[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[S. 3187 Placed on Calendar Senate (PCS)]

                                                       Calendar No. 400
112th CONGRESS
  2d Session
                                S. 3187

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              May 15, 2012

 Mr. Harkin (for himself and Mr. Enzi) introduced the following bill; 
                     which was read the first time

                              May 16, 2012

            Read the second time and placed on the calendar

_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend 
 the user-fee programs for prescription drugs and 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 Safety 
and Innovation Act''.

SEC. 2. TABLE OF CONTENTS; REFERENCES IN ACT.

    (a) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title.
Sec. 2. Table of contents; 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--FEES RELATING TO DEVICES

Sec. 201. Short title; findings.
Sec. 202. Definitions.
Sec. 203. Authority to assess and use device fees.
Sec. 204. Reauthorization; reporting requirements.
Sec. 205. Savings clause.
Sec. 206. Effective date.
Sec. 207. Sunset dates.
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 of the Food and Drug 
                            Administration 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--PEDIATRIC DRUGS AND DEVICES

Sec. 501. Permanence.
Sec. 502. Written requests.
Sec. 503. Communication with Pediatric Review Committee.
Sec. 504. Access to data.
Sec. 505. Ensuring the completion of pediatric studies.
Sec. 506. Pediatric study plans.
Sec. 507. Reauthorizations.
Sec. 508. Report.
Sec. 509. Technical amendments.
Sec. 510. Relationship Between Pediatric Labeling and New Clinical 
                            Investigation Exclusivity.
Sec. 511. Pediatric rare diseases.
            TITLE VI--MEDICAL DEVICE REGULATORY IMPROVEMENTS

Sec. 601. Reclassification procedures.
Sec. 602. Condition of approval studies.
Sec. 603. Postmarket surveillance.
Sec. 604. Sentinel.
Sec. 605. Recalls.
Sec. 606. Clinical holds on investigational device exemptions.
Sec. 607. Unique device identifier.
Sec. 608. Clarification of least burdensome standard.
Sec. 609. Custom devices.
Sec. 610. Agency documentation and review of certain decisions 
                            regarding devices.
Sec. 611. Good guidance practices relating to devices.
Sec. 612. Modification of de novo application process.
Sec. 613. Humanitarian device exemptions.
Sec. 614. Reauthorization of third-party review and inspections.
Sec. 615. 510(k) device modifications.
Sec. 616. Health information technology.
                      TITLE VII--DRUG SUPPLY CHAIN

Sec. 701. Registration of domestic drug establishments.
Sec. 702. Registration of foreign establishments.
Sec. 703. Identification of drug excipient information with product 
                            listing.
Sec. 704. Electronic system for registration and listing.
Sec. 705. Risk-based inspection frequency.
Sec. 706. Records for inspection.
Sec. 707. Failure to allow foreign inspection.
Sec. 708. Exchange of information.
Sec. 709. Enhancing the safety and quality of the drug supply.
Sec. 710. Accreditation of third-party auditors for drug 
                            establishments.
Sec. 711. Standards for admission of imported drugs.
Sec. 712. Notification.
Sec. 713. Protection against intentional adulteration.
Sec. 714. Enhanced criminal penalty for counterfeiting drugs.
Sec. 715. Extraterritorial jurisdiction.
Sec. 716. Compliance with international agreements.
            TITLE VIII--GENERATING ANTIBIOTIC INCENTIVES NOW

Sec. 801. Extension of exclusivity period for drugs.
Sec. 802. Priority review.
Sec. 803. Fast track product.
Sec. 804. GAO study.
Sec. 805. Clinical trials.
Sec. 806. Regulatory certainty and predictability.
               TITLE IX--DRUG APPROVAL AND PATIENT ACCESS

Sec. 901. Enhancement of accelerated patient access to new medical 
                            treatments.
Sec. 902. Breakthrough therapies.
Sec. 903. Consultation with external experts on rare diseases, targeted 
                            therapies, and genetic targeting of 
                            treatments.
Sec. 904. Accessibility of information on prescription drug container 
                            labels by visually-impaired and blind 
                            consumers.
Sec. 905. Risk-benefit framework.
Sec. 906. Independent study on medical innovation inducement model.
Sec. 907. Orphan product grants program.
                        TITLE X--DRUG SHORTAGES

Sec. 1001. Drug shortages.
                       TITLE XI--OTHER PROVISIONS

                      Subtitle A--Reauthorizations

Sec. 1101. Reauthorization of provision relating to exclusivity of 
                            certain drugs containing single 
                            enantiomers.
Sec. 1102. Reauthorization of the Critical Path Public-Private 
                            Partnerships.
               Subtitle B--Medical Gas Product Regulation

Sec. 1111. Regulation of medical gas products.
Sec. 1112. Regulations.
Sec. 1113. Applicability.
                  Subtitle C--Miscellaneous Provisions

Sec. 1121. Advisory committee conflicts of interest.
Sec. 1122. Guidance document regarding product promotion using the 
                            Internet.
Sec. 1123. Electronic submission of applications.
Sec. 1124. Combating prescription drug abuse.
Sec. 1125. Tanning bed labeling.
Sec. 1126. Optimizing global clinical trials.
Sec. 1127. Advancing regulatory science to promote public health 
                            innovation.
Sec. 1128. Information technology.
Sec. 1129. Reporting requirements.
Sec. 1130. Strategic integrated management plan.
Sec. 1131. Drug development and bioequivalence testing.
Sec. 1132. Patient participation in medical product discussions.
    (b) 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.

    Paragraph (7) of section 735 (21 U.S.C. 379g) is amended, in the 
matter preceding subparagraph (A), by striking ``incurred''.

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), in clauses (i) and (ii) of 
                subparagraph (A), by striking ``subsection (c)(5)'' 
                each place such term appears and inserting ``subsection 
                (c)(4)'';
                    (C) in the matter following clause (ii) in 
                paragraph (2)(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 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''; and
                    (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 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.''; 
                                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) with a potency described in 
                        terms of per 100 mL;
                            ``(ii) the same product as another product 
                        that--
                                    ``(I) was approved under an 
                                application filed under section 505(b) 
                                or 505(j); and
                                    ``(II) is not in the list of 
                                discontinued products compiled under 
                                section 505(j)(7);
                            ``(iii) the same product as another product 
                        that was approved under an abbreviated 
                        application filed under section 507 (as in 
                        effect on the day before the date of enactment 
                        of the Food and Drug Administration 
                        Modernization Act of 1997); or
                            ``(iv) the same product as another product 
                        that was approved under an abbreviated new drug 
                        application pursuant to regulations in effect 
                        prior to the implementation of the Drug Price 
                        Competition and Patent Term Restoration Act of 
                        1984.'';
            (2) in subsection (b)--
                    (A) in paragraph (1)--
                            (i) in the matter preceding subparagraph 
                        (A), by striking ``fiscal years 2008 through 
                        2012'' and inserting ``fiscal years 2013 
                        through 2017'';
                            (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 paragraph 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) in clause (i), by striking 
                                ``shall be retained'' and inserting 
                                ``subject to subparagraph (C), shall be 
                                collected and available''; and
                                    (II) in clause (ii), by striking 
                                ``shall only be collected and 
                                available'' and inserting ``shall be 
                                available''; and
                            (ii) 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 
                        though 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.--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 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. 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 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379g; 379h) shall cease to be effective 
October 1, 2017.
    (b) Reporting Requirements.--Section 736B of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379h-2) shall cease to be effective 
January 31, 2018.
    (c) Previous Sunset Provision.--Section 106 of the Prescription 
Drug User Fee Amendments of 2007 (Title I of Public Law 110-85) is 
repealed.
    (d) Technical Clarifications.--
            (1) Effective September 30, 2007, section 509 of the 
        Prescription Drug User Fee Amendments Act of 2002 (Title V of 
        Public Law 107-188) is repealed.
            (2) Effective September 30, 2002, section 107 of the Food 
        and Drug Administration Modernization Act of 1997 (Public Law 
        105-115) is repealed.
            (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--FEES RELATING TO DEVICES

SEC. 201. SHORT TITLE; FINDINGS.

    (a) Short Title.--This title 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)--
                            (i) by inserting ``and subsection (f)'' 
                        after ``subparagraph (B)''; and
                            (ii) by striking ``2008'' and inserting 
                        ``2013''; 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.--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) 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 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) by amending paragraph (3) 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) Reports.--Section 738A(a) (21 U.S.C. 379j-1(a)) is amended--
            (1) by striking ``2008 through 2012'' each place it appears 
        and inserting ``2013 through 2017''; and
            (2) by striking ``section 201(c) of the Food and Drug 
        Administration Amendments Act of 2007'' and inserting ``section 
        201(b) of the Medical Device User Fee Amendments of 2012''.

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 submissions described in section 738(a)(2)(A) of the Federal 
Food, Drug, and Cosmetic Act (as in effect 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 submissions 
described in section 738(a)(2)(A) of the Federal Food, Drug, and 
Cosmetic Act received on or after October 1, 2012, regardless of the 
date of the enactment of this Act.

SEC. 207. SUNSET DATES.

    (a) Authorizations.--Sections 737 and 738 (21 U.S.C. 739i; 739j) 
shall cease to be effective October 1, 2017.
    (b) Reporting Requirements.--Section 738A (21 U.S.C. 739j-1) shall 
cease to be effective January 31, 2018.
    (c) Previous Sunset Provision.--Section 217 of the Medical Device 
User Fee Amendments of 2007 (Title II of Public Law 110-85) is 
repealed.
    (d) Technical Clarification.--Effective September 30, 2007, section 
107 of the Medical Device User Fee and Modernization Act of 2002 
(Public Law 107- 250) is repealed.

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), 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 publish in the Federal Register a 
                notice announcing the amount of the fee required by 
                subparagraph (A).
                    ``(D) Fee due date.--The fee required by 
                subparagraph (A) shall be due no later than 30 calendar 
                days after the date of the publication of the notice 
                specified in subparagraph (C).
            ``(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 publish 
                        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 publish in the Federal Register the 
                        amount of the drug master file fee established 
                        by this paragraph for such fiscal year.
                    ``(D) Availability for reference.--
                            ``(i) In general.--Subject to subsection 
                        (g)(2)(C), for a generic drug submission to 
                        reference a Type II active pharmaceutical 
                        ingredient drug master file, the drug master 
                        file must be deemed available for reference by 
                        the Secretary.
                            ``(ii) Conditions.--A drug master file 
                        shall be deemed available for reference by the 
                        Secretary if--
                                    ``(I) the person that owns a Type 
                                II active pharmaceutical ingredient 
                                drug master file has paid the fee 
                                required under subparagraph (A) within 
                                20 calendar days after the applicable 
                                due date under subparagraph (E); and
                                    ``(II) the drug master file has not 
                                failed an initial completeness 
                                assessment by the Secretary, in 
                                accordance with criteria to be 
                                published by the Secretary.
                            ``(iii) List.--The Secretary shall make 
                        publicly available on the Internet Web site of 
                        the Food and Drug Administration a list of the 
                        drug master file numbers that correspond to 
                        drug master files that have successfully 
                        undergone an initial completeness assessment, 
                        in accordance with criteria to be published by 
                        the Secretary, and are available for reference.
                    ``(E) Fee due date.--
                            ``(i) In general.--Subject to clause (ii), 
                        a drug master file fee shall be due 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 publish 
                        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 publish 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 publish 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 publish 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 Act, a 
        generic drug submission or Type II pharmaceutical master file 
        is deemed to be `submitted' to the Food and Drug 
        Administration--
                    ``(A) if it is submitted via a Food and Drug 
                Administration electronic gateway, on the day when 
                transmission to that electronic gateway is completed, 
                except that a submission or master file that arrives on 
                a weekend, Federal holiday, or day when the Food and 
                Drug Administration office that will review that 
                submission is not otherwise open for business shall be 
                deemed to be submitted on the next day when that office 
                is open for business; or
                    ``(B) if it is submitted in physical media form, on 
                the day it arrives at the appropriate designated 
                document room of the Food and Drug Administration.
    ``(b) Fee Revenue Amounts.--
            ``(1) In general.--
                    ``(A) Fiscal year 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 publish 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, as 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.--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.
    ``(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.--The amendments made by section 302 cease to be 
effective October 1, 2017.
    (b) Reporting Requirements.--The amendments made by section 303 
cease to be effective 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 OF THE FOOD AND DRUG 
              ADMINISTRATION TO SUPPORT ACTIVITIES RELATED TO HUMAN 
              GENERIC DRUGS.

    Section 714 of the Federal Food, Drug, and Cosmetic Act, as added 
by section 208, is amended--
            (1) in subsection (b)--
                    (A) by striking ``are activities'' and inserting 
                ``are--
            ``(1) activities'';
                    (B) by striking the period at the end and inserting 
                ``; and''; and
                    (C) by adding at the end the following:
            ``(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 performance goals with respect to section 744A 
        (regarding assessment and use of human generic drug fees), as 
        set forth in the letters described in section 301(b) of the 
        Generic Drug User Fee Amendments of 2012.''.

       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 described in this clause is a request 
                        for a biosimilar biological product development 
                        meeting for a product.
                            ``(iii) Clinical protocol for ind.--A 
                        clinical protocol for an investigational new 
                        drug protocol described in this clause is a 
                        clinical protocol consistent with the 
                        provisions of section 505(i), including any 
                        regulations promulgated under section 505(i), 
                        (referred to in this section as 
                        `investigational new drug application') 
                        describing an investigation that the Secretary 
                        determines is intended to support a biosimilar 
                        biological product application for a product.
                            ``(iv) Due date.--The initial biosimilar 
                        biological product development fee shall be due 
                        by the earlier of the following:
                                    ``(I) Not later than 5 days 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; 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, 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.--The amendment made by section 402 shall cease 
to be effective October 1, 2017.
    (b) Reporting Requirements.--The amendment made by section 403 
shall cease to be effective 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--PEDIATRIC DRUGS AND DEVICES

SEC. 501. PERMANENCE.

    (a) Pediatric Studies of Drugs.--Subsection (q) of section 505A (21 
U.S.C. 355a) is amended--
            (1) in the subsection heading, by striking ``Sunset'' and 
        inserting ``Permanence'';
            (2) in paragraph (1), by striking ``on or before October 1, 
        2012,''; and
            (3) in paragraph (2), by striking ``on or before October 1, 
        2012,''.
    (b) Research Into Pediatric Uses for Drugs and Biological 
Products.--Section 505B (21 U.S.C. 355c) is amended--
            (1) by striking subsection (m); and
            (2) by redesignating subsection (n) as subsection (m).

SEC. 502. WRITTEN REQUESTS.

    (a) Federal Food, Drug, and Cosmetic Act.--Subsection (h) of 
section 505A (21 U.S.C. 355a) is amended 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.''.
    (b) Public Health Service Act.--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)''.

SEC. 503. COMMUNICATION WITH PEDIATRIC REVIEW COMMITTEE.

    Not later than 1 year after the date of enactment of this Act, the 
Secretary of Health and Human Services (referred to in this title as 
the ``Secretary'') shall issue internal standard operating procedures 
that provide for the review by the internal review committee 
established under section 505C of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355d) of any significant modifications to initial 
pediatric study plans, agreed initial pediatric study plans, and 
written requests under sections 505A and 505B of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355c). Such internal standard 
operating procedures shall be made publicly available on the Internet 
website of the Food and Drug Administration.

SEC. 504. ACCESS TO DATA.

    Not later than 3 years after the date of enactment of this Act, the 
Secretary shall make available to the public, including through posting 
on the Internet website of the Food and Drug Administration, the 
medical, statistical, and clinical pharmacology reviews of, and 
corresponding written requests issued to an applicant, sponsor, or 
holder for, pediatric studies submitted between January 4, 2002 and 
September 27, 2007 under subsection (b) or (c) of section 505A of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) for which 6 
months of market exclusivity was granted and that resulted in a 
labeling change. The Secretary shall make public the information 
described in the preceding sentence in a manner consistent with how the 
Secretary releases information under section 505A(k) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355a(k)).

SEC. 505. ENSURING THE COMPLETION OF PEDIATRIC STUDIES.

    (a) Extension of Deadline for Deferred Studies.--Section 505B (21 
U.S.C. 355c) is amended--
            (1) in subsection (a)(3)--
                    (A) by redesignating subparagraph (B) as 
                subparagraph (C);
                    (B) by inserting after subparagraph (A) the 
                following:
                    ``(B) Deferral extension.--
                            ``(i) In general.--On the initiative of the 
                        Secretary or at the request of the applicant, 
                        the Secretary may grant an extension of a 
                        deferral approved under subparagraph (A) for 
                        submission of some or all assessments required 
                        under paragraph (1) if--
                                    ``(I) the Secretary determines that 
                                the conditions described in subclause 
                                (II) or (III) of subparagraph (A)(i) 
                                continue to be met; and
                                    ``(II) the applicant submits a new 
                                timeline under subparagraph (A)(ii)(IV) 
                                and any significant updates to the 
                                information required under subparagraph 
                                (A)(ii).
                            ``(ii) Timing and information.--If the 
                        deferral extension under this subparagraph is 
                        requested by the applicant, the applicant shall 
                        submit the deferral extension request 
                        containing the information described in this 
                        subparagraph not less than 90 days prior to the 
                        date that the deferral would expire. The 
                        Secretary shall respond to such request not 
                        later than 45 days after the receipt of such 
                        letter. If the Secretary grants such an 
                        extension, the specified date shall be the 
                        extended date. The sponsor of the required 
                        assessment under paragraph (1) shall not be 
                        issued a letter described in subsection (d) 
                        unless the specified or extended date of 
                        submission for such required studies has passed 
                        or if the request for an extension is pending. 
                        For a deferral that has expired prior to the 
                        date of enactment of the Food and Drug 
                        Administration Safety and Innovation Act or 
                        that will expire prior to 270 days after the 
                        date of enactment of such Act, a deferral 
                        extension shall be requested by an applicant 
                        not later than 180 days after the date of 
                        enactment of such Act. The Secretary shall 
                        respond to any such request as soon as 
                        practicable, but not later than 1 year after 
                        the date of enactment of such Act. Nothing in 
                        this clause shall prevent the Secretary from 
                        updating the status of a study or studies 
                        publicly if components of such study or studies 
                        are late or delayed.''; and
                    (C) in subparagraph (C), as so redesignated--
                            (i) in clause (i), by adding at the end the 
                        following:
                                    ``(III) Projected completion date 
                                for pediatric studies.
                                    ``(IV) The reason or reasons why a 
                                deferral or deferral extension 
                                continues to be necessary.''; and
                            (ii) in clause (ii)--
                                    (I) by inserting ``, as well as the 
                                date of each deferral or deferral 
                                extension, as applicable,'' after 
                                ``clause (i)''; and
                                    (II) by inserting ``not later than 
                                90 days after submission to the 
                                Secretary or with the next routine 
                                quarterly update'' after 
                                ``Administration''; and
            (2) in subsection (f)--
                    (A) in the subsection heading, by inserting 
                ``Deferral Extensions,'' after ``Deferrals,'';
                    (B) in paragraph (1), by inserting ``, deferral 
                extension,'' after ``deferral''; and
                    (C) in paragraph (4)--
                            (i) in the paragraph heading, by inserting 
                        ``deferral extensions,'' after ``deferrals,''; 
                        and
                            (ii) by inserting ``, deferral 
                        extensions,'' after ``deferrals''.
    (b) Tracking of Extensions; Annual Information.--Section 
505B(f)(6)(D) (21 U.S.C. 355c(f)(6)(D)) is amended to read as follows:
                    ``(D) aggregated on an annual basis--
                            ``(i) the total number of deferrals and 
                        deferral extensions requested and granted under 
                        this section and, if granted, the reasons for 
                        each such deferral or deferral extension;
                            ``(ii) the timeline for completion of the 
                        assessments; and
                            ``(iii) the number of assessments completed 
                        and pending;''.
    (c) Action on Failure to Complete Studies.--
            (1) Issuance of letter.--Subsection (d) of section 505B (21 
        U.S.C. 355c) is amended to read as follows:
    ``(d) Submission of Assessments.--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), the following shall apply:
            ``(1) Beginning 270 days after the date of enactment of the 
        Food and Drug Administration Safety and Innovation Act, the 
        Secretary shall issue a non-compliance letter to such person 
        informing them of such failure to submit or meet the 
        requirements of the applicable subsection. Such letter shall 
        require the person to respond in writing within 45 calendar 
        days of issuance of such letter. Such response may include the 
        person's request for a deferral extension if applicable. Such 
        letter and the person's written response to such letter shall 
        be made publicly available on the Internet Web site of the Food 
        and Drug Administration 45 calendar days after issuance, with 
        redactions for any trade secrets and confidential commercial 
        information. If the Secretary determines that the letter was 
        issued in error, the requirements of this paragraph shall not 
        apply.
            ``(2) The drug or biological product that is the subject of 
        an assessment described in subsection (a)(2), applicable 
        requirements in subsection (a)(3), or request for approval of a 
        pediatric formulation, may be considered misbranded solely 
        because of that failure and subject to relevant enforcement 
        action (except that the drug or biological product shall not be 
        subject to action under section 303), but such failure shall 
        not be the basis for a proceeding--
                    ``(A) to withdraw approval for a drug under section 
                505(e); or
                    ``(B) to revoke the license for a biological 
                product under section 351 of the Public Health Service 
                Act.''.
            (2) Tracking of letters issued.--Subparagraph (D) of 
        section 505B(f)(6) (21 U.S.C. 355c(f)(6)), as amended by 
        subsection (b), is further amended--
                    (A) in clause (ii), by striking ``; and'' and 
                inserting a semicolon;
                    (B) in clause (iii), by adding ``and'' at the end; 
                and
                    (C) by adding at the end the following:
                            ``(iv) the number of postmarket non-
                        compliance letters issued pursuant to 
                        subsection (d), and the recipients of such 
                        letters;''.

SEC. 506. PEDIATRIC STUDY PLANS.

    (a) In General.--Subsection (e) of section 505B (21 U.S.C. 355c) is 
amended to read as follows:
    ``(e) Pediatric Study Plans.--
            ``(1) In general.--An applicant subject to subsection (a) 
        shall submit to the Secretary an initial pediatric study plan 
        prior to the submission of the assessments described under 
        subsection (a)(2).
            ``(2) Timing; content; meeting.--
                    ``(A) Timing.--An applicant shall submit an initial 
                pediatric study plan to the Secretary not later than 60 
                calendar days after the date of the end of phase II 
                meeting or such other equivalent time agreed upon 
                between the Secretary and the applicant. Nothing in 
                this paragraph shall preclude the Secretary from 
                accepting the submission of an initial pediatric study 
                plan earlier than the date described under the 
                preceding sentence.
                    ``(B) Content of initial plan.--The initial 
                pediatric study plan shall include--
                            ``(i) an outline of the pediatric study or 
                        studies that the applicant plans to conduct 
                        (including, to the extent practicable study 
                        objectives and design, age groups, relevant 
                        endpoints, and statistical approach);
                            ``(ii) any request for a deferral, partial 
                        waiver, or waiver under this section, if 
                        applicable, along with any supporting 
                        information; and
                            ``(iii) other information specified in the 
                        regulations promulgated under paragraph (4).
                    ``(C) Meeting.--The Secretary--
                            ``(i) shall meet with the applicant to 
                        discuss the initial pediatric study plan as 
                        soon as practicable, but not later than 90 
                        calendar days after the receipt of such plan 
                        under subparagraph (A);
                            ``(ii) may determine that a written 
                        response to the initial pediatric study plan is 
                        sufficient to communicate comments on the 
                        initial pediatric study plan, and that no 
                        meeting is necessary; and
                            ``(iii) if the Secretary determines that no 
                        meeting is necessary, shall so notify the 
                        applicant and provide written comments of the 
                        Secretary as soon as practicable, but not later 
                        than 90 calendar days after the receipt of the 
                        initial pediatric study plan.
            ``(3) Agreed initial pediatric study plan.--Not later than 
        90 calendar days following the meeting under paragraph 
        (2)(C)(i) or the receipt of a written response from the 
        Secretary under paragraph (2)(C)(iii), the applicant shall 
        document agreement on the initial pediatric study plan in a 
        submission to the Secretary marked `Agreed Initial Pediatric 
        Study Plan', and the Secretary shall confirm such agreement to 
        the applicant in writing not later than 30 calendar days of 
        receipt of such agreed initial pediatric study plan.
            ``(4) Deferral and waiver.--If the agreed initial pediatric 
        study plan contains a request from the applicant for a 
        deferral, partial waiver, or waiver under this section, the 
        written confirmation under paragraph (3) shall include a 
        recommendation from the Secretary as to whether such request 
        meets the standards under paragraphs (3) or (4) of subsection 
        (a).
            ``(5) Amendments to the plan.--At the initiative of the 
        Secretary or the applicant, the agreed initial pediatric study 
        plan may be amended at any time. The requirements of paragraph 
        (2)(C) shall apply to any such proposed amendment in the same 
        manner and to the same extent as such requirements apply to an 
        initial pediatric study plan under paragraph (1). The 
        requirements of paragraphs (3) and (4) shall apply to any 
        agreement resulting from such proposed amendment in the same 
        manner and to the same extent as such requirements apply to an 
        agreed initial pediatric study plan.
            ``(6) Internal committee.--The Secretary shall consult the 
        internal committee under section 505C on the review of the 
        initial pediatric study plan, agreed initial pediatric plan, 
        and any significant amendments to such plans.
            ``(7) Required rulemaking.--Not later than 1 year after the 
        date of enactment of the Food and Drug Administration Safety 
        and Innovation Act, the Secretary shall promulgate proposed 
        regulations and issue proposed guidance to implement the 
        provisions of this subsection.''.
    (b) Conforming Amendments.--Section 505B (21 U.S.C. 355c)is 
amended--
            (1) by amending subclause (II) of subsection (a)(3)(A)(ii) 
        to read as follows:
                                    ``(II) a pediatric study plan as 
                                described in subsection (e);''; and
            (2) in subsection (f)--
                    (A) in the subsection heading, by striking 
                ``pediatric Plans,'' and inserting ``pediatric Study 
                Plans,'';
                    (B) in paragraph (1), by striking ``all pediatric 
                plans'' and inserting ``initial pediatric study plans, 
                agreed initial pediatric study plans,''; and
                    (C) in paragraph (4)--
                            (i) in the paragraph heading, by striking 
                        ``pediatric Plans,'' and inserting ``pediatric 
                        Study Plans,''; and
                            (ii) by striking ``pediatric plans'' and 
                        inserting ``initial pediatric study plans, 
                        agreed initial pediatric study plans,''.
    (c) Effective Dates.--
            (1) Pediatric study plans.--Subsection (e) of section 505B 
        of the Federal Food, Drug, and Cosmetic Act (other than 
        paragraph (4) of such subsection), as amended by subsection 
        (a), shall take effect 180 days after the date of enactment of 
        this Act, without regard to whether the Secretary has 
        promulgated final regulations under paragraph (4) of such 
        subsection by such date.
            (2) Conforming amendments.--The amendments made by 
        subsection (b) shall take effect 180 days after the date of 
        enactment of this Act.

SEC. 507. REAUTHORIZATIONS.

    (a) Pediatric Advisory Committee.--Section 14(d) of the Best 
Pharmaceuticals for Children Act (42 U.S.C. 284m note) is amended by 
striking ``Notwithstanding section 14 of the Federal Advisory Committee 
Act, the advisory committee shall continue to operate during the five-
year period beginning on the date of the enactment of the Best 
Pharmaceuticals for Children Act of 2007'' and inserting ``Section 14 
of the Federal Advisory Committee Act shall not apply to the advisory 
committee''.
    (b) Pediatric Subcommittee of the Oncologic Drugs Advisory 
Committee.--Section 15(a)(3) 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 ``for the 
duration of the operation of the Oncologic Drugs Advisory Committee''.
    (c) Humanitarian Device Exemption Extension.--Section 
520(m)(6)(A)(iv) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360j(m)(6)(A)(iv)) is amended by striking ``2012'' and inserting 
``2017''.
    (d) Demonstration Grants to Improve Pediatric Device 
Availability.--Section 305(e) of Pediatric Medical Device Safety and 
Improvement Act (Public Law 110-85; 42 U.S.C. 282 note)) is amended by 
striking ``$6,000,000 for each of fiscal years 2008 through 2012'' and 
inserting ``$4,500,000 for each of fiscal years 2013 through 2017''.
    (e) Program for Pediatric Study of Drugs in PHSA.--Section 
409I(e)(1) of the Public Health Service Act (42 U.S.C. 284m(e)(1)) is 
amended by striking ``to carry out this section'' and all that follows 
through the end of paragraph (1) and inserting ``to carry out this 
section $25,000,000 for each of fiscal years 2012 through 2017.''.

SEC. 508. REPORT.

    (a) In General.--Not later than October 31, 2016, and at the end of 
each subsequent 5-year period, the Secretary shall submit to Congress a 
report that evaluates the effectiveness of sections 505A and 505B of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c) and 
section 409I of the Public Health Service Act (42 U.S.C. 284m) in 
ensuring that medicines used by children are tested in pediatric 
populations and properly labeled for use in children.
    (b) Contents.--The report under subsection (a) shall include--
            (1) the number and importance of drugs and biological 
        products for children for which studies have been requested or 
        required (as of the date of such report) under 505A and 505B of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c) 
        and section 409I of the Public Health Service Act (42 U.S.C. 
        284m), including--
                    (A) the number of labeling changes made to drugs 
                and biological products pursuant to such sections since 
                the date of enactment of this Act; and
                    (B) the importance of such drugs and biological 
                products in the improvement of the health of children;
            (2) the number of required studies under such section 505B 
        that have not met the initial deadline provided under such 
        section, including--
                    (A) the number of deferrals and deferral extensions 
                granted and the reasons such extensions were granted;
                    (B) the number of waivers and partial waivers 
                granted; and
                    (C) the number of letters issued under subsection 
                (d) of such section 505B;
            (3) the number of written requests issued, declined, and 
        referred to the National Institutes of Health under such 
        section 505A since the date of enactment of this Act (including 
        the reasons for such declination), and a description and status 
        of referrals made under subsection (n) of such section 505A;
            (4) the number of proposed pediatric study plans submitted 
        and agreed to as identified in the marketing application under 
        such section 505B;
            (5) any labeling changes recommended by the Pediatric 
        Advisory Committee as a result of the review by such Committee 
        of adverse events reports;
            (6) the number and current status of pediatric 
        postmarketing requirements;
            (7) the number and importance of drugs and biological 
        products for children that are not being tested for use in 
        pediatric populations, notwithstanding the existence of the 
        programs under such sections 505A and 505B and section 409I of 
        the Public Health Service Act;
            (8) the possible reasons for the lack of testing reported 
        under paragraph (7);
            (9) the number of drugs and biological products for which 
        testing is being done (as of the date of the report) and for 
        which a labeling change is required under the programs 
        described in paragraph (7), including--
                    (A) the date labeling changes are made;
                    (B) which labeling changes required the use of the 
                dispute resolution process; and
                    (C) for labeling changes that required such dispute 
                resolution process, a description of--
                            (i) the disputes;
                            (ii) the recommendations of the Pediatric 
                        Advisory Committee; and
                            (iii) the outcomes of such process; and
                    (D) an assessment of the effectiveness in improving 
                information about pediatric uses of drugs and 
                biological products;
            (10)(A) the efforts made by the Secretary to increase the 
        number of studies conducted in the neonatal population 
        (including efforts made to encourage the conduct of appropriate 
        studies in neonates by companies with products that have 
        sufficient safety and other information to make the conduct of 
        the studies ethical and safe); and
            (B) the results of such efforts;
            (11)(A) the number and importance of drugs and biological 
        products for children with cancer that are being tested as a 
        result of the programs described in paragraph (7); and
            (B) any recommendations for modifications to such programs 
        that would lead to new and better therapies for children with 
        cancer, including a detailed rationale for each recommendation;
            (12) an assessment of progress made in addressing the 
        recommendations and findings of any prior report issued by the 
        Comptroller General, the Institute of Medicine, or the 
        Secretary regarding the topics addressed in the report under 
        this section, including with respect to--
                    (A) improving public access to information from 
                pediatric studies conducted under such sections 505A 
                and 505B; and
                    (B) improving the timeliness of pediatric studies 
                and pediatric study planning under such sections 505A 
                and 505B;
            (13) any recommendations for modification to the programs 
        that would improve pediatric drug research and increase 
        pediatric labeling of drugs and biological products; and
            (14) an assessment of the successes of and limitations to 
        studying drugs for rare diseases under such sections 505A and 
        505B.
    (c) Consultation on Recommendations.--At least 180 days before the 
report is due under subsection (a), and no sooner than 4 years after 
the date of enactment of this Act, the Secretary shall consult with 
representatives of patient groups, including pediatric patient groups, 
consumer groups, regulated industry, scientific and medical 
communities, academia, and other interested parties to obtain any 
recommendations or information relevant to the effectiveness of the 
programs described in subsection (b)(7), including suggestions for 
modifications to such programs.

SEC. 509. TECHNICAL AMENDMENTS.

    (a) Pediatric Studies of Drugs in FFDCA.--Section 505A (21 U.S.C. 
355a) is amended--
            (1) in subsection (k)(2), by striking ``subsection 
        (f)(3)(F)'' and inserting ``subsection (f)(6)(F)'';
            (2) in subsection (n)--
                    (A) in the subsection heading, by striking 
                ``completed'' and inserting ``submitted''; and
                    (B) in paragraph (1)--
                            (i) in the matter preceding subparagraph 
                        (A), by striking ``have not been completed'' 
                        and inserting ``have not been submitted by the 
                        date specified in the written request issued or 
                        if the applicant or holder does not agree to 
                        the request'';
                            (ii) in subparagraph (A)--
                                    (I) in the first sentence, by 
                                inserting ``, or for which a period of 
                                exclusivity eligible for extension 
                                under subsection (b)(1) or (c)(1) of 
                                this section or under subsection (m)(2) 
                                or (m)(3) of section 351 of the Public 
                                Health Service Act has not ended'' 
                                after ``expired''; and
                                    (II) by striking ``Prior to'' and 
                                all that follows through the period at 
                                the end; and
                            (iii) in subparagraph (B), by striking ``no 
                        listed patents or has 1 or more listed patents 
                        that have expired,'' and inserting ``no 
                        unexpired listed patents and for which no 
                        unexpired periods of exclusivity eligible for 
                        extension under subsection (b)(1) or (c)(1) of 
                        this section or under subsection (m)(2) or 
                        (m)(3) of section 351 of the Public Health 
                        Service Act apply,''; and
            (3) in subsection (o)(2), by amendment 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.''.
    (b) 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)--
                            (i) in the matter preceding subparagraph 
                        (A), by inserting ``for a drug'' after ``(or 
                        supplement to an application)'';
                            (ii) in subparagraph (A), by striking ``for 
                        a'' and inserting ``, including, with respect 
                        to a drug, an application (or supplement to an 
                        application) for a'';
                            (iii) in subparagraph (B), by striking 
                        ``for a'' and inserting ``, including, with 
                        respect to a drug, an application (or 
                        supplement to an application) for a''; and
                            (iv) in the matter following subparagraph 
                        (B), by inserting ``(or supplement)'' after 
                        ``application''; and
                    (B) 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'' and inserting ``such a'';
            (2) in subsection (b)(1), in the matter preceding 
        subparagraph (A), by striking ``After providing notice'' and 
        all that follows through ``studies), the'' and inserting 
        ``The'';
            (3) in subsection (g)--
                    (A) in paragraph (1)(A), by inserting ``that 
                receives a priority review or 330 days after the date 
                of the submission of an application or supplement that 
                receives a standard review'' after ``after the date of 
                the submission of the application or supplement''; and
                    (B) in paragraph (2), by striking ``the label of 
                such product'' and inserting ``the labeling of such 
                product''; and
            (4) 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,''.
    (c) Internal Review Committee.--The heading of section 505C (21 
U.S.C. 355d) is amended by inserting ``and deferral extensions'' after 
``deferrals''.
    (d) 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 paragraph (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) there remains no patent listed pursuant to 
                section 505(b)(1) of the Federal Food, Drug, and 
                Cosmetic Act, and every three-year and five-year period 
                referred to in subsection (c)(3)(E)(ii), 
                (c)(3)(E)(iii), (c)(3)(E)(iv), (j)(5)(F)(ii), 
                (j)(5)(F)(iii), or (j)(5)(F)(iv) of section 505 of the 
                Federal Food, Drug, and Cosmetic Act, or applicable 
                twelve-year period referred to in section 351(k)(7) of 
                this Act, and any seven-year period referred to in 
                section 527 of the Federal Food, Drug, and Cosmetic Act 
                has ended for at least one form of the drug; and''; and
            (2) in paragraph (2)--
                    (A) in the paragraph heading, by striking ``for 
                drugs lacking exclusivity''; and
                    (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''.
    (e) Pediatric Subcommittee of the Oncologic 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 
in paragraph (1)(D), by striking ``section 505B(f)'' and inserting 
```section 505C'''.
    (f) Foundation of National Institutes of Health.--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) 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 title to such a provision applies beginning on the date of 
the enactment of this Act.

SEC. 510. RELATIONSHIP BETWEEN PEDIATRIC LABELING AND NEW CLINICAL 
              INVESTIGATION EXCLUSIVITY.

    (a) In General.--Section 505 (21 U.S.C. 351) is amended by adding 
at the end the following:
    ``(w) Relationship Between Pediatric Labeling and New Clinical 
Investigation Exclusivity.--The period of market exclusivity described 
in clauses (iii) and (iv) of subsection (c)(3)(E) and clauses (iii) and 
(iv) of subsection (j)(5)(F) shall not apply to a pediatric study 
conducted under section 505A or 505B that results, pursuant to section 
505B(g)(2), in the inclusion in the labeling of the product a 
determination that the product is not indicated for use in pediatric 
populations or subpopulations or information indicating that the 
results of a study were inconclusive or did not demonstrate that the 
product is safe or effective in pediatric populations or 
subpopulations.''.
    (b) Pediatric Studies of Drugs.--Section 505A(m) (21 U.S.C. 
355a(m)) is amended--
            (1) by striking ``(m) Clarification of Interaction of 
        Market Exclusivity Under This Section and Market Exclusivity 
        Awarded to An Applicant for Approval of A Drug Under Section 
        505(j).--If a'' and all that follows through the end of the 
        matter that precedes paragraph (1) and inserting the following:
    ``(m) Clarification of Interaction of Market Exclusivity Under This 
Section and Market Exclusivity Awarded to An Application or Supplement 
Under Subsection (c) or (j) of Section 505.--
            ``(1) 180-day exclusivity period.--If a 180-day period 
        under section 505(j)(5)(B)(iv) overlaps with a 6-month 
        exclusivity period under this section, so that the applicant 
        for approval of a drug under section 505(j) entitled to the 
        180-day period under that section loses a portion of the 180-
        day period to which the applicant is entitled for the drug, the 
        180-day period shall be extended from--'';
            (2) by redesignating paragraphs (1) and (2) as 
        subparagraphs (A) and (B) and moving such subparagraphs, as so 
        redesignated, 2 ems to the right; and
            (3) by adding at the end the following:
            ``(2) 3-year exclusivity period.--The 3-year period of 
        exclusivity under clauses (iii) and (iv) of subsection 
        505(c)(3)(E) and clauses (iii) and (iv) of subsection 
        505(j)(5)(F) are not available for approval of applications or 
        supplements to applications based on reports of pediatric 
        studies conducted under sections 505A or 505B that resulted, 
        pursuant to section 505A(j) or 505B(g)(2), in the inclusion in 
        the labeling of the product a determination that the product is 
        not indicated for use in pediatric populations or 
        subpopulations or information indicating that the results of an 
        assessment were inconclusive or did not demonstrate that the 
        product is safe or effective in pediatric populations or 
        subpopulation.''.
    (c) Prompt Approval of Drugs.--Section 505A(o) (21 U.S.C. 355a(o)) 
is amended--
            (1) in the heading, by striking ``section 505(j)'' and 
        inserting ``subsections (c) and (j) of Section 505'';
            (2) in paragraph (1), by striking ``under section 505(j)'' 
        and inserting ``under subsection (b)(2), (c), or (j) of section 
        505'';
            (3) in paragraph (2), in the matter preceding subparagraph 
        (A), by inserting ``clauses (iii) and (iv) of section 
        505(c)(3)(E) or'' after ``Notwithstanding''; and
            (4) in paragraph (3)--
                    (A) in subparagraph (B), by inserting ``that differ 
                from adult formulations'' before the semicolon at the 
                end; and
                    (B) in subparagraph (C)--
                            (i) by striking ``under section 505(j)'' 
                        and inserting ``under subsection (c) or (j) of 
                        section 505''; and
                            (ii) by inserting ``clauses (iii) or (iv) 
                        of section 505(c)(3)(E) or'' after 
                        ``exclusivity under''.

SEC. 511. PEDIATRIC RARE DISEASES.

    (a) Public Meeting.--Not later than 18 months after the date of 
enactment of this Act, the Secretary shall hold a public meeting to 
discuss ways to encourage and accelerate the development of new 
therapies for pediatric rare diseases.
    (b) Report.--Not later than 180 days after the date of the public 
meeting under subsection (a), the Secretary shall issue a report that 
includes a strategic plan for encouraging and accelerating the 
development of new therapies for treating pediatric rare diseases.

            TITLE VI--MEDICAL DEVICE REGULATORY IMPROVEMENTS

SEC. 601. RECLASSIFICATION PROCEDURES.

    (a) Classification Changes.--
            (1) In general.--Section 513(e)(1) (21 U.S.C. 360c(e)(1)) 
        is amended to read as follows:
    ``(e)(1)(A) Based on new information respecting a device, the 
Secretary may, upon the initiative of the Secretary or upon petition of 
an interested person, change the classification of such device, and 
revoke, on account of the change in classification, any regulation or 
requirement in effect under section 514 or 515 with respect to such 
device, by administrative order published in the Federal Register 
following publication of a proposed reclassification order in the 
Federal Register, a meeting of a device classification panel described 
in subsection (b), and consideration of comments to a public docket, 
notwithstanding subchapter II of Chapter 5 of title 5 of the United 
States Code. An order under this subsection changing the classification 
of a device from class III to class II may provide that such 
classification shall not take effect until the effective date of a 
performance standard established under section 514 for such device.
    ``(B) Authority to issue such administrative order shall not be 
delegated below the Commissioner. The Commissioner shall issue such an 
order as proposed by the Director of the Center for Devices and 
Radiological Health unless the Commissioner, in consultation with the 
Office of the Secretary of Health and Human Services, concludes that 
the order exceeds the legal authority of the Food and Drug 
Administration or that the order would be lawful, but unlikely to 
advance the public health.''.
            (2) Technical and conforming amendments.--
                    (A) Section 513(e)(2) (21 U.S.C. 360c(e)(2)) is 
                amended by striking ``regulation promulgated'' and 
                inserting ``an order issued''.
                    (B) Section 514(a)(1) (21 U.S.C. 360d(a)(1)) is 
                amended by striking ``under a regulation under section 
                513(e) but such regulation'' and inserting ``under an 
                administrative order under section 513(e) (or a 
                regulation promulgated under such section prior to the 
                date of enactment of the Food and Drug Administration 
                Safety and Innovation Act) but such order (or 
                regulation)'';
                    (C) Section 517(a)(1) (21 U.S.C. 360g(a)(1)) is 
                amended by striking ``or changing the classification of 
                a device to class I'' and inserting ``, an 
                administrative order changing the classification of a 
                device to class I,''.
            (3) Devices reclassified prior to the date of enactment of 
        this act.--
                    (A) In general.--The amendments made by this 
                subsection shall have no effect on a regulation 
                promulgated with respect to the classification of a 
                device under section 513(e) of the Federal Food, Drug, 
                and Cosmetic Act prior to the date of enactment of this 
                Act.
                    (B) Applicability of other provisions.--In the case 
                of a device reclassified under section 513(e) of the 
                Federal Food, Drug, and Cosmetic Act by regulation 
                prior to the date of enactment of this Act, section 
                517(a)(1) of the Federal Food, Drug, and Cosmetic Act 
                (21 U.S.C. 360g(a)(1)) shall apply to such regulation 
                promulgated under section 513(e) of such Act with 
                respect to such device in the same manner such section 
                517(a)(1) applies to an administrative order issued 
                with respect to a device reclassified after the date of 
                enactment of this Act.
    (b) Devices Marketed Before May 28, 1976.--
            (1) Premarket approval.--Section 515 (21 U.S.C. 360e) is 
        amended--
                    (A) in subsection (a), by striking ``regulation 
                promulgated under subsection (b)'' and inserting ``an 
                order issued under subsection (b) (or a regulation 
                promulgated under such subsection prior to the date of 
                enactment of the Food and Drug Administration Safety 
                and Innovation Act)'';
                    (B) in subsection (b)--
                            (i) in paragraph (1)--
                                    (I) in the heading, by striking 
                                ``Regulation'' and inserting ``Order''; 
                                and
                                    (II) in the matter following 
                                subparagraph (B)--
                                            (aa) by striking ``by 
                                        regulation, promulgated in 
                                        accordance with this 
                                        subsection'' and inserting ``by 
                                        administrative order following 
                                        publication of a proposed order 
                                        in the Federal Register, a 
                                        meeting of a device 
                                        classification panel described 
                                        in section 513(b), and 
                                        consideration of comments from 
                                        all affected stakeholders, 
                                        including patients, payors, and 
                                        providers, notwithstanding 
                                        subchapter II of chapter 5 of 
                                        title 5, United States Code''; 
                                        and
                                            (bb) by adding at the end 
                                        the following:
``Authority to issue such administrative order shall not be delegated 
below the Commissioner. Before publishing such administrative order, 
the Commissioner shall consult with the Office of the Secretary. The 
Commissioner shall issue such an order as proposed by the Director of 
the Center for Devices and Radiological Health unless the Commissioner, 
in consultation with the Office of the Secretary, concludes that the 
order exceeds the legal authority of the Food and Drug Administration 
or that the order would be lawful, but unlikely to advance the public 
health.'';
                    
                            (ii) in paragraph (2)--
                                    (I) by striking subparagraph (B); 
                                and
                                    (II) in subparagraph (A)--
                                            (aa) by striking ``(2)(A) A 
                                        proceeding for the promulgation 
                                        of a regulation under paragraph 
                                        (1) respecting a device shall 
                                        be initiated by the publication 
                                        in the Federal Register of a 
                                        notice of proposed rulemaking. 
                                        Such notice shall contain--'' 
                                        and inserting ``(2) A proposed 
                                        order required under paragraph 
                                        (1) shall contain--'';
                                            (bb) by redesignating 
                                        clauses (i) through (iv) as 
                                        subparagraphs (A) through (D), 
                                        respectively;
                                            (cc) in subparagraph (A), 
                                        as so redesignated, by striking 
                                        ``regulation'' and inserting 
                                        ``order''; and
                                            (dd) in subparagraph (C), 
                                        as so redesignated, by striking 
                                        ``regulation'' and inserting 
                                        ``order'';
                            (iii) in paragraph (3)--
                                    (I) by striking ``proposed 
                                regulation'' each place such term 
                                appears and inserting ``proposed 
                                order'';
                                    (II) by striking ``paragraph (2) 
                                and after'' and inserting ``paragraph 
                                (2),'';
                                    (III) by inserting ``and a meeting 
                                of a device classification panel 
                                described in section 513(b),'' after 
                                ``such proposed regulation and 
                                findings,'';
                                    (IV) by striking ``(A) promulgate 
                                such regulation'' and inserting ``(A) 
                                issue an administrative order under 
                                paragraph (1)'';
                                    (V) by striking ``paragraph 
                                (2)(A)(ii)'' and inserting ``paragraph 
                                (2)(B)''; and
                                    (VI) by striking ``promulgation of 
                                the regulation'' and inserting 
                                ``issuance of the administrative 
                                order''; and
                            (iv) by striking paragraph (4); and
                    (C) in subsection (i)--
                            (i) in paragraph (2)--
                                    (I) in the matter preceding 
                                subparagraph (A)--
                                            (aa) by striking ``December 
                                        1, 1995'' and inserting ``the 
                                        date that is 2 years after the 
                                        date of enactment of the Food 
                                        and Drug Administration Safety 
                                        and Innovation Act''; and
                                            (bb) by striking ``publish 
                                        a regulation in the Federal 
                                        Register'' and inserting 
                                        ``issue an administrative order 
                                        following publication of a 
                                        proposed order in the Federal 
                                        Register, a meeting of a device 
                                        classification panel described 
                                        in section 513(b), and 
                                        consideration of comments from 
                                        all affected stakeholders, 
                                        including patients, payors, and 
                                        providers, notwithstanding 
                                        subchapter II of chapter 5 of 
                                        title 5, United States Code,'';
                                    (II) in subparagraph (B), by 
                                striking ``final regulation has been 
                                promulgated under section 515(b)'' and 
                                inserting ``administrative order has 
                                been issued under subsection (b) (or no 
                                regulation has been promulgated under 
                                such subsection prior to the date of 
                                enactment of the Food and Drug 
                                Administration Safety and Innovation 
                                Act)'';
                                    (III) in the matter following 
                                subparagraph (B), by striking 
                                ``regulation requires'' and inserting 
                                ``administrative order issued under 
                                this paragraph requires''; and
                                    (IV) by striking the third and 
                                fourth sentences; and
                            (ii) in paragraph (3)--
                                    (I) by striking ``regulation 
                                requiring'' each place such term 
                                appears and inserting ``order 
                                requiring''; and
                                    (II) by striking ``promulgation of 
                                a section 515(b) regulation'' and 
                                inserting ``issuance of an 
                                administrative order under subsection 
                                (b)''.
            (2) Technical and conforming amendments.--Section 501(f) 
        (21 U.S.C. 351(f)) is amended--
                    (A) in subparagraph (1)(A)--
                            (i) in subclause (i), by striking ``a 
                        regulation promulgated'' and inserting ``an 
                        order issued''; and
                            (ii) in subclause (ii), by striking 
                        ``promulgation of such regulation'' and 
                        inserting ``issuance of such order'';
                    (B) in subparagraph (2)(B)--
                            (i) by striking ``a regulation 
                        promulgated'' and inserting ``an order 
                        issued''; and
                            (ii) by striking ``promulgation of such 
                        regulation'' and inserting ``issuance of such 
                        order''; and
                    (C) by adding at the end the following:
    ``(3) In the case of a device with respect to which a regulation 
was promulgated under section 515(b) prior to the date of enactment of 
the Food and Drug Administration Safety and Innovation Act, a reference 
in this subsection to an order issued under section 515(b) shall be 
deemed to include such regulation.''.
            (3) Approval by regulation prior to the date of enactment 
        of this act.--The amendments made by this subsection shall have 
        no effect on a regulation that was promulgated prior to the 
        date of enactment of this Act requiring that a device have an 
        approval under section 515 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 360e) of an application for premarket 
        approval.
    (c) Reporting.--The Secretary of Health and Human Services shall 
annually post on the Internet web site of the Food and Drug 
Administration--
            (1) the number and type of class I and class II devices 
        reclassified as class II or class III in the previous calendar 
        year under section 513(e)(1) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 360c(e)(1));
            (2) the number and type of class II and class III devices 
        reclassified as class I or class II in the previous calendar 
        year under such section 513(e)(1); and
            (3) the number and type of devices reclassified in the 
        previous calendar year under section 515 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 360e).

SEC. 602. CONDITION OF APPROVAL STUDIES.

    Section 515(d)(1)(B)(ii) (21 U.S.C. 360e(d)(1)(B)(ii)) is amended--
            (1) by striking ``(ii)'' and inserting ``(ii)(I)''; and
            (2) by adding at the end the following:
    ``(II) An order approving an application for a device may require 
as a condition to such approval that the applicant conduct a postmarket 
study regarding the device.''.

SEC. 603. POSTMARKET SURVEILLANCE.

    Section 522 (21 U.S.C. 360l) is amended--
            (1) in subsection (a)(1)(A), in the matter preceding clause 
        (i), by inserting ``, at the time of approval or clearance of a 
        device or at any time thereafter,'' after ``by order''; and
            (2) in subsection (b)(1), by inserting ``The manufacturer 
        shall commence surveillance under this section not later than 
        15 months after the day on which the Secretary issues an order 
        under this section.'' after the second sentence.

SEC. 604. SENTINEL.

    Section 519 (21 U.S.C. 360i) is amended by adding at the end the 
following:
    ``(h) Inclusion of Devices in the Postmarket Risk Identification 
and Analysis System.--
            ``(1) In general.--
                    ``(A) Application to devices.--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.
                    ``(B) Exception.--Subclause (II) of clause (i) of 
                section 505(k)(3)(C) shall not apply to devices.
                    ``(C) Clarification.--With respect to devices, the 
                private sector health-related electronic data provided 
                under section 505(k)(3)(C)(i)(III)(bb) may include 
                medical device utilization data, health insurance 
                claims data, and procedure and device registries.
            ``(2) Data.--In expanding the system as described in 
        paragraph (1)(A), the Secretary shall use relevant data with 
        respect to devices cleared under section 510(k) or approved 
        under section 515, including claims data, patient survey data, 
        and any other data deemed appropriate by the Secretary.
            ``(3) Stakeholder input.--To help ensure effective 
        implementation of the system described in paragraph (1)(A), the 
        Secretary shall engage outside stakeholders in development of 
        the system through a public hearing, advisory committee 
        meeting, public docket, or other like public measures, as 
        appropriate.
            ``(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 for devices.''.

SEC. 605. RECALLS.

    (a) Assessment of Device Recall Information.--
            (1) In general.--
                    (A) Assessment program.--The Secretary of Health 
                and Human Services (referred to in this section as the 
                ``Secretary'') shall enhance the Food and Drug 
                Administration's recall program to routinely and 
                systematically assess--
                            (i) information submitted to the Secretary 
                        pursuant to a device recall order under section 
                        518(e) of the Federal Food, Drug, and Cosmetic 
                        Act (21 U.S.C. 360h(e)); and
                            (ii) information required to be reported to 
                        the Secretary regarding a correction or removal 
                        of a device under section 519(g) of such Act 
                        (21 U.S.C. 360i(g)).
                    (B) Use.--The Secretary shall use the assessment of 
                information described under subparagraph (A) to 
                proactively identify strategies for mitigating health 
                risks presented by defective or unsafe devices.
            (2) Design.--The program under paragraph (1) shall, at a 
        minimum, identify--
                    (A) trends in the numbers and types of device 
                recalls;
                    (B) the types of devices in each device class that 
                are most frequently recalled;
                    (C) the causes of device recalls; and
                    (D) any other information as the Secretary 
                determines appropriate.
    (b) Audit Check Procedures.--The Secretary shall clarify procedures 
for conducting device recall audit checks to improve the ability of 
investigators to perform these checks in a consistent manner.
    (c) Assessment Criteria.--The Secretary shall develop explicit 
criteria for assessing whether a person subject to a recall order under 
section 518(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360h(e)) or to a requirement under section 519(g) of such Act (21 
U.S.C. 360i(g)) has performed an effective recall under such section 
518(e) or an effective correction or removal action under such section 
519(g), respectively.
    (d) Termination of Recalls.--The Secretary shall document the basis 
for the termination by the Food and Drug Administration of--
            (1) an individual device recall ordered under section 
        518(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        360h(e)); and
            (2) any correction or removal action for which a report is 
        required to be submitted to the Secretary under section 519(g) 
        of such Act (21 U.S.C. 360i(g)).

SEC. 606. CLINICAL HOLDS ON INVESTIGATIONAL DEVICE EXEMPTIONS.

    Section 520(g) (21 U.S.C. 360j(g)) is amended by adding at the end 
the following:
    ``(8)(A) At any time, the Secretary may prohibit the sponsor of an 
investigation from conducting the investigation (referred to in this 
paragraph as a `clinical hold') if the Secretary makes a determination 
described in subparagraph (B). The Secretary shall specify the basis 
for the clinical hold, including the specific information available to 
the Secretary which served as the basis for such clinical hold, and 
confirm such determination in writing.
    ``(B) For purposes of subparagraph (A), a determination described 
in this subparagraph with respect to a clinical hold is a determination 
that--
            ``(i) the device involved represents an unreasonable risk 
        to the safety of the persons who are the subjects of the 
        clinical investigation, taking into account the qualifications 
        of the clinical investigators, information about the device, 
        the design of the clinical investigation, the condition for 
        which the device is to be investigated, and the health status 
        of the subjects involved; or
            ``(ii) the clinical hold should be issued for such other 
        reasons as the Secretary may by regulation establish.
    ``(C) Any written request to the Secretary from the sponsor of an 
investigation that a clinical hold be removed shall receive a decision, 
in writing and specifying the reasons therefor, within 30 days after 
receipt of such request. Any such request shall include sufficient 
information to support the removal of such clinical hold.''.

SEC. 607. UNIQUE DEVICE IDENTIFIER.

    Section 519(f) (21 U.S.C. 360i(f)) is amended--
            (1) by striking ``The Secretary shall promulgate'' and 
        inserting ``Not later than December 31, 2012, the Secretary 
        shall issue proposed''; and
            (2) by adding at the end the following: ``The Secretary 
        shall finalize the proposed regulations not later than 6 months 
        after the close of the comment period and shall implement the 
        final regulations with respect to devices that are implantable, 
        life-saving, and life sustaining not later than 2 years after 
        the regulations are finalized.''.

SEC. 608. 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. 609. CUSTOM DEVICES.

    Section 520(b) (21 U.S.C. 360j(b)) 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 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 created or 
                modified as described in paragraph (1) notifies the 
                Secretary on an annual basis, in a manner prescribed by 
                the Secretary, of the manufacture of such device.
            ``(3) Exception.--Paragraph (1) shall not apply to oral 
        facial devices.
            ``(4) 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. 610. AGENCY DOCUMENTATION AND REVIEW OF CERTAIN DECISIONS 
              REGARDING DEVICES.

    Chapter V (21 U.S.C. 351 et seq.) is amended by inserting after 
section 517 the following:

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

    ``(a) Documentation of Rationale for Denial.--If the Secretary 
renders a final decision to deny clearance of a premarket notification 
under section 510(k) or approval of a premarket application under 
section 515, or when the Secretary disapproves an application for an 
investigational exemption under 520(g), the written correspondence to 
the applicant communicating that decision shall provide a substantive 
summary of the scientific and regulatory rationale for the decision.
    ``(b) Review of Denial.--
            ``(1) In general.--A person who has submitted a report 
        under section 510(k), an application under section 515, or an 
        application for an exemption under section 520(g) and for whom 
        clearance of the report or approval of the application is 
        denied may request a supervisory review of the decision to deny 
        such clearance or approval. Such review shall be conducted by 
        an individual at the organizational level above the 
        organization level at which the decision to deny the clearance 
        of the report or approval of the application is made.
            ``(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 
        denial 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 involve consultation with experts outside 
                of the Food and Drug Administration, or in cases in 
                which the sponsor seeks to introduce evidence not 
                already in the administrative record at the time the 
                denial decision was made.''.

SEC. 611. GOOD GUIDANCE PRACTICES RELATING TO DEVICES.

    Subparagraph (C) of section 701(h)(1) (21 U.S.C. 371(h)(1)) is 
amended--
            (1) by striking ``(C) For guidance documents'' and 
        inserting ``(C)(i) For guidance documents''; and
            (2) by adding at the end the following:
            ``(ii) With respect to devices, if a notice to industry 
        guidance letter, a notice to industry advisory letter, or any 
        similar notice sets forth initial interpretations of a 
        regulation or policy or sets forth changes in interpretation or 
        policy, such notice shall be treated as a guidance document for 
        purposes of this subparagraph.''.

SEC. 612. MODIFICATION OF DE NOVO APPLICATION PROCESS.

    (a) In General.--Section 513(f)(2) (21 U.S.C. 360c(f)(2)) is 
amended--
            (1) by redesignating subparagraphs (B) and (C) as 
        subparagraphs (C) and (D), respectively;
            (2) by amending subparagraph (A) to read as follows:
    ``(A) In the case of a type of device that has not previously been 
classified under this Act, a person may do one of the following:
            ``(i) Submit a report under section 510(k), and, if the 
        device is classified into class III under paragraph (1), such 
        person may request, not later than 30 days after receiving 
        written notice of such a classification, the Secretary to 
        classify the device under the criteria set forth in 
        subparagraphs (A) through (C) of subsection (a)(1). The person 
        may, in the request, recommend to the Secretary a 
        classification for the device. Any such request shall describe 
        the device and provide detailed information and reasons for the 
        recommended classification.
            ``(ii) Submit a request for initial classification of the 
        device under this subparagraph, if the person declares that 
        there is no legally marketed device upon which to base a 
        substantial equivalence determination as that term is defined 
        in subsection (i). Subject to subparagraph (B), the Secretary 
        shall classify the device under the criteria set forth in 
        subparagraphs (A) through (C) of subsection (a)(1). 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. Requests under this clause shall be 
        subject to the electronic copy requirements of section 
        745A(b).'';
            (3) by inserting after subparagraph (A) the following:
    ``(B) The Secretary may decline to undertake a classification 
request submitted under clause (2)(A)(ii) if the Secretary identifies a 
legally marketed device that could provide a reasonable basis for 
review of substantial equivalence under paragraph (1), or when the 
Secretary determines that the device submitted is not of low-moderate 
risk or that general controls would be inadequate to control the risks 
and special controls to mitigate the risks cannot be developed.''; and
            (4) in subparagraph (C), as so redesignated--
                    (A) in clause (i), by striking ``Not later than 60 
                days after the date of the submission of the request 
                under subparagraph (A),'' and inserting ``Not later 
                than 120 days after the date of the submission of the 
                request under subparagraph (A)(i) or 150 days after the 
                date of the submission of the request under 
                subparagraph (A)(ii),''; and
                    (B) in clause (ii), by inserting ``or is classified 
                in'' after ``remains in''.
    (b) GAO Report.--Not later than 2 years after the date of enactment 
of this Act, the Comptroller General of the United States shall 
complete a study and submit to Congress a report on the effectiveness 
of the review pathway under section 513(f)(2)(A) of the Federal Food, 
Drug, and Cosmetic Act, as amended by this Act.
    (c) Conforming Amendment.--Section 513(f)(1)(B) (21 U.S.C. 
360c(f)(1)(B)) is amended by inserting ``a request under paragraph (2) 
or'' after ``response to''.

SEC. 613. HUMANITARIAN DEVICE EXEMPTIONS.

    (a) In General.--Section 520(m) (21 U.S.C. 360j(m)) is amended--
            (1) in paragraph (6)--
                    (A) in subparagraph (A)--
                            (i) 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.''; and
                            (ii) 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 annual distribution number 
        for such device. In this paragraph, the term `annual 
        distribution number' means the number of such devices 
        reasonably needed to treat, diagnose, or cure a population of 
        4,000 individuals in the United States. The Secretary shall 
        determine the annual distribution number when the Secretary 
        grants such exemption.''; and
                    (B) by amending subparagraph (C) to read as 
                follows:
    ``(C) A person may petition the Secretary to modify the annual 
distribution number determined by the Secretary under subparagraph 
(A)(ii) with respect to a device if additional information arises, and 
the Secretary may modify such annual distribution number.'';
            (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 section 520(m)(6)(A)(i) (as amended by 
subsection (a)). If the Secretary of Health and Human Services 
determines that such subclause (I) or (II) applies with respect to a 
device, clauses (ii), (iii), and (iv) of subparagraph (A) and 
subparagraphs (B), (C), (D), and (E) of paragraph (6) of such section 
520(m) shall apply to such device, and the Secretary shall determine 
the annual distribution number for purposes of clause (ii) of such 
subparagraph (A) when making the determination under this subsection.
    (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) (as amended by subsection (a)) 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).

SEC. 614. REAUTHORIZATION OF THIRD-PARTY REVIEW AND INSPECTIONS.

    (a) Third Party Review.--Section 523(c) (21 U.S.C. 360m(c)) is 
amended by striking ``2012'' and inserting ``2017''.
    (b) Third Party Inspections.--Section 704(g)(11) (21 U.S.C. 
374(g)(11)) is amended by striking ``2012'' and inserting ``2017''.

SEC. 615. 510(K) DEVICE MODIFICATIONS.

    Having acknowledged to Congress potential unintended consequences 
that may result from the implementation of the Food and Drug 
Administration 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'', the Secretary of Health and Human 
Services shall withdraw such guidance promptly and ensure that, before 
any future guidance document on this issue is made final, affected 
stakeholders are provided with an opportunity to comment.

SEC. 616. HEALTH INFORMATION TECHNOLOGY.

    (a) Limitation.--Notwithstanding any other provision of law, the 
Secretary of Health and Human Services (referred to in this section as 
the ``Secretary'') may issue final guidance on medical mobile 
applications only after the requirements under subsections (b) and (c) 
are met.
    (b) Report.--Not later than 18 months after the date of enactment 
of this Act, the Secretary, 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 Health, Education, Labor, and Pensions 
of the Senate and the Committee on Energy and Commerce of the House of 
Representatives a report that contains a proposed strategy and 
recommendations on an appropriate, risk-based regulatory framework 
pertaining to medical device regulation and health information 
technology software, including mobile applications, that promotes 
innovation and protects patient safety.
    (c) Working Group.--
            (1) In general.--In carrying out subsection (b), the 
        Secretary shall convene a working group of external 
        stakeholders and experts to provide appropriate input on the 
        strategy and recommendations required for the report under 
        subsection (b).
            (2) Representatives.--The Secretary shall determine the 
        number of representatives participating in the working group, 
        and shall ensure that the working group is geographically 
        diverse and includes representatives of patients, consumers, 
        health care providers, startup companies, health plans or other 
        third-party payers, venture capital investors, information 
        technology vendors, small businesses, purchasers, employers, 
        and other stakeholders with relevant expertise, as determined 
        by the Secretary.
            (3) Other requirements.--
                    (A) FACA.--The Federal Advisory Committee Act (5 
                U.S.C. App.) shall apply to the working group under 
                this section.
                    (B) FFDCA advisory committees.--The requirements 
                for advisory committees under section 712 of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379d-
                1), as amended by section 1121, shall not apply to the 
                working group under this section.

                      TITLE VII--DRUG SUPPLY CHAIN

SEC. 701. REGISTRATION OF DOMESTIC DRUG ESTABLISHMENTS.

    Section 510 (21 U.S.C. 360) is amended--
            (1) in subsection (b)--
                    (A) in paragraph (1), by striking ``On or before'' 
                and all that follows through the period at the end and 
                inserting the following: ``During the period beginning 
                on October 1 and ending on December 31 of each year, 
                every person who owns or operates any establishment in 
                any State engaged in the manufacture, preparation, 
                propagation, compounding, or processing of a drug or 
                drugs shall register with the Secretary--
            ``(A) the name of such person, places of business of such 
        person, all such establishments, the unique facility identifier 
        of each such establishment, and a point of contact e-mail 
        address; and
            ``(B) the name and place of business of each importer that 
        takes physical possession of and supplies a drug (other than an 
        excipient) to such person, including all establishments of each 
        such drug importer, the unique facility identifier of each such 
        drug importer establishment, and a point of contact e-mail 
        address for each such drug importer.''; and
                    (B) by adding at the end the following:
    ``(3) The Secretary may specify the unique facility identifier 
system that shall be used by registrants under paragraph (1).''; and
            (2) in subsection (c), by striking ``with the Secretary his 
        name, place of business, and such establishment'' and inserting 
        ``with the Secretary--
            ``(1) with respect to drugs, the information described 
        under subsection (b)(1); and
            ``(2) with respect to devices, the information described 
        under subsection (b)(2).''.

SEC. 702. REGISTRATION OF FOREIGN ESTABLISHMENTS.

    (a) Enforcement of Registration of Foreign Establishments.--Section 
502(o) (21 U.S.C. 352(o)) is amended by striking ``in any State''.
    (b) Registration of Foreign Drug Establishments.--Section 510(i) 
(U.S.C. 360(i)) is amended--
            (1) in paragraph (1)--
                    (A) by amending the matter preceding subparagraph 
                (A) to read as follows: ``Every person who owns or 
                operates any establishment within any foreign country 
                engaged in the manufacture, preparation, propagation, 
                compounding, or processing of a drug or device that is 
                imported or offered for import into the United States 
                shall, through electronic means in accordance with the 
                criteria of the Secretary--'';
                    (B) by amending subparagraph (A) to read as 
                follows:
            ``(A) upon first engaging in any such activity, immediately 
        submit a registration to the Secretary that includes--
                    ``(i) with respect to drugs, the name and place of 
                business of such person, all such establishments, the 
                unique facility identifier of each such establishment, 
                a point of contact e-mail address, the name of the 
                United States agent of each such establishment, the 
                name and place of business of each drug importer with 
                which such person conducts business to import or offer 
                to import drugs into the United States, including all 
                establishments of each such drug importer, the unique 
                facility identifier of each such establishment, and a 
                point of contact e-mail address for each such drug 
                importer; and
                    ``(ii) with respect to devices, the name and place 
                of business of the establishment, the name of the 
                United States agent for the establishment, the name of 
                each importer of such device in the United States that 
                is known to the establishment, and the name of each 
                person who imports or offers for import such device to 
                the United States for purposes of importation; and''; 
                and
                    (C) by amending subparagraph (B) to read as 
                follows:
            ``(B) each establishment subject to the requirements of 
        subparagraph (A) shall thereafter register with the Secretary 
        during the period beginning on October 1 and ending on December 
        31 of each year.''; and
            (2) by adding at the end the following:
    ``(4) The Secretary may specify the unique facility identifier 
system that shall be used by registrants under paragraph (1) with 
respect to drugs.''.

SEC. 703. IDENTIFICATION OF DRUG EXCIPIENT INFORMATION WITH PRODUCT 
              LISTING.

    Section 510(j)(1) (21 U.S.C. 360(j)(1)) is amended--
            (1) in subparagraph (C), by striking ``; and'' and 
        inserting a semicolon;
            (2) in subparagraph (D), by striking the period at the end 
        and inserting ``; and''; and
            (3) by adding at the end the following:
            ``(E) in the case of a drug contained in the applicable 
        list, the name and place of business of each manufacturer of an 
        excipient of the listed drug with which the person listing the 
        drug conducts business, including all establishments used in 
        the production of such excipient, the unique facility 
        identifier of each such establishment, and a point of contact 
        e-mail address for each such excipient manufacturer.''.

SEC. 704. ELECTRONIC SYSTEM FOR REGISTRATION AND LISTING.

    Section 510(p) (21 U.S.C. 360(p)) is amended--
            (1) by striking ``(p) Registrations and listings'' and 
        inserting the following:
    ``(p) Electronic Registration and Listing.--
            ``(1) In general.--Registration and listing''; and
            (2) by adding at the end the following:
            ``(2) Electronic database.--Not later than 2 years after 
        the Secretary specifies a unique facility identifier system 
        under subsections (b) and (i), the Secretary shall maintain an 
        electronic database, which shall not be subject to inspection 
        under subsection (f), populated with the information submitted 
        as described under paragraph (1) that--
                    ``(A) enables personnel of the Food and Drug 
                Administration to search the database by any field of 
                information submitted in a registration described under 
                paragraph (1), or combination of such fields; and
                    ``(B) uses the unique facility identifier system to 
                link with other relevant databases within the Food and 
                Drug Administration, including the database for 
                submission of information under section 801(r).
            ``(3) Risk-based information and coordination.--The 
        Secretary shall ensure the accuracy and coordination of 
        relevant Food and Drug Administration databases in order to 
        identify and inform risk-based inspections under section 
        510(h).''.

SEC. 705. RISK-BASED INSPECTION FREQUENCY.

    Section 510(h) (21 U.S.C. 360(h)) is amended to read as follows:
    ``(h) Inspections.--
            ``(1) In general.--Every establishment that is required to 
        be registered with the Secretary under this section shall be 
        subject to inspection pursuant to section 704.
            ``(2) Biennial inspections for devices.--Every 
        establishment described in paragraph (1) that is engaged in the 
        manufacture, propagation, compounding, or processing of a 
        device or devices classified in class II or III shall be so 
        inspected by one or more officers or employees duly designated 
        by the Secretary, or by persons accredited to conduct 
        inspections under section 704(g), at least once in the 2-year 
        period beginning with the date of registration of such 
        establishment pursuant to this section and at least once in 
        every successive 2-year period thereafter.
            ``(3) Risk-based schedule for drugs.--The Secretary, acting 
        through one or more officers or employees duly designated by 
        the Secretary, shall inspect establishments described in 
        paragraph (1) that are engaged in the manufacture, preparation, 
        propagation, compounding, or processing of a drug or drugs 
        (referred to in this subsection as `drug establishments') in 
        accordance with a risk-based schedule established by the 
        Secretary.
            ``(4) Risk factors.--In establishing the risk-based 
        scheduled under paragraph (3), the Secretary shall inspect 
        establishments according to the known safety risks of such 
        establishments, which shall be based on the following factors:
                    ``(A) The compliance history of the establishment.
                    ``(B) The record, history, and nature of recalls 
                linked to the establishment.
                    ``(C) The inherent risk of the drug manufactured, 
                prepared, propagated, compounded, or processed at the 
                establishment.
                    ``(D) The certifications described under sections 
                801(r) and 809 for the establishment.
                    ``(E) Whether the establishment has been inspected 
                in the preceding 4-year period.
                    ``(F) Any other criteria deemed necessary and 
                appropriate by the Secretary for purposes of allocating 
                inspection resources.
            ``(5) Effect of status.--In determining the risk associated 
        with an establishment for purposes of establishing a risk-based 
        schedule under paragraph (3), the Secretary shall not consider 
        whether the drugs manufactured, prepared, propagated, 
        compounded, or processed by such establishment are drugs 
        described in section 503(b).
            ``(6) Annual report on inspections of establishments.--Not 
        later than February 1 of each year, the Secretary shall submit 
        a report to Congress regarding--
                    ``(A)(i) the number of domestic and foreign 
                establishments registered pursuant to this section in 
                the previous fiscal year; and
                    ``(ii) the number of such domestic establishments 
                and the number of such foreign establishments that the 
                Secretary inspected in the previous fiscal year;
                    ``(B) with respect to establishments that 
                manufacture, prepare, propagate, compound, or process 
                an active ingredient of a drug, a finished drug 
                product, or an excipient of a drug, the number of each 
                such type of establishment; and
                    ``(C) the percentage of the budget of the Food and 
                Drug Administration used to fund the inspections 
                described under subparagraph (A).
            ``(7) Public availability of annual reports.--The Secretary 
        shall make the report required under paragraph (6) available to 
        the public on the Internet Web site of the Food and Drug 
        Administration.''.

SEC. 706. 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 is 
entitled to 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 within a reasonable time frame, within reasonable limits and in 
a reasonable manner, and in electronic form, at the expense of such 
person. The Secretary's request shall include a clear description of 
the records requested.
    ``(B) Upon receipt of the records requested under subparagraph (A), 
the Secretary shall provide to the person confirmation of the receipt 
of such records.
    ``(C) Nothing in this paragraph supplants the authority of the 
Secretary to conduct inspections otherwise permitted under this Act in 
order to ensure compliance by an establishment with this Act.''.

SEC. 707. FAILURE TO ALLOW FOREIGN INSPECTION.

    Section 801(a) (21 U.S.C. 381(a)) is amended by adding at the end 
the following: ``Notwithstanding any other provision of this 
subsection, the Secretary of Homeland Security shall, upon request from 
the Secretary of Health and Human Services refuse to admit into the 
United States any article if the article was manufactured, prepared, 
propagated, compounded, processed, or held at an establishment that has 
refused to permit the Secretary of Health and Human Services to enter 
or inspect the establishment in the same manner and to the same extent 
as the Secretary may inspect establishments under section 704.''.

SEC. 708. EXCHANGE OF INFORMATION.

    Section 708 (21 U.S.C. 379) is amended--
            (1) by striking ``confidential information'' and all that 
        follows through ``The Secretary'' and inserting ``confidential 
        information.
    ``(a) Contractors.--The Secretary''; and
            (2) by adding at the end the following:
    ``(b) Ability to Receive and Protect Confidential Information.--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, except pursuant to 
an order of a court of the United States. 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.
            ``(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 
                        that 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 to humans or animals.
            ``(4) Effect of subsection.--Nothing in this subsection 
        affects the ability of the Secretary to enter into any written 
        agreement authorized by other provisions of law to share 
        confidential information.''.

SEC. 709. ENHANCING THE SAFETY AND QUALITY OF THE DRUG SUPPLY.

    Section 501 (21 U.S.C. 351) is amended by adding at the end the 
following flush text:
``For purposes of subsection (a)(2)(B), the term `current good 
manufacturing practice' includes the implementation of oversight and 
controls over the manufacture of drugs to ensure quality, including 
managing the risk of and establishing the safety of raw materials, 
materials used in the manufacturing of drugs, and finished drug 
products.''.

SEC. 710. ACCREDITATION OF THIRD-PARTY AUDITORS FOR DRUG 
              ESTABLISHMENTS.

    (a) In General.--Chapter VIII (21 U.S.C. 381 et seq.) is amended by 
adding at the end the following:

``SEC. 809. ACCREDITATION OF THIRD-PARTY AUDITORS FOR DRUG 
              ESTABLISHMENTS.

    ``(a) Definitions.--In this section:
            ``(1) Accreditation body.--The term `accreditation body' 
        means an authority that performs accreditation of third-party 
        auditors.
            ``(2) Accredited third-party auditor.--The term `accredited 
        third-party auditor' means a third-party auditor (which may be 
        an individual) accredited by an accreditation body to conduct 
        drug safety and quality audits.
            ``(3) Audit agent.--The term `audit agent' means an 
        individual who is an employee or agent of an accredited third-
        party auditor and, although not individually accredited, is 
        qualified to conduct drug safety and quality audits on behalf 
        of an accredited third-party auditor.
            ``(4) Consultative audit.--The term `consultative audit' 
        means an audit of an eligible entity intended for internal 
        purposes only to determine whether an establishment is in 
        compliance with the provisions of this Act and applicable 
        industry practices, or any other such service.
            ``(5) Drug safety and quality audit.--The term `drug safety 
        and quality audit'--
                    ``(A) means an audit of an eligible entity to 
                certify that the eligible entity meets the requirements 
                of this Act applicable to drugs, including the 
                requirements of section 501 with respect to drugs; and
                    ``(B) is not a consultative audit.
            ``(6) Eligible entity.--The term `eligible entity' means an 
        entity, including a foreign drug establishment registered under 
        section 510(c), in the drug supply chain that chooses to be 
        audited by an accredited third-party auditor or the audit agent 
        of such accredited third-party auditor.
            ``(7) Third-party auditor.--The term `third-party auditor' 
        means a foreign government, agency of a foreign government or 
        any other third party (which may be an individual), as the 
        Secretary determines appropriate in accordance with the 
        criteria described in subsection (c)(1), that is eligible to be 
        considered for accreditation to conduct drug safety and quality 
        audits.
    ``(b) Accreditation System.--
            ``(1) Recognition of accreditation bodies.--
                    ``(A) In general.--Not later than 2 years after 
                date of enactment of the Food and Drug Administration 
                Safety and Innovation Act, the Secretary shall 
                establish a system for the recognition of accreditation 
                bodies that accredit third-party auditors to conduct 
                drug safety and quality audits.
                    ``(B) Direct accreditation.--
                            ``(i) In general.--If, by the date that is 
                        2 years after the date of establishment of the 
                        system described in subparagraph (A), the 
                        Secretary has not identified and recognized an 
                        accreditation body to meet the requirements of 
                        this section, the Secretary may directly 
                        accredit third-party auditors.
                            ``(ii) Certain direct accreditations.--
                        Notwithstanding subparagraph (A) or clause (i), 
                        the Secretary may directly accredit any foreign 
                        government or any agency of a foreign 
                        government as a third-party auditor at any time 
                        after the date of enactment of the Food and 
                        Drug Administration Safety and Innovation Act.
            ``(2) Notification.--Each accreditation body recognized by 
        the Secretary shall submit to the Secretary--
                    ``(A) a list of all accredited third-party auditors 
                accredited by such body (including the name, contact 
                information, and scope and duration of accreditation 
                for each such auditor), and the audit agents of such 
                auditors; and
                    ``(B) updated lists as needed to ensure the list 
                held by the Secretary is accurate.
            ``(3) Revocation of recognition as an accreditation body.--
        The Secretary shall promptly revoke, after the opportunity for 
        an informal hearing, the recognition of any accreditation body 
        found not to be in compliance with the requirements of this 
        section.
            ``(4) Reinstatement.--The Secretary shall establish 
        procedures to reinstate recognition of an accreditation body if 
        the Secretary determines, based on evidence presented by such 
        accreditation body, that revocation was inappropriate or that 
        the body meets the requirements for recognition under this 
        section.
            ``(5) Model accreditation standards.--
                    ``(A) In general.--Not later than 18 months after 
                the date of enactment of the Food and Drug 
                Administration Safety and Innovation Act, the Secretary 
                shall develop model standards, including standards for 
                drug safety and quality audit results, reports, and 
                certifications, and each recognized accreditation body 
                shall ensure that third-party auditors and audit agents 
                of such auditors meet such standards in order to 
                qualify such third-party auditors as accredited third-
                party auditors under this section.
                    ``(B) Content.--The standards developed under 
                subparagraph (A) may--
                            ``(i) include a description of required 
                        standards relating to the training procedures, 
                        competency, management responsibilities, 
                        quality control, and conflict of interest 
                        requirements of accredited third-party 
                        auditors; and
                            ``(ii) set forth procedures for the 
                        periodic renewal of the accreditation of 
                        accredited third-party auditors.
                    ``(C) Requirement to provide results and reports to 
                the secretary.--An accreditation body (or, in the case 
                of direct accreditation under subsection (b)(1)(B), the 
                Secretary) may not accredit a third-party auditor 
                unless such third-party auditor agrees to provide to 
                the Secretary, upon request, the results and reports of 
                any drug safety and quality audit conducted pursuant to 
                the accreditation provided under this section.
            ``(6) Disclosure.--The Secretary shall maintain on the 
        Internet Web site of the Food and Drug Administration a list of 
        recognized accreditation bodies and accredited third-party 
        auditors under this section.
    ``(c) Accredited Third-party Auditors.--
            ``(1) Requirements for accreditation as a third-party 
        auditor.--
                    ``(A) Foreign governments.--Prior to accrediting a 
                foreign government or an agency of a foreign government 
                as an accredited third-party auditor, the accreditation 
                body (or, in the case of direct accreditation under 
                subsection (b)(1)(B), the Secretary) shall perform such 
                reviews and audits of drug safety programs, systems, 
                and standards of the government or agency of the 
                government as the Secretary deems necessary, including 
                requirements under the standards developed under 
                subsection (b)(5), to determine that the foreign 
                government or agency of the foreign government is 
                capable of adequately ensuring that eligible entities 
                or drugs certified by such government or agency meet 
                the requirements of this Act.
                    ``(B) Other third parties.--Prior to accrediting 
                any other third party to be an accredited third-party 
                auditor, the accreditation body (or, in the case of 
                direct accreditation under subsection (b)(1)(B), the 
                Secretary) shall perform such reviews and audits of the 
                training and qualifications of audit agents used by 
                that party and conduct such reviews of internal systems 
                and such other investigation of the party as the 
                Secretary deems necessary, including requirements under 
                the standards developed under subsection (b)(5), to 
                determine that the third-party auditor is capable of 
                adequately ensuring that an eligible entity or drug 
                certified by such third-party auditor meets the 
                requirements of this Act.
            ``(2) Use of audit agents.--An accredited third-party 
        auditor may conduct drug safety and quality audits and may 
        employ or use audit agents to conduct drug safety and quality 
        audits, but must ensure that such audit agents comply with all 
        requirements the Secretary deems necessary, including 
        requirements under paragraph (1) and subsection (b)(5).
            ``(3) Revocation of accreditation.--
                    ``(A) In general.--The Secretary shall promptly 
                revoke, after the opportunity for an informal hearing, 
                the accreditation of an accredited third-party 
                auditor--
                            ``(i) if, following an evaluation, the 
                        Secretary finds that the accredited third-party 
                        auditor is not in compliance with the 
                        requirements of this section; or
                            ``(ii) following a refusal to allow United 
                        States officials to conduct such audits and 
                        investigations as may be necessary to determine 
                        compliance with the requirements set forth in 
                        this section.
                    ``(B) Additional basis for revocation of 
                accreditation.--The Secretary may revoke accreditation 
                from an accredited third-party auditor in the case that 
                such third-party auditor is accredited by an 
                accreditation body for which recognition as an 
                accreditation body under subsection (b)(3) is revoked, 
                if the Secretary determines that there is good cause 
                for the revocation of accreditation.
            ``(4) Reaccreditation.--The Secretary shall establish 
        procedures to reinstate the accreditation of a third-party 
        auditor for which accreditation has been revoked under 
        paragraph (3)--
                    ``(A) if the Secretary determines, based on 
                evidence presented, that--
                            ``(i) the third-party auditor satisfies the 
                        requirements of this section; and
                            ``(ii) adequate grounds for revocation no 
                        longer exist; and
                    ``(B) in the case of a third-party auditor 
                accredited by an accreditation body for which 
                recognition as an accreditation body is revoked under 
                subsection (b)(3)--
                            ``(i) if the third-party auditor becomes 
                        accredited not later than 1 year after 
                        revocation of accreditation under paragraph 
                        (3), through direct accreditation under 
                        subsection (b)(1)(B), or by an accreditation 
                        body in good standing; or
                            ``(ii) under such other conditions as the 
                        Secretary may require.
            ``(5) Requirement to issue certification of eligible 
        entities for compliance with current good manufacturing 
        practice.--
                    ``(A) In general.--An accreditation body (or, in 
                the case of direct accreditation under subsection 
                (b)(1)(B), the Secretary) may not accredit a third-
                party auditor unless such third-party auditor agrees to 
                issue a written and, as appropriate, electronic, 
                document or certification, as the Secretary may require 
                under this Act, regarding compliance with section 501. 
                The Secretary may consider any such document or 
                certification to satisfy requirements under section 
                801(r) and to target inspection resources under section 
                510(h).
                    ``(B) Requirements for issuing certification.--
                            ``(i) In general.--An accredited third-
                        party auditor shall issue a drug certification 
                        described in subparagraph (A) only after 
                        conducting a drug safety and quality audit and 
                        such other activities that may be necessary to 
                        establish compliance with the provisions of 
                        section 501.
                            ``(ii) Provision of certification.--Only an 
                        accredited third-party auditor or the Secretary 
                        may provide a drug certification described in 
                        subparagraph (A).
                    ``(C) Records.--Following any accreditation of a 
                third-party auditor, the Secretary may, at any time, 
                require the accredited third-party auditor or any audit 
                agent of such auditor to submit to the Secretary a drug 
                safety and quality audit report and such other reports 
                or documents required as part of the drug safety and 
                quality audit process, for any eligible entity for 
                which the accredited third-party auditor or audit agent 
                of such auditor performed a drug safety and quality 
                audit. The Secretary may require documentation that the 
                eligible entity is in compliance with any applicable 
                registration requirements.
                    ``(D) Limitation.--The requirement under 
                subparagraph (C) shall not include any report or other 
                documents resulting from a consultative audit, except 
                that the Secretary may access the results of a 
                consultative audit in accordance with section 704.
                    ``(E) Declaration of audit type.--Before an 
                accredited third-party auditor begins any audit or 
                provides any consultative service to an eligible 
                entity, both the accredited third-party auditor and 
                eligible entity shall establish in writing whether the 
                audit is intended to be a drug safety and quality 
                audit. Any audit, inspection, or consultative service 
                of any type provided by an accredited third-party 
                auditor on behalf of an eligible entity shall be 
                presumed to be a drug safety and quality audit in the 
                absence of such a written agreement. Once a drug safety 
                and quality audit is initiated, it shall be subject to 
                the requirements of this section, and no person may 
                withhold from the Secretary any document subject to 
                subparagraph (C) on the grounds that the audit was a 
                consultative audit or otherwise not a drug safety and 
                quality audit.
                    ``(F) Rule of construction.--Nothing in this 
                section shall be construed to limit the authority of 
                the Secretary under section 704.
            ``(6) Requirements regarding serious risks to the public 
        health.--If, at any time during a drug safety and quality 
        audit, an accredited third-party auditor or an audit agent of 
        such auditor discovers a condition that could cause or 
        contribute to a serious risk to the public health, such auditor 
        shall immediately notify the Secretary of--
                    ``(A) the identity and location of the eligible 
                entity subject to the drug safety and quality audit; 
                and
                    ``(B) such condition.
            ``(7) Limitations.--
                    ``(A) In general.--An audit agent of an accredited 
                third-party auditor may not perform a drug safety and 
                quality audit of an eligible entity if such audit agent 
                has performed a drug safety and quality audit or 
                consultative audit of such eligible entity during the 
                previous 13-month period.
                    ``(B) Waiver.--The Secretary may waive the 
                application of subparagraph (A) if the Secretary 
                determines that there is insufficient access to 
                accredited third-party auditors in a country or region 
                or that the use of the same audit agent or accredited 
                third-party auditor is otherwise necessary.
            ``(8) Conflicts of interest.--
                    ``(A) Accreditation bodies.--A recognized 
                accreditation body shall--
                            ``(i) not be owned, managed, or controlled 
                        by any person that owns or operates a third-
                        party auditor to be accredited by such body;
                            ``(ii) in carrying out accreditation of 
                        third-party auditors under this section, have 
                        procedures to ensure against the use of any 
                        officer or employee of such body that has a 
                        financial conflict of interest regarding a 
                        third-party auditor to be accredited by such 
                        body; and
                            ``(iii) annually make available to the 
                        Secretary disclosures of the extent to which 
                        such body and the officers and employees of 
                        such body have maintained compliance with 
                        clauses (i) and (ii) relating to financial 
                        conflicts of interest.
                    ``(B) Accredited third-party auditors.--An 
                accredited third-party auditor shall--
                            ``(i) not be owned, managed, or controlled 
                        by any person that owns or operates an eligible 
                        entity to be certified by such auditor;
                            ``(ii) in carrying out drug safety and 
                        quality audits of eligible entities under this 
                        section, have procedures to ensure against the 
                        use of any officer or employee of such auditor 
                        that has a financial conflict of interest 
                        regarding an eligible entity to be certified by 
                        such auditor; and
                            ``(iii) annually make available to the 
                        Secretary disclosures of the extent to which 
                        such auditor and the officers and employees of 
                        such auditor have maintained compliance with 
                        clauses (i) and (ii) relating to financial 
                        conflicts of interest.
                    ``(C) Audit agents.--An audit agent shall--
                            ``(i) not own or operate an eligible entity 
                        to be audited by such agent;
                            ``(ii) in carrying out audits of eligible 
                        entities under this section, have procedures to 
                        ensure that such agent does not have a 
                        financial conflict of interest regarding an 
                        eligible entity to be audited by such agent; 
                        and
                            ``(iii) annually make available to the 
                        Secretary disclosures of the extent to which 
                        such agent has maintained compliance with 
                        clauses (i) and (ii) relating to financial 
                        conflicts of interest.
    ``(d) False Statements.--Any statement or representation made--
            ``(1) by an employee or agent of an eligible entity to an 
        accredited third-party auditor or audit agent; or
            ``(2) by an accreditation body, accredited third-party 
        auditor, or audit agent of such auditor to the Secretary, shall 
        be subject to section 1001 of title 18, United States Code.
    ``(e) Monitoring.--To ensure compliance with the requirements of 
this section, the Secretary--
            ``(1) shall periodically, or at least once every 4 years, 
        reevaluate the accreditation bodies described in subsection 
        (b)(1);
            ``(2) shall periodically, or at least once every 4 years, 
        evaluate the performance of each accredited third-party 
        auditor, through the review of regulatory audit reports by such 
        auditors, the compliance history as available of eligible 
        entities certified by such auditors, and any other measures 
        deemed necessary by the Secretary;
            ``(3) may at any time, conduct an onsite audit of any 
        eligible entity certified by an accredited third-party auditor, 
        with or without the auditor present; and
            ``(4) shall take any other measures deemed necessary by the 
        Secretary.
    ``(f) Effect of Audit.--The results of a drug safety and quality 
audit by an accredited third-party auditor under this section--
            ``(1) may be used by the eligible entity--
                    ``(A) as documentation of compliance with section 
                501(a)(2)(B) or section 801(r); and
                    ``(B) for other purposes as determined appropriate 
                by the Secretary; and
            ``(2) shall be used by the Secretary in establishing the 
        risk-based inspection schedules under section 510(h).
    ``(g) Costs.--
            ``(1) Authorized fees of secretary.--The Secretary may 
        assess fees on accreditation bodies and accredited third-party 
        auditors in such an amount necessary to establish and 
        administer the recognition and accreditation program under this 
        section. The Secretary may require accredited third-party 
        auditors and audit agents to reimburse the Food and Drug 
        Administration for the work performed to carry out this 
        section. The Secretary shall not generate surplus revenue from 
        such a reimbursement mechanism. Fees authorized under this 
        paragraph shall be collected and available for obligation only 
        to the extent and in the amount provided in advance in 
        appropriation Acts. Such fees are authorized to remain 
        available until expended.
            ``(2) Authorized fees for recognized accreditation 
        bodies.--An accreditation body recognized by the Secretary 
        under subsection (b) may assess a reasonable fee to accredit 
        third-party auditors.
    ``(h) Limitations.--
            ``(1) No effect on section 704 inspections.--The drug 
        safety and quality audits performed under this section shall 
        not be considered inspections under section 704.
            ``(2) No effect on inspection authority.--Nothing in this 
        section affects the authority of the Secretary to inspect any 
        eligible entity pursuant to this Act.
    ``(i) Regulations.--
            ``(1) In general.--Not later than 18 months after the date 
        of enactment of the Food and Drug Administration Safety and 
        Innovation Act, the Secretary shall adopt final regulations 
        implementing this section.
            ``(2) Procedure.--In promulgating the regulations 
        implementing this section, the Secretary shall--
                    ``(A) issue a notice of proposed rulemaking that 
                includes the proposed regulation;
                    ``(B) provide a period of not less than 60 days for 
                comments on the proposed regulation; and
                    ``(C) publish the final regulation not less than 30 
                days before the effective date of the regulation.
            ``(3) Content.--Such regulations shall include--
                    ``(A) requirements that, to the extent practicable, 
                drug safety and quality audits performed under this 
                section be unannounced;
                    ``(B) a structure to decrease the potential for 
                conflicts of interest, including timing and public 
                disclosure, for fees paid by eligible entities to 
                accredited third-party auditors; and
                    ``(C) appropriate limits on financial affiliations 
                between an accredited third-party auditor or audit 
                agents of such auditor and any person that owns or 
                operates an eligible entity to be audited by such 
                auditor, as described in subparagraphs (A) and (B).
            ``(4) Restrictions.--Notwithstanding any other provision of 
        law, the Secretary shall promulgate regulations implementing 
        this section only as described in paragraph (2).''.
    (b) Report on Accredited Third-party Auditors.--Not later than 
January 20, 2017, the Comptroller General of the United States shall 
submit to Congress a report that addresses the following, with respect 
to the period beginning on the date of implementation of section 809 of 
the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)) 
and ending on the date of such report:
            (1) The extent to which drug safety and quality audits 
        completed by accredited third-party auditors under such section 
        809 are being used by the Secretary of Health and Human 
        Services (referred to in this subsection as the ``Secretary'') 
        in establishing or applying the risk-based inspection schedules 
        under section 510(h) of such Act (as amended by section 705).
            (2) The extent to which drug safety and quality audits 
        completed by accredited third-party auditors or agents are 
        assisting the Food and Drug Administration in evaluating 
        compliance with sections 501(a)(2)(B) of such Act (21 U.S.C. 
        351(a)(2)(B)) and 801(r) of such Act (as added by section 711).
            (3) Whether the Secretary has been able to access drug 
        safety and quality audit reports completed by accredited third-
        party auditors under such section 809.
            (4) Whether accredited third-party auditors accredited 
        under such section 809 have adhered to the conflict of interest 
        provisions set forth in such section.
            (5) The extent to which the Secretary has audited 
        recognized accreditation bodies or accredited third-party 
        auditors to ensure compliance with the requirements of such 
        section 809.
            (6) The number of waivers under subsection (c)(7)(B) of 
        such section 809 issued during the most recent 12-month period 
        and the official justification by the Secretary for each 
        determination that there was insufficient access to an 
        accredited third-party auditor.
            (7) The number of times a manufacturer has used the same 
        accredited third-party auditor for 2 or more consecutive drug 
        safety and quality audits under such section 809.
            (8) Recommendations to Congress regarding the accreditation 
        program under such section 809, including whether Congress 
        should continue, modify, or terminate the program.

SEC. 711. STANDARDS FOR ADMISSION OF IMPORTED DRUGS.

    Section 801 (21 U.S.C. 381) is amended--
            (1) in subsection (o), by striking ``drug or''; and
            (2) by adding at the end the following:
    ``(r)(1) The Secretary may require, as a condition of granting 
admission to a drug imported or offered for import into the United 
States, that the importer electronically submit information 
demonstrating that the drug complies with applicable requirements of 
this Act.
    ``(2) The information described under paragraph (1) may include--
            ``(A) 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;
            ``(B) facility information, such as proof of registration 
        and the unique facility identifier;
            ``(C) indication of compliance with current good 
        manufacturing practice, testing results, certifications 
        relating to satisfactory inspections, and compliance with the 
        country of export regulations; and
            ``(D) any other information deemed necessary and 
        appropriate by the Secretary to assess compliance of the 
        article being offered for import.
    ``(3) Information requirements referred to in paragraph (2)(C) may, 
at the discretion of the Secretary, be satisfied--
            ``(A) by certifications from accredited third parties, as 
        described under section 809;
            ``(B) through representation by a foreign government, if 
        such inspection is conducted using standards and practices as 
        determined appropriate by the Secretary; or
            ``(C) other appropriate documentation or evidence as 
        described by the Secretary.
    ``(4)(A) Not later than 18 months after the date of enactment of 
the Food and Drug Administration Safety and Innovation Act, the 
Secretary shall adopt final regulations implementing this subsection. 
Such requirements shall be appropriate for the type of import, such as 
whether the drug is for import into the United States for use in 
preclinical research or in a clinical investigation under an 
investigational new drug exemption under 505(i).
    ``(B) In promulgating the regulations implementing this subsection, 
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.
    ``(C) Notwithstanding any other provision of law, the Secretary 
shall promulgate regulations implementing this subsection only as 
described in subparagraph (B).''.

SEC. 712. NOTIFICATION.

    (a) Prohibited Acts.--Section 301 (21 U.S.C. 331) is amended by 
adding at the end the following:
    ``(aaa) The failure to notify the Secretary in violation of section 
568.''.
    (b) Notification.--
            (1) In general.--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 covered person 
if the covered person knows--
            ``(1) of a substantial loss or theft of such drug; or
            ``(2) that such drug--
                    ``(A) has been or is being counterfeited; and
                    ``(B)(i) is a counterfeit product in commerce in 
                the United States; or
                    ``(ii) is offered for import into the United 
                States.
    ``(b) Manner of Notification.--Notification under this section 
shall be made in a reasonable time, in such reasonable manner, and by 
such reasonable means as the Secretary may require by regulation or 
specify in guidance.
    ``(c) Definition.--In this section, the term `covered person' 
means--
            ``(1) a person who is required to register under section 
        510 with respect to an establishment engaged in the 
        manufacture, preparation, propagation, compounding, or 
        processing of a drug; or
            ``(2) a person engaged in the wholesale distribution (as 
        defined in section 503(e)(3)(B)) of a drug.''.
            (2) Applicability.--Notifications under section 568 of the 
        Federal Food, Drug, and Cosmetic Act (as added by paragraph 
        (1)) apply to losses, thefts, or counterfeiting, as described 
        in subsection (a) of such section 568, that occur on or after 
        the date of enactment of this Act.

SEC. 713. 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 adulterates a drug such that the drug is adulterated 
under subsection (a)(1), (b), (c), or (d) of section 501 and has a 
reasonable probability of causing serious adverse health consequences 
or death to humans or animals shall be imprisoned for not more than 20 
years or fined not more than $1,000,000, or both.''.

SEC. 714. ENHANCED CRIMINAL PENALTY FOR COUNTERFEITING DRUGS.

    Section 303(b) (21 U.S.C. 333(b)), as amended by section 713, is 
further amended by adding at the end the following:
    ``(8) Notwithstanding subsection (a)(2), any person who knowingly 
and intentionally violates section 301(i) shall be imprisoned for not 
more than 20 years or fined not more than $4,000,000 or both.''.

SEC. 715. 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. 716. COMPLIANCE WITH INTERNATIONAL AGREEMENTS.

    Nothing in this title (or an amendment made by this title) shall be 
construed in a manner inconsistent with the obligations of the United 
States under the Agreement Establishing the World Trade Organization, 
or any other treaty or international agreement to which the United 
States is a party.

            TITLE VIII--GENERATING ANTIBIOTIC INCENTIVES NOW

SEC. 801. EXTENSION OF EXCLUSIVITY PERIOD FOR DRUGS.

    (a) In General.--Chapter V (21 U.S.C. 351 et seq.) is amended by 
inserting after section 505D 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 designated as a qualified 
infectious disease product under subsection (d), the 4- and 5-year 
periods described in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of 
section 505, the 3-year periods described in clauses (iii) and (iv) of 
subsection (c)(3)(E) and clauses (iii) and (iv) of subsection (j)(5)(F) 
of section 505, or the 7-year period described in section 527, as 
applicable, shall be extended by 5 years.
    ``(b) Relation to Pediatric Exclusivity.--Any extension under 
subsection (a) of a period shall be in addition to any extension of the 
period under section 505A with respect to the drug.
    ``(c) Limitations.--Subsection (a) does not apply to the approval 
of--
            ``(1) a supplement to an application under section 505(b) 
        for any qualified infectious disease product for which an 
        extension described in subsection (a) is in effect or has 
        expired;
            ``(2) a subsequent application filed with respect to a 
        product approved under section 505 for a change that results in 
        a new indication, route of administration, dosing schedule, 
        dosage form, delivery system, delivery device, or strength; or
            ``(3) an application for a product that is not approved for 
        the use for which it received a designation under subsection 
        (d).
    ``(d) Designation.--
            ``(1) In general.--The manufacturer or sponsor of a drug 
        may request the Secretary to designate a drug as a qualified 
        infectious disease product at any time before the submission of 
        an application under section 505(b) for such drug. The 
        Secretary shall, not later than 60 days after the submission of 
        such a request, determine whether the drug is a qualified 
        infectious disease product.
            ``(2) Limitation.--Except as provided in paragraph (3), a 
        designation under this subsection shall not be withdrawn for 
        any reason, including modifications to the list of qualifying 
        pathogens under subsection (f)(2)(C).
            ``(3) Revocation of designation.--The Secretary may revoke 
        a designation of a drug as a qualified infectious disease 
        product if the Secretary finds that the request for such 
        designation contained an untrue statement of material fact.
    ``(e) Regulations.--
            ``(1) In general.--Not later than 2 years after the date of 
        enactment of the Food and Drug Administration Safety and 
        Innovation Act, the Secretary shall adopt final regulations 
        implementing this section.
            ``(2) Procedure.--In promulgating a regulation implementing 
        this section, the Secretary shall--
                    ``(A) issue a notice of proposed rulemaking that 
                includes the proposed regulation;
                    ``(B) provide a period of not less than 60 days for 
                comments on the proposed regulation; and
                    ``(C) publish the final regulation not less than 30 
                days before the effective date of the regulation.
            ``(3) Restrictions.--Notwithstanding any other provision of 
        law, the Secretary shall promulgate regulations implementing 
        this section only as described in paragraph (2), except that 
        the Secretary may issue interim guidance for sponsors seeking 
        designation under subsection (d) prior to the promulgation of 
        such regulations.
            ``(4) Designation prior to regulations.--The Secretary may 
        designate drugs as qualified infectious disease products under 
        subsection (d) prior to the promulgation of regulations under 
        this subsection.
    ``(f) Qualifying Pathogen.--
            ``(1) Definition.--In this section, the term `qualifying 
        pathogen' means a pathogen identified and listed by the 
        Secretary under paragraph (2) that has the potential to pose a 
        serious threat to public health, such as--
                    ``(A) resistant gram positive pathogens, including 
                methicillin-resistant Staphylococcus aureus, 
                vancomycin-resistant Staphylococcus aureus, and 
                vancomycin-resistant enterococcus;
                    ``(B) multi-drug resistant gram negative bacteria, 
                including Acinetobacter, Klebsiella, Pseudomonas, and 
                E. coli species;
                    ``(C) multi-drug resistant tuberculosis; and
                    ``(D) Clostridium difficile.
            ``(2) List of qualifying pathogens.--
                    ``(A) In general.--The Secretary shall establish 
                and maintain a list of qualifying pathogens, and shall 
                make public the methodology for developing such list.
                    ``(B) Considerations.--In establishing and 
                maintaining the list of pathogens described under this 
                section the Secretary shall--
                            ``(i) consider--
                                    ``(I) the impact on the public 
                                health due to drug-resistant organisms 
                                in humans;
                                    ``(II) the rate of growth of drug-
                                resistant organisms in humans;
                                    ``(III) the increase in resistance 
                                rates in humans; and
                                    ``(IV) the morbidity and mortality 
                                in humans; and
                            ``(ii) consult with experts in infectious 
                        diseases and antibiotic resistance, including 
                        the Centers for Disease Control and Prevention, 
                        the Food and Drug Administration, medical 
                        professionals, and the clinical research 
                        community.
                    ``(C) Review.--Every 5 years, or more often as 
                needed, the Secretary shall review, provide 
                modifications to, and publish the list of qualifying 
                pathogens under subparagraph (A) and shall by 
                regulation revise the list as necessary, in accordance 
                with subsection (e).
    ``(g) Qualified Infectious Disease Product.--The term `qualified 
infectious disease product' means an antibacterial or antifungal drug 
for human use intended to treat serious or life-threatening infections, 
including those caused by--
            ``(1) an antibacterial or antifungal resistant pathogen, 
        including novel or emerging infectious pathogens; or
            ``(2) qualifying pathogens listed by the Secretary under 
        subsection (f).''.
    (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. 802. PRIORITY REVIEW.

    (a) Amendment.--Chapter V (21 U.S.C. 351 et seq.) is amended by 
inserting after section 524 the following:

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

    ``If the Secretary designates a drug under section 505E(d) as a 
qualified infectious disease product, then the Secretary shall give 
priority review to any application submitted for approval for such drug 
under section 505(b).''.
    (b) Application.--Section 524A of the Federal Food, Drug, and 
Cosmetic Act, as added by subsection (a), applies only with respect to 
an application that is submitted under section 505(b) of such Act (21 
U.S.C. 355(b)) on or after the date of the enactment of this Act.

SEC. 803. FAST TRACK PRODUCT.

    Section 506(a)(1) (21 U.S.C. 356(a)(1)), as amended by section 
901(b), is amended by inserting ``, or if the Secretary designates the 
drug as a qualified infectious disease product under section 505E(d)'' 
before the period at the end of the first sentence.

SEC. 804. GAO STUDY.

    (a) In General.--The Comptroller General of the United States 
shall--
            (1) conduct a study--
                    (A) on the need for, and public health impact of, 
                incentives to encourage the research, development, and 
                marketing of qualified infectious disease biological 
                products and antifungal products; and
                    (B) consistent with trade and confidentiality data 
                protections, assessing, for all antibacterial and 
                antifungal drugs, including biological products, the 
                average or aggregate--
                            (i) costs of all clinical trials for each 
                        phase;
                            (ii) percentage of success or failure at 
                        each phase of clinical trials; and
                            (iii) public versus private funding levels 
                        of the trials for each phase; and
            (2) not later than 1 year after the date of enactment of 
        this Act, submit a report to Congress on the results of such 
        study, including any recommendations of the Comptroller General 
        on appropriate incentives for addressing such need.
    (b) Contents.--The part of the study described in subsection 
(a)(1)(A) shall include--
            (1) an assessment of any underlying regulatory issues 
        related to qualified infectious disease products, including 
        qualified infectious disease biological products;
            (2) an assessment of the management by the Food and Drug 
        Administration of the review of qualified infectious disease 
        products, including qualified infectious disease biological 
        products and the regulatory certainty of related regulatory 
        pathways for such products;
            (3) a description of any regulatory impediments to the 
        clinical development of new qualified infectious disease 
        products, including qualified infectious disease biological 
        products, and the efforts of the Food and Drug Administration 
        to address such impediments; and
            (4) recommendations with respect to--
                    (A) improving the review and predictability of 
                regulatory pathways for such products; and
                    (B) overcoming any regulatory impediments 
                identified in paragraph (3).
    (c) 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 intended to treat a 
        serious or life-threatening infection described in section 
        505E(g) of the Federal Food, Drug, and Cosmetic Act, as added 
        by section 801.
            (3) The term ``qualified infectious disease product'' has 
        the meaning given such term in section 505E(g) of the Federal 
        Food, Drug, and Cosmetic Act, as added by section 801.

SEC. 805. CLINICAL TRIALS.

    (a) Review and Revision of Guidance Documents.--
            (1) In general.--The Secretary of Health and Human Services 
        (referred to in this section as the ``Secretary'') shall review 
        and, as appropriate, revise not fewer than 3 guidance documents 
        per year, which shall include--
                    (A) reviewing the guidance documents of the Food 
                and Drug Administration for the conduct of clinical 
                trials with respect to antibacterial and antifungal 
                drugs; and
                    (B) as appropriate, revising such guidance 
                documents to reflect developments in scientific and 
                medical information and technology and to ensure 
                clarity regarding the procedures and requirements for 
                approval of antibacterial and antifungal drugs 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 micro-biological 
        surrogate markers, the use of non-inferiority versus 
        superiority trials, trial enrollment, data requirements, and 
        appropriate delta values for non-inferiority trials.
            (3) Rule of construction.--Except to the extent to which 
        the Secretary makes revisions under paragraph (1)(B), nothing 
        in this section shall be construed to repeal or otherwise 
        effect the guidance documents of the Food and Drug 
        Administration.
    (b) Recommendations for Investigations.--
            (1) Request.--The sponsor of a drug intended to be 
        designated as a qualified infectious disease product may 
        request that the Secretary provide written recommendations for 
        nonclinical and clinical investigations which the Secretary 
        believes may be necessary to be conducted with the drug before 
        such drug may be approved under section 505 of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 355) for use in 
        treating, detecting, preventing, or identifying a qualifying 
        pathogen, as defined in section 505E of such Act.
            (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) GAO Study.--Not later than January 1, 2016, the Comptroller 
General of the United States shall submit to Congress a report--
            (1) regarding the review and revision of the clinical trial 
        guidance documents required under subsection (a) and the impact 
        such review and revision has had on the review and approval of 
        qualified infectious disease products;
            (2) assessing--
                    (A) the effectiveness of the results-oriented 
                metrics managers employ to ensure that reviewers of 
                such products are familiar with, and consistently 
                applying, clinical trial guidance documents; and
                    (B) the predictability of related regulatory 
                pathways and review;
            (3) identifying any outstanding regulatory impediments to 
        the clinical development of qualified infectious disease 
        products;
            (4) reporting on the progress the Food and Drug 
        Administration has made in addressing the impediments 
        identified under paragraph (3); and
            (5) containing recommendations regarding how to improve the 
        review of, and regulatory pathway for, such products.
    (d) Qualified Infectious Disease Product.--For purposes of this 
section, the term ``qualified infectious disease product'' has the 
meaning given such term in section 505E(g) of the Federal Food, Drug, 
and Cosmetic Act, as added by section 801.

SEC. 806. REGULATORY CERTAINTY AND PREDICTABILITY.

    (a) Initial Strategy and Implementation Plan.--Not later than 1 
year after the date of enactment of this Act, the Secretary of Health 
and Human Services (referred to in this section as the ``Secretary'') 
shall submit to Congress a strategy and implementation plan with 
respect to the requirements of this Act. The strategy and 
implementation plan shall include--
            (1) a description of the regulatory challenges to clinical 
        development, approval, and licensure of qualified infectious 
        disease products;
            (2) the regulatory and scientific priorities of the 
        Secretary with respect to such challenges; and
            (3) the steps the Secretary will take to ensure regulatory 
        certainty and predictability with respect to qualified 
        infectious disease products, including steps the Secretary will 
        take to ensure managers and reviewers are familiar with related 
        regulatory pathways, requirements of the Food and Drug 
        Administration, guidance documents related to such products, 
        and applying such requirements consistently.
    (b) Subsequent Report.--Not later than 3 years after the date of 
enactment of this Act, the Secretary shall submit to Congress a report 
on--
            (1) the progress made toward the priorities identified 
        under subsection (a)(2);
            (2) the number of qualified infectious disease products 
        that have been submitted for approval or licensure on or after 
        the date of enactment of this Act;
            (3) a list of qualified infectious disease products with 
        information on the types of exclusivity granted for each 
        product, consistent with the information published under 
        section 505(j)(7)(A)(iii) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355(j)(7)(A)(iii));
            (4) the number of such qualified infectious disease 
        products and that have been approved or licensed on or after 
        the date of enactment of this Act; and
            (5) the number of calendar days it took for the approval or 
        licensure of the qualified infectious disease products approved 
        or licensed on or after the date of enactment of this Act.
    (c) Qualified Infectious Disease Product.--For purposes of this 
section, the term ``qualified infectious disease product'' has the 
meaning given such term in section 505E(g) of the Federal Food, Drug, 
and Cosmetic Act, as added by section 801.

               TITLE IX--DRUG APPROVAL AND PATIENT ACCESS

SEC. 901. ENHANCEMENT OF ACCELERATED PATIENT ACCESS TO NEW MEDICAL 
              TREATMENTS.

    (a) Findings; Sense of Congress.--
            (1) Findings.--Congress finds as follows:
                    (A) The Food and Drug Administration (referred to 
                in this section 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 Congress that 
        the Food and Drug Administration 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 of Drugs for Serious or Life-Threatening 
Diseases or Conditions.--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 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) 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.--
                    ``(A) Accelerated approval.--The Secretary may 
                approve an application for approval of a product for a 
                serious or life-threatening disease or condition, 
                including a fast track product, under section 505(c) or 
                section 351(a) of the Public Health Service Act upon a 
                determination that the product has an effect on a 
                surrogate endpoint that is reasonably likely to predict 
                clinical benefit, or on a clinical endpoint that can be 
                measured earlier than irreversible morbidity or 
                mortality, that is reasonably likely to predict an 
                effect on irreversible morbidity or mortality or other 
                clinical benefit, taking into account the severity, 
                rarity, or prevalence of the condition and the 
                availability or lack of alternative treatments. The 
                approval described in the preceding sentence is 
                referred to in this section as `accelerated approval'.
                    ``(B) Evidence.--The evidence to support that an 
                endpoint is reasonably likely to predict clinical 
                benefit under subparagraph (A) may include 
                epidemiological, pathophysiological, therapeutic, 
                pharmacologic, or other evidence developed using 
                biomarkers, for example, or other scientific methods or 
                tools.
            ``(2) Limitation.--Approval of a product under this 
        subsection may be subject to 1 or both of the following 
        requirements:
                    ``(A) That the sponsor conduct appropriate post-
                approval studies to verify and describe the predicted 
                effect on irreversible morbidity or mortality or other 
                clinical benefit.
                    ``(B) That the sponsor submit copies of all 
                promotional materials related to the product during the 
                preapproval review period and, following approval and 
                for such period thereafter as the Secretary determines 
                to be appropriate, at least 30 days prior to 
                dissemination of the materials.
            ``(3) Expedited withdrawal of approval.--The Secretary may 
        withdraw approval of a product approved under accelerated 
        approval using expedited procedures (as prescribed by the 
        Secretary in regulations which shall include an opportunity for 
        an informal hearing) if--
                    ``(A) the sponsor fails to conduct any required 
                post-approval study of the drug with due diligence;
                    ``(B) a study required to verify and describe the 
                predicted effect on irreversible morbidity or mortality 
                or other clinical benefit of the product fails to 
                verify and describe such effect or benefit;
                    ``(C) other evidence demonstrates that the product 
                is not safe or effective under the conditions of use; 
                or
                    ``(D) the sponsor disseminates false or misleading 
                promotional materials with respect to the product.
    ``(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 
        significant unmet medical needs exist.
    ``(e) Construction.--
            ``(1) Purpose.--The amendments made by the Food and Drug 
        Administration Safety and Innovation Act to this section are 
        intended to encourage the Secretary to utilize innovative and 
        flexible approaches to the assessment of products under 
        accelerated approval for treatments for patients with serious 
        or life-threatening diseases or conditions and unmet medical 
        needs.
            ``(2) Construction.--Nothing in this section shall be 
        construed to alter the standards of evidence under subsection 
        (c) or (d) of section 505 (including the substantial evidence 
        standard in section 505(d)) of this Act or under section 351(a) 
        of the Public Health Service Act. Such sections and standards 
        of evidence apply to the review and approval of products under 
        this section, including whether a product is safe and 
        effective. Nothing in this section alters the ability of the 
        Secretary to rely on evidence that does not come from adequate 
        and well-controlled investigations for the purpose of 
        determining whether an endpoint is reasonably likely to predict 
        clinical benefit as described in subsection (b)(1)(B).''.
    (c) Guidance; Amended Regulations.--
            (1) Draft guidance.--Not later than 1 year 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 to implement the amendments made by 
        this section. In developing such guidance, the Secretary shall 
        specifically consider issues arising under the accelerated 
        approval and fast track processes under section 506 of the 
        Federal Food, Drug, and Cosmetic Act, as amended by subsection 
        (b), for drugs designated for a rare disease or condition under 
        section 526 of such Act (21 U.S.C. 360bb) and shall also 
        consider any unique issues associated with very rare diseases.
            (2) Final guidance.--Not later than 1 year after the 
        issuance of draft guidance under paragraph (1), and after an 
        opportunity for public comment, the Secretary shall issue final 
        guidance.
            (3) Conforming changes.--The Secretary shall issue, as 
        necessary, conforming amendments to the applicable regulations 
        under title 21, Code of Federal Regulations, governing 
        accelerated approval.
            (4) No effect of inaction on requests.--If the Secretary 
        fails to issue final guidance or amended regulations as 
        required by this subsection, such failure 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 
        subsection (b).
    (d) Independent Review.--The Secretary may, in conjunction with 
other planned reviews, 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 
subsection (b), and the impact of such processes on the development and 
timely availability of innovative treatments for patients suffering 
from serious or life-threatening conditions. Any such evaluation shall 
include consultation with regulated industries, patient advocacy and 
disease research foundations, and relevant academic medical centers.

SEC. 902. BREAKTHROUGH THERAPIES.

    (a) In General.--Section 506 (21 U.S.C. 356), as amended by section 
901, is further amended--
            (1) by redesignating subsections (a) through (c) as 
        subsections (b) through (d), respectively;
            (2) by redesignating subsection (d) as subsection (f);
            (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 (f)(1), as so redesignated, by striking 
        ``applicable to accelerated approval'' and inserting 
        ``applicable to breakthrough therapies, accelerated approval, 
        and''; and
            (5) by adding at the end the following:
    ``(g) 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. 903. 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 712, 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 (c).
            ``(2) Consultation with external experts.--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 (c), when such consultation is necessary because 
        the Secretary lacks specific scientific, medical, or technical 
        expertise necessary for the performance of its regulatory 
        responsibilities and the necessary expertise can be provided by 
        the external experts.
    ``(b) External Experts.--For purposes of subsection (a)(2), 
external experts are those who possess scientific or medical training 
that the Secretary lacks with respect to one or more rare diseases.
    ``(c) 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) demographics and the clinical description of patient 
        populations.
    ``(d) 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.
    ``(e) Protection of Proprietary Information.--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.
    ``(f) 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.
    ``(g) No Right or Obligation.--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. 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. 
Nothing in this section is intended to increase the number of review 
cycles as in effect before the date of enactment of this section.''.

SEC. 904. ACCESSIBILITY OF INFORMATION ON PRESCRIPTION DRUG CONTAINER 
              LABELS BY VISUALLY-IMPAIRED AND BLIND CONSUMERS.

    (a) Establishment of Working Group.--
            (1) In general.--The Architectural and Transportation 
        Barriers Compliance Board (referred to in this section as the 
        ``Access Board'') shall convene a stakeholder working group 
        (referred to in this section as the ``working group'') to 
        develop best practices on access to information on prescription 
        drug container labels for individuals who are blind or visually 
        impaired.
            (2) Members.--The working group shall be comprised of 
        representatives of national organizations representing blind 
        and visually-impaired individuals, national organizations 
        representing the elderly, and industry groups representing 
        stakeholders, including retail, mail order, and independent 
        community pharmacies, who would be impacted by such best 
        practices. Representation within the working group shall be 
        divided equally between consumer and industry advocates.
            (3) Best practices.--
                    (A) In general.--The working group shall develop, 
                not later than 1 year after the date of the enactment 
                of this Act, best practices for pharmacies to ensure 
                that blind and visually-impaired individuals have safe, 
                consistent, reliable, and independent access to the 
                information on prescription drug container labels.
                    (B) Public availability.--The best practices 
                developed under subparagraph (A) may be made publicly 
                available, including through the Internet Web sites of 
                the working group participant organizations, and 
                through other means, in a manner that provides access 
                to interested individuals, including individuals with 
                disabilities.
                    (C) Limitations.--The best practices developed 
                under subparagraph (A) shall not be construed as 
                accessibility guidelines or standards of the Access 
                Board, and shall not confer any rights or impose any 
                obligations on working group participants or other 
                persons. Nothing in this section shall be construed to 
                limit or condition any right, obligation, or remedy 
                available under the Americans with Disabilities Act of 
                1990 (42 U.S.C. 12101 et seq.) or any other Federal or 
                State law requiring effective communication, barrier 
                removal, or nondiscrimination on the basis of 
                disability.
            (4) Considerations.--In developing and issuing the best 
        practices under paragraph (3)(A), the working group shall 
        consider--
                    (A) the use of--
                            (i) Braille;
                            (ii) auditory means, such as--
                                    (I) ``talking bottles'' that 
                                provide audible container label 
                                information;
                                    (II) digital voice recorders 
                                attached to the prescription drug 
                                container; and
                                    (III) radio frequency 
                                identification tags;
                            (iii) enhanced visual means, such as--
                                    (I) large font labels or large font 
                                ``duplicate'' labels that are affixed 
                                or matched to a prescription drug 
                                container;
                                    (II) high-contrast printing; and
                                    (III) sans-serf font; and
                            (iv) other relevant alternatives as 
                        determined by the working group;
                    (B) whether there are technical, financial, 
                manpower, or other factors unique to pharmacies with 20 
                or fewer retail locations which may pose significant 
                challenges to the adoption of the best practices; and
                    (C) such other factors as the working group 
                determines to be appropriate.
            (5) Information campaign.--Upon completion of development 
        of the best practices under subsection (a)(3), the National 
        Council on Disability, in consultation with the working group, 
        shall conduct an informational and educational campaign 
        designed to inform individuals with disabilities, pharmacists, 
        and the public about such best practices.
            (6) FACA waiver.--The Federal Advisory Committee Act (5 
        U.S.C. App.) shall not apply to the working group.
    (b) GAO Study.--
            (1) In general.--Beginning 18 months after the completion 
        of the development of best practices under subsection 
        (a)(3)(A), the Comptroller General of the United States shall 
        conduct a review of the extent to which pharmacies are 
        utilizing such best practices, and the extent to which barriers 
        to accessible information on prescription drug container labels 
        for blind and visually-impaired individuals continue.
            (2) Report.--Not later than September 30, 2016, the 
        Comptroller General of the United States shall submit to 
        Congress a report on the review conducted under paragraph (1). 
        Such report shall include recommendations about how best to 
        reduce the barriers experienced by blind and visually-impaired 
        individuals to independently accessing information on 
        prescription drug container labels.
    (c) Definitions.--In this section--
            (1) the term ``pharmacy'' includes a pharmacy that receives 
        prescriptions and dispenses prescription drugs through an 
        Internet Web site or by mail;
            (2) the term ``prescription drug'' means a drug subject to 
        section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 353(b)(1)); and
            (3) the term ``prescription drug container label'' means 
        the label with the directions for use that is affixed to the 
        prescription drug container by the pharmacist and dispensed to 
        the consumer.

SEC. 905. RISK-BENEFIT FRAMEWORK.

    Section 505(d) (21 U.S.C. 355(d)) is amended by adding at the end 
the following: ``The Secretary shall implement a structured risk-
benefit assessment framework in the new drug approval process to 
facilitate the balanced consideration of benefits and risks, a 
consistent and systematic approach to the discussion and regulatory 
decisionmaking, and the communication of the benefits and risks of new 
drugs. Nothing in the preceding sentence shall alter the criteria for 
evaluating an application for premarket approval of a drug.''.

SEC. 906. INDEPENDENT STUDY ON MEDICAL INNOVATION INDUCEMENT MODEL.

    (a) In General.--The Secretary of Health and Human Services shall 
enter into an agreement with the National Academies to provide expert 
consultation and conduct a study that evaluates the feasibility and 
possible consequences of the use of innovation inducement prizes to 
reward successful medical innovations. Under the agreement, the 
National Academies shall submit to the Secretary a report on such study 
not later than 15 months after the date of enactment of this Act.
    (b) Requirements.--
            (1) In general.--The study conducted under subsection (a) 
        shall model at least 3 separate segments on the medical 
        technologies market as candidate targets for the new incentive 
        system and consider different medical innovation inducement 
        prize design issues, including the challenges presented in the 
        implementation of prizes for end products, open source dividend 
        prizes, and prizes for upstream research.
            (2) Market segments.--The segments on the medical 
        technologies market that shall be considered under paragraph 
        (1) include--
                    (A) all pharmaceutical and biologic drugs and 
                vaccines;
                    (B) drugs and vaccines used solely for the 
                treatment of HIV/AIDS; and
                    (C) antibiotics.
    (c) Elements.--The study conducted under subsection (a) shall 
include consideration of each of the following:
            (1) Whether a system of large innovation inducement prizes 
        could work as a replacement for the existing product monopoly/
        patent-based system, as in effect on the date of enactment of 
        this Act.
            (2) How large the innovation prize funds would have to be 
        in order to induce at least as much research and development 
        investment in innovation as is induced under the current system 
        of time-limited market exclusivity, as in effect on the date of 
        enactment of this Act.
            (3) Whether a system of large innovation inducement prizes 
        would be more or less expensive than the current system of 
        time-limited market exclusivity, as in effect on the date of 
        enactment of this Act, calculated over different time periods.
            (4) Whether a system of large innovation inducement prizes 
        would expand access to new products and improve health 
        outcomes.
            (5) The type of information and decisionmaking skills that 
        would be necessary to manage end product prizes.
            (6) Whether there would there be major advantages in 
        rewarding the incremental impact of innovations, as benchmarked 
        against existing products.
            (7) How open-source dividend prizes could be managed, and 
        whether such prizes would increase access to knowledge, 
        materials, data and technologies.
            (8) Whether a system of competitive intermediaries for 
        interim research prizes would provide an acceptable solution to 
        the valuation challenges for interim prizes.

SEC. 907. ORPHAN PRODUCT GRANTS PROGRAM.

    (a) Reauthorization of Program.--Section 5(c) of the Orphan Drug 
Act (21 U.S.C. 360ee(c)) is amended by striking ``2008 through 2012'' 
and inserting ``2013 through 2017''.
    (b) Human Clinical Testing.--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''.

                        TITLE X--DRUG SHORTAGES

SEC. 1001. DRUG SHORTAGES.

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

``SEC. 506C. DISCONTINUANCE OR INTERRUPTION IN THE PRODUCTION OF LIFE-
              SAVING DRUGS.

    ``(a) In General.--A manufacturer of a drug--
            ``(1) that is--
                    ``(A) life-supporting;
                    ``(B) life-sustaining;
                    ``(C) intended for use in the prevention of a 
                debilitating disease or condition;
                    ``(D) a sterile injectable product; or
                    ``(E) used in emergency medical care or during 
                surgery; and
            ``(2) that is not a radio pharmaceutical drug product, a 
        human tissue replaced by a recombinant product, a product 
        derived from human plasma protein, or any other product as 
        designated by the Secretary,
shall notify the Secretary, in accordance with subsection (b), of a 
permanent discontinuance in the manufacture of the drug or an 
interruption of the manufacture of the drug that could lead to a 
meaningful disruption in the supply of that drug in the United States.
    ``(b) Timing.--A notice required under 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) Expedited Inspections and Reviews.--If, based on 
notifications described in subsection (a) or any other relevant 
information, the Secretary concludes that there is, or is likely to be, 
a drug shortage of a drug described in subsection (a), the Secretary 
may--
            ``(1) expedite the review of a supplement to a new drug 
        application submitted under section 505(b), an abbreviated new 
        drug application submitted under section 505(j), or a 
        supplement to such an application submitted under section 
        505(j) that could help mitigate or prevent such shortage; or
            ``(2) expedite an inspection or reinspection of an 
        establishment that could help mitigate or prevent such drug 
        shortage.
    ``(d) Coordination.--
            ``(1) Task force and strategic plan.--
                    ``(A) In general.--
                            ``(i) Task force.--As soon as practicable 
                        after the date of enactment of the Food and 
                        Drug Administration Safety and Innovation Act, 
                        the Secretary shall establish a Task Force to 
                        develop and implement a strategic plan for 
                        enhancing the Secretary's response to 
                        preventing and mitigating drug shortages.
                            ``(ii) Strategic plan.--The strategic plan 
                        described in clause (i) shall include--
                                    ``(I) plans for enhanced 
                                interagency and intraagency 
                                coordination, communication, and 
                                decisionmaking;
                                    ``(II) plans for ensuring that drug 
                                shortages are considered when the 
                                Secretary initiates a regulatory action 
                                that could precipitate a drug shortage 
                                or exacerbate an existing drug 
                                shortage;
                                    ``(III) plans for effective 
                                communication with outside 
                                stakeholders, including who the 
                                Secretary should alert about potential 
                                or actual drug shortages, how the 
                                communication should occur, and what 
                                types of information should be shared; 
                                and
                                    ``(IV) plans for considering the 
                                impact of drug shortages on research 
                                and clinical trials.
                            ``(iii) Consultation.--In carrying out this 
                        subparagraph, the Task Force shall ensure 
                        consultation with the appropriate offices 
                        within the Food and Drug Administration, 
                        including the Office of the Commissioner, the 
                        Center for Drug Evaluation and Research, the 
                        Office of Regulatory Affairs, and employees 
                        within the Department of Health and Human 
                        Services with expertise regarding drug 
                        shortages. The Secretary shall engage external 
                        stakeholders and experts as appropriate.
                    ``(B) Timing.--Not later than 1 year after the date 
                of enactment Food and Drug Administration Safety and 
                Innovation Act, the Task Force shall--
                            ``(i) publish the strategic plan described 
                        in subparagraph (A); and
                            ``(ii) submit such plan to Congress.
            ``(2) Communication.--The Secretary shall ensure that, 
        prior to any enforcement action or issuance of a warning letter 
        that the Secretary determines could reasonably be anticipated 
        to lead to a meaningful disruption in the supply in the United 
        States of a drug described under subsection (a), there is 
        communication with the appropriate office of the Food and Drug 
        Administration with expertise regarding drug shortages 
        regarding whether the action or letter could cause, or 
        exacerbate, a shortage of the drug.
            ``(3) Action.--If the Secretary determines, after the 
        communication described in paragraph (2), that an enforcement 
        action or a warning letter could reasonably cause or exacerbate 
        a shortage of a drug described under subsection (a), then the 
        Secretary shall evaluate the risks associated with the impact 
        of such shortage upon patients and those risks associated with 
        the violation involved before taking such action or issuing 
        such letter, unless there is imminent risk of serious adverse 
        health consequences or death to humans.
            ``(4) Reporting by other entities.--The Secretary shall 
        identify or establish a mechanism by which healthcare providers 
        and other third-party organizations may report to the Secretary 
        evidence of a drug shortage.
            ``(5) Review and construction.--No determination, finding, 
        action, or omission of the Secretary under this subsection 
        shall--
                    ``(A) be subject to judicial review; or
                    ``(B) be construed to establish a defense to an 
                enforcement action by the Secretary.
    ``(e) Recordkeeping and Reporting.--
            ``(1) Recordkeeping.--The Secretary shall maintain records 
        related to drug shortages, including with respect to each of 
        the following:
                    ``(A) The number of manufacturers that submitted a 
                notification to the Secretary under subsection (a) in 
                each calendar year.
                    ``(B) The number of drug shortages that occurred in 
                each calendar year and a list of drug names, drug 
                types, and classes that were the subject of such 
                shortages.
                    ``(C) A list of the known factors contributing to 
                the drug shortages described in subparagraph (B).
                    ``(D)(i) A list of major actions taken by the 
                Secretary to prevent or mitigate the drug shortages 
                described in subparagraph (B).
                    ``(ii) The Secretary shall include in the list 
                under clause (i) the following:
                            ``(I) The number of applications for which 
                        the Secretary expedited review under subsection 
                        (c)(1) in each calendar year.
                            ``(II) The number of establishment 
                        inspections or reinspections that the Secretary 
                        expedited under subsection (c)(2) in each 
                        calendar year.
                    ``(E) The number of notifications submitted to the 
                Secretary under subsection (a) in each calendar year.
                    ``(F) The names of manufacturers that the Secretary 
                has learned did not comply with the notification 
                requirement under subsection (a) in each calendar year.
                    ``(G) The number of times in each calendar year 
                that the Secretary determined under subsection (d)(3) 
                that an enforcement action or a warning letter could 
                reasonably cause or exacerbate a shortage of a drug 
                described under subsection (a), but did not evaluate 
                the risks associated with the impact of such shortage 
                upon patients and those risks associated with the 
                violation involved before taking such action or issuing 
                such letter on the grounds that there was imminent risk 
                of serious adverse health consequences or death to 
                humans, and a summary of the determinations.
                    ``(H) A summary of the communications made and 
                actions taken under subsection (d) in each calendar 
                year.
                    ``(I) Any other information the Secretary deems 
                appropriate to better prevent and mitigate drug 
                shortages.
            ``(2) Trend analysis.--The Secretary is authorized to 
        retain a third party to conduct a study, if the Secretary 
        believes such a study would help clarify the causes, trends, or 
        solutions related to drug shortages.
            ``(3) Annual summary.--Not later than 18 months after the 
        date of enactment of the Food and Drug Administration Safety 
        and Innovation Act, and annually thereafter, the Secretary 
        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 summarizing, with 
        respect to the 1-year period preceding such report, the 
        information described in paragraph (1). Such report shall not 
        include any information that is exempt from disclosure under 
        subsection (a) of section 552 of title 5, United States Code, 
        by reason of subsection (b)(4) of such section.
    ``(f) Definitions.--For purposes of this section--
            ``(1) the term `drug'--
                    ``(A) means a drug (as defined in section 201(g)) 
                that is intended for human use; and
                    ``(B) does not include biological products (as 
                defined in section 351 of the Public Health Service 
                Act), unless otherwise provided by the Secretary in the 
                regulations promulgated under subsection (h);
            ``(2) the term `drug shortage' or `shortage', with respect 
        to a drug, means a period of time when the demand or projected 
        demand for the drug within the United States exceeds the supply 
        of the drug; and
            ``(3) the term `meaningful disruption'--
                    ``(A) means a change in production that is 
                reasonably likely to lead to a reduction in the supply 
                of a drug by a manufacturer that is more than 
                negligible and impacts the ability of the manufacturer 
                to fill orders or meet expected demand for its product; 
                and
                    ``(B) does not include interruptions in 
                manufacturing 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.
    ``(g) Distribution.--To the maximum extent practicable, the 
Secretary may distribute information on drug shortages and on the 
permanent discontinuation of the drugs described in this section to 
appropriate provider and patient organizations, except that any such 
distribution shall not include any information that is exempt from 
disclosure under section 552 of title 5, United States Code, by reason 
of subsection (b)(4) of such section.
    ``(h) Regulations.--
            ``(1) In general.--Not later than 18 months after the date 
        of enactment of the Food and Drug Administration Safety and 
        Innovation Act, the Secretary shall adopt a final regulation 
        implementing this section.
            ``(2) Inclusion of biological products.--
                    ``(A) In general.--The Secretary may by regulation 
                apply this section to biological products (as defined 
                in section 351 of the Public Health Service Act) if the 
                Secretary determines such inclusion would benefit the 
                public health.
                    ``(B) Rule for vaccines.--If the Secretary applies 
                this section to vaccines pursuant to subparagraph (A), 
                the Secretary shall--
                            ``(i) consider whether the notification 
                        requirement under subsection (a) may be 
                        satisfied by submitting a notification to the 
                        Centers for Disease Control and Prevention 
                        under the vaccine shortage notification program 
                        of such Centers; and
                            ``(ii) explain the determination made by 
                        the Secretary under clause (i) in the 
                        regulation.
            ``(3) Procedure.--In promulgating a regulation implementing 
        this section, the Secretary shall--
                    ``(A) issue a notice of proposed rulemaking that 
                includes the proposed regulation;
                    ``(B) provide a period of not less than 60 days for 
                comments on the proposed regulation; and
                    ``(C) publish the final regulation not less than 30 
                days before the regulation's effective date.
            ``(4) Restrictions.--Notwithstanding any other provision of 
        Federal law, in implementing this section, the Secretary shall 
        only promulgate regulations as described in paragraph (3).''.
    (b) Effect of Notification.--The submission of a notification to 
the Secretary of Health and Human Services (referred to in this section 
as the ``Secretary'') for purposes of complying with the requirement in 
section 506C(a) of the Federal Food, Drug, and Cosmetic Act (as amended 
by subsection (a)) shall not be construed--
            (1) as an admission that any product that is the subject of 
        such notification violates any provision of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); or
            (2) as evidence of an intention to promote or market the 
        product for an indication or use for which the product has not 
        been approved by the Secretary.
    (c) Internal Review.--Not later than 2 years after the date of 
enactment of this Act, the Secretary shall--
            (1) analyze and review the regulations promulgated under 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
        seq.), the guidances or policies issued under such Act related 
        to drugs intended for human use, and the practices of the Food 
        and Drug Administration regarding enforcing such Act related to 
        manufacturing of such drugs, to identify any such regulations, 
        guidances, policies, or practices that cause, exacerbate, 
        prevent, or mitigate drug shortages (as defined in section 506C 
        of the Federal Food, Drug, and Cosmetic Act (as amended by 
        subsection (a)); and
            (2) determine how regulations, guidances, policies, or 
        practices identified under paragraph (1) should be modified, 
        streamlined, expanded, or discontinued in order to reduce or 
        prevent such drug shortages, taking into consideration the 
        effect of any changes on the public health.
    (d) Study on Market Factors Contributing to Drug Shortages and 
Stockpiling.--
            (1) In general.--Not later than 1 year after the date of 
        enactment of this Act, the Comptroller General of the United 
        States, in consultation with the Secretary, the Department of 
        Health and Human Services Office of the Inspector General, the 
        Attorney General, and Chairman of the Federal Trade Commission, 
        shall publish a report reviewing any findings that drug 
        shortages (as so defined) have led market participants to 
        stockpile affected drugs or sell them at significantly 
        increased prices, the impact of such activities on Federal 
        revenue, and any economic factors that have exacerbated or 
        created a market for such actions.
            (2) Content.--The report under paragraph (1) shall 
        include--
                    (A) an analysis of the incidence of any of the 
                activities described in paragraph (1) and the effect of 
                such activities on the public health;
                    (B) an evaluation of whether in such cases there is 
                a correlation between drugs in shortage and--
                            (i) the number of manufacturers producing 
                        such drugs;
                            (ii) the pricing structure, including 
                        Federal reimbursements, for such drugs before 
                        such drugs were in shortage, and to the extent 
                        possible, revenue received by each such 
                        manufacturer of such drugs;
                            (iii) pricing structure and revenue, to the 
                        extent possible, for the same drugs when sold 
                        under the conditions described in paragraph 
                        (1); and
                            (iv) the impact of contracting practices by 
                        market participants (including manufacturers, 
                        distributors, group purchasing organizations, 
                        and providers) on competition, access to drugs, 
                        and pricing of drugs;
                    (C) whether the activities described in paragraph 
                (1) are consistent with applicable law; and
                    (D) recommendations to Congress on what, if any, 
                additional reporting or enforcement actions are 
                necessary.
            (3) Trade secret and confidential information.--Nothing in 
        this subsection alters or amends section 1905 of title 18, 
        United States Code, or section 552(b)(4) of title 5, United 
        States Code.
    (e) Guidance Regarding Repackaging.--Not later than 1 year after 
the date of enactment of this Act, the Secretary shall issue guidance 
that clarifies the policy of the Food and Drug Administration regarding 
hospital pharmacies repackaging and safely transferring repackaged 
drugs among hospitals within a common health system during a drug 
shortage, as identified by the Secretary.

                       TITLE XI--OTHER PROVISIONS

                      Subtitle A--Reauthorizations

SEC. 1101. REAUTHORIZATION OF PROVISION RELATING TO EXCLUSIVITY OF 
              CERTAIN DRUGS CONTAINING SINGLE ENANTIOMERS.

    (a) In General.--Section 505(u)(4) (21 U.S.C. 355(u)(4)) is amended 
by striking ``2012'' and inserting ``2017''.
    (b) Amendment.--Section 505(u)(1)(A)(ii)(II) (21 U.S.C. 
355(u)(1)(A)(ii)(II)) is amended by inserting ``clinical'' after 
``any''.

SEC. 1102. REAUTHORIZATION OF THE CRITICAL PATH PUBLIC-PRIVATE 
              PARTNERSHIPS.

    Section 566(f) (21 U.S.C. 360bbb-5(f)) is amended by striking 
``2012'' and inserting ``2017''.

               Subtitle B--Medical Gas Product Regulation

SEC. 1111. REGULATION OF MEDICAL GAS PRODUCTS.

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

                  ``Subchapter G--Medical Gas Products

``SEC. 575. DEFINITIONS.

    ``In this subchapter:
            ``(1) The term `designated medical gas product' 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 product deemed 
                appropriate by the Secretary, unless any period of 
                exclusivity under section 505(c)(3)(E)(ii) or 
                505(j)(5)(F)(ii), or the extension of any such period 
                under section 505A, applicable to such medical gas 
                product has not expired.
            ``(2) The term `medical gas product' 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 GAS PRODUCTS.

    ``(a) Certification of Designated Medical Gas Products.--
            ``(1) Submission.--
                    ``(A) In general.--Beginning on the date of 
                enactment of this section, any person may file with the 
                Secretary a request for a certification of a designated 
                medical gas product.
                    ``(B) Content.--A request under subparagraph (A) 
                shall contain--
                            ``(i) a description of the medical gas 
                        product;
                            ``(ii) the name and address of the sponsor;
                            ``(iii) the name and address of the 
                        facility or facilities where the gas product is 
                        or will be manufactured; and
                            ``(iv) any other information deemed 
                        appropriate by the Secretary to determine 
                        whether the medical gas product is a designated 
                        medical gas product.
            ``(2) Grant of certification.--A certification described 
        under paragraph (1)(A) shall be determined to have been granted 
        unless, not later than 60 days after the filing of a request 
        under paragraph (1), the Secretary finds that--
                    ``(A) the medical gas product subject to the 
                certification is not a designated medical gas product;
                    ``(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 gas product is a designated medical 
                gas product; or
                    ``(C) granting the request would be contrary to 
                public health.
            ``(3) Effect of certification.--
                    ``(A) In general.--
                            ``(i) Approved uses.--A designated medical 
                        gas product for which a certification is 
                        granted under paragraph (2) is deemed, alone or 
                        in combination with another designated gas 
                        product or products as medically appropriate, 
                        to have in effect an approved application under 
                        section 505 or 512, subject to all applicable 
                        postapproval requirements, for the following 
                        indications for use:
                                    ``(I) Oxygen for the treatment or 
                                prevention of hypoxemia or hypoxia.
                                    ``(II) Nitrogen for use in hypoxic 
                                challenge testing.
                                    ``(III) Nitrous oxide for 
                                analgesia.
                                    ``(IV) Carbon dioxide for use in 
                                extracorporeal membrane oxygenation 
                                therapy or respiratory stimulation.
                                    ``(V) Helium for the treatment of 
                                upper airway obstruction or increased 
                                airway resistance.
                                    ``(VI) Medical air to reduce the 
                                risk of hyperoxia.
                                    ``(VII) Carbon monoxide for use in 
                                lung diffusion testing.
                                    ``(VIII) Any other indication for 
                                use for a designated medical gas 
                                product or combination of designated 
                                medical gas products deemed appropriate 
                                by the Secretary, unless any period of 
                                exclusivity under clause (iii) or (iv) 
                                of section 505(c)(3)(E), under clause 
                                (iii) or (iv) of section 505(j)(5)(F), 
                                or under section 527, or the extension 
                                of any such period under section 505A, 
                                applicable to such indication for use 
                                for such gas product or combination of 
                                products has not expired.
                            ``(ii) Labeling.--The requirements 
                        established in sections 503(b)(4) and 502(f) 
                        shall be deemed to have been met for a 
                        designated medical gas product if the labeling 
                        on final use containers of such gas product 
                        bears the information required by section 
                        503(b)(4) and a warning statement concerning 
                        the use of the gas product, as determined by 
                        the Secretary by regulation, as well as 
                        appropriate directions and warnings concerning 
                        storage and handling.
                    ``(B) Inapplicability of exclusivity provisions.--
                            ``(i) Effect on ineligibility.--No 
                        designated medical gas product deemed under 
                        paragraph (3)(A)(i) to have in effect an 
                        approved application shall be eligible for any 
                        periods of exclusivity under sections 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 sections 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 shall prohibit, limit, 
                        or otherwise affect the submission, grant, or 
                        effect of a certification under this section, 
                        except as provided in paragraph 
                        (3)(A)(i)(VIII).
            ``(4) Withdrawal, suspension, or revocation of approval.--
                    ``(A) In general.--Nothing in this subchapter 
                limits the authority of the Secretary to withdraw or 
                suspend approval of a drug, including a designated 
                medical gas product deemed under this section to have 
                in effect an approved application, under section 505 or 
                section 512.
                    ``(B) Revocation.--The Secretary may revoke the 
                grant of a certification under this section 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 product shall 
        be subject to section 503(b)(1) unless the Secretary exercises 
        the authority provided in section 503(b)(3) to remove such gas 
        product from the requirements of section 503(b)(1) or the use 
        in question is authorized pursuant to another provision of this 
        Act relating to use of medical products in emergencies.
            ``(2) Exception for oxygen.--
                    ``(A) In general.--Notwithstanding paragraph (1), 
                oxygen may be provided without a prescription for the 
                following uses:
                            ``(i) The use in the event of 
                        depressurization or other environmental oxygen 
                        deficiency.
                            ``(ii) The use in the event of oxygen 
                        deficiency or use in emergency resuscitation, 
                        when administered by properly trained 
                        personnel.
                    ``(B) Labeling.--For oxygen provided pursuant to 
                subparagraph (A), the requirements established in 
                section 503(b)(4) shall be deemed to have been met if 
                the labeling of the oxygen bears a warning that the 
                medical gas product can be used for emergency use only 
                and for all other medical applications a prescription 
                is required.
    ``(c) Inapplicability of Drugs Fees to Designated Medical Gas 
Products.--A designated medical gas product deemed under this section 
to have in effect an approved application shall not be assessed fees 
under section 736(a) on the basis of such deemed approval.''.

SEC. 1112. REGULATIONS.

    (a) Review of Regulations.--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, after 
obtaining input from medical gas product manufacturers, and any other 
interested members of the public, submit a report to the Committee on 
Health, Education, Labor, and Pensions of the Senate and the Committee 
on Energy and Commerce of the House of Representatives regarding any 
changes to the Federal drug regulations in title 21, Code of Federal 
Regulations that the Secretary determines to be necessary.
    (b) Amended Regulations.--If the Secretary determines that changes 
to the Federal drug regulations in title 21, Code of Federal 
Regulations are necessary under subsection (a), the Secretary shall 
issue final regulations implementing such changes not later than 4 
years after the date of enactment of this Act.

SEC. 1113. APPLICABILITY.

    Nothing in this subtitle or the amendments made by this subtitle 
shall apply to--
            (1) a drug that is covered by an application under section 
        505 or 512 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355, 360b) approved prior to May 1, 2012; or
            (2) any of the gases listed in subparagraphs (A) through 
        (G) of section 575(1) of such Act (as added by section 1111), 
        or any mixture 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)(i) of such Act (as added by section 1111); 
                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--Miscellaneous Provisions

SEC. 1121. ADVISORY COMMITTEE CONFLICTS OF INTEREST.

    Section 712 (21 U.S.C. 379d-1) is amended--
            (1) in subsection (b)--
                    (A) by striking paragraph (2); and
                    (B) in paragraph (1)--
                            (i) by redesignating subparagraph (B) as 
                        paragraph (2) and moving such paragraph, as so 
                        redesignated, 2 ems to the left;
                            (ii) in subparagraph (A), by redesignating 
                        clauses (i) through (iii) as subparagraphs (A) 
                        through (C), respectively, and moving such 
                        subparagraphs, as so redesignated, 2 ems to the 
                        left;
                            (iii) in subparagraph (A), as so 
                        redesignated, by inserting ``, including 
                        strategies to increase the number of special 
                        Government employees across medical and 
                        scientific specialties in areas where the 
                        Secretary would benefit from specific 
                        scientific, medical, or technical expertise 
                        necessary for the performance of its regulatory 
                        responsibilities'' before the semicolon at the 
                        end;
                            (iv) by striking ``(1) Recruitment.--'' and 
                        inserting ``(1) Recruitment in general.--The 
                        Secretary shall--'';
                            (v) by striking ``(A) In general.--The 
                        Secretary shall--'';
                            (vi) by redesignating clauses (i) through 
                        (iii) of paragraph (2) (as so redesignated) as 
                        subparagraphs (A) through (C), respectively, 
                        and moving such subparagraphs, as so 
                        redesignated, 2 ems to the left;
                            (vii) in paragraph (2) (as so 
                        redesignated), in the matter before 
                        subparagraph (A) (as so redesignated), by 
                        striking ``subparagraph (A)'' and inserting 
                        ``paragraph (1)''; and
                            (viii) by adding at the end the following:
            ``(3) Recruitment through referrals.--In carrying out 
        paragraph (1), the Secretary shall, in order to further the 
        goal of including in advisory committees highly qualified and 
        specialized experts in the specific diseases to be considered 
        by such advisory committees, at least every 180 days, request 
        referrals from a variety of stakeholders, such as the Institute 
        of Medicine, the National Institutes of Health, product 
        developers, patient groups, disease advocacy organizations, 
        professional societies, medical societies, including the 
        American Academy of Medical Colleges, and other governmental 
        organizations.'';
            (2) by amending subsection (c)(2)(C) to read as follows:
                    ``(C) Consideration by secretary.--The Secretary 
                shall ensure that each determination made under 
                subparagraph (B) considers the type, nature, and 
                magnitude of the financial interests at issue and the 
                public health interest in having the expertise of the 
                member with respect to the particular matter before the 
                advisory committee.'';
            (3) in subsection (e), by inserting ``, and shall make 
        publicly available,'' after ``House of Representatives''; and
            (4) by adding at the end the following:
    ``(g) Guidance on Reported Financial Interest or Involvement.--The 
Secretary shall issue guidance that describes how the Secretary reviews 
the financial interests and involvement of advisory committee members 
that are reported under subsection (c)(1) but that the Secretary 
determines not to meet the definition of a disqualifying interest under 
section 208 of title 18, United States Code for the purposes of 
participating in a particular matter.''.

SEC. 1122. GUIDANCE DOCUMENT REGARDING PRODUCT PROMOTION USING THE 
              INTERNET.

    Not later than 2 years after the date of enactment this Act, the 
Secretary of Health and Human Services shall issue guidance that 
describes Food and Drug Administration policy regarding the promotion, 
using the Internet (including social media), of medical products that 
are regulated by such Administration.

SEC. 1123. 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. 1124. 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. 1125. TANNING BED LABELING.

    Not later than 18 months after the date of enactment of this Act, 
the Secretary of Health and Human Services shall determine whether to 
amend the warning label requirements for sunlamp products to include 
specific requirements to more clearly and effectively convey the risks 
that such products pose for the development of irreversible damage to 
the eyes and skin, including skin cancer.

SEC. 1126. OPTIMIZING GLOBAL CLINICAL TRIALS.

    Subchapter E of chapter V (21 U.S.C. 360bbb et seq.), as amended by 
section 903, is further amended by adding at the end the following:

``SEC. 569A. OPTIMIZING GLOBAL CLINICAL TRIALS.

    ``(a) In General.--The Secretary shall--
            ``(1) work with other regulatory authorities of similar 
        standing, medical research companies, and international 
        organizations to foster and encourage uniform, scientifically-
        driven clinical trial standards with respect to medical 
        products around the world; and
            ``(2) enhance the commitment to provide consistent parallel 
        scientific advice to manufacturers seeking simultaneous global 
        development of new medical products in order to--
                    ``(A) enhance medical product development;
                    ``(B) facilitate the use of foreign data; and
                    ``(C) minimize the need to conduct duplicative 
                clinical studies, preclinical studies, or non-clinical 
                studies.
    ``(b) Medical Product.--In this section, the term `medical product' 
means a drug, as defined in subsection (g) of section 201, a device, as 
defined in subsection (h) of such section, or a biological product, as 
defined in section 351(i) of the Public Health Service Act.
    ``(c) Savings Clause.--Nothing in this section shall alter the 
criteria for evaluating the safety or effectiveness of a medical 
product under this Act.

``SEC. 569B. USE OF CLINICAL INVESTIGATION DATA FROM OUTSIDE THE UNITED 
              STATES.

    ``(a) In General.--In determining whether to approve, license, or 
clear a drug or device pursuant to an application submitted under this 
chapter, the Secretary shall accept data from clinical investigations 
conducted outside of the United States, including the European Union, 
if the applicant demonstrates that such data are adequate under 
applicable standards to support approval, licensure, or clearance of 
the drug or device in the United States.
    ``(b) Notice to Sponsor.--If the Secretary finds under subsection 
(a) that the data from clinical investigations conducted outside the 
United States, including in the European Union, are inadequate for the 
purpose of making a determination on approval, clearance, or licensure 
of a drug or device pursuant to an application submitted under this 
chapter, the Secretary shall provide written notice to the sponsor of 
the application of such finding and include the rationale for such 
finding.''.

SEC. 1127. ADVANCING REGULATORY SCIENCE TO PROMOTE PUBLIC HEALTH 
              INNOVATION.

    (a) In General.--Not later than 1 year after the date of enactment 
of this Act, the Secretary of Health and Human Services (referred to in 
this section as the ``Secretary'') shall develop a strategy and 
implementation plan for advancing regulatory science for medical 
products in order to promote the public health and advance innovation 
in regulatory decisionmaking.
    (b) Requirements.--The strategy and implementation plan developed 
under subsection (a) shall be consistent with the user fee performance 
goals in the Prescription Drug User Fee Agreement commitment letter, 
the Generic Drug User Fee Agreement commitment letter, and the 
Biosimilar User Fee Agreement commitment letter transmitted by the 
Secretary to Congress on January 13, 2012, and the Medical Device User 
Fee Agreement commitment letter transmitted by the Secretary to 
Congress on April 20, 2012, and shall--
            (1) identify a clear vision of the fundamental role of 
        efficient, consistent, and predictable, science-based decisions 
        throughout regulatory decisionmaking of the Food and Drug 
        Administration with respect to medical products;
            (2) identify the regulatory science priorities of the Food 
        and Drug Administration directly related to fulfilling the 
        mission of the agency with respect to decisionmaking concerning 
        medical products and allocation of resources towards such 
        regulatory science priorities;
            (3) identify regulatory and scientific gaps that impede the 
        timely development and review of, and regulatory certainty with 
        respect to, the approval, licensure, or clearance of medical 
        products, including with respect to companion products and new 
        technologies, and facilitating the timely introduction and 
        adoption of new technologies and methodologies in a safe and 
        effective manner;
            (4) identify clear, measurable metrics by which progress on 
        the priorities identified under paragraph (2) and gaps 
        identified under paragraph (3) will be measured by the Food and 
        Drug Administration, including metrics specific to the 
        integration and adoption of advances in regulatory science 
        described in paragraph (5) and improving medical product 
        decisionmaking, in a predictable and science-based manner; and
            (5) set forth how the Food and Drug Administration will 
        ensure that advances in regulatory science for medical products 
        are adopted, as appropriate, on an ongoing basis and in an 
        manner integrated across centers, divisions, and branches of 
        the Food and Drug Administration, including by senior managers 
        and reviewers, including through the--
                    (A) development, updating, and consistent 
                application of guidance documents that support medical 
                product decisionmaking; and
                    (B) the adoption of the tools, methods, and 
                processes under section 566 of the Federal Food, Drug, 
                and Cosmetic Act (21 U.S.C. 360bbb-5).
    (c) Annual Performance Reports.--As part of the annual performance 
reports submitted to Congress under sections 736B(a) (as amended by 
section 104), 738A(a) (as amended by section 204), 744C(a) (as added by 
section 303), and 744I(a) (as added by section 403) of the Federal 
Food, Drug, and Cosmetic Act for each of fiscal years 2013 through 
2017, the Secretary shall annually report on the progress made with 
respect to--
            (1) advancing the regulatory science priorities identified 
        under paragraph (2) of subsection (b) and resolving the gaps 
        identified under paragraph (3) of such subsection, including 
        reporting on specific metrics identified under paragraph (4) of 
        such subsection;
            (2) the integration and adoption of advances in regulatory 
        science as set forth in paragraph (5) of such subsection; and
            (3) the progress made in advancing the regulatory science 
        goals outlined in the Prescription Drug User Fee Agreement 
        commitment letter, the Generic Drug User Fee Agreement 
        commitment letter, and the Biosimilar User Fee Agreement 
        commitment letter transmitted by the Secretary to Congress on 
        January 13, 2012, and the Medical Device User Fee Agreement 
        transmitted by the Secretary to Congress on April 20, 2012.
    (d) Independent Assessment.--Not later than January 1, 2016, the 
Comptroller General of the United States shall submit to Congress a 
report--
            (1) detailing the progress made by the Food and Drug 
        Administration in meeting the priorities and addressing the 
        gaps identified in subsection (b), including any outstanding 
        gaps; and
            (2) containing recommendations, as appropriate, on how 
        regulatory science initiatives for medical products can be 
        strengthened and improved to promote the public health and 
        advance innovation in regulatory decisionmaking.
    (e) Medical Product.--In this section, the term ``medical product'' 
means a drug, as defined in subsection (g) of section 201 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321), a device, as 
defined in subsection (h) of such section, or a biological product, as 
defined in section 351(i) of the Public Health Service Act.

SEC. 1128. INFORMATION TECHNOLOGY.

    (a) HHS Report.--Not later than 1 year after the date of enactment 
of this Act, the Secretary of Health and Human Services shall--
            (1) report to Congress on--
                    (A) the milestones and a completion date for 
                developing and implementing a comprehensive information 
                technology strategic plan to align the information 
                technology systems modernization projects with the 
                strategic goals of the Food and Drug Administration, 
                including results-oriented goals, strategies, 
                milestones, performance measures;
                    (B) efforts to finalize and approve a comprehensive 
                inventory of the information technology systems of the 
                Food and Drug Administration that includes information 
                describing each system, such as costs, system function 
                or purpose, and status information, and incorporate use 
                of the system portfolio into the information investment 
                management process of the Food and Drug Administration;
                    (C) the ways in which the Food and Drug 
                Administration uses the plan described in subparagraph 
                (A) to guide and coordinate the modernization projects 
                and activities of the Food and Drug Administration, 
                including the interdependencies among projects and 
                activities; and
                    (D) the extent to which the Food and Drug 
                Administration has fulfilled or is implementing 
                recommendations of the Government Accountability Office 
                with respect to the Food and Drug Administration and 
                information technology; and
            (2) develop--
                    (A) a documented enterprise architecture program 
                management plan that includes the tasks, activities, 
                and timeframes associated with developing and using the 
                architecture and addresses how the enterprise 
                architecture program management will be performed in 
                coordination with other management disciplines, such as 
                organizational strategic planning, capital planning and 
                investment control, and performance management; and
                    (B) a skills inventory, needs assessment, gap 
                analysis, and initiatives to address skills gaps as 
                part of a strategic approach to information technology 
                human capital planning.
    (b) GAO Report.--Not later than January 1, 2016, the Comptroller 
General of the United States shall issue a report regarding the 
strategic plan described in subsection (a)(1)(A) and related actions 
carried out by the Food and Drug Administration. Such report shall 
assess the progress the Food and Drug Administration has made on--
            (1) the development and implementation of a comprehensive 
        information technology strategic plan, including the results-
        oriented goals, strategies, milestones, and performance 
        measures identified in subsection (a)(1)(A);
            (2) the effectiveness of the comprehensive information 
        technology strategic plan described in subsection (a)(1)(A), 
        including the results-oriented goals and performance measures; 
        and
            (3) the extent to which the Food and Drug Administration 
        has fulfilled recommendations of the Government Accountability 
        Office with respect to such agency and information technology.

SEC. 1129. REPORTING REQUIREMENTS.

    Subchapter A of chapter VII (21 U.S.C. 371 et seq.), as amended by 
section 208, is further amended by adding at the end the following:

``SEC. 715. REPORTING REQUIREMENTS.

    ``(a) New Drugs.--Beginning with fiscal year 2013 and ending with 
fiscal year 2017, not later than 120 days after the end of each fiscal 
year for which fees are collected under part 2 of subchapter C, the 
Secretary shall prepare and submit to the Committee on Health 
Education, Labor, and Pensions of the Senate and the Committee on 
Energy and Commerce of the House of Representatives a report 
concerning, for all applications for approval of a new drug under 
section 505(b) of this Act or a new biological product under section 
351(a) of the Public Health Service Act filed in the previous fiscal 
year--
            ``(1) the number of such applications that met the goals 
        identified for purposes of part 2 of subchapter C 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;
            ``(2) the percentage of such applications that were 
        approved;
            ``(3) the percentage of such applications that were issued 
        complete response letters;
            ``(4) the percentage of such applications that were subject 
        to a refuse-to-file action;
            ``(5) the percentage of such applications that were 
        withdrawn; and
            ``(6) the average total time to decision by the Secretary 
        for all applications for approval of a new drug under section 
        505(b) of this Act or a new biological product under section 
        351(a) of the Public Health Service Act filed in the previous 
        fiscal year, including the number of calendar days spent during 
        the review by the Food and Drug Administration and the number 
        of calendar days spent by the sponsor responding to a complete 
        response letter.''.
    ``(b) Generic Drugs.--Beginning with fiscal year 2013 and ending 
after fiscal year 2017, not later than 120 days after the end of each 
fiscal year for which fees are collected under part 7 of subchapter C, 
the Secretary shall prepare and submit to the Committee on Health 
Education, Labor, and Pensions of the Senate and the Committee on 
Energy and Commerce of the House of Representatives a report 
concerning, for all applications for approval of a generic drug under 
section 505(j), amendments to such applications, and prior approval 
supplements with respect to such applications filed in the previous 
fiscal year--
            ``(1) the number of such applications that met the goals 
        identified for purposes of part 7 of subchapter C, 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;
            ``(2) the average total time to decision by the Secretary 
        for applications for approval of a generic drug under section 
        505(j), amendments to such applications, and prior approval 
        supplements with respect to such applications filed in the 
        previous fiscal year, including the number of calendar days 
        spent during the review by the Food and Drug Administration and 
        the number of calendar days spent by the sponsor responding to 
        a complete response letter;
            ``(3) the total number of applications under section 
        505(j), amendments to such applications, and prior approval 
        supplements with respect to such applications that were pending 
        with the Secretary for more than 10 months on the date of 
        enactment of the Food and Drug Administration Safety and 
        Innovation Act; and
            ``(4) the number of applications described in paragraph (3) 
        on which the Food and Drug Administration took final regulatory 
        action in the previous fiscal year.
    ``(c) Biosimilar Biological Products.--
            ``(1) In general.--Beginning with fiscal year 2014, not 
        later than 120 days after the end of each fiscal year for which 
        fees are collected under part 8 of subchapter C, the Secretary 
        shall prepare and submit to the Committee on Health Education, 
        Labor, and Pensions of the Senate and the Committee on Energy 
        and Commerce of the House of Representatives a report 
        concerning--
                    ``(A) the number of applications for approval filed 
                under section 351(k) of the Public Health Service Act; 
                and
                    ``(B) the percentage of applications described in 
                subparagraph (A) that were approved by the Secretary.
            ``(2) Additional information.--As part of the performance 
        report described in paragraph (1), the Secretary shall include 
        an explanation of how the Food and Drug Administration is 
        managing the biological product review program to ensure that 
        the user fees collected under part 2 are not used to review an 
        application under section 351(k) of the Public Health Service 
        Act.''.

SEC. 1130. STRATEGIC INTEGRATED MANAGEMENT PLAN.

    (a) Strategic Integrated Management Plan.--Not later than 1 year 
after the date of enactment of this Act, the Secretary of Health and 
Human Services (referred to in this section as the ``Secretary'') shall 
submit to Congress a strategic integrated management plan for the 
Center for Drug Evaluation and Research, the Center for Biologics 
Evaluation and Research, and the Center for Devices and Radiological 
Health. Such strategic management plan shall--
            (1) identify strategic institutional goals and priorities 
        for the Center for Drug Evaluation and Research, the Center for 
        Biologics Evaluation and Research, and the Center for Devices 
        and Radiological Health;
            (2) describe the actions the Secretary will take to 
        recruit, retain, train, and continue to develop the workforce 
        at the Center for Drug Evaluation and Research, the Center for 
        Biologics Evaluation and Research, and the Center for Devices 
        and Radiological Health to fulfill the public health mission of 
        the Food and Drug Administration; and
            (3) identify results-oriented, outcome-based measures that 
        the Secretary will use to measure the progress of achieving the 
        strategic goals and priorities identified under paragraph (1) 
        and the effectiveness of the actions identified under paragraph 
        (2), including metrics to ensure that managers and reviewers of 
        the Center for Drug Evaluation and Research, the Center for 
        Biologics Evaluation and Research, and the Center for Devices 
        and Radiological Health are familiar with and appropriately and 
        consistently apply the requirements under the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), including new 
        requirements under parts 2, 3, 7, and 8 of subchapter C of 
        title VII of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 379f et seq.).
    (b) Report.--Not later than January 1, 2016, the Comptroller 
General of the United States shall issue a report regarding the 
strategic management plan described in subsection (a) and related 
actions carried out by the Food and Drug Administration. Such report 
shall--
            (1) assess the effectiveness of the actions described in 
        subsection (a)(2) in recruiting, retaining, training, and 
        developing the workforce at the Center for Drug Evaluation and 
        Research, the Center for Biologics Evaluation and Research, and 
        the Center for Devices and Radiological Health in fulfilling 
        the public health mission of the Food and Drug Administration;
            (2) assess the effectiveness of the measures identified 
        under subsection (a)(3) in gauging progress against the 
        strategic goals and priorities identified under subsection 
        (a)(1);
            (3) assess the extent to which the Center for Drug 
        Evaluation and Research, the Center for Biologics Evaluation 
        and Research, and the Center for Devices and Radiological 
        Health are using the identified results-oriented set of 
        performance measures in tracking their workload by strategic 
        goals and the effectiveness of such measures;
            (4) assess the extent to which performance information is 
        collected, analyzed, and acted on by managers; and
            (5) make recommendations, as appropriate, regarding how the 
        strategic management plan and related actions of the Center for 
        Drug Evaluation and Research, the Center for Biologics 
        Evaluation and Research, and the Center for Devices and 
        Radiological Health could be improved to fulfill the public 
        health mission of the Food and Drug Administration in as 
        efficient and effective manner as possible.

SEC. 1131. DRUG DEVELOPMENT AND BIOEQUIVALENCE TESTING.

    (a) In General.--Section 505-1 (21 U.S.C. 355-1) is amended by 
adding at the end the following:
    ``(k) Drug Development and Bioequivalence Testing.--
            ``(1) In general.--Notwithstanding any other provision of 
        law, if a drug is a covered drug, no elements to ensure safe 
        use shall prohibit, or be construed or applied to prohibit, 
        supply of such drug to any eligible drug developer for the 
        purpose of developing, or conducting bioequivalence testing 
        necessary to support, an application under subsection (b)(2) or 
        (j) of section 505 of this Act or section 351(k) of the Public 
        Health Service Act, if the Secretary has issued a written 
        notice described in paragraph (2), and the eligible drug 
        developer has agreed to comply with the terms of the notice.
            ``(2) Written notice.--For purposes of this subsection, the 
        Secretary shall issue a written notice to an eligible drug 
        developer and the holder of an application for a covered drug 
        authorizing the supply of a drug to such eligible drug 
        developer for purposes of bioequivalence testing if--
                    ``(A) the eligible drug developer has agreed to 
                comply with any conditions the Secretary considers 
                necessary; and
                    ``(B) the eligible drug developer has submitted and 
                the Secretary has approved a protocol for 
                bioequivalence testing that includes protections that 
                the Secretary finds will provide assurance of safety 
                comparable to the assurance of safety provided by the 
                elements to ensure safe use in the risk evaluation and 
                mitigation strategy for the covered drug.
            ``(3) Additional required element.--The Secretary shall 
        require as an element of each risk evaluation and mitigation 
        strategy approved by the Secretary that the holder of an 
        application for a covered drug shall not restrict the resale of 
        the covered drug to an eligible drug developer that receives a 
        written notice from the Secretary under paragraph (2).
            ``(4) Penalties.--For purposes of subsection (f)(8) and 
        sections 301, 303(f)(4), 502(y), and 505(p), it shall be a 
        violation of the risk evaluation and mitigation strategy for 
        the holder of the application for a covered drug to restrict 
        the sale of the drug to an eligible drug developer. The 
        Secretary shall provide written notice to the Committee on 
        Health, Education, Labor, and Pensions of the Senate and the 
        Committee on Energy and Commerce of the House of 
        Representatives of any penalty assessed under this subsection 
        within 7 days of such assessment.
            ``(5) Liability.--Unless the holder of the application for 
        a covered drug and the eligible developer are the same entity, 
        the holder of an application for a covered drug shall not be 
        liable for any claim arising out of the eligible drug 
        developer's testing necessary to support an application under 
        subsection (b)(2) or (j) of section 505 of this Act or section 
        351(k) of the Public Health Service Act for a drug obtained 
        under this subsection. Nothing in this subsection shall be 
        construed to expand or limit the liability of the eligible drug 
        developer or the holder of an application for a covered drug 
        for any other claim.
            ``(6) Definitions.--
                    ``(A) Covered drug.--Notwithstanding subsection 
                (b)(2), for purposes of this subsection, the term 
                `covered drug' means a drug, including a biological 
                product licensed under section 351(a) of the Public 
                Health Service Act, that is subject to a risk 
                evaluation and mitigation strategy with elements to 
                ensure safe use under subsection (f), or a drug, 
                including a biological product licensed under section 
                351(a) of the Public Health Service Act, required to 
                have a risk evaluation and mitigation strategy with 
                elements to ensure safe use under section 909(b) of the 
                Food and Drug Administration Amendments Act of 2007.
                    ``(B) Eligible drug developer.--For purposes of 
                this subsection, the term `eligible drug developer' 
                means a sponsor seeking to develop an application for 
                submission under subsection (b)(2) or (j) of section 
                505 of this Act or section 351(k) of the Public Health 
                Service Act.
            ``(7) Effect on other law.--Nothing in this subsection 
        shall affect the authority of the Federal Trade Commission to 
        enforce the Federal Trade Commission Act (15 U.S.C. 41-58), the 
        Sherman Act (15 U.S.C. 1-7)), or any other statute properly 
        under such Commission's jurisdiction.''.
    (b) Technical and Conforming Amendment.--Section 505-1(c)(2) (21 
U.S.C. 355-1(c)(2)) is amended by striking ``(e) and (f)'' and 
inserting ``(e), (f), and (k)(3)''.

SEC. 1132. PATIENT PARTICIPATION IN MEDICAL PRODUCT DISCUSSIONS.

    Subchapter E of chapter V (21 U.S.C. 360bbb et seq.), as amended by 
section 1126, is further amended by adding at the end the following:

``SEC. 569C. PATIENT PARTICIPATION IN MEDICAL PRODUCT DISCUSSION.

    ``(a) In General.--The Secretary shall develop and implement 
strategies to solicit the views of patients during the medical product 
development process and consider the perspectives of patients during 
regulatory discussions, including by--
            ``(1) fostering participation of a patient representative 
        who may serve as a special government employee in appropriate 
        agency meetings with medical product sponsors and 
        investigators; and
            ``(2) exploring means to provide for identification of 
        patient representatives who do not have any, or have minimal, 
        financial interests in the medical products industry.
    ``(b) Financial Interest.--In this section, the term `financial 
interest' means a financial interest under section 208(a) of title 18, 
United States Code.''.
                                                       Calendar No. 400

112th CONGRESS

  2d Session

                                S. 3187

_______________________________________________________________________

                                 A BILL

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

_______________________________________________________________________

                              May 16, 2012

            Read the second time and placed on the calendar