant has ceased its own 
                distribution of the product, whether or not the 
                applicant has ordered recall of all previously 
                distributed lots of the product, except that a 
                routine, temporary interruption in supply shall 
                not render a product withdrawn from sale.
          (4) The term ``final dosage form'' means, with 
        respect to a prescription drug product, a finished 
        dosage form which is approved for administration to a 
        patient without substantial further manufacturing (such 
        as capsules, tablets, or lyophilized products before 
        reconstitution).
          (5) The term ``prescription drug establishment'' 
        means a foreign or domestic place of business which is 
        at one general physical location consisting of one or 
        more buildings all of which are within five miles of 
        each other and at which one or more prescription drug 
        products are manufactured in final dosage form. For 
        purposes of this paragraph, the term ``manufactured'' 
        does not include packaging.
          (6) The term ``process for the review of human drug 
        applications'' means the following activities of the 
        Secretary with respect to the review of human drug 
        applications and supplements:
                  (A) The activities necessary for the review 
                of human drug applications and supplements.
                  (B) The issuance of action letters which 
                approve human drug applications or which set 
                forth in detail the specific deficiencies in 
                such applications and, where appropriate, the 
                actions necessary to place such applications in 
                condition for approval.
                  (C) The inspection of prescription drug 
                establishments and other facilities undertaken 
                as part of the Secretary's review of pending 
                human drug applications and supplements.
                  (D) Activities necessary for the review of 
                applications for licensure of establishments 
                subject to section 351 of the Public Health 
                Service Act and for the release of lots of 
                biologics under such section.
                  (E) Monitoring of research conducted in 
                connection with the review of human drug 
                applications.
                  (F) Postmarket safety activities with respect 
                to drugs approved under human drug applications 
                or supplements, including the following 
                activities:
                          (i) Collecting, developing, and 
                        reviewing safety information on 
                        approved drugs, including adverse event 
                        reports.
                          (ii) Developing and using improved 
                        adverse-event data-collection systems, 
                        including information technology 
                        systems.
                          (iii) Developing and using improved 
                        analytical tools to assess potential 
                        safety problems, including access to 
                        external data bases.
                          (iv) Implementing and enforcing 
                        section 505(o) (relating to 
                        postapproval studies and clinical 
                        trials and labeling changes) and 
                        section 505(p) (relating to risk 
                        evaluation and mitigation strategies).
                          (v) Carrying out section 505(k)(5) 
                        (relating to adverse event reports and 
                        postmarket safety activities).
          (7) The term ``costs of resources allocated for the 
        process for the review of human drug applications'' 
        means the expenses in connection with the process for 
        the review of human drug applications for--
                  (A) officers and employees of the Food and 
                Drug Administration, contractors of the Food 
                and Drug Administration, advisory committees, 
                and costs related to such officers, employees, 
                and committees and to contracts with such 
                contractors,
                  (B) management of information, and the 
                acquisition, maintenance, and repair of 
                computer resources,
                  (C) leasing, maintenance, renovation, and 
                repair of facilities and acquisition, 
                maintenance, and repair of fixtures, furniture, 
                scientific equipment, and other necessary 
                materials and supplies, and
                  (D) collecting fees under section 736 and 
                accounting for resources allocated for the 
                review of human drug applications and 
                supplements.
          (8) The term ``adjustment factor'' applicable to a 
        fiscal year is the Consumer Price Index for all urban 
        consumers (all items; United States city average) for 
        October of the preceding fiscal year divided by such 
        Index for October 1996.
          (9) The term ``person'' includes an affiliate 
        thereof.
          (10) The term ``active'', with respect to a 
        commercial investigational new drug application, means 
        such an application to which information was submitted 
        during the relevant period.
          (11) The term ``affiliate'' means a business entity 
        that has a relationship with a second business entity 
        if, directly or indirectly--
                  (A) one business entity controls, or has the 
                power to control, the other business entity; or
                  (B) a third party controls, or has power to 
                control, both of the business entities.
          (12) The term ``skin-test diagnostic product''--
                  (A) means a product--
                          (i) for prick, scratch, intradermal, 
                        or subcutaneous administration;
                          (ii) expected to produce a limited, 
                        local reaction at the site of 
                        administration (if positive), rather 
                        than a systemic effect;
                          (iii) not intended to be a preventive 
                        or therapeutic intervention; and
                          (iv) intended to detect an immediate- 
                        or delayed-type skin hypersensitivity 
                        reaction to aid in the diagnosis of--
                                  (I) an allergy to an 
                                antimicrobial agent;
                                  (II) an allergy that is not 
                                to an antimicrobial agent, if 
                                the diagnostic product was 
                                authorized for marketing prior 
                                to October 1, 2022; or
                                  (III) infection with fungal 
                                or mycobacterial pathogens; and
                  (B) includes positive and negative controls 
                required to interpret the results of a product 
                described in subparagraph (A).

SEC. 736. AUTHORITY TO ASSESS AND USE DRUG FEES.

  (a) Types of Fees.--Beginning in [fiscal year 2018] fiscal 
year 2023, the Secretary shall assess and collect fees in 
accordance with this section as follows:
          (1) Human drug application fee.--
                  (A) In general.--Each person that submits, on 
                or after September 1, 1992, a human drug 
                application shall be subject to a fee as 
                follows:
                          (i) A fee established under 
                        subsection [(c)(5)] (c)(6) for a human 
                        drug application for which clinical 
                        data (other than bioavailability or 
                        bioequivalence studies) with respect to 
                        safety or effectiveness are required 
                        for approval.
                          (ii) A fee established under 
                        subsection [(c)(5)] (c)(6) 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. Such fee shall 
                        be half of the amount of the fee 
                        established under clause (i).
                  (B) Payment.--The fee required by 
                subparagraph (A) shall be due upon submission 
                of the application.
                  (C) Exception for previously filed 
                application.--If a human drug application was 
                submitted by a person that paid the fee for 
                such application, was accepted for filing, and 
                was not approved or was withdrawn prior to 
                approval (without a waiver), the submission of 
                a human drug application for the same product 
                by the same person (or the person's licensee, 
                assignee, or successor) shall not be subject to 
                a fee under subparagraph (A).
                  (D) Refund of fee if application refused for 
                filing or withdrawn before filing.--The 
                Secretary shall refund 75 percent of the fee 
                paid under subparagraph (B) for any application 
                which is refused for filing or withdrawn 
                without a waiver before filing.
                  (E) Fees for applications previously refused 
                for filing or withdrawn before filing.--A human 
                drug application that was submitted but was 
                refused for filing, or was withdrawn before 
                being accepted or refused for filing, shall be 
                subject to the full fee under subparagraph (A) 
                upon being resubmitted or filed over protest, 
                unless the fee is waived or reduced under 
                subsection (d).
                  (F) Exception for designated orphan drug.--A 
                human drug application for a prescription drug 
                product that has been designated as a drug for 
                a rare disease or condition pursuant to section 
                526 shall not be subject to a fee under 
                subparagraph (A), unless the human drug 
                application includes an indication for other 
                than a rare disease or condition.
                  (G) Refund of fee if application withdrawn.--
                If an application is withdrawn after the 
                application was filed, the Secretary may refund 
                the fee or a portion of the fee if no 
                substantial work was performed on the 
                application after the application was filed. 
                The Secretary shall have the sole discretion to 
                refund a fee or a portion of the fee under this 
                subparagraph. A determination by the Secretary 
                concerning a refund under this paragraph shall 
                not be reviewable.
                  (H) Exception for skin-test diagnostic 
                products.--A human drug application for a skin-
                test diagnostic product shall not be subject to 
                a fee under subparagraph (A).
          (2) Prescription drug program fee.--
                  (A) In general.--[Except as provided in 
                subparagraphs (B) and (C)]
                          (i) Fee._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)] subsection (c)(6) 
                        for each prescription drug product that 
                        is identified in such a human drug 
                        application approved as of October 1 of 
                        such fiscal year. Such fee shall be due 
                        on the later of the first business day 
                        on or after October 1 of each fiscal 
                        year or the first business day after 
                        the enactment of an appropriations Act 
                        providing for the collection and 
                        obligation of fees for such fiscal year 
                        under this section. Such fee shall be 
                        paid only once for each product for a 
                        fiscal year in which the fee is 
                        payable.
                          (ii) Special rule.--If a drug product 
                        that is identified in a human drug 
                        application approved as of October 1 of 
                        a fiscal year is not a prescription 
                        drug product as of that date because 
                        the drug product is in the discontinued 
                        section of a list referenced in section 
                        735(3)(A)(iii), and on any subsequent 
                        day during such fiscal year the drug 
                        product is a prescription drug product, 
                        then except as provided in 
                        subparagraphs (B) and (C), each person 
                        who is named as the applicant in a 
                        human drug application with respect to 
                        such product, and who, after September 
                        1, 1992, had pending before the 
                        Secretary a human drug application or 
                        supplement with respect to such 
                        product, shall pay the annual 
                        prescription drug program fee 
                        established for a fiscal year under 
                        subsection (c)(6) for such prescription 
                        drug product. Such fee shall be due on 
                        the last business day of such fiscal 
                        year and shall be paid only once for 
                        each such product for a fiscal year in 
                        which the fee is payable.
                  [(B) Exception for certain prescription drug 
                products.--A prescription drug program fee 
                shall not be assessed for a prescription drug 
                product under subparagraph (A) if such product 
                is--
                          [(i) identified on the list compiled 
                        under section 505(j)(7) with a potency 
                        described in terms of per 100 mL;
                          [(ii) the same product as another 
                        product that--
                                  [(I) was approved under an 
                                application filed under section 
                                505(b) or 505(j); and
                                  [(II) is not in the list of 
                                discontinued products compiled 
                                under section 505(j)(7);
                          [(iii) the same product as another 
                        product that was approved under an 
                        abbreviated application filed under 
                        section 507 (as in effect on the day 
                        before the date of enactment of the 
                        Food and Drug Administration 
                        Modernization Act of 1997); or
                          [(iv) the same product as another 
                        product that was approved under an 
                        abbreviated new drug application 
                        pursuant to regulations in effect prior 
                        to the implementation of the Drug Price 
                        Competition and Patent Term Restoration 
                        Act of 1984.]
                  (B) Exception for certain prescription drug 
                products.--A prescription drug program fee 
                shall not be assessed for a prescription drug 
                product under subparagraph (A) if such product 
                is--
                          (i) a large volume parenteral product 
                        (a sterile aqueous drug product 
                        packaged in a single-dose container 
                        with a volume greater than or equal to 
                        100 mL, not including powders for 
                        reconstitution or pharmacy bulk 
                        packages) identified on the list 
                        compiled under section 505(j)(7);
                          (ii) pharmaceutically equivalent (as 
                        defined in section 314.3 of title 21, 
                        Code of Federal Regulations (or any 
                        successor regulation)) to another 
                        product on the list of products 
                        compiled under section 505(j)(7) (not 
                        including the discontinued section of 
                        such list); or
                          (iii) a skin-test diagnostic product.
                  (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.
  (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.]
          (1) In general.--For each of the fiscal years 2023 
        through 2027, fees under subsection (a) shall, except 
        as provided in subsections (c), (d), (f), and (g), be 
        established to generate a total revenue amount under 
        such subsection that is equal to the sum of--
                  (A) the annual base revenue for the fiscal 
                year (as determined under paragraph (3));
                  (B) the dollar amount equal to the inflation 
                adjustment for the fiscal year (as determined 
                under subsection (c)(1));
                  (C) the dollar amount equal to the strategic 
                hiring and retention adjustment for the fiscal 
                year (as determined under subsection (c)(2));
                  (D) the dollar amount equal to the capacity 
                planning adjustment for the fiscal year (as 
                determined under subsection (c)(3));
                  (E) the dollar amount equal to the operating 
                reserve adjustment for the fiscal year, if 
                applicable (as determined under subsection 
                (c)(4));
                  (F) the dollar amount equal to the additional 
                direct cost adjustment for the fiscal year (as 
                determined under subsection (c)(5)); and
                  (G) additional dollar amounts for each fiscal 
                year as follows:
                          (i) $65,773,693 for fiscal year 2023.
                          (ii) $25,097,671 for fiscal year 
                        2024.
                          (iii) $14,154,169 for fiscal year 
                        2025.
                          (iv) $4,864,860 for fiscal year 2026.
                          (v) $1,314,620 for fiscal year 2027.
          (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).]
          (3) Annual base revenue.--For purposes of paragraph 
        (1), the dollar amount of the annual base revenue for a 
        fiscal year shall be--
                  (A) for fiscal year 2023, $1,151,522,958; and
                  (B) for fiscal years 2024 through 2027, the 
                dollar amount of the total revenue amount 
                established under paragraph (1) for the 
                previous fiscal year, not including any 
                adjustments made under subsection (c)(4) or 
                (c)(5).
  (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] 
                        Washington-Arlington-Alexandria, DC-VA-
                        MD-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) Strategic hiring and retention adjustment.--For 
        each fiscal year, after the annual base revenue 
        established in subsection (b)(1)(A) is adjusted for 
        inflation in accordance with paragraph (1), the 
        Secretary shall further increase the fee revenue and 
        fees by the following amounts:
                  (A) For fiscal year 2023, $9,000,000.
                  (B) For each of fiscal years 2024 through 
                2027, $4,000,000.
          [ (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) of the fee revenue 
                and fees resulting from the adjustment and the 
                methodologies under this paragraph.]
          (3) Capacity planning adjustment.--
                  (A) In general.--For each fiscal year, after 
                the annual base revenue established in 
                subsection (b)(1)(A) is adjusted in accordance 
                with paragraphs (1) and (2), such revenue shall 
                be adjusted further for such fiscal year, in 
                accordance with this paragraph, to reflect 
                changes in the resource capacity needs of the 
                Secretary for the process for the review of 
                human drug applications.
                  (B) Methodology.--For purposes of this 
                paragraph, the Secretary shall employ the 
                capacity planning methodology utilized by the 
                Secretary in setting fees for fiscal year 2021, 
                as described in the notice titled 
                ``Prescription Drug User Fee Rates for Fiscal 
                Year 2021'' published in the Federal Register 
                on August 3, 2020 (85 Fed. Reg. 46651). The 
                workload categories used in applying such 
                methodology in forecasting shall include only 
                the activities described in that notice and, as 
                feasible, additional activities that are also 
                directly related to the direct review of 
                applications and supplements, including 
                additional formal meeting types, the direct 
                review of postmarketing commitments and 
                requirements, the direct review of risk 
                evaluation and mitigation strategies, and the 
                direct review of annual reports for approved 
                prescription drug products. Subject to the 
                exceptions in the preceding sentence, the 
                Secretary shall not include as workload 
                categories in applying such methodology in 
                forecasting any non-core review activities, 
                including those activities that the Secretary 
                referenced for potential future use in such 
                notice but did not utilize in setting fees for 
                fiscal year 2021.
                  (C) Limitation.--Under no circumstances shall 
                an adjustment under this paragraph result in 
                fee revenue for a fiscal year that is less than 
                the sum of the amounts under subsections 
                (b)(1)(A) (the annual base revenue for the 
                fiscal year), (b)(1)(B) (the dollar amount of 
                the inflation adjustment for the fiscal year), 
                and (b)(1)(C) (the dollar amount of the 
                strategic hiring and retention adjustment for 
                the fiscal year).
                  (D) Publication in federal register.--The 
                Secretary shall publish in the Federal Register 
                notice under paragraph (6) of the fee revenue 
                and fees resulting from the adjustment and the 
                methodologies under this paragraph.
          [(3)] (4) 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.]
                  (A) Increase.--For fiscal year 2023 and 
                subsequent fiscal years, the Secretary shall, 
                in addition to adjustments under paragraphs 
                (1), (2), and (3), further increase the fee 
                revenue and fees if such an adjustment is 
                necessary to provide for operating reserves of 
                carryover user fees for the process for the 
                review of human drug applications for each 
                fiscal year in at least the following amounts:
                          (i) For fiscal year 2023, at least 8 
                        weeks of operating reserves.
                          (ii) For fiscal year 2024, at least 9 
                        weeks of operating reserves.
                          (iii) For fiscal year 2025 and 
                        subsequent fiscal years, at least 10 
                        weeks of operating reserves.
                  (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)] paragraph 
                (6) 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) Additional direct cost adjustment.--
                  (A) Increase.--The Secretary shall, in 
                addition to adjustments under paragraphs (1), 
                (2), (3), and (4), further increase the fee 
                revenue and fees--
                          (i) for fiscal year 2023, by 
                        $44,386,150; and
                          (ii) for each of fiscal years 2024 
                        through 2027, by the amount set forth 
                        in clauses (i) through (iv) of 
                        subparagraph (B), as applicable, 
                        multiplied by the Consumer Price Index 
                        for urban consumers (Washington-
                        Arlington-Alexandria, DC-VA-MD-WV; Not 
                        Seasonally Adjusted; All Items; Annual 
                        Index) for the most recent year of 
                        available data, divided by such Index 
                        for 2021.
                  (B) Applicable amounts.--The amounts referred 
                to in subparagraph (A)(ii) are the following:
                          (i) For fiscal year 2024, 
                        $60,967,993.
                          (ii) For fiscal year 2025, 
                        $35,799,314.
                          (iii) For fiscal year 2026, $35,799, 
                        314.
                          (iv) For fiscal year 2027, 
                        $35,799,314.
          [(5)] (6) Annual fee setting.--The Secretary shall, 
        not later than 60 days before the start of each fiscal 
        year that begins after [September 30, 2017] September 
        30, 2022--
                  (A) establish, for 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)] (7) 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.--
          (1) In general.--The Secretary shall grant to a 
        person who is named as the applicant in a human drug 
        application a waiver from or a reduction of one or more 
        fees assessed to that person under subsection (a) where 
        the Secretary finds that--
                  (A) such waiver or reduction is necessary to 
                protect the public health,
                  (B) the assessment of the fee would present a 
                significant barrier to innovation because of 
                limited resources available to such person or 
                other circumstances, or
                  (C) the applicant involved is a small 
                business submitting its first human drug 
                application to the Secretary for review.
          (2) Considerations.--In determining whether to grant 
        a waiver or reduction of a fee under paragraph (1), the 
        Secretary shall consider only the circumstances and 
        assets of the applicant involved and any affiliate of 
        the applicant.
          (3) Rules relating to small businesses.--
                  (A) Definition.--In paragraph (1)(C), the 
                term ``small business'' means an entity that 
                has fewer than 500 employees, including 
                employees of affiliates, and that does not have 
                a drug product that has been approved under a 
                human drug application and introduced or 
                delivered for introduction into interstate 
                commerce.
                  (B) Waiver of application fee.--The Secretary 
                shall waive under paragraph (1)(C) the 
                application fee for the first human drug 
                application that a small business or its 
                affiliate submits to the Secretary for review. 
                After a small business or its affiliate is 
                granted such a waiver, the small business or 
                its affiliate shall pay application fees for 
                all subsequent human drug applications 
                submitted to the Secretary for review in the 
                same manner as an entity that does not qualify 
                as a small business.
  (e) Effect of Failure To Pay Fees.--A human drug application 
or supplement submitted by a person subject to fees under 
subsection (a) shall be considered incomplete and shall not be 
accepted for filing by the Secretary until all such fees owed 
by such person have been paid.
  (f) Limitations.--
          (1) In general.--Fees under subsection (a) shall be 
        refunded for a fiscal year beginning after fiscal year 
        1997 unless appropriations for salaries and expenses of 
        the Food and Drug Administration for such fiscal year 
        (excluding the amount of fees appropriated for such 
        fiscal year) are equal to or greater than the amount of 
        appropriations for the salaries and expenses of the 
        Food and Drug Administration for the fiscal year 1997 
        (excluding the amount of fees appropriated for such 
        fiscal year) multiplied by the adjustment factor 
        applicable to the fiscal year involved.
          (2) Authority.--If the Secretary does not assess fees 
        under subsection (a) during any portion of a fiscal 
        year because of paragraph (1) and if at a later date in 
        such fiscal year the Secretary may assess such fees, 
        the Secretary may assess and collect such fees, without 
        any modification in the rate, for human drug 
        applications and prescription drug program fees at any 
        time in such fiscal year notwithstanding the provisions 
        of subsection (a) relating to the date fees are to be 
        paid.
          (3) Limitation.--Beginning on October 1, 2023, the 
        authorities under section 735(7)(C) shall include only 
        expenditures for leasing and necessary scientific 
        equipment.
  (g) Crediting and Availability of Fees.--
          (1) In general.--Subject to paragraph (2)(C), fees 
        authorized under subsection (a) shall be collected and 
        available for obligation only to the extent and in the 
        amount provided in advance in appropriations Acts. Such 
        fees are authorized to remain available until expended. 
        Such sums as may be necessary may be transferred from 
        the Food and Drug Administration salaries and expenses 
        appropriation account without fiscal year limitation to 
        such appropriation account for salaries and expenses 
        with such fiscal year limitation. The sums transferred 
        shall be available solely for the process for the 
        review of human drug applications.
          (2) Collections and appropriation acts.--
                  (A) In general.--The fees authorized by this 
                section--
                          (i) subject to subparagraph (C), 
                        shall be collected and available in 
                        each fiscal year in an amount not to 
                        exceed the amount specified in 
                        appropriation Acts, or otherwise made 
                        available for obligation, for such 
                        fiscal year, and
                          (ii) shall be available to defray 
                        increases in the costs of the resources 
                        allocated for the process for the 
                        review of human drug applications 
                        (including increases in such costs for 
                        an additional number of full-time 
                        equivalent positions in the Department 
                        of Health and Human Services to be 
                        engaged in such process) over such 
                        costs, excluding costs paid from fees 
                        collected under this section, for 
                        fiscal year 1997 multiplied by the 
                        adjustment factor.
                  (B) Compliance.--The Secretary shall be 
                considered to have met the requirements of 
                subparagraph (A)(ii) in any fiscal year if the 
                costs funded by appropriations and allocated 
                for the process for the review of human drug 
                applications--
                          (i) are not more than 3 percent below 
                        the level specified in subparagraph 
                        (A)(ii); or
                          (ii)(I) are more than 3 percent below 
                        the level specified in subparagraph 
                        (A)(ii), and fees assessed for the 
                        fiscal year following the subsequent 
                        fiscal year are decreased by the amount 
                        in excess of 3 percent by which such 
                        costs fell below the level specified in 
                        such subparagraph; and
                          (II) such costs are not more than 5 
                        percent below the level specified in 
                        such subparagraph.
                  (C) Provision for early payments.--Payment of 
                fees authorized under this section for a fiscal 
                year, prior to the due date for such fees, may 
                be accepted by the Secretary in accordance with 
                authority provided in advance in a prior year 
                appropriations Act.
          (3) Authorization of appropriations.--For each of the 
        [fiscal years 2018 through 2022] fiscal years 2023 
        through 2027, there is authorized to be appropriated 
        for fees under this section an amount equal to the 
        total revenue amount determined under subsection (b) 
        for the fiscal year, as adjusted or otherwise affected 
        under subsection (c).
  (h) Collection of Unpaid Fees.--In any case where the 
Secretary does not receive payment of a fee assessed under 
subsection (a) within 30 days after it is due, such fee shall 
be treated as a claim of the United States Government subject 
to subchapter II of chapter 37 of title 31, United States Code.
  [(i) Written Requests for Waivers, Reductions, and Refunds.--
To qualify for consideration for a waiver or reduction under 
subsection (d), or for a refund of any fee collected in 
accordance with subsection (a), a person shall submit to the 
Secretary a written request for such waiver, reduction, or 
refund not later than 180 days after such fee is due.]
  (i) Written Requests for Waivers, Reductions, Exemptions, and 
Returns; Disputes Concerning Fees.--To qualify for 
consideration for a waiver or reduction under subsection (d), 
an exemption under subsection (k), or the return of any fee 
paid under this section, including if the fee is claimed to 
have been paid in error, a person shall--
          (1) not later than 180 days after such fee is due, 
        submit to the Secretary a written request justifying 
        such waiver, reduction, exemption, or return; and
          (2) include in the request any legal authorities 
        under which the request is made.
  (j) Construction.--This section may not be construed to 
require that the number of full-time equivalent positions in 
the Department of Health and Human Services, for officers, 
employers, and advisory committees not engaged in the process 
of the review of human drug applications, be reduced to offset 
the number of officers, employees, and advisory committees so 
engaged.
  (k) Orphan Drugs.--
          (1) Exemption.--A drug designated under section 526 
        for a rare disease or condition and approved under 
        section 505 or under section 351 of the Public Health 
        Service Act shall be exempt from prescription drug 
        program fees under this section, if the drug meets all 
        of the following conditions:
                  (A) The drug meets the public health 
                requirements contained in this Act as such 
                requirements are applied to requests for 
                waivers for prescription drug program fees.
                  (B) The drug is owned or licensed and is 
                marketed by a company that had less than 
                $50,000,000 in gross worldwide revenue [during 
                the previous year] as determined under 
                paragraph (2).
          [(2) Evidence of qualification.--An exemption under 
        paragraph (1) applies with respect to a drug only if 
        the applicant involved submits a certification that its 
        gross annual revenues did not exceed $50,000,000 for 
        the preceding 12 months before the exemption was 
        requested.]
          (2) Evidence of qualification.--An exemption under 
        paragraph (1) applies with respect to a drug only if 
        the applicant involved submits a certification that the 
        applicant's gross annual revenues did not exceed 
        $50,000,000 for the last calendar year ending prior to 
        the fiscal year for which the exemption is requested. 
        Such certification shall be supported by--
                  (A) tax returns submitted to the United 
                States Internal Revenue Service; or
                  (B) as necessary, other appropriate financial 
                information.

           *       *       *       *       *       *       *


SEC. 736B. REAUTHORIZATION; REPORTING REQUIREMENTS.

  (a) Performance Report.--
          (1) In general.--[Beginning with fiscal year 2018, 
        not] Not later than 120 days after the end of each 
        fiscal year for which fees are collected under this 
        part, the Secretary shall prepare and 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 concerning--
                  (A) the progress of the Food and Drug 
                Administration in achieving the goals 
                identified in the letters described in section 
                101(b) of the [Prescription Drug User Fee 
                Amendments of 2017] Prescription Drug User Fee 
                Amendments of 2022 during such fiscal year and 
                the future plans of the Food and Drug 
                Administration for meeting the goals, including 
                the status of the independent assessment 
                described in such letters; and
                  (B) the progress of the Center for Drug 
                Evaluation and Research and the Center for 
                Biologics Evaluation and Research in achieving 
                the goals, and future plans for meeting the 
                goals, including, for each review division--
                          (i) the number of original standard 
                        new drug applications and biologics 
                        license applications filed per fiscal 
                        year for each review division;
                          (ii) the number of original priority 
                        new drug applications and biologics 
                        license applications filed per fiscal 
                        year for each review division;
                          (iii) the number of standard efficacy 
                        supplements filed per fiscal year for 
                        each review division;
                          (iv) the number of priority efficacy 
                        supplements filed per fiscal year for 
                        each review division;
                          (v) the number of applications filed 
                        for review under accelerated approval 
                        per fiscal year for each review 
                        division;
                          (vi) the number of applications filed 
                        for review as fast track products per 
                        fiscal year for each review division;
                          (vii) the number of applications 
                        filed for orphan-designated products 
                        per fiscal year for each review 
                        division; and
                          (viii) the number of breakthrough 
                        designations for a fiscal year for each 
                        review division.
          (2) Inclusion.--The report under this subsection for 
        a fiscal year shall include information on all previous 
        cohorts for which the Secretary has not given a 
        complete response on all human drug applications and 
        supplements in the cohort.
          (3) Real time reporting.--
                  (A) In general.--[Not later than 30 calendar 
                days after the end of the second quarter of 
                fiscal year 2018, and not later than 30 
                calendar days after the end of each quarter of 
                each fiscal year thereafter] Not later than 30 
                calendar days after the end of each quarter of 
                each fiscal year for which fees are collected 
                under this part, the Secretary shall post the 
                data described in subparagraph (B) on the 
                internet website of the Food and Drug 
                Administration for such quarter and on a 
                cumulative basis for such fiscal year, and may 
                remove duplicative data from the annual 
                performance report under this subsection.
                  (B) Data.--The Secretary shall post the 
                following data in accordance with subparagraph 
                (A):
                          (i) The number and titles of draft 
                        and final guidance on topics related to 
                        the process for the review of human 
                        drug applications, and whether such 
                        guidances were issued as required by 
                        statute or pursuant to a commitment 
                        under the letters described in section 
                        101(b) of the [Prescription Drug User 
                        Fee Amendments of 2017] Prescription 
                        Drug User Fee Amendments of 2022.
                          (ii) The number and titles of public 
                        meetings held on topics related to the 
                        process for the review of human drug 
                        applications, and whether such meetings 
                        were required by statute or pursuant to 
                        a commitment under the letters 
                        described in section 101(b) of the 
                        [Prescription Drug User Fee Amendments 
                        of 2017] Prescription Drug User Fee 
                        Amendments of 2022.
                          (iii) The number of new drug 
                        applications and biological licensing 
                        applications approved.
                          (iv) The number of new drug 
                        applications and biological licensing 
                        applications filed.
                          (v) For fiscal years 2023 and 2024, 
                        of the meeting requests from sponsors 
                        for which the Secretary has determined 
                        that a face-to-face meeting is 
                        appropriate, the number of face-to-face 
                        meetings requested by sponsors to be 
                        conducted in person (in such manner as 
                        the Secretary shall prescribe on the 
                        internet website of the Food and Drug 
                        Administration), and the number of such 
                        in-person meetings granted by the 
                        Secretary.
          (4) Rationale for pdufa program changes.--[Beginning 
        with fiscal year 2020, the] The Secretary shall include 
        in the annual report under paragraph (1)--
                  (A) data, analysis, and discussion of the 
                changes in the number of full-time equivalents 
                hired as agreed upon in the letters described 
                in section 101(b) of the [Prescription Drug 
                User Fee Amendments of 2017] Prescription Drug 
                User Fee Amendments of 2022 and the number of 
                full time equivalents funded by budget 
                authority at the Food and Drug Administration 
                by each division within the Center for Drug 
                Evaluation and Research, the Center for 
                Biologics Evaluation and Research, the Office 
                of Regulatory Affairs, and the Office of the 
                Commissioner;
                  (B) data, analysis, and discussion of the 
                changes in the fee revenue amounts and costs 
                for the process for the review of human drugs, 
                including identifying drivers of such changes; 
                and
                  (C) for each of the Center for Drug 
                Evaluation and Research, the Center for 
                Biologics Evaluation and Research, the Office 
                of Regulatory Affairs, and the Office of the 
                Commissioner, the number of employees for whom 
                time reporting is required and the number of 
                employees for whom time reporting is not 
                required.
          (5) Analysis.--For each fiscal year, the Secretary 
        shall include in the report under paragraph (1) an 
        analysis of the following:
                  (A) The difference between the aggregate 
                number of human drug applications filed and the 
                aggregate number of approvals, accounting for--
                          (i) such applications filed during 
                        one fiscal year for which a decision is 
                        not scheduled to be made until the 
                        following fiscal year;
                          (ii) the aggregate number of 
                        applications for each fiscal year that 
                        did not meet the goals identified in 
                        the letters described in section 101(b) 
                        of the [Prescription Drug User Fee 
                        Amendments of 2017] Prescription Drug 
                        User Fee Amendments of 2022 for the 
                        applicable fiscal year.
                  (B) Relevant data to determine whether the 
                Center for Drug Evaluation and Research and the 
                Center for Biologics Evaluation and Research 
                have met performance enhancement goals 
                identified in the letters described in section 
                101(b) of the [Prescription Drug User Fee 
                Amendments of 2017] Prescription Drug User Fee 
                Amendments of 2022 for the applicable fiscal 
                year.
                  (C) The most common causes and trends of 
                external or other circumstances affecting the 
                ability of the Center for Drug Evaluation and 
                Research, the Center for Biologics Evaluation 
                and Research, Office of Regulatory Affairs, and 
                the Food and Drug Administration to meet the 
                review time and performance enhancement goals 
                identified in the letters described in section 
                101(b) of the [Prescription Drug User Fee 
                Amendments of 2017] Prescription Drug User Fee 
                Amendments of 2022.
  (b) Fiscal Report.--[Beginning with fiscal year 2018, not] 
Not later than 120 days after the end of each fiscal year for 
which fees are collected under this part, the Secretary shall 
prepare and submit to the Committee on Energy and Commerce of 
the House of Representatives and the Committee on Health, 
Education, Labor, and Pensions of the Senate a report on the 
implementation of the authority for such fees during such 
fiscal year and the use, by the Food and Drug Administration, 
of the fees collected for such fiscal year.
  (c) Corrective Action Report.--[Beginning with fiscal year 
2018, for] For each fiscal year for which fees are collected 
under this part, the Secretary shall prepare and submit a 
corrective action report to the Committee on Energy and 
Commerce and the Committee on Appropriations of the House of 
Representatives and the Committee on Health, Education, Labor, 
and Pensions and the Committee on Appropriations of the Senate. 
The report shall include the following information, as 
applicable:
          (1) Goals met.--For each fiscal year, if the 
        Secretary determines, based on the analysis under 
        subsection (a)(5), that each of the goals identified in 
        the letters described in section 101(b) of the 
        [Prescription Drug User Fee Amendments of 2017] 
        Prescription Drug User Fee Amendments of 2022 for the 
        applicable fiscal year have been met, the corrective 
        action report shall include recommendations on ways in 
        which the Secretary can improve and streamline the 
        human drug application review process.
          (2) Goals missed.--For any of the goals identified in 
        the letters described in section 101(b) of the 
        [Prescription Drug User Fee Amendments of 2017] 
        Prescription Drug User Fee Amendments of 2022 for the 
        applicable fiscal year that the Secretary determines to 
        not have been met, the corrective action report shall 
        include--
                  (A) a detailed justification for such 
                determination and a description, as applicable, 
                of the types of circumstances and trends under 
                which human drug applications that missed the 
                review goal time were approved during the first 
                cycle review, or application review goals were 
                missed; and
                  (B) with respect to performance enhancement 
                goals that were not achieved, a description of 
                efforts the Food and Drug Administration has 
                put in place for the fiscal year in which the 
                report is submitted to improve the ability of 
                such agency to meet each such goal for the such 
                fiscal year.
  (d) Enhanced Communication.--
          (1) Communications with congress.--Each fiscal year, 
        as applicable and requested, representatives from the 
        Centers with expertise in the review of human drugs 
        shall meet with representatives from the Committee on 
        Health, Education, Labor, and Pensions of the Senate 
        and the Committee on Energy and Commerce of the House 
        of Representatives to report on the contents described 
        in the reports under this section.
          (2) Participation in congressional hearing.--Each 
        fiscal year, as applicable and requested, 
        representatives from the Food and Drug Administration 
        shall participate in a public hearing before the 
        Committee on Health, Education, Labor, and Pensions of 
        the Senate and the Committee on Energy and Commerce of 
        the House of Representatives, to report on the contents 
        described in the reports under this section. Such 
        hearing shall occur not later than 120 days after the 
        end of each fiscal year for which fees are collected 
        under this part.
  (e) Public Availability.--The Secretary shall make the 
reports required under subsections (a) and (b) available to the 
public on the Internet Web site of the Food and Drug 
Administration.
  (f) Reauthorization.--
          (1) Consultation.--In developing recommendations to 
        present to the Congress with respect to the goals, and 
        plans for meeting the goals, for the process for the 
        review of human drug applications for the first 5 
        fiscal years after [fiscal year 2022] fiscal year 2027, 
        and for the reauthorization of this part for such 
        fiscal years, the Secretary shall consult with--
                  (A) the Committee on Energy and Commerce of 
                the House of Representatives;
                  (B) the Committee on Health, Education, 
                Labor, and Pensions of the Senate;
                  (C) scientific and academic experts;
                  (D) health care professionals;
                  (E) representatives of patient and consumer 
                advocacy groups; and
                  (F) the regulated industry.
          (2) Prior public input.--Prior to beginning 
        negotiations with the regulated industry on the 
        reauthorization of this part, the Secretary shall--
                  (A) publish a notice in the Federal Register 
                requesting public input on the reauthorization;
                  (B) hold a public meeting at which the public 
                may present its views on the reauthorization, 
                including specific suggestions for changes to 
                the goals referred to in subsection (a);
                  (C) provide a period of 30 days after the 
                public meeting to obtain written comments from 
                the public suggesting changes to this part; and
                  (D) publish the comments on the Food and Drug 
                Administration's Internet Web site.
          (3) Periodic consultation.--Not less frequently than 
        once every month during negotiations with the regulated 
        industry, the Secretary shall hold discussions with 
        representatives of patient and consumer advocacy groups 
        to continue discussions of their views on the 
        reauthorization and their suggestions for changes to 
        this part as expressed under paragraph (2).
          (4) Public review of recommendations.--After 
        negotiations with the regulated industry, the Secretary 
        shall--
                  (A) present the recommendations developed 
                under paragraph (1) to the Congressional 
                committees specified in such paragraph;
                  (B) publish such recommendations in the 
                Federal Register;
                  (C) provide for a period of 30 days for the 
                public to provide written comments on such 
                recommendations;
                  (D) hold a meeting at which the public may 
                present its views on such recommendations; and
                  (E) after consideration of such public views 
                and comments, revise such recommendations as 
                necessary.
          (5) Transmittal of recommendations.--Not later than 
        [January 15, 2022] January 15, 2027, the Secretary 
        shall transmit to the Congress the revised 
        recommendations under paragraph (4), a summary of the 
        views and comments received under such paragraph, and 
        any changes made to the recommendations in response to 
        such views and comments.
          (6) Minutes of negotiation meetings.--
                  (A) Public availability.--Before presenting 
                the recommendations developed under paragraphs 
                (1) through (5) to the Congress, the Secretary 
                shall make publicly available, on the public 
                Web site of the Food and Drug Administration, 
                minutes of all negotiation meetings conducted 
                under this subsection between the Food and Drug 
                Administration and the regulated industry.
                  (B) Content.--The minutes described under 
                subparagraph (A) shall summarize any 
                substantive proposal made by any party to the 
                negotiations as well as significant 
                controversies or differences of opinion during 
                the negotiations and their resolution.

           *       *       *       *       *       *       *


                    PART 3--FEES RELATING TO DEVICES

SEC. 737. DEFINITIONS.

   For purposes of this part:
          (1) The term ``premarket application'' means--
                  (A) an application for approval of a device 
                submitted under section 515(c) or section 351 
                of the Public Health Service Act; or
                  (B) a product development protocol described 
                in section 515(f).
        Such term does not include a supplement, a premarket 
        report, or a premarket notification submission.
          (2) The term ``premarket report'' means a report 
        submitted under section 515(c)(2).
          (3) The term ``premarket notification submission'' 
        means a report submitted under section 510(k).
          (4)(A) The term ``supplement'', with respect to a 
        panel-track supplement, a 180-day supplement, a real-
        time supplement, or an efficacy supplement, means a 
        request to the Secretary to approve a change in a 
        device for which--
                  (i) an application or report has been 
                approved under section 515(d), or an 
                application has been approved under section 351 
                of the Public Health Service Act; or
                  (ii) a notice of completion has become 
                effective under section 515(f).
          (B) The term ``panel-track supplement'' means a 
        supplement to an approved premarket application or 
        premarket report under section 515 that requests a 
        significant change in design or performance of the 
        device, or a new indication for use of the device, and 
        for which substantial clinical data are necessary to 
        provide a reasonable assurance of safety and 
        effectiveness.
          (C) The term ``180-day supplement'' means a 
        supplement to an approved premarket application or 
        premarket report under section 515 that is not a panel-
        track supplement and requests a significant change in 
        components, materials, design, specification, software, 
        color additives, or labeling.
          (D) The term ``real-time supplement'' means a 
        supplement to an approved premarket application or 
        premarket report under section 515 that requests a 
        minor change to the device, such as a minor change to 
        the design of the device, software, sterilization, or 
        labeling, and for which the applicant has requested and 
        the agency has granted a meeting or similar forum to 
        jointly review and determine the status of the 
        supplement.
          (E) The term ``efficacy supplement'' means a 
        supplement to an approved premarket application under 
        section 351 of the Public Health Service Act that 
        requires substantive clinical data.
          (5) The term ``30-day notice'' means a notice under 
        section 515(d)(5) that is limited to a request to make 
        modifications to manufacturing procedures or methods of 
        manufacture affecting the safety and effectiveness of 
        the device.
          (6) The term ``request for classification 
        information'' means a request made under section 513(g) 
        for information respecting the class in which a device 
        has been classified or the requirements applicable to a 
        device.
          (7) The term ``annual fee'', for periodic reporting 
        concerning a class III device, means the annual fee 
        associated with periodic reports required by a 
        premarket application approval order.
          (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.
          (9) The term ``process for the review of device 
        applications'' means the following activities of the 
        Secretary with respect to the review of premarket 
        applications, premarket reports, supplements, [and 
        premarket notification submissions] premarket 
        notification submissions, and de novo classification 
        requests:
                  (A) The activities necessary for the review 
                of premarket applications, premarket reports, 
                supplements, and premarket notification 
                submissions.
                  (B) The issuance of action letters that allow 
                the marketing of devices or which set forth in 
                detail the specific deficiencies in such 
                applications, reports, supplements, or 
                submissions and, where appropriate, the actions 
                necessary to place them in condition for 
                approval.
                  (C) The inspection of manufacturing 
                establishments and other facilities undertaken 
                as part of the Secretary's review of pending 
                premarket applications, premarket reports, and 
                supplements.
                  (D) Monitoring of research conducted in 
                connection with the review of such 
                applications, reports, supplements, [and 
                submissions] submissions, and requests.
                  (E) Review of device applications subject to 
                section 351 of the Public Health Service Act 
                for an investigational new drug application 
                under section 505(i) or for an investigational 
                device exemption under section 520(g) and 
                activities conducted in anticipation of the 
                submission of such applications under section 
                505(i) or 520(g).
                  (F) The development of guidance, policy 
                documents, or regulations to improve the 
                process for the review of premarket 
                applications, premarket reports, supplements, 
                [and premarket notification submissions] 
                premarket notification submissions, and de novo 
                classification requests.
                  (G) The development of voluntary test 
                methods, consensus standards, or mandatory 
                performance standards under section 514 in 
                connection with the review of such 
                applications, reports, supplements, [or 
                submissions] submissions, or requests and 
                related activities.
                  (H) The provision of technical assistance to 
                device manufacturers in connection with the 
                submission of such applications, reports, 
                supplements, [or submissions] submissions, or 
                requests.
                  (I) Any activity undertaken under section 513 
                or 515(i) in connection with the initial 
                classification or reclassification of a device 
                or under section 515(b) in connection with any 
                requirement for approval of a device.
                  (J) Evaluation of postmarket studies required 
                as a condition of an approval of a premarket 
                application or premarket report under section 
                515 or a premarket application under section 
                351 of the Public Health Service Act.
                  (K) Compiling, developing, and reviewing 
                information on relevant devices to identify 
                safety and effectiveness issues for devices 
                subject to premarket applications, premarket 
                reports, supplements, [or premarket 
                notification submissions] premarket 
                notification submissions, or de novo 
                classification requests.
          (10) The term ``costs of resources allocated for the 
        process for the review of device applications'' means 
        the expenses in connection with the process for the 
        review of device applications for--
                  (A) officers and employees of the Food and 
                Drug Administration, contractors of the Food 
                and Drug Administration, advisory committees, 
                and costs related to such officers, employees, 
                and committees and to contracts with such 
                contractors;
                  (B) management of information, and the 
                acquisition, maintenance, and repair of 
                computer resources;
                  (C) leasing, maintenance, renovation, and 
                repair of facilities and acquisition, 
                maintenance, and repair of fixtures, furniture, 
                scientific equipment, and other necessary 
                materials and supplies; and
                  (D) collecting fees and accounting for 
                resources allocated for the review of premarket 
                applications, premarket reports, supplements, 
                submissions, and de novo classification 
                requests.
          (11) The term ``adjustment factor'' applicable to a 
        fiscal year is the Consumer Price Index for all urban 
        consumers (all items; United States city average) for 
        October of the preceding fiscal year divided by such 
        Index for October [2016] 2021.
          (12) The term ``person'' includes an affiliate 
        thereof.
          (13) The term ``affiliate'' means a business entity 
        that has a relationship with a second business entity 
        (whether domestic or international) if, directly or 
        indirectly--
                  (A) one business entity controls, or has the 
                power to control, the other business entity; or
                  (B) a third party controls, or has power to 
                control, both of the business entities.
          (14) The term ``establishment subject to a 
        registration fee'' means an establishment that is 
        registered (or is required to register) with the 
        Secretary under section 510 because such establishment 
        is engaged in the manufacture, preparation, 
        propagation, compounding, or processing of a device.

SEC. 738. AUTHORITY TO ASSESS AND USE DEVICE FEES.

  (a) Types of Fees.--
          (1) In general.--Beginning in [fiscal year 2018] 
        fiscal year 2023, the Secretary shall assess and 
        collect fees in accordance with this section.
          (2) Premarket application, premarket report, 
        supplement, and submission fee, and annual fee for 
        periodic reporting concerning a class iii device.--
                  (A) In general.--Except as provided in 
                subparagraph (B) and subsections (d) and (e) 
                each person who submits any of the following, 
                on or after [October 1, 2017] October 1, 2022, 
                shall be subject to a fee established under 
                subsection (c) for the fiscal year involved in 
                accordance with the following:
                          (i) A premarket application.
                          (ii) For a premarket report, a fee 
                        equal to the fee that applies under 
                        clause (i).
                          (iii) For a panel track supplement, a 
                        fee equal to [75 percent] 80 percent of 
                        the fee that applies under clause (i).
                          (iv) For a 180-day supplement, a fee 
                        equal to 15 percent of the fee that 
                        applies under clause (i).
                          (v) For a real-time supplement, a fee 
                        equal to 7 percent of the fee that 
                        applies under clause (i).
                          (vi) For a 30-day notice, a fee equal 
                        to 1.6 percent of the fee that applies 
                        under clause (i).
                          (vii) For an efficacy supplement, a 
                        fee equal to the fee that applies under 
                        clause (i).
                          (viii) For a premarket notification 
                        submission, a fee equal to [3.4 
                        percent] 4.5 percent of the fee that 
                        applies under clause (i).
                          (ix) For a request for classification 
                        information, a fee equal to 1.35 
                        percent of the fee that applies under 
                        clause (i).
                          (x) For periodic reporting concerning 
                        a class III device, an annual fee equal 
                        to 3.5 percent of the fee that applies 
                        under clause (i).
                          (xi) For a de novo classification 
                        request, a fee equal to 30 percent of 
                        the fee that applies under clause (i).
                  (B) Exceptions.--
                          (i) Humanitarian device exemption.--
                        An application under section 520(m) is 
                        not subject to any fee under 
                        subparagraph (A).
                          (ii) Further manufacturing use.--No 
                        fee shall be required under 
                        subparagraph (A) for the submission of 
                        a premarket application under section 
                        351 of the Public Health Service Act 
                        for a product licensed for further 
                        manufacturing use only.
                          (iii) State or federal government 
                        sponsors.--No fee shall be required 
                        under subparagraph (A) for a premarket 
                        application, premarket report, 
                        supplement, [or premarket notification 
                        submission] premarket notification 
                        submission, or de novo classification 
                        request submitted by a State or Federal 
                        Government entity unless the device 
                        involved is to be distributed 
                        commercially.
                          (iv) Premarket notifications by third 
                        parties.--No fee shall be required 
                        under subparagraph (A) for a premarket 
                        notification submission reviewed by an 
                        accredited person pursuant to section 
                        523.
                          (v) Pediatric conditions of use.--
                                  (I) In general.--No fee shall 
                                be required under subparagraph 
                                (A) for a premarket 
                                application, premarket report, 
                                premarket notification 
                                submission, or de novo 
                                classification request if the 
                                proposed conditions of use for 
                                the device involved are solely 
                                for a pediatric population. No 
                                fee shall be required under 
                                such subparagraph for a 
                                supplement if the sole purpose 
                                of the supplement is to propose 
                                conditions of use for a 
                                pediatric population.
                                  (II) Subsequent proposal of 
                                adult conditions of use.--In 
                                the case of a person who 
                                submits a premarket application 
                                or premarket report for which, 
                                under subclause (I), a fee 
                                under subparagraph (A) is not 
                                required, any supplement to 
                                such application that proposes 
                                conditions of use for any adult 
                                population is subject to the 
                                fee that applies under such 
                                subparagraph for a premarket 
                                application.
                  (C) Payment.--The fee required by 
                subparagraph (A) shall be due upon submission 
                of the premarket application, premarket report, 
                supplement, premarket notification submission, 
                30-day notice, request for classification 
                information, [or periodic reporting concerning 
                a class III device] periodic reporting 
                concerning a class III device, or de novo 
                classification request. Applicants submitting 
                portions of applications pursuant to section 
                515(c)(4) shall pay such fees upon submission 
                of the first portion of such applications.
                  (D) Refunds.--
                          (i) Application refused for filing.--
                        The Secretary shall refund 75 percent 
                        of the fee paid under subparagraph (A) 
                        for any application, report, or 
                        supplement that is refused for filing.
                          (ii) Application withdrawn before 
                        filing.--The Secretary shall refund 75 
                        percent of the fee paid under 
                        subparagraph (A) for any application, 
                        report, or supplement that is withdrawn 
                        prior to the filing decision of the 
                        Secretary.
                          (iii) Application withdrawn before 
                        first action.--After receipt of a 
                        request for a refund of the fee paid 
                        under subparagraph (A) for a premarket 
                        application, premarket report, or 
                        supplement that is withdrawn after 
                        filing but before a first action, the 
                        Secretary may return some or all of the 
                        fee. The amount of refund, if any, 
                        shall be based on the level of effort 
                        already expended on the review of such 
                        application, report, or supplement.
                          (iv) Modular applications withdrawn 
                        before first action.--The Secretary 
                        shall refund 75 percent of the 
                        application fee paid for an application 
                        submitted under section 515(c)(4) that 
                        is withdrawn before a second portion is 
                        submitted and before a first action on 
                        the first portion.
                          (v) Later withdrawn modular 
                        applications.--If an application 
                        submitted under section 515(c)(4) is 
                        withdrawn after a second or subsequent 
                        portion is submitted but before any 
                        first action, the Secretary may return 
                        a portion of the fee. The amount of 
                        refund, if any, shall be based on the 
                        level of effort already expended on the 
                        review of the portions submitted.
                          (vi) Sole discretion to refund.--The 
                        Secretary shall have sole discretion to 
                        refund a fee or portion of the fee 
                        under clause (iii) or (v). A 
                        determination by the Secretary 
                        concerning a refund under clause (iii) 
                        or (v) shall not be reviewable.
          (3) Annual establishment registration fee.--
                  (A) In general.--Except as provided in 
                subparagraph (B), each establishment subject to 
                a registration fee shall be subject to a fee 
                for each initial or annual registration under 
                section 510 beginning with its registration for 
                fiscal year 2008.
                  (B) Exception.--No fee shall be required 
                under subparagraph (A) for an establishment 
                operated by a State or Federal governmental 
                entity or an Indian tribe (as defined in the 
                Indian Self Determination and Educational 
                Assistance Act), unless a device manufactured 
                by the establishment is to be distributed 
                commercially.
                  (C) Payment.--The fee required under 
                subparagraph (A) shall be due once each fiscal 
                year, upon the later of--
                          (i) the initial or annual 
                        registration (as applicable) of the 
                        establishment under section 510; 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 year under 
                        this section.
  (b) Fee Amounts.--
          (1) In general.--Subject to subsections (c), (d), 
        (e), and (h), for each of fiscal years [2018 through 
        2022] 2023 through 2027, 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:


----------------------------------------------------------------------------------------------------------------
                                                             Fiscal     Fiscal     Fiscal     Fiscal     Fiscal
                        [Fee Type                          Year 2018  Year 2019  Year 2020  Year 2021  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]
----------------------------------------------------------------------------------------------------------------

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


----------------------------------------------------------------------------------------------------------------
                                                             Fiscal     Fiscal     Fiscal     Fiscal     Fiscal
                         Fee Type                          Year 2023  Year 2024  Year 2025  Year 2026  Year 2027
----------------------------------------------------------------------------------------------------------------
Premarket Application....................................   $425,000   $435,000   $445,000   $455,000   $470,000
Establishment Registration...............................     $6,250     $6,875     $7,100     $7,575     $8,465
----------------------------------------------------------------------------------------------------------------

          [(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.]
          (3) Total revenue amounts specified.--For purposes of 
        paragraph (1), the total revenue amounts specified in 
        this paragraph are as follows:
                  (A) $312,606,000 for fiscal year 2023.
                  (B) $335,750,000 for fiscal year 2024.
                  (C) $350,746,400 for fiscal year 2025.
                  (D) $366,486,300 for fiscal year 2026.
                  (E) $418,343,000 for fiscal year 2027.
  (c) Annual Fee Setting; Adjustments.--
          (1) In general.--The Secretary shall, 60 days before 
        the start of each fiscal year after September 30, 
        [2017] 2022, establish fees under subsection (a), based 
        on amounts specified under subsection (b) and the 
        adjustments provided under this subsection, and publish 
        such fees, and the rationale for any adjustments to 
        such fees, in the Federal Register.
          (2) Inflation adjustments.--
                  (A) Adjustment to total revenue amounts.--For 
                fiscal year [2018] 2023 and each subsequent 
                fiscal year, the Secretary shall adjust the 
                total revenue amount specified in subsection 
                (b)(3) for such fiscal year by multiplying such 
                amount by the applicable inflation adjustment 
                under subparagraph (B) for such year.
                  (B) Applicable inflation adjustment.--The 
                applicable inflation adjustment for [fiscal 
                year 2018] fiscal year 2023 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] fiscal year 
                        2022.
                  (C) Base inflation adjustment.--
                          (i) In general.--Subject to further 
                        adjustment under clause (ii), the base 
                        inflation adjustment for a fiscal year 
                        is the sum of one plus--
                                  (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 0.60; and
                                  (II) the average annual 
                                percent change that occurred in 
                                the Consumer Price Index for 
                                urban consumers ([Washington-
                                Baltimore, DC-MD-VA-WV] 
                                Washington-Arlington-
                                Alexandria, DC-VA-MD-WV; Not 
                                Seasonally Adjusted; All items; 
                                Annual Index) for the first 3 
                                years of the preceding 4 years 
                                of available data multiplied by 
                                0.40.
                          (ii) Limitations.--For purposes of 
                        subparagraph (B), if the base inflation 
                        adjustment for a fiscal year under 
                        clause (i)--
                                  (I) is less than 1, such 
                                adjustment shall be considered 
                                to be equal to 1; or
                                  (II) is greater than 1.04, 
                                such adjustment shall be 
                                considered to be equal to 1.04.
                  (D) Adjustment to base fee amounts.--For each 
                of [fiscal years 2018 through 2022] fiscal 
                years 2023 through 2027, 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).
          (3) Volume-based adjustments to establishment 
        registration base fees.--For each of fiscal years [2018 
        through 2022] 2023 through 2027, after the base fee 
        amounts specified in subsection (b)(2) are adjusted 
        under paragraph (2)(D), the base establishment 
        registration fee amounts specified in such subsection 
        shall be increased, as the Secretary estimates is 
        necessary in order for total fee collections for such 
        fiscal year to generate the total revenue amounts, as 
        adjusted under paragraph (2).
          (4) Performance improvement adjustment.--
                  (A) In general.--For each of fiscal years 
                2025 through 2027, after the adjustments under 
                paragraphs (2) and (3), the base establishment 
                registration fee amounts for such fiscal year 
                shall be increased to reflect changes in the 
                resource needs of the Secretary due to improved 
                review performance goals for the process for 
                the review of device applications identified in 
                the letters described in section 201(b) of the 
                Medical Device User Fee Amendments of 2022, as 
                the Secretary determines necessary to achieve 
                an increase in total fee collections for such 
                fiscal year equal to the following amounts:
                          (i) For fiscal year 2025, the product 
                        of--
                                  (I) the amount determined 
                                under subparagraph (B)(i)(I); 
                                and
                                  (II) the applicable inflation 
                                adjustment under paragraph 
                                (2)(B) for such fiscal year.
                          (ii) For fiscal year 2026, the 
                        product of--
                                  (I) the sum of the amounts 
                                determined under subparagraphs 
                                (B)(i)(II), (B)(ii)(I), and 
                                (B)(iii)(I); and
                                  (II) the applicable inflation 
                                adjustment under paragraph 
                                (2)(B) for such fiscal year.
                          (iii) For fiscal year 2027, the 
                        product of--
                                  (I) the sum of the amounts 
                                determined under subparagraphs 
                                (B)(i)(III), (B)(ii)(II), and 
                                (B)(iii)(II); and
                                  (II) the applicable inflation 
                                adjustment under paragraph 
                                (2)(B) for such fiscal year.
                  (B) Amounts.--
                          (i) Pre-submission amount.--For 
                        purposes of subparagraph (A), with 
                        respect to the pre-submission written 
                        feedback goal, the amounts determined 
                        under this subparagraph are as follows:
                                  (I) For fiscal year 2025, 
                                $15,396,600 if such goal for 
                                fiscal year 2023 is met.
                                  (II) For fiscal year 2026:
                                          (aa) $15,396,600 if 
                                        such goal for fiscal 
                                        year 2023 is met and 
                                        such goal for fiscal 
                                        year 2024 is not met.
                                          (bb) $36,792,200 if 
                                        such goal for fiscal 
                                        year 2024 is met.
                                  (III) For fiscal year 2027:
                                          (aa) $15,396,600 if 
                                        such goal for fiscal 
                                        year 2023 is met and 
                                        such goal for each of 
                                        fiscal years 2024 and 
                                        2025 is not met.
                                          (bb) $36,792,200 if 
                                        such goal for fiscal 
                                        year 2024 is met and 
                                        such goal for fiscal 
                                        year 2025 is not met.
                                          (cc) $40,572,600 if 
                                        such goal for fiscal 
                                        year 2025 is met.
                          (ii) De novo classification amount.--
                        For purposes of subparagraph (A), with 
                        respect to the de novo decision goal, 
                        the amounts determined under this 
                        subparagraph are as follows:
                                  (I) For fiscal year 2026, 
                                $6,323,500 if such goal for 
                                fiscal year 2023 is met.
                                  (II) For fiscal year 2027:
                                          (aa) $6,323,500 if 
                                        such goal for fiscal 
                                        year 2023 is met and 
                                        such goal for fiscal 
                                        year 2024 is not met.
                                          (bb) $11,765,400 if 
                                        such goal for fiscal 
                                        year 2024 is met.
                          (iii) Premarket notification and 
                        premarket approval amount.--For 
                        purposes of subparagraph (A), with 
                        respect to the 510(k) decision goal, 
                        510(k) shared outcome total time to 
                        decision goal, PMA decision goal, and 
                        PMA shared outcome total time to 
                        decision goal, the amounts determined 
                        under this subparagraph are as follows:
                                  (I) For fiscal year 2026, 
                                $1,020,000 if the four goals 
                                for fiscal year 2023 are met.
                                  (II) For fiscal year 2027:
                                          (aa) $1,020,000 if 
                                        the four goals for 
                                        fiscal year 2023 are 
                                        met and one or more of 
                                        the four goals for 
                                        fiscal year 2024 are 
                                        not met.
                                          (bb) $3,906,000 if 
                                        the four goals for 
                                        fiscal year 2024 are 
                                        met.
                  (C) Performance calculation.--For purposes of 
                this paragraph, performance of the goals listed 
                in subparagraph (D) shall be determined as 
                specified in the letters described in section 
                201(b) of the Medical Device User Fee 
                Amendments of 2022 and based on data available 
                as of the following dates:
                          (i) The performance of the pre-
                        submission written feedback goal shall 
                        be based on data available as of--
                                  (I) for fiscal year 2023, 
                                March 31, 2024;
                                  (II) for fiscal year 2024, 
                                March 31, 2025; and
                                  (III) for fiscal year 2025, 
                                March 31, 2026.
                          (ii) The performance of the de novo 
                        decision goal, 510(k) decision goal, 
                        510(k) shared outcome total time to 
                        decision goal, PMA decision goal, and 
                        PMA shared outcome total time to 
                        decision goal shall be based on data 
                        available as of--
                                  (I) for fiscal year 2023, 
                                March 31, 2025; and
                                  (II) for fiscal year 2024, 
                                March 31, 2026.
                  (D) Goals defined.--For purposes of this 
                paragraph, the terms ``pre-submission written 
                feedback goal'', ``de novo decision goal'', 
                ``510(k) decision goal'', ``510(k) shared 
                outcome total time to decision goal'', ``PMA 
                decision goal'', and ``PMA shared outcome total 
                time to decision goal'' refer to the goals 
                identified by the same names in the letters 
                described in section 201(b) of the Medical 
                Device User Fee Amendments of 2022.
          (5) Hiring adjustment.--
                  (A) In general.--For each of fiscal years 
                2025 through 2027, after the adjustments under 
                paragraphs (2), (3), and (4), if applicable, if 
                the number of hires to support the process for 
                the review of device applications falls below 
                the thresholds specified in subparagraph (B) 
                for the applicable fiscal years, the base 
                establishment registration fee amounts shall be 
                decreased as the Secretary determines necessary 
                to achieve a reduction in total fee collections 
                equal to the hiring adjustment amount under 
                subparagraph (C).
                  (B) Thresholds.--The thresholds specified in 
                this subparagraph are as follows:
                          (i) For fiscal year 2025, the 
                        threshold is 123 hires for fiscal year 
                        2023.
                          (ii) For fiscal year 2026, the 
                        threshold is 38 hires for fiscal year 
                        2024.
                          (iii) For fiscal year 2027, the 
                        threshold is--
                                  (I) 22 hires for fiscal year 
                                2025 if the base establishment 
                                registration fees are not 
                                increased by the amount 
                                determined under paragraph 
                                (4)(A)(i); or
                                  (II) 75 hires for fiscal year 
                                2025 if such fees are so 
                                increased.
                  (C) Hiring adjustment amount.--The hiring 
                adjustment amount for fiscal year 2025 and each 
                subsequent fiscal year is the product of--
                          (i) the number of hires by which the 
                        hiring goal specified in subparagraph 
                        (D) for the fiscal year before the 
                        prior fiscal year was not met;
                          (ii) $72,877; and
                          (iii) the applicable inflation 
                        adjustment under paragraph (2)(B) for 
                        the fiscal year for which the hiring 
                        goal was not met.
                  (D) Hiring goals.--The hiring goals for each 
                of fiscal years 2023 through 2025 are as 
                follows:
                          (i) For fiscal year 2023, 144 hires.
                          (ii) For fiscal year 2024, 42 hires.
                          (iii) For fiscal year 2025:
                                  (I) 24 hires if the base 
                                establishment registration fees 
                                are not increased by the amount 
                                determined under paragraph 
                                (4)(A)(i).
                                  (II) 83 hires if the base 
                                establishment registration fees 
                                are increased by the amount 
                                determined under paragraph 
                                (4)(A)(i).
                  (E) Number of hires.--For purposes of this 
                paragraph, the number of hires shall be 
                determined by the Secretary as set forth in the 
                letters described in section 201(b) of the 
                Medical Device User Fee Amendments of 2022.
          (6) Operating reserve adjustment.--
                  (A) In general.--For each of fiscal years 
                2023 through 2027, after the adjustments under 
                paragraphs (2), (3), (4), and (5), if 
                applicable, if the Secretary has operating 
                reserves of carryover user fees for the process 
                for the review of device applications in excess 
                of the designated amount in subparagraph (B), 
                the Secretary shall decrease the base 
                establishment registration fee amounts to 
                provide for not more than such designated 
                amount of operating reserves.
                  (B) Designated amount.--Subject to 
                subparagraph (C), for each fiscal year, the 
                designated amount in this subparagraph is equal 
                to the sum of--
                          (i) 13 weeks of operating reserves of 
                        carryover user fees; and
                          (ii) 1 month of operating reserves 
                        maintained pursuant to paragraph (8).
                  (C) Excluded amount.--For the period of 
                fiscal years 2023 through 2026, a total amount 
                equal to $118,000,000 shall not be considered 
                part of the designated amount under 
                subparagraph (B) and shall not be subject to 
                the decrease under subparagraph (A).
          [(4)] (7) 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 device applications.
          [(5)] (8) Supplement.--
                  (A) In general.--The Secretary may use 
                unobligated carryover balances from fees 
                collected in previous fiscal years to ensure 
                that sufficient fee revenues are available in 
                that fiscal year, so long as the Secretary 
                maintains unobligated carryover balances of not 
                less than 1 month of operating reserves for the 
                first month of the next fiscal year.
                  (B) Notice to congress.--Not later than 14 
                days before the Secretary anticipates the use 
                of funds described in subparagraph (A), the 
                Secretary shall provide notice to the Committee 
                on Health, Education, Labor, and Pensions and 
                the Committee on Appropriations of the Senate 
                and the Committee on Energy and Commerce and 
                the Committee on Appropriations of the House of 
                Representatives.
  (d) Small Businesses; Fee Waiver and Fee Reduction Regarding 
Premarket Approval Fees.--
          (1) In general.--The Secretary shall grant a waiver 
        of the fee required under subsection (a) for one 
        premarket application, or one premarket report, where 
        the Secretary finds that the applicant involved is a 
        small business submitting its first premarket 
        application to the Secretary, or its first premarket 
        report, respectively, for review. For the purposes of 
        this paragraph, the term ``small business'' means an 
        entity that reported $30,000,000 or less of gross 
        receipts or sales in its most recent Federal income tax 
        return for a taxable year, including such returns of 
        all of its affiliates. In addition, for subsequent 
        premarket applications, premarket reports, and 
        supplements where the Secretary finds that the 
        applicant involved is a small business, the fees 
        specified in clauses (i) through (vii) and clauses 
        (ix), (x), and (xi) of subsection (a)(2)(A) may be paid 
        at a reduced rate in accordance with paragraph (2)(C).
          (2) Rules relating to premarket approval fees.--
                  (A) Definition.--For purposes of this 
                paragraph, the term ``small business'' means an 
                entity that reported $100,000,000 or less of 
                gross receipts or sales in its most recent 
                Federal income tax return for a taxable year, 
                including such returns of all of its 
                affiliates.
                  (B) Evidence of qualification.--
                          (i) In general.--An applicant shall 
                        pay the higher fees established by the 
                        Secretary each year unless the 
                        applicant submits evidence that it 
                        qualifies for a waiver of the fee or 
                        the lower fee rate.
                          (ii) Firms submitting tax returns to 
                        the united states internal revenue 
                        service.--The applicant shall support 
                        its claim that it meets the definition 
                        under subparagraph (A) by submission of 
                        a copy of its most recent Federal 
                        income tax return for a taxable year, 
                        and a copy of such returns of its 
                        affiliates, which show an amount of 
                        gross sales or receipts that is less 
                        than the maximum established in 
                        subparagraph (A). The applicant, and 
                        each of such affiliates, shall certify 
                        that the information provided is a true 
                        and accurate copy of the actual tax 
                        forms they submitted to the Internal 
                        Revenue Service. If no tax forms are 
                        submitted for any affiliate, the 
                        applicant shall certify that the 
                        applicant has no affiliates.
                          (iii) Firms not submitting tax 
                        returns to the united states internal 
                        revenue service.--In the case of an 
                        applicant that has not previously 
                        submitted a Federal income tax return, 
                        the applicant and each of its 
                        affiliates shall demonstrate that it 
                        meets the definition under subparagraph 
                        (A) by submission of a signed 
                        certification, in such form as the 
                        Secretary may direct through a notice 
                        published in the Federal Register, that 
                        the applicant or affiliate meets the 
                        criteria for a small business and a 
                        certification, in English, from the 
                        national taxing authority, if extant, 
                        of the country in which the applicant 
                        or, if applicable, affiliate is 
                        headquartered. The certification from 
                        such taxing authority shall bear the 
                        official seal of such taxing authority 
                        and shall provide the applicant's or 
                        affiliate's gross receipts or sales for 
                        the most recent year in both the local 
                        currency of such country and in United 
                        States dollars, the exchange rate used 
                        in converting such local currency to 
                        dollars, and the dates during which 
                        these receipts or sales were collected. 
                        The applicant shall also submit a 
                        statement signed by the head of the 
                        applicant's firm or by its chief 
                        financial officer that the applicant 
                        has submitted certifications for all of 
                        its affiliates, or that the applicant 
                        has no affiliates.
                  (C) Reduced fees.--Where the Secretary finds 
                that the applicant involved meets the 
                definition under subparagraph (A), the fees 
                established under subsection (c)(1) may be paid 
                at a reduced rate of--
                          (i) 25 percent of the fee established 
                        under such subsection for a premarket 
                        application, a premarket report, a 
                        supplement, periodic reporting 
                        concerning a class III device, or a de 
                        novo classification request; and
                          (ii) 50 percent of the fee 
                        established under such subsection for a 
                        30-day notice or a request for 
                        classification information.
                  (D) Request for fee waiver or reduction.--An 
                applicant seeking a fee waiver or reduction 
                under this subsection shall submit supporting 
                information to the Secretary at least 60 days 
                before the fee is required pursuant to 
                subsection (a). The decision of the Secretary 
                regarding whether an entity qualifies for such 
                a waiver or reduction is not reviewable.
  (e) Small Businesses; Fee Reduction Regarding Premarket 
Notification Submissions.--
          (1) In general.--For fiscal year 2008 and each 
        subsequent fiscal year, where the Secretary finds that 
        the applicant involved is a small business, the fee 
        specified in subsection (a)(2)(A)(viii) may be paid at 
        a reduced rate in accordance with paragraph (2)(C).
          (2) Rules relating to premarket notification 
        submissions.--
                  (A) Definition.--For purposes of this 
                subsection, the term ``small business'' means 
                an entity that reported $100,000,000 or less of 
                gross receipts or sales in its most recent 
                Federal income tax return for a taxable year, 
                including such returns of all of its 
                affiliates.
                  (B) Evidence of qualification.--
                          (i) In general.--An applicant shall 
                        pay the higher fees established by the 
                        Secretary each year unless the 
                        applicant submits evidence that it 
                        qualifies for the lower fee rate.
                          (ii) Firms submitting tax returns to 
                        the united states internal revenue 
                        service.--The applicant shall support 
                        its claim that it meets the definition 
                        under subparagraph (A) by submission of 
                        a copy of its most recent Federal 
                        income tax return for a taxable year, 
                        and a copy of such returns of its 
                        affiliates, which show an amount of 
                        gross sales or receipts that is less 
                        than the maximum established in 
                        subparagraph (A). The applicant, and 
                        each of such affiliates, shall certify 
                        that the information provided is a true 
                        and accurate copy of the actual tax 
                        forms they submitted to the Internal 
                        Revenue Service. If no tax forms are 
                        submitted for any affiliate, the 
                        applicant shall certify that the 
                        applicant has no affiliates.
                          (iii) Firms not submitting tax 
                        returns to the united states internal 
                        revenue service.--In the case of an 
                        applicant that has not previously 
                        submitted a Federal income tax return, 
                        the applicant and each of its 
                        affiliates shall demonstrate that it 
                        meets the definition under subparagraph 
                        (A) by submission of a signed 
                        certification, in such form as the 
                        Secretary may direct through a notice 
                        published in the Federal Register, that 
                        the applicant or affiliate meets the 
                        criteria for a small business and a 
                        certification, in English, from the 
                        national taxing authority, if extant, 
                        of the country in which the applicant 
                        or, if applicable, affiliate is 
                        headquartered. The certification from 
                        such taxing authority shall bear the 
                        official seal of such taxing authority 
                        and shall provide the applicant's or 
                        affiliate's gross receipts or sales for 
                        the most recent year in both the local 
                        currency of such country and in United 
                        States dollars, the exchange rate used 
                        in converting such local currency to 
                        dollars, and the dates during which 
                        these receipts or sales were collected. 
                        The applicant shall also submit a 
                        statement signed by the head of the 
                        applicant's firm or by its chief 
                        financial officer that the applicant 
                        has submitted certifications for all of 
                        its affiliates, or that the applicant 
                        has no affiliates.
                  (C) Reduced fees.--For fiscal year 2008 and 
                each subsequent fiscal year, where the 
                Secretary finds that the applicant involved 
                meets the definition under subparagraph (A), 
                the fee for a premarket notification submission 
                may be paid at 25 percent of the fee that 
                applies under subsection (a)(2)(A)(viii), and 
                as established under subsection (c)(1).
                  (D) Request for reduction.--An applicant 
                seeking a fee reduction under this subsection 
                shall submit supporting information to the 
                Secretary at least 60 days before the fee is 
                required pursuant to subsection (a). The 
                decision of the Secretary regarding whether an 
                entity qualifies for such a reduction is not 
                reviewable.
  (f) Effect of Failure To Pay Fees.--
          (1) No acceptance of submissions.--A premarket 
        application, premarket report, supplement, premarket 
        notification submission, 30-day notice, request for 
        classification information, periodic reporting 
        concerning a class III device, or de novo 
        classification request submitted by a person subject to 
        fees under subsections (a)(2) and (a)(3) shall be 
        considered incomplete and shall not be accepted by the 
        Secretary until all such fees owed by such person have 
        been paid.
          (2) No registration.--Registration information 
        submitted under section 510 by an establishment subject 
        to a registration fee shall be considered incomplete 
        and shall not be accepted by the Secretary until the 
        registration fee under subsection (a)(3) owed for the 
        establishment has been paid. Until the fee is paid and 
        the registration is complete, the establishment is 
        deemed to have failed to register in accordance with 
        section 510.
  (g) Conditions.--
          (1) Performance goals; termination of program.--With 
        respect to the amount that, under the salaries and 
        expenses account of the Food and Drug Administration, 
        is appropriated for a fiscal year for devices and 
        radiological products, fees may not be assessed under 
        subsection (a) for the fiscal year, and the Secretary 
        is not expected to meet any performance goals 
        identified for the fiscal year, if--
                  (A) the amount so appropriated for the fiscal 
                year, excluding the amount of fees appropriated 
                for the fiscal year, is more than 1 percent 
                less than [$320,825,000] $398,566,000 
                multiplied by the adjustment factor applicable 
                to such fiscal year; or
                  (B) fees were not assessed under subsection 
                (a) for the previous fiscal year.
          (2) Authority.--If the Secretary does not assess fees 
        under subsection (a) during any portion of a fiscal 
        year because of paragraph (1) and if at a later date in 
        such fiscal year the Secretary may assess such fees, 
        the Secretary may assess and collect such fees, without 
        any modification in the rate for premarket 
        applications, supplements, premarket reports, premarket 
        notification submissions, 30-day notices, requests for 
        classification information, periodic reporting 
        concerning a class III device, de novo classification 
        requests, and establishment registrations at any time 
        in such fiscal year, notwithstanding the provisions of 
        subsection (a) relating to the date fees are to be 
        paid.
          (3) Limitation.--Beginning on October 1, 2023, the 
        authorities under section 737(9)(C) shall include only 
        leasing and necessary scientific equipment.
  (h) Crediting and Availability of Fees.--
          (1) In general.--Subject to paragraph (2)(C), fees 
        authorized under subsection (a) shall be collected and 
        available for obligation only to the extent and in the 
        amount provided in advance in appropriation Acts. Such 
        fees are authorized to be appropriated to remain 
        available until expended. Such sums as may be necessary 
        may be transferred from the Food and Drug 
        Administration salaries and expenses appropriation 
        account without fiscal year limitation to such 
        appropriation account for salaries and expenses with 
        such fiscal year limitation. The sums transferred shall 
        be available solely for the process for the review of 
        device applications.
          (2) Collections and appropriation acts.--
                  (A) In general.--The fees authorized by this 
                section--
                          (i) subject to subparagraph (C), 
                        shall be collected and available in 
                        each fiscal year in an amount not to 
                        exceed the amount specified in 
                        appropriation Acts, or otherwise made 
                        available for obligation, for such 
                        fiscal year, and
                          (ii) shall be available to defray 
                        increases in the costs of the resources 
                        allocated for the process for the 
                        review of device applications 
                        (including increases in such costs for 
                        an additional number of full-time 
                        equivalent positions in the Department 
                        of Health and Human Services to be 
                        engaged in such process) over such 
                        costs, excluding costs paid from fees 
                        collected under this section, for 
                        fiscal year 2009 multiplied by the 
                        adjustment factor.
                  (B) Compliance.--
                          (i) In general.--The Secretary shall 
                        be considered to have met the 
                        requirements of subparagraph (A)(ii) in 
                        any fiscal year if the costs funded by 
                        appropriations and allocated for the 
                        process for the review of device 
                        applications--
                          (I) are not more than 3 percent below 
                        the level specified in subparagraph 
                        (A)(ii); or
                          (II)(aa) are more than 3 percent 
                        below the level specified in 
                        subparagraph (A)(ii), and fees assessed 
                        for a subsequent fiscal year are 
                        decreased by the amount in excess of 3 
                        percent by which such costs fell below 
                        the level specified in such 
                        subparagraph; and
                          (bb) such costs are not more than 5 
                        percent below the level specified in 
                        such subparagraph.
                          (ii) More than 5 percent.--To the 
                        extent such costs are more than 5 
                        percent below the specified level in 
                        subparagraph (A)(ii), fees may not be 
                        collected under this section for that 
                        fiscal year.
                  (C) Provision for early payments.--Payment of 
                fees authorized under this section for a fiscal 
                year, prior to the due date for such fees, may 
                be accepted by the Secretary in accordance with 
                authority provided in advance in a prior year 
                appropriations Act.
          [(3) Authorizations of appropriations.--For each of 
        the fiscal years 2018 through 2022, there is authorized 
        to be appropriated for fees under this section an 
        amount equal to the total revenue amount specified 
        under subsection (b)(3) for the fiscal year, as 
        adjusted under subsection (c).]
          (3) Authorization of appropriations.--
                  (A) In general.--For each of fiscal years 
                2023 through 2027, there is authorized to be 
                appropriated for fees under this section an 
                amount equal to the revenue amount determined 
                under subparagraph (B), less the amount of 
                reductions determined under subparagraph (C).
                  (B) Revenue amount.--For purposes of this 
                paragraph, the revenue amount for each fiscal 
                year is the sum of--
                          (i) the total revenue amount under 
                        subsection (b)(3) for the fiscal year, 
                        as adjusted under paragraphs (2) and 
                        (3) of subsection (c); and
                          (ii) the performance improvement 
                        adjustment amount for the fiscal year 
                        under subsection (c)(4), if applicable.
                  (C) Reductions.--For purposes of this 
                paragraph, the amount of reductions for each 
                fiscal year is the sum of--
                          (i) the hiring adjustment amount for 
                        the fiscal year under subsection 
                        (c)(5), if applicable; and
                          (ii) the operating reserve adjustment 
                        amount for the fiscal year under 
                        subsection (c)(6), if applicable.
  (i) Collection of Unpaid Fees.--In any case where the 
Secretary does not receive payment of a fee assessed under 
subsection (a) within 30 days after it is due, such fee shall 
be treated as a claim of the United States Government subject 
to subchapter II of chapter 37 of title 31, United States Code.
  (j) Written Requests for Refunds.--To qualify for 
consideration for a refund under subsection (a)(2)(D), a person 
shall submit to the Secretary a written request for such refund 
not later than 180 days after such fee is due.
  (k) Construction.--This section may not be construed to 
require that the number of full-time equivalent positions in 
the Department of Health and Human Services, for officers, 
employees, and advisory committees not engaged in the process 
of the review of device applications, be reduced to offset the 
number of officers, employees, and advisory committees so 
engaged.

SEC. 738A. REAUTHORIZATION; REPORTING REQUIREMENTS.

  (a) Reports.--
          (1) Performance report.--
                          (A) In general.--
                                  (i) General requirements.--
                                Beginning with [fiscal year 
                                2018] fiscal year 2023, for 
                                each fiscal year for which fees 
                                are collected under this part, 
                                the Secretary shall prepare and 
                                submit to the Committee on 
                                Health, Education, Labor, and 
                                Pensions of the Senate and the 
                                Committee on Energy and 
                                Commerce of the House of 
                                Representatives annual reports 
                                concerning the progress of the 
                                Food and Drug Administration in 
                                achieving the goals identified 
                                in the letters described in 
                                section 201(b) of the [Medical 
                                Device User Fee Amendments of 
                                2017] Medical Device User Fee 
                                Amendments of 2022 during such 
                                fiscal year and the future 
                                plans of the Food and Drug 
                                Administration for meeting the 
                                goals.
                                  (ii) Additional 
                                information.--Beginning with 
                                [fiscal year 2018] fiscal year 
                                2023, the annual report under 
                                this subparagraph shall include 
                                the progress of the Center for 
                                Devices and Radiological Health 
                                in achieving the goals, and 
                                future plans for meeting the 
                                goals, including--
                                          (I) the number of 
                                        premarket applications 
                                        filed under section 515 
                                        per fiscal year for 
                                        each review division;
                                          (II) the number of 
                                        reports submitted under 
                                        section 510(k) per 
                                        fiscal year for each 
                                        review division; and
                                          (III) the number of 
                                        expedited development 
                                        and priority review 
                                        designations under 
                                        section 515C per fiscal 
                                        year.
                                  (iii) Real time reporting.--
                                          (I) In general.--Not 
                                        later than 30 calendar 
                                        days after the end of 
                                        the second quarter of 
                                        [fiscal year 2018] 
                                        fiscal year 2023, and 
                                        not later than 30 
                                        calendar days after the 
                                        end of each quarter of 
                                        each fiscal year 
                                        thereafter, the 
                                        Secretary shall post 
                                        the data described in 
                                        subclause (II) on the 
                                        internet website of the 
                                        Food and Drug 
                                        Administration for such 
                                        quarter and on a 
                                        cumulative basis for 
                                        such fiscal year, and 
                                        may remove duplicative 
                                        data from the annual 
                                        report under this 
                                        subparagraph.
                                          (II) Data.--The 
                                        Secretary shall post 
                                        the following data in 
                                        accordance with 
                                        subclause (I):
                                                  (aa) The 
                                                number and 
                                                titles of draft 
                                                and final 
                                                guidance on 
                                                topics related 
                                                to the process 
                                                for the review 
                                                of devices, and 
                                                whether such 
                                                guidances were 
                                                issued as 
                                                required by 
                                                statute or 
                                                pursuant to the 
                                                letters 
                                                described in 
                                                section 201(b) 
                                                of the [Medical 
                                                Device User Fee 
                                                Amendments of 
                                                2017] Medical 
                                                Device User Fee 
                                                Amendments of 
                                                2022; and
                                                  (bb) The 
                                                number and 
                                                titles of 
                                                public meetings 
                                                held on topics 
                                                related to the 
                                                process for the 
                                                review of 
                                                devices, and if 
                                                such meetings 
                                                were required 
                                                by statute or 
                                                pursuant to a 
                                                commitment 
                                                under the 
                                                letters 
                                                described in 
                                                section 201(b) 
                                                of the [Medical 
                                                Device User Fee 
                                                Amendments of 
                                                2017] Medical 
                                                Device User Fee 
                                                Amendments of 
                                                2022.
                                  (iv) Rationale for mdufa 
                                program changes.--Beginning 
                                with [fiscal year 2020] fiscal 
                                year 2023, the Secretary shall 
                                include in the annual report 
                                under paragraph (1)--
                                          (I) data, analysis, 
                                        and discussion of the 
                                        changes in the number 
                                        of full-time 
                                        equivalents hired as 
                                        agreed upon in the 
                                        letters described in 
                                        section 201(b) of the 
                                        [Medical Device User 
                                        Fee Amendments of 2017] 
                                        Medical Device User Fee 
                                        Amendments of 2022 and 
                                        the number of full time 
                                        equivalents funded by 
                                        budget authority at the 
                                        Food and Drug 
                                        Administration by each 
                                        division within the 
                                        Center for Devices and 
                                        Radiological Health, 
                                        the Center for 
                                        Biologics Evaluation 
                                        and Research, the 
                                        Office of Regulatory 
                                        Affairs, and the Office 
                                        of the Commissioner;
                                          (II) data, analysis, 
                                        and discussion of the 
                                        changes in the fee 
                                        revenue amounts and 
                                        costs for the process 
                                        for the review of 
                                        devices, including 
                                        identifying drivers of 
                                        such changes; and
                                          (III) for each of the 
                                        Center for Devices and 
                                        Radiological Health, 
                                        the Center for 
                                        Biologics Evaluation 
                                        and Research, the 
                                        Office of Regulatory 
                                        Affairs, and the Office 
                                        of the Commissioner, 
                                        the number of employees 
                                        for whom time reporting 
                                        is required and the 
                                        number of employees for 
                                        whom time reporting is 
                                        not required.
                                  [(iv)] (v) Analysis.--For 
                                each fiscal year, the Secretary 
                                shall include in the report 
                                under clause (i) an analysis of 
                                the following:
                                          (I) The difference 
                                        between the aggregate 
                                        number of premarket 
                                        applications filed 
                                        under section 515 and 
                                        aggregate reports 
                                        submitted under section 
                                        510(k) and the 
                                        aggregate number of 
                                        major deficiency 
                                        letters, not approvable 
                                        letters, and denials 
                                        for such applications 
                                        issued by the agency, 
                                        accounting for--
                                                  (aa) the 
                                                number of 
                                                applications 
                                                filed and 
                                                reports 
                                                submitted 
                                                during one 
                                                fiscal year for 
                                                which a 
                                                decision is not 
                                                scheduled to be 
                                                made until the 
                                                following 
                                                fiscal year; 
                                                and
                                                  (bb) the 
                                                aggregate 
                                                number of 
                                                applications 
                                                for each fiscal 
                                                year that did 
                                                not meet the 
                                                goals as 
                                                identified by 
                                                the letters 
                                                described in 
                                                section 201(b) 
                                                of the [Medical 
                                                Device User Fee 
                                                Amendments of 
                                                2017] Medical 
                                                Device User Fee 
                                                Amendments of 
                                                2022 for the 
                                                applicable 
                                                fiscal year.
                                          (II) Relevant data to 
                                        determine whether the 
                                        Center for Devices and 
                                        Radiological Health has 
                                        met performance 
                                        enhancement goals 
                                        identified by the 
                                        letters described in 
                                        section 201(b) of the 
                                        [Medical Device User 
                                        Fee Amendments of 2017] 
                                        Medical Device User Fee 
                                        Amendments of 2022 for 
                                        the applicable fiscal 
                                        year.
                                          (III) The most common 
                                        causes and trends for 
                                        external or other 
                                        circumstances affecting 
                                        the ability of the 
                                        Center for Devices and 
                                        Radiological Health, 
                                        the Office of 
                                        Regulatory Affairs, or 
                                        the Food and Drug 
                                        Administration to meet 
                                        review time and 
                                        performance enhancement 
                                        goals identified by the 
                                        letters described in 
                                        section 201(b) of the 
                                        [Medical Device User 
                                        Fee Amendments of 2017] 
                                        Medical Device User Fee 
                                        Amendments of 2022.
                  (B) Publication.--With regard to information 
                to be reported by the Food and Drug 
                Administration to industry on a quarterly and 
                annual basis pursuant to the letters described 
                in section 201(b) of the [Medical Device User 
                Fee Amendments of 2017] Medical Device User Fee 
                Amendments of 2022, the Secretary shall make 
                such information publicly available on the 
                Internet Web site of the Food and Drug 
                Administration not later than 60 days after the 
                end of each quarter or 120 days after the end 
                of each fiscal year, respectively, to which 
                such information applies. This information 
                shall include the status of the independent 
                assessment identified in the letters described 
                in such section 201(b).
                  (C) Updates.--The Secretary shall include in 
                each report under subparagraph (A) information 
                on all previous cohorts for which the Secretary 
                has not given a complete response on all device 
                premarket applications and reports, 
                supplements, and premarket notifications in the 
                cohort.
          (2) Corrective action report.--Beginning with [fiscal 
        year 2018] fiscal year 2023, for each fiscal year for 
        which fees are collected under this part, the Secretary 
        shall prepare and submit a corrective action report to 
        the Committee on Energy and Commerce and the Committee 
        on Appropriations of the House of Representatives and 
        the Committee on Health, Education, Labor, and Pensions 
        and the Committee on Appropriations of the Senate. The 
        report shall include the following information, as 
        applicable:
                  (A) Goals met.--For each fiscal year, if the 
                Secretary determines, based on the analysis 
                under paragraph (1)(A)(iv), that each of the 
                goals identified by the letters described in 
                section 201(b) of the [Medical Device User Fee 
                Amendments of 2017] Medical Device User Fee 
                Amendments of 2022 for the applicable fiscal 
                year have been met, the corrective action 
                report shall include recommendations on ways in 
                which the Secretary can improve and streamline 
                the medical device application review process.
                  (B) Goals missed.--For each of the goals 
                identified by the letters described in section 
                201(b) of the [Medical Device User Fee 
                Amendments of 2017] Medical Device User Fee 
                Amendments of 2022 for the applicable fiscal 
                year that the Secretary determines to not have 
                been met, the corrective action report shall 
                include--
                          (i) a justification for such 
                        determination;
                          (ii) a description of the types of 
                        circumstances, in the aggregate, under 
                        which applications or reports submitted 
                        under section 515 or notifications 
                        submitted under section 510(k) missed 
                        the review goal times but were approved 
                        during the first cycle review, as 
                        applicable;
                          (iii) a summary and any trends with 
                        regard to the circumstances for which a 
                        review goal was missed; and
                          (iv) the performance enhancement 
                        goals that were not achieved during the 
                        previous fiscal year and a description 
                        of efforts the Food and Drug 
                        Administration has put in place for the 
                        fiscal year in which the report is 
                        submitted to improve the ability of 
                        such agency to meet each such goal for 
                        the such fiscal year.
          (3) Enhanced communication.--
                  (A) Communications with congress.--Each 
                fiscal year, as applicable and requested, 
                representatives from the Centers with expertise 
                in the review of devices shall meet with 
                representatives from the Committee on Health, 
                Education, Labor, and Pensions of the Senate 
                and the Committee on Energy and Commerce of the 
                House of Representatives to report on the 
                contents described in the reports under this 
                section.
                  (B) Participation in congressional hearing.--
                Each fiscal year, as applicable and requested, 
                representatives from the Food and Drug 
                Administration shall participate in a public 
                hearing before the Committee on Health, 
                Education, Labor, and Pensions of the Senate 
                and the Committee on Energy and Commerce of the 
                House of Representatives, to report on the 
                contents described in the reports under this 
                section. Such hearing shall occur not later 
                than 120 days after the end of each fiscal year 
                for which fees are collected under this part.
          (4) Fiscal report.--For fiscal years [2018 through 
        2022] 2023 through 2027, not later than 120 days after 
        the end of each fiscal year during which fees are 
        collected under this part, the Secretary shall prepare 
        and submit to the Committee on Health, Education, 
        Labor, and Pensions of the Senate and the Committee on 
        Energy and Commerce of the House of Representatives, a 
        report on the implementation of the authority for such 
        fees during such fiscal year and the use, by the Food 
        and Drug Administration, of the fees collected during 
        such fiscal year for which the report is made.
          (5) Public availability.--The Secretary shall make 
        the reports required under paragraphs (1) and (2) 
        available to the public on the Internet Web site of the 
        Food and Drug Administration.
  (b) Reauthorization.--
          (1) Consultation.--In developing recommendations to 
        present to Congress with respect to the goals, and 
        plans for meeting the goals, for the process for the 
        review of device applications for the first 5 fiscal 
        years after fiscal year [2022] 2027, and for the 
        reauthorization of this part for such fiscal years, the 
        Secretary shall consult with--
                  (A) the Committee on Energy and Commerce of 
                the House of Representatives;
                  (B) the Committee on Health, Education, 
                Labor, and Pensions of the Senate;
                  (C) scientific and academic experts;
                  (D) health care professionals;
                  (E) representatives of patient and consumer 
                advocacy groups; and
                  (F) the regulated industry.
          (2) Prior public input.--Prior to beginning 
        negotiations with the regulated industry on the 
        reauthorization of this part, the Secretary shall--
                  (A) publish a notice in the Federal Register 
                requesting public input on the reauthorization;
                  (B) hold a public meeting at which the public 
                may present its views on the reauthorization, 
                including specific suggestions for changes to 
                the goals referred to in subsection (a)(1);
                  (C) provide a period of 30 days after the 
                public meeting to obtain written comments from 
                the public suggesting changes to this part; and
                  (D) publish the comments on the Food and Drug 
                Administration's Internet Web site.
          (3) Periodic consultation.--Not less frequently than 
        once every month during negotiations with the regulated 
        industry, the Secretary shall hold discussions with 
        representatives of patient and consumer advocacy groups 
        to continue discussions of their views on the 
        reauthorization and their suggestions for changes to 
        this part as expressed under paragraph (2).
          (4) Public review of recommendations.--After 
        negotiations with the regulated industry, the Secretary 
        shall--
                  (A) present the recommendations developed 
                under paragraph (1) to the Congressional 
                committees specified in such paragraph;
                  (B) publish such recommendations in the 
                Federal Register;
                  (C) provide for a period of 30 days for the 
                public to provide written comments on such 
                recommendations;
                  (D) hold a meeting at which the public may 
                present its views on such recommendations; and
                  (E) after consideration of such public views 
                and comments, revise such recommendations as 
                necessary.
          (5) Transmittal of recommendations.--Not later than 
        January 15, [2022] 2027, the Secretary shall transmit 
        to Congress the revised recommendations under paragraph 
        (4), a summary of the views and comments received under 
        such paragraph, and any changes made to the 
        recommendations in response to such views and comments.
          (6) Minutes of negotiation meetings.--
                  (A) Public availability.--Before presenting 
                the recommendations developed under paragraphs 
                (1) through (5) to the Congress, the Secretary 
                shall make publicly available, on the public 
                Web site of the Food and Drug Administration, 
                minutes of all negotiation meetings conducted 
                under this subsection between the Food and Drug 
                Administration and the regulated industry.
                  (B) Content.--The minutes described under 
                subparagraph (A) shall summarize any 
                substantive proposal made by any party to the 
                negotiations as well as significant 
                controversies or differences of opinion during 
                the negotiations and their resolution.

           *       *       *       *       *       *       *


PART 7--FEES RELATING TO GENERIC DRUGS

           *       *       *       *       *       *       *


SEC. 744B. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG FEES.

  (a) Types of Fees.--Beginning in [fiscal year 2018] fiscal 
year 2023, the Secretary shall assess and collect fees in 
accordance with this section as follows:
          (1) One-time backlog fee for abbreviated new drug 
        applications pending on october 1, 2012.--
                  (A) In general.--Each person that owns an 
                abbreviated new drug application that is 
                pending on October 1, 2012, and that has not 
                received a tentative approval prior to that 
                date, shall be subject to a fee for each such 
                application, as calculated under subparagraph 
                (B).
                  (B) Method of fee amount calculation.--The 
                amount of each one-time backlog fee shall be 
                calculated by dividing $50,000,000 by the total 
                number of abbreviated new drug applications 
                pending on October 1, 2012, that have not 
                received a tentative approval as of that date.
                  (C) Notice.--Not later than October 31, 2012, 
                the Secretary shall publish in the Federal 
                Register a notice announcing the amount of the 
                fee required by subparagraph (A).
                  (D) Fee due date.--The fee required by 
                subparagraph (A) shall be due no later than 30 
                calendar days after the date of the publication 
                of the notice specified in subparagraph (C).
                  (E) Sunset.--This paragraph shall cease to be 
                effective October 1, 2022.
          (2) Drug master file fee.--
                  (A) In general.--Each person that owns a Type 
                II active pharmaceutical ingredient drug master 
                file that is referenced on or after October 1, 
                2012, in a generic drug submission by any 
                initial letter of authorization shall be 
                subject to a drug master file fee.
                  (B) One-time payment.--If a person has paid a 
                drug master file fee for a Type II active 
                pharmaceutical ingredient drug master file, the 
                person shall not be required to pay a 
                subsequent drug master file fee when that Type 
                II active pharmaceutical ingredient drug master 
                file is subsequently referenced in generic drug 
                submissions.
                  (C) Notice.--Not later than 60 days before 
                the start of each of fiscal years [2018 through 
                2022] 2023 through 2027, the Secretary shall 
                publish in the Federal Register the amount of 
                the drug master file fee established by this 
                paragraph for such fiscal year.
                  (D) Availability for reference.--
                          (i) In general.--Subject to 
                        subsection (g)(2)(C), for a generic 
                        drug submission to reference a Type II 
                        active pharmaceutical ingredient drug 
                        master file, the drug master file must 
                        be deemed available for reference by 
                        the Secretary.
                          (ii) Conditions.--A drug master file 
                        shall be deemed available for reference 
                        by the Secretary if--
                                  (I) the person that owns a 
                                Type II active pharmaceutical 
                                ingredient drug master file has 
                                paid the fee required under 
                                subparagraph (A) within 20 
                                calendar days after the 
                                applicable due date under 
                                subparagraph (E); and
                                  (II) the drug master file has 
                                not failed an initial 
                                completeness assessment by the 
                                Secretary, in accordance with 
                                criteria to be published by the 
                                Secretary.
                          (iii) List.--The Secretary shall make 
                        publicly available on the Internet Web 
                        site of the Food and Drug 
                        Administration a list of the drug 
                        master file numbers that correspond to 
                        drug master files that have 
                        successfully undergone an initial 
                        completeness assessment, in accordance 
                        with criteria to be published by the 
                        Secretary, and are available for 
                        reference.
                  (E) Fee due date.--
                          (i) In general.--Subject to clause 
                        (ii), a drug master file fee shall be 
                        due on the earlier of--
                                  (I) the date on which the 
                                first generic drug submission 
                                is submitted that references 
                                the associated Type II active 
                                pharmaceutical ingredient drug 
                                master file; or
                                  (II) the date on which the 
                                drug master file holder 
                                requests the initial 
                                completeness assessment.
                          (ii) Limitation.--No fee shall be due 
                        under subparagraph (A) for a fiscal 
                        year until the later of--
                                  (I) 30 calendar days after 
                                publication of the notice 
                                provided for in subparagraph 
                                (C); or
                                  (II) 30 calendar days after 
                                the date of enactment of an 
                                appropriations Act providing 
                                for the collection and 
                                obligation of fees for such 
                                year under this section.
          (3) Abbreviated new drug application filing fee.--
                  (A) In general.--Each applicant that submits, 
                on or after October 1, 2012, an abbreviated new 
                drug application shall be subject to a fee for 
                each such submission in the amount established 
                under subsection (d).
                  (B) Notice.--Not later than 60 days before 
                the start of each of fiscal years [2018 through 
                2022] 2023 through 2027, 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) Refund of fee if abbreviated new drug 
                application is not considered to have been 
                received, is withdrawn prior to being received, 
                or is no longer received.--
                          (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) Fee for an application the secretary 
                considers not to have been received, or that 
                has been withdrawn.--An abbreviated new drug 
                application that was submitted on or after 
                October 1, 2012, and that the Secretary 
                considers not to have been received, or that 
                has been withdrawn, shall, upon resubmission of 
                the application or a subsequent new submission 
                following the applicant's withdrawal of the 
                application, be subject to a full fee under 
                subparagraph (A).
                  (F) Additional fee for active pharmaceutical 
                ingredient information not included by 
                reference to type ii active pharmaceutical 
                ingredient drug master file.--An applicant that 
                submits a generic drug submission on or after 
                October 1, 2017, shall pay a fee, in the amount 
                determined under subsection (d)(2), in addition 
                to the fee required under subparagraph (A), 
                if--
                          (i) such submission contains 
                        information concerning the manufacture 
                        of an active pharmaceutical ingredient 
                        at a facility by means other than 
                        reference by a letter of authorization 
                        to a Type II active pharmaceutical drug 
                        master file; and
                          (ii) a fee in the amount equal to the 
                        drug master file fee established in 
                        paragraph (2) has not been previously 
                        paid with respect to such information.
          (4) Generic drug facility fee and active 
        pharmaceutical ingredient facility fee.--
                  (A) In general.--Facilities identifiedin at 
                least one generic drug submission that is 
                approved to produce a finished dosage form of a 
                human generic drug or an active pharmaceutical 
                ingredient contained in a human generic drug 
                shall be subject to fees as follows:
                          (i) Generic drug facility.--Each 
                        person that owns a facility which is 
                        identified in at least one generic drug 
                        submission that is approved to produce 
                        one or more finished dosage forms of a 
                        human generic drug shall be assessed an 
                        annual fee for each such facility.
                          (ii) Active pharmaceutical ingredient 
                        facility.--Each person that owns a 
                        facility which 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 generic drug submission, shall 
                        be assessed an annual fee for each such 
                        facility.
                          (iii) Facilities producing both 
                        active pharmaceutical ingredients and 
                        finished dosage forms.--Each person 
                        that owns a facility identified, or 
                        intended to be identified, in at least 
                        one generic drug submission that is 
                        pending or approved to produce both one 
                        or more finished dosage forms subject 
                        to clause (i) and one or more active 
                        pharmaceutical ingredients subject to 
                        clause (ii) shall be subject only to 
                        the fee attributable to the manufacture 
                        of the finished dosage forms for that 
                        facility.
                  (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] 2023 through 2027, 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] 2023 through 2027, 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.
          (6) Date of submission.--For purposes of this Act, a 
        generic drug submission or Type II pharmaceutical 
        master file is deemed to be ``submitted'' to the Food 
        and Drug Administration--
                  (A) if it is submitted via a Food and Drug 
                Administration electronic gateway, on the day 
                when transmission to that electronic gateway is 
                completed, except that a submission or master 
                file that arrives on a weekend, Federal 
                holiday, or day when the Food and Drug 
                Administration office that will review that 
                submission is not otherwise open for business 
                shall be deemed to be submitted on the next day 
                when that office is open for business; or
                  (B) if it is submitted in physical media 
                form, on the day it arrives at the appropriate 
                designated document room of the Food and Drug 
                Administration.
  (b) Fee Revenue Amounts.--
          (1) In general.--
                  (A) Fiscal year [2018] 2023.--For fiscal year 
                [2018] 2023, fees under subsection (a) shall be 
                established to generate a total estimated 
                revenue amount under such subsection of 
                [$493,600,000] $582,500,000.
                  [(B) Fiscal years 2019 through 2022.--For 
                each of the fiscal years 2019 through 2022, 
                fees under paragraphs (2) through (5) of 
                subsection (a) shall be established to generate 
                a total estimated revenue amount under such 
                subsection that is equal to $493,600,000, as 
                adjusted pursuant to subsection (c).]
                  (B) Fiscal years 2024 through 2027.--
                          (i) In general.--For each of the 
                        fiscal years 2024 through 2027, fees 
                        under paragraphs (2) through (5) of 
                        subsection (a) shall be established to 
                        generate a total estimated revenue 
                        amount under such subsection that is 
                        equal to the base revenue amount for 
                        the fiscal year under clause (ii), as 
                        adjusted pursuant to subsection (c).
                          (ii) Base revenue amount.--The base 
                        revenue amount for a fiscal year 
                        referred to in clause (i) is equal to 
                        the total revenue amount established 
                        under this paragraph for the previous 
                        fiscal year, not including any 
                        adjustments made for such previous 
                        fiscal year under subsection (c)(3).
          (2) Types of fees.--In establishing fees under 
        paragraph (1) to generate the revenue amounts specified 
        in such paragraph for a fiscal year, such fees shall be 
        derived from the fees under paragraphs (2) through (5) 
        of subsection (a) as follows:
                  (A) Five percent shall be derived from fees 
                under subsection (a)(2) (relating to drug 
                master files).
                  (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] twenty-four percent 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) [Seven percent] Six percent shall be 
                derived from fees under subsection 
                (a)(4)(A)(ii) (relating to active 
                pharmaceutical ingredient facilities). 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, including its territories 
                and possessions.
                  (E)(i) [Thirty-five percent] Thirty-six 
                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.--
          (1) Inflation adjustment.--For fiscal year [2019] 
        2024 and subsequent fiscal years, the revenues 
        established in subsection (b) shall be adjusted by the 
        Secretary by notice, published in the Federal Register, 
        for a fiscal year, [to equal the product of the total 
        revenues established in such notice for the prior 
        fiscal year multiplied] to equal the base revenue 
        amount for the fiscal year (as specified in subsection 
        (b)(1)(B)) multiplied by an amount equal to the sum 
        of--
                  (A) one;
                  (B) 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 human generic 
                drug activities for the first 3 years of the 
                preceding 4 fiscal years; and
                  (C) the average annual percent change that 
                occurred in the Consumer Price Index for urban 
                consumers ([Washington-Baltimore, DC-MD-VA-WV] 
                Washington-Arlington-Alexandria, DC-VA-MD-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 human generic drug activities for the first 
                3 years of the preceding 4 fiscal years.
          [(2) Final year adjustment.--For fiscal year 2022, 
        the Secretary may, in addition to adjustments under 
        paragraph (1), further increase the fee revenues and 
        fees established in subsection (b) if such an 
        adjustment is necessary to provide for not more than 3 
        months of operating reserves of carryover user fees for 
        human generic drug activities for the first 3 months of 
        fiscal year 2023. If such an adjustment is necessary, 
        the rationale for the amount of the increase shall be 
        contained in the annual notice establishing fee 
        revenues and fees for fiscal year 2022. If the 
        Secretary has carryover balances for such activities in 
        excess of 3 months of such operating reserves, the 
        adjustment under this subparagraph shall not be made.]
          (2) Capacity planning adjustment.--
                  (A) In general.--Beginning with fiscal year 
                2024, the Secretary shall, in addition to the 
                adjustment under paragraph (1), further 
                increase the fee revenue and fees under this 
                section for a fiscal year, in accordance with 
                this paragraph, to reflect changes in the 
                resource capacity needs of the Secretary for 
                human generic drug activities.
                  (B) Capacity planning methodology.--The 
                Secretary shall establish a capacity planning 
                methodology for purposes of this paragraph, 
                which shall--
                          (i) be derived from the methodology 
                        and recommendations made in the report 
                        titled ``Independent Evaluation of the 
                        GDUFA Resource Capacity Planning 
                        Adjustment Methodology: Evaluation and 
                        Recommendations'' announced in the 
                        Federal Register on August 3, 2020;
                          (ii) incorporate approaches and 
                        attributes determined appropriate by 
                        the Secretary, including approaches and 
                        attributes made in such report, except 
                        that in incorporating such approaches 
                        and attributes the workload categories 
                        used in forecasting resources shall 
                        only be the workload categories 
                        specified in section VIII.B.2.e. of the 
                        letters described in section 301(b) of 
                        the Generic Drug User Fee Amendments of 
                        2022; and
                          (iii) be effective beginning with 
                        fiscal year 2024.
                  (C) Limitations.--
                          (i) In general.--Under no 
                        circumstances shall an adjustment under 
                        this paragraph result in fee revenue 
                        for a fiscal year that is less than the 
                        sum of the amounts under subsection 
                        (b)(1)(B)(ii) (the base revenue amount 
                        for the fiscal year) and paragraph (1) 
                        (the dollar amount of the inflation 
                        adjustment for the fiscal year).
                          (ii) Percentage limitation.--An 
                        adjustment under this paragraph shall 
                        not exceed three percent of the sum 
                        described in clause (i) for the fiscal 
                        year, except that such limitation shall 
                        be four percent if--
                                  (I) for purposes of a fiscal 
                                year 2024 adjustment, the 
                                Secretary determines that 
                                during the period from April 1, 
                                2021, through March 31, 2023--
                                          (aa) the total number 
                                        of abbreviated new drug 
                                        applications submitted 
                                        was greater than or 
                                        equal to 2,000; or
                                          (bb) thirty-five 
                                        percent or more of 
                                        abbreviated new drug 
                                        applications submitted 
                                        related to complex 
                                        products (as that term 
                                        is defined in section 
                                        XI of the letters 
                                        described in section 
                                        301(b) of the Generic 
                                        Drug User Fee 
                                        Amendments of 2022);
                                  (II) for purposes of a fiscal 
                                year 2025 adjustment, the 
                                Secretary determines that 
                                during the period from April 1, 
                                2022, through March 31, 2024--
                                          (aa) the total number 
                                        of abbreviated new drug 
                                        applications submitted 
                                        was greater than or 
                                        equal to 2,300; or
                                          (bb) thirty-five 
                                        percent or more of 
                                        abbreviated new drug 
                                        applications submitted 
                                        related to complex 
                                        products (as so 
                                        defined);
                                  (III) for purposes of a 
                                fiscal year 2026 adjustment, 
                                the Secretary determines that 
                                during the period from April 1, 
                                2023, through March 31, 2025--
                                          (aa) the total number 
                                        of abbreviated new drug 
                                        applications submitted 
                                        was greater than or 
                                        equal to 2,300; or
                                          (bb) thirty-five 
                                        percent or more of 
                                        abbreviated new drug 
                                        applications submitted 
                                        related to complex 
                                        products (as so 
                                        defined); and
                                  (IV) for purposes of a fiscal 
                                year 2027 adjustment, the 
                                Secretary determines that 
                                during the period from April 1, 
                                2024, through March 31, 2026--
                                          (aa) the total number 
                                        of abbreviated new drug 
                                        applications submitted 
                                        was greater than or 
                                        equal to 2,300; or
                                          (bb) thirty-five 
                                        percent or more of 
                                        abbreviated new drug 
                                        applications submitted 
                                        related to complex 
                                        products (as so 
                                        defined).
                  (D) Publication in federal register.--The 
                Secretary shall publish in the Federal Register 
                notice referred to in subsection (a) the fee 
                revenue and fees resulting from the adjustment 
                and the methodology under this paragraph.
          (3) Operating reserve adjustment.--
                  (A) In general.--For fiscal year 2024 and 
                each subsequent fiscal year, the Secretary may, 
                in addition to adjustments under paragraphs (1) 
                and (2), further increase the fee revenue and 
                fees under this section for such fiscal year if 
                such an adjustment is necessary to provide 
                operating reserves of carryover user fees for 
                human generic drug activities for not more than 
                the number of weeks specified in subparagraph 
                (B) with respect to that fiscal year.
                  (B) Number of weeks.--The number of weeks 
                specified in this subparagraph is--
                          (i) 8 weeks for fiscal year 2024;
                          (ii) 9 weeks for fiscal year 2025; 
                        and
                          (iii) 10 weeks for each of fiscal 
                        year 2026 and 2027.
                  (C) Decrease.--If the Secretary has carryover 
                balances for human generic drug activities in 
                excess of 12 weeks of the operating reserves 
                referred to in subparagraph (A), the Secretary 
                shall decrease the fee revenue and fees 
                referred to in such subparagraph to provide for 
                not more than 12 weeks of such operating 
                reserves.
                  (D) Rationale for adjustment.--If an 
                adjustment under this paragraph is made, the 
                rationale for the amount of the increase or 
                decrease (as applicable) in fee revenue and 
                fees shall be contained in the annual Federal 
                Register notice under subsection (a) publishing 
                the fee revenue and fees for the fiscal year 
                involved.
  (d) Annual Fee Setting.--
          (1) Fiscal years [2018 through 2022] 2023 through 
        2027.--Not [more than 60 days before the first day of 
        each of fiscal years 2018 through 2022] later than 60 
        days before the first day of each of fiscal years 2023 
        through 2027, 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) Fee for active pharmaceutical ingredient 
        information not included by reference to type ii active 
        pharmaceutical ingredient drug master file.--In 
        establishing the fee under paragraph (1), the amount of 
        the fee under subsection (a)(3)(F) shall be determined 
        by multiplying--
                  (A) the sum of--
                          (i) the total number of such active 
                        pharmaceutical ingredients in such 
                        submission; and
                          (ii) for each such ingredient that is 
                        manufactured at more than one such 
                        facility, the total number of such 
                        additional facilities; and
                  (B) the amount equal to the drug master file 
                fee established in subsection (a)(2) for such 
                submission.
  (e) Limitations.--
          (1) In general.--The total amount of fees charged, as 
        adjusted under subsection (c), for a fiscal year may 
        not exceed the total costs for such fiscal year for the 
        resources allocated for human generic drug activities.
          (2) Leasing and necessary equipment.--Beginning on 
        October 1, 2023, the authorities under section 
        744A(11)(C) shall include only leasing and necessary 
        scientific equipment.
  (f) Identification of Facilities.--
          (1) Required submission of facility identification.--
        Each person that owns a facility described in 
        subsection (a)(4)(A) or a site or organization required 
        to be identified by paragraph (3) shall submit to the 
        Secretary the information required under this 
        subsection each year. Such information shall, for each 
        fiscal year, be submitted, updated, or reconfirmed on 
        or before June 1 of the previous fiscal year.
          (2) Information required to be submitted.--At a 
        minimum, the submission required by paragraph (1) shall 
        include for each such facility--
                  (A) identification of a facility identified 
                in an approved or pending generic drug 
                submission;
                  (B) whether the facility manufactures active 
                pharmaceutical ingredients or finished dosage 
                forms, or both;
                  (C) whether or not the facility is located 
                within the United States and its territories 
                and possessions;
                  (D) whether the facility manufactures 
                positron emission tomography drugs solely, or 
                in addition to other drugs;
                  (E) whether the facility manufactures drugs 
                that are not generic drugs; and
                  (F) whether the facility is a contract 
                manufacturing organization facility.
          (3) Certain sites and organizations.--
                  (A) In general.--Any person that owns or 
                operates a site or organization described in 
                subparagraph (B) shall submit to the Secretary 
                information concerning the ownership, name, and 
                address of the site or organization.
                  (B) Sites and organizations.--A site or 
                organization is described in this subparagraph 
                if it is identified in a generic drug 
                submission and is--
                          (i) a site in which a bioanalytical 
                        study is conducted;
                          (ii) a clinical research 
                        organization;
                          (iii) a contract analytical testing 
                        site; or
                          (iv) a contract repackager site.
                  (C) Notice.--The Secretary may, by notice 
                published in the Federal Register, specify the 
                means and format for submission of the 
                information under subparagraph (A) and may 
                specify, as necessary for purposes of this 
                section, any additional information to be 
                submitted.
                  (D) Inspection authority.--The Secretary's 
                inspection authority under section 704(a)(1) 
                shall extend to all such sites and 
                organizations.
  (g) Effect of Failure To Pay Fees.--
          (1) Generic drug backlog fee.--Failure to pay the fee 
        under subsection (a)(1) shall result in the Secretary 
        placing the person that owns the abbreviated new drug 
        application subject to that fee on a publicly available 
        arrears list, such that no new abbreviated new drug 
        applications or supplement submitted on or after 
        October 1, 2012, from that person, or any affiliate of 
        that person, will be received within the meaning of 
        section 505(j)(5)(A) until such outstanding fee is 
        paid. This paragraph shall cease to be effective on 
        October 1, 2022.
          (2) Drug master file fee.--
                  (A) Failure to pay the fee under subsection 
                (a)(2) within 20 calendar days after the 
                applicable due date under subparagraph (E) of 
                such subsection (as described in subsection 
                (a)(2)(D)(ii)(I)) shall result in the Type II 
                active pharmaceutical ingredient drug master 
                file not being deemed available for reference.
                  (B)(i) Any generic drug submission submitted 
                on or after October 1, 2012, that references, 
                by a letter of authorization, a Type II active 
                pharmaceutical ingredient drug master file that 
                has not been deemed available for reference 
                shall not be received within the meaning of 
                section 505(j)(5)(A) unless the condition 
                specified in clause (ii) is met.
                  (ii) The condition specified in this clause 
                is that the fee established under subsection 
                (a)(2) has been paid within 20 calendar days of 
                the Secretary providing the notification to the 
                sponsor of the abbreviated new drug application 
                or supplement of the failure of the owner of 
                the Type II active pharmaceutical ingredient 
                drug master file to pay the drug master file 
                fee as specified in subparagraph (C).
                  (C)(i) If an abbreviated new drug application 
                or supplement to an abbreviated new drug 
                application references a Type II active 
                pharmaceutical ingredient drug master file for 
                which a fee under subsection (a)(2)(A) has not 
                been paid by the applicable date under 
                subsection (a)(2)(E), the Secretary shall 
                notify the sponsor of the abbreviated new drug 
                application or supplement of the failure of the 
                owner of the Type II active pharmaceutical 
                ingredient drug master file to pay the 
                applicable fee.
                  (ii) If such fee is not paid within 20 
                calendar days of the Secretary providing the 
                notification, the abbreviated new drug 
                application or supplement to an abbreviated new 
                drug application shall not be received within 
                the meaning of section 505(j)(5)(A).
          (3) Abbreviated new drug application fee [and prior 
        approval supplement fee].--Failure to pay a fee under 
        subparagraph (A) or (F) of subsection (a)(3) within 20 
        calendar days of the applicable due date under 
        subparagraph (C) of such subsection shall result in the 
        abbreviated new drug application or the prior approval 
        supplement to an abbreviated new drug application not 
        being received within the meaning of section 
        505(j)(5)(A) until such outstanding fee is paid.
          (4) Generic drug facility fee and active 
        pharmaceutical ingredient facility fee.--
                  (A) In general.--Failure to pay the fee under 
                subsection (a)(4) within 20 calendar days of 
                the due date as specified in subparagraph (D) 
                of such subsection shall result in the 
                following:
                          (i) The Secretary shall place the 
                        facility on a publicly available 
                        arrears list, such that no new 
                        abbreviated new drug application or 
                        supplement submitted on or after 
                        October 1, 2012, from the person that 
                        is responsible for paying such fee, or 
                        any affiliate of that person, will be 
                        received within the meaning of section 
                        505(j)(5)(A).
                          (ii) Any new generic drug submission 
                        submitted on or after October 1, 2012, 
                        that references such a facility shall 
                        not be received, within the meaning of 
                        section 505(j)(5)(A) if the outstanding 
                        facility fee is not paid within 20 
                        calendar days of the Secretary 
                        providing the notification to the 
                        sponsor of the failure of the owner of 
                        the facility to pay the facility fee 
                        under subsection (a)(4)(C).
                          (iii) All drugs or active 
                        pharmaceutical ingredients manufactured 
                        in such a facility or containing an 
                        ingredient manufactured in such a 
                        facility shall be deemed misbranded 
                        under section 502(aa).
                  (B) Application of penalties.--The penalties 
                under this paragraph shall apply until the fee 
                established by subsection (a)(4) is paid or the 
                facility is removed from all generic drug 
                submissions that refer to the facility.
                  (C) Nonreceival for nonpayment.--
                          (i) Notice.--If an abbreviated new 
                        drug application or supplement to an 
                        abbreviated new drug application 
                        submitted on or after October 1, 2012, 
                        references a facility for which a 
                        facility fee has not been paid by the 
                        applicable date under subsection 
                        (a)(4)(C), the Secretary shall notify 
                        the sponsor of the generic drug 
                        submission of the failure of the owner 
                        of the facility to pay the facility 
                        fee.
                          (ii) Nonreceival.--If the facility 
                        fee is not paid within 20 calendar days 
                        of the Secretary providing the 
                        notification under clause (i), the 
                        abbreviated new drug application or 
                        supplement to an abbreviated new drug 
                        application shall not be received 
                        within the meaning of section 
                        505(j)(5)(A).
          (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.
  (h) Limitations.--
          (1) In general.--Fees under subsection (a) shall be 
        refunded for a fiscal year beginning after fiscal year 
        2012, unless appropriations for salaries and expenses 
        of the Food and Drug Administration for such fiscal 
        year (excluding the amount of fees appropriated for 
        such fiscal year) are equal to or greater than the 
        amount of appropriations for the salaries and expenses 
        of the Food and Drug Administration for fiscal year 
        2009 (excluding the amount of fees appropriated for 
        such fiscal year) multiplied by the adjustment factor 
        (as defined in section 744A) applicable to the fiscal 
        year involved.
          (2) Authority.--If the Secretary does not assess fees 
        under subsection (a) during any portion of a fiscal 
        year and if at a later date in such fiscal year the 
        Secretary may assess such fees, the Secretary may 
        assess and collect such fees, without any modification 
        in the rate, at any time in such fiscal year 
        notwithstanding the provisions of subsection (a) 
        relating to the date fees are to be paid.
  (i) Crediting and Availability of Fees.--
          (1) In general.--Fees authorized under subsection (a) 
        shall be collected and available for obligation only to 
        the extent and in the amount provided in advance in 
        appropriations Acts, subject to paragraph (2). Such 
        fees are authorized to remain available until expended. 
        Such sums as may be necessary may be transferred from 
        the Food and Drug Administration salaries and expenses 
        appropriation account without fiscal year limitation to 
        such appropriation account for salaries and expenses 
        with such fiscal year limitation. The sums transferred 
        shall be available solely for human generic drug 
        activities.
          (2) Collections and appropriation acts.--
                  (A) In general.--The fees authorized by this 
                section--
                          (i) subject to subparagraph (C), 
                        shall be collected and available in 
                        each fiscal year in an amount not to 
                        exceed the amount specified in 
                        appropriation Acts, or otherwise made 
                        available for obligation for such 
                        fiscal year; and
                          (ii) shall be available for a fiscal 
                        year beginning after fiscal year 2012 
                        to defray the costs of human generic 
                        drug activities (including such costs 
                        for an additional number of full-time 
                        equivalent positions in the Department 
                        of Health and Human Services to be 
                        engaged in such activities), only if 
                        the Secretary allocates for such 
                        purpose an amount for such fiscal year 
                        (excluding amounts from fees collected 
                        under this section) no less than 
                        $97,000,000 multiplied by the 
                        adjustment factor defined in section 
                        744A(3) applicable to the fiscal year 
                        involved.
                  (B) Compliance.--The Secretary shall be 
                considered to have met the requirements of 
                subparagraph (A)(ii) in any fiscal year if the 
                costs funded by appropriations and allocated 
                for human generic activities are not more than 
                10 percent below the level specified in such 
                subparagraph.
                  (C) Provision for early payments.--Payment of 
                fees authorized under this section for a fiscal 
                year, prior to the due date for such fees, may 
                be accepted by the Secretary in accordance with 
                authority provided in advance in a prior year 
                appropriations Act.
          (3) Authorization of appropriations.--For each of the 
        [fiscal years 2018 through 2022] fiscal years 2023 
        through 2027, there is authorized to be appropriated 
        for fees under this section an amount equivalent to the 
        total revenue amount determined under subsection (b) 
        for the fiscal year, as adjusted under subsection (c), 
        if applicable, or as otherwise affected under paragraph 
        (2) of this subsection.
  (j) Collection of Unpaid Fees.--In any case where the 
Secretary does not receive payment of a fee assessed under 
subsection (a) within 30 calendar days after it is due, such 
fee shall be treated as a claim of the United States Government 
subject to subchapter II of chapter 37 of title 31, United 
States Code.
  (k) Construction.--This section may not be construed to 
require that the number of full-time equivalent positions in 
the Department of Health and Human Services, for officers, 
employees, and advisory committees not engaged in human generic 
drug activities, be reduced to offset the number of officers, 
employees, and advisory committees so engaged.
  (l) Positron Emission Tomography Drugs.--
          (1) Exemption from fees.--Submission of an 
        application for a positron emission tomography drug or 
        active pharmaceutical ingredient for a positron 
        emission tomography drug shall not require the payment 
        of any fee under this section. Facilities that solely 
        produce positron emission tomography drugs shall not be 
        required to pay a facility fee as established in 
        subsection (a)(4).
          (2) Identification requirement.--Facilities that 
        produce positron emission tomography drugs or active 
        pharmaceutical ingredients of such drugs are required 
        to be identified pursuant to subsection (f).
  (m) Disputes Concerning Fees.--To qualify for the return of a 
fee claimed to have been paid in error under this section, a 
person shall submit to the Secretary a written request 
justifying such return within 180 calendar days after such fee 
was paid.
  (n) Substantially Complete Applications.--An abbreviated new 
drug application that is not considered to be received within 
the meaning of section 505(j)(5)(A) because of failure to pay 
an applicable fee under this provision within the time period 
specified in subsection (g) shall be deemed not to have been 
``substantially complete'' on the date of its submission within 
the meaning of section 505(j)(5)(B)(iv)(II)(cc). An abbreviated 
new drug application that is not substantially complete on the 
date of its submission solely because of failure to pay an 
applicable fee under the preceding sentence shall be deemed 
substantially complete and received within the meaning of 
section 505(j)(5)(A) as of the date such applicable fee is 
received.
  (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 a 
        designated affiliate of such person, shall submit, on 
        behalf of the person and the affiliates of such person, 
        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 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.

SEC. 744C. REAUTHORIZATION; REPORTING REQUIREMENTS.

  (a) Performance Report.--
          (1) General requirements.--[Beginning with fiscal 
        year 2018, not] Not later than 120 days after the end 
        of each fiscal year for which fees are collected under 
        this part, the Secretary shall prepare and 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 concerning 
        the progress of the Food and Drug Administration in 
        achieving the goals identified in the letters described 
        in section 301(b) of the [Generic Drug User Fee 
        Amendments of 2017] Generic Drug User Fee Amendments of 
        2022 during such fiscal year and the future plans of 
        the Food and Drug Administration for meeting the goals.
          (2) Real time reporting.--
                  (A) In general.--[Not later than 30 calendar 
                days after the end of the second quarter of 
                fiscal year 2018, and not later than 30 
                calendar days after the end of each quarter of 
                each fiscal year thereafter] Not later than 30 
                calendar days after the end of each quarter of 
                each fiscal year for which fees are collected 
                under this part, the Secretary shall post the 
                data described in subparagraph (B) on the 
                internet website of the Food and Drug 
                Administration, and may remove duplicative data 
                from the annual report under this subsection.
                  (B) Data.--The Secretary shall post the 
                following data in accordance with subparagraph 
                (A):
                          (i) The number and titles of draft 
                        and final guidance on topics related to 
                        human generic drug activities and 
                        whether such guidances were issued as 
                        required by statute or pursuant to a 
                        commitment under the letters described 
                        in section 301(b) of the [Generic Drug 
                        User Fee Amendments of 2017] Generic 
                        Drug User Fee Amendments of 2022.
                          (ii) The number and titles of public 
                        meetings held on topics related to 
                        human generic drug activities and 
                        whether such meetings were required by 
                        statute or pursuant to a commitment 
                        under the letters described in section 
                        301(b) of the [Generic Drug User Fee 
                        Amendments of 2017] Generic Drug User 
                        Fee Amendments of 2022.
          (3) Rationale for gdufa program changes.--[Beginning 
        with fiscal year 2020, the] The Secretary shall include 
        in the annual report under paragraph (1)--
                  (A) data, analysis, and discussion of the 
                changes in the number of full-time equivalents 
                hired as agreed upon in the letters described 
                in section 301(b) of the [Generic Drug User Fee 
                Amendments of 2017] Generic Drug User Fee 
                Amendments of 2022 and the number of full time 
                equivalents funded by budget authority at the 
                Food and Drug Administration by each division 
                within the Center for Drug Evaluation and 
                Research, the Center for Biologics Evaluation 
                and Research, the Office of Regulatory Affairs, 
                and the Office of the Commissioner;
                  (B) data, analysis, and discussion of the 
                changes in the fee revenue amounts and costs 
                for human generic drug activities, including 
                identifying drivers of such changes; and
                  (C) for each of the Center for Drug 
                Evaluation and Research, the Center for 
                Biologics Evaluation and Research, the Office 
                of Regulatory Affairs, and the Office of the 
                Commissioner, the number of employees for whom 
                time reporting is required and the number of 
                employees for whom time reporting is not 
                required.
          (4) Analysis.--For each fiscal year, the Secretary 
        shall include in the report an analysis of the 
        following:
                  (A) The difference between the aggregate 
                number of abbreviated new drug applications 
                filed and the aggregate number of approvals or 
                aggregate number of complete response letters 
                issued by the agency, accounting for--
                          (i) such applications filed during 
                        one fiscal year for which a decision is 
                        not scheduled to be made until the 
                        following fiscal year; and
                          (ii) the aggregate number of 
                        applications for each fiscal year that 
                        did not meet the goals identified by 
                        the letters described in section 301(b) 
                        of the [Generic Drug User Fee 
                        Amendments of 2017] Generic Drug User 
                        Fee Amendments of 2022 for the 
                        applicable fiscal year.
                  (B) Relevant data to determine whether the 
                Food and Drug Administration has met the 
                performance enhancement goals identified by the 
                letters described in section 301(b) of the 
                [Generic Drug User Fee Amendments of 2017] 
                Generic Drug User Fee Amendments of 2022 for 
                the applicable fiscal year.
                  (C) The most common causes and trends for 
                external or other circumstances that affected 
                the ability of the Secretary to meet review 
                time and performance enhancement goals 
                identified by the letters described in section 
                301(b) of the [Generic Drug User Fee Amendments 
                of 2017] Generic Drug User Fee Amendments of 
                2022.
  (b) Fiscal Report.--[Beginning with fiscal year 2018, not] 
Not later than 120 days after the end of each fiscal year for 
which fees are collected under this part, the Secretary shall 
prepare and submit to the Committee on Energy and Commerce of 
the House of Representatives and the Committee on Health, 
Education, Labor, and Pensions of the Senate a report on the 
implementation of the authority for such fees during such 
fiscal year and the use, by the Food and Drug Administration, 
of the fees collected for such fiscal year.
  (c) Corrective Action Report.--[Beginning with fiscal year 
2018, for] For each fiscal year for which fees are collected 
under this part, the Secretary shall prepare and submit a 
corrective action report to the Committee on Energy and 
Commerce and the Committee on Appropriations of the House of 
Representatives and the Committee on Health, Education, Labor, 
and Pensions and the Committee on Appropriations of the Senate. 
The report shall include the following information, as 
applicable:
          (1) Goals met.--For each fiscal year, if the 
        Secretary determines, based on the analysis under 
        subsection (a)(4), that each of the goals identified by 
        the letters described in section 301(b) of the [Generic 
        Drug User Fee Amendments of 2017] Generic Drug User Fee 
        Amendments of 2022 for the applicable fiscal year have 
        been met, the corrective action report shall include 
        recommendations on ways in which the Secretary can 
        improve and streamline the abbreviated new drug 
        application review process.
          (2) Goals missed.--For each of the goals identified 
        by the letters described in section 301(b) of the 
        [Generic Drug User Fee Amendments of 2017] Generic Drug 
        User Fee Amendments of 2022 for the applicable fiscal 
        year that the Secretary determines to not have been 
        met, the corrective action report shall include--
                  (A) a detailed justification for such 
                determination and a description, as applicable, 
                of the types of circumstances and trends under 
                which abbreviated new drug applications missed 
                the review goal times but were approved during 
                the first cycle review, or review goals were 
                missed; and
                  (B) with respect to performance enhancement 
                goals that were not achieved, a detailed 
                description of efforts the Food and Drug 
                Administration has put in place for the fiscal 
                year in which the report is submitted to 
                improve the ability of such agency to meet each 
                such goal for the such fiscal year.
  (d) Enhanced Communication.--
          (1) Communications with congress.--Each fiscal year, 
        as applicable and requested, representatives from the 
        Centers with expertise in the review of human drugs 
        shall meet with representatives from the Committee on 
        Health, Education, Labor, and Pensions of the Senate 
        and the Committee on Energy and Commerce of the House 
        of Representatives to report on the contents described 
        in the reports under this section.
          (2) Participation in congressional hearing.--Each 
        fiscal year, as applicable and requested, 
        representatives from the Food and Drug Administration 
        shall participate in a public hearing before the 
        Committee on Health, Education, Labor, and Pensions of 
        the Senate and the Committee on Energy and Commerce of 
        the House of Representatives, to report on the contents 
        described in the reports under this section. Such 
        hearing shall occur not later than 120 days after the 
        end of each fiscal year for which fees are collected 
        under this part.
  (e) Public Availability.--The Secretary shall make the 
reports required under subsections (a) and (b) available to the 
public on the Internet Web site of the Food and Drug 
Administration.
  (f) Reauthorization.--
          (1) Consultation.--In developing recommendations to 
        present to the Congress with respect to the goals, and 
        plans for meeting the goals, for human generic drug 
        activities for the first 5 fiscal years after [fiscal 
        year 2022] fiscal year 2027, and for the 
        reauthorization of this part for such fiscal years, the 
        Secretary shall consult with--
                  (A) the Committee on Energy and Commerce of 
                the House of Representatives;
                  (B) the Committee on Health, Education, 
                Labor, and Pensions of the Senate;
                  (C) scientific and academic experts;
                  (D) health care professionals;
                  (E) representatives of patient and consumer 
                advocacy groups; and
                  (F) the generic drug industry.
          (2) Prior public input.--Prior to beginning 
        negotiations with the generic drug industry on the 
        reauthorization of this part, the Secretary shall--
                  (A) publish a notice in the Federal Register 
                requesting public input on the reauthorization;
                  (B) hold a public meeting at which the public 
                may present its views on the reauthorization, 
                including specific suggestions for changes to 
                the goals referred to in subsection (a);
                  (C) provide a period of 30 days after the 
                public meeting to obtain written comments from 
                the public suggesting changes to this part; and
                  (D) publish the comments on the Food and Drug 
                Administration's Internet Web site.
          (3) Periodic consultation.--Not less frequently than 
        once every month during negotiations with the generic 
        drug industry, the Secretary shall hold discussions 
        with representatives of patient and consumer advocacy 
        groups to continue discussions of their views on the 
        reauthorization and their suggestions for changes to 
        this part as expressed under paragraph (2).
          (4) Public review of recommendations.--After 
        negotiations with the generic drug industry, the 
        Secretary shall--
                  (A) present the recommendations developed 
                under paragraph (1) to the congressional 
                committees specified in such paragraph;
                  (B) publish such recommendations in the 
                Federal Register;
                  (C) provide for a period of 30 days for the 
                public to provide written comments on such 
                recommendations;
                  (D) hold a meeting at which the public may 
                present its views on such recommendations; and
                  (E) after consideration of such public views 
                and comments, revise such recommendations as 
                necessary.
          (5) Transmittal of recommendations.--Not later than 
        [January 15, 2022] January 15, 2027, the Secretary 
        shall transmit to the Congress the revised 
        recommendations under paragraph (4), a summary of the 
        views and comments received under such paragraph, and 
        any changes made to the recommendations in response to 
        such views and comments.
          (6) Minutes of negotiation meetings.--
                  (A) Public availability.--Before presenting 
                the recommendations developed under paragraphs 
                (1) through (5) to the Congress, the Secretary 
                shall make publicly available, on the Internet 
                Web site of the Food and Drug Administration, 
                minutes of all negotiation meetings conducted 
                under this subsection between the Food and Drug 
                Administration and the generic drug industry.
                  (B) Content.--The minutes described under 
                subparagraph (A) shall summarize any 
                substantive proposal made by any party to the 
                negotiations as well as significant 
                controversies or differences of opinion during 
                the negotiations and their resolution.

        PART 8--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

SEC. 744G. DEFINITIONS.

   For purposes of this part:
          [(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) for October of the 
        preceding fiscal year divided by such Index for October 
        2011.]
          (1) The term ``adjustment factor'' applicable to a 
        fiscal year is the Consumer Price Index for urban 
        consumers (Washington-Arlington-Alexandria, DC-VA-MD-
        WV; Not Seasonally Adjusted; All items; Annual Index) 
        for September of the preceding fiscal year divided by 
        such Index for September 2011.
          (2) The term ``affiliate'' means a business entity 
        that has a relationship with a second business entity 
        if, directly or indirectly--
                  (A) one business entity controls, or has the 
                power to control, the other business entity; or
                  (B) a third party controls, or has power to 
                control, both of the business entities.
          (3) The term ``biosimilar biological product''means a 
        specific strength of a biological product in final 
        dosage form for which a biosimilar biological product 
        application has been approved.
          (4)(A) Subject to subparagraph (B), the term 
        ``biosimilar biological product application'' means an 
        application for licensure of a biological product under 
        section 351(k) of the Public Health Service Act.
          (B) Such term does not include--
                  (i) a supplement to such an application;
                  (ii) an application filed under section 
                351(k) of the Public Health Service Act that 
                cites as the reference product a bovine blood 
                product for topical application licensed before 
                September 1, 1992, or a large volume parenteral 
                drug product approved before such date;
                  (iii) an application filed under section 
                351(k) of the Public Health Service Act with 
                respect to--
                          (I) whole blood or a blood component 
                        for transfusion;
                          [(II) an allergenic extract product;]
                          [(III)] (II) an in vitro diagnostic 
                        biological product; or
                          [(IV)] (III) a biological product for 
                        further manufacturing use only; or
                  (iv) an application for licensure under 
                section 351(k) of the Public Health Service Act 
                that is submitted by a State or Federal 
                Government entity for a product that is not 
                distributed commercially.
          (5) The term ``biosimilar biological product 
        development meeting'' means any meeting, other than a 
        biosimilar initial advisory meeting, regarding the 
        content of a development program, including a proposed 
        design for, or data from, a study intended to support a 
        biosimilar biological product application.
          (6) The term ``biosimilar biological product 
        development program'' means the program under this part 
        for expediting the process for the review of 
        submissions in connection with biosimilar biological 
        product development.
          (7)(A) The term ``biosimilar biological product 
        establishment'' means a foreign or domestic place of 
        business--
                  (i) that is at one general physical location 
                consisting of one or more buildings, all of 
                which are within 5 miles of each other; and
                  (ii) at which one or more biosimilar 
                biological products are manufactured in final 
                dosage form.
          (B) For purposes of subparagraph (A)(ii), the term 
        ``manufactured'' does not include packaging.
          (8) The term ``biosimilar initial advisory 
        meeting''--
                  (A) means a meeting, if requested, that is 
                limited to--
                          (i) a general discussion regarding 
                        whether licensure under section 351(k) 
                        of the Public Health Service Act may be 
                        feasible for a particular product; and
                          (ii) if so, general advice on the 
                        expected content of the development 
                        program; and
                  (B) does not include any meeting that 
                involves substantive review of summary data or 
                full study reports.
          (9) The term ``costs of resources allocated for the 
        process for the review of biosimilar biological product 
        applications'' means the expenses in connection with 
        the process for the review of biosimilar biological 
        product applications for--
                  (A) officers and employees of the Food and 
                Drug Administration, contractors of the Food 
                and Drug Administration, advisory committees, 
                and costs related to such officers employees 
                and committees and to contracts with such 
                contractors;
                  (B) management of information, and the 
                acquisition, maintenance, and repair of 
                computer resources;
                  (C) leasing, maintenance, renovation, and 
                repair of facilities and acquisition, 
                maintenance, and repair of fixtures, furniture, 
                scientific equipment, and other necessary 
                materials and supplies; and
                  (D) collecting fees under section 744H and 
                accounting for resources allocated for the 
                review of submissions in connection with 
                biosimilar biological product development, 
                biosimilar biological product applications, and 
                supplements.
          (10) The term ``final dosage form'' means, with 
        respect to a biosimilar biological product, a finished 
        dosage form which is approved for administration to a 
        patient without substantial further manufacturing (such 
        as lyophilized products before reconstitution).
          (11) The term ``financial hold''--
                  (A) means an order issued by the Secretary to 
                prohibit the sponsor of a clinical 
                investigation from continuing the investigation 
                if the Secretary determines that the 
                investigation is intended to support a 
                biosimilar biological product application and 
                the sponsor has failed to pay any fee for the 
                product required under subparagraph (A), (B), 
                or (D) of section 744H(a)(1); and
                  (B) does not mean that any of the bases for a 
                ``clinical hold'' under section 505(i)(3) have 
                been determined by the Secretary to exist 
                concerning the investigation.
          (12) The term ``person'' includes an affiliate of 
        such person.
          (13) The term ``process for the review of biosimilar 
        biological product applications'' means the following 
        activities of the Secretary with respect to the review 
        of submissions in connection with biosimilar biological 
        product development, biosimilar biological product 
        applications, and supplements:
                  (A) The activities necessary for the review 
                of submissions in connection with biosimilar 
                biological product development, biosimilar 
                biological product applications, and 
                supplements.
                  (B) Actions related to submissions in 
                connection with biosimilar biological product 
                development, the issuance of action letters 
                which approve biosimilar biological product 
                applications or which set forth in detail the 
                specific deficiencies in such applications, and 
                where appropriate, the actions necessary to 
                place such applications in condition for 
                approval.
                  (C) The inspection of biosimilar biological 
                product establishments and other facilities 
                undertaken as part of the Secretary's review of 
                pending biosimilar biological product 
                applications and supplements.
                  (D) Activities necessary for the release of 
                lots of biosimilar biological products under 
                section 351(k) of the Public Health Service 
                Act.
                  (E) Monitoring of research conducted in 
                connection with the review of biosimilar 
                biological product applications.
                  (F) Postmarket safety activities with respect 
                to biologics approved under biosimilar 
                biological product applications or supplements, 
                including the following activities:
                          (i) Collecting, developing, and 
                        reviewing safety information on 
                        biosimilar biological products, 
                        including adverse-event reports.
                          (ii) Developing and using improved 
                        adverse-event data-collection systems, 
                        including information technology 
                        systems.
                          (iii) Developing and using improved 
                        analytical tools to assess potential 
                        safety problems, including access to 
                        external data bases.
                          (iv) Implementing and enforcing 
                        section 505(o) (relating to 
                        postapproval studies and clinical 
                        trials and labeling changes) and 
                        section 505(p) (relating to risk 
                        evaluation and mitigation strategies).
                          (v) Carrying out section 505(k)(5) 
                        (relating to adverse-event reports and 
                        postmarket safety activities).
          (14) The term ``supplement'' means a request to the 
        Secretary to approve a change in a biosimilar 
        biological product application which has been approved, 
        including a supplement requesting that the Secretary 
        determine that the biosimilar biological product meets 
        the standards for interchangeability described in 
        section 351(k)(4) of the Public Health Service Act.

SEC. 744H. AUTHORITY TO ASSESS AND USE BIOSIMILAR BIOLOGICAL PRODUCT 
                    FEES.

  (a) Types of Fees.--Beginning in [fiscal year 2018] fiscal 
year 2023, the Secretary shall assess and collect fees in 
accordance with this section as follows:
          (1) Biosimilar biological product development program 
        fees.--
                  (A) Initial biosimilar biological product 
                development fee.--
                          (i) In general.--Each person that 
                        submits to the Secretary a meeting 
                        request described under clause (ii) or 
                        a clinical protocol for an 
                        investigational new drug protocol 
                        described under clause (iii) shall pay 
                        for the product named in the meeting 
                        request or the investigational new drug 
                        application the initial biosimilar 
                        biological product development fee 
                        established under subsection (c)(5).
                          (ii) Meeting request.--The meeting 
                        request described in this clause is a 
                        request for a biosimilar biological 
                        product development meeting for a 
                        product.
                          (iii) Clinical protocol for ind.--A 
                        clinical protocol for an 
                        investigational new drug protocol 
                        described in this clause is a clinical 
                        protocol consistent with the provisions 
                        of section 505(i), including any 
                        regulations promulgated under section 
                        505(i), (referred to in this section as 
                        ``investigational new drug 
                        application'') describing an 
                        investigation that the Secretary 
                        determines is intended to support a 
                        biosimilar biological product 
                        application for a product.
                          (iv) Due date.--The initial 
                        biosimilar biological product 
                        development fee shall be due by the 
                        earlier of the following:
                                  (I) Not later than [5 days] 7 
                                days after the Secretary grants 
                                a request for a biosimilar 
                                biological product development 
                                meeting.
                                  (II) The date of submission 
                                of an investigational new drug 
                                application describing an 
                                investigation that the 
                                Secretary determines is 
                                intended to support a 
                                biosimilar biological product 
                                application.
                          (v) Transition rule.--Each person 
                        that has submitted an investigational 
                        new drug application prior to the date 
                        of enactment of the Biosimilar User Fee 
                        Act of 2012 shall pay the initial 
                        biosimilar biological product 
                        development fee by the earlier of the 
                        following:
                                  (I) Not later than 60 days 
                                after the date of the enactment 
                                of the Biosimilar User Fee Act 
                                of 2012, if the Secretary 
                                determines that the 
                                investigational new drug 
                                application describes an 
                                investigation that is intended 
                                to support a biosimilar 
                                biological product application.
                                  (II) Not later than [5 days] 
                                7 days after the Secretary 
                                grants a request for a 
                                biosimilar biological product 
                                development meeting.
                  (B) Annual biosimilar biological product 
                development fee.--
                          (i) In general.--A person that pays 
                        an initial biosimilar biological 
                        product development fee for a product 
                        shall pay for such product, beginning 
                        in the fiscal year following the fiscal 
                        year in which the initial biosimilar 
                        biological product development fee was 
                        paid, an annual fee established under 
                        subsection (c)(5)for the biosimilar 
                        biological product development program 
                        (referred to in this section as 
                        ``annual biosimilar biological product 
                        development fee''), except where such 
                        product (including, where applicable, 
                        ownership of the relevant 
                        investigational new drug application) 
                        is transferred to a licensee, assignee, 
                        or successor of such person, and 
                        written notice of such transfer is 
                        provided to the Secretary, in which 
                        case such licensee, assignee, or 
                        successor shall pay the annual 
                        biosimilar biological product 
                        development fee.
                          (ii) Due date.--The annual biosimilar 
                        biological product development fee for 
                        each fiscal year will 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.
                          (iii) Exception.--The annual 
                        biosimilar biological product 
                        development fee for each fiscal year 
                        will be due on the date specified in 
                        clause (ii), unless the person has--
                                  (I) submitted a marketing 
                                application for the biological 
                                product that was accepted for 
                                filing; [or]
                                  (II) discontinued 
                                participation in the biosimilar 
                                biological product development 
                                program for the product under 
                                subparagraph (C)[.]; or
                                  (III) been administratively 
                                removed from the biosimilar 
                                biological product development 
                                program for the product under 
                                subparagraph (E)(v).
                          (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] is subsequently 
                        accepted for filing, 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.
                  (C) Discontinuation of fee obligation.--A 
                person may discontinue participation in the 
                biosimilar biological product development 
                program for a product, effective October 1 of a 
                fiscal year, by, not later than August 1 of the 
                preceding fiscal year--
                          (i) if no investigational new drug 
                        application concerning the product has 
                        been submitted, submitting to the 
                        Secretary a written declaration that 
                        the person has no present intention of 
                        further developing the product as a 
                        biosimilar biological product; or
                          (ii) if an investigational new drug 
                        application concerning the product has 
                        been submitted, withdrawing the 
                        investigational new drug application in 
                        accordance with part 312 of title 21, 
                        Code of Federal Regulations (or any 
                        successor regulations).
                  [(D) Reactivation fee.--
                          [(i) In general.--A person that has 
                        discontinued participation in the 
                        biosimilar biological product 
                        development program for a product under 
                        subparagraph (C) shall, if the person 
                        seeks to resume participation in such 
                        program, pay a fee (referred to in this 
                        section as ``reactivation fee'') by the 
                        earlier of the following:
                                  [(I) Not later than 5 days 
                                after the Secretary grants a 
                                request by such person for a 
                                biosimilar biological product 
                                development meeting for the 
                                product (after the date on 
                                which such participation was 
                                discontinued).
                                  [(II) Upon the date of 
                                submission (after the date on 
                                which such participation was 
                                discontinued) by such person of 
                                an investigational new drug 
                                application describing an 
                                investigation that the 
                                Secretary determines is 
                                intended to support a 
                                biosimilar biological product 
                                application for that product.
                          [(ii) Application of annual fee.--A 
                        person that pays a reactivation fee for 
                        a product shall pay for such product, 
                        beginning in the next fiscal year, the 
                        annual biosimilar biological product 
                        development fee under subparagraph 
                        (B).]
                  (D) Reactivation fee.--
                          (i) In general.--A person that has 
                        discontinued participation in the 
                        biosimilar biological product 
                        development program for a product under 
                        subparagraph (C), or who has been 
                        administratively removed from the 
                        biosimilar biological product 
                        development program for a product under 
                        subparagraph (E)(v), shall, if the 
                        person seeks to resume participation in 
                        such program, pay all annual biosimilar 
                        biological product development fees 
                        previously assessed for such product 
                        and still owed and a fee (referred to 
                        in this section as ``reactivation 
                        fee'') by the earlier of the following:
                                  (I) Not later than 7 days 
                                after the Secretary grants a 
                                request by such person for a 
                                biosimilar biological product 
                                development meeting for the 
                                product (after the date on 
                                which such participation was 
                                discontinued or the date of 
                                administrative removal, as 
                                applicable).
                                  (II) Upon the date of 
                                submission (after the date on 
                                which such participation was 
                                discontinued or the date of 
                                administrative removal, as 
                                applicable) by such person of 
                                an investigational new drug 
                                application describing an 
                                investigation that the 
                                Secretary determines is 
                                intended to support a 
                                biosimilar biological product 
                                application for that product.
                          (ii) Application of annual fee.--A 
                        person that pays a reactivation fee for 
                        a product shall pay for such product, 
                        beginning in the next fiscal year, the 
                        annual biosimilar biological product 
                        development fee under subparagraph (B), 
                        except where such product (including, 
                        where applicable, ownership of the 
                        relevant investigational new drug 
                        application) is transferred to a 
                        licensee, assignee, or successor of 
                        such person, and written notice of such 
                        transfer is provided to the Secretary, 
                        in which case such licensee, assignee, 
                        or successor shall pay the annual 
                        biosimilar biological product 
                        development fee.
                  (E) Effect of failure to pay fees.--
                          (i) No biosimilar biological product 
                        development meetings.--If a person has 
                        failed to pay an initial or annual 
                        biosimilar biological product 
                        development fee as required under 
                        subparagraph (A) or (B), or a 
                        reactivation fee as required under 
                        subparagraph (D), the Secretary shall 
                        not provide a biosimilar biological 
                        product development meeting relating to 
                        the product for which fees are owed.
                          (ii) No receipt of investigational 
                        new drug applications.--Except in 
                        extraordinary circumstances, the 
                        Secretary shall not consider an 
                        investigational new drug application to 
                        have been received under section 
                        505(i)(2) if--
                                  (I) the Secretary determines 
                                that the investigation is 
                                intended to support a 
                                biosimilar biological product 
                                application; and
                                  (II) the sponsor has failed 
                                to pay an initial or annual 
                                biosimilar biological product 
                                development fee for the product 
                                as required under subparagraph 
                                (A) or (B), or a reactivation 
                                fee as required under 
                                subparagraph (D).
                          (iii) Financial hold.--
                        Notwithstanding section 505(i)(2), 
                        except in extraordinary circumstances, 
                        the Secretary shall prohibit the 
                        sponsor of a clinical investigation 
                        from continuing the investigation if--
                                  (I) the Secretary determines 
                                that the investigation is 
                                intended to support a 
                                biosimilar biological product 
                                application; and
                                  (II) the sponsor has failed 
                                to pay an initial or annual 
                                biosimilar biological product 
                                development fee for the product 
                                as required under subparagraph 
                                (A) or (B), or a reactivation 
                                fee for the product as required 
                                under subparagraph (D).
                          (iv) No acceptance of biosimilar 
                        biological product applications or 
                        supplements.--If a person has failed to 
                        pay an initial or annual biosimilar 
                        biological product development fee as 
                        required under subparagraph (A) or (B), 
                        or a reactivation fee as required under 
                        subparagraph (D), any biosimilar 
                        biological product application or 
                        supplement submitted by that person 
                        shall be considered incomplete and 
                        shall not be accepted for filing by the 
                        Secretary until all such fees owed by 
                        such person have been paid.
                          (v) Administrative removal from the 
                        biosimilar biological product 
                        development program.--If a person has 
                        failed to pay an annual biosimilar 
                        biological product development fee for 
                        a product as required under 
                        subparagraph (B) for a period of two 
                        consecutive fiscal years, the Secretary 
                        may administratively remove such person 
                        from the biosimilar biological product 
                        development program for the product. At 
                        least 30 days prior to administratively 
                        removing a person from the biosimilar 
                        biological product development program 
                        for a product under this clause, the 
                        Secretary shall provide written notice 
                        to such person of the intended 
                        administrative removal.
                  (F) Limits regarding fees.--
                          (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).
                          (ii) No waivers, exemptions, or 
                        reductions.--The Secretary shall not 
                        grant a waiver, exemption, or reduction 
                        of any initial or annual biosimilar 
                        biological product development fee due 
                        or payable under subparagraph (A) or 
                        (B), or any reactivation fee due or 
                        payable under subparagraph (D).
          (2) Biosimilar biological product application fee.--
                  (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 
                        subparagraph (A), (B), or (D).
                  (C) Payment due date.--Any fee required by 
                subparagraph (A) shall be due upon submission 
                of the application for which such fee applies.
                  (D) Exception for previously filed 
                application.--If a biosimilar biological 
                product application was submitted by a person 
                that paid the fee for such application, was 
                accepted for filing, and was not approved or 
                was withdrawn prior to approval (without a 
                waiver), the submission of a biosimilar 
                biological product application for the same 
                product by the same person (or the person's 
                licensee, assignee, or successor) shall not be 
                subject to a fee under subparagraph (A).
                  (E) Refund of application fee if application 
                refused for filing or withdrawn before 
                filing.--The Secretary shall refund 75 percent 
                of the fee paid under this paragraph for any 
                application which is refused for filing or 
                withdrawn without a waiver before filing.
                  (F) Fees for applications previously refused 
                for filing or withdrawn before filing.--A 
                biosimilar biological product application that 
                was submitted but was refused for filing, or 
                was withdrawn before being accepted or refused 
                for filing, shall be subject to the full fee 
                under subparagraph (A) upon being resubmitted 
                or filed over protest, unless the fee is waived 
                under subsection (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) may be dispensed only under 
                        prescription pursuant to section 
                        503(b); and
                          [(ii)] (iii) 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.
                  (E) Movement to discontinued list.--
                          (i) Date of inclusion.--If a written 
                        request to place a product on the list 
                        referenced in subparagraph (A) of 
                        discontinued biosimilar biological 
                        products is submitted to the Secretary 
                        on behalf of an applicant, and the 
                        request identifies the date the product 
                        is withdrawn from sale, then for 
                        purposes of assessing the biosimilar 
                        biological product program fee, the 
                        Secretary shall consider such product 
                        to have been included on such list on 
                        the later of--
                                  (I) the date such request was 
                                received; or
                                  (II) if the product will be 
                                withdrawn from sale on a future 
                                date, such future date when the 
                                product is withdrawn from sale.
                          (ii) Treatment as withdrawn from 
                        sale.--For purposes of clause (i), a 
                        product shall be considered withdrawn 
                        from sale once the applicant has ceased 
                        its own distribution of the product, 
                        whether or not the applicant has 
                        ordered recall of all previously 
                        distributed lots of the product, except 
                        that a routine, temporary interruption 
                        in supply shall not render a product 
                        withdrawn from sale.
                          (iii) Special rule.--If a biosimilar 
                        biological product that is identified 
                        in a biosimilar biological product 
                        application approved as of October 1 of 
                        a fiscal year appears, as of October 1 
                        of such fiscal year, on the list 
                        referenced in subparagraph (A) of 
                        discontinued biosimilar biological 
                        products, and on any subsequent day 
                        during such fiscal year the biosimilar 
                        biological product does not appear on 
                        such list, then except as provided in 
                        subparagraph (D), each person who is 
                        named as the applicant in a biosimilar 
                        biological product application with 
                        respect to such product shall pay the 
                        annual biosimilar biological product 
                        program fee established for a fiscal 
                        year under subsection (c)(5) for such 
                        biosimilar biological product. 
                        Notwithstanding subparagraph (B), such 
                        fee shall be due on the last business 
                        day of such fiscal year and shall be 
                        paid only once for each such product 
                        for each fiscal year.
          [(4) Biosimilar biological product fee.--
                  [(A) In general.--Each person who is named as 
                the applicant in a biosimilar biological 
                product application shall pay for each such 
                biosimilar biological product the annual fee 
                established under subsection (c)(5).
                  [(B) Due date.--The biosimilar biological 
                product 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 fee shall be paid 
                only once for each product for each fiscal 
                year.]
  (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)).]
          (1) In general.--For each of the fiscal years 2023 
        through 2027, fees under subsection (a) shall, except 
        as provided in subsection (c), be established to 
        generate a total revenue amount equal to the sum of--
                  (A) the annual base revenue for the fiscal 
                year (as determined under paragraph (3));
                  (B) the dollar amount equal to the inflation 
                adjustment for the fiscal year (as determined 
                under subsection (c)(1));
                  (C) the dollar amount equal to the strategic 
                hiring and retention adjustment (as determined 
                under subsection (c)(2));
                  (D) the dollar amount equal to the capacity 
                planning adjustment for the fiscal year (as 
                determined under subsection (c)(3));
                  (E) the dollar amount equal to the operating 
                reserve adjustment for the fiscal year, if 
                applicable (as determined under subsection 
                (c)(4));
                  (F) for fiscal year 2023 an additional amount 
                of $4,428,886; and
                  (G) for fiscal year 2024 an additional amount 
                of $320,569.
          [(3)] (2) 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 
                        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)] (B) 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)] (C) 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).]
          (3) Annual base revenue.--For purposes of paragraph 
        (1), the dollar amount of the annual base revenue for a 
        fiscal year shall be--
                  (A) for fiscal year 2023, $43,376,922; and
                  (B) for fiscal years 2024 through 2027, the 
                dollar amount of the total revenue amount 
                established under paragraph (1) for the 
                previous fiscal year, excluding any adjustments 
                to such revenue amount under subsection (c)(4).
  (c) Adjustments; Annual Fee Setting.--
          (1) Inflation adjustment.--
                  (A) In general.--For purposes of [subsection 
                (b)(2)(B)] 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)] 
                        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 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] 
                        Washington-Arlington-Alexandria, DC-VA-
                        MD-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)(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.
                  [(B) Methodology.--The Secretary shall 
                publish under paragraph (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.]
          (2) Strategic hiring and retention adjustment.--For 
        each fiscal year, after the annual base revenue under 
        subsection (b)(1)(A) is adjusted for inflation in 
        accordance with paragraph (1), the Secretary shall 
        further increase the fee revenue and fees by $150,000.
          (3) Capacity planning adjustment.--
                  (A) In general.--For each fiscal year, the 
                Secretary shall, in addition to the adjustments 
                under paragraphs (1) and (2), further adjust 
                the fee revenue and fees under this section for 
                a fiscal year to reflect changes in the 
                resource capacity needs of the Secretary for 
                the process for the review of biosimilar 
                biological product applications.
                  (B) Methodology.--For purposes of this 
                paragraph, the Secretary shall employ the 
                capacity planning methodology utilized by the 
                Secretary in setting fees for fiscal year 2021, 
                as described in the notice titled ``Biosimilar 
                User Fee Rates for Fiscal Year 2021'' published 
                in the Federal Register on August 4, 2020 (85 
                Fed. Reg. 47220). The workload categories used 
                in applying such methodology in forecasting 
                shall include only the activities described in 
                that notice and, as feasible, additional 
                activities that are also directly related to 
                the direct review of biosimilar biological 
                product applications and supplements, including 
                additional formal meeting types, the direct 
                review of postmarketing commitments and 
                requirements, the direct review of risk 
                evaluation and mitigation strategies, and the 
                direct review of annual reports for approved 
                biosimilar biological products. Subject to the 
                exceptions in the preceding sentence, the 
                Secretary shall not include as workload 
                categories in applying such methodology in 
                forecasting any non-core review activities, 
                including those activities that the Secretary 
                referenced for potential future use in such 
                notice but did not utilize in setting fees for 
                fiscal year 2021.
                  (C) Limitations.--Under no circumstances 
                shall an adjustment under this paragraph result 
                in fee revenue for a fiscal year that is less 
                than the sum of the amounts under subsections 
                (b)(1)(A) (the annual base revenue for the 
                fiscal year), (b)(1)(B) (the dollar amount of 
                the inflation adjustment for the fiscal year), 
                and (b)(1)(C) (the dollar amount of the 
                strategic hiring and retention adjustment).
                  (D) Publication in federal register.--The 
                Secretary shall publish in the Federal Register 
                notice under paragraph (5) the fee revenue and 
                fees resulting from the adjustment and the 
                methodologies under this paragraph.
          (4) Operating reserve adjustment.--
                  (A) Increase.--For fiscal year 2023 and 
                subsequent fiscal years, the Secretary shall, 
                in addition to adjustments under paragraphs 
                (1), (2), and (3), further increase the fee 
                revenue and fees if such an adjustment is 
                necessary to provide for at least 10 weeks of 
                operating reserves of carryover user fees for 
                the process for the review of biosimilar 
                biological product applications.
                  (B) Decrease.--
                          (i) Fiscal year 2023.--For fiscal 
                        year 2023, if the Secretary has 
                        carryover balances for such process in 
                        excess of 33 weeks of such operating 
                        reserves, the Secretary shall decrease 
                        such fee revenue and fees to provide 
                        for not more than 33 weeks of such 
                        operating reserves.
                          (ii) Fiscal year 2024.--For fiscal 
                        year 2024, if the Secretary has 
                        carryover balances for such process in 
                        excess of 27 weeks of such operating 
                        reserves, the Secretary shall decrease 
                        such fee revenue and fees to provide 
                        for not more than 27 weeks of such 
                        operating reserves.
                          (iii) Fiscal year 2025 and subsequent 
                        fiscal years.--For fiscal year 2025 and 
                        subsequent fiscal years, if the 
                        Secretary has carryover balances for 
                        such process in excess of 21 weeks of 
                        such operating reserves, the Secretary 
                        shall decrease such fee revenue and 
                        fees to provide for not more than 21 
                        weeks of such operating reserves.
                  (C) Federal register notice.--If an 
                adjustment under subparagraph (A) or (B) is 
                made, the rationale for the amount of the 
                increase or decrease in fee revenue and fees 
                shall be contained in the annual Federal 
                Register notice under paragraph (5)(B) 
                establishing fee revenue and fees for the 
                fiscal year involved.
          (5) Annual fee setting.--For fiscal year [2018] 2023 
        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.--
          (1) Waiver of application fee.--The Secretary shall 
        grant to a person who is named in a biosimilar 
        biological product application a waiver from the 
        application fee assessed to that person under 
        subsection (a)(2)(A) for the first biosimilar 
        biological product application that a small business or 
        its affiliate submits to the Secretary for review. 
        After a small business or its affiliate is granted such 
        a waiver, the small business or its affiliate shall pay 
        application fees for all subsequent biosimilar 
        biological product applications submitted to the 
        Secretary for review in the same manner as an entity 
        that is not a small business.
          (2) Considerations.--In determining whether to grant 
        a waiver of a fee under paragraph (1), the Secretary 
        shall consider only the circumstances and assets of the 
        applicant involved and any affiliate of the applicant.
          (3) Small business defined.--In this subsection, the 
        term ``small business'' means an entity that has fewer 
        than 500 employees, including employees of affiliates, 
        and does not have a drug product that has been approved 
        under a human drug application (as defined in section 
        735) or a biosimilar biological product application (as 
        defined in section 744G(4)) and introduced or delivered 
        for introduction into interstate commerce.
  (e) Effect of Failure To Pay Fees.--A biosimilar biological 
product application or supplement submitted by a person subject 
to fees under subsection (a) shall be considered incomplete and 
shall not be accepted for filing by the Secretary until all 
such fees owed by such person have been paid.
  (f) Crediting and Availability of Fees.--
          (1) In general.--Subject to paragraph (2), fees 
        authorized under subsection (a) shall be collected and 
        available for obligation only to the extent and in the 
        amount provided in advance in appropriations Acts. Such 
        fees are authorized to remain available until expended. 
        Such sums as may be necessary may be transferred from 
        the Food and Drug Administration salaries and expenses 
        appropriation account without fiscal year limitation to 
        such appropriation account for salaries and expenses 
        with such fiscal year limitation. The sums transferred 
        shall be available solely for the process for the 
        review of biosimilar biological product applications.
          (2) Collections and appropriation acts.--
                  (A) In general.--Subject to subparagraphs (C) 
                and (D), the fees authorized by this section 
                shall be collected and available in each fiscal 
                year in an amount not to exceed the amount 
                specified in appropriation Acts, or otherwise 
                made available for obligation for such fiscal 
                year.
                  (B) Use of fees and limitations.--
                          (i) In general.--The fees authorized 
                        by this section shall be available for 
                        a fiscal year beginning after fiscal 
                        year 2012 to defray the costs of the 
                        process for the review of biosimilar 
                        biological product applications 
                        (including such costs for an additional 
                        number of full-time equivalent 
                        positions in the Department of Health 
                        and Human Services to be engaged in 
                        such process), only if the Secretary 
                        allocates for such purpose an amount 
                        for such fiscal year (excluding amounts 
                        from fees collected under this section) 
                        no less than $20,000,000, multiplied by 
                        the adjustment factor applicable to the 
                        fiscal year involved.
                          (ii) Leasing and necessary 
                        equipment.--Beginning on October 1, 
                        2023, the authorities under section 
                        744G(9)(C) shall include only leasing 
                        and necessary scientific equipment.
                  (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.
                  (D) Provision for early payments.--Payment of 
                fees authorized under this section for a fiscal 
                year, prior to the due date for such fees, may 
                be accepted by the Secretary in accordance with 
                authority provided in advance in a prior year 
                appropriations Act.
          (3) Authorization of appropriations.--For each of 
        fiscal years [2018 through 2022] 2023 through 2027, 
        there is authorized to be appropriated for fees under 
        this section an amount equivalent to the total amount 
        of fees assessed for such fiscal year under this 
        section.
  (g) Collection of Unpaid Fees.--In any case where the 
Secretary does not receive payment of a fee assessed under 
subsection (a) within 30 days after it is due, such fee shall 
be treated as a claim of the United States Government subject 
to subchapter II of chapter 37 of title 31, United States Code.
  [(h) Written Requests for Waivers and Refunds.--To qualify 
for consideration for a waiver under subsection (d), or for a 
refund of any fee collected in accordance with subsection 
(a)(2)(A), a person shall submit to the Secretary a written 
request for such waiver or refund not later than 180 days after 
such fee is due.]
  (h) Written Requests for Waivers and Returns; Disputes 
Concerning Fees.--To qualify for consideration for a waiver 
under subsection (d), or for the return of any fee paid under 
this section, including if the fee is claimed to have been paid 
in error, a person shall submit to the Secretary a written 
request justifying such waiver or return and, except as 
otherwise specified in this section, such written request shall 
be submitted to the Secretary not later than 180 days after 
such fee is due. A request submitted under this paragraph shall 
include any legal authorities under which the request is made.
  (i) Construction.--This section may not be construed to 
require that the number of full-time equivalent positions in 
the Department of Health and Human Services, for officers, 
employers, and advisory committees not engaged in the process 
of the review of biosimilar biological product applications, be 
reduced to offset the number of officers, employees, and 
advisory committees so engaged.

SEC. 744I. REAUTHORIZATION; REPORTING REQUIREMENTS.

  (a) Performance Report.--
          (1) General requirements.--[Beginning with fiscal 
        year 2018, not] Not later than 120 days after the end 
        of each fiscal year for which fees are collected under 
        this part, the Secretary shall prepare and 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 concerning 
        the progress of the Food and Drug Administration in 
        achieving the goals identified in the letters described 
        in section 401(b) of the [Biosimilar User Fee 
        Amendments of 2017] Biosimilar User Fee Amendments of 
        2022 during such fiscal year and the future plans of 
        the Food and Drug Administration for meeting such 
        goals. The report for a fiscal year shall include 
        information on all previous cohorts for which the 
        Secretary has not given a complete response on all 
        biosimilar biological product applications and 
        supplements in the cohort.
          (2) Additional information.--[Beginning with fiscal 
        year 2018, the] The report under this subsection shall 
        include the progress of the Food and Drug 
        Administration in achieving the goals, and future plans 
        for meeting the goals, including--
                  (A) information on all previous cohorts for 
                which the Secretary has not given a complete 
                response on all biosimilar biological product 
                applications and supplements in the cohort;
                  (B) the number of original biosimilar 
                biological product applications filed per 
                fiscal year, and the number of approvals issued 
                by the agency for such applications; and
                  (C) the number of resubmitted original 
                biosimilar biological product applications 
                filed per fiscal year and the number of 
                approvals letters issued by the agency for such 
                applications.
          (3) Real time reporting.--
                  (A) In general.--[Not later than 30 calendar 
                days after the end of the second quarter of 
                fiscal year 2018, and not later than 30 
                calendar days after the end of each quarter of 
                each fiscal year thereafter] Not later than 30 
                calendar days after the end of each quarter of 
                each fiscal year for which fees are collected 
                under this part, the Secretary shall post the 
                data described in subparagraph (B) for such 
                quarter and on a cumulative basis for the 
                fiscal year on the internet website of the Food 
                and Drug Administration, and may remove 
                duplicative data from the annual report under 
                this subsection.
                  (B) Data.--The Secretary shall post the 
                following data in accordance with subparagraph 
                (A):
                          (i) The number and titles of draft 
                        and final guidance on topics related to 
                        the process for the review of 
                        biosimilars, and whether such guidances 
                        were required by statute or pursuant to 
                        a commitment under the letters 
                        described in section 401(b) of the 
                        [Biosimilar User Fee Amendments of 
                        2017] Biosimilar User Fee Amendments of 
                        2022.
                          (ii) The number and titles of public 
                        meetings held on topics related to the 
                        process for the review of biosimilars, 
                        and whether such meetings were required 
                        by statute or pursuant to a commitment 
                        under the letters described in section 
                        401(b) of the [Biosimilar User Fee 
                        Amendments of 2017] Biosimilar User Fee 
                        Amendments of 2022.
          (4) Rationale for bsufa program changes.--Beginning 
        with fiscal year 2020, the Secretary shall include in 
        the annual report under paragraph (1)--
                  (A) data, analysis, and discussion of the 
                changes in the number of full-time equivalents 
                hired as agreed upon in the letters described 
                in section 401(b) of the [Biosimilar User Fee 
                Amendments of 2017] Biosimilar User Fee 
                Amendments of 2022 and the number of full time 
                equivalents funded by budget authority at the 
                Food and Drug Administration by each division 
                within the Center for Drug Evaluation and 
                Research, the Center for Biologics Evaluation 
                and Research, the Office of Regulatory Affairs, 
                and the Office of the Commissioner;
                  (B) data, analysis, and discussion of the 
                changes in the fee revenue amounts and costs 
                for the process for the review of biosimilar 
                biological product applications, including 
                identifying drivers of such changes; and
                  (C) for each of the Center for Drug 
                Evaluation and Research, the Center for 
                Biologics Evaluation and Research, the Office 
                of Regulatory Affairs, and the Office of the 
                Commissioner, the number of employees for whom 
                time reporting is required and the number of 
                employees for whom time reporting is not 
                required.
          (5) Analysis.--For each fiscal year, the Secretary 
        shall include in the report an analysis of the 
        following:
                  (A) The difference between the aggregate 
                number of biosimilar biological product 
                applications and supplements filed and the 
                aggregate number of approvals issued by the 
                agency, accounting for--
                          (i) such applications filed during 
                        one fiscal year for which a decision is 
                        not scheduled to be made until the 
                        following fiscal year; and
                          (ii) the aggregate number of 
                        applications for each fiscal year that 
                        did not meet the goals identified by 
                        the letters described in section 401(b) 
                        of the [Biosimilar User Fee Amendments 
                        of 2017] Biosimilar User Fee Amendments 
                        of 2022 for the applicable fiscal year.
                  (B) Relevant data to determine whether the 
                Center for Drug Evaluation and Research and the 
                Center for Biologics Evaluation and Research 
                have met the performance enhancement goals 
                identified by the letters described in section 
                401(b) of the [Biosimilar User Fee Amendments 
                of 2017] Biosimilar User Fee Amendments of 2022 
                for the applicable fiscal year.
                  (C) The most common causes and trends for 
                external or other circumstances affecting the 
                ability of the Secretary to meet review time 
                and performance enhancement goals identified by 
                the letters described in section 401(b) of the 
                Biosimilar User Fee Amendments of 2017.
  (b) Fiscal Report.--[Not later than 120 days after the end of 
fiscal year 2018 and each subsequent fiscal year for which fees 
are collected under this part] Not later than 120 days after 
the end of each fiscal year for which fees are collected under 
this part, the Secretary shall prepare and submit to the 
Committee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Education, Labor, 
and Pensions of the Senate a report on the implementation of 
the authority for such fees during such fiscal year and the 
use, by the Food and Drug Administration, of the fees collected 
for such fiscal year.
  (c) Corrective Action Report.--[Beginning with fiscal year 
2018, and for] For each fiscal year for which fees are 
collected under this part, the Secretary shall prepare and 
submit a corrective action report to the Committee on Energy 
and Commerce and Committee on Appropriations of the House of 
Representatives and the Committee on Health, Education, Labor, 
and Pensions and Committee on Appropriations of the Senate. The 
report shall include the following information, as applicable:
          (1) Goals met.--For each fiscal year, if the 
        Secretary determines, based on the analysis under 
        subsection (a)(5), that each of the goals identified by 
        the letters described in section 401(b) of the 
        [Biosimilar User Fee Amendments of 2017] Biosimilar 
        User Fee Amendments of 2022 for the applicable fiscal 
        year have been met, the corrective action report shall 
        include recommendations on ways in which the Secretary 
        can improve and streamline the biosimilar biological 
        product application review process.
          (2) Goals missed.--For each of the goals identified 
        by the letters described in section 401(b) of the 
        [Biosimilar User Fee Amendments of 2017] Biosimilar 
        User Fee Amendments of 2022 for the applicable fiscal 
        year that the Secretary determines to not have been 
        met, the corrective action report shall include--
                  (A) a justification for such determination 
                and a description of the types of circumstances 
                and trends, as applicable, under which 
                biosimilar biological product applications 
                missed the review goal times but were approved 
                during the first cycle review, or review goals 
                were missed; and
                  (B) with respect to performance enhancement 
                goals that were not achieved, a description of 
                efforts the Food and Drug Administration has 
                put in place for the fiscal year in which the 
                report is submitted to improve the ability of 
                such agency to meet each such goal for the such 
                fiscal year.
  (d) Enhanced Communication.--
          (1) Communications with congress.--Each fiscal year, 
        as applicable and requested, representatives from the 
        Centers with expertise in the review of human drugs 
        shall meet with representatives from the Committee on 
        Health, Education, Labor, and Pensions of the Senate 
        and the Committee on Energy and Commerce of the House 
        of Representatives to report on the contents described 
        in the reports under this section.
          (2) Participation in congressional hearing.--Each 
        fiscal year, as applicable and requested, 
        representatives from the Food and Drug Administration 
        shall participate in a public hearing before the 
        Committee on Health, Education, Labor, and Pensions of 
        the Senate and the Committee on Energy and Commerce of 
        the House of Representatives, to report on the contents 
        described in the reports under this section. Such 
        hearing shall occur not later than 120 days after the 
        end of each fiscal year for which fees are collected 
        under this part.
  (e) Public Availability.--The Secretary shall make the 
reports required under subsections (a) and (b) available to the 
public on the Internet Web site of the Food and Drug 
Administration.
  (f) Reauthorization.--
          (1) Consultation.--In developing recommendations to 
        present to the Congress with respect to the goals 
        described in subsection (a), and plans for meeting the 
        goals, for the process for the review of biosimilar 
        biological product applications for the first 5 fiscal 
        years after [fiscal year 2022] fiscal year 2027, and 
        for the reauthorization of this part for such fiscal 
        years, the Secretary shall consult with--
                  (A) the Committee on Energy and Commerce of 
                the House of Representatives;
                  (B) the Committee on Health, Education, 
                Labor, and Pensions of the Senate;
                  (C) scientific and academic experts;
                  (D) health care professionals;
                  (E) representatives of patient and consumer 
                advocacy groups; and
                  (F) the regulated industry.
          (2) Public review of recommendations.--After 
        negotiations with the regulated industry, the Secretary 
        shall--
                  (A) present the recommendations developed 
                under paragraph (1) to the congressional 
                committees specified in such paragraph;
                  (B) publish such recommendations in the 
                Federal Register;
                  (C) provide for a period of 30 days for the 
                public to provide written comments on such 
                recommendations;
                  (D) hold a meeting at which the public may 
                present its views on such recommendations; and
                  (E) after consideration of such public views 
                and comments, revise such recommendations as 
                necessary.
          (3) Transmittal of recommendations.--Not later than 
        [January 15, 2022] January 15, 2027, the Secretary 
        shall transmit to the Congress the revised 
        recommendations under paragraph (2), a summary of the 
        views and comments received under such paragraph, and 
        any changes made to the recommendations in response to 
        such views and comments.

           *       *       *       *       *       *       *


CHAPTER VIII--IMPORTS AND EXPORTS

           *       *       *       *       *       *       *



SEC. 809. RECOGNITION OF FOREIGN GOVERNMENT INSPECTIONS.

  (a) Inspection.--The Secretary--
          (1) may enter into arrangements and agreements with a 
        foreign government or an agency of a foreign government 
        to recognize the inspection of foreign establishments 
        registered under section 510(i) in order to facilitate 
        preapproval or risk-based inspections in accordance 
        with the schedule established in paragraph (2) or (3) 
        of section 510(h);
          (2) may enter into arrangements and agreements with a 
        foreign government or an agency of a foreign government 
        under this section only with a foreign government or an 
        agency of a foreign government that the Secretary has 
        determined as having the capability of conducting 
        inspections that meet the applicable requirements of 
        this Act; and
          (3) shall perform such reviews and audits of drug 
        safety programs, systems, and standards of a foreign 
        government or agency for the foreign government as the 
        Secretary deems necessary to determine that the foreign 
        government or agency of the foreign government is 
        capable of conducting inspections that meet the 
        applicable requirements of this Act.
  (b) Results of Inspection.--The results of inspections 
performed by a foreign government or an agency of a foreign 
government under this section may be used as--
          (1) evidence of compliance with section 501(a)(2)(B) 
        or section 801(r); and
          (2) for any other purposes as determined appropriate 
        by the Secretary.
  (c) Periodic Review.--
          (1) In general.--Beginning not later than 1 year 
        after the date of the enactment of the Food and Drug 
        Amendments of 2022, the Secretary shall periodically 
        assess whether additional arrangements and agreements 
        with a foreign government or an agency of a foreign 
        government, as allowed under this section, are 
        appropriate.
          (2) Reports to congress.--Beginning not later than 4 
        years after the date of the enactment of the Food and 
        Drug Amendments of 2022, and every 4 years thereafter, 
        the Secretary shall submit to the Committee on Energy 
        and Commerce of the House of Representatives and the 
        Committee on Health, Education, Labor, and Pensions of 
        the Senate a report describing the findings and 
        conclusions of each review conducted under paragraph 
        (1).

           *       *       *       *       *       *       *

                              ----------                              


                    FDA REAUTHORIZATION ACT OF 2017




           *       *       *       *       *       *       *
TITLE I--FEES RELATING TO DRUGS

           *       *       *       *       *       *       *


SEC. 104. SUNSET DATES.

  [(a) Authorization.--Sections 735 and 736 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379g; 379h) shall cease 
to be effective October 1, 2022.
  [(b) Reporting Requirements.--Section 736B of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379h-2) shall cease to 
be effective January 31, 2023.]
  (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) 
are repealed.

           *       *       *       *       *       *       *


TITLE II--FEES RELATING TO DEVICES

           *       *       *       *       *       *       *


SEC. 210. SUNSET DATES.

  [(a) Authorization.--Sections 737 and 738 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 739i; 739j) shall cease 
to be effective October 1, 2022.
  [(b) Reporting Requirements.--Section 738A (21 U.S.C. 739j-1) 
of the Federal Food, Drug, and Cosmetic Act (regarding 
reauthorization and reporting requirements) shall cease to be 
effective January 31, 2023.]
  (c) Previous Sunset Provision.--Effective October 1, 2017, 
section 207(a) of the Food and Drug Administration Safety and 
Innovation Act (Public Law 112-144) is repealed.

TITLE III--FEES RELATING TO GENERIC DRUGS

           *       *       *       *       *       *       *


SEC. 305. SUNSET DATES.

  [(a) Authorization.--Sections 744A and 744B of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-41; 379j-42) shall 
cease to be effective October 1, 2022.
  [(b) Reporting Requirements.--Section 744C of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-43) shall cease to 
be effective January 31, 2023.]
  (c) Previous Sunset Provision.--
          (1) In general.--Effective October 1, 2017, section 
        304 of the Food and Drug Administration Safety and 
        Innovation Act (Public Law 112-144) is repealed.
          (2) Conforming amendment.--The Food and Drug 
        Administration Safety and Innovation Act (Public Law 
        112-144) is amended in the table of contents in section 
        2 by striking the item relating to section 304.

           *       *       *       *       *       *       *


TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

           *       *       *       *       *       *       *


SEC. 405. SUNSET DATES.

  [(a) Authorization.--Sections 744G and 744H of the Federal 
Food, Drug, and Cosmetic Act shall cease to be effective 
October 1, 2022.
  [(b) Reporting Requirements.--Section 744I of the Federal 
Food, Drug, and Cosmetic 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) is repealed.
          (2) Conforming amendment.--The Food and Drug 
        Administration Safety and Innovation Act (Public Law 
        112-144) is amended in the table of contents in section 
        2 by striking the item relating to section 404.

           *       *       *       *       *       *       *


TITLE VIII--IMPROVING GENERIC DRUG ACCESS

           *       *       *       *       *       *       *


SEC. 807. REPORTING ON PENDING GENERIC DRUG APPLICATIONS AND PRIORITY 
                    REVIEW APPLICATIONS.

  Not later than 180 calendar days after the date of enactment 
of this Act, and quarterly thereafter until October 1, [2022] 
2027, the Secretary of Health and Human Services shall post on 
the internet website of the Food and Drug Administration a 
report that provides, with respect to the months covered by the 
report--
          (1) with respect to applications filed under section 
        505(j) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355(j)) that, during the most recent calendar 
        year, were subject to priority review under paragraph 
        (11) of such section 505(j) (as added by section 801) 
        or expedited development and review under section 506H 
        of the Federal Food, Drug, and Cosmetic Act (as added 
        by section 803), the numbers of such applications (with 
        denotation of such applications that were filed prior 
        to October 1, 2014) that are--
                  (A) awaiting action by the applicant;
                  (B) awaiting action by the Secretary; and
                  (C) approved by the Secretary;
          (2) the number of applications filed under section 
        505(j) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355(j)) and prior approval supplements withdrawn 
        in each month;
          (3) the mean and median approval and tentative 
        approval times and the number of review cycles for such 
        applications;
          (4) the number and type of meetings requested and 
        held under such section 506H (as added by section 803); 
        and
          (5) the number of such applications on which the 
        Secretary has taken action pursuant to subsection (c) 
        of such section 506H (as added by section 803) and any 
        effect such section 506H may have on the length of time 
        for approval of applications under such section 505(j) 
        and the number of review cycles for such approvals.

           *       *       *       *       *       *       *


TITLE IX--ADDITIONAL PROVISIONS

           *       *       *       *       *       *       *


[SEC. 902. ANNUAL REPORT ON INSPECTIONS.

  [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. 
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:
          [(1) The median time following a request from staff 
        of the Food and Drug Administration reviewing an 
        application or report to the beginning of the 
        inspection, and the median time from the beginning of 
        an inspection to the issuance of a report pursuant to 
        section 704(b) of the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 374(b)).
          [(2) The median time from the issuance of a report 
        pursuant to such section 704(b) to the sending of a 
        warning letter, issuance of an import alert, or holding 
        of a regulatory meeting for inspections for which the 
        Secretary concluded that regulatory or enforcement 
        action was indicated.
          [(3) The median time from the sending of a warning 
        letter, issuance of an import alert, or holding of a 
        regulatory meeting to resolution of the regulatory or 
        enforcement action indicated for inspections for which 
        the Secretary concluded that such action was indicated.
          [(4) The number of times that a facility was issued a 
        report pursuant to such section 704(b) and approval of 
        an application was delayed due to the issuance of a 
        withhold recommendation.]

SEC. 902. ANNUAL REPORT ON INSPECTIONS.

  Not later than 120 days after the end of each fiscal year, 
the Secretary of Health and Human Services shall post on the 
public website of the Food and Drug Administration information 
related to inspections of facilities necessary for approval of 
a drug under subsection (c) or (j) of section 505 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), approval 
of a device under section 515 of such Act (21 U.S.C. 360e), or 
clearance of a device under section 510(k) of such Act (21 
U.S.C. 360(k)) that were conducted during the previous fiscal 
year. Such information shall include the following:
          (1) The median time following a request from staff of 
        the Food and Drug Administration reviewing an 
        application or report to the beginning of the 
        inspection, including--
                  (A) the median time for drugs described in 
                section 505(j)(11)(A)(i) of the Federal Food, 
                Drug, and Cosmetic Act (21 U.S.C. 
                355(j)(11)(A)(i));
                  (B) the median time for drugs described in 
                section 506C(a) of such Act (21 U.S.C. 356c(a)) 
                only; and
                  (C) the median time for drugs on the drug 
                shortage list in effect under section 506E of 
                such Act (21 U.S.C. 356e).
          (2) The median time from the issuance of a report 
        pursuant to section 704(b) of such Act (21 U.S.C. 
        374(b)) to the sending of a warning letter, issuance of 
        an import alert, or holding of a regulatory meeting for 
        inspections for which the Secretary concluded that 
        regulatory or enforcement action was indicated, 
        including the median time for each category of drugs 
        listed in subparagraphs (A) through (C) of paragraph 
        (1).
          (3) The median time from the sending of a warning 
        letter, issuance of an import alert, or holding of a 
        regulatory meeting to resolution of the actions 
        indicated to address the conditions or practices 
        observed during an inspection.
          (4) The number of facilities that failed to implement 
        adequate corrective or preventive actions following a 
        report pursuant to such section 704(b), resulting in a 
        withhold recommendation, including the number of such 
        times for each category of drugs listed in 
        subparagraphs (A) through (C) of paragraph (1).

           *       *       *       *       *       *       *

                              ----------                              


                       PUBLIC HEALTH SERVICE ACT


TITLE IV--NATIONAL RESEARCH INSTITUTES

           *       *       *       *       *       *       *



Part B--General Provisions Respecting National Research Institutes

           *       *       *       *       *       *       *



SEC. 409I. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS.

  (a) List of Priority Issues in Pediatric Therapeutics.--
          (1) In general.--Not later than one year after the 
        date of the enactment of the Best Pharmaceuticals for 
        Children Act of 2007, the Secretary, acting through the 
        Director of the National Institutes of Health and in 
        consultation with the Commissioner of Food and Drugs 
        and experts in pediatric research, shall develop and 
        publish a priority list of needs in pediatric 
        therapeutics, including drugs, biological products, or 
        indications that require study. The list shall be 
        revised every three years.
          (2) Consideration of available information.--In 
        developing and prioritizing the list under paragraph 
        (1), the Secretary--
                  (A) shall consider--
                          (i) therapeutic gaps in pediatrics 
                        that may include developmental 
                        pharmacology, pharmacogenetic 
                        determinants of drug response, 
                        metabolism of drugs and biologics in 
                        children, and pediatric clinical 
                        trials;
                          (ii) particular pediatric diseases, 
                        disorders or conditions where more 
                        complete knowledge and testing of 
                        therapeutics, including drugs and 
                        biologics, and identification of 
                        biomarkers for such diseases, 
                        disorders, or conditions, may be 
                        beneficial in pediatric populations; 
                        and
                          (iii) the adequacy of necessary 
                        infrastructure to conduct pediatric 
                        pharmacological research, including 
                        research networks and trained pediatric 
                        investigators; and
                  (B) may consider the availability of 
                qualified countermeasures (as defined in 
                section 319F-1), security countermeasures (as 
                defined in section 319F-2), and qualified 
                pandemic or epidemic products (as defined in 
                section 319F-3) to address the needs of 
                pediatric populations, in consultation with the 
                Assistant Secretary for Preparedness and 
                Response, consistent with the purposes of this 
                section.
  (b) Pediatric Studies and Research.--The Secretary, acting 
through the National Institutes of Health, shall award funds to 
entities that have the expertise to conduct pediatric clinical 
trials or other research (including qualified universities, 
hospitals, laboratories, contract research organizations, 
practice groups, federally funded programs such as pediatric 
pharmacology research units, other public or private 
institutions, or individuals) to enable the entities to conduct 
the drug studies or other research on the issues described in 
paragraphs (1) and (2)(A) of subsection (a). The Secretary may 
use contracts, grants, or other appropriate funding mechanisms 
to award funds under this subsection.
  (c) Process for Proposed Pediatric Study Requests and 
Labeling Changes.--
          (1) Submission of proposed pediatric study request.--
        The Director of the National Institutes of Health 
        shall, as appropriate, submit proposed pediatric study 
        requests for consideration by the Commissioner of Food 
        and Drugs for pediatric studies of a specific pediatric 
        indication identified under subsection (a). Such a 
        proposed pediatric study request shall be made in a 
        manner equivalent to a written request made under 
        subsection (b) or (c) of section 505A of the Federal 
        Food, Drug, and Cosmetic Act, or section 351(m) of this 
        Act, including with respect to the information provided 
        on the pediatric studies to be conducted pursuant to 
        the request. The Director of the National Institutes of 
        Health may submit a proposed pediatric study request 
        for a drug for which--
                  (A)(i) there is an approved application under 
                section 505(j) of the Federal Food, Drug, and 
                Cosmetic Act or section 351(k) of this Act; or
                  (ii) there is a submitted application that 
                could be approved under the criteria of such 
                section; and
                  (B) there remains no patent listed pursuant 
                to section 505(b)(1) of the Federal Food, Drug, 
                and Cosmetic Act, and every three-year and 
                five-year period referred to in subsection 
                (c)(3)(E)(ii), (c)(3)(E)(iii), (c)(3)(E)(iv), 
                (j)(5)(F)(ii), (j)(5)(F)(iii), or (j)(5)(F)(iv) 
                of section 505 of the Federal Food, Drug, and 
                Cosmetic Act, or applicable twelve-year period 
                referred to in section 351(k)(7) of this Act, 
                and any seven-year period referred to in 
                section 527 of the Federal Food, Drug, and 
                Cosmetic Act has ended for at least one form of 
                the drug; and
                  (C) additional studies are needed to assess 
                the safety and effectiveness of the use of the 
                drug in the pediatric population.
          (2) Written request to holders of approved 
        applications.--The Commissioner of Food and Drugs, in 
        consultation with the Director of the National 
        Institutes of Health, may issue a written request based 
        on the proposed pediatric study request for the 
        indication or indications submitted pursuant to 
        paragraph (1) (which shall include a timeframe for 
        negotiations for an agreement) for pediatric studies 
        concerning a drug identified under subsection (a) to 
        all holders of an approved application for the drug. 
        Such a written request shall be made in a manner 
        equivalent to the manner in which a written request is 
        made under subsection (b) or (c) of section 505A of the 
        Federal Food, Drug, and Cosmetic Act or section 351(m) 
        of this Act, including with respect to information 
        provided on the pediatric studies to be conducted 
        pursuant to the request and using appropriate 
        formulations for each age group for which the study is 
        requested.
          (3) Requests for proposals.--If the Commissioner of 
        Food and Drugs does not receive a response to a written 
        request issued under paragraph (2) not later than 30 
        days after the date on which a request was issued, the 
        Secretary, acting through the Director of the National 
        Institutes of Health and in consultation with the 
        Commissioner of Food and Drugs, shall publish a request 
        for proposals to conduct the pediatric studies 
        described in the written request in accordance with 
        subsection (b).
          (4) Disqualification.--A holder that receives a first 
        right of refusal shall not be entitled to respond to a 
        request for proposals under paragraph (3).
          (5) Contracts, grants, or other funding mechanisms.--
        A contract, grant, or other funding may be awarded 
        under this section only if a proposal is submitted to 
        the Secretary in such form and manner, and containing 
        such agreements, assurances, and information as the 
        Secretary determines to be necessary to carry out this 
        section.
          (6) Reporting of studies.--
                  (A) In general.--On completion of a pediatric 
                study in accordance with an award under this 
                section, a report concerning the study shall be 
                submitted to the Director of the National 
                Institutes of Health and the Commissioner of 
                Food and Drugs. The report shall include all 
                data generated in connection with the study, 
                including a written request if issued.
                  (B) Availability of reports.--
                          (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--
                                  (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--
                                          (aa) human research 
                                        participants, including 
                                        with respect to 
                                        privacy, security, 
                                        informed consent, and 
                                        protected health 
                                        information; and
                                          (bb) proprietary 
                                        interests, confidential 
                                        commercial information, 
                                        and intellectual 
                                        property rights; and
                                  (II) assigned a docket number 
                                by the Commissioner of Food and 
                                Drugs and made available for 
                                the submission of public 
                                comments.
                          (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.
                  (C) Action by commissioner.--The Commissioner 
                of Food and Drugs shall take action in a timely 
                and appropriate manner in response to the 
                reports submitted under subparagraph (A), and 
                shall begin such action upon receipt of the 
                report under subparagraph (A), in accordance 
                with paragraph (7).
          (7) Requests for labeling change.--Within the 180-day 
        period after the date on which a report is submitted 
        under paragraph (6)(A), the Commissioner of Food and 
        Drugs shall--
                  (A) review the report and such other data as 
                are available concerning the safe and effective 
                use in the pediatric population of the drug 
                studied;
                  (B) negotiate with the holders of approved 
                applications for the drug studied for any 
                labeling changes that the Commissioner of Food 
                and Drugs determines to be appropriate and 
                requests the holders to make; and
                  (C)(i) include in the public docket file a 
                reference to the location of the report on the 
                internet website of the National Institutes of 
                Health and a copy of any requested labeling 
                changes; and
                  (ii) publish through a posting on the Web 
                site of the Food and Drug Administration a 
                summary of the report and a copy of any 
                requested labeling changes.
          (8) Dispute resolution.--
                  (A) Referral to pediatric advisory 
                committee.--If, not later than the end of the 
                180-day period specified in paragraph (7), the 
                holder of an approved application for the drug 
                involved does not agree to any labeling change 
                requested by the Commissioner of Food and Drugs 
                under that paragraph, the Commissioner of Food 
                and Drugs shall refer the request to the 
                Pediatric Advisory Committee.
                  (B) Action by the pediatric advisory 
                committee.--Not later than 90 days after 
                receiving a referral under subparagraph (A), 
                the Pediatric Advisory Committee shall--
                          (i) review the available information 
                        on the safe and effective use of the 
                        drug in the pediatric population, 
                        including study reports submitted under 
                        this section; and
                          (ii) make a recommendation to the 
                        Commissioner of Food and Drugs as to 
                        appropriate labeling changes, if any.
          (9) FDA determination.--Not later than 30 days after 
        receiving a recommendation from the Pediatric Advisory 
        Committee under paragraph (8)(B)(ii) with respect to a 
        drug, the Commissioner of Food and Drugs shall consider 
        the recommendation and, if appropriate, make a request 
        to the holders of approved applications for the drug to 
        make any labeling change that the Commissioner of Food 
        and Drugs determines to be appropriate.
          (10) Failure to agree.--If a holder of an approved 
        application for a drug, within 30 days after receiving 
        a request to make a labeling change under paragraph 
        (9), does not agree to make a requested labeling 
        change, the Commissioner of Food and Drugs may deem the 
        drug to be misbranded under the Federal Food, Drug, and 
        Cosmetic Act.
          (11) No effect on authority.--Nothing in this 
        subsection limits the authority of the United States to 
        bring an enforcement action under the Federal Food, 
        Drug, and Cosmetic Act when a drug lacks appropriate 
        pediatric labeling. Neither course of action (the 
        Pediatric Advisory Committee process or an enforcement 
        action referred to in the preceding sentence) shall 
        preclude, delay, or serve as the basis to stay the 
        other course of action.
  (d) Authorization of Appropriations.--
          (1) In general.--There are authorized to be 
        appropriated to carry out this section, $25,000,000 for 
        each of fiscal years [2018 through 2022] 2023 through 
        2027.
          (2) Availability.--Any amount appropriated under 
        paragraph (1) shall remain available to carry out this 
        section until expended.

           *       *       *       *       *       *       *

                              ----------                              


      PEDIATRIC MEDICAL DEVICE SAFETY AND IMPROVEMENT ACT OF 2007




           *       *       *       *       *       *       *
TITLE III--PEDIATRIC MEDICAL DEVICE SAFETY AND IMPROVEMENT ACT OF 2007

           *       *       *       *       *       *       *


SEC. 305. DEMONSTRATION GRANTS FOR IMPROVING PEDIATRIC DEVICE 
                    AVAILABILITY.

  (a) In general.--
          (1) Request for proposals.--Not later than 90 days 
        after the date of the enactment of this Act, the 
        Secretary of Health and Human Services shall issue a 
        request for proposals for 1 or more grants or contracts 
        to nonprofit consortia for demonstration projects to 
        promote pediatric device development.
          (2) Determination on grants or contracts.--Not later 
        than 180 days after the date the Secretary of Health 
        and Human Services issues a request for proposals under 
        paragraph (1), the Secretary shall make a determination 
        on the grants or contracts under this section.
  (b) Application.--A nonprofit consortium that desires to 
receive a grant or contract under this section shall submit an 
application to the Secretary of Health and Human Services at 
such time, in such manner, and containing such information as 
the Secretary may require.
  (c) Use of Funds.--A nonprofit consortium that receives a 
grant or contract under this section shall facilitate the 
development, production, and distribution of pediatric medical 
devices by--
          (1) encouraging innovation and connecting qualified 
        individuals with pediatric device ideas with potential 
        manufacturers;
          (2) mentoring and managing pediatric device projects 
        through the development process, including product 
        identification, prototype design, device development, 
        and marketing;
          (3) connecting innovators and physicians to existing 
        Federal and non-Federal resources, including resources 
        from the Food and Drug Administration, the National 
        Institutes of Health, the Small Business 
        Administration, the Department of Energy, the 
        Department of Education, the National Science 
        Foundation, the Department of Veterans Affairs, the 
        Agency for Healthcare Research and Quality, and the 
        National Institute of Standards and Technology;
          (4) assessing the scientific and medical merit of 
        proposed pediatric device projects;
          (5) providing assistance and advice as needed on 
        business development, personnel training, prototype 
        development, postmarket needs, and other activities 
        consistent with the purposes of this section; and
          (6) providing regulatory consultation to device 
        sponsors in support of the submission of an application 
        for a pediatric device, where appropriate.
  (d) Coordination.--
          (1) National institutes of health.--Each consortium 
        that receives a grant or contract under this section 
        shall--
                  (A) coordinate with the National Institutes 
                of Health's pediatric device contact point or 
                office, designated under section 402(b)(23) of 
                the Public Health Service Act, as added by 
                section 304(a) of this Act; and
                  (B) provide to the National Institutes of 
                Health any identified pediatric device needs 
                that the consortium lacks sufficient capacity 
                to address or those needs in which the 
                consortium has been unable to stimulate 
                manufacturer interest.
          (2) Food and drug administration.--Each consortium 
        that receives a grant or contract under this section 
        shall coordinate with the Commissioner of Food and 
        Drugs and device companies to facilitate the 
        application for approval or clearance of devices 
        labeled for pediatric use.
          (3) Effectiveness and outcomes.--Each consortium that 
        receives a grant or contract under this section shall 
        annually report to the Secretary of Health and Human 
        Services on the status of pediatric device development, 
        production, and distribution that has been facilitated 
        by the consortium.
  (e) Authorization of appropriations.--There are authorized to 
be appropriated to carry out this section $5,250,000 for each 
of fiscal years [2018 through 2022] 2023 through 2027.

           *       *       *       *       *       *       *

                              ----------                              


                            ORPHAN DRUG ACT


  grants and contracts for development of drugs for rare diseases and 
                               conditions

  Sec. 5. (a) The Secretary may make grants to and enter into 
contracts with public and private entities and individuals to 
assist in (1) defraying the costs of developing drugs for rare 
diseases or conditions, including qualified testing expenses, 
(2) defraying the costs of developing medical devices for rare 
diseases or conditions, [and (3)] (3) defraying the costs of 
developing medical foods for rare diseases or conditions, and 
(4) developing regulatory science pertaining to the chemistry, 
manufacturing, and controls of individualized medical products 
to treat individuals with rare diseases or conditions.
  (b) For purposes of subsection (a):
          (1) The term ``qualified testing'' means--
                  (A) human clinical testing--
                          (i) which is carried out under an 
                        exemption for a drug for a rare disease 
                        or condition under section 505(i) of 
                        the Federal Food, Drug, and Cosmetic 
                        Act (or regulations issued under such 
                        section); and
                          (ii) which occurs before the date on 
                        which an application with respect to 
                        such drug is submitted under section 
                        505(b) of such Act or under section 351 
                        of the Public Health Service Act;
                  (B) preclinical testing involving a drug for 
                a rare disease or condition which occurs after 
                the date such drug is designated under section 
                526 of such Act and before the date on which an 
                application with respect to such drug is 
                submitted under section 505(b) of such Act or 
                under section 351 of the Public Health Service 
                Act; and
                  (C) prospectively planned and designed 
                observational studies and other analyses 
                conducted to assist in the understanding of the 
                natural history of a rare disease or condition 
                and in the development of a therapy, including 
                studies and analyses to--
                          (i) develop or validate a drug 
                        development tool related to a rare 
                        disease or condition; or
                          (ii) understand the full spectrum of 
                        the disease manifestations, including 
                        describing genotypic and phenotypic 
                        variability and identifying and 
                        defining distinct subpopulations 
                        affected by a rare disease or 
                        condition.
          (2) The term ``rare disease or condition'' means (1) 
        in the case of a drug, any disease or condition which 
        (A) affects less than 200,000 persons in the United 
        States, or (B) affects more than 200,000 in the United 
        States and for which there is no reasonable expectation 
        that the cost of developing and making available in the 
        United States a drug for such disease or condition will 
        be recovered from sales in the United States of such 
        drugs, (2) in the case of a medical device, any disease 
        or condition that occurs so infrequently in the United 
        States that there is no reasonable expectation that a 
        medical device for such disease or condition will be 
        developed without assistance under subsection (a), and 
        (3) in the case of a medical food, any disease or 
        condition that occurs so infrequently in the United 
        States that there is no reasonable expectation that a 
        medical food for such disease or condition will be 
        developed without assistance under subsection (a). 
        Determinations under the preceding sentence with 
        respect to any drug shall be made on the basis of the 
        facts and circumstances as of the date the request for 
        designation of the drug under section 526 of the 
        Federal Food, Drug, and Cosmetic Act is made.
          (3) The term ``medical food'' means a food which is 
        formulated to be consumed or administered enterally 
        under the supervision of a physician and which is 
        intended for the specific dietary management of a 
        disease or condition for which distinctive nutritional 
        requirements, based on recognized scientific 
        principles, are established by medical evaluation.
  (c) Authorization of Appropriations.--For grants and 
contracts under subsection (a), there is authorized to be 
appropriated $30,000,000 for each of fiscal years [2018 through 
2022] 2023 through 2027.
                              ----------                              


                         21ST CENTURY CURES ACT


SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

  (a) Short Title.--This Act may be cited as the ``21st Century 
Cures Act''.
  (b) Table of Contents.--The table of contents for this Act is 
as follows:


Sec. 1. Short title; table of contents.

                 section DIVISION A--21ST CENTURY CURES

     * * * * * * *

                         TITLE III--DEVELOPMENT

              Subtitle A--Patient-Focused Drug Development

     * * * * * * *
[Sec. 3003. Streamlining patient input.]
Sec. 3003. Streamlining patient and blood donor input.

           *       *       *       *       *       *       *


DIVISION A--21ST CENTURY CURES

           *       *       *       *       *       *       *


                         TITLE III--DEVELOPMENT

Subtitle A--Patient-Focused Drug Development

           *       *       *       *       *       *       *


[SEC. 3003. STREAMLINING PATIENT INPUT.

  [Chapter 35 of title 44, United States Code, shall not apply 
to the collection of information to which a response is 
voluntary, that is initiated by the Secretary under section 
569C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb-8c) (as amended by section 3001) or section 3002.]

SEC. 3003. STREAMLINING PATIENT AND BLOOD DONOR INPUT.

  Chapter 35 of title 44, United States Code, shall not apply 
to the collection of information to which a response is 
voluntary, to solicit--
          (1) the views and perspectives of patients under 
        section 569C of the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 360bbb-8c) (as amended by section 3001) 
        or section 3002; or
          (2) information from blood donors or potential blood 
        donors to support the development of recommendations by 
        the Secretary of Health and Human Services acting 
        through the Commissioner of Food and Drugs concerning 
        blood donation.

           *       *       *       *       *       *       *


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