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[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5651 Engrossed in House (EH)]

112th CONGRESS
  2d Session
                                H. R. 5651

_______________________________________________________________________

                                 AN ACT

 
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend 
 the user-fee programs for prescription drugs and for medical devices, 
 to establish user-fee programs for generic drugs and biosimilars, and 
                          for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Food and Drug Administration Reform 
Act of 2012''.

SEC. 2. TABLE OF CONTENTS.

    The table of contents of this Act is as follows:

Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. References in Act.
                    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--MEDICAL DEVICE USER FEE AMENDMENTS OF 2012

Sec. 201. Short title; findings.
Sec. 202. Definitions.
Sec. 203. Authority to assess and use device fees.
Sec. 204. Reauthorization; reporting requirements.
Sec. 205. Savings clause.
Sec. 206. Effective date.
Sec. 207. Sunset clause.
Sec. 208. Streamlined hiring authority to support activities related to 
                            the process for the review of device 
                            applications.
               TITLE III--FEES RELATING TO GENERIC DRUGS

Sec. 301. Short title.
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. Amendment with respect to misbranding.
Sec. 307. Streamlined hiring authority to support activities related to 
                            human generic drugs.
       TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

Sec. 401. Short title; finding.
Sec. 402. Fees relating to biosimilar biological products.
Sec. 403. Reauthorization; reporting requirements.
Sec. 404. Sunset dates.
Sec. 405. Effective date.
Sec. 406. Savings clause.
Sec. 407. Conforming amendment.
 TITLE V--REAUTHORIZATION OF BEST PHARMACEUTICALS FOR CHILDREN ACT AND 
                     PEDIATRIC RESEARCH EQUITY ACT

Sec. 501. Permanent extension of Best Pharmaceuticals for Children Act 
                            and Pediatric Research Equity Act.
Sec. 502. Food and Drug Administration Report.
Sec. 503. Internal Committee for Review of Pediatric Plans, 
                            Assessments, Deferrals, Deferral 
                            Extensions, and Waivers.
Sec. 504. Staff of Office of Pediatric Therapeutics.
Sec. 505. Continuation of operation of Pediatric Advisory Committee.
Sec. 506. Pediatric Subcommittee of the Oncologic Drugs Advisory 
                            Committee.
     TITLE VI--FOOD AND DRUG ADMINISTRATION ADMINISTRATIVE REFORMS

Sec. 601. Public participation in issuance of FDA guidance documents.
Sec. 602. Conflicts of interest.
Sec. 603. Electronic submission of applications.
Sec. 604. Notification of FDA intent to regulate laboratory-developed 
                            tests.
           TITLE VII--MEDICAL DEVICE REGULATORY IMPROVEMENTS

                  Subtitle A--Premarket Predictability

Sec. 701. Investigational device exemptions.
Sec. 702. Clarification of least burdensome standard.
Sec. 703. Agency documentation and review of significant decisions.
Sec. 704. Transparency in clearance process.
Sec. 705. Device Modifications Requiring Premarket Notification Prior 
                            to Marketing.
                    Subtitle B--Patients Come First

Sec. 711. Establishment of schedule and promulgation of regulation.
Sec. 712. Program to improve the device recall system.
               Subtitle C--Novel Device Regulatory Relief

Sec. 721. Modification of de novo application process.
     Subtitle D--Keeping America Competitive Through Harmonization

Sec. 731. Harmonization of device premarket review, inspection, and 
                            labeling symbols; report.
Sec. 732. Participation in international fora.
  Subtitle E--FDA Renewing Efficiency From Outside Reviewer Management

Sec. 741. Reauthorization of Third Party Review.
Sec. 742. Reauthorization of third party inspection.
                 Subtitle F--Humanitarian Device Reform

Sec. 751. Expanded access to humanitarian use devices.
               Subtitle G--Records and Reports on Devices

Sec. 761. Unique device identification system regulations.
Sec. 762. Effective device sentinel program.
                       Subtitle H--Miscellaneous

Sec. 771. Custom devices.
Sec. 772. Pediatric device reauthorization.
Sec. 773. Report on regulation of health information technology.
                TITLE VIII--DRUG REGULATORY IMPROVEMENTS

                     Subtitle A--Drug Supply Chain

Sec. 801. Registration of producers of drugs.
Sec. 802. Inspection of drugs.
Sec. 803. Drug supply quality and safety.
Sec. 804. Prohibition against delaying, denying, limiting, or refusing 
                            inspection.
Sec. 805. Destruction of adulterated, misbranded, or counterfeit drugs 
                            offered for import.
Sec. 806. Administrative detention.
Sec. 807. Enhanced criminal penalty for counterfeit drugs.
Sec. 808. Unique facility identification number.
Sec. 809. Documentation for admissibility of imports.
Sec. 810. Registration of commercial importers.
Sec. 811. Notification.
Sec. 812. Exchange of information.
Sec. 813. Extraterritorial jurisdiction.
Sec. 814. Protection against intentional adulteration.
Sec. 815. Records for inspection.
                     Subtitle B--Medical Gas Safety

Sec. 821. Regulation of medical gases.
Sec. 822. Changes to regulations.
Sec. 823. Rules of construction.
            Subtitle C--Generating Antibiotic Incentives Now

Sec. 831. Extension of exclusivity period for drugs.
Sec. 832. Study on incentives for qualified infectious disease 
                            biological products.
Sec. 833. Clinical trials.
Sec. 834. Reassessment of qualified infectious disease product 
                            incentives in 5 years.
Sec. 835. Guidance on pathogen-focused antibacterial drug development.
                    Subtitle D--Accelerated Approval

Sec. 841. Expedited approval of drugs for serious or life-threatening 
                            diseases or conditions.
Sec. 842. Guidance; amended regulations.
Sec. 843. Independent review.
               Subtitle E--Critical Path Reauthorization

Sec. 851. Reauthorization of the critical path public-private 
                            partnerships.
                       Subtitle F--Miscellaneous

Sec. 861. Reauthorization of provision relating to exclusivity of 
                            certain drugs containing single 
                            enantiomers.
Sec. 862. Extension of period for first applicant To obtain tentative 
                            approval without forfeiting 180-day 
                            exclusivity period.
Sec. 863. Final agency action relating to petitions and civil actions.
Sec. 864. Deadline for determination on certain petitions.
Sec. 865. Rare pediatric disease priority review voucher incentive 
                            program.
Sec. 866. Combating prescription drug abuse.
Sec. 867. Assessment and modification of REMS.
Sec. 868. Consultation with external experts on rare diseases, targeted 
                            therapies, and genetic targeting of 
                            treatments.
Sec. 869. Breakthrough therapies.
Sec. 870. Grants and Contracts for the Development of Orphan Drugs.
                        TITLE IX--DRUG SHORTAGES

Sec. 901. Discontinuance and interruptions of manufacturing of certain 
                            drugs.
Sec. 902. Drug shortage list.
Sec. 903. Quotas applicable to drugs in shortage.
Sec. 904. Expedited review of major manufacturing changes for potential 
                            and verified shortages of drugs that are 
                            life-supporting, life-sustaining, or 
                            intended for use in the prevention of a 
                            debilitating disease or condition.
Sec. 905. Study on drug shortages.
Sec. 906. Annual report on drug shortages.
Sec. 907. Attorney General report on drug shortages.
Sec. 908. Hospital repackaging of drugs in shortage.

SEC. 3. REFERENCES IN ACT.

    Except as otherwise specified, amendments made by this Act to a 
section or other provision of law are amendments to such section or 
other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
301 et seq.).

                    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 2012''.
    (b) Finding.--The Congress finds that the fees authorized by the 
amendments made in this title will be dedicated toward expediting the 
drug development process and the process for the review of human drug 
applications, including postmarket drug safety activities, as set forth 
in the goals identified for purposes of part 2 of subchapter C of 
chapter VII of the Federal Food, Drug, and Cosmetic Act, in the letters 
from the Secretary of Health and Human Services to the Chairman of the 
Committee on Health, Education, Labor, and Pensions of the Senate and 
the Chairman of the Committee on Energy and Commerce of the House of 
Representatives, as set forth in the Congressional Record.

SEC. 102. DEFINITIONS.

    Section 735(7) (21 U.S.C. 379g) is amended by striking ``expenses 
incurred in connection with'' and inserting ``expenses in connection 
with''.

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

    Section 736 (21 U.S.C. 379h) is amended--
            (1) in subsection (a)--
                    (A) in the matter preceding paragraph (1), by 
                striking ``fiscal year 2008'' and inserting ``fiscal 
                year 2013'';
                    (B) in paragraph (1)(A)--
                            (i) in clause (i), by striking ``(c)(5)'' 
                        and inserting ``(c)(4)''; and
                            (ii) in clause (ii), by striking ``(c)(5)'' 
                        and inserting ``(c)(4)'';
                    (C) in the matter following clause (ii) in 
                paragraph (2)(A)--
                            (i) by striking ``(c)(5)'' and inserting 
                        ``(c)(4)''; and
                            (ii) by striking ``payable on or before 
                        October 1 of each year'' and inserting ``due on 
                        the later of the first business day on or after 
                        October 1 of such 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'';
                    (D) in paragraph (3)--
                            (i) in subparagraph (A)--
                                    (I) by striking ``subsection 
                                (c)(5)'' and inserting ``subsection 
                                (c)(4)''; and
                                    (II) by striking ``payable on or 
                                before October 1 of each year.'' and 
                                inserting ``due on the later of the 
                                first business day on or after October 
                                1 of each such fiscal year or the first 
                                business day after the enactment of an 
                                appropriations Act providing for the 
                                collection and obligation of fees for 
                                each such fiscal year under this 
                                section.''; and
                            (ii) by amending subparagraph (B) to read 
                        as follows:
                    ``(B) Exception.--A prescription drug product shall 
                not be assessed a fee under subparagraph (A) if such 
                product is--
                            ``(i) identified on the list compiled under 
                        section 505(j)(7)(A) 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)(A);
                            ``(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.'';
            (2) in subsection (b)--
                    (A) in paragraph (1)--
                            (i) in the language preceding subparagraph 
                        (A), by striking ``fiscal years 2008 through 
                        2012'' and inserting ``fiscal years 2013 
                        through 2017''; and
                            (ii) in subparagraph (A), by striking 
                        ``$392,783,000; and'' and inserting 
                        ``$693,099,000;''; and
                            (iii) by striking subparagraph (B) and 
                        inserting the following:
                    ``(B) the dollar amount equal to the inflation 
                adjustment for fiscal year 2013 (as determined under 
                paragraph (3)(A)); and
                    ``(C) the dollar amount equal to the workload 
                adjustment for fiscal year 2013 (as determined under 
                paragraph (3)(B)).''; and
                    (B) by striking paragraphs (3) and (4) and 
                inserting the following:
            ``(3) Fiscal year 2013 inflation and workload 
        adjustments.--For purposes of paragraph (1), the dollar amount 
        of the inflation and workload adjustments for fiscal year 2013 
        shall be determined as follows:
                    ``(A) Inflation adjustment.--The inflation 
                adjustment for fiscal year 2013 shall be the sum of--
                            ``(i) $652,709,000 multiplied by the result 
                        of an inflation adjustment calculation 
                        determined using the methodology described in 
                        subsection (c)(1)(B); and
                            ``(ii) $652,709,000 multiplied by the 
                        result of an inflation adjustment calculation 
                        determined using the methodology described in 
                        subsection (c)(1)(C).
                    ``(B) Workload adjustment.--Subject to subparagraph 
                (C), the workload adjustment for fiscal 2013 shall be--
                            ``(i) $652,709,000 plus the amount of the 
                        inflation adjustment calculated under 
                        subparagraph (A); multiplied by
                            ``(ii) the amount (if any) by which a 
                        percentage workload adjustment for fiscal year 
                        2013, as determined using the methodology 
                        described in subsection (c)(2)(A), would exceed 
                        the percentage workload adjustment (as so 
                        determined) for fiscal year 2012, if both such 
                        adjustment percentages were calculated using 
                        the 5-year base period consisting of fiscal 
                        years 2003 through 2007.
                    ``(C) Limitation.--Under no circumstances shall the 
                adjustment under subparagraph (B) result in fee 
                revenues for fiscal year 2013 that are less than the 
                sum of the amount under paragraph (1)(A) and the amount 
                under paragraph (1)(B).'';
            (3) by striking subsection (c) and inserting the following:
    ``(c) Adjustments.--
            ``(1) Inflation adjustment.--For fiscal year 2014 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 by the 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 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
                    ``(C) the average annual percent change that 
                occurred in the Consumer Price Index for urban 
                consumers (Washington-Baltimore, DC-MD-VA-WV; Not 
                Seasonally Adjusted; All items; Annual Index) for the 
                first 3 years of the preceding 4 years of available 
                data multiplied by the proportion of all costs other 
                than personnel compensation and benefits costs to total 
                costs of the process for the review of human drug 
                applications (as defined in section 735(6)) for the 
                first 3 years of the preceding 4 fiscal years.
        The adjustment made each fiscal year under this paragraph shall 
        be added on a compounded basis to the sum of all adjustments 
        made each fiscal year after fiscal year 2013 under this 
        paragraph.
            ``(2) Workload adjustment.--For fiscal year 2014 and 
        subsequent fiscal years, after the fee revenues established in 
        subsection (b) are adjusted for a fiscal year for inflation in 
        accordance with paragraph (1), the fee revenues shall be 
        adjusted further for such fiscal year to reflect changes in the 
        workload of the Secretary for the process for the review of 
        human drug applications. With respect to such adjustment:
                    ``(A) The adjustment shall be determined by the 
                Secretary based on a weighted average of the change in 
                the total number of human drug applications (adjusted 
                for changes in review activities, as described in the 
                notice that the Secretary is required to publish in the 
                Federal Register under this subparagraph), efficacy 
                supplements, and manufacturing supplements submitted to 
                the Secretary, and the change in the total number of 
                active commercial investigational new drug applications 
                (adjusted for changes in review activities, as so 
                described) during the most recent 12-month period for 
                which data on such submissions is available. The 
                Secretary shall publish in the Federal Register the fee 
                revenues and fees resulting from the adjustment and the 
                supporting methodologies.
                    ``(B) Under no circumstances shall the adjustment 
                result in fee revenues for a fiscal year that are less 
                than the sum of the amount under subsection (b)(1)(A) 
                and the amount under subsection (b)(1)(B), as adjusted 
                for inflation under paragraph (1).
                    ``(C) The Secretary shall contract with an 
                independent accounting or consulting firm to 
                periodically review the adequacy of the adjustment and 
                publish the results of those reviews. The first review 
                shall be conducted and published by the end of fiscal 
                year 2013 (to examine the performance of the adjustment 
                since fiscal year 2009), and the second review shall be 
                conducted and published by the end of fiscal year 2015 
                (to examine the continued performance of the 
                adjustment). The reports shall evaluate whether the 
                adjustment reasonably represents actual changes in 
                workload volume and complexity and present options to 
                discontinue, retain, or modify any elements of the 
                adjustment. The reports shall be published for public 
                comment. After review of the reports and receipt of 
                public comments, the Secretary shall, if warranted, 
                adopt appropriate changes to the methodology. If the 
                Secretary adopts changes to the methodology based on 
                the first report, the changes shall be effective for 
                the first fiscal year for which fees are set after the 
                Secretary adopts such changes and each subsequent 
                fiscal year.
            ``(3) Final year adjustment.--For fiscal year 2017, the 
        Secretary may, in addition to adjustments under this paragraph 
        and paragraphs (1) and (2), 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 the process for the review 
        of human drug applications for the first 3 months of fiscal 
        year 2018. 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 2017. 
        If the Secretary has carryover balances for such process in 
        excess of 3 months of such operating reserves, the adjustment 
        under this subparagraph shall not be made.
            ``(4) Annual fee setting.--The Secretary shall, not later 
        than 60 days before the start of each fiscal year that begins 
        after September 30, 2012, establish, for the next fiscal year, 
        application, product, and establishment fees under subsection 
        (a), based on the revenue amounts established under subsection 
        (b) and the adjustments provided under this subsection.
            ``(5) 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.''; 
        and
            (4) in subsection (g)--
                    (A) in paragraph (1), by striking ``Fees 
                authorized'' and inserting ``Subject to paragraph 
                (2)(C), fees authorized'';
                    (B) in paragraph (2)--
                            (i) in subparagraph (A)(i), by striking 
                        ``shall be retained'' and inserting ``shall be 
                        collected and available'';
                            (ii) in subparagraph (A)(ii), by striking 
                        ``shall only be collected and available'' and 
                        inserting ``shall be available''; and
                            (iii) by adding at the end the following 
                        new 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.'';
                    (C) in paragraph (3), by striking ``fiscal years 
                2008 through 2012'' and inserting ``fiscal years 2013 
                through 2017''; and
                    (D) in paragraph (4)--
                            (i) by striking ``fiscal years 2008 through 
                        2010'' and inserting ``fiscal years 2013 
                        through 2015'';
                            (ii) by striking ``fiscal year 2011'' and 
                        inserting ``fiscal year 2016'';
                            (iii) by striking ``fiscal years 2008 
                        through 2011'' and inserting ``fiscal years 
                        2013 through 2016''; and
                            (iv) by striking ``fiscal year 2012'' and 
                        inserting ``fiscal year 2017''.

SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS.

    Section 736B (21 U.S.C. 379h-2) is amended--
            (1) by amending subsection (a) to read as follows:
    ``(a) Performance Report.--
            ``(1) In general.--Beginning with fiscal year 2013, 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 2012 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; and
                            ``(vii) the number of applications filed 
                        for orphan-designated products per 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.''.
            (2) in subsection (b), by striking ``2008'' and inserting 
        ``2013''; and
            (3) in subsection (d), by striking ``2012'' each place it 
        appears and inserting ``2017''.

SEC. 105. SUNSET DATES.

    (a) Authorization.--Sections 735 and 736 (21 U.S.C. 379g; 379h) are 
repealed October 1, 2017.
    (b) Reporting Requirements.--Section 736B (21 U.S.C. 379h-2) is 
repealed January 31, 2018.
    (c) Previous Sunset Provision.--
            (1) In general.--Section 106 of the Prescription Drug User 
        Fee Amendments of 2007 (Title I of Public Law 110-85) is 
        repealed.
            (2) Conforming amendment.--The Food and Drug Administration 
        Amendments Act of 2007 (Public Law 110-85) is amended in the 
        table of contents in section 2, by striking the item relating 
        to section 106.
    (d) Technical Clarifications.--
            (1) Effective September 30, 2007--
                    (A) section 509 of the Prescription Drug User Fee 
                Amendments Act of 2002 (Title V of Public Law 107-188) 
                is repealed; and
                    (B) the Public Health Security and Bioterrorism 
                Preparedness and Response Act of 2002 (Public Law 107-
                188) is amended in the table of contents in section 
                1(b), by striking the item relating to section 509.
            (2) Effective September 30, 2002--
                    (A) section 107 of the Food and Drug Administration 
                Modernization Act of 1997 (Public Law 105-115) is 
                repealed; and
                    (B) the table of contents in section 1(c) of such 
                Act is amended by striking the item related to section 
                107.
            (3) Effective September 30, 1997, section 105 of the 
        Prescription Drug User Fee Act of 1992 (Public Law 102-571) is 
        repealed.

SEC. 106. EFFECTIVE DATE.

    The amendments made by this title shall take effect on October 1, 
2012, or the date of the enactment of this Act, whichever is later, 
except that fees under part 2 of subchapter C of chapter VII of the 
Federal Food, Drug, and Cosmetic Act shall be assessed for all human 
drug applications received on or after October 1, 2012, 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, 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, 2007, but before October 1, 2012, 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 2012.

          TITLE II--MEDICAL DEVICE USER FEE AMENDMENTS OF 2012

SEC. 201. SHORT TITLE; FINDINGS.

    (a) Short Title.--This Act may be cited as the ``Medical Device 
User Fee Amendments of 2012''.
    (b) Findings.--The Congress finds that the fees authorized under 
the amendments made by this title will be dedicated toward expediting 
the process for the review of device applications and for assuring the 
safety and effectiveness of devices, as set forth in the goals 
identified for purposes of part 3 of subchapter C of chapter VII of the 
Federal Food, Drug, and Cosmetic Act in the letters from the Secretary 
of Health and Human Services to the Chairman of the Committee on 
Health, Education, Labor, and Pensions of the Senate and the Chairman 
of the Committee on Energy and Commerce of the House of 
Representatives, as set forth in the Congressional Record.

SEC. 202. DEFINITIONS.

    Section 737 (21 U.S.C. 379i) is amended--
            (1) in paragraph (9), by striking ``incurred'' after 
        ``expenses'';
            (2) in paragraph (10), by striking ``October 2001'' and 
        inserting ``October 2011''; and
            (3) in paragraph (13), by striking ``is required to 
        register'' and all that follows through the end of paragraph 
        (13) and inserting the following: ``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. 203. AUTHORITY TO ASSESS AND USE DEVICE FEES.

    (a) Types of Fees.--Section 738(a) (21 U.S.C. 379j(a)) is amended--
            (1) in paragraph (1), by striking ``fiscal year 2008'' and 
        inserting ``fiscal year 2013'';
            (2) in paragraph (2)(A)--
                    (A) in the matter preceding clause (i)--
                            (i) by striking ``subsections (d) and (e)'' 
                        and inserting ``subsections (d), (e), and 
                        (f)'';
                            (ii) by striking ``October 1, 2002'' and 
                        inserting ``October 1, 2012''; and
                            (iii) by striking ``subsection (c)(1)'' and 
                        inserting ``subsection (c)''; and
                    (B) in clause (viii), by striking ``1.84'' and 
                inserting ``2''; and
            (3) in paragraph (3)--
                    (A) in subparagraph (A), by inserting ``and 
                subsection (f)'' after ``subparagraph (B)''; and
                    (B) in subparagraph (C), by striking ``initial 
                registration'' and all that follows through ``section 
                510.'' and inserting ``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.--Section 738(b) (21 U.S.C. 379j(b)) is amended to 
read as follows:
    ``(b) Fee Amounts.--
            ``(1) In general.--Subject to subsections (c), (d), (e), 
        (f), and (i), for each of fiscal years 2013 through 2017, 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 2013  Year 2014  Year 2015  Year 2016  Year 2017
----------------------------------------------------------------------------------------------------------------
Premarket Application....................................   $248,000   $252,960   $258,019   $263,180   $268,443
Establishment Registration...............................     $2,575     $3,200     $3,750     $3,872     $3,872
----------------------------------------------------------------------------------------------------------------

            ``(3) Total revenue amounts.--For purposes of paragraph 
        (1), the total revenue amounts specified in this paragraph are 
        as follows:
                    ``(A) $97,722,301 for fiscal year 2013.
                    ``(B) $112,580,497 for fiscal year 2014.
                    ``(C) $125,767,107 for fiscal year 2015.
                    ``(D) $129,339,949 for fiscal year 2016.
                    ``(E) $130,184,348 for fiscal year 2017.''.
    (c) Annual Fee Setting; Adjustments.--Section 738(c) (21 U.S.C. 
379j(c)) is amended--
            (1) in the subsection heading, by inserting ``; 
        Adjustments'' after ``Setting'';
            (2) by striking paragraphs (1) and (2);
            (3) by redesignating paragraphs (3) and (4) as paragraphs 
        (4) and (5), respectively; and
            (4) by inserting before paragraph (4), as so redesignated, 
        the following:
            ``(1) In general.--The Secretary shall, 60 days before the 
        start of each fiscal year after September 30, 2012, 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 2014 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 to total 
                revenue amounts.--The applicable inflation adjustment 
                for a fiscal year is--
                            ``(i) for fiscal year 2014, the base 
                        inflation adjustment under subparagraph (C) for 
                        such fiscal year; and
                            ``(ii) for fiscal year 2015 and each 
                        subsequent fiscal year, 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 2014.
                    ``(C) Base inflation adjustment to total revenue 
                amounts.--
                            ``(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; 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 2014 through 2017, the base fee amounts 
                specified in subsection (b)(2) shall be adjusted as 
                needed, 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 2014 through 
        2017, 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 
        further adjusted, 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).''.
    (d) Fee Waiver or Reduction.--Section 738 (21 U.S.C. 379j) is 
amended by--
            (1) redesignating subsections (f) through (k) as 
        subsections (g) through (l), respectively; and
            (2) by inserting after subsection (e) the following new 
        subsection (f):
    ``(f) Fee Waiver or Reduction.--
            ``(1) In general.--The Secretary may, at the Secretary's 
        sole discretion, grant a waiver or reduction of fees under 
        subsection (a)(2) or (a)(3) if the Secretary finds that such 
        waiver or reduction is in the interest of public health.
            ``(2) Limitation.--The sum of all fee waivers or reductions 
        granted by the Secretary in any fiscal year under paragraph (1) 
        shall not exceed 2 percent of the total fee revenue amounts 
        established for such year under subsection (c).
            ``(3) Duration.--The authority provided by this subsection 
        terminates October 1, 2017.''.
    (e) Conditions.--Section 738(h)(1)(A) (21 U.S.C. 379j(h)(1)(A)), as 
redesignated by subsection (d)(1), is amended by striking 
``$205,720,000'' and inserting ``$280,587,000''.
    (f) Crediting and Availability of Fees.--Section 738(i) (21 U.S.C. 
379j(i)), as redesignated by subsection (d)(1), is amended--
            (1) in paragraph (1), by striking ``Fees authorized'' and 
        inserting ``Subject to paragraph (2)(C), fees authorized'';
            (2) in paragraph (2)--
                    (A) in subparagraph (A)--
                            (i) in clause (i), by striking ``shall be 
                        retained'' and inserting ``subject to 
                        subparagraph (C), shall be collected and 
                        available''; and
                            (ii) in clause (ii)--
                                    (I) by striking ``collected and'' 
                                after ``shall only be''; and
                                    (II) by striking ``fiscal year 
                                2002'' and inserting ``fiscal year 
                                2009''; and
                    (B) by adding at the end, the following:
                    ``(C) Provision for early year 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) in paragraph (3), by amending to read as follows:
            ``(3) Authorizations of appropriations.--For each of the 
        fiscal years 2013 through 2017, 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) and, for fiscal 
        year 2017 only, as further adjusted under paragraph (4).''; and
            (4) in paragraph (4)--
                    (A) by striking ``fiscal years 2008, 2009, and 
                2010'' and inserting ``fiscal years 2013, 2014, and 
                2015'';
                    (B) by striking ``fiscal year 2011'' and inserting 
                ``fiscal year 2016'';
                    (C) by striking ``June 30, 2011'' and inserting 
                ``June 30, 2016'';
                    (D) by striking ``the amount of fees specified in 
                aggregate in'' and inserting ``the cumulative amount 
                appropriated pursuant to'';
                    (E) by striking ``aggregate amount in'' before 
                ``excess shall be credited''; and
                    (F) by striking ``fiscal year 2012'' and inserting 
                ``fiscal year 2017''.
    (g) Conforming Amendment.--Section 515(c)(4)(A) (21 U.S.C. 
360e(c)(4)(A)) is amended by striking ``738(g)'' and inserting 
``738(h)''.

SEC. 204. REAUTHORIZATION; REPORTING REQUIREMENTS.

    (a) Reauthorization.--Section 738A(b) (21 U.S.C. 379j-1(b)) is 
amended--
            (1) in paragraph (1), by striking ``2012'' and inserting 
        ``2017''; and
            (2) in paragraph (5), by striking ``2012'' and inserting 
        ``2017''.
    (b) Performance Reports.--Section 738A(a) (21 U.S.C. 379j-1(a)) is 
amended--
            (1) by striking paragraph (1) and inserting the following:
            ``(1) Performance report.--
                    ``(A) In general.--Beginning with fiscal year 2013, 
                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 2012 during such fiscal 
                year and the future plans of the Food and Drug 
                Administration for meeting the goals.
                    ``(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 Act of 2012, the Secretary 
                shall make such information publicly available on the 
                Internet Website 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.''; and
            (2) in paragraph (2), by striking ``2008 through 2012'' and 
        inserting ``2013 through 2017''.

SEC. 205. 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, 
2007, but before October 1, 2012, 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 2013.

SEC. 206. EFFECTIVE DATE.

    The amendments made by this title shall take effect on October 1, 
2012, or the date of the enactment of this Act, whichever is later, 
except that fees under part 3 of subchapter C of chapter VII of the 
Federal Food, Drug, and Cosmetic Act shall be assessed for all 
submissions listed in section 738(a)(2)(A) of such Act received on or 
after October 1, 2012, regardless of the date of the enactment of this 
Act.

SEC. 207. SUNSET CLAUSE.

    (a) In General.--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, 2017. Section 738A (21 U.S.C. 739j-1) of the Federal Food, 
Drug, and Cosmetic Act (regarding reauthorization and reporting 
requirements) is repealed January 31, 2018.
    (b) Previous Sunset Provision.--
            (1) In general.--Section 217 of the Medical Device User Fee 
        Amendments of 2007 (Title II of Public Law 110-85) is repealed.
            (2) Conforming amendment.--The Food and Drug Administration 
        Amendments Act of 2007 (Public Law 110-85) is amended in the 
        table of contents in section 2, by striking the item relating 
        to section 217.
    (c) Technical Clarification.--Effective September 30, 2007--
            (1) section 107 of the Medical Device User Fee and 
        Modernization Act of 2002 (Public Law 107-250) is repealed; and
            (2) the table of contents in section 1(b) of such Act is 
        amended by striking the item related to section 107.

SEC. 208. STREAMLINED HIRING AUTHORITY TO SUPPORT ACTIVITIES RELATED TO 
              THE PROCESS FOR THE REVIEW OF DEVICE APPLICATIONS.

    Subchapter A of chapter VII (21 U.S.C. 371 et seq.) is amended by 
inserting after section 713 the following new section:

``SEC. 714. STREAMLINED HIRING AUTHORITY.

    ``(a) In General.--In addition to any other personnel authorities 
under other provisions of law, the Secretary may, without regard to the 
provisions of title 5, United States Code, governing appointments in 
the competitive service, appoint employees to positions in the Food and 
Drug Administration to perform, administer, or support activities 
described in subsection (b), if the Secretary determines that such 
appointments are needed to achieve the objectives specified in 
subsection (c).
    ``(b) Activities Described.--The activities described in this 
subsection are activities under this Act related to the process for the 
review of device applications (as defined in section 737(8)).
    ``(c) Objectives Specified.--The objectives specified in this 
subsection are with respect to the activities under subsection (b)(1), 
the goals referred to in section 738A(a)(1).
    ``(d) Internal Controls.--The Secretary shall institute appropriate 
internal controls for appointments under this section.
    ``(e) Sunset.--The authority to appoint employees under this 
section shall terminate on the date that is three years after the date 
of enactment of this section.''.

               TITLE III--FEES RELATING TO GENERIC DRUGS

SEC. 301. SHORT TITLE.

    (a) Short Title.--This title may be cited as the ``Generic Drug 
User Fee Amendments of 2012''.
    (b) Finding.--The Congress finds that the fees authorized by the 
amendments made in this title will be dedicated to human generic drug 
activities, as set forth in the goals identified for purposes of part 7 
of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic 
Act, in the letters from the Secretary of Health and Human Services to 
the Chairman of the Committee on Health, Education, Labor, and Pensions 
of the Senate and the Chairman of the Committee on Energy and Commerce 
of the House of Representatives, as set forth in the Congressional 
Record.

SEC. 302. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG FEES.

    Subchapter C of chapter VII (21 U.S.C. 379f et seq.) is amended by 
adding at the end the following:

                ``PART 7--FEES RELATING TO GENERIC DRUGS

``SEC. 744A. DEFINITIONS.

    ``For purposes of this part:
            ``(1) The term `abbreviated new drug application'--
                    ``(A) means an application submitted under section 
                505(j), an abbreviated application submitted 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 an abbreviated new drug 
                application submitted pursuant to regulations in effect 
                prior to the implementation of the Drug Price 
                Competition and Patent Term Restoration Act of 1984; 
                and
                    ``(B) does not include an application for a 
                positron emission tomography drug.
            ``(2) The term `active pharmaceutical ingredient' means--
                    ``(A) a substance, or a mixture when the substance 
                is unstable or cannot be transported on its own, 
                intended--
                            ``(i) to be used as a component of a drug; 
                        and
                            ``(ii) to furnish pharmacological activity 
                        or other direct effect in the diagnosis, cure, 
                        mitigation, treatment, or prevention of 
                        disease, or to affect the structure or any 
                        function of the human body; or
                    ``(B) a substance intended for final 
                crystallization, purification, or salt formation, or 
                any combination of those activities, to become a 
                substance or mixture described in subparagraph (A).
            ``(3) The term `adjustment factor' means a factor 
        applicable to a fiscal year that 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 2011.
            ``(4) 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.
            ``(5)(A) The term `facility'--
                    ``(i) means a business or other entity--
                            ``(I) under one management, either direct 
                        or indirect; and
                            ``(II) at one geographic location or 
                        address engaged in manufacturing or processing 
                        an active pharmaceutical ingredient or a 
                        finished dosage form; and
                    ``(ii) does not include a business or other entity 
                whose only manufacturing or processing activities are 
                one or more of the following: repackaging, relabeling, 
                or testing.
            ``(B) For purposes of subparagraph (A), separate buildings 
        within close proximity are considered to be at one geographic 
        location or address if the activities in them are--
                    ``(i) closely related to the same business 
                enterprise;
                    ``(ii) under the supervision of the same local 
                management; and
                    ``(iii) capable of being inspected by the Food and 
                Drug Administration during a single inspection.
            ``(C) If a business or other entity would meet the 
        definition of a facility under this paragraph but for being 
        under multiple management, the business or other entity is 
        deemed to constitute multiple facilities, one per management 
        entity, for purposes of this paragraph.
            ``(6) The term `finished dosage form' means--
                    ``(A) a drug product in the form in which it will 
                be administered to a patient, such as a tablet, 
                capsule, solution, or topical application;
                    ``(B) a drug product in a form in which 
                reconstitution is necessary prior to administration to 
                a patient, such as oral suspensions or lyophilized 
                powders; or
                    ``(C) any combination of an active pharmaceutical 
                ingredient with another component of a drug product for 
                purposes of production of a drug product described in 
                subparagraph (A) or (B).
            ``(7) The term `generic drug submission' means an 
        abbreviated new drug application, an amendment to an 
        abbreviated new drug application, or a prior approval 
        supplement to an abbreviated new drug application.
            ``(8) The term `human generic drug activities' means the 
        following activities of the Secretary associated with generic 
        drugs and inspection of facilities associated with generic 
        drugs:
                    ``(A) The activities necessary for the review of 
                generic drug submissions, including review of drug 
                master files referenced in such submissions.
                    ``(B) The issuance of--
                            ``(i) approval letters which approve 
                        abbreviated new drug applications or 
                        supplements to such applications; or
                            ``(ii) complete response letters 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 issuance of letters related to Type II 
                active pharmaceutical drug master files which--
                            ``(i) set forth in detail the specific 
                        deficiencies in such submissions, and where 
                        appropriate, the actions necessary to resolve 
                        those deficiencies; or
                            ``(ii) document that no deficiencies need 
                        to be addressed.
                    ``(D) Inspections related to generic drugs.
                    ``(E) Monitoring of research conducted in 
                connection with the review of generic drug submissions 
                and drug master files.
                    ``(F) Postmarket safety activities with respect to 
                drugs approved under abbreviated new 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) insofar as those 
                        activities relate to abbreviated new drug 
                        applications.
                            ``(v) Carrying out section 505(k)(5) 
                        (relating to adverse-event reports and 
                        postmarket safety activities).
                    ``(G) Regulatory science activities related to 
                generic drugs.
            ``(9) The term `positron emission tomography drug' has the 
        meaning given to the term `compounded positron emission 
        tomography drug' in section 201(ii), except that paragraph 
        (1)(B) of such section shall not apply.
            ``(10) The term `prior approval supplement' means a request 
        to the Secretary to approve a change in the drug substance, 
        drug product, production process, quality controls, equipment, 
        or facilities covered by an approved abbreviated new drug 
        application when that change has a substantial potential to 
        have an adverse effect on the identity, strength, quality, 
        purity, or potency of the drug product as these factors may 
        relate to the safety or effectiveness of the drug product.
            ``(11) The term `resources allocated for human generic drug 
        activities' means the expenses 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 and employees 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 subsection (a) and 
                accounting for resources allocated for the review of 
                abbreviated new drug applications and supplements and 
                inspection related to generic drugs.
            ``(12) The term `Type II active pharmaceutical ingredient 
        drug master file' means a submission of information to the 
        Secretary by a person that intends to authorize the Food and 
        Drug Administration to reference the information to support 
        approval of a generic drug submission without the submitter 
        having to disclose the information to the generic drug 
        submission applicant.

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

    ``(a) Types of Fees.--Beginning in fiscal year 2013, 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 cause to be published 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).
            ``(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.--
                            ``(i) Fiscal year 2013.--Not later than 
                        October 31, 2012, the Secretary shall cause to 
                        be published in the Federal Register a notice 
                        announcing the amount of the drug master file 
                        fee for fiscal year 2013.
                            ``(ii) Fiscal year 2014 through 2017.--Not 
                        later than 60 days before the start of each of 
                        fiscal years 2014 through 2017, the Secretary 
                        shall cause to be published 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 no later 
                        than the date on which the first generic drug 
                        submission is submitted that references the 
                        associated Type II active pharmaceutical 
                        ingredient drug master file.
                            ``(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 clause (i) or (ii) of subparagraph 
                                (C), as applicable; or
                                    ``(II) 30 calendar days after the 
                                date of enactment of an appropriations 
                                Act providing for the collection and 
                                obligation of fees under this section.
            ``(3) Abbreviated new drug application and prior approval 
        supplement filing fee.--
                    ``(A) In general.--Each applicant that submits, on 
                or after October 1, 2012, an abbreviated new drug 
                application or a prior approval supplement to an 
                abbreviated new drug application shall be subject to a 
                fee for each such submission in the amount established 
                under subsection (d).
                    ``(B) Notice.--
                            ``(i) Fiscal year 2013.--Not later than 
                        October 31, 2012, the Secretary shall cause to 
                        be published in the Federal Register a notice 
                        announcing the amount of the fees under 
                        subparagraph (A) for fiscal year 2013.
                            ``(ii) Fiscal years 2014 through 2017.--Not 
                        later than 60 days before the start of each of 
                        fiscal years 2014 through 2017, the Secretary 
                        shall cause to be published in the Federal 
                        Register the amount of the fees under 
                        subparagraph (A) for such fiscal year.
                    ``(C) Fee due date.--
                            ``(i) In general.--Except as provided in 
                        clause (ii), 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.
                            ``(ii) Special rule for 2013.--For fiscal 
                        year 2013, such fees shall be due on the later 
                        of--
                                    ``(I) the date on which the fee is 
                                due under clause (i);
                                    ``(II) 30 calendar days after 
                                publication of the notice referred to 
                                in subparagraph (B)(i); or
                                    ``(III) if an appropriations Act is 
                                not enacted providing for the 
                                collection and obligation of fees under 
                                this section by the date of submission 
                                of the application or prior approval 
                                supplement for which the fees under 
                                subparagraphs (A) and (F) apply, 30 
                                calendar days after the date that such 
                                an appropriations Act is enacted.
                    ``(D) Refund of fee if abbreviated new drug 
                application is not considered to have been received.--
                The Secretary shall refund 75 percent of the fee paid 
                under subparagraph (A) for any abbreviated new drug 
                application or prior approval supplement to an 
                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.
                    ``(E) Fee for an application the secretary 
                considers not to have been received, or that has been 
                withdrawn.--An abbreviated new drug application or 
                prior approval supplement 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, 2012, shall pay a 
                fee, in the amount determined under subsection (d)(3), 
                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 identified, or 
                intended to be identified, in at least one generic drug 
                submission that is pending or 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 or 
                        intended to be identified in at least one 
                        generic drug submission that is pending or 
                        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 produces, or which is pending review to 
                        produce, one or more active pharmaceutical 
                        ingredients identified, or intended to be 
                        identified, in at least one generic drug 
                        submission that is pending or approved or in a 
                        Type II active pharmaceutical ingredient drug 
                        master file referenced in such a 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 to fees 
                        under both such clauses for that facility.
                    ``(B) Amount.--The amount of fees established under 
                subparagraph (A) shall be established under subsection 
                (d).
                    ``(C) Notice.--
                            ``(i) Fiscal year 2013.--For fiscal year 
                        2013, the Secretary shall cause to be published 
                        in the Federal Register a notice announcing the 
                        amount of the fees provided for in subparagraph 
                        (A) within the timeframe specified in 
                        subsection (d)(1)(B).
                            ``(ii) Fiscal years 2014 through 2017.--
                        Within the timeframe specified in subsection 
                        (d)(2), the Secretary shall cause to be 
                        published in the Federal Register the amount of 
                        the fees under subparagraph (A) for such fiscal 
                        year.
                    ``(D) Fee due date.--
                            ``(i) Fiscal year 2013.--For fiscal year 
                        2013, the fees under subparagraph (A) shall be 
                        due on the later of--
                                    ``(I) not later than 45 days after 
                                the publication of the notice under 
                                subparagraph (B); or
                                    ``(II) if an appropriations Act is 
                                not enacted providing for the 
                                collection and obligation of fees under 
                                this section by the date of the 
                                publication of such notice, 30 days 
                                after the date that such an 
                                appropriations Act is enacted.
                            ``(ii) Fiscal years 2014 through 2017.--For 
                        each of fiscal years 2014 through 2017, 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 under this section 
                                for such year.
            ``(5) Date of submission.--For purposes of this part, 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; and
                    ``(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 2013.--For fiscal year 2013, fees 
                under subsection (a) shall be established to generate a 
                total estimated revenue amount under such subsection of 
                $299,000,000. Of that amount--
                            ``(i) $50,000,000 shall be generated by the 
                        one-time backlog fee for generic drug 
                        applications pending on October 1, 2012, 
                        established in subsection (a)(1); and
                            ``(ii) $249,000,000 shall be generated by 
                        the fees under paragraphs (2) through (4) of 
                        subsection (a).
                    ``(B) Fiscal years 2014 through 2017.--For each of 
                the fiscal years 2014 through 2017, fees under 
                paragraphs (2) through (4) of subsection (a) shall be 
                established to generate a total estimated revenue 
                amount under such subsection that is equal to 
                $299,000,000, as adjusted pursuant to subsection (c).
            ``(2) Types of fees.--In establishing fees under paragraph 
        (1) to generate the revenue amounts specified in paragraph 
        (1)(A)(ii) for fiscal year 2013 and paragraph (1)(B) for each 
        of fiscal years 2014 through 2017, such fees shall be derived 
        from the fees under paragraphs (2) through (4) of subsection 
        (a) as follows:
                    ``(A) 6 percent shall be derived from fees under 
                subsection (a)(2) (relating to drug master files).
                    ``(B) 24 percent shall be derived from fees under 
                subsection (a)(3) (relating to abbreviated new drug 
                applications and supplements). The amount of a fee for 
                a prior approval supplement shall be half the amount of 
                the fee for an abbreviated new drug application.
                    ``(C) 56 percent shall be derived from fees under 
                subsection (a)(4)(A)(i) (relating to generic drug 
                facilities). The amount of the fee for a facility 
                located outside the United States and its territories 
                and possessions shall be not less than $15,000 and not 
                more than $30,000 higher than the amount of the fee for 
                a facility located in the United States and its 
                territories and possessions, as determined by the 
                Secretary on the basis of data concerning the 
                difference in cost between inspections of facilities 
                located in the United States, including its territories 
                and possessions, and those located outside of the 
                United States and its territories and possessions.
                    ``(D) 14 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 not 
                less than $15,000 and not more than $30,000 higher than 
                the amount of the fee for a facility located in the 
                United States, including its territories and 
                possessions, as determined by the Secretary on the 
                basis of data concerning the difference in cost between 
                inspections of facilities located in the United States 
                and its territories and possessions and those located 
                outside of the United States and its territories and 
                possessions.
    ``(c) Adjustments.--
            ``(1) Inflation adjustment.--For fiscal year 2014 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, 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; 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.
        The adjustment made each fiscal year under this subsection 
        shall be added on a compounded basis to the sum of all 
        adjustments made each fiscal year after fiscal year 2013 under 
        this subsection.
            ``(2) Final year adjustment.--For fiscal year 2017, 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 2018. Such fees may only be used in 
        fiscal year 2018. 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 2017. 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.
    ``(d) Annual Fee Setting.--
            ``(1) Fiscal year 2013.--For fiscal year 2013--
                    ``(A) the Secretary shall establish, by October 31, 
                2012, the one-time generic drug backlog fee for generic 
                drug applications pending on October 1, 2012, the drug 
                master file fee, the abbreviated new drug application 
                fee, and the prior approval supplement fee under 
                subsection (a), based on the revenue amounts 
                established under subsection (b); and
                    ``(B) the Secretary shall establish, not later than 
                45 days after the date to comply with the requirement 
                for identification of facilities in subsection (f)(2), 
                the generic drug facility fee and active pharmaceutical 
                ingredient facility fee under subsection (a) based on 
                the revenue amounts established under subsection (b).
            ``(2) Fiscal years 2014 through 2017.--Not more than 60 
        days before the first day of each of fiscal years 2014 through 
        2017, the Secretary shall establish the drug master file fee, 
        the abbreviated new drug application fee, the prior approval 
        supplement fee, the generic drug facility fee, and the active 
        pharmaceutical ingredient facility fee under subsection (a) for 
        such fiscal year, based on the revenue amounts established 
        under subsection (b) and the adjustments provided under 
        subsection (c).
            ``(3) Fee for active pharmaceutical ingredient information 
        not included by reference to type ii active pharmaceutical 
        ingredient drug master file.--In establishing the fees under 
        paragraphs (1) and (2), 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) Limit.--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.
    ``(f) Identification of Facilities.--
            ``(1) Publication of notice; deadline for compliance.--Not 
        later than October 1, 2012, the Secretary shall cause to be 
        published in the Federal Register a notice requiring each 
        person that owns a facility described in subsection (a)(4)(A), 
        or a site or organization required to be identified by 
        paragraph (4), to submit to the Secretary information on the 
        identity of each such facility, site, or organization. The 
        notice required by this paragraph shall specify the type of 
        information to be submitted and the means and format for 
        submission of such information.
            ``(2) 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 (4) shall submit to the Secretary the information 
        required under this subsection each year. Such information 
        shall--
                    ``(A) for fiscal year 2013, be submitted not later 
                than 60 days after the publication of the notice under 
                paragraph (1); and
                    ``(B) for each subsequent fiscal year, be 
                submitted, updated, or reconfirmed on or before June 1 
                of the previous year.
            ``(3) Contents of notice.--At a minimum, the submission 
        required by paragraph (2) shall include for each such 
        facility--
                    ``(A) identification of a facility identified or 
                intended to be 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; and
                    ``(E) whether the facility manufactures drugs that 
                are not generic drugs.
            ``(4) 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 an 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.
            ``(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 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).
    ``(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 the 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, for Type II active 
        pharmaceutical ingredient drug master files, abbreviated new 
        drug applications and prior approval supplements, and generic 
        drug facilities and active pharmaceutical ingredient facilities 
        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 subparagraphs (C) and (D), 
                        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) Fee collection during first program year.--
                Until the date of enactment of an Act making 
                appropriations through September 30, 2013 for the 
                salaries and expenses account of the Food and Drug 
                Administration, fees authorized by this section for 
                fiscal year 2013, may be collected and shall be 
                credited to such account and remain available until 
                expended.
                    ``(D) Provision for early payments in subsequent 
                years.--Payment of fees authorized under this section 
                for a fiscal year (after fiscal year 2013), 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 2013 through 2017, 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.''.

SEC. 303. REAUTHORIZATION; REPORTING REQUIREMENTS.

    Part 7 of subchapter C of chapter VII, as added by section 302 of 
this Act, is amended by inserting after section 744B the following:

``SEC. 744C. REAUTHORIZATION; REPORTING REQUIREMENTS.

    ``(a) Performance Report.--
            ``(1) In general.--Beginning with fiscal year 2013, 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 2012 during such fiscal 
        year and the future plans of the Food and Drug Administration 
        for meeting the goals.
            ``(2) Regulatory science accountability metrics.--The 
        report required by paragraph (1) shall describe the amounts 
        spent, data generated, and activities undertaken, including any 
        FDA Advisory Committee consideration, by the Secretary for each 
        of the local acting bioequivalence topics (Topics 1-3) in the 
        Regulatory Science Plan described in the letters described in 
        section 301(b) of the Generic Drug User Fee Amendments of 2012.
    ``(b) Fiscal Report.--Beginning with fiscal year 2013, 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) 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.
    ``(d) 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 2017, 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, 2017, 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.''.

SEC. 304. SUNSET DATES.

    (a) Authorization.--Sections 744A and 744B, as added by section 302 
of this Act, are repealed October 1, 2017.
    (b) Reporting Requirements.--Section 744C, as added by section 303 
of this Act, is repealed January 31, 2018.

SEC. 305. EFFECTIVE DATE.

    The amendments made by this title shall take effect on October 1, 
2012, or the date of the enactment of this title, whichever is later, 
except that fees under section 302 shall be assessed for all human 
generic drug submissions and Type II active pharmaceutical drug master 
files received on or after October 1, 2012, regardless of the date of 
enactment of this title.

SEC. 306. AMENDMENT WITH RESPECT TO MISBRANDING.

    Section 502 (21 U.S.C. 352) is amended by adding at the end the 
following:
    ``(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 
744A(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.''.

SEC. 307. STREAMLINED HIRING AUTHORITY TO SUPPORT ACTIVITIES RELATED TO 
              HUMAN GENERIC DRUGS.

    Section 714, as added by section 208 of this Act, is amended--
            (1) by amending subsection (b) to read as follows:
    ``(b) Activities Described.--The activities described in this 
subsection are--
            ``(1) activities under this Act related to the process for 
        the review of device applications (as defined in section 
        737(8)); and
            ``(2) activities under this Act related to human generic 
        drug activities (as defined in section 744A).''; and
            (2) by amending subsection (c) to read as follows:
    ``(c) Objectives Specified.--The objectives specified in this 
subsection are--
            ``(1) with respect to the activities under subsection 
        (b)(1), the goals referred to in section 738A(a)(1); and
            ``(2) with respect to the activities under subsection 
        (b)(2), the goals referred to in section 744C(a).''.

       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 Act of 2012''.
    (b) Finding.--The Congress finds that the fees authorized by the 
amendments made in this title will be dedicated to expediting the 
process for the review of biosimilar biological product applications, 
including postmarket safety activities, as set forth in the goals 
identified for purposes of part 8 of subchapter C of chapter VII of the 
Federal Food, Drug, and Cosmetic Act, in the letters from the Secretary 
of Health and Human Services to the Chairman of the Committee on 
Health, Education, Labor, and Pensions of the Senate and the Chairman 
of the Committee on Energy and Commerce of the House of 
Representatives, as set forth in the Congressional Record.

SEC. 402. FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS.

    Subchapter C of chapter VII (21 U.S.C. 379f et seq.) is amended by 
inserting after part 7, as added by title III of this Act, the 
following:

       ``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 that is the Consumer Price Index for all urban consumers 
        (Washington-Baltimore, DC-MD-VA-WV; Not Seasonally Adjusted; 
        All items) 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 
        product 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) an in vitro diagnostic biological 
                        product; or
                            ``(IV) 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 five 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 2013, the Secretary 
shall assess and collect fees in accordance with this section as 
follows:
            ``(1) Biosimilar 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 
                        (b)(1)(A).
                            ``(ii) Meeting request.--The meeting 
                        request defined 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 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 Biosimilars 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 
                                Biosimilars 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 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 (b)(1)(B) for biosimilar biological 
                        product development (referred to in this 
                        section as `annual biosimilar biological 
                        product development fee').
                            ``(ii) Due date.--The annual biosimilar 
                        biological product development program 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 
                        development program 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).
                    ``(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, by 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 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 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) 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).
                    ``(E) Effect of failure to pay biosimilar 
                development program 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.
                    ``(F) Limits regarding biosimilar development 
                program fees.--
                            ``(i) No refunds.--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 and 
        supplement fee.--
                    ``(A) In general.--Each person that submits, on or 
                after October 1, 2012, a biosimilar biological product 
                application or a supplement shall be subject to the 
                following fees:
                            ``(i) A fee for a biosimilar biological 
                        product application that is equal to--
                                    ``(I) the amount of the fee 
                                established under subsection (b)(1)(D) 
                                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; minus
                                    ``(II) the cumulative amount of 
                                fees paid, if any, under subparagraphs 
                                (A), (B), and (D) of paragraph (1) for 
                                the product that is the subject of the 
                                application.
                            ``(ii) A fee for a biosimilar biological 
                        product application for which clinical data 
                        (other than comparative bioavailability 
                        studies) with respect to safety or 
                        effectiveness are not required, that is equal 
                        to--
                                    ``(I) half of the amount of the fee 
                                established under subsection (b)(1)(D) 
                                for a biosimilar biological product 
                                application; minus
                                    ``(II) the cumulative amount of 
                                fees paid, if any, under subparagraphs 
                                (A), (B), and (D) of paragraph (1) for 
                                that product.
                            ``(iii) A fee for a supplement for which 
                        clinical data (other than comparative 
                        bioavailability studies) with respect to safety 
                        or effectiveness are required, that is equal to 
                        half of the amount of the fee established under 
                        subsection (b)(1)(D) for a biosimilar 
                        biological product application.
                    ``(B) Reduction in fees.--Notwithstanding section 
                404 of the Biosimilars User Fee Act of 2012, 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 be entitled to the 
                reduction of any biosimilar biological product 
                application fees that may be assessed at the time when 
                such biosimilar biological product application is 
                submitted, by the cumulative amount of fees paid under 
                subparagraphs (A), (B), and (D) of paragraph (1) for 
                that product.
                    ``(C) Payment due date.--Any fee required by 
                subparagraph (A) shall be due upon submission of the 
                application or supplement for which such fee applies.
                    ``(D) Exception for previously filed application or 
                supplement.--If a biosimilar biological product 
                application or supplement was submitted by a person 
                that paid the fee for such application or supplement, 
                was accepted for filing, and was not approved or was 
                withdrawn (without a waiver), the submission of a 
                biosimilar biological product application or a 
                supplement 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 or supplement 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 or supplement 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 (c).
            ``(3) Biosimilar biological product establishment fee.--
                    ``(A) In general.--Except as provided in 
                subparagraph (E), each person that is named as the 
                applicant in a biosimilar biological product 
                application shall be assessed an annual fee established 
                under subsection (b)(1)(E) for each biosimilar 
                biological product establishment that is listed in the 
                approved biosimilar biological product application as 
                an establishment that manufactures the biosimilar 
                biological product named in such application.
                    ``(B) Assessment in fiscal years.--The 
                establishment fee shall be assessed in each fiscal year 
                for which the biosimilar biological product named in 
                the application is assessed a fee under paragraph (4) 
                unless the biosimilar biological product establishment 
                listed in the application does not engage in the 
                manufacture of the biosimilar biological product during 
                such fiscal year.
                    ``(C) Due date.--The establishment fee for a fiscal 
                year shall be due on the later of--
                            ``(i) the first business day on or after 
                        October 1 of such fiscal year; or
                            ``(ii) 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.
                    ``(D) Application to establishment.--
                            ``(i) Each biosimilar biological product 
                        establishment shall be assessed only one fee 
                        per biosimilar biological product 
                        establishment, notwithstanding the number of 
                        biosimilar biological products manufactured at 
                        the establishment, subject to clause (ii).
                            ``(ii) In the event an establishment is 
                        listed in a biosimilar biological product 
                        application by more than one applicant, the 
                        establishment fee for the fiscal year shall be 
                        divided equally and assessed among the 
                        applicants whose biosimilar biological products 
                        are manufactured by the establishment during 
                        the fiscal year and assessed biosimilar 
                        biological product fees under paragraph (4).
                    ``(E) Exception for new products.--If, during the 
                fiscal year, an applicant initiates or causes to be 
                initiated the manufacture of a biosimilar biological 
                product at an establishment listed in its biosimilar 
                biological product application--
                            ``(i) that did not manufacture the 
                        biosimilar biological product in the previous 
                        fiscal year; and
                            ``(ii) for which the full biosimilar 
                        biological product establishment fee has been 
                        assessed in the fiscal year at a time before 
                        manufacture of the biosimilar biological 
                        product was begun,
                the applicant shall not be assessed a share of the 
                biosimilar biological product establishment fee for the 
                fiscal year in which the manufacture of the product 
                began.
            ``(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 (b)(1)(F).
                    ``(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 Setting and Amounts.--
            ``(1) In general.--Subject to paragraph (2), the Secretary 
        shall, 60 days before the start of each fiscal year that begins 
        after September 30, 2012, establish, for the next fiscal year, 
        the fees under subsection (a). Except as provided in subsection 
        (c), such fees shall be in the following amounts:
                    ``(A) Initial biosimilar biological product 
                development fee.--The initial biosimilar biological 
                product development fee under subsection (a)(1)(A) for 
                a fiscal year shall be equal to 10 percent of the 
                amount established under section 736(c)(4) for a human 
                drug application described in section 736(a)(1)(A)(i) 
                for that fiscal year.
                    ``(B) Annual biosimilar biological product 
                development fee.--The annual biosimilar biological 
                product development fee under subsection (a)(1)(B) for 
                a fiscal year shall be equal to 10 percent of the 
                amount established under section 736(c)(4) for a human 
                drug application described in section 736(a)(1)(A)(i) 
                for that fiscal year.
                    ``(C) Reactivation fee.--The reactivation fee under 
                subsection (a)(1)(D) for a fiscal year shall be equal 
                to 20 percent of the amount of the fee established 
                under section 736(c)(4) for a human drug application 
                described in section 736(a)(1)(A)(i) for that fiscal 
                year.
                    ``(D) Biosimilar biological product application 
                fee.--The biosimilar biological product application fee 
                under subsection (a)(2) for a fiscal year shall be 
                equal to the amount established under section 736(c)(4) 
                for a human drug application described in section 
                736(a)(1)(A)(i) for that fiscal year.
                    ``(E) Biosimilar biological product establishment 
                fee.--The biosimilar biological product establishment 
                fee under subsection (a)(3) for a fiscal year shall be 
                equal to the amount established under section 736(c)(4) 
                for a prescription drug establishment for that fiscal 
                year.
                    ``(F) Biosimilar biological product fee.--The 
                biosimilar biological product fee under subsection 
                (a)(4) for a fiscal year shall be equal to the amount 
                established under section 736(c)(4) for a prescription 
                drug product for that fiscal year.
            ``(2) Limit.--The total amount of fees charged for a fiscal 
        year under this section may not exceed the total amount for 
        such fiscal year of the costs of resources allocated for the 
        process for the review of biosimilar biological product 
        applications.
    ``(c) 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--
                    ``(A) 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; and
                    ``(B) all supplement fees for all supplements to 
                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.
    ``(d) 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 fees owed by such person 
have been paid.
    ``(e) 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 limitation.--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.
                    ``(C) Fee collection during first program year.--
                Until the date of enactment of an Act making 
                appropriations through September 30, 2013, for the 
                salaries and expenses account of the Food and Drug 
                Administration, fees authorized by this section for 
                fiscal year 2013 may be collected and shall be credited 
                to such account and remain available until expended.
                    ``(D) Provision for early payments in subsequent 
                years.--Payment of fees authorized under this section 
                for a fiscal year (after fiscal year 2013), 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 2013 through 2017, 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.
    ``(f) 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.
    ``(g) Written Requests for Waivers and Refunds.--To qualify for 
consideration for a waiver under subsection (c), 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) 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. 403. REAUTHORIZATION; REPORTING REQUIREMENTS.

    Part 8 of subchapter C of chapter VII, as added by section 402 of 
this Act, is further amended by inserting after section 744H the 
following:

``SEC. 744I. REAUTHORIZATION; REPORTING REQUIREMENTS.

    ``(a) Performance Report.--Beginning with fiscal year 2013, 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 Act of 2012 
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.
    ``(b) Fiscal Report.--Not later than 120 days after the end of 
fiscal year 2013 and each subsequent 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) 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.
    ``(d) Study.--
            ``(1) In general.--The Secretary shall contract with an 
        independent accounting or consulting firm to study the workload 
        volume and full costs associated with the process for the 
        review of biosimilar biological product applications.
            ``(2) Interim results.--Not later than June 1, 2015, the 
        Secretary shall publish, for public comment, interim results of 
        the study described under paragraph (1).
            ``(3) Final results.--Not later than September 30, 2016, 
        the Secretary shall publish, for public comment, the final 
        results of the study described under paragraph (1).
    ``(e) 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 
        2017, 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, 2017, 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.''.

SEC. 404. SUNSET DATES.

    (a) Authorization.--Sections 744G and 744H, as added by section 402 
of this Act, are repealed October 1, 2017.
    (b) Reporting Requirements.--Section 744I, as added by section 403 
of this Act, is repealed January 31, 2018.

SEC. 405. EFFECTIVE DATE.

    (a) In General.--Except as provided under subsection (b), the 
amendments made by this title shall take effect on the later of--
            (1) October 1, 2012; or
            (2) the date of the enactment of this title.
    (b) Exception.--Fees under part 8 of subchapter C of chapter VII of 
the Federal Food, Drug, and Cosmetic Act, as added by this title, shall 
be assessed for all biosimilar biological product applications received 
on or after October 1, 2012, regardless of the date of the enactment of 
this title.

SEC. 406. SAVINGS CLAUSE.

    Notwithstanding the amendments made by this title, part 2 of 
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic 
Act, as in effect on the day before the date of the enactment of this 
title, shall continue to be in effect with respect to human drug 
applications and supplements (as defined in such part as of such day) 
that were accepted by the Food and Drug Administration for filing on or 
after October 1, 2007, but before October 1, 2012, with respect to 
assessing and collecting any fee required by such part for a fiscal 
year prior to fiscal year 2013.

SEC. 407. CONFORMING AMENDMENT.

    Section 735(1)(B) (21 U.S.C. 379g(1)(B)) is amended by striking 
``or (k)''.

 TITLE V--REAUTHORIZATION OF BEST PHARMACEUTICALS FOR CHILDREN ACT AND 
                     PEDIATRIC RESEARCH EQUITY ACT

SEC. 501. PERMANENT EXTENSION OF BEST PHARMACEUTICALS FOR CHILDREN ACT 
              AND PEDIATRIC RESEARCH EQUITY ACT.

    (a) Program for Pediatric Studies of Drugs.--Section 409I(c) of the 
Public Health Service Act (42 U.S.C. 284m(c)) is amended--
            (1) in subsection (c)(1)--
                    (A) in the matter preceding subparagraph (A), by 
                inserting ``or section 351(m) of this Act,'' after 
                ``Cosmetic Act,'';
                    (B) in subparagraph (A)(i), by inserting ``or 
                section 351(k) of this Act'' after ``Cosmetic Act''; 
                and
                    (C) by amending subparagraph (B) to read as 
                follows:
                    ``(B)(i) there remains no patent listed pursuant to 
                section 505(b)(1) of the Federal Food, Drug, and 
                Cosmetic Act; and
                    ``(ii) 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'';
            (2) in subsection (c)(2)--
                    (A) in the heading of paragraph (2), by striking 
                ``for drugs lacking exclusivity'';
                    (B) by striking ``under section 505 of the Federal 
                Food, Drug, and Cosmetic Act''; and
                    (C) by striking ``505A of such Act'' and inserting 
                ``505A of the Federal Food, Drug, and Cosmetic Act or 
                section 351(m) of this Act''; and
            (3) in subsection (e)(1), by striking ``to carry out this 
        section'' and all that follows through the end of paragraph (1) 
        and inserting ``$25,000,000 for each of fiscal years 2013 
        through 2017.''.
    (b) Pediatric Studies of Drugs in FFDCA.--Section 505A (21 U.S.C. 
355a) is amended--
            (1) in subsection (d)(1)(A), by adding at the end the 
        following: ``If a request under this subparagraph does not 
        request studies in neonates, such request shall include a 
        statement describing the rationale for not requesting studies 
        in neonates.'';
            (2) by amending subsection (h) to read as follows:
    ``(h) Relationship to Pediatric Research Requirements.--Exclusivity 
under this section shall only be granted for the completion of a study 
or studies that are the subject of a written request and for which 
reports are submitted and accepted in accordance with subsection 
(d)(3). Written requests under this section may consist of a study or 
studies required under section 505B.'';
            (3) in subsection (k)(2), by striking ``subsection 
        (f)(3)(F)'' and inserting ``subsection (f)(6)(F)'';
            (4) in subsection (l)--
                    (A) in paragraph (1)--
                            (i) in the paragraph heading, by striking 
                        ``year one'' and inserting ``first 18-month 
                        period''; and
                            (ii) by striking ``one-year'' and inserting 
                        ``18-month'';
                    (B) in paragraph (2)--
                            (i) in the paragraph heading, by striking 
                        ``years'' and inserting ``periods''; and
                            (ii) by striking ``one-year period'' and 
                        inserting ``18-month period'';
                    (C) by redesignating paragraph (3) as paragraph 
                (4); and
                    (D) by inserting after paragraph (2) the following:
            ``(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.'';
            (5) in subsection (n)--
                    (A) in the subsection heading, by striking 
                ``Completed'' and inserting ``Submitted''; and
                    (B) in paragraph (1)--
                            (i) in the text preceding subparagraph (A), 
                        by striking ``have not been completed'' and 
                        inserting ``have not been submitted by the date 
                        specified in the written request issued and 
                        agreed upon''; and
                            (ii) by revising subparagraphs (A) and (B) 
                        to read as follows:
                    ``(A) For a drug for which there remains any listed 
                patent or exclusivity protection eligible for extension 
                under subsection (b)(1) or (c)(1) of this section, or 
                any exclusivity protection eligible for extension under 
                subsection (m)(2) or (m)(3) of section 351 of the 
                Public Health Service Act, the Secretary shall make a 
                determination regarding whether an assessment shall be 
                required to be submitted under section 505B(b).
                    ``(B) For a drug that has no remaining listed 
                patents or exclusivity protection eligible for 
                extension under subsection (b)(1) or (c)(1) of this 
                section, or any exclusivity protection eligible for 
                extension under subsection (m)(2) or (m)(3) of section 
                351 of the Public Health Service Act, the Secretary 
                shall refer the drug for inclusion on the list 
                established under section 409I of the Public Health 
                Service Act for the conduct of studies.'';
            (6) in subsection (o)(2), by amending subparagraph (B) to 
        read as follows:
                    ``(B) a statement of any appropriate pediatric 
                contraindications, warnings, precautions, or other 
                information that the Secretary considers necessary to 
                assure safe use.''; and
            (7) by striking subsection (q) (relating to a sunset).
    (c) Research Into Pediatric Uses for Drugs and Biological Projects 
in FFDCA.--Section 505B (21 U.S.C. 355c) is amended--
            (1) in subsection (a)--
                    (A) in paragraph (1), in the matter before 
                subparagraph (A), by inserting ``for a drug'' after 
                ``(or supplement to an application)'';
                    (B) in paragraph (3)--
                            (i) by redesignating subparagraph (B) as 
                        subparagraph (D); and
                            (ii) by inserting after subparagraph (A) 
                        the following:
                    ``(B) Deferral extension.--On the initiative of the 
                Secretary or at the request of the applicant, the 
                Secretary may grant an extension of a deferral under 
                subparagraph (A) if--
                            ``(i) the Secretary finds that the criteria 
                        specified in subclause (II) or (III) of 
                        subparagraph (A)(i) continue to be met; and
                            ``(ii) the applicant submits the materials 
                        required under subparagraph (A)(ii).
                    ``(C) Consideration during deferral period.--If the 
                Secretary has under this paragraph deferred the date by 
                which an assessment must be submitted, then until the 
                date specified in the deferral under subparagraph (A) 
                (including any extension of such date under 
                subparagraph (B))--
                            ``(i) the assessment shall not be 
                        considered late or delayed; and
                            ``(ii) the Secretary shall not classify the 
                        assessment as late or delayed in any report, 
                        database, or public posting.''; and
                            (iii) in subparagraph (D), as redesignated, 
                        by amending clause (ii) to read as follows:
                            ``(ii) Public availability.--Not later than 
                        60 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 Web 
                        site of the Food and Drug Administration--
                                    ``(I) such information;
                                    ``(II) the name of the applicant 
                                for the product subject to the 
                                assessment;
                                    ``(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.''; and
                    (C) in paragraph (4)(C)--
                            (i) in the first sentence, by inserting 
                        ``partial'' before ``waiver is granted''; and
                            (ii) in the second sentence, by striking 
                        ``either a full or partial waiver'' and 
                        inserting ``a partial waiver'';
            (2) in subsection (b)(1), by striking ``After providing 
        notice in the form of a letter (that, for a drug approved under 
        section 505, references a declined written request under 
        section 505A for a labeled indication which written request is 
        not referred under section 505A(n)(1)(A) to the Foundation of 
        the National Institutes of Health for the pediatric studies), 
        the Secretary'' and inserting ``The Secretary'';
            (3) by amending subsection (d) to read as follows:
    ``(d) Failure To Meet Requirements.--If a person fails to submit a 
required assessment described in subsection (a)(2), fails to meet the 
applicable requirements in subsection (a)(3), 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)--
            ``(1)(A) the Secretary shall issue a letter to such person 
        informing such person of such failure;
            ``(B) not later than 30 calendar days after the issuance of 
        a letter under subparagraph (A), the person who receives such 
        letter shall submit to the Secretary a written response to such 
        letter; and
            ``(C) not later than 45 calendar days after the issuance of 
        a letter under subparagraph (A), the Secretary shall make such 
        letter, and any response to such letter under subparagraph (B), 
        available to the public on the Web site of the Food and Drug 
        Administration, with appropriate redactions made to protect 
        trade secrets and confidential commercial information, except 
        that, if the Secretary determines that the letter under 
        subparagraph (A) was issued in error, the requirements of this 
        subparagraph shall not apply with respect to such letter; and
            ``(2)(A) the drug or biological product that is the subject 
        of the required assessment, applicable requirements in 
        subsection (a)(3), or required 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
            ``(B) the failure to submit the required assessment, meet 
        the applicable requirements in subsection (a)(3), or submit the 
        required request for approval of a pediatric formulation shall 
        not be the basis for a proceeding--
                    ``(i) to withdraw approval for a drug under section 
                505(e); or
                    ``(ii) to revoke the license for a biological 
                product under section 351 of the Public Health Service 
                Act.'';
            (4) by amending subsection (e) to read as follows:
    ``(e) Initial Pediatric Plan.--
            ``(1) In general.--
                    ``(A) Submission.--An applicant who is required to 
                submit an assessment under subsection (a)(1) shall 
                submit an initial pediatric plan.
                    ``(B) Timing.--An applicant shall submit the 
                initial pediatric plan under paragraph (1)--
                            ``(i) before the date on which the 
                        applicant submits the assessments under 
                        subsection (a)(2); and
                            ``(ii) not later than--
                                    ``(I) 60 calendar days after the 
                                date of 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 
                plan earlier than the date otherwise applicable under 
                this subparagraph.
                    ``(C) Contents.--The initial pediatric plan shall 
                include--
                            ``(i) an outline of the pediatric studies 
                        that the applicant plans to conduct;
                            ``(ii) any request for a deferral, partial 
                        waiver, or waiver under this section, along 
                        with supporting information; and
                            ``(iii) other information the Secretary 
                        determines necessary, including any information 
                        specified in regulations under paragraph (5).
            ``(2) Meeting.--
                    ``(A) In general.--Subject to subparagraph (B), not 
                later than 90 calendar days after receiving an initial 
                pediatric plan under paragraph (1), the Secretary shall 
                meet with the applicant to discuss the plan.
                    ``(B) Written response.--If the Secretary 
                determines that a written response to the initial 
                pediatric plan is sufficient to communicate comments on 
                the initial pediatric plan, and that no meeting is 
                necessary the Secretary shall, not later than 90 days 
                after receiving an initial pediatric plan under 
                paragraph (1)--
                            ``(i) notify the applicant of such 
                        determination; and
                            ``(ii) provide to the applicant the 
                        Secretary's written comments on the plan.
            ``(3) Agreed initial pediatric plan.--
                    ``(A) Submission.--The applicant shall submit to 
                the Secretary a document reflecting the agreement 
                between the Secretary and the applicant on the initial 
                pediatric plan (referred to in this subsection as an 
                `agreed initial pediatric plan').
                    ``(B) Confirmation.--Not later than 30 days after 
                receiving the agreed initial pediatric plan under 
                subparagraph (A), the Secretary shall provide written 
                confirmation to the applicant that such plan reflects 
                the agreement of the Secretary.
                    ``(C) Deferral and waiver.--If the agreed initial 
                pediatric plan contains a request from the applicant 
                for a deferral, partial waiver, or waiver under this 
                section, the written confirmation under subparagraph 
                (B) shall include a recommendation from the Secretary 
                as to whether such request meets the standards under 
                paragraphs (3) or (4) of subsection (a).
                    ``(D) Amendments to the plan.--At the initiative of 
                the Secretary or the applicant, the agreed initial 
                pediatric plan may be amended at any time. The 
                requirements of paragraph (2) shall apply to any such 
                proposed amendment in the same manner and to the same 
                extent as such requirements apply to an initial 
                pediatric plan under paragraph (1). The requirements of 
                subparagraphs (A) through (C) of this paragraph 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 
                plan.
            ``(4) Internal committee.--The Secretary shall consult the 
        internal committee under section 505C on the review of the 
        initial pediatric plan, greed initial pediatric plan, and any 
        amendments to such plans.
            ``(5) Mandatory rulemaking.--Not later than one year after 
        the date of enactment of the Food and Drug Administration 
        Reform Act of 2012, the Secretary shall promulgate proposed 
        regulations and guidance to implement the provisions of this 
        subsection.
            ``(6) Effective date.--The provisions of this subsection 
        shall take effect 180 calendar days after the date of enactment 
        of the Food and Drug Administration Reform Act of 2012, 
        irrespective of whether the Secretary has promulgated final 
        regulations to carry out this subsection by such date.'';
            (5) in subsection (f)--
                    (A) in the subsection heading, by inserting 
                ``Deferral Extensions,'' after ``Deferrals,'';
                    (B) in paragraph (4)--
                            (i) in the paragraph heading, by inserting 
                        ``deferral extensions,'' after ``deferrals,''; 
                        and
                            (ii) in the second sentence, by inserting 
                        ``, deferral extensions,'' after ``deferrals''; 
                        and
                    (C) in paragraph (6)(D)--
                            (i) by inserting ``and deferral 
                        extensions'' before ``requested and granted''; 
                        and
                            (ii) by inserting ``and deferral 
                        extensions'' after ``the reasons for such 
                        deferrals'';
            (6) in subsection (g)--
                    (A) in paragraph (1)(A), by striking ``after the 
                date of the submission of the application or 
                supplement'' and inserting ``after the date of the 
                submission of an 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''; and
                    (B) in paragraph (2), by striking ``the label of 
                such product'' and inserting ``the labeling of such 
                product'';
            (7) in subsection (h)(1)--
                    (A) by inserting ``an application (or supplement to 
                an application) that contains'' after ``date of 
                submission of''; and
                    (B) by inserting ``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,'' after ``under this section,'';
            (8) in subsection (i)--
                    (A) in paragraph (1)--
                            (i) in the paragraph heading, by striking 
                        ``year one'' and inserting ``first 18-month 
                        period''; and
                            (ii) by striking ``one-year'' and inserting 
                        ``18-month'';
                    (B) in paragraph (2)--
                            (i) in the paragraph heading, by striking 
                        ``years'' and inserting ``periods''; and
                            (ii) by striking ``one-year period'' and 
                        inserting ``18-month period'';
                    (C) by redesignating paragraph (3) as paragraph 
                (4); and
                    (D) by inserting after paragraph (2) the following:
            ``(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.'';
            (9) by striking subsection (m) (relating to integration 
        with other pediatric studies); and
            (10) by redesignating subsection (n) as subsection (m).
    (d) Pediatric Studies of Biological Products in PHSA.--Section 
351(m)(1) of the Public Health Service Act (42 U.S.C. 262(m)(1)) is 
amended by striking ``(f), (i), (j), (k), (l), (p), and (q)'' and 
inserting ``(f), (h), (i), (j), (k), (l), (n), and (p)''.
    (e) Application; Transition Rule.--
            (1) Application.--Notwithstanding any provision of section 
        505A and 505B of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355a, 355c) stating that a provision applies beginning 
        on the date of the enactment of the Best Pharmaceuticals for 
        Children Act of 2007 or the date of the enactment of the 
        Pediatric Research Equity Act of 2007, any amendment made by 
        this Act to such a provision applies beginning on the date of 
        the enactment of this Act.
            (2) Transitional rule for adverse event reporting.--With 
        respect to a drug for which a labeling change described under 
        section 505A(l)(1) or 505B(i)(1) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355a(l)(1); 355c(i)(1)) is approved or 
        made, respectively, during the one-year period that ends on the 
        day before the date of enactment of this Act, the Secretary 
        shall apply section 505A(l) and section 505B(i), as applicable, 
        to such drug, as such sections were in effect on such day.
    (f) Conforming Amendment.--Section 499(c)(1)(C) of the Public 
Health Service Act (42 U.S.C. 290b(c)(1)(C)) is amended by striking 
``for which the Secretary issues a certification in the affirmative 
under section 505A(n)(1)(A) of the Federal Food, Drug, and Cosmetic 
Act''.
    (g) Public Meeting on Pediatric Cancers.--Not later than December 
31, 2013, the Secretary of Health and Human Services shall hold a 
public meeting on the impact of sections 505A and 505B of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c) on the development 
of new therapies for children with cancer.

SEC. 502. FOOD AND DRUG ADMINISTRATION REPORT.

    (a) In General.--Not later than four years after the date of 
enactment of this Act and every five years thereafter, the Secretary of 
Health and Human Services 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, and make 
publicly available, including through posting on the Web site of the 
Food and Drug Administration, a report on the implementation of section 
505A and 505B.
    (b) Contents.--The report described in paragraph (1) shall 
include--
            (1) an assessment of the effectiveness of sections 505A and 
        505B in improving information about pediatric uses for approved 
        drugs and biologics, including the number and type of labeling 
        changes made since the date of enactment of this Act;
            (2) the number of waivers and partial waivers granted under 
        section 505B since the date of enactment of this Act, and the 
        reasons such waivers and partial waivers were granted;
            (3) the number of deferrals and deferral extensions granted 
        under section 505B since the date of enactment of this Act, and 
        the reasons such deferrals and deferral extensions were 
        granted;
            (4) the number of letters issued under section 505B(d);
            (5) an assessment of the timeliness and effectiveness of 
        pediatric study planning since the date of enactment of this 
        Act, including the number of pediatric plans not submitted in 
        accordance with the requirements of section 505B(e) and any 
        resulting rulemaking;
            (6) the number of written requests issued, accepted, and 
        declined under section 505A since the date of enactment of this 
        Act, and a listing of any important gaps in pediatric 
        information as a result of such declined requests;
            (7) a description and current status of referrals made 
        under section 505A(n);
            (8) an assessment of the effectiveness of studying drugs 
        for rare diseases under 505A;
            (9) an assessment of the effectiveness of studying drugs 
        for children with cancer under 505A and 505B, and any 
        recommendations for modifications to the programs under such 
        sections that would lead to new and better therapies for 
        children with cancer;
            (10) an assessment of the effectiveness of studying drugs 
        in the neonate population under 505A and 505B;
            (11) an assessment of the effectiveness of studying 
        biological products in pediatric populations under 505A and 
        505B;
            (12) an assessment of the Secretary's efforts to address 
        the suggestions and options described in the report required 
        under 505A(p); and
            (13) any suggestions for modification to the programs that 
        would improve pediatric drug research and increase pediatric 
        labeling of drugs and biologics that the Secretary determines 
        to be appropriate.
    (c) Stakeholder Comment.--At least 180 days prior to the submission 
of the report required in paragraph (1), the Secretary shall consult 
with representatives of patient groups, including pediatric patient 
groups, consumer groups, regulated industry, academia, and other 
interested parties to obtain any recommendations or information 
relevant to the study and report including suggestions for 
modifications that would improve pediatric drug research and pediatric 
labeling of drugs and biologics.

SEC. 503. INTERNAL COMMITTEE FOR REVIEW OF PEDIATRIC PLANS, 
              ASSESSMENTS, DEFERRALS, DEFERRAL EXTENSIONS, AND WAIVERS.

    Section 505C (21 U.S.C. 355d) is amended--
            (1) in the section heading, by inserting ``deferral 
        extensions,'' after ``deferrals,''; and
            (2) by inserting ``neonatology'' after ``pediatric 
        ethics''.

SEC. 504. STAFF OF OFFICE OF PEDIATRIC THERAPEUTICS.

    Section 6(c) of the Best Pharmaceuticals for Children Act (21 
U.S.C. 393a(c)) is amended--
            (1) in paragraph (1), by striking ``and'' at the end;
            (2) by redesignating paragraph (2) as paragraph (4);
            (3) by inserting after paragraph (1) the following:
            ``(2) one or more additional individuals with expertise in 
        neonatology;
            ``(3) one or more additional individuals with expertise in 
        pediatric epidemiology; and''.

SEC. 505. CONTINUATION OF OPERATION OF PEDIATRIC ADVISORY COMMITTEE.

    Section 14(d) of the Best Pharmaceuticals for Children Act (42 
U.S.C. 284m note) is amended by striking ``during the five-year period 
beginning on the date of the enactment of the Best Pharmaceuticals for 
Children Act of 2007'' and inserting ``to carry out the advisory 
committee's responsibilities under sections 505A, 505B, and 520(m) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c, and 
360j(m))''.

SEC. 506. PEDIATRIC SUBCOMMITTEE OF THE ONCOLOGIC DRUGS ADVISORY 
              COMMITTEE.

    Section 15(a) of the Best Pharmaceuticals for Children Act (Public 
Law 107-109), as amended by section 502(e) of the Food and Drug 
Administration Amendments Act of 2007 (Public Law 110-85), is amended--
            (1) in paragraph (1)(D), by striking ``section 505B(f)'' 
        and inserting ``section 505C''; and
            (2) in paragraph (3), by striking ``during the five-year 
        period beginning on the date of the enactment of the Best 
        Pharmaceuticals for Children Act of 2007'' and inserting ``to 
        carry out the Subcommittee's responsibilities under this 
        section''.

     TITLE VI--FOOD AND DRUG ADMINISTRATION ADMINISTRATIVE REFORMS

SEC. 601. PUBLIC PARTICIPATION IN ISSUANCE OF FDA GUIDANCE DOCUMENTS.

    Section 701(h)(1) (21 U.S.C. 371(h)(1)) is amended by striking 
subparagraph (C) and inserting the following:
    ``(C) For any guidance document that sets forth initial 
interpretations of a statute or regulation, sets forth changes in 
interpretation or policy that are of more than a minor nature, includes 
complex scientific issues, or covers highly controversial issues--
            ``(i) the Secretary--
                    ``(I) at least 30 days before issuance of a draft 
                of such guidance document, shall publish notice in the 
                Federal Register of the Secretary's intent to prepare 
                such guidance document; and
                    ``(II) during preparation and before issuance of 
                such guidance document, may meet with interested 
                stakeholders, including industry, medical, and 
                scientific experts and others, and solicit public 
                comment;
            ``(ii) if the Secretary for good cause finds that, with 
        respect to such guidance document, compliance with clause (i) 
        is impracticable, unnecessary, or contrary to the public 
        interest--
                    ``(I) the Secretary shall publish such finding and 
                a brief statement of the reasons for such finding in 
                the Federal Register;
                    ``(II) clause (i) shall not apply with respect to 
                such guidance document; and
                    ``(III) during a 90-day period beginning not later 
                than the date of issuance of such guidance document, 
                the Secretary may meet with interested stakeholders, 
                including industry, medical, and scientific experts and 
                others, and shall solicit public comment;
            ``(iii) beginning on the date of enactment of the Food and 
        Drug Administration Reform Act of 2012, upon issuance of a 
        draft guidance document under clause (i) or (ii), the Secretary 
        shall--
                    ``(I) designate the document as draft or final; and
                    ``(II) not later than 18 months after the close of 
                the comment period for such guidance, issue a final 
                version of such guidance document in accordance with 
                clauses (i) and (ii);
            ``(iv) the Secretary may extend the deadline for issuing 
        final guidance under clause (iii)(II) by not more than 180 days 
        upon submission by the Secretary of a notification of such 
        extension in the Federal Register;
            ``(v) if the Secretary issues a draft guidance document and 
        fails to finalize the draft by the deadline determined under 
        clause (iii)(II), as extended under clause (iv), the Secretary 
        shall, beginning on the date of such deadline, treat the draft 
        as null and void; and
            ``(vi) not less than every 5 years after the issuance of a 
        final guidance document in accordance with clause (iii), the 
        Secretary shall--
                    ``(I) conduct a retrospective analysis of such 
                guidance document to ensure it is not outmoded, 
                ineffective, insufficient, or excessively burdensome; 
                and
                    ``(II) based on such analysis, modify, streamline, 
                expand, or repeal the guidance document in accordance 
                with what has been learned.
    ``(D) With respect to devices, a notice to industry guidance 
letter, a notice to industry advisory letter, and any similar notice 
that sets forth initial interpretations of a statute or regulation or 
sets forth changes in interpretation or policy shall be treated as a 
guidance document for purposes of subparagraph (C).
    ``(E) The following shall not be treated as a guidance document for 
purposes of subparagraph (C):
            ``(i) Any document that does not set forth an initial 
        interpretation or a reinterpretation of a statute or 
        regulation.
            ``(ii) Any document that sets forth or changes a policy 
        relating to internal procedures of the Food and Drug 
        Administration.
            ``(iii) Agency reports, general information documents 
        provided to consumers or health professionals, speeches, 
        journal articles and editorials, media interviews, press 
        materials, warning letters, memoranda of understanding, or 
        communications directed to individual persons or firms.''.

SEC. 602. CONFLICTS OF INTEREST.

    (a) In General.--Section 712 (21 U.S.C. 379d-1) is amended--
            (1) by striking subsections (b) and (c) and inserting the 
        following subsections:
    ``(b) Recruitment for Advisory Committees.--
            ``(1) In general.--The Secretary shall--
                    ``(A) develop and implement strategies on effective 
                outreach to potential members of advisory committees at 
                universities, colleges, other academic research 
                centers, professional and medical societies, and 
                patient and consumer groups;
                    ``(B) seek input from professional medical and 
                scientific societies to determine the most effective 
                informational and recruitment activities;
                    ``(C) at least every 180 days, request referrals 
                for potential members of advisory committees from a 
                variety of stakeholders, including--
                            ``(i) product developers, patient groups, 
                        and disease advocacy organizations; and
                            ``(ii) relevant--
                                    ``(I) professional societies;
                                    ``(II) medical societies;
                                    ``(III) academic organizations; and
                                    ``(IV) governmental organizations; 
                                and
                    ``(D) in carrying out subparagraphs (A) and (B), 
                take into account the levels of activity (including the 
                numbers of annual meetings) and the numbers of 
                vacancies of the advisory committees.
            ``(2) Recruitment activities.--The recruitment activities 
        under paragraph (1) may include--
                    ``(A) advertising the process for becoming an 
                advisory committee member at medical and scientific 
                society conferences;
                    ``(B) making widely available, including by using 
                existing electronic communications channels, the 
                contact information for the Food and Drug 
                Administration point of contact regarding advisory 
                committee nominations; and
                    ``(C) developing a method through which an entity 
                receiving funding from the National Institutes of 
                Health, the Agency for Healthcare Research and Quality, 
                the Centers for Disease Control and Prevention, or the 
                Veterans Health Administration can identify a person 
                whom the Food and Drug Administration can contact 
                regarding the nomination of individuals to serve on 
                advisory committees.
            ``(3) Expertise.--In carrying out this subsection, the 
        Secretary shall seek to ensure that the Secretary has access to 
        the most current expert advice.
    ``(c) Disclosure of Determinations and Certifications.--
Notwithstanding section 107(a)(2) of the Ethics in Government Act of 
1978, the following shall apply:
            ``(1) 15 or more days in advance.--As soon as practicable, 
        but (except as provided in paragraph (2)) not later than 15 
        days prior to a meeting of an advisory committee to which a 
        written determination as referred to in section 208(b)(1) of 
        title 18, United States Code, or a written certification as 
        referred to in section 208(b)(3) of such title, applies, the 
        Secretary shall disclose (other than information exempted from 
        disclosure under section 552 or section 552a of title 5, United 
        States Code (popularly known as the Freedom of Information Act 
        and the Privacy Act of 1974, respectively)) on the Internet 
        Website of the Food and Drug Administration--
                    ``(A) the type, nature, and magnitude of the 
                financial interests of the advisory committee member to 
                which such determination or certification applies; and
                    ``(B) the reasons of the Secretary for such 
                determination or certification, including, as 
                appropriate, the public health interest in having the 
                expertise of the member with respect to the particular 
                matter before the advisory committee.
            ``(2) Less than 30 days in advance.--In the case of a 
        financial interest that becomes known to the Secretary less 
        than 30 days prior to a meeting of an advisory committee to 
        which a written determination as referred to in section 
        208(b)(1) of title 18, United States Code, or a written 
        certification as referred to in section 208(b)(3) of such title 
        applies, the Secretary shall disclose (other than information 
        exempted from disclosure under section 552 or 552a of title 5, 
        United States Code) on the Internet Website of the Food and 
        Drug Administration, the information described in subparagraphs 
        (A) and (B) of paragraph (1) as soon as practicable after the 
        Secretary makes such determination or certification, but in no 
        case later than the date of such meeting.'';
            (2) in subsection (d), by striking ``subsection (c)(3)'' 
        and inserting ``subsection (c)'';
            (3) by amending subsection (e) to read as follows:
    ``(e) Annual Report.--
            ``(1) In general.--Not later than February 1 of each year, 
        the Secretary shall submit to the Committee on Appropriations 
        and the Committee on Health, Education, Labor, and Pensions of 
        the Senate, and the Committee on Appropriations and the 
        Committee on Energy and Commerce of the House of 
        Representatives, a report that describes--
                    ``(A) with respect to the fiscal year that ended on 
                September 30 of the previous year, the number of 
                persons nominated for participation at meetings for 
                each advisory committee, the number of persons so 
                nominated, and willing to serve, the number of 
                vacancies on each advisory committee, and the number of 
                persons contacted for service as members on each 
                advisory committee meeting for each advisory committee 
                who did not participate because of the potential for 
                such participation to constitute a disqualifying 
                financial interest under section 208 of title 18, 
                United States Code;
                    ``(B) with respect to such year, the number of 
                persons contacted for services as members for each 
                advisory committee meeting for each advisory committee 
                who did not participate because of reasons other than 
                the potential for such participation to constitute a 
                disqualifying financial interest under section 208 of 
                title 18, United States Code;
                    ``(C) with respect to such year, the number of 
                members attending meetings for each advisory committee; 
                and
                    ``(D) with respect to such year, the aggregate 
                number of disclosures required under subsection (d) and 
                the percentage of individuals to whom such disclosures 
                did not apply who served on such committee.
            ``(2) Public availability.--Not later than 30 days after 
        submitting any report under paragraph (1) to the committees 
        specified in such paragraph, the Secretary shall make each such 
        report available to the public.''; and
            (4) in subsection (f), by striking ``shall review 
        guidance'' and all that follows through the end of the 
        subsection and inserting the following: ``shall--
            ``(1) review guidance of the Food and Drug Administration 
        with respect to advisory committees regarding disclosure of 
        conflicts of interest and the application of section 208 of 
        title 18, United States Code; and
            ``(2) update such guidance as necessary to ensure that the 
        Food and Drug Administration receives appropriate access to 
        needed scientific expertise, with due consideration of the 
        requirements of such section 208.''.
    (b) Applicability.--The amendments made by subsection (a) apply 
beginning on October 1, 2012.

SEC. 603. ELECTRONIC SUBMISSION OF APPLICATIONS.

    Subchapter D of chapter VII (21 U.S.C. 379k et seq.) is amended by 
inserting after section 745 the following:

``SEC. 745A. ELECTRONIC FORMAT FOR SUBMISSIONS.

    ``(a) Drugs and Biologics.--
            ``(1) In general.--Beginning no earlier than 24 months 
        after the issuance of a final guidance issued after public 
        notice and opportunity for comment, submissions under 
        subsection (b), (i), or (j) of section 505 of this Act or 
        subsection (a) or (k) of section 351 of the Public Health 
        Service Act shall be submitted in such electronic format as 
        specified by the Secretary in such guidance.
            ``(2) Guidance contents.--In the guidance under paragraph 
        (1), the Secretary may--
                    ``(A) provide a timetable for establishment by the 
                Secretary of further standards for electronic 
                submission as required by such paragraph; and
                    ``(B) set forth criteria for waivers of and 
                exemptions from the requirements of this subsection.
            ``(3) Exception.--This subsection shall not apply to 
        submissions described in section 561.
    ``(b) Devices.--
            ``(1) In general.--Beginning after the issuance of final 
        guidance implementing this paragraph, pre-submissions and 
        submissions for devices under section 510(k), 513(f)(2)(A), 
        515(c), 515(d), 515(f), 520(g), 520(m), or 564 of this Act or 
        section 351 of the Public Health Service Act, and any 
        supplements to such pre-submissions or submissions, shall 
        include an electronic copy of such pre-submissions or 
        submissions.
            ``(2) Guidance contents.--In the guidance under paragraph 
        (1), the Secretary may--
                    ``(A) provide standards for the electronic copy 
                required under such paragraph; and
                    ``(B) set forth criteria for waivers of and 
                exemptions from the requirements of this subsection.''.

SEC. 604. NOTIFICATION OF FDA INTENT TO REGULATE LABORATORY-DEVELOPED 
              TESTS.

    The Food and Drug Administration may not issue any draft or final 
guidance on the regulation of laboratory-developed tests under the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) without, 
at least 60 days prior to such issuance--
            (1) notifying 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 
        Administration's intent to take such action; and
            (2) including in such notification the anticipated details 
        of such action.

           TITLE VII--MEDICAL DEVICE REGULATORY IMPROVEMENTS

                  Subtitle A--Premarket Predictability

SEC. 701. INVESTIGATIONAL DEVICE EXEMPTIONS.

    Section 520(g) (21 U.S.C. 360j(g)) is amended--
            (1) in paragraph (2)(B)(ii), by inserting ``safety or 
        effectiveness'' before ``data obtained''; and
            (2) in paragraph (4), by adding at the end the following:
    ``(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.''.

SEC. 702. CLARIFICATION OF LEAST BURDENSOME STANDARD.

    (a) Premarket Approval.--Section 513(a)(3)(D) (21 U.S.C. 
360c(a)(3)(D)) is amended--
            (1) by redesignating clause (iii) as clause (v); and
            (2) by inserting after clause (ii) the following:
    ``(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.''.
    (b) Premarket Notification Under Section 510(k).--Section 
513(i)(1)(D) (21 U.S.C. 360c(i)(1)(D)) is amended--
            (1) by striking ``(D) Whenever'' and inserting ``(D)(i) 
        Whenever''; and
            (2) by adding at the end the following:
    ``(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.''.

SEC. 703. AGENCY DOCUMENTATION AND REVIEW OF SIGNIFICANT DECISIONS.

    Chapter V is amended by inserting after section 517 (21 U.S.C. 
360g) the following:

``SEC. 517A. AGENCY DOCUMENTATION AND REVIEW OF SIGNIFICANT DECISIONS 
              REGARDING DEVICES.

    ``(a) Documentation of Rationale for Significant Decisions.--
            ``(1) In general.--The Secretary shall completely document 
        the scientific and regulatory rationale for any significant 
        decision of the Center for Devices and Radiological Health 
        regarding submission or review of a report under section 
        510(k), an application under section 515, or an application for 
        an exemption under section 520(g), including documentation of 
        significant controversies or differences of opinion and the 
        resolution of such controversies or differences of opinion.
            ``(2) Provision of documentation.--Upon request, the 
        Secretary shall furnish such complete documentation to the 
        person who is seeking to submit, or who has submitted, such 
        report or application.
    ``(b) Review of Significant Decisions.--
            ``(1) Request for supervisory review of significant 
        decision.--Any person may request a supervisory review of the 
        significant decision described in subsection (a)(1). Such 
        review may be conducted at the next supervisory level or higher 
        above the individual who made the significant decision.
            ``(2) Submission of request.--A person requesting a 
        supervisory review under paragraph (1) shall submit such 
        request to the Secretary not later than 30 days after such 
        decision and shall indicate in the request whether such person 
        seeks an in-person meeting or a teleconference review.
            ``(3) Timeframe.--
                    ``(A) In general.--Except as provided in 
                subparagraph (B), the Secretary shall schedule an in-
                person or teleconference review, if so requested, not 
                later than 30 days after such request is made. The 
                Secretary shall issue a decision to the person 
                requesting a review under this subsection not later 
                than 45 days after the request is made under paragraph 
                (1), or, in the case of a person who requests an in-
                person meeting or teleconference, 30 days after such 
                meeting or teleconference.
                    ``(B) Exception.--Subparagraph (A) shall not apply 
                in cases that are referred to experts outside of the 
                Food and Drug Administration.''.

SEC. 704. TRANSPARENCY IN CLEARANCE PROCESS.

    (a) Publication of Detailed Decision Summaries.--Section 520(h) (21 
U.S.C. 360j(h)) is amended by adding at the end the following:
    ``(5) Subject to subsection (c) and section 301(j), the Secretary 
shall regularly publish detailed decision summaries for each clearance 
of a device under section 510(k) requiring clinical data.''.
    (b) Application.--The requirement of section 520(h)(5) of the 
Federal Food, Drug, and Cosmetic Act, as added by subsection (a), 
applies only with respect to clearance of a device occurring after the 
date of the enactment of this Act.

SEC. 705. DEVICE MODIFICATIONS REQUIRING PREMARKET NOTIFICATION PRIOR 
              TO MARKETING.

    Section 510(n) (21 U.S.C. 360(n)) is amended by--
            (1) striking ``(n) The Secretary'' and inserting ``(n)(1) 
        The Secretary''; and
            (2) by adding at the end the following:
            ``(2)(A) Not later than 18 months after the 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.''.

                    Subtitle B--Patients Come First

SEC. 711. ESTABLISHMENT OF SCHEDULE AND PROMULGATION OF REGULATION.

    (a) Establishment of Schedule.--Not later than 90 days after the 
date of enactment of this Act, the Secretary of Health and Human 
Services shall establish the schedule referred to in section 515(i)(3) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(i)(3)).
    (b) Regulation.--Not later than one year after the date that the 
schedule is established under such section 515(i)(3) (as required by 
subsection (a)) the Secretary shall issue a final regulation under 
section 515(b) of such Act for each device that the Secretary requires 
to remain in class III through a determination under section 515(i)(2) 
of such Act.

SEC. 712. PROGRAM TO IMPROVE THE DEVICE RECALL SYSTEM.

    Chapter V is amended by inserting after section 518 (21 U.S.C. 
360h) the following:

``SEC. 518A. PROGRAM TO IMPROVE THE DEVICE RECALL SYSTEM.

    ``(a) In General.--The Secretary shall--
            ``(1) establish a program to routinely and systematically 
        assess information relating to device recalls and use such 
        information to proactively identify strategies for mitigating 
        health risks presented by defective or unsafe devices;
            ``(2) clarify procedures for conducting device recall audit 
        checks to improve the ability of investigators to perform those 
        checks in a consistent manner;
            ``(3) develop detailed criteria for assessing whether a 
        person performing a device recall has performed an effective 
        correction or action plan for the recall; and
            ``(4) document the basis for each termination by the Food 
        and Drug Administration of a device recall.
    ``(b) Assessment Content.--The program established under subsection 
(a)(1) shall, at a minimum, identify--
            ``(1) trends in the number and types of device recalls;
            ``(2) devices that are most frequently the subject of a 
        recall; and
            ``(3) underlying causes of device recalls.
    ``(c) Definition.--In this section, the term `recall' means--
            ``(1) the removal from the market of a device pursuant to 
        an order of the Secretary under subsection (b) or (e) of 
        section 518; or
            ``(2) the correction or removal from the market of a device 
        at the initiative of the manufacturer or importer of the device 
        that is required to be reported to the Secretary under section 
        519(g).''.

               Subtitle C--Novel Device Regulatory Relief

SEC. 721. MODIFICATION OF DE NOVO APPLICATION PROCESS.

    (a) In General.--Section 513(f)(2) (21 U.S.C. 360c(f)(2)) is 
amended--
            (1) by inserting ``(i)'' after ``(2)(A)'';
            (2) in subparagraph (A)(i), as so designated by paragraph 
        (1), by striking ``under the criteria set forth'' and all that 
        follows through the end of subparagraph (A) and inserting a 
        period;
            (3) by adding at the end of subparagraph (A) the following:
    ``(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 of a device pursuant to a request under 
clause (ii) if the Secretary--
            ``(I) identifies a legally marketed device that would 
        permit a substantial equivalence determination under paragraph 
        (1) for the device; or
            ``(II) determines that the device submitted is not of low-
        moderate risk or special controls to mitigate the risks cannot 
        be developed for the device.
    ``(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.''; and
            (4) in subparagraph (B), by striking ``Not later than 60 
        days after the date of the submission of the request under 
        subparagraph (A), the Secretary'' and inserting ``The 
        Secretary''.
    (b) Conforming Amendments.--Section 513(f) of such Act (21 U.S.C. 
360c(f)) is amended in paragraph (1)--
            (1) in subparagraph (A), by striking ``, or'' at the end 
        and inserting a semicolon;
            (2) in subparagraph (B), by striking the period and 
        inserting ``; or''; and
            (3) by inserting after subparagraph (B) the following:
            ``(C) the device is classified pursuant to a request 
        submitted under paragraph (2).''.

     Subtitle D--Keeping America Competitive Through Harmonization

SEC. 731. HARMONIZATION OF DEVICE PREMARKET REVIEW, INSPECTION, AND 
              LABELING SYMBOLS; REPORT.

    (a) In General.--Paragraph (4) of section 803(c) (21 U.S.C. 383(c)) 
is amended to read as follows:
    ``(4) With respect to devices, the Secretary may, when appropriate, 
enter into arrangements with nations regarding methods and approaches 
to harmonizing regulatory requirements for activities, including 
inspections and common international labeling symbols.''.
    (b) Report.--Not later than 3 years after the date of enactment of 
this Act, the Secretary of Health and Human Services shall 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 Food and Drug Administration's 
harmonization activities, itemizing methods and approaches that have 
been harmonized pursuant to section 803(c)(4) of the Federal Food, 
Drug, and Cosmetic Act, as amended by subsection (a).

SEC. 732. PARTICIPATION IN INTERNATIONAL FORA.

    Paragraph (3) of section 803(c) (21 U.S.C. 383(c)) is amended--
            (1) by striking ``(3)'' and inserting ``(3)(A)''; and
            (2) by adding at the end the following:
    ``(B) In carrying out subparagraph (A), the Secretary may 
participate in appropriate fora, including the International Medical 
Device Regulators Forum, and may--
            ``(i) provide guidance to such fora on strategies, 
        policies, directions, membership, and other activities of a 
        forum as appropriate;
            ``(ii) to the extent appropriate, solicit, review, and 
        consider comments from industry, academia, health care 
        professionals, and patient groups regarding the activities of 
        such fora; and
            ``(iii) to the extent appropriate, inform the public of the 
        Secretary's activities within such fora, and share with the 
        public any documentation relating to a forum's strategies, 
        policies, and other activities of such fora.''.

  Subtitle E--FDA Renewing Efficiency From Outside Reviewer Management

SEC. 741. REAUTHORIZATION OF THIRD PARTY REVIEW.

    (a) Periodic Reaccreditation.--Section 523(b)(2) (21 U.S.C. 
360m(b)(2)) is amended by adding at the end of the following:
                    ``(E) 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.''.
    (b) Duration of Authority.--Section 523(c) (21 U.S.C. 360m(c)) is 
amended by striking ``October 1, 2012'' and inserting ``October 1, 
2017''.

SEC. 742. REAUTHORIZATION OF THIRD PARTY INSPECTION.

    Section 704(g)(11) (21 U.S.C. 374(g)(11)) is amended by striking 
``October 1, 2012'' and inserting ``October 1, 2017''.

                 Subtitle F--Humanitarian Device Reform

SEC. 751. EXPANDED ACCESS TO HUMANITARIAN USE DEVICES.

    (a) In General.--Section 520(m) (21 U.S.C. 360j(m)) is amended--
            (1) in paragraph (6)--
                    (A) in subparagraph (A)--
                            (i) in the matter preceding clause (i), by 
                        striking ``subparagraph (D)'' and inserting 
                        ``subparagraph (C)'';
                            (ii) by striking clause (i) and inserting 
                        the following:
            ``(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.'';
                            (iii) by striking clause (ii) and inserting 
                        the following:
            ``(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 number of such devices 
        needed to treat, diagnose, or cure a population of 4,000 
        individuals in the United States (referred to in this paragraph 
        as the `annual distribution number').''; and
                            (iv) in clause (iv), by striking ``2012'' 
                        and inserting ``2017'';
                    (B) by striking subparagraph (C);
                    (C) by redesignating subparagraphs (D) and (E) as 
                subparagraphs (C) and (D), respectively; and
                    (D) in subparagraph (C), as so redesignated, by 
                striking ``and modified under subparagraph (C), if 
                applicable,'';
            (2) in paragraph (7), by striking ``regarding a device'' 
        and inserting ``regarding a device described in paragraph 
        (6)(A)(i)(I)''; and
            (3) in paragraph (8), by striking ``of all devices 
        described in paragraph (6)'' and inserting ``of all devices 
        described in paragraph (6)(A)(i)(I)''.
    (b) Applicability to Existing Devices.--A sponsor of a device for 
which an exemption was approved under paragraph (2) of section 520(m) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)) before 
the date of enactment of this Act may seek a determination under 
subclause (I) or (II) of paragraph (6)(A)(i) of such section 520(m) (as 
amended by subsection (a)). If the Secretary determines that such 
subclause (I) or (II) applies with respect to a device, then clauses 
(ii), (iii), and (iv) of subparagraph (A) and subparagraphs (B), (C), 
and (D) of paragraph (6) of such section 520(m) shall apply to such 
device.
    (c) Report.--Not later than January 1, 2017, the Comptroller 
General of the United States shall submit to Congress a report that 
evaluates and describes--
            (1) the effectiveness of the amendments made by subsection 
        (a) in stimulating innovation with respect to medical devices, 
        including any favorable or adverse impact on pediatric device 
        development;
            (2) the impact of such amendments on pediatric device 
        approvals for devices that received a humanitarian use 
        designation under section 520(m) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 360j(m)) prior to the date of enactment 
        of this Act;
            (3) the status of public and private insurance coverage of 
        devices granted an exemption under paragraph (2) of such 
        section 520(m) and costs to patients of such devices;
            (4) the impact that paragraph (4) of such section 520(m) 
        has had on access to and insurance coverage of devices granted 
        an exemption under paragraph (2) of such section 520(m); and
            (5) the effect of the amendments made by subsection (a) on 
        patients described in such section 520(m).

               Subtitle G--Records and Reports on Devices

SEC. 761. UNIQUE DEVICE IDENTIFICATION SYSTEM REGULATIONS.

    Not later than 120 days after the date of enactment of this Act, 
the Secretary of Health and Human Services shall promulgate the 
regulations required by section 519(f) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360i(f)).

SEC. 762. EFFECTIVE DEVICE SENTINEL PROGRAM.

    (a) Inclusion of Devices in Postmarket Risk Identification and 
Analysis System.--Section 519 (21 U.S.C. 360i) is amended by adding at 
the end the following:
    ``(h) Inclusion of Devices in Postmarket Risk Identification and 
Analysis System.--
            ``(1) In general.--The Secretary shall amend the procedures 
        established and maintained under clauses (i), (ii), (iii), and 
        (v) of section 505(k)(3)(C) in order to expand the postmarket 
        risk identification and analysis system established under such 
        section to include and apply to devices.
            ``(2) Data.--In expanding the system as described in 
        paragraph (1), the Secretary shall use relevant data with 
        respect to devices cleared under section 510(k) or approved 
        under section 515, which may include claims data, patient 
        survey data, and standardized analytic files that allow for the 
        pooling and analysis of data from disparate data environments.
            ``(3) Stakeholder input.--To help ensure effective 
        implementation of the system as described in paragraph (1) with 
        respect to devices, the Secretary shall engage outside 
        stakeholders in development of the system, and gather 
        information from outside stakeholders regarding the content of 
        an effective sentinel program, through a public hearing, 
        advisory committee meeting, maintenance of a public docket, or 
        other similar public measures.
            ``(4) Voluntary surveys.--Chapter 35 of title 44, United 
        States Code, shall not apply to the collection of voluntary 
        information from health care providers, such as voluntary 
        surveys or questionnaires, initiated by the Secretary for 
        purposes of postmarket risk identification, mitigation, and 
        analysis for devices.''.
    (b) Amendments to Postmarket Risk Identification and Analysis 
System.--Section 505(k)(3)(C)(i) (21 U.S.C. 355(k)(3)(C)(i)) is 
amended--
            (1) by striking subclause (II);
            (2) by redesignating subclauses (III) through (VI) as 
        subclauses (II) through (V), respectively; and
            (3) in item (bb) of subclause (II), as so redesignated, by 
        striking ``pharmaceutical purchase data and health insurance 
        claims data'' and inserting ``medical device utilization data, 
        health insurance claims data, and procedure and device 
        registries''.

                       Subtitle H--Miscellaneous

SEC. 771. CUSTOM DEVICES.

    Section 520(b) (21 U.S.C. 360j) is amended to read as follows:
    ``(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).''.

SEC. 772. PEDIATRIC DEVICE REAUTHORIZATION.

    (a) Final Rule Relating To Tracking of Pediatric Uses of Devices.--
The Secretary of Health and Human Services shall issue--
            (1) a proposed rule implementing section 515A(a)(2) of the 
        Federal Food, Drug and Cosmetic Act (21 U.S.C. 360e-1(a)(2)) 
        not later than December 31, 2012; and
            (2) a final rule implementing such section not later than 
        December 31, 2013.
    (b) Demonstration Grants To Improve Pediatric Device 
Availability.--Section 305(e) of the Pediatric Medical Device Safety 
and Improvement Act of 2007 (Title III of Public Law 110-85) is amended 
by striking ``2008 through 2012'' and inserting ``2013 through 2017''.

SEC. 773. REPORT ON REGULATION OF HEALTH INFORMATION TECHNOLOGY.

    (a) Report.--Not later than 18 months after the date of the 
enactment of this Act, the Secretary of Health and Human Services, in 
consultation with the Commissioner of Food and Drugs, the National 
Coordinator for Health Information Technology, and the Chairman of the 
Federal Communications Commission, shall submit to the Committee on 
Energy and Commerce of the House of Representatives and the appropriate 
committees of the Senate a report that contains--
            (1) a strategy for coordinating the regulation of health 
        information technology in order to avoid regulatory 
        duplication; and
            (2) recommendations on an appropriate regulatory framework 
        for health information technology, including a risk-based 
        framework.
    (b) Definition.--In this section, the terms ``health information 
technology'' has the meaning given such term in section 3000(5) of the 
Public Health Service Act and includes technologies such as electronic 
health records, personal health records, mobile medical applications, 
computerized health care provider order entry systems, and clinical 
decision support.

                TITLE VIII--DRUG REGULATORY IMPROVEMENTS

                     Subtitle A--Drug Supply Chain

SEC. 801. REGISTRATION OF PRODUCERS OF DRUGS.

    (a) Timing.--Section 510 (21 U.S.C. 360) is amended--
            (1) in subsection (b)(1), by striking ``On or before'' and 
        inserting ``During the period beginning on October 1 and ending 
        on''; and
            (2) in subsection (i)(1)(B)(i), by striking ``on or 
        before'' and inserting ``during the period beginning on October 
        1 and ending on''.
    (b) Establishments Not Duly Registered; Misbranding.--Section 
502(o) (21 U.S.C. 352(o)) is amended by striking ``in any State''.

SEC. 802. INSPECTION OF DRUGS.

    Subsection (h) of section 510 (21 U.S.C. 360) is amended--
            (1) by striking ``(h)'' and inserting ``(h)(1)'';
            (2) by inserting ``with respect to the manufacture, 
        preparation, propagation, compounding, or processing of a 
        device'' after ``registered with the Secretary pursuant to this 
        section'';
            (3) by striking ``of a drug or drugs or''; and
            (4) by adding at the end the following:
    ``(2) Inspections With Respect to Drug Establishments.--With 
respect to the manufacture, preparation, propagation, compounding, or 
processing of a drug:
            ``(A) 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.
            ``(B) Risk-based schedule.--In the case of an establishment 
        that is engaged in the manufacture, preparation, propagation, 
        compounding, or processing of a drug or drugs (referred to in 
        this subsection as a `drug establishment'), the inspections 
        required under subparagraph (A) shall be conducted by officers 
        or employees duly designated by the Secretary, on a risk-based 
        schedule established by the Secretary.
            ``(C) Risk factors.--In establishing the risk-based 
        schedule under subparagraph (B), the Secretary shall allocate 
        resources to inspect establishments according to the known 
        safety risks of such establishments, based on the following 
        factors:
                    ``(i) The compliance history of the establishment.
                    ``(ii) The inspection frequency and history of the 
                establishment, including whether it has been inspected 
                pursuant to section 704 within the last four years.
                    ``(iii) The record, history, and nature of recalls 
                linked to the establishment.
                    ``(iv) The inherent risk of the drug manufactured, 
                prepared, propagated, compounded, or processed at the 
                establishment.
                    ``(v) Any other criteria deemed necessary and 
                appropriate by the Secretary for purposes of allocating 
                inspection resources.
            ``(D) Effect of status.--In determining the risk associated 
        with an establishment for purposes of establishing a risk-based 
        schedule under subparagraph (B), the Secretary shall not 
        consider whether the drugs manufactured, prepared, propagated, 
        compounded, or processed by such establishment are drugs 
        described in section 503(b)(1).
            ``(E) Annual report on inspections of establishments.--Not 
        later than February 1 of each year, the Secretary shall submit 
        to Congress a report that contains the following:
                    ``(i) The number of domestic and foreign 
                establishments registered pursuant to this section in 
                the previous calendar year.
                    ``(ii) The number of such registered domestic and 
                foreign establishments that the Secretary inspected in 
                the previous calendar year.
                    ``(iii) The number of such registered 
                establishments that list one or more drugs approved 
                pursuant to an application filed under section 505(j).
                    ``(iv) The number of such registered establishments 
                that list one or more drugs approved pursuant to an 
                application filed under section 505(b).
                    ``(v) The number of registered establishments that 
                list both drug products approved pursuant to an 
                application filed under section 505(j) and drug 
                products approved pursuant to an application filed 
                under section 505(b).
                    ``(vi) A description of how the Secretary 
                implemented the risk-based schedule under subparagraph 
                (B) utilizing the factors under subparagraph (C).
            ``(F) Public availability of annual reports.--The Secretary 
        shall make the report required under subparagraph (E) available 
        to the public on the Internet Web site of the Food and Drug 
        Administration.''.

SEC. 803. DRUG SUPPLY QUALITY AND SAFETY.

    Paragraph (a) of section 501 (21 U.S.C. 351) is amended by adding 
at the end the following: ``For purposes of subparagraph (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.''.

SEC. 804. PROHIBITION AGAINST DELAYING, DENYING, LIMITING, OR REFUSING 
              INSPECTION.

    (a) In General.--Section 501 (21 U.S.C. 351) is amended by adding 
at the end the following:
    ``(j) If it is a drug 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.''.
    (b) Guidance.--Not later than 1 year after the date of enactment of 
this section, the Secretary of Health and Human Services shall issue 
guidance that defines the circumstances that would constitute delaying, 
denying, or limiting inspection, or refusing to permit entry or 
inspection, for purposes of section 501(j) of the Federal Food, Drug, 
and Cosmetic Act (as added by subsection (a)).

SEC. 805. DESTRUCTION OF ADULTERATED, MISBRANDED, OR COUNTERFEIT DRUGS 
              OFFERED FOR IMPORT.

    (a) In General.--The sixth sentence of section 801(a) (21 U.S.C. 
381(a)) is amended by inserting before the period at the end the 
following: ``, except that the Secretary of Health and Human Services, 
in consultation with the Secretary of Homeland Security, may cause the 
destruction, without the opportunity for export, of any drug refused 
admission that has reasonable probability of causing serious adverse 
health consequences or death, as determined by the Secretary of Health 
and Human Services, or that is valued at an amount that is $2,000 or 
less (or such higher amount as the Secretary of Homeland Security may 
set by regulation pursuant to section 498 of the Tariff Act of 1930 (19 
U.S.C. 1498))''.
    (b) Notice.--Section 801(a) (21 U.S.C. 381(a)), as amended by 
subsection (a), is further amended by inserting after the sixth 
sentence the following: ``The Secretary of Health and Human Services 
shall issue regulations providing for notice and an opportunity for a 
hearing on the destruction of a drug under the previous sentence. For a 
drug with a value less than and or equal to $2,000 (or, as described in 
the sixth sentence of this subsection, such higher amount as the 
Secretary of Homeland Security may set by regulation pursuant to 
section 498 of the Tariff Act of 1930 (19 U.S.C. 1498)) the regulations 
under the previous sentence shall provide for prompt notice and an 
opportunity for a hearing for the owner or consignee before or after 
the destruction has occurred. For a drug with a value greater than 
$2,000 (or, as described in the sixth sentence of this subsection, such 
higher amount as the Secretary of Homeland Security may set by 
regulation pursuant to section 498 of the Tariff Act of 1930 (19 U.S.C. 
1498)) that has reasonable probability of causing serious adverse 
health consequences or death as determined by the Secretary of Health 
and Human Services, the regulations under the seventh sentence of this 
subsection shall provide for notice and an opportunity for a hearing to 
the owner or consignee before the destruction occurs.''.
    (c) Restitution.--In the regulations described in the seventh 
sentence of section 801(a) of the Federal Food, Drug, and Cosmetic Act 
(as added by subsection (b)), the Secretary of Health and Human 
Services shall establish an administrative process whereby an owner or 
consignee of a drug destroyed without an opportunity for a hearing on 
destruction may obtain restitution for the value of the drug destroyed 
under the sixth sentence of such section upon demonstration that such 
drug was wrongfully destroyed.
    (d) Conforming Amendment.--The first sentence of section 801(a) (21 
U.S.C. 381(a)) is amended by inserting ``, except as otherwise 
described in the sixth and seventh sentences of this subsection,'' 
after ``giving notice thereof''.

SEC. 806. ADMINISTRATIVE DETENTION.

    (a) In General.--Section 304(g) (21 U.S.C. 335a(g)) is amended--
            (1) in paragraph (1), by inserting ``, drug,'' after 
        ``device'', each place it appears;
            (2) in paragraph (2)(A), by inserting ``, drug,'' after 
        ``(B), a device''; and
            (3) in paragraph (2)(B), by inserting ``or drug'' after 
        ``device'' each place it appears.
    (b) Regulation.--Not later than 2 years after the date of the 
enactment of this Act, the Secretary of Health and Human Services shall 
promulgate regulations to implement administrative detention authority 
with respect to drugs, as authorized by the amendments made by 
subsection (a). Before promulgating such regulations, the Secretary 
shall consult with stakeholders, including manufacturers of drugs.
    (c) Effective Date.--The amendments made by subsection (a) shall 
not take effect until the Secretary has issued a final regulation under 
subsection (b).

SEC. 807. ENHANCED CRIMINAL PENALTY FOR COUNTERFEIT DRUGS.

    (a) In General.--Section 303(a) (21 U.S.C. 333(a)) is amended by 
adding at the end the following:
    ``(3) Notwithstanding paragraph (2), any person who engages in any 
conduct described in section 301(i)(2) knowing or having reason to know 
that the conduct concerns the rendering of a drug as a counterfeit 
drug, or who engages in conduct described in section 301(i)(3) knowing 
or having reason to know that the conduct will cause a drug to be a 
counterfeit drug or knowing or having reason to know that a drug held, 
sold, or dispensed is a counterfeit drug, shall be fined in accordance 
with title 18, United States Code, or imprisoned not more than 20 
years, or both, except that if the use of the counterfeit drug by a 
consumer is the proximate cause of the death of the consumer, the term 
of imprisonment shall be any term of years or for life.''.
    (b) Conforming Amendment.--Section 201(g)(2) (21 U.S.C. 321(g)(2)) 
is amended by adding at the end the following sentence: ``The term 
`counterfeit drug' shall not include a drug or placebo intended for use 
in a clinical trial that is intentionally labeled or marked to maintain 
proper blinding of the study.''.

SEC. 808. UNIQUE FACILITY IDENTIFICATION NUMBER.

    (a) Domestic Establishments.--Section 510 (21 U.S.C. 360) is 
amended--
            (1) in subsection (b)(1), by striking ``and all such 
        establishments'' and inserting ``all such establishments, and 
        the unique facility identifier of each such establishment''; 
        and
            (2) in subsection (c), by striking ``and such 
        establishment'' and inserting ``such establishment, and the 
        unique facility identifier of such establishment''.
    (b) Foreign Establishments.--Subparagraph (A) of section 510(i)(1) 
(21 U.S.C. 360(i)(1)) is amended by inserting ``the unique facility 
identifier of the establishment,'' after ``the name and place of 
business of the establishment,''.
    (c) Guidance.--Section 510 (21 U.S.C. 360) is amended by adding at 
the end the following:
    ``(q) Guidance on Submission of Unique Facility Identifiers.--
            ``(1) In general.--Not later than 2 years after the date of 
        the enactment of this subsection, the Secretary shall, by 
        guidance, specify--
                    ``(A) the unique facility identifier system to be 
                used to meet the requirements of--
                            ``(i) subsections (b)(1), (c), and 
                        (i)(1)(A) of this section; and
                            ``(ii) section 801(s) (relating to 
                        registration of commercial importers); and
                    ``(B) the form, manner, and timing of submissions 
                of unique facility identifiers under the provisions 
                specified in subparagraph (A).
            ``(2) Consideration.--In developing the guidance under 
        paragraph (1), the Secretary shall take into account the 
        utilization of existing unique identification schemes and 
        compatibility with customs automated systems.''.
    (d) Importation.--Section 801(a) (21 U.S.C. 381(a)) is amended by 
inserting ``or (5) for an article that is a drug, the appropriate 
unique facility identifiers under subsection (s) (relating to 
commercial importers) and section 510(i) (relating to foreign 
establishments), as specified by the Secretary, are not provided,'' 
before ``then such article shall be refused admission''.

SEC. 809. DOCUMENTATION FOR ADMISSIBILITY OF IMPORTS.

    Section 801 (21 U.S.C. 381) is amended by adding at the end the 
following:
    ``(r) Documentation.--
            ``(1) Submission.--The Secretary may require, in 
        consultation with the Secretary of Homeland Security acting 
        through U.S. Customs and Border Protection as determined 
        appropriate by the Secretary, the submission of documentation 
        or other information for a drug that is imported or offered for 
        import into the United States.
            ``(2) Refusal of admission.--A drug imported or offered for 
        import into the United States shall be refused admission unless 
        all documentation and information the Secretary requires under 
        this Act, the Public Health Service Act, or both, as 
        appropriate, for such article is submitted.
            ``(3) Regulations.--
                    ``(A) Documents and information.--The Secretary 
                shall issue a regulation to specify the documentation 
                or other information that is described in paragraph 
                (1). Such information may include--
                            ``(i) information demonstrating the 
                        regulatory status of the drug, such as the new 
                        drug application, abbreviated new drug 
                        application, or investigational new drug or 
                        Drug Master File number;
                            ``(ii) facility information, such as proof 
                        of registration and the unique facility 
                        identifier; and
                            ``(iii) indication of compliance with 
                        current good manufacturing practice, such as 
                        satisfactory testing results, certifications 
                        relating to satisfactory inspections, and 
                        compliance with the country of export 
                        regulations.
                    ``(B) Exemption.--The Secretary may, by regulation, 
                exempt drugs imported for research purposes only and 
                other types of drug imports from some or all of the 
                requirements of this subsection.
            ``(4) Effective date.--The final rule under paragraph 
        (3)(A) shall take effect not less than 180 days after the 
        Secretary promulgates such final rule.''.

SEC. 810. REGISTRATION OF COMMERCIAL IMPORTERS.

    (a) Prohibitions.--Section 301 (21 U.S.C. 331) is amended by adding 
at the end the following:
    ``(aaa) The failure to register in accordance with section 
801(s).''.
    (b) Registration.--Section 801 (21 U.S.C. 381), as amended by 
section 809, is further amended by adding at the end the following:
    ``(s) Registration of Commercial Importers.--
            ``(1) Registration.--The Secretary shall require a 
        commercial importer of drugs--
                    ``(A) to be registered with the Secretary in a form 
                and manner specified by the Secretary; and
                    ``(B) consistent with the guidance under section 
                510(q), to submit, at the time of registration, a 
                unique identifier for the principal place of business 
                for which the importer is required to register under 
                this subsection.
            ``(2) Regulations.--
                    ``(A) In general.--The Secretary, in consultation 
                with the Secretary of Homeland Security acting through 
                U.S. Customs and Border Protection, shall promulgate 
                regulations to establish good importer practices that 
                specify the measures an importer shall take to ensure 
                imported drugs are in compliance with the requirements 
                of this Act and the Public Health Service Act.
                    ``(B) Expedited clearance for certain importers.--
                In promulgating good importer practice regulations 
                under subparagraph (A), the Secretary may, as 
                appropriate, take into account differences among 
                importers and types of imports, and, based on the level 
                of risk posed by the imported drug, provide for 
                expedited clearance for those importers that volunteer 
                to participate in partnership programs for highly 
                compliant companies.
            ``(3) Discontinuance of registration.--The Secretary shall 
        discontinue the registration of any commercial importer of 
        drugs that fails to comply with the regulations promulgated 
        under this subsection.
            ``(4) Exemptions.--The Secretary, by notice in the Federal 
        Register, may establish exemptions from the requirements of 
        this subsection.''.
    (c) Misbranding.--Section 502(o) (21 U.S.C. 352) is amended by 
inserting ``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),'' after ``not duly registered under section 510,''.
    (d) Regulations.--
            (1) In general.--Not later than 36 months after the date of 
        the enactment of this Act, the Secretary of Health and Human 
        Services, in consultation with the Secretary of Homeland 
        Security acting through U.S. Customs and Border Protection, 
        shall promulgate the regulations required to carry out section 
        801(s) of the Federal Food, Drug, and Cosmetic Act, as added by 
        subsection (b).
            (2) Effective date.--In establishing the effective date of 
        the regulations under paragraph (1), the Secretary of Health 
        and Human Services shall, in consultation with the Secretary of 
        Homeland Security acting through U.S. Customs and Border 
        Protection, as determined appropriate by the Secretary of 
        Health and Human Services, provide a reasonable period of time 
        for an importer of a drug to comply with good importer 
        practices, taking into account differences among importers and 
        types of imports, including based on the level of risk posed by 
        the imported product.

SEC. 811. NOTIFICATION.

    (a) Prohibited Acts.--Section 301 (21 U.S.C. 331), as amended by 
section 810, is further amended by adding at the end the following:
    ``(bbb) The failure to notify the Secretary in violation of section 
568.''.
    (b) Notification.--Subchapter E of chapter V (21 U.S.C. 360bbb et 
seq.) is amended by adding at the end the following:

``SEC. 568. NOTIFICATION.

    ``(a) Notification to Secretary.--With respect to a drug, the 
Secretary may require notification to the Secretary by a regulated 
person if the regulated person knows--
            ``(1) that the use of such drug in the United States may 
        result in serious injury or death;
            ``(2) of a significant loss or known theft of such drug 
        intended for use in the United States; or
            ``(3) that--
                    ``(A) such drug has been or is being counterfeited; 
                and
                    ``(B)(i) the counterfeit product is in commerce in 
                the United States or could be reasonably expected to be 
                introduced into commerce; or
                    ``(ii) such drug has been or is being imported into 
                the United States or may reasonably be expected to be 
                offered for import into the United States.
    ``(b) Manner of Notification.--Notification under this section 
shall be made in such manner and by such means as the Secretary may 
specify by regulation or guidance.
    ``(c) Savings Clause.--Nothing in this section shall be construed 
as limiting any other authority of the Secretary to require 
notifications related to a drug under any other provision of this Act 
or the Public Health Service Act.
    ``(d) Definition.--In this section, the term `regulated person' 
means--
            ``(1) a person who is required to register under section 
        510 or 801(s);
            ``(2) a wholesale distributor of a drug product; or
            ``(3) any other person that distributes drugs except a 
        person that distributes drugs exclusively for retail sale.''.

SEC. 812. EXCHANGE OF INFORMATION.

    Section 708 (21 U.S.C. 379) is amended--
            (1) by striking ``The Secretary may provide'' and inserting 
        the following:
    ``(a) Contractors.--The Secretary may provide''; and
            (2) by adding at the end the following:
    ``(b) Ability To Receive and Protect Confidential Information.--
Except pursuant to an order of a court of the United States, the 
Secretary shall not be required to disclose under section 552 of title 
5, United States Code, or any other provision of law, any information 
relating to drugs obtained from a Federal, State, or local government 
agency, or from a foreign government agency, if the agency has 
requested that the information be kept confidential. For purposes of 
section 552 of title 5, United States Code, this subsection shall be 
considered a statute described in section 552(b)(3)(B).
    ``(c) Authority To Enter Into Memoranda of Understanding for 
Purposes of Information Exchange.--The Secretary may enter into written 
agreements regarding the exchange of information referenced in section 
301(j) subject to the following criteria:
            ``(1) Certification.--The Secretary may only enter into 
        written agreements under this subsection with foreign 
        governments that the Secretary has certified as having the 
        authority and demonstrated ability to protect trade secret 
        information from disclosure. Responsibility for this 
        certification shall not be delegated to any officer or employee 
        other than the Commissioner of Food and Drugs.
            ``(2) Written agreement.--The written agreement under this 
        subsection shall include a commitment by the foreign government 
        to protect information exchanged under this subsection from 
        disclosure unless and until the sponsor gives written 
        permission for disclosure or the Secretary makes a declaration 
        of a public health emergency pursuant to section 319 of the 
        Public Health Service Act that is relevant to the information.
            ``(3) Information exchange.--The Secretary may provide to a 
        foreign government that has been certified under paragraph (1), 
        and that has executed a written agreement under paragraph (2), 
        information referenced in section 301(j) in the following 
        circumstances:
                    ``(A) Information concerning the inspection of a 
                facility may be provided if--
                            ``(i) the Secretary reasonably believes, or 
                        the written agreement described in paragraph 
                        (2) establishes, that the government has 
                        authority to otherwise obtain such information; 
                        and
                            ``(ii) the written agreement executed under 
                        paragraph (2) limits the recipient's use of the 
                        information to the recipient's civil regulatory 
                        purposes.
                    ``(B) Information not described in subparagraph (A) 
                may be provided as part of an investigation, or to 
                alert the foreign government to the potential need for 
                an investigation, if the Secretary has reasonable 
                grounds to believe that a drug has a reasonable 
                probability of causing serious adverse health 
                consequences or death.
    ``(d) No Limitation on Authority.--This section shall not affect 
the authority of the Secretary to provide or disclose information under 
any other provision of law.''.

SEC. 813. EXTRATERRITORIAL JURISDICTION.

    Chapter III (21 U.S.C. 331 et seq.) is amended by adding at the end 
the following:

``SEC. 311. EXTRATERRITORIAL JURISDICTION.

    ``There is extraterritorial jurisdiction over any violation of this 
Act relating to any article regulated under this Act if such article 
was intended for import into the United States or if any act in 
furtherance of the violation was committed in the United States.''.

SEC. 814. PROTECTION AGAINST INTENTIONAL ADULTERATION.

    Section 303(b) (21 U.S.C. 333(b)) is amended by adding at the end 
the following:
    ``(7) Notwithstanding subsection (a)(2), any person that knowingly 
and intentionally engages in an activity that results in a drug 
becoming adulterated under subsection (a)(1), (b), (c), or (d) of 
section 501 and having a reasonable probability of causing serious 
adverse health consequences or death shall be imprisoned for not more 
than 20 years or fined not more than $1,000,000, or both.''.

SEC. 815. RECORDS FOR INSPECTION.

    Section 704(a) (21 U.S.C. 374(a)) is amended by adding at the end 
the following:
    ``(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 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.
    ``(B) Upon receipt of the records requested under subparagraph (A), 
the Secretary shall provide to the person confirmation of receipt.
    ``(C) 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.''.

                     Subtitle B--Medical Gas Safety

SEC. 821. REGULATION OF MEDICAL GASES.

    Chapter V (21 U.S.C. 351 et seq.) is amended by adding at the end 
the following:

                     ``Subchapter G--Medical Gases

``SEC. 575. DEFINITIONS.

    ``In this subchapter:
            ``(1) The term `designated medical gas' means any of the 
        following:
                    ``(A) Oxygen that meets the standards set forth in 
                an official compendium.
                    ``(B) Nitrogen that meets the standards set forth 
                in an official compendium.
                    ``(C) Nitrous oxide that meets the standards set 
                forth in an official compendium.
                    ``(D) Carbon dioxide that meets the standards set 
                forth in an official compendium.
                    ``(E) Helium that meets the standards set forth in 
                an official compendium.
                    ``(F) Carbon monoxide that meets the standards set 
                forth in an official compendium.
                    ``(G) Medical air that meets the standards set 
                forth in an official compendium.
                    ``(H) Any other medical gas deemed appropriate by 
                the Secretary, after taking into account any 
                investigational new drug application or investigational 
                new animal drug application for the same medical gas 
                submitted in accordance with regulations applicable to 
                such applications in title 21 of the Code of Federal 
                Regulations, unless any period of exclusivity under 
                section 505(c)(3)(E)(ii) or section 505(j)(5)(F)(ii), 
                or the extension of any such period under section 505A, 
                applicable to such medical gas has not expired.
            ``(2) The term `medical gas' means a drug that--
                    ``(A) is manufactured or stored in a liquefied, 
                nonliquefied, or cryogenic state; and
                    ``(B) is administered as a gas.

``SEC. 576. REGULATION OF MEDICAL GASES.

    ``(a) Certification of Designated Medical Gases.--
            ``(1) Submission.--Beginning 180 days after the date of 
        enactment of this section, any person may file with the 
        Secretary a request for certification of a medical gas as a 
        designated medical gas. Any such request shall contain the 
        following information:
                    ``(A) A description of the medical gas.
                    ``(B) The name and address of the sponsor.
                    ``(C) The name and address of the facility or 
                facilities where the medical gas is or will be 
                manufactured.
                    ``(D) Any other information deemed appropriate by 
                the Secretary to determine whether the medical gas is a 
                designated medical gas.
            ``(2) Grant of certification.--The certification requested 
        under paragraph (1) is deemed to be granted unless, within 60 
        days of the filing of such request, the Secretary finds that--
                    ``(A) the medical gas subject to the certification 
                is not a designated medical gas;
                    ``(B) the request does not contain the information 
                required under paragraph (1) or otherwise lacks 
                sufficient information to permit the Secretary to 
                determine that the medical gas is a designated medical 
                gas; or
                    ``(C) denying the request is necessary to protect 
                the public health.
            ``(3) Effect of certification.--
                    ``(A) In general.--
                            ``(i) Approved uses.--A designated medical 
                        gas for which a certification is granted under 
                        paragraph (2) is deemed, alone or in 
                        combination, as medically appropriate, with 
                        another designated medical gas or gases for 
                        which a certification or certifications have 
                        been granted, to have in effect an approved 
                        application under section 505 or 512, subject 
                        to all applicable post-approval requirements, 
                        for the following indications for use:
                                    ``(I) In the case of oxygen, the 
                                treatment or prevention of hypoxemia or 
                                hypoxia.
                                    ``(II) In the case of nitrogen, use 
                                in hypoxic challenge testing.
                                    ``(III) In the case of nitrous 
                                oxide, analgesia.
                                    ``(IV) In the case of carbon 
                                dioxide, use in extracorporeal membrane 
                                oxygenation therapy or respiratory 
                                stimulation.
                                    ``(V) In the case of helium, the 
                                treatment of upper airway obstruction 
                                or increased airway resistance.
                                    ``(VI) In the case of medical air, 
                                to reduce the risk of hyperoxia.
                                    ``(VII) In the case of carbon 
                                monoxide, use in lung diffusion 
                                testing.
                                    ``(VIII) Any other indication for 
                                use for a designated medical gas or 
                                combination of designated medical gases 
                                deemed appropriate by the Secretary, 
                                unless any period of exclusivity under 
                                clause (iii) or (iv) of section 
                                505(c)(3)(E), clause (iii) or (iv) of 
                                section 505(j)(5)(F), or section 527, 
                                or the extension of any such period 
                                under section 505A, applicable to such 
                                indication for use for such gas or 
                                combination of gases has not expired.
                            ``(ii) Labeling.--The requirements of 
                        sections 503(b)(4) and 502(f) are deemed to 
                        have been met for a designated medical gas if 
                        the labeling on final use container for such 
                        medical gas bears--
                                    ``(I) the information required by 
                                section 503(b)(4);
                                    ``(II) a warning statement 
                                concerning the use of the medical gas 
                                as determined by the Secretary by 
                                regulation; and
                                    ``(III) appropriate directions and 
                                warnings concerning storage and 
                                handling.
                    ``(B) Inapplicability of exclusivity provisions.--
                            ``(i) No exclusivity for a certified 
                        medical gas.--No designated medical gas deemed 
                        under subparagraph (A)(i) to have in effect an 
                        approved application is eligible for any period 
                        of exclusivity under section 505(c), 505(j), or 
                        527, or the extension of any such period under 
                        section 505A, on the basis of such deemed 
                        approval.
                            ``(ii) Effect on certification.--No period 
                        of exclusivity under section 505(c), 505(j), or 
                        section 527, or the extension of any such 
                        period under section 505A, with respect to an 
                        application for a drug product shall prohibit, 
                        limit, or otherwise affect the submission, 
                        grant, or effect of a certification under this 
                        section, except as provided in subsection 
                        (a)(3)(A)(i)(VIII) and section 575(1)(H).
            ``(4) Withdrawal, suspension, or revocation of approval.--
                    ``(A) Withdrawal, suspension of approval.--Nothing 
                in this subchapter limits the Secretary's authority to 
                withdraw or suspend approval of a drug product, 
                including a designated medical gas deemed under this 
                section to have in effect an approved application under 
                section 505 or section 512 of this Act.
                    ``(B) Revocation of certification.--The Secretary 
                may revoke the grant of a certification under paragraph 
                (2) if the Secretary determines that the request for 
                certification contains any material omission or 
                falsification.
    ``(b) Prescription Requirement.--
            ``(1) In general.--A designated medical gas shall be 
        subject to the requirements of section 503(b)(1) unless the 
        Secretary exercises the authority provided in section 503(b)(3) 
        to remove such medical gas from the requirements of section 
        503(b)(1), the gas is approved for use without a prescription 
        pursuant to an application under section 505 or 512, or the use 
        in question is authorized pursuant to another provision of this 
        Act relating to use of medical products in emergencies.
            ``(2) Oxygen.--
                    ``(A) No prescription required for certain uses.--
                Notwithstanding paragraph (1), oxygen may be provided 
                without a prescription for the following uses:
                            ``(i) For use in the event of 
                        depressurization or other environmental oxygen 
                        deficiency.
                            ``(ii) For oxygen deficiency or for use in 
                        emergency resuscitation, when administered by 
                        properly trained personnel.
                    ``(B) Labeling.--For oxygen provided pursuant to 
                subparagraph (A), the requirements of section 503(b)(4) 
                shall be deemed to have been met if its labeling bears 
                a warning that the oxygen can be used for emergency use 
                only and for all other medical applications a 
                prescription is required.

``SEC. 577. INAPPLICABILITY OF DRUG FEES TO DESIGNATED MEDICAL GASES.

    ``A designated medical gas, alone or in combination with another 
designated gas or gases (as medically appropriate) deemed under section 
576 to have in effect an approved application shall not be assessed 
fees under section 736(a) on the basis of such deemed approval.''.

SEC. 822. CHANGES TO REGULATIONS.

    (a) Report.--Not later than 18 months after the date of the 
enactment of this Act, the Secretary, after obtaining input from 
medical gas manufacturers and any other interested members of the 
public, shall--
            (1) determine whether any changes to the Federal drug 
        regulations are necessary for medical gases; and
            (2) 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 regarding any such 
        changes.
    (b) Regulations.--If the Secretary determines under subsection (a) 
that changes to the Federal drug regulations are necessary for medical 
gases, the Secretary shall issue final regulations revising the Federal 
drug regulations with respect to medical gases not later than 48 months 
after the date of the enactment of this Act.
    (c) Definitions.--In this section:
            (1) The term ``Federal drug regulations'' means regulations 
        in title 21 of the Code of Federal Regulations pertaining to 
        drugs.
            (2) The term ``medical gas'' has the meaning given to such 
        term in section 575 of the Federal Food, Drug, and Cosmetic 
        Act, as added by section 821 of this Act.
            (3) The term ``Secretary'' means the Secretary of Health 
        and Human Services, acting through the Commissioner of Food and 
        Drugs.

SEC. 823. RULES OF CONSTRUCTION.

    Nothing in this subtitle and the amendments made by this subtitle 
applies with respect to--
            (1) a drug that is approved prior to May 1, 2012, pursuant 
        to an application submitted under section 505 or 512 of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355, 360b);
            (2) any gas listed in subparagraphs (A) through (G) of 
        section 575(1) of the Federal Food, Drug, and Cosmetic Act, as 
        added by section 821 of this Act, or any combination of any 
        such gases, for an indication that--
                    (A) is not included in, or is different from, those 
                specified in subclauses (I) through (VII) of section 
                576(a)(3)(A)(i) of such Act; and
                    (B) is approved on or after May 1, 2012, pursuant 
                to an application submitted under Section 505 or 512; 
                or
            (3) any designated medical gas added pursuant to 
        subparagraph (H) of section 575(1) of such Act for an 
        indication that--
                    (A) is not included in, or is different from, those 
                originally added pursuant to subparagraph (H) of 
                section 575(1) and section 576(a)(3)(A)(i)(VIII); and
                    (B) is approved on or after May 1, 2012, pursuant 
                to an application submitted under section 505 or 512 of 
                such Act.

            Subtitle C--Generating Antibiotic Incentives Now

SEC. 831. EXTENSION OF EXCLUSIVITY PERIOD FOR DRUGS.

    (a) In General.--The Federal Food, Drug, and Cosmetic Act is 
amended by inserting after section 505D (21 U.S.C. 355e) the following:

``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 determined to be a qualified 
infectious disease product under subsection (d), then the four- and 
five-year periods described in subsections (c)(3)(E)(ii) and 
(j)(5)(F)(ii) of section 505, the three-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 seven year period 
described in section 527, as applicable, shall be extended by five 
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 by the same sponsor or 
        manufacturer of a qualified infectious disease product 
        described in paragraph (1) (or a licensor, predecessor in 
        interest, or other related entity) for--
                    ``(A) a change (not including a modification to the 
                active moiety of the qualified infectious disease 
                product) that results in a new indication, route of 
                administration, dosing schedule, dosage form, delivery 
                system, delivery device, or strength; or
                    ``(B) a modification to the active moiety of the 
                qualified infectious disease product that does not 
                result in a change in safety or effectiveness; or
            ``(3) a product that does not meet the definition of a 
        qualified infectious disease product under subsection (f) based 
        upon its approved uses.
    ``(d) Determination.--The manufacturer or sponsor of a drug may 
request that the Secretary designate a drug as a qualified infectious 
disease product at any time in the drug development process prior to 
the submission of an application under section 505(b) for the drug, but 
not later than 45 days before the submission of such application. The 
Secretary shall, not later than 30 days after the submission of such 
request, determine whether the drug is a qualified infectious disease 
product.
    ``(e) Regulations.--The Secretary shall promulgate regulations for 
carrying out this section. The Secretary shall promulgate the initial 
regulations for carrying out this section not later than 12 months 
after the date of the enactment of this section.
    ``(f) Definitions.--In this section:
            ``(1) Qualified infectious disease product.--The term 
        `qualified infectious disease product' means an antibacterial 
        or antifungal drug for human use that treats or prevents an 
        infection caused by a qualifying pathogen.
            ``(2) Qualifying pathogen.--The term `qualifying pathogen' 
        means--
                    ``(A) resistant gram-positive pathogens, including 
                methicillin-resistant Staphylococcus aureus (MRSA), 
                vancomycin-resistant Staphylococcus aureus (VRSA), and 
                vancomycin-resistant enterococcus (VRE);
                    ``(B) multidrug resistant gram-negative bacteria, 
                including Acinetobacter, Klebsiella, Pseudomonas, and 
                E. coli species;
                    ``(C) multi-drug resistant tuberculosis; or
                    ``(D) any other infectious pathogen identified for 
                purposes of this section by the Secretary.''.
    (b) Application.--Section 505E of the Federal Food, Drug, and 
Cosmetic Act, as added by subsection (a), applies only with respect to 
a drug that is first approved under section 505(c) of such Act (21 
U.S.C. 355(c)) on or after the date of the enactment of this Act.

SEC. 832. STUDY ON INCENTIVES FOR QUALIFIED INFECTIOUS DISEASE 
              BIOLOGICAL PRODUCTS.

    (a) In General.--The Comptroller General of the United States 
shall--
            (1) conduct a study on the need for incentives to encourage 
        research on and development and marketing of qualified 
        infectious disease biological products; and
            (2) not later than 1 year after the date of the enactment 
        of this Act, submit a report to the Congress on the results of 
        such study, including any recommendations of the Comptroller 
        General on appropriate incentives for addressing such need.
    (b) Definitions.--In this section:
            (1) The term ``biological product'' has the meaning given 
        to such term in section 351 of the Public Health Service Act 
        (42 U.S.C. 262).
            (2) The term ``qualified infectious disease biological 
        product'' means a biological product for human use that treats 
        or prevents an infection caused by a qualifying pathogen.
            (3) The term ``qualifying pathogen'' has the meaning given 
        to such term in section 505E of the Federal Food, Drug, and 
        Cosmetic Act, as added by section 831 of this Act.

SEC. 833. CLINICAL TRIALS.

    (a) Review and Revision of Guidelines.--
            (1) In general.--Not later than 1 year after the date of 
        the enactment of this Act, and not later than 4 years 
        thereafter, the Secretary shall--
                    (A) review the guidance of the Food and Drug 
                Administration for the conduct of clinical trials with 
                respect to antibacterial and antifungal drugs; and
                    (B) as appropriate, revise such guidance to reflect 
                developments in scientific and medical information and 
                technology and to ensure clarity regarding the 
                procedures and requirements for approval of an 
                antibiotic and antifungal drug under chapter V of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et 
                seq.).
            (2) Issues for review.--At a minimum, the review under 
        paragraph (1) shall address the appropriate animal models of 
        infection, in vitro techniques, valid microbiological surrogate 
        markers, the use of noninferiority versus superiority trials, 
        and appropriate delta values for noninferiority trials.
            (3) Rule of construction.--Except to the extent to which 
        the Secretary of Health and Human Services makes revisions 
        under paragraph (1)(B), nothing in this section shall be 
        construed to repeal or otherwise affect the guidance of the 
        Food and Drug Administration.
    (b) Recommendations for Investigations.--
            (1) Request.--The sponsor of a drug intended to be used to 
        treat or prevent a qualifying pathogen may request that the 
        Secretary provide written recommendations for nonclinical and 
        clinical investigations which may be conducted with the drug 
        before it may be approved for such use under section 505 of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355).
            (2) Recommendations.--If the Secretary has reason to 
        believe that a drug for which a request is made under this 
        subsection is a qualified infectious disease product, the 
        Secretary shall provide the person making the request written 
        recommendations for the nonclinical and clinical investigations 
        which the Secretary believes, on the basis of information 
        available to the Secretary at the time of the request, would be 
        necessary for approval under section 505 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 355) of such drug for the use 
        described in paragraph (1).
    (c) Definitions.--In this section:
            (1) The term ``drug'' has the meaning given to such term in 
        section 201 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 321).
            (2) The term ``qualified infectious disease product'' has 
        the meaning given to such term in section 505E of the Federal 
        Food, Drug, and Cosmetic Act, as added by section 831 of this 
        Act.
            (3) The term ``qualifying pathogen'' has the meaning given 
        to such term in section 505E of the Federal Food, Drug, and 
        Cosmetic Act, as added by section 831 of this Act.
            (4) The term ``Secretary'' means the Secretary of Health 
        and Human Services, acting through the Commissioner of Food and 
        Drugs.

SEC. 834. REASSESSMENT OF QUALIFIED INFECTIOUS DISEASE PRODUCT 
              INCENTIVES IN 5 YEARS.

    Not later than five years after the date of enactment of this Act, 
the Secretary of Health and Human Services shall, in consultation with 
the Food and Drug Administration, Centers for Disease Control and 
Prevention and other appropriate agencies, 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 that 
contains the following:
            (1)(A) The number of initial designations of drugs as 
        qualified infectious disease products under section 505E of the 
        Federal Food, Drug, and Cosmetic Act;
            (B) the number of qualified infectious disease products 
        approved under this program; and
            (C) whether such products address the need for 
        antibacterial and antifungal drugs to treat serious and life-
        threatening infections.
            (2) Recommendations--
                    (A) based on the information in paragraph (1) and 
                any other relevant data, on any changes that should be 
                made to the list of pathogens that are defined as 
                qualifying pathogens under section 505E(f)(2) of the 
                Federal Food, Drug, and Cosmetic Act, as added by 
                section 831; and
                    (B) on whether any additional program (such as the 
                development of public-private collaborations to advance 
                antibacterial drug innovation) or changes to the 
                incentives under this subtitle may be needed to promote 
                the development of antibacterial drugs.
            (3) An examination of--
                    (A) the adoption of programs to measure the use of 
                antibacterial drugs in health care settings; and
                    (B) the implementation and effectiveness of 
                antimicrobial stewardship protocols across all health 
                care settings.
            (4) Any recommendations for ways to encourage further 
        development and establishment of stewardship programs.

SEC. 835. GUIDANCE ON PATHOGEN-FOCUSED ANTIBACTERIAL DRUG DEVELOPMENT.

    (a) Draft Guidance.--Not later than June 30, 2013, in order to 
facilitate the development of antibacterial drugs for serious or life-
threatening bacterial infections, particularly in areas of unmet need, 
the Secretary of Health and Human Services shall publish draft guidance 
that--
            (1) specifies how preclinical and clinical data can be 
        utilized to inform an efficient and streamlined pathogen-
        focused antibacterial drug development program that meets the 
        approval standards of the Food and Drug Administration; and
            (2) provides advice on approaches for the development of 
        antibacterial drugs that target a more limited spectrum of 
        pathogens.
    (b) Final Guidance.--Not later than December 31, 2014, after notice 
and opportunity for public comment on the draft guidance under 
subsection (a), the Secretary of Health and Human Services shall 
publish final guidance consistent with this section.

                    Subtitle D--Accelerated Approval

SEC. 841. EXPEDITED APPROVAL OF DRUGS FOR SERIOUS OR LIFE-THREATENING 
              DISEASES OR CONDITIONS.

    (a) Findings; Sense of Congress.--
            (1) Findings.--The Congress finds as follows:
                    (A) The Food and Drug Administration (referred to 
                in this subsection as the ``FDA'') serves a critical 
                role in helping to assure that new medicines are safe 
                and effective. Regulatory innovation is 1 element of 
                the Nation's strategy to address serious and life-
                threatening diseases or conditions by promoting 
                investment in and development of innovative treatments 
                for unmet medical needs.
                    (B) During the 2 decades following the 
                establishment of the accelerated approval mechanism, 
                advances in medical sciences, including genomics, 
                molecular biology, and bioinformatics, have provided an 
                unprecedented understanding of the underlying 
                biological mechanism and pathogenesis of disease. A new 
                generation of modern, targeted medicines is under 
                development to treat serious and life-threatening 
                diseases, some applying drug development strategies 
                based on biomarkers or pharmacogenomics, predictive 
                toxicology, clinical trial enrichment techniques, and 
                novel clinical trial designs, such as adaptive clinical 
                trials.
                    (C) As a result of these remarkable scientific and 
                medical advances, the FDA should be encouraged to 
                implement more broadly effective processes for the 
                expedited development and review of innovative new 
                medicines intended to address unmet medical needs for 
                serious or life-threatening diseases or conditions, 
                including those for rare diseases or conditions, using 
                a broad range of surrogate or clinical endpoints and 
                modern scientific tools earlier in the drug development 
                cycle when appropriate. This may result in fewer, 
                smaller, or shorter clinical trials for the intended 
                patient population or targeted subpopulation without 
                compromising or altering the high standards of the FDA 
                for the approval of drugs.
                    (D) Patients benefit from expedited access to safe 
                and effective innovative therapies to treat unmet 
                medical needs for serious or life-threatening diseases 
                or conditions.
                    (E) For these reasons, the statutory authority in 
                effect on the day before the date of enactment of this 
                Act governing expedited approval of drugs for serious 
                or life-threatening diseases or conditions should be 
                amended in order to enhance the authority of the FDA to 
                consider appropriate scientific data, methods, and 
                tools, and to expedite development and access to novel 
                treatments for patients with a broad range of serious 
                or life-threatening diseases or conditions.
            (2) Sense of congress.--It is the sense of the Congress 
        that the FDA should apply the accelerated approval and fast 
        track provisions set forth in section 506 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 356), as amended by this 
        section, to help expedite the development and availability to 
        patients of treatments for serious or life-threatening diseases 
        or conditions while maintaining safety and effectiveness 
        standards for such treatments.
    (b) Expedited Approval.--Section 506 (21 U.S.C. 356) is amended to 
read as follows:

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

    ``(a) Designation of Drug as a 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. 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) of this Act 
        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.
    ``(b) Accelerated Approval of a Drug for a Serious or Life-
Threatening Disease or Condition, Including a Fast Track Product.--
            ``(1) In general.--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) of this Act or section 351(a) of the Public 
        Health Service Act upon making a determination that the product 
        has an effect on--
                    ``(A) a surrogate endpoint that is reasonably 
                likely to predict clinical benefit; or
                    ``(B) 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 or rarity of the disease or 
        condition and the availability of alternative treatments. The 
        evidence to support that an endpoint is reasonably likely to 
        predict clinical benefit may include epidemiological, 
        pathophysiologic, pharmacologic, therapeutic or other evidence 
        developed using, for example, biomarkers, or other scientific 
        methods or tools.
            ``(2) Limitation.--Approval of a product under this 
        subsection may, as determined by the Secretary, be subject to 
        the following requirements--
                    ``(A) that the sponsor conduct appropriate post-
                approval studies to verify and describe the predicted 
                effect of the product on irreversible morbidity or 
                mortality or other clinical benefit; and
                    ``(B) that the sponsor submit copies of all 
                promotional materials related to the product, at least 
                30 days prior to dissemination of the materials--
                            ``(i) during the preapproval review period; 
                        and
                            ``(ii) following approval, for a period 
                        that the Secretary determines to be 
                        appropriate.
            ``(3) Expedited withdrawal of approval.--The Secretary may 
        withdraw approval of a product approved pursuant to this 
        subsection 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 
                post-approval study of the product 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.
    ``(c) 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.
    ``(d) 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 accelerated approval 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 there 
        exist significant unmet medical needs.''.

SEC. 842. GUIDANCE; AMENDED REGULATIONS.

    (a) Initial Guidance.--Not later than one year after the date of 
enactment of this Act, the Secretary of Health and Human Services (in 
this subtitle referred to as the ``Secretary'') shall issue draft 
guidance to implement the amendment made by section 841.
    (b) Final Guidance.--Not later than one year after the issuance of 
draft guidance under subsection (a), after an opportunity for public 
comment, the Secretary shall--
            (1) issue final guidance to implement the amendment made by 
        section 841; and
            (2) amend the regulations governing accelerated approval in 
        parts 314 and 601 of title 21, Code of Federal Regulations, as 
        necessary to conform such regulations with the amendments made 
        by section 841.
    (c) Considerations.--In developing the guidance under subsections 
(a) and (b)(1) and the amendments under subsection (b)(2), the 
Secretary shall consider--
            (1) issues arising under the accelerated approval and fast 
        track processes under section 506 of the Federal Food, Drug, 
        and Cosmetic Act (as amended by section 841) for drugs 
        designated for a rare disease or condition under section 526 of 
        the Federal, Food, Drug, and Cosmetic Act; and
            (2) how to incorporate novel approaches to the review of 
        surrogate endpoints based on pathophysiologic and pharmacologic 
        evidence in such guidance, especially in instances where the 
        low prevalence of a disease renders the existence or collection 
        of other types of data unlikely or impractical.
    (d) No Delay in Review or Approval.--The issuance (or non-issuance) 
of guidance or conforming regulations implementing the amendments made 
by section 841 shall not preclude the review of, or action on, a 
request for designation or an application for approval submitted 
pursuant to section 506 of the Federal Food, Drug, and Cosmetic Act, as 
amended by section 841.

SEC. 843. INDEPENDENT REVIEW.

    (a) In General.--The Secretary may, in conjunction with other 
planned reviews of the new drug review process, contract with an 
independent entity with expertise in assessing the quality and 
efficiency of biopharmaceutical development and regulatory review 
programs, to evaluate the Food and Drug Administration's application of 
the processes described in section 506 of the Federal Food, Drug, and 
Cosmetic Act, as amended by section 841, and the impact of such 
processes on the development and timely availability of innovative 
treatments for patients suffering from serious or life-threatening 
conditions.
    (b) Consultation.--Any evaluation under subsection (a) shall 
include consultation with regulated industries, patient advocacy and 
disease research foundations, and relevant academic medical centers.

               Subtitle E--Critical Path Reauthorization

SEC. 851. REAUTHORIZATION OF THE CRITICAL PATH PUBLIC-PRIVATE 
              PARTNERSHIPS.

    Subsection (f) of section 566 (21 U.S.C. 360bbb-5) is amended to 
read as follows:
    ``(f) Authorization of Appropriations.--To carry out this section, 
there is authorized to be appropriated $6,000,000 for each of fiscal 
years 2013 through 2017.''.

                       Subtitle F--Miscellaneous

SEC. 861. REAUTHORIZATION OF PROVISION RELATING TO EXCLUSIVITY OF 
              CERTAIN DRUGS CONTAINING SINGLE ENANTIOMERS.

    Section 505(u)(4) (21 U.S.C. 355(u)(4)) is amended by striking 
``2012'' and inserting ``2017''.

SEC. 862. EXTENSION OF PERIOD FOR FIRST APPLICANT TO OBTAIN TENTATIVE 
              APPROVAL WITHOUT FORFEITING 180-DAY EXCLUSIVITY PERIOD.

    (a) Extension.--
            (1) In general.--If a first applicant files an application 
        during the 30-month period ending on the date of enactment of 
        this Act and such application initially contains a 
        certification described in paragraph (2)(A)(vii)(IV) of section 
        505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        355(j)), or if a first applicant files an application and the 
        application is amended during such period to first contain such 
        a certification, the phrase ``30 months'' in paragraph 
        (5)(D)(i)(IV) of such section shall, with respect to such 
        application, be read as meaning--
                    (A) during the period beginning on the date of 
                enactment of this Act, and ending on September 30, 
                2013, ``45 months'';
                    (B) during the period beginning on October 1, 2013, 
                and ending on September 30, 2014, ``42 months'';
                    (C) during the period beginning on October 1, 2014, 
                and ending on September 30, 2015, ``39 months''; and
                    (D) during the period beginning on October 1, 2015, 
                and ending on September 30, 2016, ``36 months''.
            (2) Conforming amendment.--In the case of an application to 
        which an extended period under paragraph (1) applies, the 
        reference to the 30-month period under section 505(q)(1)(G) of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        355(q)(1)(G)) shall be read to be the applicable period under 
        paragraph (1).
    (b) Period for Obtaining Tentative Approval of Certain 
Applications.--If an application is filed on or before the date of 
enactment of this Act and such application is amended during the period 
beginning on the day after the date of enactment of this Act and ending 
on September 30, 2017, to first contain a certification described in 
paragraph (2)(A)(vii)(IV) of section 505(j) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355(j)), the date of the filing of such 
amendment (rather than the date of the filing of such application) 
shall be treated as the beginning of the 30-month period described in 
paragraph (5)(D)(i)(IV) of such section 505(j).
    (c) Definitions.--For the purposes of this section, the terms 
``application'' and ``first applicant'' mean application and first 
applicant, as such terms are used in section 505(j)(5)(D)(i)(IV) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(D)(i)(IV)).

SEC. 863. FINAL AGENCY ACTION RELATING TO PETITIONS AND CIVIL ACTIONS.

    Section 505(q) (21 U.S.C. 355(q)) is amended--
            (1) in paragraph (1)--
                    (A) in subparagraph (A), by striking ``subsection 
                (b)(2) or (j)'' inserting ``subsection (b)(2) or (j) of 
                the Act or 351(k) of the Public Health Service Act''; 
                and
                    (B) in subparagraph (F), by striking ``180 days'' 
                and inserting ``150 days'';
            (2) in paragraph (2)(A)--
                    (A) in the subparagraph heading, by striking 
                ``180'' and inserting ``150''; and
                    (B) in clause (i), by striking ``180-day'' and 
                inserting ``150-day''; and
            (3) in paragraph (5), by striking ``subsection (b)(2) or 
        (j)'' inserting ``subsection (b)(2) or (j) of the Act or 351(k) 
        of the Public Health Service Act''.

SEC. 864. DEADLINE FOR DETERMINATION ON CERTAIN PETITIONS.

    (a) In General.--Section 505 (21 U.S.C. 355) is amended by adding 
at the end the following:
    ``(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.''.
    (b) Application.--The amendment made by subsection (a) shall apply 
to any petition that is submitted pursuant to subsection (b) of section 
314.161 of title 21, Code of Federal Regulations (or any successor 
regulations), on or after the date of enactment of this Act.

SEC. 865. RARE PEDIATRIC DISEASE PRIORITY REVIEW VOUCHER INCENTIVE 
              PROGRAM.

    Subchapter B of Chapter V (21 U.S.C. 360aa et seq.) is amended by 
adding at the end the following:

``SEC. 529. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR RARE PEDIATRIC 
              DISEASES.

    ``(a) Definitions.--In this section:
            ``(1) Priority review.--The term `priority review', with 
        respect to a human drug application as defined in section 
        735(1), means review and action by the Secretary on such 
        application not later than 6 months after receipt by the 
        Secretary of such application, 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.
            ``(2) Priority review voucher.--The term `priority review 
        voucher' means a voucher issued by the Secretary to the sponsor 
        of a rare pediatric disease product application that entitles 
        the holder of such voucher to priority review of a single human 
        drug application submitted under section 505(b)(1) or section 
        351(a) of the Public Health Service Act after the date of 
        approval of the rare pediatric disease product application.
            ``(3) Rare pediatric disease.--The term `rare pediatric 
        disease' means a disease that meets each of the following 
        criteria:
                    ``(A) The disease primarily affects individuals 
                aged from birth to 18 years, including age groups often 
                called neonates, infants, children, and adolescents.
                    ``(B) The disease is a rare disease or condition, 
                within the meaning of section 526.
            ``(4) Rare pediatric disease product application.--The term 
        `rare pediatric disease product application' means a human drug 
        application, as defined in section 735(1), that--
                    ``(A) is for a drug or biological product--
                            ``(i) that is for the prevention or 
                        treatment of a rare pediatric disease; and
                            ``(ii) that contains no active ingredient 
                        (including any ester or salt of the active 
                        ingredient) that has been previously approved 
                        in any other application under section 
                        505(b)(1), 505(b)(2), or 505(j) of this Act or 
                        section 351(a) or 351(k) of the Public Health 
                        Service Act;
                    ``(B) is submitted under section 505(b)(1) of this 
                Act or section 351(a) of the Public Health Service Act;
                    ``(C) the Secretary deems eligible for priority 
                review;
                    ``(D) that relies on clinical data derived from 
                studies examining a pediatric population and dosages of 
                the drug intended for that population;
                    ``(E) that does not seek approval for an adult 
                indication in the original rare pediatric disease 
                product application; and
                    ``(F) is approved after the date of the enactment 
                of the Prescription Drug User Fee Amendments of 2012.
    ``(b) Priority Review Voucher.--
            ``(1) In general.--The Secretary shall award a priority 
        review voucher to the sponsor of a rare pediatric disease 
        product application upon approval by the Secretary of such rare 
        pediatric disease product application.
            ``(2) Transferability.--
                    ``(A) In general.--The sponsor of a rare pediatric 
                disease product application that receives a priority 
                review voucher under this section may transfer 
                (including by sale) the entitlement to such voucher. 
                There is no limit on the number of times a priority 
                review voucher may be transferred before such voucher 
                is used.
                    ``(B) Notification of transfer.--Each person to 
                whom a voucher is transferred shall notify the 
                Secretary of such change in ownership of the voucher 
                not later than 30 days after such transfer.
            ``(3) Limitation.--A sponsor of a rare pediatric disease 
        product application may not receive a priority review voucher 
        under this section if the rare pediatric disease product 
        application was submitted to the Secretary prior to the date 
        that is 90 days after the date of enactment of the Prescription 
        Drug User Fee Amendments of 2012.
            ``(4) Notification.--
                    ``(A) In general.--The sponsor of a human drug 
                application shall notify the Secretary not later than 
                90 days prior to submission of the human drug 
                application that is the subject of a priority review 
                voucher of an intent to submit the human drug 
                application, including the date on which the sponsor 
                intends to submit the application. Such notification 
                shall be a legally binding commitment to pay for the 
                user fee to be assessed in accordance with this 
                section.
                    ``(B) Transfer after notice.--The sponsor of a 
                human drug application that provides notification of 
                the intent of such sponsor to use the voucher for the 
                human drug application under subparagraph (A) may 
                transfer the voucher after such notification is 
                provided, if such sponsor has not yet submitted the 
                human drug application described in the notification.
            ``(5) Termination of authority.--The Secretary may not 
        award any priority review vouchers under paragraph (1) after 
        the last day of the 1-year period that begins on the date that 
        the Secretary awards the third rare pediatric disease priority 
        voucher under this section.
    ``(c) Priority Review User Fee.--
            ``(1) In general.--The Secretary shall establish a user fee 
        program under which a sponsor of a human drug application that 
        is the subject of a priority review voucher shall pay to the 
        Secretary a fee determined under paragraph (2). Such fee shall 
        be in addition to any fee required to be submitted by the 
        sponsor under chapter VII.
            ``(2) Fee amount.--The amount of the priority review user 
        fee shall be determined each fiscal year by the Secretary, 
        based on the difference between--
                    ``(A) the average cost incurred by the Food and 
                Drug Administration in the review of a human drug 
                application subject to priority review in the previous 
                fiscal year; and
                    ``(B) the average cost incurred by the Food and 
                Drug Administration in the review of a human drug 
                application that is not subject to priority review in 
                the previous fiscal year.
            ``(3) Annual fee setting.--The Secretary shall establish, 
        before the beginning of each fiscal year beginning after 
        September 30, 2012, the amount of the priority review user fee 
        for that fiscal year.
            ``(4) Payment.--
                    ``(A) In general.--The priority review user fee 
                required by this subsection shall be due upon the 
                notification by a sponsor of the intent of such sponsor 
                to use the voucher, as specified in subsection 
                (b)(4)(A). All other user fees associated with the 
                human drug application shall be due as required by the 
                Secretary or under applicable law.
                    ``(B) Complete application.--An application 
                described under subparagraph (A) for which the sponsor 
                requests the use of a priority review voucher shall be 
                considered incomplete if the fee required by this 
                subsection and all other applicable user fees are not 
                paid in accordance with the Secretary's procedures for 
                paying such fees.
                    ``(C) No waivers, exemptions, reductions, or 
                refunds.--The Secretary may not grant a waiver, 
                exemption, reduction, or refund of any fees due and 
                payable under this section.
            ``(5) Offsetting collections.--Fees collected pursuant to 
        this subsection for any fiscal year--
                    ``(A) shall be deposited and credited as offsetting 
                collections to the account providing appropriations to 
                the Food and Drug Administration; and
                    ``(B) shall not be collected for any fiscal year 
                except to the extent provided in advance in 
                appropriation Acts.
    ``(d) Designation Process.--
            ``(1) In general.--Upon the request of the manufacturer or 
        the sponsor of a new drug, the Secretary may designate--
                    ``(A) the new drug as a drug for a rare pediatric 
                disease; and
                    ``(B) the application for the new drug as a rare 
                pediatric disease product application.
            ``(2) Request for designation.--The request for a 
        designation under paragraph (1), shall be made at the same time 
        a request for designation of orphan disease status under 
        section 526 or fast-track designation under section 506 is 
        made. Requesting designation under this subsection is not a 
        prerequisite to receiving a priority review voucher under this 
        section.
            ``(3) Determination by secretary.--Not later than 60 days 
        after a request is submitted under paragraph (1), the Secretary 
        shall determine whether--
                    ``(A) the disease or condition that is the subject 
                of such request is a rare pediatric disease; and
                    ``(B) the application for the new drug is a rare 
                pediatric disease product application.
    ``(e) Marketing of Rare Pediatric Disease Products.--
            ``(1) In general.--The Secretary shall deem a rare 
        pediatric disease product application incomplete if such 
        application does not contain a description of the plan of the 
        sponsor of such application to market the product in the United 
        States.
            ``(2) Revocation.--The Secretary may revoke any priority 
        review voucher awarded under subsection (b) if the rare 
        pediatric disease product for which such voucher was awarded is 
        not marketed in the United States within the 365 day period 
        beginning on the date of the approval of such drug under 
        section 505 of this Act or section 351 of the Public Health 
        Service Act.
            ``(3) Postapproval production report.--The sponsor of an 
        approved rare pediatric disease product shall submit a report 
        to the Secretary not later than 5 years after the approval of 
        the applicable rare pediatric disease product application. Such 
        report shall provide the following information, with respect to 
        each of the first 4 years after approval of such product:
                    ``(A) The estimated population in the United States 
                suffering from the rare pediatric disease.
                    ``(B) The estimated demand in the United States for 
                such rare pediatric disease product.
                    ``(C) The actual amount of such rare pediatric 
                disease product distributed in the United States.
    ``(f) Notice and Report.--
            ``(1) Notice of issuance of voucher and approval of 
        products under voucher.--The Secretary shall publish a notice 
        in the Federal Register and on the Web site of the Food and 
        Drug Administration not later than 30 days after the occurrence 
        of each of the following:
                    ``(A) The Secretary issues a priority review 
                voucher under this section.
                    ``(B) The Secretary approves a drug pursuant to an 
                application submitted under section 505(b) of this Act 
                or section 351(a) of the Public Health Service Act for 
                which the sponsor of the application used a priority 
                review voucher under this section.
            ``(2) Report.--If, after the last day of the 1-year period 
        that begins on the date that the Secretary awards the third 
        rare pediatric disease priority voucher under this section, a 
        sponsor of an application submitted under section 505(b) of 
        this Act or section 351(a) of the Public Health Service Act for 
        a drug uses a priority review voucher under this section for 
        such application, 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 document--
                    ``(A) notifying such Committees of the use of such 
                voucher; and
                    ``(B) identifying the drug for which such priority 
                review voucher is used.
    ``(g) Eligibility for Other Programs.--Nothing in this section 
precludes a sponsor who seeks a priority review voucher under this 
section from participating in any other incentive program, including 
under this Act.
    ``(h) Relation to Other Provisions.--The provisions of this section 
shall supplement, not supplant, any other provisions of this Act or the 
Public Health Service Act that encourage the development of drugs for 
tropical diseases and rare pediatric diseases.
    ``(i) GAO Study and Report.--
            ``(1) Study.--
                    ``(A) In general.--Beginning on the date that the 
                Secretary awards the third rare pediatric disease 
                priority voucher under this section, the Comptroller 
                General of the United States shall conduct a study of 
                the effectiveness of awarding rare pediatric disease 
                priority vouchers under this section in the development 
                of on human drug products that treat or prevent such 
                diseases.
                    ``(B) Contents of study.--In conducting the study 
                under subparagraph (A), the Comptroller General shall 
                examine the following:
                            ``(i) The indications for which each rare 
                        disease product for which a priority review 
                        voucher was awarded was approved under section 
                        505 or section 351 of the Public Health Service 
                        Act.
                            ``(ii) Whether, and to what extent, an 
                        unmet need related to the treatment or 
                        prevention of a rare pediatric disease was met 
                        through the approval of such a rare disease 
                        product.
                            ``(iii) The value of the priority review 
                        voucher if transferred.
                            ``(iv) Identification of each drug for 
                        which a priority review voucher was used.
                            ``(v) The length of the period of time 
                        between the date on which a priority review 
                        voucher was awarded and the date on which it 
                        was used.
            ``(2) Report.--Not later than 1 year after the date under 
        paragraph (1)(A), 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 results of 
        the study under paragraph (1).''.

SEC. 866. COMBATING PRESCRIPTION DRUG ABUSE.

    (a) In General.--To combat the significant rise in prescription 
drug abuse and the consequences of such abuse, the Secretary of Health 
and Human Services (referred to in this section as the ``Secretary''), 
acting through the Commissioner of Food and Drugs (referred to in this 
section as the ``Commissioner'') and in coordination with other Federal 
agencies, as appropriate, shall review current Federal initiatives and 
identify gaps and opportunities with respect to ensuring the safe use 
of prescription drugs with the potential for abuse.
    (b) Report.--Not later than 1 year after the date of enactment of 
this Act, the Secretary shall issue a report to Congress on the 
findings of the review under subsection (a). Such report shall include 
recommendations on--
            (1) how best to leverage and build upon existing Federal 
        and federally funded data sources, such as prescription drug 
        monitoring program data and the sentinel initiative of the Food 
        and Drug Administration under section 505(k)(3) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 351(k)(3)), as it 
        relates to collection of information relevant to adverse 
        events, patient safety, and patient outcomes, to create a 
        centralized data clearinghouse and early warning tool;
            (2) how best to develop and disseminate widely best 
        practices models and suggested standard requirements to States 
        for achieving greater interoperability and effectiveness of 
        prescription drug monitoring programs, especially with respect 
        to producing standardized data on adverse events, patient 
        safety, and patient outcomes; and
            (3) how best to develop provider and patient education 
        tools and a strategy to widely disseminate such tools and 
        assess the efficacy of such tools.
    (c) Guidance on Tamper-Deterrent Products.--Not later than 6 months 
after the date of enactment of this Act, the Secretary, acting through 
the Commissioner, shall promulgate guidance on the development of 
tamper-deterrent drug products.

SEC. 867. ASSESSMENT AND MODIFICATION OF REMS.

    (a) Assessment and Modification of Approved Strategy.--Section 505-
1(g) (21 U.S.C. 355-1(g)) is amended--
            (1) in paragraph (1), by striking ``, and propose a 
        modification to,'';
            (2) in paragraph (2)--
                    (A) in the matter before subparagraph (A)--
                            (i) by striking ``, subject to paragraph 
                        (5),''; and
                            (ii) by striking ``, and may propose a 
                        modification to,'';
                    (B) in subparagraph (C), by striking ``new safety 
                or effectiveness information indicates that'' and all 
                that follows and inserting the following: ``an 
                assessment is needed to evaluate whether the approved 
                strategy should be modified to--
                            ``(i) ensure the benefits of the drug 
                        outweigh the risks of the drug; or
                            ``(ii) minimize the burden on the health 
                        care delivery system of complying with the 
                        strategy.''; and
                    (C) by striking subparagraph (D);
            (3) in paragraph (3), by striking ``for a drug shall 
        include--'' and all that follows and inserting the following 
        ``for a drug shall include, with respect to each goal included 
        in the strategy, an assessment of the extent to which the 
        approved strategy, including each element of the strategy, is 
        meeting the goal or whether 1 or more such goals or such 
        elements should be modified.''; and
            (4) by amending paragraph (4) to read as follows:
            ``(4) Modification.--
                    ``(A) On initiative of responsible person.--After 
                the approval of a risk evaluation and mitigation 
                strategy by the Secretary, the responsible person may, 
                at any time, submit to the Secretary a proposal to 
                modify the approved strategy. Such proposal may propose 
                the addition, modification, or removal of any goal or 
                element of the approved strategy and shall include an 
                adequate rationale to support such proposed addition, 
                modification, or removal of any goal or element of the 
                strategy.
                    ``(B) On initiative of secretary.--After the 
                approval of a risk evaluation and mitigation strategy 
                by the Secretary, the Secretary may, at any time, 
                require a responsible person to submit a proposed 
                modification to the strategy within 120 days or within 
                such reasonable time as the Secretary specifies, if the 
                Secretary, in consultation with the offices described 
                in subsection (c)(2), determines that 1 or more goals 
                or elements should be added, modified, or removed from 
                the approved strategy to--
                            ``(i) ensure the benefits of the drug 
                        outweigh the risks of the drug; or
                            ``(ii) minimize the burden on the health 
                        care delivery system of complying with the 
                        strategy.''.
    (b) Review of Proposed Strategies; Review of Assessments and 
Modifications of Approved Strategies.--Section 505-1(h) (21 U.S.C. 355-
1(h)) is amended--
            (1) in the subsection heading by inserting ``and 
        Modifications'' after ``Review of Assessments'';
            (2) in paragraph (1)--
                    (A) by inserting ``and proposed modification to'' 
                after ``under subsection (a) and each assessment of''; 
                and
                    (B) by inserting ``, and, if necessary, promptly 
                initiate discussions with the responsible person about 
                such proposed strategy, assessment, or modification'' 
                after ``subsection (g)'';
            (3) by striking paragraph (2);
            (4) by redesignating paragraphs (3) through (9) as 
        paragraphs (2) through (8), respectively;
            (5) in paragraph (2), as redesignated by paragraph (4)--
                    (A) by amending subparagraph (A) to read as 
                follows:
                    ``(A) In general.--
                            ``(i) Timeframe.--Unless the dispute 
                        resolution process described under paragraph 
                        (3) or (4) applies, and, except as provided in 
                        clause (ii) or clause (iii) below, the 
                        Secretary, in consultation with the offices 
                        described in subsection (c)(2), shall review 
                        and act on the proposed risk evaluation and 
                        mitigation strategy for a drug or any proposed 
                        modification to any required strategy within 
                        180 days of receipt of the proposed strategy or 
                        modification.
                            ``(ii) Minor modifications.--The Secretary 
                        shall review and act on a proposed minor 
                        modification, as defined by the Secretary in 
                        guidance, within 60 days of receipt of such 
                        modification.
                            ``(iii) REMS modification due to safety 
                        label changes.--Not later than 60 days after 
                        the Secretary receives a proposed modification 
                        to an approved risk evaluation and mitigation 
                        strategy to conform the strategy to approved 
                        safety label changes, including safety labeling 
                        changes initiated by the sponsor in accordance 
                        with FDA regulatory requirements, or to a 
                        safety label change that the Secretary has 
                        directed the holder of the application to make 
                        pursuant to section 505(o)(4), the Secretary 
                        shall review and act on such proposed 
                        modification to the approved strategy.
                            ``(iv) Guidance.--The Secretary shall 
                        establish, through guidance, that responsible 
                        persons may implement certain modifications to 
                        an approved risk evaluation and mitigation 
                        strategy following notification to the 
                        Secretary.''; and
                    (B) by amending subparagraph (C) to read as 
                follows:
                    ``(C) Public availability.--Upon acting on a 
                proposed risk evaluation and mitigation strategy or 
                proposed modification to a risk evaluation and 
                mitigation strategy under subparagraph (A), the 
                Secretary shall make publicly available an action 
                letter describing the actions taken by the Secretary 
                under such subparagraph (A).''.
            (6) in paragraph (4), as redesignated by paragraph (4)--
                    (A) in subparagraph (A)(i)--
                            (i) by striking ``Not earlier than 15 days, 
                        and not later than 35 days, after discussions 
                        under paragraph (2) have begun, the'' and 
                        inserting ``The''; and
                            (ii) by inserting ``, after the sponsor is 
                        required to make a submission under subsection 
                        (a)(2) or (g),'' before ``request in writing''; 
                        and
                    (B) in subparagraph (I)--
                            (i) by striking clauses (i) and (ii); and
                            (ii) by striking ``if the Secretary--'' and 
                        inserting ``if the Secretary has complied with 
                        the timing requirements of scheduling review by 
                        the Drug Safety Oversight Board, providing a 
                        written recommendation, and issuing an action 
                        letter under subparagraphs (B), (F), and (G), 
                        respectively.'';
            (7) in paragraph (5), as redesignated by paragraph (4)--
                    (A) in subparagraph (A), by striking ``any of 
                subparagraphs (B) through (D)'' and inserting 
                ``subparagraph (B) or (C)''; and
                    (B) in subparagraph (C), by striking ``paragraph 
                (4) or (5)'' and inserting ``paragraph (3) or (4)''; 
                and
            (8) in paragraph (8), as redesignated by paragraph (4), by 
        striking ``paragraphs (7) and (8)'' and inserting ``paragraphs 
        (6) and (7).''.
    (c) Guidance.--Not later than 1 year after the date of enactment of 
this Act, the Secretary of Health and Human Services shall issue 
guidance that, for purposes of section 505-1(h)(2)(A) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355-1(h)(2)(A)), describes the 
types of modifications to approved risk evaluation and mitigation 
strategies that shall be considered to be minor modifications of such 
strategies.

SEC. 868. CONSULTATION WITH EXTERNAL EXPERTS ON RARE DISEASES, TARGETED 
              THERAPIES, AND GENETIC TARGETING OF TREATMENTS.

    Subchapter E of chapter V (21 U.S.C. 360bbb et seq.), as amended by 
section 811(b), is further amended by adding at the end the following:

``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 (c). 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.
    ``(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.--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--
            ``(1) such consultation will--
                    ``(A) facilitate the Secretary's ability to 
                complete the Secretary's review;
                    ``(B) address outstanding deficiencies in the 
                application; and
                    ``(C) increase the likelihood of an approval 
                decision in the current review cycle; or
            ``(2) the sponsor authorized such consultation.''.

SEC. 869. BREAKTHROUGH THERAPIES.

    (a) In General.--Section 506 (21 U.S.C. 356), as amended by section 
841, is further amended--
            (1) by redesignating subsection (d) as subsection (e);
            (2) by redesignating subsections (a) through (c) as 
        subsections (b) through (d), respectively;
            (3) by inserting before subsection (b), as so redesignated, 
        the following:
    ``(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 non-
                        clinical 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.'';
            (4) in subsection (e)(1), as so redesignated, by striking 
        ``applicable to accelerated approval'' and inserting 
        ``applicable to breakthrough therapies, accelerated 
        approval,''; and
            (5) by adding at the end the following:
    ``(f) Report.--Beginning in fiscal year 2013, the Secretary shall 
annually 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, and make publicly available, 
with respect to this section for the previous fiscal year--
            ``(1) the number of drugs for which a sponsor requested 
        designation as a breakthrough therapy;
            ``(2) the number of products designated as a breakthrough 
        therapy; and
            ``(3) for each product designated as a breakthrough 
        therapy, a summary of the actions taken under subsection 
        (a)(3).''.
    (b) Guidance; Amended Regulations.--
            (1) In general.--
                    (A) Guidance.--Not later than 18 months after the 
                date of enactment of this Act, the Secretary of Health 
                and Human Services (referred to in this section as the 
                ``Secretary'') shall issue draft guidance on 
                implementing the requirements with respect to 
                breakthrough therapies, as set forth in section 506(a) 
                of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                356(a)), as amended by this section. The Secretary 
                shall issue final guidance not later than 1 year after 
                the close of the comment period for the draft guidance.
                    (B) Amended regulations.--
                            (i) In general.--If the Secretary 
                        determines that it is necessary to amend the 
                        regulations under title 21, Code of Federal 
                        Regulations in order to implement the 
                        amendments made by this section to section 
                        506(a) of the Federal Food, Drug, and Cosmetic 
                        Act, the Secretary shall amend such regulations 
                        not later than 2 years after the date of 
                        enactment of this Act.
                            (ii) Procedure.--In amending regulations 
                        under clause (i), the Secretary shall--
                                    (I) issue a notice of proposed 
                                rulemaking that includes the proposed 
                                regulation;
                                    (II) provide a period of not less 
                                than 60 days for comments on the 
                                proposed regulation; and
                                    (III) publish the final regulation 
                                not less than 30 days before the 
                                effective date of the regulation.
                            (iii) Restrictions.--Notwithstanding any 
                        other provision of law, the Secretary shall 
                        promulgate regulations implementing the 
                        amendments made by section only as described in 
                        clause (ii).
            (2) Requirements.--Guidance issued under this section 
        shall--
                    (A) specify the process and criteria by which the 
                Secretary makes a designation under section 506(a)(3) 
                of the Federal Food, Drug, and Cosmetic Act; and
                    (B) specify the actions the Secretary shall take to 
                expedite the development and review of a breakthrough 
                therapy pursuant to such designation under such section 
                506(a)(3), including updating good review management 
                practices to reflect breakthrough therapies.
    (c) Independent Review.--Not later than 3 years after the date of 
enactment of this Act, the Comptroller General of the United States, in 
consultation with appropriate experts, shall assess the manner by which 
the Food and Drug Administration has applied the processes described in 
section 506(a) of the Federal Food, Drug, and Cosmetic Act, as amended 
by this section, and the impact of such processes on the development 
and timely availability of innovative treatments for patients affected 
by serious or life-threatening conditions. Such assessment shall be 
made publicly available upon completion.
    (d) Conforming Amendments.--Section 506B(e) (21 U.S.C. 356b) is 
amended by striking ``section 506(b)(2)(A)'' each place such term 
appears and inserting ``section 506(c)(2)(A)''.

SEC. 870. GRANTS AND CONTRACTS FOR THE DEVELOPMENT OF ORPHAN DRUGS.

    (a) Qualified Testing Definition.--Section 5(b)(1)(A)(ii) of the 
Orphan Drug Act (21 U.S.C. 360ee(b)(1)(A)(ii)) is amended by striking 
``after the date such drug is designated under section 526 of such Act 
and''.
    (b) Authorization of Appropriations.--Section 5(c) of the Orphan 
Drug Act (21 U.S.C. 360ee(c)) is amended to read as follows:
    ``(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 2013 through 2017.''.

                        TITLE IX--DRUG SHORTAGES

SEC. 901. DISCONTINUANCE AND INTERRUPTIONS OF MANUFACTURING OF CERTAIN 
              DRUGS.

    (a) In General.--Section 506C (21 U.S.C. 356c) is amended to read 
as follows:

``SEC. 506C. DISCONTINUANCE AND INTERRUPTIONS OF MANUFACTURING OF 
              CERTAIN DRUGS.

    ``(a) In General.--A manufacturer of a drug subject to section 
503(b)(1)--
            ``(1) that is--
                    ``(A) life-supporting;
                    ``(B) life-sustaining; or
                    ``(C) intended for use in the prevention or 
                treatment of a debilitating disease or condition; and
            ``(2) that is not a radio pharmaceutical drug product, a 
        product derived from human plasma protein and their recombinant 
        analogs, or any other product as designated by the Secretary,
shall notify the Secretary of a discontinuance of the manufacture of 
the drug, or an interruption of the manufacture of the drug that is 
likely to lead to a meaningful disruption in the manufacturer's supply 
of the drug, and the reason for such discontinuance or interruption, in 
accordance with subsection (b).
    ``(b) Timing.--A notice required by subsection (a) shall be 
submitted to the Secretary--
            ``(1) at least 6 months prior to the date of the 
        discontinuance or interruption; or
            ``(2) if compliance with paragraph (1) is not possible, as 
        soon as practicable.
    ``(c) Distribution.--To the maximum extent practicable, the 
Secretary shall distribute information on the discontinuation or 
interruption of the manufacture of the drugs described in subsection 
(a) to appropriate organizations, including physician, health provider, 
and patient organizations, as described in section 506D.
    ``(d) Confidentiality.--Nothing in this section 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.
    ``(e) Coordination With Attorney General.--Not later than 30 days 
after the receipt of a notification described in subsection (a), the 
Secretary shall--
            ``(1) determine whether the notification pertains to a 
        controlled substance subject to a production quota under 
        section 306 of the Controlled Substances Act; and
            ``(2) if necessary, as determined by the Secretary--
                    ``(A) notify the Attorney General that the 
                Secretary has received such a notification;
                    ``(B) request that the Attorney General increase 
                the aggregate and individual production quotas under 
                section 306 of the Controlled Substances Act applicable 
                to such controlled substance and any ingredient therein 
                to a level the Secretary deems necessary to address a 
                shortage of a controlled substance based on the best 
                available market data; and
                    ``(C) if the Attorney General determines that the 
                level requested is not necessary to address a shortage 
                of a controlled substance, the Attorney General shall 
                provide to the Secretary a written response detailing 
                the basis for the Attorney General's determination.
        The Secretary shall make the written response provided under 
        subparagraph (C) available to the public on the Web site of the 
        Food and Drug Administration.
    ``(f) Failure To Meet Requirements.--If a person fails to submit 
information required under subsection (a) in accordance with subsection 
(b)--
            ``(1) the Secretary shall issue a letter to such person 
        informing such person of such failure;
            ``(2) not later than 30 calendar days after the issuance of 
        a letter under paragraph (1), the person who receives such 
        letter shall submit to the Secretary a written response to such 
        letter setting forth the basis for noncompliance and providing 
        information required under subsection (a); and
            ``(3) not later than 45 calendar days after the issuance of 
        a letter under paragraph (1), the Secretary shall make such 
        letter and any response to such letter under paragraph (2) 
        available to the public on the Web site of the Food and Drug 
        Administration, with appropriate redactions made to protect 
        information described in subsection (d), except that, if the 
        Secretary determines that the letter under paragraph (1) was 
        issued in error or, after review of such response, the person 
        had a reasonable basis for not notifying as required under 
        subsection (a), the requirements of this paragraph shall not 
        apply.''.
    (b) Regulations.--
            (1) In general.--Not later than 18 months after the date of 
        the enactment of this Act, the Secretary of Health and Human 
        Services, after issuing a notice of proposed rule and holding a 
        public hearing, shall promulgate final regulations that 
        implement the amendment made by subsection (a).
            (2) Contents.--Such regulations shall, for purposes of 
        section 506C of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 356c)--
                    (A) define the terms ``life-supporting'', ``life-
                sustaining'', and ``intended for use in the prevention 
                or treatment of a debilitating disease or condition''; 
                and
                    (B) define the term ``interruption of the 
                manufacture of the drug that is likely to lead to a 
                meaningful disruption in the manufacturer's supply of 
                the drug'' to mean a change in production that is 
                highly likely to lead to more than a negligible 
                reduction in the supply of the drug and affects the 
                ability of the manufacturer to meet demand for such 
                drug, but not to include a change in production due to 
                matters such as routine maintenance or insignificant 
                changes in manufacturing so long as the manufacturer 
                expects to resume operations in a short period of time.

SEC. 902. DRUG SHORTAGE LIST.

    Title V (21 U.S.C. 351 et seq.) is amended by inserting after 
section 506C the following new section:

``SEC. 506D. DRUG SHORTAGE LIST.

    ``(a) Establishment.--The Secretary shall maintain an up-to-date 
list of drugs that are determined by the Secretary to be in shortage in 
the United States.
    ``(b) Contents.--For each drug on such list, the Secretary shall 
include the following information:
            ``(1) The name of the drug in shortage.
            ``(2) The name of each manufacturer of such drug.
            ``(3) The reason for the shortage, as determined by the 
        Secretary, selecting from the following categories:
                    ``(A) Requirements related to complying with good 
                manufacturing practices.
                    ``(B) Regulatory delay.
                    ``(C) Shortage of an active ingredient.
                    ``(D) Shortage of an inactive ingredient component.
                    ``(E) Discontinuation of the manufacture of the 
                drug.
                    ``(F) Delay in shipping of the drug.
                    ``(G) Demand increase for the drug.
            ``(4) The estimated duration of the shortage as determined 
        by the Secretary.
    ``(c) Public Availability.--
            ``(1) In general.--Subject to paragraphs (2) and (3), the 
        Secretary shall make the information in such list publicly 
        available.
            ``(2) Trade secrets and confidential information.--Nothing 
        in this section alters or amends section 1905 of title 18, 
        United States Code, or section 552(b)(4) of title 5 of such 
        Code.
            ``(3) Public health exception.--The Secretary may choose 
        not to make information collected under this section publicly 
        available under paragraph (1) if the Secretary determines that 
        disclosure of such information would adversely affect the 
        public health (such as by increasing the possibility of 
        hoarding or other disruption of the availability of drug 
        products to patients).''.

SEC. 903. QUOTAS APPLICABLE TO DRUGS IN SHORTAGE.

    Section 306 of the Controlled Substances Act (21 U.S.C. 826) is 
amended by adding at the end the following:
    ``(h)(1) Not later than 30 days after the receipt of a request 
described in paragraph (2), the Attorney General shall--
            ``(A) complete review of such request; and
            ``(B)(i) as necessary to address a shortage of a controlled 
        substance, increase the aggregate and individual production 
        quotas under this section applicable to such controlled 
        substance and any ingredient therein to the level requested; or
            ``(ii) if the Attorney General determines that the level 
        requested is not necessary to address a shortage of a 
        controlled substance, the Attorney General shall provide a 
        written response detailing the basis for the Attorney General's 
        determination.
        The Secretary shall make the written response provided under 
        subparagraph (B)(ii) available to the public on the Web site of 
        the Food and Drug Administration.
    ``(2) A request is described in this paragraph if--
            ``(A) the request pertains to a controlled substance on the 
        list of drugs in shortage maintained under section 506D of the 
        Federal Food, Drug, and Cosmetic Act;
            ``(B) the request is submitted by the manufacturer of the 
        controlled substance; and
            ``(C) the controlled substance is in schedule II.''.

SEC. 904. EXPEDITED REVIEW OF MAJOR MANUFACTURING CHANGES FOR POTENTIAL 
              AND VERIFIED SHORTAGES OF DRUGS THAT ARE LIFE-SUPPORTING, 
              LIFE-SUSTAINING, OR INTENDED FOR USE IN THE PREVENTION OF 
              A DEBILITATING DISEASE OR CONDITION.

    Subsection (c) of section 506A (21 U.S.C. 356a) is amended by 
adding at the end the following new paragraph:
            ``(3) Changes addressing a drug shortage.--
                    ``(A) Certification.--
                            ``(i) Description.--A certification is 
                        described in this subparagraph if the 
                        manufacturer, having notified the Secretary of 
                        an interruption or discontinuance of a drug in 
                        accordance with Section 506C, certifies (in 
                        such certification) that the major 
                        manufacturing change for which approval is 
                        being sought may prevent or alleviate a 
                        discontinuance or interruption of such drug.
                            ``(ii) Bad faith exception.--Subparagraphs 
                        (B) and (C) do not apply in the case of a 
                        certification which the Secretary determines to 
                        be made in bad faith.
                    ``(B) Expedited review.--If a certification 
                described in subparagraph (A) is submitted in 
                connection with a supplemental application for a major 
                manufacturing change, the Secretary shall--
                            ``(i) expedite any technical review or 
                        inspection necessary for consideration of the 
                        supplemental application;
                            ``(ii) provide any technical assistance 
                        necessary to facilitate approval of the 
                        supplemental application; and
                            ``(iii) not later than 60 days after 
                        receipt of the certification, complete review 
                        of the supplemental application.''.

SEC. 905. STUDY ON DRUG SHORTAGES.

    (a) Study.--The Comptroller General of the United States shall 
conduct a study to examine the cause of drug shortages and formulate 
recommendations on how to prevent or alleviate such shortages.
    (b) Consideration.--In conducting the study under this section, the 
Comptroller General shall consider the following questions:
            (1) What are the dominant characteristics of drugs that 
        have gone into actual shortage over the preceding three years?
            (2) Are there systemic high-risk factors (such as drug 
        pricing structure, including Federal reimbursements, or the 
        number of manufacturers producing a drug product) that have led 
        to the concentration of drug shortages in certain drug products 
        that have made such products vulnerable to drug shortages?
            (3) Is there a reason why drug shortages have occurred 
        primarily in the sterile injectable market and in certain 
        therapeutic areas?
            (4) How have regulations, guidance documents, regulatory 
        practices, and other actions of Federal departments and 
        agencies (including the effectiveness of interagency and 
        intraagency coordination, communication, strategic planning, 
        and decision-making) affected drug shortages?
            (5) How does hoarding affect drug shortages?
            (6) How would incentives alleviate or prevent drug 
        shortages?
            (7) How are healthcare providers, including hospitals and 
        physicians responding to drug shortages, to what extent are 
        such providers able to adjust care effectively to compensate 
        for such shortages, and what impediments exist that hinder 
        provider ability to adjust to such shortages?
    (c) Consultation With Stakeholders.--In conducting the study under 
this section, the Comptroller General shall consult with relevant 
stakeholders, including physicians, pharmacists, hospitals, patients, 
drug manufacturers, and other health providers.
    (d) Report.--Note later than 18 months after the date of the 
enactment of this Act, the Comptroller General 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 the results of the study under this section.

SEC. 906. ANNUAL REPORT ON DRUG SHORTAGES.

    Not later than 18 months after the date of the enactment of this 
Act, and annually thereafter, 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 drug shortages that--
            (1) 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) describes the Food and Drug Administration's efforts to 
        expedite the review of new manufacturing sites, new suppliers, 
        and specification changes to prevent or alleviate a drug 
        shortage;
            (3) describes the coordination between the Food and Drug 
        Administration and the Drug Enforcement Administration on 
        efforts to prevent or alleviate drug shortages;
            (4) 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;
            (5) identifies the number of instances in which the Food 
        and Drug Administration asked firms to increase production to 
        prevent or alleviate a shortage;
            (6) identifies the number of notifications submitted to the 
        Secretary under section 506C of the Federal Food, Drug, and 
        Cosmetic Act, as amended by section 901 of this Act, including 
        the percentage of such notifications for a drug that is a 
        sterile injectable;
            (7) describes the Food and Drug Administration's 
        implementation of section 506D of the Federal Food, Drug, and 
        Cosmetic Act (relating to a drug shortage list), as added by 
        section 902 of this Act, and identifies--
                    (A) the name of each drug on the list under such 
                section 506D at any point during the period covered by 
                the report;
                    (B) the name of each manufacturer of each such 
                drug;
                    (C) the reason for the shortage of each such drug; 
                and
                    (D) the anticipated or, if known, actual duration 
                of the shortage of each such drug;
            (8) identifies whether, and how, the Food and Drug 
        Administration expedited the review of regulatory submissions 
        to prevent or alleviate shortages, including how the 
        Administration utilized the authority in section 506A(c)(3) of 
        the Federal Food, Drug, and Cosmetic Act, as added by section 
        904 of this Act;
            (9) identifies the number of certifications submitted under 
        such section 506A(c)(3) and, for each such certification, 
        whether the Food and Drug Administration completed expedited 
        review within 60 days as required by subparagraph (B) of such 
        section 506A(c)(3);
            (10) describes the Secretary's public engagement on drug 
        shortages with stakeholders, including physicians, pharmacists, 
        patients, hospitals, drug manufacturers, and other health 
        providers; and
            (11) contains the Secretary's plan for addressing drug 
        shortages in the upcoming year, including with respect to the 
        issues described in paragraphs (1) through (10).

SEC. 907. ATTORNEY GENERAL REPORT ON DRUG SHORTAGES.

    Not later than 6 months after the date of the enactment of this 
Act, and annually thereafter, the Attorney General shall submit to the 
Committee on Energy and Commerce of the House of Representatives and 
the Committee on the Judiciary of the Senate a report on drug shortages 
that--
            (1) identifies the number of requests received under 
        section 306(h) of the Controlled Substances Act (as added by 
        section 903 of this Act), the average review time for such 
        requests, the number of requests granted and denied under such 
        section, and, for each of the requests denied under such 
        section, the basis for such denial;
            (2) describes the coordination between the Drug Enforcement 
        Administration and Food and Drug Administration on efforts to 
        prevent or alleviate drug shortages; and
            (3) identifies drugs containing a controlled substance 
        subject to section 306 of the Controlled Substances Act when 
        such a drug is determined by the Secretary of Health and Human 
        Services to be in shortage.

SEC. 908. HOSPITAL REPACKAGING OF DRUGS IN SHORTAGE.

    Chapter V (21 U.S.C. 351 et seq.), as amended by section 902 of 
this Act, is further amended by inserting after section 506D the 
following:

``SEC. 506E. HOSPITAL REPACKAGING OF DRUGS IN SHORTAGE.

    ``(a) Definitions.--In this section:
            ``(1) Drug.--The term `drug' excludes any controlled 
        substance (as such term is defined in section 102 of the 
        Controlled Substances Act).
            ``(2) Health system.--The term `health system' means a 
        collection of hospitals that are owned and operated by the same 
        entity and that share access to databases with drug order 
        information for their patients.
            ``(3) Repackage.--For the purposes of this section only, 
        the term `repackage', with respect to a drug, means to divide 
        the volume of a drug into smaller amounts in order to--
                    ``(A) extend the supply of a drug in response to 
                the placement of the drug on a drug shortage list 
                described in subsection (b); and
                    ``(B) facilitate access to the drug by hospitals 
                within the same health system.
    ``(b) Exclusion From Registration.--Notwithstanding any other 
provision of this Act, a hospital shall not be considered an 
establishment for which registration is required under section 510 
solely because it repackages a drug and transfers it to another 
hospital within the same health system in accordance with the 
conditions in subsection (c)--
            ``(1) during any period in which the drug is listed on the 
        Drug Shortage List of the Food and Drug Administration; or
            ``(2) during the 60-day period following any period 
        described in paragraph (1).
    ``(c) Conditions.--Subsection (b) shall only apply to a hospital, 
with respect to the repackaging of a drug for transfers to another 
hospital within the same health system, if the following conditions are 
met:
            ``(1) Drug for intrasystem use only.--In no case may a drug 
        that has been repackaged in accordance with this section be 
        sold or otherwise distributed by the health system or a 
        hospital within the system to an entity or individual that is 
        not a hospital within such health system.
            ``(2) Compliance with state rules.--Repackaging of a drug 
        under this section shall be done in compliance with applicable 
        State requirements in which the health system is located.
    ``(d) Termination.--This section shall not apply on or after the 
date on which the Secretary issues final guidance that clarifies the 
policy of the Food and Drug Administration regarding hospital 
pharmacies repackaging and safely transferring repackaged drugs to 
other hospitals within the same health system during a drug 
shortage.''.

            Passed the House of Representatives May 30, 2012.

            Attest:

                                                                 Clerk.
112th CONGRESS

  2d Session

                               H. R. 5651

_______________________________________________________________________

                                 AN ACT

To amend the Federal Food, Drug, and Cosmetic Act to revise and extend 
 the user-fee programs for prescription drugs and for medical devices, 
 to establish user-fee programs for generic drugs and biosimilars, and 
                          for other purposes.
```