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[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[S. 3187 Enrolled Bill (ENR)]

        S.3187

                      One Hundred Twelfth Congress

                                 of the

                        United States of America

                          AT THE SECOND SESSION

          Begun and held at the City of Washington on Tuesday,
            the third day of January, two thousand and twelve

                                 An Act

 
 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 clause.
Sec. 208. Streamlined hiring authority to support activities related to 
          the process for the review of device applications.

                TITLE III--FEES RELATING TO GENERIC DRUGS

Sec. 301. Short title.
Sec. 302. Authority to assess and use human generic drug fees.
Sec. 303. Reauthorization; reporting requirements.
Sec. 304. Sunset dates.
Sec. 305. Effective date.
Sec. 306. Amendment with respect to misbranding.
Sec. 307. Streamlined hiring authority to support activities related to 
          human generic drugs.
Sec. 308. Additional reporting requirements.

        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.
Sec. 408. Additional reporting requirements.

                  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. Pediatric rare diseases.
Sec. 511. Staff of Office of Pediatric Therapeutics.

            TITLE VI--MEDICAL DEVICE REGULATORY IMPROVEMENTS

Sec. 601. Investigational device exemptions.
Sec. 602. Clarification of least burdensome standard.
Sec. 603. Agency documentation and review of significant decisions.
Sec. 604. Device modifications requiring premarket notification prior to 
          marketing.
Sec. 605. Program to improve the device recall system.
Sec. 606. Clinical holds on investigational device exemptions.
Sec. 607. Modification of de novo application process.
Sec. 608. Reclassification procedures.
Sec. 609. Harmonization of device premarket review, inspection, and 
          labeling symbols.
Sec. 610. Participation in international fora.
Sec. 611. Reauthorization of third-party review.
Sec. 612. Reauthorization of third-party inspection.
Sec. 613. Humanitarian device exemptions.
Sec. 614. Unique device identifier.
Sec. 615. Sentinel.
Sec. 616. Postmarket surveillance.
Sec. 617. Custom devices.
Sec. 618. Health information technology.
Sec. 619. Good guidance practices relating to devices.
Sec. 620. Pediatric device consortia.

                      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. Prohibition against delaying, denying, limiting, or refusing 
          inspection.
Sec. 708. Destruction of adulterated, misbranded, or counterfeit drugs 
          offered for import.
Sec. 709. Administrative detention.
Sec. 710. Exchange of information.
Sec. 711. Enhancing the safety and quality of the drug supply.
Sec. 712. Recognition of foreign government inspections.
Sec. 713. Standards for admission of imported drugs.
Sec. 714. Registration of commercial importers.
Sec. 715. Notification.
Sec. 716. Protection against intentional adulteration.
Sec. 717. Penalties for counterfeiting drugs.
Sec. 718. Extraterritorial jurisdiction.

            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. Clinical trials.
Sec. 805. Reassessment of qualified infectious disease product 
          incentives in 5 years.
Sec. 806. Guidance on pathogen-focused antibacterial drug development.

               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. Grants and Contracts for the Development of Orphan Drugs.
Sec. 907. Reporting of inclusion of demographic subgroups in clinical 
          trials and data analysis in applications for drugs, biologics, 
          and devices.
Sec. 908. Rare pediatric disease priority review voucher incentive 
          program.

                         TITLE X--DRUG SHORTAGES

Sec. 1001. Discontinuance or interruption in the production of life-
          saving drugs.
Sec. 1002. Annual reporting on drug shortages.
Sec. 1003. Coordination; task force and strategic plan.
Sec. 1004. Drug shortage list.
Sec. 1005. Quotas applicable to drugs in shortage.
Sec. 1006. Attorney General report on drug shortages.
Sec. 1007. Hospital repackaging of drugs in shortage.
Sec. 1008. Study on 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 gases.
Sec. 1112. Changes to regulations.
Sec. 1113. Rules of construction.

                  Subtitle C--Miscellaneous Provisions

Sec. 1121. Guidance document regarding product promotion using the 
          Internet.
Sec. 1122. Combating prescription drug abuse.
Sec. 1123. Optimizing global clinical trials.
Sec. 1124. Advancing regulatory science to promote public health 
          innovation.
Sec. 1125. Information technology.
Sec. 1126. Nanotechnology.
Sec. 1127. Online pharmacy report to Congress.
Sec. 1128. Report on small businesses.
Sec. 1129. Protections for the commissioned corps of the public health 
          service act.
Sec. 1130. Compliance date for rule relating to sunscreen drug products 
          for over-the-counter human use.
Sec. 1131. Strategic integrated management plan.
Sec. 1132. Assessment and modification of REMS.
Sec. 1133. Extension of period for first applicant to obtain tentative 
          approval without forfeiting 180-day-exclusivity period.
Sec. 1134. Deadline for determination on certain petitions.
Sec. 1135. Final agency action relating to petitions and civil actions.
Sec. 1136. Electronic submission of applications.
Sec. 1137. Patient participation in medical product discussions.
Sec. 1138. Ensuring adequate information regarding pharmaceuticals for 
          all populations, particularly underrepresented subpopulations, 
          including racial subgroups.
Sec. 1139. Scheduling of hydrocodone.
Sec. 1140. Study on Drug Labeling by Electronic Means.
Sec. 1141. Recommendations on interoperability standards.
Sec. 1142. Conflicts of interest.
Sec. 1143. Notification of FDA intent to regulate laboratory-developed 
          tests.

                       Subtitle D--Synthetic Drugs

Sec. 1151. Short title.
Sec. 1152. Addition of synthetic drugs to schedule I of the Controlled 
          Substances Act.
Sec. 1153. Temporary scheduling to avoid imminent hazards to public 
          safety expansion.

    (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.
    Section 735(7) (21 U.S.C. 379g) is amended by striking ``expenses 
incurred in connection with'' and inserting ``expenses in connection 
with''.
    SEC. 103. AUTHORITY TO ASSESS AND USE DRUG FEES.
    Section 736 (21 U.S.C. 379h) is amended--
        (1) in subsection (a)--
            (A) in the matter preceding paragraph (1), by striking 
        ``fiscal year 2008'' and inserting ``fiscal year 2013'';
            (B) in paragraph (1)(A)--
                (i) in clause (i), by striking ``(c)(5)'' and inserting 
            ``(c)(4)''; and
                (ii) in clause (ii), by striking ``(c)(5)'' and 
            inserting ``(c)(4)'';
            (C) in the matter following clause (ii) in paragraph 
        (2)(A)--
                (i) by striking ``(c)(5)'' and inserting ``(c)(4)''; 
            and
                (ii) by striking ``payable on or before October 1 of 
            each year'' and inserting ``due on the later of the first 
            business day on or after October 1 of 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'';
            (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), by striking ``shall be 
            retained'' and inserting ``subject to subparagraph (C), 
            shall be collected and available'';
                (ii) in subparagraph (A)(ii), by striking ``shall only 
            be collected and available'' and inserting ``shall be 
            available''; and
                (iii) by adding at the end the following new 
            subparagraph:
            ``(C) Provision for early payments.--Payment of fees 
        authorized under this section for a fiscal year, prior to the 
        due date for such fees, may be accepted by the Secretary in 
        accordance with authority provided in advance in a prior year 
        appropriations Act.'';
            (C) in paragraph (3), by striking ``fiscal years 2008 
        through 2012'' and inserting ``fiscal years 2013 through 
        2017''; and
            (D) in paragraph (4)--
                (i) by striking ``fiscal years 2008 through 2010'' and 
            inserting ``fiscal years 2013 through 2015'';
                (ii) by striking ``fiscal year 2011'' and inserting 
            ``fiscal year 2016'';
                (iii) by striking ``fiscal years 2008 through 2011'' 
            and inserting ``fiscal years 2013 through 2016''; and
                (iv) by striking ``fiscal year 2012'' and inserting 
            ``fiscal year 2017''.
    SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS.
    Section 736B (21 U.S.C. 379h-2) is amended--
        (1) by amending subsection (a) to read as follows:
    ``(a) Performance Report.--
        ``(1) In general.--Beginning with fiscal year 2013, not later 
    than 120 days after the end of each fiscal year for which fees are 
    collected under this part, the Secretary shall prepare and submit 
    to the Committee on Energy and Commerce of the House of 
    Representatives and the Committee on Health, Education, Labor, and 
    Pensions of the Senate a report concerning--
            ``(A) the progress of the Food and Drug Administration in 
        achieving the goals identified in the letters described in 
        section 101(b) of the Prescription Drug User Fee Amendments of 
        2012 during such fiscal year and the future plans of the Food 
        and Drug Administration for meeting the goals, including the 
        status of the independent assessment described in such letters; 
        and
            ``(B) the progress of the Center for Drug Evaluation and 
        Research and the Center for Biologics Evaluation and Research 
        in achieving the goals, and future plans for meeting the goals, 
        including, for each review division--
                ``(i) the number of original standard new drug 
            applications and biologics license applications filed per 
            fiscal year for each review division;
                ``(ii) the number of original priority new drug 
            applications and biologics license applications filed per 
            fiscal year for each review division;
                ``(iii) the number of standard efficacy supplements 
            filed per fiscal year for each review division;
                ``(iv) the number of priority efficacy supplements 
            filed per fiscal year for each review division;
                ``(v) the number of applications filed for review under 
            accelerated approval per fiscal year for each review 
            division;
                ``(vi) the number of applications filed for review as 
            fast track products per fiscal year for each review 
            division;
                ``(vii) the number of applications filed for orphan-
            designated products per fiscal year for each review 
            division; and
                ``(viii) the number of breakthrough designations for a 
            fiscal year for each review division.
        ``(2) Inclusion.--The report under this subsection for a fiscal 
    year shall include information on all previous cohorts for which 
    the Secretary has not given a complete response on all human drug 
    applications and supplements in the cohort.''.
        (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.--
        (1) In general.--Section 106 of the Food and Drug 
    Administration Amendments Act of 2007 (Public Law 110-85) is 
    repealed.
        (2) Conforming amendment.--The Food and Drug Administration 
    Amendments Act of 2007 (Public Law 110-85) is amended in the table 
    of contents in section 2, by striking the item relating to section 
    106.
    (d) Technical Clarifications.--
        (1) Effective September 30, 2007--
            (A) section 509 of the Prescription Drug User Fee 
        Amendments Act of 2002 (Title V of Public Law 107-188) is 
        repealed; and
            (B) the Public Health Security and Bioterrorism 
        Preparedness and Response Act of 2002 (Public Law 107-188) is 
        amended in the table of contents in section 1(b), by striking 
        the item relating to section 509.
        (2) Effective September 30, 2002--
            (A) section 107 of the Food and Drug Administration 
        Modernization Act of 1997 (Public Law 105-115) is repealed; and
            (B) the table of contents in section 1(c) of such Act is 
        amended by striking the item related to section 107.
        (3) Effective September 30, 1997, section 105 of the 
    Prescription Drug User Fee Act of 1992 (Public Law 102-571) is 
    repealed.
    SEC. 106. EFFECTIVE DATE.
    The amendments made by this title shall take effect on October 1, 
2012, or the date of the enactment of this Act, whichever is later, 
except that fees under part 2 of subchapter C of chapter VII of the 
Federal Food, Drug, and Cosmetic Act shall be assessed for all human 
drug applications received on or after October 1, 2012, regardless of 
the date of the enactment of this Act.
    SEC. 107. SAVINGS CLAUSE.
    Notwithstanding the amendments made by this title, part 2 of 
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic 
Act, as in effect on the day before the date of the enactment of this 
title, shall continue to be in effect with respect to human drug 
applications and supplements (as defined in such part as of such day) 
that on or after October 1, 2007, but before October 1, 2012, were 
accepted by the Food and Drug Administration for filing with respect to 
assessing and collecting any fee required by such part for a fiscal 
year prior to fiscal year 2012.

                   TITLE II--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), by inserting ``and subsection 
        (f)'' after ``subparagraph (B)''; and
            (B) in subparagraph (C), by striking ``initial 
        registration'' and all that follows through ``section 510.'' 
        and inserting ``later of--
                ``(i) the initial or annual registration (as 
            applicable) of the establishment under section 510; or
                ``(ii) the first business day after the date of 
            enactment of an appropriations Act providing for the 
            collection and obligation of fees for such year under this 
            section.''.
    (b) Fee Amounts.--Section 738(b) (21 U.S.C. 379j(b)) is amended to 
read as follows:
    ``(b) Fee Amounts.--
        ``(1) In general.--Subject to subsections (c), (d), (e), (f), 
    and (i), for each of fiscal years 2013 through 2017, fees under 
    subsection (a) shall be derived from the base fee amounts specified 
    in paragraph (2), to generate the total revenue amounts specified 
    in paragraph (3).
        ``(2) Base fee amounts specified.--For purposes of paragraph 
    (1), the base fee amounts specified in this paragraph are as 
    follows:

----------------------------------------------------------------------------------------------------------------
                                                             Fiscal     Fiscal     Fiscal     Fiscal     Fiscal
                        ``Fee Type                         Year 2013  Year 2014  Year 2015  Year 2016  Year 2017
----------------------------------------------------------------------------------------------------------------
Premarket Application....................................   $248,000   $252,960   $258,019   $263,180   $268,443
Establishment Registration...............................     $2,575     $3,200     $3,750     $3,872     $3,872
----------------------------------------------------------------------------------------------------------------

        ``(3) Total revenue amounts specified.--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) Performance Reports.--Section 738A(a) (21 U.S.C. 379j-1(a)) is 
amended--
        (1) by striking paragraph (1) and inserting the following:
        ``(1) Performance report.--
            ``(A) In general.--Beginning with fiscal year 2013, for 
        each fiscal year for which fees are collected under this part, 
        the Secretary shall prepare and submit to the Committee on 
        Health, Education, Labor, and Pensions of the Senate and the 
        Committee on Energy and Commerce of the House of 
        Representatives annual reports concerning the progress of the 
        Food and Drug Administration in achieving the goals identified 
        in the letters described in section 201(b) of the Medical 
        Device User Fee Amendments of 2012 during such fiscal year and 
        the future plans of the Food and Drug Administration for 
        meeting the goals.
            ``(B) Publication.--With regard to information to be 
        reported by the Food and Drug Administration to industry on a 
        quarterly and annual basis pursuant to the letters described in 
        section 201(b) of the Medical Device User Fee Amendments Act of 
        2012, the Secretary shall make such information publicly 
        available on the Internet Web site of the Food and Drug 
        Administration not later than 60 days after the end of each 
        quarter or 120 days after the end of each fiscal year, 
        respectively, to which such information applies. This 
        information shall include the status of the independent 
        assessment identified in the letters described in such section 
        201(b).
            ``(C) Updates.--The Secretary shall include in each report 
        under subparagraph (A) information on all previous cohorts for 
        which the Secretary has not given a complete response on all 
        device premarket applications and reports, supplements, and 
        premarket notifications in the cohort.''; and
        (2) in paragraph (2), by striking ``2008 through 2012'' and 
    inserting ``2013 through 2017''.
    SEC. 205. SAVINGS CLAUSE.
    Notwithstanding the amendments made by this title, part 3 of 
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379i et seq.), as in effect on the day before the date of 
the enactment of this title, shall continue to be in effect with 
respect to the submissions listed in section 738(a)(2)(A) of such Act 
(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 all 
submissions listed in section 738(a)(2)(A) of such Act received on or 
after October 1, 2012, regardless of the date of the enactment of this 
Act.
    SEC. 207. SUNSET CLAUSE.
    (a) In General.--Sections 737 and 738 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 739i; 739j) shall cease to be effective 
October 1, 2017. Section 738A (21 U.S.C. 739j-1) of the Federal Food, 
Drug, and Cosmetic Act (regarding reauthorization and reporting 
requirements) shall cease to be effective January 31, 2018.
    (b) Previous Sunset Provision.--
        (1) In general.--Section 217 of the Food and Drug 
    Administration Amendments Act of 2007 (Title II of Public Law 110-
    85) is repealed.
        (2) Conforming amendment.--The Food and Drug Administration 
    Amendments Act of 2007 (Public Law 110-85) is amended in the table 
    of contents in section 2, by striking the item relating to section 
    217.
    (c) Technical Clarification.--Effective September 30, 2007--
        (1) section 107 of the Medical Device User Fee and 
    Modernization Act of 2002 (Public Law 107-250) is repealed; and
        (2) the table of contents in section 1(b) of such Act is 
    amended by striking the item related to section 107.
    SEC. 208. STREAMLINED HIRING AUTHORITY TO SUPPORT ACTIVITIES 
      RELATED TO THE PROCESS FOR THE REVIEW OF DEVICE APPLICATIONS.
    Subchapter A of chapter VII (21 U.S.C. 371 et seq.) is amended by 
inserting after section 713 the following new section:
    ``SEC. 714. STREAMLINED HIRING AUTHORITY.
    ``(a) In General.--In addition to any other personnel authorities 
under other provisions of law, the Secretary may, without regard to the 
provisions of title 5, United States Code, governing appointments in 
the competitive service, appoint employees to positions in the Food and 
Drug Administration to perform, administer, or support activities 
described in subsection (b), if the Secretary determines that such 
appointments are needed to achieve the objectives specified in 
subsection (c).
    ``(b) Activities Described.--The activities described in this 
subsection are activities under this Act related to the process for the 
review of device applications (as defined in section 737(8)).
    ``(c) Objectives Specified.--The objectives specified in this 
subsection are with respect to the activities under subsection (b), 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 3 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) Six percent shall be derived from fees under 
        subsection (a)(2) (relating to drug master files).
            ``(B) Twenty-four 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) Fifty-six 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) Fourteen 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 a publicly available arrears list, such that no new abbreviated 
    new drug applications or supplement submitted on or after October 
    1, 2012, from that person, or any affiliate of that person, will be 
    received within the meaning of section 505(j)(5)(A) until such 
    outstanding fee is paid.
        ``(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 fiscal year 2009 (excluding the amount 
    of fees appropriated for such fiscal year) multiplied by the 
    adjustment factor (as defined in section 744A) applicable to the 
    fiscal year involved.
        ``(2) Authority.--If the Secretary does not assess fees under 
    subsection (a) during any portion of a fiscal year and if at a 
    later date in such fiscal year the Secretary may assess such fees, 
    the Secretary may assess and collect such fees, without any 
    modification in the rate, for Type II active pharmaceutical 
    ingredient drug master files, abbreviated new drug applications and 
    prior approval supplements, and generic drug facilities and active 
    pharmaceutical ingredient facilities at any time in such fiscal 
    year notwithstanding the provisions of subsection (a) relating to 
    the date fees are to be paid.
    ``(i) Crediting and Availability of Fees.--
        ``(1) In general.--Fees authorized under subsection (a) shall 
    be collected and available for obligation only to the extent and in 
    the amount provided in advance in appropriations Acts, subject to 
    paragraph (2). Such fees are authorized to remain available until 
    expended. Such sums as may be necessary may be transferred from the 
    Food and Drug Administration salaries and expenses appropriation 
    account without fiscal year limitation to such appropriation 
    account for salaries and expenses with such fiscal year limitation. 
    The sums transferred shall be available solely for human generic 
    drug activities.
        ``(2) Collections and appropriation acts.--
            ``(A) In general.--The fees authorized by this section--
                ``(i) subject to subparagraphs (C) and (D), shall be 
            collected and available in each fiscal year in an amount 
            not to exceed the amount specified in appropriation Acts, 
            or otherwise made available for obligation for such fiscal 
            year; and
                ``(ii) shall be available for a fiscal year beginning 
            after fiscal year 2012 to defray the costs of human generic 
            drug activities (including such costs for an additional 
            number of full-time equivalent positions in the Department 
            of Health and Human Services to be engaged in such 
            activities), only if the Secretary allocates for such 
            purpose an amount for such fiscal year (excluding amounts 
            from fees collected under this section) no less than 
            $97,000,000 multiplied by the adjustment factor defined in 
            section 744A(3) applicable to the fiscal year involved.
            ``(B) Compliance.--The Secretary shall be considered to 
        have met the requirements of subparagraph (A)(ii) in any fiscal 
        year if the costs funded by appropriations and allocated for 
        human generic activities are not more than 10 percent below the 
        level specified in such subparagraph.
            ``(C) Fee collection during first program year.--Until the 
        date of enactment of an Act making appropriations through 
        September 30, 2013 for the salaries and expenses account of the 
        Food and Drug Administration, fees authorized by this section 
        for fiscal year 2013, may be collected and shall be credited to 
        such account and remain available until expended.
            ``(D) Provision for early payments in subsequent years.--
        Payment of fees authorized under this section for a fiscal year 
        (after fiscal year 2013), prior to the due date for such fees, 
        may be accepted by the Secretary in accordance with authority 
        provided in advance in a prior year appropriations Act.
        ``(3) Authorization of appropriations.--For each of the fiscal 
    years 2013 through 2017, there is authorized to be appropriated for 
    fees under this section an amount equivalent to the total revenue 
    amount determined under subsection (b) for the fiscal year, as 
    adjusted under subsection (c), if applicable, or as otherwise 
    affected under paragraph (2) of this subsection.
    ``(j) Collection of Unpaid Fees.--In any case where the Secretary 
does not receive payment of a fee assessed under subsection (a) within 
30 calendar days after it is due, such fee shall be treated as a claim 
of the United States Government subject to subchapter II of chapter 37 
of title 31, United States Code.
    ``(k) Construction.--This section may not be construed to require 
that the number of full-time equivalent positions in the Department of 
Health and Human Services, for officers, employees, and advisory 
committees not engaged in human generic drug activities, be reduced to 
offset the number of officers, employees, and advisory committees so 
engaged.
    ``(l) Positron Emission Tomography Drugs.--
        ``(1) Exemption from fees.--Submission of an application for a 
    positron emission tomography drug or active pharmaceutical 
    ingredient for a positron emission tomography drug shall not 
    require the payment of any fee under this section. Facilities that 
    solely produce positron emission tomography drugs shall not be 
    required to pay a facility fee as established in subsection (a)(4).
        ``(2) Identification requirement.--Facilities that produce 
    positron emission tomography drugs or active pharmaceutical 
    ingredients of such drugs are required to be identified pursuant to 
    subsection (f).
    ``(m) Disputes Concerning Fees.--To qualify for the return of a fee 
claimed to have been paid in error under this section, a person shall 
submit to the Secretary a written request justifying such return within 
180 calendar days after such fee was paid.
    ``(n) Substantially Complete Applications.--An abbreviated new drug 
application that is not considered to be received within the meaning of 
section 505(j)(5)(A) because of failure to pay an applicable fee under 
this provision within the time period specified in subsection (g) shall 
be deemed not to have been `substantially complete' on the date of its 
submission within the meaning of section 505(j)(5)(B)(iv)(II)(cc). An 
abbreviated new drug application that is not substantially complete on 
the date of its submission solely because of failure to pay an 
applicable fee under the preceding sentence shall be deemed 
substantially complete and received within the meaning of section 
505(j)(5)(A) as of the date such applicable fee is received.''.
    SEC. 303. REAUTHORIZATION; REPORTING REQUIREMENTS.
    Part 7 of subchapter C of chapter VII, as added by section 302 of 
this Act, is amended by inserting after section 744B the following:
``SEC. 744C. REAUTHORIZATION; REPORTING REQUIREMENTS.
    ``(a) Performance Report.--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.--Sections 744A and 744B of the Federal Food, 
Drug, and Cosmetic Act, as added by section 302 of this Act, shall 
cease to be effective October 1, 2017.
    (b) Reporting Requirements.--Section 744C of the Federal Food, 
Drug, and Cosmetic Act, as added by section 303 of this Act, shall 
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 TO SUPPORT ACTIVITIES 
      RELATED TO HUMAN GENERIC DRUGS.
    Section 714, as added by section 208 of this Act, is amended--
        (1) by amending subsection (b) to read as follows:
    ``(b) Activities Described.--The activities described in this 
subsection are--
        ``(1) activities under this Act related to the process for the 
    review of device applications (as defined in section 737(8)); and
        ``(2) activities under this Act related to human generic drug 
    activities (as defined in section 744A).''; and
        (2) by amending subsection (c) to read as follows:
    ``(c) Objectives Specified.--The objectives specified in this 
subsection are--
        ``(1) with respect to the activities under subsection (b)(1), 
    the goals referred to in section 738A(a)(1); and
        ``(2) with respect to the activities under subsection (b)(2), 
    the goals referred to in section 744C(a).''.
    SEC. 308. ADDITIONAL 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) 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.''.

       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 5 miles of 
        each other; and
            ``(ii) at which one or more biosimilar biological products 
        are manufactured in final dosage form.
        ``(B) For purposes of subparagraph (A)(ii), the term 
    `manufactured' does not include packaging.
        ``(8) The term `biosimilar initial advisory meeting'--
            ``(A) means a meeting, if requested, that is limited to--
                ``(i) a general discussion regarding whether licensure 
            under section 351(k) of the Public Health Service Act may 
            be feasible for a particular product; and
                ``(ii) if so, general advice on the expected content of 
            the development program; and
            ``(B) does not include any meeting that involves 
        substantive review of summary data or full study reports.
        ``(9) The term `costs of resources allocated for the process 
    for the review of biosimilar biological product applications' means 
    the expenses in connection with the process for the review of 
    biosimilar biological product applications for--
            ``(A) officers and employees of the Food and Drug 
        Administration, contractors of the Food and Drug 
        Administration, advisory committees, and costs related to such 
        officers employees and committees and to contracts with such 
        contractors;
            ``(B) management of information, and the acquisition, 
        maintenance, and repair of computer resources;
            ``(C) leasing, maintenance, renovation, and repair of 
        facilities and acquisition, maintenance, and repair of 
        fixtures, furniture, scientific equipment, and other necessary 
        materials and supplies; and
            ``(D) collecting fees under section 744H and accounting for 
        resources allocated for the review of submissions in connection 
        with biosimilar biological product development, biosimilar 
        biological product applications, and supplements.
        ``(10) The term `final dosage form' means, with respect to a 
    biosimilar biological product, a finished dosage form which is 
    approved for administration to a patient without substantial 
    further manufacturing (such as lyophilized products before 
    reconstitution).
        ``(11) The term `financial hold'--
            ``(A) means an order issued by the Secretary to prohibit 
        the sponsor of a clinical investigation from continuing the 
        investigation if the Secretary determines that the 
        investigation is intended to support a biosimilar biological 
        product application and the sponsor has failed to pay any fee 
        for the product required under subparagraph (A), (B), or (D) of 
        section 744H(a)(1); and
            ``(B) does not mean that any of the bases for a `clinical 
        hold' under section 505(i)(3) have been determined by the 
        Secretary to exist concerning the investigation.
        ``(12) The term `person' includes an affiliate of such person.
        ``(13) The term `process for the review of biosimilar 
    biological product applications' means the following activities of 
    the Secretary with respect to the review of submissions in 
    connection with biosimilar biological product development, 
    biosimilar biological product applications, and supplements:
            ``(A) The activities necessary for the review of 
        submissions in connection with biosimilar biological product 
        development, biosimilar biological product applications, and 
        supplements.
            ``(B) Actions related to submissions in connection with 
        biosimilar biological product development, the issuance of 
        action letters which approve biosimilar biological product 
        applications or which set forth in detail the specific 
        deficiencies in such applications, and where appropriate, the 
        actions necessary to place such applications in condition for 
        approval.
            ``(C) The inspection of biosimilar biological product 
        establishments and other facilities undertaken as part of the 
        Secretary's review of pending biosimilar biological product 
        applications and supplements.
            ``(D) Activities necessary for the release of lots of 
        biosimilar biological products under section 351(k) of the 
        Public Health Service Act.
            ``(E) Monitoring of research conducted in connection with 
        the review of biosimilar biological product applications.
            ``(F) Postmarket safety activities with respect to 
        biologics approved under biosimilar biological product 
        applications or supplements, including the following 
        activities:
                ``(i) Collecting, developing, and reviewing safety 
            information on biosimilar biological products, including 
            adverse-event reports.
                ``(ii) Developing and using improved adverse-event 
            data-collection systems, including information technology 
            systems.
                ``(iii) Developing and using improved analytical tools 
            to assess potential safety problems, including access to 
            external data bases.
                ``(iv) Implementing and enforcing section 505(o) 
            (relating to postapproval studies and clinical trials and 
            labeling changes) and section 505(p) (relating to risk 
            evaluation and mitigation strategies).
                ``(v) Carrying out section 505(k)(5) (relating to 
            adverse-event reports and postmarket safety activities).
        ``(14) The term `supplement' means a request to the Secretary 
    to approve a change in a biosimilar biological product application 
    which has been approved, including a supplement requesting that the 
    Secretary determine that the biosimilar biological product meets 
    the standards for interchangeability described in section 351(k)(4) 
    of the Public Health Service Act.
``SEC. 744H. AUTHORITY TO ASSESS AND USE BIOSIMILAR BIOLOGICAL PRODUCT 
FEES.
    ``(a) Types of Fees.--Beginning in fiscal year 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, withdrawing the 
            investigational new drug application in accordance with 
            part 312 of title 21, Code of Federal Regulations (or any 
            successor regulations).
            ``(D) Reactivation fee.--
                ``(i) In general.--A person that has discontinued 
            participation in the biosimilar biological product 
            development program for a product under subparagraph (C) 
            shall pay a fee (referred to in this section as 
            `reactivation fee') by the earlier of the following:

                    ``(I) Not later than 5 days after the Secretary 
                grants a request for a biosimilar biological product 
                development meeting for the product (after the date on 
                which such participation was discontinued).
                    ``(II) Upon the date of submission (after the date 
                on which such participation was discontinued) of an 
                investigational new drug application describing an 
                investigation that the Secretary determines is intended 
                to support a biosimilar biological product application 
                for that product.

                ``(ii) Application of annual fee.--A person that pays a 
            reactivation fee for a product shall pay for such product, 
            beginning in the next fiscal year, the annual biosimilar 
            biological product development fee under subparagraph (B).
            ``(E) Effect of failure to pay biosimilar development 
        program fees.--
                ``(i) No biosimilar biological product development 
            meetings.--If a person has failed to pay an initial or 
            annual biosimilar biological product development fee as 
            required under subparagraph (A) or (B), or a reactivation 
            fee as required under subparagraph (D), the Secretary shall 
            not provide a biosimilar biological product development 
            meeting relating to the product for which fees are owed.
                ``(ii) No receipt of investigational new drug 
            applications.--Except in extraordinary circumstances, the 
            Secretary shall not consider an investigational new drug 
            application to have been received under section 505(i)(2) 
            if--

                    ``(I) the Secretary determines that the 
                investigation is intended to support a biosimilar 
                biological product application; and
                    ``(II) the sponsor has failed to pay an initial or 
                annual biosimilar biological product development fee 
                for the product as required under subparagraph (A) or 
                (B), or a reactivation fee as required under 
                subparagraph (D).

                ``(iii) Financial hold.--Notwithstanding section 
            505(i)(2), except in extraordinary circumstances, the 
            Secretary shall prohibit the sponsor of a clinical 
            investigation from continuing the investigation if--

                    ``(I) the Secretary determines that the 
                investigation is intended to support a biosimilar 
                biological product application; and
                    ``(II) the sponsor has failed to pay an initial or 
                annual biosimilar biological product development fee 
                for the product as required under subparagraph (A) or 
                (B), or a reactivation fee for the product as required 
                under subparagraph (D).

                ``(iv) No acceptance of biosimilar biological product 
            applications or supplements.--If a person has failed to pay 
            an initial or annual biosimilar biological product 
            development fee as required under subparagraph (A) or (B), 
            or a reactivation fee as required under subparagraph (D), 
            any biosimilar biological product application or supplement 
            submitted by that person shall be considered incomplete and 
            shall not be accepted for filing by the Secretary until all 
            such fees owed by such person have been paid.
            ``(F) Limits regarding biosimilar development program 
        fees.--
                ``(i) No refunds.--The Secretary shall not refund any 
            initial or annual biosimilar biological product development 
            fee paid under subparagraph (A) or (B), or any reactivation 
            fee paid under subparagraph (D).
                ``(ii) No waivers, exemptions, or reductions.--The 
            Secretary shall not grant a waiver, exemption, or reduction 
            of any initial or annual biosimilar biological product 
            development fee due or payable under subparagraph (A) or 
            (B), or any reactivation fee due or payable under 
            subparagraph (D).
        ``(2) Biosimilar biological product application and supplement 
    fee.--
            ``(A) In general.--Each person that submits, on or after 
        October 1, 2012, a biosimilar biological product application or 
        a supplement shall be subject to the following fees:
                ``(i) A fee for a biosimilar biological product 
            application that is equal to--

                    ``(I) the amount of the fee established under 
                subsection (b)(1)(D) for a biosimilar biological 
                product application for which clinical data (other than 
                comparative bioavailability studies) with respect to 
                safety or effectiveness are required for approval; 
                minus
                    ``(II) the cumulative amount of fees paid, if any, 
                under subparagraphs (A), (B), and (D) of paragraph (1) 
                for the product that is the subject of the application.

                ``(ii) A fee for a biosimilar biological product 
            application for which clinical data (other than comparative 
            bioavailability studies) with respect to safety or 
            effectiveness are not required, that is equal to--

                    ``(I) half of the amount of the fee established 
                under subsection (b)(1)(D) for a biosimilar biological 
                product application; minus
                    ``(II) the cumulative amount of fees paid, if any, 
                under subparagraphs (A), (B), and (D) of paragraph (1) 
                for that product.

                ``(iii) A fee for a supplement for which clinical data 
            (other than comparative bioavailability studies) with 
            respect to safety or effectiveness are required, that is 
            equal to half of the amount of the fee established under 
            subsection (b)(1)(D) for a biosimilar biological product 
            application.
            ``(B) Reduction in fees.--Notwithstanding section 404 of 
        the Biosimilars User Fee Act of 2012, any person who pays a fee 
        under subparagraph (A), (B), or (D) of paragraph (1) for a 
        product before October 1, 2017, but submits a biosimilar 
        biological product application for that product after such 
        date, shall be entitled to the reduction of any biosimilar 
        biological product application fees that may be assessed at the 
        time when such biosimilar biological product application is 
        submitted, by the cumulative amount of fees paid under 
        subparagraphs (A), (B), and (D) of paragraph (1) for that 
        product.
            ``(C) Payment due date.--Any fee required by subparagraph 
        (A) shall be due upon submission of the application or 
        supplement for which such fee applies.
            ``(D) Exception for previously filed application or 
        supplement.--If a biosimilar biological product application or 
        supplement was submitted by a person that paid the fee for such 
        application or supplement, was accepted for filing, and was not 
        approved or was withdrawn (without a waiver), the submission of 
        a biosimilar biological product application or a supplement for 
        the same product by the same person (or the person's licensee, 
        assignee, or successor) shall not be subject to a fee under 
        subparagraph (A).
            ``(E) Refund of application fee if application refused for 
        filing or withdrawn before filing.--The Secretary shall refund 
        75 percent of the fee paid under this paragraph for any 
        application or supplement which is refused for filing or 
        withdrawn without a waiver before filing.
            ``(F) Fees for applications previously refused for filing 
        or withdrawn before filing.--A biosimilar biological product 
        application or supplement that was submitted but was refused 
        for filing, or was withdrawn before being accepted or refused 
        for filing, shall be subject to the full fee under subparagraph 
        (A) upon being resubmitted or filed over protest, unless the 
        fee is waived under subsection (c).
        ``(3) Biosimilar biological product establishment fee.--
            ``(A) In general.--Except as provided in subparagraph (E), 
        each person that is named as the applicant in a biosimilar 
        biological product application shall be assessed an annual fee 
        established under subsection (b)(1)(E) for each biosimilar 
        biological product establishment that is listed in the approved 
        biosimilar biological product application as an establishment 
        that manufactures the biosimilar biological product named in 
        such application.
            ``(B) Assessment in fiscal years.--The establishment fee 
        shall be assessed in each fiscal year for which the biosimilar 
        biological product named in the application is assessed a fee 
        under paragraph (4) unless the biosimilar biological product 
        establishment listed in the application does not engage in the 
        manufacture of the biosimilar biological product during such 
        fiscal year.
            ``(C) Due date.--The establishment fee for a fiscal year 
        shall be due on the later of--
                ``(i) the first business day on or after October 1 of 
            such fiscal year; or
                ``(ii) the first business day after the enactment of an 
            appropriations Act providing for the collection and 
            obligation of fees for such fiscal year under this section.
            ``(D) Application to establishment.--
                ``(i) Each biosimilar biological product establishment 
            shall be assessed only one fee per biosimilar biological 
            product establishment, notwithstanding the number of 
            biosimilar biological products manufactured at the 
            establishment, subject to clause (ii).
                ``(ii) In the event an establishment is listed in a 
            biosimilar biological product application by more than one 
            applicant, the establishment fee for the fiscal year shall 
            be divided equally and assessed among the applicants whose 
            biosimilar biological products are manufactured by the 
            establishment during the fiscal year and assessed 
            biosimilar biological product fees under paragraph (4).
            ``(E) Exception for new products.--If, during the fiscal 
        year, an applicant initiates or causes to be initiated the 
        manufacture of a biosimilar biological product at an 
        establishment listed in its biosimilar biological product 
        application--
                ``(i) that did not manufacture the biosimilar 
            biological product in the previous fiscal year; and
                ``(ii) for which the full biosimilar biological product 
            establishment fee has been assessed in the fiscal year at a 
            time before manufacture of the biosimilar biological 
            product was begun,
        the applicant shall not be assessed a share of the biosimilar 
        biological product establishment fee for the fiscal year in 
        which the manufacture of the product began.
        ``(4) Biosimilar biological product fee.--
            ``(A) In general.--Each person who is named as the 
        applicant in a biosimilar biological product application shall 
        pay for each such biosimilar biological product the annual fee 
        established under subsection (b)(1)(F).
            ``(B) Due date.--The biosimilar biological product fee for 
        a fiscal year shall be due on the later of--
                ``(i) the first business day on or after October 1 of 
            each such year; or
                ``(ii) the first business day after the enactment of an 
            appropriations Act providing for the collection and 
            obligation of fees for such year under this section.
            ``(C) One fee per product per year.--The biosimilar 
        biological product fee shall be paid only once for each product 
        for each fiscal year.
    ``(b) Fee Setting and Amounts.--
        ``(1) In general.--Subject to paragraph (2), the Secretary 
    shall, 60 days before the start of each fiscal year that begins 
    after September 30, 2012, establish, for the next fiscal year, the 
    fees under subsection (a). Except as provided in subsection (c), 
    such fees shall be in the following amounts:
            ``(A) Initial biosimilar biological product development 
        fee.--The initial biosimilar biological product development fee 
        under subsection (a)(1)(A) for a fiscal year shall be equal to 
        10 percent of the amount established under section 736(c)(4) 
        for a human drug application described in section 
        736(a)(1)(A)(i) for that fiscal year.
            ``(B) Annual biosimilar biological product development 
        fee.--The annual biosimilar biological product development fee 
        under subsection (a)(1)(B) for a fiscal year shall be equal to 
        10 percent of the amount established under section 736(c)(4) 
        for a human drug application described in section 
        736(a)(1)(A)(i) for that fiscal year.
            ``(C) Reactivation fee.--The reactivation fee under 
        subsection (a)(1)(D) for a fiscal year shall be equal to 20 
        percent of the amount of the fee established under section 
        736(c)(4) for a human drug application described in section 
        736(a)(1)(A)(i) for that fiscal year.
            ``(D) Biosimilar biological product application fee.--The 
        biosimilar biological product application fee under subsection 
        (a)(2) for a fiscal year shall be equal to the amount 
        established under section 736(c)(4) for a human drug 
        application described in section 736(a)(1)(A)(i) for that 
        fiscal year.
            ``(E) Biosimilar biological product establishment fee.--The 
        biosimilar biological product establishment fee under 
        subsection (a)(3) for a fiscal year shall be equal to the 
        amount established under section 736(c)(4) for a prescription 
        drug establishment for that fiscal year.
            ``(F) Biosimilar biological product fee.--The biosimilar 
        biological product fee under subsection (a)(4) for a fiscal 
        year shall be equal to the amount established under section 
        736(c)(4) for a prescription drug product for that fiscal year.
        ``(2) Limit.--The total amount of fees charged for a fiscal 
    year under this section may not exceed the total amount for such 
    fiscal year of the costs of resources allocated for the process for 
    the review of biosimilar biological product applications.
    ``(c) Application Fee Waiver for Small Business.--
        ``(1) Waiver of application fee.--The Secretary shall grant to 
    a person who is named in a biosimilar biological product 
    application a waiver from the application fee assessed to that 
    person under subsection (a)(2)(A) for the first biosimilar 
    biological product application that a small business or its 
    affiliate submits to the Secretary for review. After a small 
    business or its affiliate is granted such a waiver, the small 
    business or its affiliate shall pay--
            ``(A) application fees for all subsequent biosimilar 
        biological product applications submitted to the Secretary for 
        review in the same manner as an entity that is not a small 
        business; and
            ``(B) all supplement fees for all supplements to biosimilar 
        biological product applications submitted to the Secretary for 
        review in the same manner as an entity that is not a small 
        business.
        ``(2) Considerations.--In determining whether to grant a waiver 
    of a fee under paragraph (1), the Secretary shall consider only the 
    circumstances and assets of the applicant involved and any 
    affiliate of the applicant.
        ``(3) Small business defined.--In this subsection, the term 
    `small business' means an entity that has fewer than 500 employees, 
    including employees of affiliates, and does not have a drug product 
    that has been approved under a human drug application (as defined 
    in section 735) or a biosimilar biological product application (as 
    defined in section 744G(4)) and introduced or delivered for 
    introduction into interstate commerce.
    ``(d) Effect of Failure To Pay Fees.--A biosimilar biological 
product application or supplement submitted by a person subject to fees 
under subsection (a) shall be considered incomplete and shall not be 
accepted for filing by the Secretary until all fees owed by such person 
have been paid.
    ``(e) Crediting and Availability of Fees.--
        ``(1) In general.--Subject to paragraph (2), fees authorized 
    under subsection (a) shall be collected and available for 
    obligation only to the extent and in the amount provided in advance 
    in appropriations Acts. Such fees are authorized to remain 
    available until expended. Such sums as may be necessary may be 
    transferred from the Food and Drug Administration salaries and 
    expenses appropriation account without fiscal year limitation to 
    such appropriation account for salaries and expenses with such 
    fiscal year limitation. The sums transferred shall be available 
    solely for the process for the review of biosimilar biological 
    product applications.
        ``(2) Collections and appropriation acts.--
            ``(A) In general.--Subject to subparagraphs (C) and (D), 
        the fees authorized by this section shall be collected and 
        available in each fiscal year in an amount not to exceed the 
        amount specified in appropriation Acts, or otherwise made 
        available for obligation for such fiscal year.
            ``(B) Use of fees and limitation.--The fees authorized by 
        this section shall be available for a fiscal year beginning 
        after fiscal year 2012 to defray the costs of the process for 
        the review of biosimilar biological product applications 
        (including such costs for an additional number of full-time 
        equivalent positions in the Department of Health and Human 
        Services to be engaged in such process), only if the Secretary 
        allocates for such purpose an amount for such fiscal year 
        (excluding amounts from fees collected under this section) no 
        less than $20,000,000, multiplied by the adjustment factor 
        applicable to the fiscal year involved.
            ``(C) Fee collection during first program year.--Until the 
        date of enactment of an Act making appropriations through 
        September 30, 2013, for the salaries and expenses account of 
        the Food and Drug Administration, fees authorized by this 
        section for fiscal year 2013 may be collected and shall be 
        credited to such account and remain available until expended.
            ``(D) Provision for early payments in subsequent years.--
        Payment of fees authorized under this section for a fiscal year 
        (after fiscal year 2013), prior to the due date for such fees, 
        may be accepted by the Secretary in accordance with authority 
        provided in advance in a prior year appropriations Act.
        ``(3) Authorization of appropriations.--For each of fiscal 
    years 2013 through 2017, there is authorized to be appropriated for 
    fees under this section an amount equivalent to the total amount of 
    fees assessed for such fiscal year under this section.
    ``(f) Collection of Unpaid Fees.--In any case where the Secretary 
does not receive payment of a fee assessed under subsection (a) within 
30 days after it is due, such fee shall be treated as a claim of the 
United States Government subject to subchapter II of chapter 37 of 
title 31, United States Code.
    ``(g) Written Requests for Waivers and Refunds.--To qualify for 
consideration for a waiver under subsection (c), or for a refund of any 
fee collected in accordance with subsection (a)(2)(A), a person shall 
submit to the Secretary a written request for such waiver or refund not 
later than 180 days after such fee is due.
    ``(h) Construction.--This section may not be construed to require 
that the number of full-time equivalent positions in the Department of 
Health and Human Services, for officers, employers, and advisory 
committees not engaged in the process of the review of biosimilar 
biological product applications, be reduced to offset the number of 
officers, employees, and advisory committees so engaged.''.
    SEC. 403. REAUTHORIZATION; REPORTING REQUIREMENTS.
    Part 8 of subchapter C of chapter VII, as added by section 402, is 
further amended by inserting after section 744H the following:
``SEC. 744I. REAUTHORIZATION; REPORTING REQUIREMENTS.
    ``(a) Performance Report.--Beginning with fiscal year 2013, not 
later than 120 days after the end of each fiscal year for which fees 
are collected under this part, the Secretary shall prepare and submit 
to the Committee on Energy and Commerce of the House of Representatives 
and the Committee on Health, Education, Labor, and Pensions of the 
Senate a report concerning the progress of the Food and Drug 
Administration in achieving the goals identified in the letters 
described in section 401(b) of the Biosimilar User Fee Act of 2012 
during such fiscal year and the future plans of the Food and Drug 
Administration for meeting such goals. The report for a fiscal year 
shall include information on all previous cohorts for which the 
Secretary has not given a complete response on all biosimilar 
biological product applications and supplements in the cohort.
    ``(b) Fiscal Report.--Not later than 120 days after the end of 
fiscal year 2013 and each subsequent fiscal year for which fees are 
collected under this part, the Secretary shall prepare and submit to 
the Committee on Energy and Commerce of the House of Representatives 
and the Committee on Health, Education, Labor, and Pensions of the 
Senate a report on the implementation of the authority for such fees 
during such fiscal year and the use, by the Food and Drug 
Administration, of the fees collected for such fiscal year.
    ``(c) Public Availability.--The Secretary shall make the reports 
required under subsections (a) and (b) available to the public on the 
Internet Web site of the Food and Drug Administration.
    ``(d) Study.--
        ``(1) In general.--The Secretary shall contract with an 
    independent accounting or consulting firm to study the workload 
    volume and full costs associated with the process for the review of 
    biosimilar biological product applications.
        ``(2) Interim results.--Not later than June 1, 2015, the 
    Secretary shall publish, for public comment, interim results of the 
    study described under paragraph (1).
        ``(3) Final results.--Not later than September 30, 2016, the 
    Secretary shall publish, for public comment, the final results of 
    the study described under paragraph (1).
    ``(e) Reauthorization.--
        ``(1) Consultation.--In developing recommendations to present 
    to the Congress with respect to the goals described in subsection 
    (a), and plans for meeting the goals, for the process for the 
    review of biosimilar biological product applications for the first 
    5 fiscal years after fiscal year 2017, and for the reauthorization 
    of this part for such fiscal years, the Secretary shall consult 
    with--
            ``(A) the Committee on Energy and Commerce of the House of 
        Representatives;
            ``(B) the Committee on Health, Education, Labor, and 
        Pensions of the Senate;
            ``(C) scientific and academic experts;
            ``(D) health care professionals;
            ``(E) representatives of patient and consumer advocacy 
        groups; and
            ``(F) the regulated industry.
        ``(2) Public review of recommendations.--After negotiations 
    with the regulated industry, the Secretary shall--
            ``(A) present the recommendations developed under paragraph 
        (1) to the congressional committees specified in such 
        paragraph;
            ``(B) publish such recommendations in the Federal Register;
            ``(C) provide for a period of 30 days for the public to 
        provide written comments on such recommendations;
            ``(D) hold a meeting at which the public may present its 
        views on such recommendations; and
            ``(E) after consideration of such public views and 
        comments, revise such recommendations as necessary.
        ``(3) Transmittal of recommendations.--Not later than January 
    15, 2017, the Secretary shall transmit to the Congress the revised 
    recommendations under paragraph (2), a summary of the views and 
    comments received under such paragraph, and any changes made to the 
    recommendations in response to such views and comments.''.
    SEC. 404. SUNSET DATES.
    (a) Authorization.--Sections 744G and 744H of the Federal Food, 
Drug, and Cosmetic Act, as added by section 402 of this Act, shall 
cease to be effective October 1, 2017.
    (b) Reporting Requirements.--Section 744I of the Federal Food, 
Drug, and Cosmetic Act, as added by section 403 of this Act, 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)''.
    SEC. 408. ADDITIONAL REPORTING REQUIREMENTS.
    Section 715, as added by section 308 of this Act, is amended by 
adding at the end the following:
    ``(b) 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.''.

                  TITLE V--PEDIATRIC DRUGS AND DEVICES

    SEC. 501. PERMANENCE.
    (a) Pediatric Studies of Drugs.--Section 505A (21 U.S.C. 355a) is 
amended by striking subsection (q) (relating to a sunset).
    (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) In General.--
        (1) 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.''.
        (2) 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)''.
    (b) Neonates.--Subparagraph (A) of section 505A(d)(1) is amended by 
adding at the end the following: ``If a request under this subparagraph 
does not request studies in neonates, such request shall include a 
statement describing the rationale for not requesting studies in 
neonates.''.
    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. 355a, 355c). Such internal standard 
operating procedures shall be made publicly available on the Internet 
Web site 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 Web site 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) by amending clause (ii) to read as follows:
                ``(ii) Public availability.--Not later than 90 days 
            after the submission to the Secretary of the information 
            submitted through the annual review under clause (i), the 
            Secretary shall make available to the public in an easily 
            accessible manner, including through the Internet Web site 
            of the Food and Drug Administration--

                    ``(I) such information;
                    ``(II) the name of the applicant for the product 
                subject to the assessment;
                    ``(III) the date on which the product was approved; 
                and
                    ``(IV) the date of each deferral or deferral 
                extension under this paragraph for the product.''; and

        (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 60 
    calendar days after issuance, with redactions for any trade secrets 
    and confidential commercial information. If the Secretary 
    determines that the letter was issued in error, the requirements of 
    this paragraph shall not apply.
        ``(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 the initial 
        pediatric plan under paragraph (1)--
                ``(i) before the date on which the applicant submits 
            the assessments under subsection (a)(2); and
                ``(ii) not later than--

                    ``(I) 60 calendar days after the date of the end-
                of-Phase 2 meeting (as such term is used in section 
                312.47 of title 21, Code of Federal Regulations, or 
                successor regulations); or
                    ``(II) such other time as may be agreed upon 
                between the Secretary and the applicant.

        Nothing in this section shall preclude the Secretary from 
        accepting the submission of an initial pediatric plan earlier 
        than the date otherwise applicable under this subparagraph.
            ``(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 (7).
            ``(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 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 Date.--
        (1) In general.--Subject to paragraph (2), the amendments made 
    by this section shall take effect 180 calendar days after the date 
    of enactment of this Act, irrespective of whether the Secretary has 
    promulgated final regulations to carry out such amendments.
        (2) Rule of construction.--Paragraph (1) shall not be construed 
    to affect the deadline for promulgation of proposed regulations 
    under section 505B(e)(7) of the Federal Food, Drug, and Cosmetic 
    Act, as added by subsection (a) of this section.
    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 ``during the five-year period beginning on the date of the 
enactment of the Best Pharmaceuticals for Children Act of 2007'' and 
inserting ``to carry out the advisory committee's responsibilities 
under sections 505A, 505B, and 520(m) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355a, 355c, and 360j(m))''.
    (b) Pediatric Subcommittee of the Oncologic Drugs Advisory 
Committee.--Section 15(a)(3) 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 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) 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 2013 through 2017.''.
    SEC. 508. REPORT.
    (a) In General.--Not later than four years after the date of 
enactment of this Act and every five years thereafter, 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, and make publicly available, including 
through posting on the Internet Web site of the Food and Drug 
Administration, a report on the implementation of sections 505A and 
505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 
355c).
    (b) Contents.--Each report under subsection (a) shall include--
        (1) an assessment of the effectiveness of sections 505A and 
    505B of the Federal Food, Drug, and Cosmetic Act in improving 
    information about pediatric uses for approved drugs and biological 
    products, including the number and type of labeling changes made 
    since the date of enactment of this Act and the importance of such 
    uses 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 505B, 
    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) an assessment of the timeliness and effectiveness of 
    pediatric study planning since the date of enactment of this Act, 
    including the number of initial pediatric study plans not submitted 
    in accordance with the requirements of subsection (e) of such 
    section 505B and any resulting rulemaking;
        (4) the number of written requests issued, accepted, and 
    declined under such section 505A since the date of enactment of 
    this Act, and a listing of any important gaps in pediatric 
    information as a result of such declined requests;
        (5) a description and current status of referrals made under 
    subsection (n) of such section 505A;
        (6) an assessment of the effectiveness of studying biological 
    products in pediatric populations under such sections 505A and 505B 
    and section 409I of the Public Health Service Act (42 U.S.C. 284m);
        (7)(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;
        (8)(A) the number and importance of drugs and biological 
    products for children with cancer that are being tested as a result 
    of the programs under such sections 505A and 505B and under section 
    409I of the Public Health Service Act; 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;
        (9) any recommendations for modification to such programs that 
    would improve pediatric drug research and increase pediatric 
    labeling of drugs and biological products;
        (10) an assessment of the successes of and limitations to 
    studying drugs for rare diseases under such sections 505A and 505B; 
    and
        (11) an assessment of the Secretary's efforts to address the 
    suggestions and options described in any prior report issued by the 
    Comptroller General, Institute of Medicine, or the Secretary, and 
    any subsequent reports, including recommendations therein, 
    regarding the topics addressed in the reports 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.
    (c) Stakeholder Comment.--At least 180 days prior to the submission 
of each report under subsection (a), the Secretary shall consult with 
representatives of patient groups (including pediatric patient groups), 
consumer groups, regulated industry, academia, and other interested 
parties to obtain any recommendations or information relevant to the 
report including suggestions for modifications that would improve 
pediatric drug research and pediatric labeling of drugs and biological 
products.
    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 (l)--
            (A) in paragraph (1)--
                (i) in the paragraph heading, by striking ``year one'' 
            and inserting ``first 18-month period''; and
                (ii) by striking ``one-year'' and inserting ``18-
            month'';
            (B) in paragraph (2)--
                (i) in the paragraph heading, by striking ``years'' and 
            inserting ``periods''; and
                (ii) by striking ``one-year period'' and inserting 
            ``18-month period'';
            (C) by redesignating paragraph (3) as paragraph (4); and
            (D) by inserting after paragraph (2) the following:
        ``(3) Preservation of authority.--Nothing in this subsection 
    shall prohibit the Office of Pediatric Therapeutics from providing 
    for the review of adverse event reports by the Pediatric Advisory 
    Committee prior to the 18-month period referred to in paragraph 
    (1), if such review is necessary to ensure safe use of a drug in a 
    pediatric population.'';
        (3) 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
        (4) in subsection (o)(2), by amending subparagraph (B) to read 
    as follows:
            ``(B) a statement of any appropriate pediatric 
        contraindications, warnings, precautions, or other information 
        that the Secretary considers necessary to assure safe use.''.
    (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), in the matter before subparagraph 
        (A), by inserting ``for a drug'' after ``(or supplement to an 
        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'';
        (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,''; and
        (5) in subsection (i)--
            (A) in paragraph (1)--
                (i) in the paragraph heading, by striking ``year one'' 
            and inserting ``first 18-month period''; and
                (ii) by striking ``one-year'' and inserting ``18-
            month'';
            (B) in paragraph (2)--
                (i) in the paragraph heading, by striking ``years'' and 
            inserting ``periods''; and
                (ii) by striking ``one-year period'' and inserting 
            ``18-month period'';
            (C) by redesignating paragraph (3) as paragraph (4); and
            (D) by inserting after paragraph (2) the following:
        ``(3) Preservation of authority.--Nothing in this subsection 
    shall prohibit the Office of Pediatric Therapeutics from providing 
    for the review of adverse event reports by the Pediatric Advisory 
    Committee prior to the 18-month period referred to in paragraph 
    (1), if such review is necessary to ensure safe use of a drug in a 
    pediatric population.''.
    (c) Internal Committee for Review of Pediatric Plans, Assessments, 
Deferrals, Deferral Extensions, and Waivers.--Section 505C (21 U.S.C. 
355d) is amended--
        (1) in the section heading, by inserting ``deferral 
    extensions,'' after ``deferrals,''; and
        (2) by inserting ``neonatology,'' after ``pediatric ethics,''.
    (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'';
            (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; Transition Rule.--
        (1) Application.--Notwithstanding any provision of section 505A 
    and 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
    355a, 355c) stating that a provision applies beginning on the date 
    of the enactment of the Best Pharmaceuticals for Children Act of 
    2007 or the date of the enactment of the Pediatric Research Equity 
    Act of 2007, any amendment made by this Act to such a provision 
    applies beginning on the date of the enactment of this Act.
        (2) Transitional rule for adverse event reporting.--With 
    respect to a drug for which a labeling change described under 
    section 505A(l)(1) or 505B(i)(1) of the Federal Food, Drug, and 
    Cosmetic Act (21 U.S.C. 355a(l)(1); 355c(i)(1)) is approved or 
    made, respectively, during the one-year period that ends on the day 
    before the date of enactment of this Act, the Secretary shall apply 
    section 505A(l) and section 505B(i), as applicable, to such drug, 
    as such sections were in effect on such day.
    SEC. 510. PEDIATRIC RARE DISEASES.
    (a) Public Meeting.--Not later than 18 months after the date of 
enactment of this Act, the Secretary shall hold at least one 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.
    SEC. 511. STAFF OF OFFICE OF PEDIATRIC THERAPEUTICS.
    Section 6 of the Best Pharmaceuticals for Children Act (21 U.S.C. 
393a) is amended--
        (1) in subsection (c)--
            (A) in paragraph (1), by striking ``and'' at the end;
            (B) by redesignating paragraph (2) as paragraph (4); and
            (C) by inserting after paragraph (1) the following:
        ``(2) subject to subsection (d), one or more additional 
    individuals with necessary expertise in a pediatric subpopulation 
    that is, as determined through consideration of the reports and 
    recommendations issued by the Institute of Medicine and the 
    Comptroller General of the United States, less likely to be studied 
    as a part of a written request issued under section 505A of the 
    Federal Food, Drug, and Cosmetic Act or an assessment under section 
    505B of such Act;
        ``(3) one or more additional individuals with expertise in 
    pediatric epidemiology; and''; and
        (2) by adding at the end the following:
    ``(d) Neonatology Expertise.--For the 5-year period beginning on 
the date of enactment of this subsection, at least one of the 
individuals described in subsection (c)(2) shall have expertise in 
neonatology.''.

            TITLE VI--MEDICAL DEVICE REGULATORY IMPROVEMENTS

    SEC. 601. INVESTIGATIONAL DEVICE EXEMPTIONS.
    Section 520(g) (21 U.S.C. 360j(g)) is amended--
        (1) in paragraph (2)(B)(ii), by inserting ``safety or 
    effectiveness'' before ``data obtained''; and
        (2) in paragraph (4), by adding at the end the following:
    ``(C) Consistent with paragraph (1), the Secretary shall not 
disapprove an application under this subsection because the Secretary 
determines that--
        ``(i) the investigation may not support a substantial 
    equivalence or de novo classification determination or approval of 
    the device;
        ``(ii) the investigation may not meet a requirement, including 
    a data requirement, relating to the approval or clearance of a 
    device; or
        ``(iii) an additional or different investigation may be 
    necessary to support clearance or approval of the device.''.
    SEC. 602. 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. 603. AGENCY DOCUMENTATION AND REVIEW OF SIGNIFICANT DECISIONS.
    Chapter V is amended by inserting after section 517 (21 U.S.C. 
360g) the following:
``SEC. 517A. AGENCY DOCUMENTATION AND REVIEW OF SIGNIFICANT DECISIONS 
REGARDING DEVICES.
    ``(a) Documentation of Rationale for Significant Decisions.--
        ``(1) In general.--The Secretary shall provide a substantive 
    summary of the scientific and regulatory rationale for any 
    significant decision of the Center for Devices and Radiological 
    Health regarding submission or review of a report under section 
    510(k), an application under section 515, or an application for an 
    exemption under section 520(g), including documentation of 
    significant controversies or differences of opinion and the 
    resolution of such controversies or differences of opinion.
        ``(2) Provision of documentation.--Upon request, the Secretary 
    shall furnish such substantive summary to the person who is seeking 
    to submit, or who has submitted, such report or application.
    ``(b) Review of Significant Decisions.--
        ``(1) Request for supervisory review of significant decision.--
    Any person may request a supervisory review of the significant 
    decision described in subsection (a)(1). Such review may be 
    conducted at the next supervisory level or higher above the 
    individual who made the significant decision.
        ``(2) Submission of request.--A person requesting a supervisory 
    review under paragraph (1) shall submit such request to the 
    Secretary not later than 30 days after such decision and shall 
    indicate in the request whether such person seeks an in-person 
    meeting or a teleconference review.
        ``(3) Timeframe.--
            ``(A) In general.--Except as provided in subparagraph (B), 
        the Secretary shall schedule an in-person or teleconference 
        review, if so requested, not later than 30 days after such 
        request is made. The Secretary shall issue a decision to the 
        person requesting a review under this subsection not later than 
        45 days after the request is made under paragraph (1), or, in 
        the case of a person who requests an in-person meeting or 
        teleconference, 30 days after such meeting or teleconference.
            ``(B) Exception.--Subparagraph (A) shall not apply in cases 
        that are referred to experts outside of the Food and Drug 
        Administration.''.
    SEC. 604. DEVICE MODIFICATIONS REQUIRING PREMARKET NOTIFICATION 
      PRIOR TO MARKETING.
    Section 510(n) (21 U.S.C. 360(n)) is amended by--
        (1) striking ``(n) The Secretary'' and inserting ``(n)(1) The 
    Secretary''; and
        (2) by adding at the end the following:
        ``(2)(A) Not later than 18 months after the date of enactment 
    of this paragraph, the Secretary shall submit to the Committee on 
    Energy and Commerce of the House of Representatives and the 
    Committee on Health, Education, Labor, and Pensions of the Senate a 
    report regarding when a premarket notification under subsection (k) 
    should be submitted for a modification or change to a legally 
    marketed device. The report shall include the Secretary's 
    interpretation of the following terms: `could significantly affect 
    the safety or effectiveness of the device', `a significant change 
    or modification in design, material, chemical composition, energy 
    source, or manufacturing process', and `major change or 
    modification in the intended use of the device'. The report also 
    shall discuss possible processes for industry to use to determine 
    whether a new submission under subsection (k) is required and shall 
    analyze how to leverage existing quality system requirements to 
    reduce premarket burden, facilitate continual device improvement, 
    and provide reasonable assurance of safety and effectiveness of 
    modified devices. In developing such report, the Secretary shall 
    consider the input of interested stakeholders.
        ``(B) The Secretary shall withdraw the Food and Drug 
    Administration draft guidance entitled `Guidance for Industry and 
    FDA Staff--510(k) Device Modifications: Deciding When to Submit a 
    510(k) for a Change to an Existing Device', dated July 27, 2011, 
    and shall not use this draft guidance as part of, or for the basis 
    of, any premarket review or any compliance or enforcement decisions 
    or actions. The Secretary shall not issue--
            ``(i) any draft guidance or proposed regulation that 
        addresses when to submit a premarket notification submission 
        for changes and modifications made to a manufacturer's 
        previously cleared device before the receipt by the Committee 
        on Energy and Commerce of the House of Representatives and the 
        Committee on Health, Education, Labor, and Pensions of the 
        Senate of the report required in subparagraph (A); and
            ``(ii) any final guidance or regulation on that topic for 
        one year after date of receipt of such report by the Committee 
        on Energy and Commerce of the House of Representatives and the 
        Committee on Health, Education, Labor, and Pensions of the 
        Senate.
        ``(C) The Food and Drug Administration guidance entitled 
    `Deciding When to Submit a 510(k) for a Change to an Existing 
    Device', dated January 10, 1997, shall be in effect until the 
    subsequent issuance of guidance or promulgation, if appropriate, of 
    a regulation described in subparagraph (B), and the Secretary shall 
    interpret such guidance in a manner that is consistent with the 
    manner in which the Secretary has interpreted such guidance since 
    1997.''.
    SEC. 605. PROGRAM TO IMPROVE THE DEVICE RECALL SYSTEM.
    Chapter V is amended by inserting after section 518 (21 U.S.C. 
360h) the following:
``SEC. 518A. PROGRAM TO IMPROVE THE DEVICE RECALL SYSTEM.
    ``(a) In General.--The Secretary shall--
        ``(1) establish a program to routinely and systematically 
    assess information relating to device recalls and use such 
    information to proactively identify strategies for mitigating 
    health risks presented by defective or unsafe devices;
        ``(2) clarify procedures for conducting device recall audit 
    checks to improve the ability of investigators to perform those 
    checks in a consistent manner;
        ``(3) develop detailed criteria for assessing whether a person 
    performing a device recall has performed an effective correction or 
    action plan for the recall; and
        ``(4) document the basis for each termination by the Food and 
    Drug Administration of a device recall.
    ``(b) Assessment Content.--The program established under subsection 
(a)(1) shall, at a minimum, identify--
        ``(1) trends in the number and types of device recalls;
        ``(2) devices that are most frequently the subject of a recall; 
    and
        ``(3) underlying causes of device recalls.
    ``(c) Termination of Recalls.--The Secretary shall document the 
basis for the termination by the Food and Drug Administration of a 
device recall.
    ``(d) Definition.--In this section, the term `recall' means--
        ``(1) the removal from the market of a device pursuant to an 
    order of the Secretary under subsection (b) or (e) of section 518; 
    or
        ``(2) the correction or removal from the market of a device at 
    the initiative of the manufacturer or importer of the device that 
    is required to be reported to the Secretary under section 
    519(g).''.
    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. MODIFICATION OF DE NOVO APPLICATION PROCESS.
    (a) In General.--Section 513(f)(2) (21 U.S.C. 360c(f)(2)) is 
amended--
        (1) by inserting ``(i)'' after ``(2)(A)'';
        (2) in subparagraph (A)(i), as so designated by paragraph (1), 
    by striking ``under the criteria set forth'' and all that follows 
    through the end of subparagraph (A) and inserting a period;
        (3) by adding at the end of subparagraph (A) the following:
    ``(ii) In lieu of submitting a report under section 510(k) and 
submitting a request for classification under clause (i) for a device, 
if a person determines there is no legally marketed device upon which 
to base a determination of substantial equivalence (as defined in 
subsection (i)), a person may submit a request under this clause for 
the Secretary to classify the device.
    ``(iii) Upon receipt of a request under clause (i) or (ii), the 
Secretary shall classify the device subject to the request under the 
criteria set forth in subparagraphs (A) through (C) of subsection 
(a)(1) within 120 days.
    ``(iv) Notwithstanding clause (iii), the Secretary may decline to 
undertake a classification request submitted under clause (ii) if the 
Secretary identifies a legally marketed device that could provide a 
reasonable basis for review of substantial equivalence under paragraph 
(1), or when the Secretary determines that the device submitted is not 
of low-moderate risk or that general controls would be inadequate to 
control the risks and special controls to mitigate the risks cannot be 
developed.
    ``(v) The person submitting the request for classification under 
this subparagraph may recommend to the Secretary a classification for 
the device and shall, if recommending classification in class II, 
include in the request an initial draft proposal for applicable special 
controls, as described in subsection (a)(1)(B), that are necessary, in 
conjunction with general controls, to provide reasonable assurance of 
safety and effectiveness and a description of how the special controls 
provide such assurance. Any such request shall describe the device and 
provide detailed information and reasons for the recommended 
classification.''; and
        (4) in subparagraph (B), by striking ``Not later than 60 days 
    after the date of the submission of the request under subparagraph 
    (A), the Secretary'' and inserting ``The Secretary''.
    (b) Conforming Amendments.--Section 513(f) (21 U.S.C. 360c(f)) is 
amended in paragraph (1)--
        (1) in subparagraph (A), by striking ``, or'' at the end and 
    inserting a semicolon;
        (2) in subparagraph (B), by striking the period and inserting 
    ``; or''; and
        (3) by inserting after subparagraph (B) the following:
        ``(C) the device is classified pursuant to a request submitted 
    under paragraph (2).''.
    SEC. 608. 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)(i) Based on new information respecting a device, the 
Secretary may, upon the initiative of the Secretary or upon petition of 
an interested person, change the classification of such device, and 
revoke, on account of the change in classification, any regulation or 
requirement in effect under section 514 or 515 with respect to such 
device, by administrative order published in the Federal Register 
following publication of a proposed reclassification order in the 
Federal Register, a meeting of a device classification panel described 
in subsection (b), and consideration of comments to a public docket, 
notwithstanding subchapter II of chapter 5 of title 5, United States 
Code. The proposed reclassification order published in the Federal 
Register shall set forth the proposed reclassification, and a 
substantive summary of the valid scientific evidence concerning the 
proposed reclassification, including--
        ``(I) the public health benefit of the use of the device, and 
    the nature and, if known, incidence of the risk of the device;
        ``(II) in the case of a reclassification from class II to class 
    III, why general controls pursuant to subsection (a)(1)(A) and 
    special controls pursuant to subsection (a)(1)(B) together are not 
    sufficient to provide a reasonable assurance of safety and 
    effectiveness for such device; and
        ``(III) in the case of reclassification from class III to class 
    II, why general controls pursuant to subsection (a)(1)(A) and 
    special controls pursuant to subsection (a)(1)(B) together are 
    sufficient to provide a reasonable assurance of safety and 
    effectiveness for such device.
    ``(ii) An order under this subsection changing the classification 
of a device from class III to class II may provide that such 
classification shall not take effect until the effective date of a 
performance standard established under section 514 for such device.
    ``(B) Authority to issue such administrative order shall not be 
delegated below the Director of the Center for Devices and Radiological 
Health, acting in consultation with the Commissioner.''.
        (2) 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 Director of the 
                    Center for Devices and Radiological Health, acting 
                    in consultation with the Commissioner.'';
                (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. 609. HARMONIZATION OF DEVICE PREMARKET REVIEW, INSPECTION, AND 
      LABELING SYMBOLS.
    Paragraph (4) of section 803(c) (21 U.S.C. 383(c)) is amended to 
read as follows:
    ``(4) With respect to devices, the Secretary may, when appropriate, 
enter into arrangements with nations regarding methods and approaches 
to harmonizing regulatory requirements for activities, including 
inspections and common international labeling symbols.''.
    SEC. 610. PARTICIPATION IN INTERNATIONAL FORA.
    Paragraph (3) of section 803(c) (21 U.S.C. 383(c)) is amended--
        (1) by striking ``(3)'' and inserting ``(3)(A)''; and
        (2) by adding at the end the following:
    ``(B) In carrying out subparagraph (A), the Secretary may 
participate in appropriate fora, including the International Medical 
Device Regulators Forum, and may--
        ``(i) provide guidance to such fora on strategies, policies, 
    directions, membership, and other activities of a forum as 
    appropriate;
        ``(ii) to the extent appropriate, solicit, review, and consider 
    comments from industry, academia, health care professionals, and 
    patient groups regarding the activities of such fora; and
        ``(iii) to the extent appropriate, inform the public of the 
    Secretary's activities within such fora, and share with the public 
    any documentation relating to a forum's strategies, policies, and 
    other activities of such fora.''.
    SEC. 611. REAUTHORIZATION OF THIRD-PARTY REVIEW.
    (a) Periodic Reaccreditation.--Section 523(b)(2) (21 U.S.C. 
360m(b)(2)) is amended by adding at the end of the following:
            ``(E) Periodic reaccreditation.--
                ``(i) Period.--Subject to suspension or withdrawal 
            under subparagraph (B), any accreditation under this 
            section shall be valid for a period of 3 years after its 
            issuance.
                ``(ii) Response to reaccreditation request.--Upon the 
            submission of a request by an accredited person for 
            reaccreditation under this section, the Secretary shall 
            approve or deny such request not later than 60 days after 
            receipt of the request.
                ``(iii) Criteria.--Not later than 120 days after the 
            date of the enactment of this subparagraph, the Secretary 
            shall establish and publish in the Federal Register 
            criteria to reaccredit or deny reaccreditation to persons 
            under this section. The reaccreditation of persons under 
            this section shall specify the particular activities under 
            subsection (a), and the devices, for which such persons are 
            reaccredited.''.
    (b) Duration of Authority.--Section 523(c) (21 U.S.C. 360m(c)) is 
amended by striking ``October 1, 2012'' and inserting ``October 1, 
2017''.
    SEC. 612. REAUTHORIZATION OF THIRD-PARTY INSPECTION.
    Section 704(g)(11) (21 U.S.C. 374(g)(11)) is amended by striking 
``October 1, 2012'' and inserting ``October 1, 2017''.
    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.
    SEC. 614. 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, taking into account patient access to 
    medical devices and therapies.''.
    SEC. 615. 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 as described in paragraph (1) with 
    respect to devices, the Secretary shall engage outside stakeholders 
    in development of the system, and gather information from outside 
    stakeholders regarding the content of an effective sentinel 
    program, through a public hearing, advisory committee meeting, 
    maintenance of a public docket, or other similar public measures.
        ``(4) Voluntary surveys.--Chapter 35 of title 44, United States 
    Code, shall not apply to the collection of voluntary information 
    from health care providers, such as voluntary surveys or 
    questionnaires, initiated by the Secretary for purposes of 
    postmarket risk identification, mitigation, and analysis for 
    devices.''.
    SEC. 616. 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. 617. 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 of individuals described in clause (i) or (ii) of 
        subparagraph (E); and
            ``(G) may have common, standardized design characteristics, 
        chemical and material compositions, and manufacturing processes 
        as commercially distributed devices.
        ``(2) Limitations.--Paragraph (1) shall apply to a device only 
    if--
            ``(A) such device is for the purpose of treating a 
        sufficiently rare condition, such that conducting clinical 
        investigations on such device would be impractical;
            ``(B) production of such device under paragraph (1) is 
        limited to no more than 5 units per year of a particular device 
        type, provided that such replication otherwise complies with 
        this section; and
            ``(C) the manufacturer of such device notifies the 
        Secretary on an annual basis, in a manner prescribed by the 
        Secretary, of the manufacture of such device.
        ``(3) Guidance.--Not later than 2 years after the date of 
    enactment of this section, the Secretary shall issue final guidance 
    on replication of multiple devices described in paragraph 
    (2)(B).''.
    SEC. 618. HEALTH INFORMATION TECHNOLOGY.
    (a) Report.--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''), acting through the Commissioner of 
Food and Drugs, and in consultation with the National Coordinator for 
Health Information Technology and the Chairman of the Federal 
Communications Commission, shall post on the Internet Web sites of the 
Food and Drug Administration, the Federal Communications Commission, 
and the Office of the National Coordinator for Health Information 
Technology, a report that contains a proposed strategy and 
recommendations on an appropriate, risk-based regulatory framework 
pertaining to health information technology, including mobile medical 
applications, that promotes innovation, protects patient safety, and 
avoids regulatory duplication.
    (b) Working Group.--
        (1) In general.--In carrying out subsection (a), the Secretary 
    may convene a working group of external stakeholders and experts to 
    provide appropriate input on the strategy and recommendations 
    required for the report under subsection (a).
        (2) Representatives.--If the Secretary convenes the working 
    group under paragraph (1), 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 determine the number of 
    representatives participating in the working group, and shall, to 
    the extent practicable, 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, health information technology vendors, small 
    businesses, purchasers, employers, and other stakeholders with 
    relevant expertise, as determined by the Secretary.
    SEC. 619. 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. 620. PEDIATRIC DEVICE CONSORTIA.
    (a) In General.--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 ``$5,250,000 for each of fiscal years 2013 through 
2017''.
    (b) Final Rule Relating To Tracking of Pediatric Uses of Devices.--
The Secretary of Health and Human Services shall issue--
        (1) a proposed rule implementing section 515A(a)(2) of the 
    Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e-1(a)(2)) not 
    later than December 31, 2012; and
        (2) a final rule implementing such section not later than 
    December 31, 2013.

                      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 
        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) by adding at the end the following:
    ``(3) The Secretary shall specify the unique facility identifier 
system that shall be used by registrants under paragraph (1). The 
requirement to include a unique facility identifier in a registration 
under paragraph (1) shall not apply until the date that the identifier 
system is specified by the Secretary under the preceding sentence.''; 
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 of each importer of such drug in the 
        United States that is known to the establishment, and the name 
        of each person who imports or offers for import such drug to 
        the United States for purposes of importation; and
            ``(ii) with respect to devices, the name and place of 
        business of the establishment, the name of the United States 
        agent for the establishment, the name of each importer of such 
        device in the United States that is known to the establishment, 
        and the name of each person who imports or offers for import 
        such device to the United States for purposes of importation; 
        and''; 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 shall specify the unique facility identifier 
system that shall be used by registrants under paragraph (1) with 
respect to drugs. The requirement to include a unique facility 
identifier in a registration under paragraph (1) with respect to drugs 
shall not apply until the date that the identifier system is specified 
by the Secretary under the preceding sentence.''.
    SEC. 703. IDENTIFICATION OF DRUG EXCIPIENT INFORMATION WITH PRODUCT 
      LISTING.
    Section 510(j) (21 U.S.C. 360(j)) is amended--
        (1) in paragraph (1)--
            (A) in subparagraph (C), by striking ``; and'' and 
        inserting a semicolon;
            (B) in subparagraph (D), by striking the period at the end 
        and inserting ``; and''; and
            (C) 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.''; and
        (2) by adding at the end the following:
    ``(4) The Secretary shall require persons subject to this 
subsection to use, for purposes of this subsection, the unique facility 
identifier systems specified under subsections (b)(3) and (i)(4) with 
respect to drugs. Such requirement shall not apply until the date that 
the identifier system under subsection (b)(3) or (i)(4), as applicable, 
is specified by the Secretary.''.
    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.--Registrations and listings''; 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), in any State, 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 inspection frequency and history of the 
        establishment, including whether the establishment has been 
        inspected pursuant to section 704 within the last 4 years.
            ``(E) Whether the establishment has been inspected by a 
        foreign government or an agency of a foreign government 
        recognized under section 809.
            ``(F) Any other criteria deemed necessary and appropriate 
        by the Secretary for purposes of allocating inspection 
        resources.
        ``(5) Effect of status.--In determining the risk associated 
    with an establishment for purposes of establishing a risk-based 
    schedule under paragraph (3), the Secretary shall not consider 
    whether the drugs manufactured, prepared, propagated, compounded, 
    or processed by such establishment are drugs described in section 
    503(b).
        ``(6) Annual report on inspections of establishments.--
    Beginning in 2014, not later than February 1 of each year, the 
    Secretary shall make available on the Internet Web site of the Food 
    and Drug Administration a report regarding--
            ``(A)(i) the number of domestic and foreign establishments 
        registered pursuant to this section in the previous 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).''.
    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 may 
inspect under this section from a person that owns or operates an 
establishment that is engaged in the manufacture, preparation, 
propagation, compounding, or processing of a drug shall, upon the 
request of the Secretary, be provided to the Secretary by such person, 
in advance of or in lieu of an inspection, within a reasonable 
timeframe, within reasonable limits, and in a reasonable manner, and in 
either electronic or physical form, at the expense of such person. The 
Secretary's request shall include a sufficient description of the 
records requested.
    ``(B) Upon receipt of the records requested under subparagraph (A), 
the Secretary shall provide to the person confirmation of receipt.
    ``(C) Nothing in this paragraph supplants the authority of the 
Secretary to conduct inspections otherwise permitted under this Act in 
order to ensure compliance with this Act.''.
    SEC. 707. PROHIBITION AGAINST DELAYING, DENYING, LIMITING, OR 
      REFUSING INSPECTION.
    (a) In General.--Section 501 (21 U.S.C. 351) is amended by adding 
at the end the following:
    ``(j) If it is a drug and it has been manufactured, processed, 
packed, or held in any factory, warehouse, or establishment and the 
owner, operator, or agent of such factory, warehouse, or establishment 
delays, denies, or limits an inspection, or refuses to permit entry or 
inspection.''.
    (b) Guidance.--Not later than 1 year after the date of enactment of 
this section, the Secretary of Health and Human Services shall issue 
guidance that defines the circumstances that would constitute delaying, 
denying, or limiting inspection, or refusing to permit entry or 
inspection, for purposes of section 501(j) of the Federal Food, Drug, 
and Cosmetic Act (as added by subsection (a)).
    SEC. 708. DESTRUCTION OF ADULTERATED, MISBRANDED, OR COUNTERFEIT 
      DRUGS OFFERED FOR IMPORT.
    (a) In General.--The sixth sentence of section 801(a) (21 U.S.C. 
381(a)) is amended by inserting before the period at the end the 
following: ``, except that the Secretary of Health and Human Services 
may destroy, without the opportunity for export, any drug refused 
admission under this section, if such drug is valued at an amount that 
is $2,500 or less (or such higher amount as the Secretary of the 
Treasury may set by regulation pursuant to section 498(a)(1) of the 
Tariff Act of 1930 (19 U.S.C. 1498(a)(1)) and was not brought into 
compliance as described under subsection (b).''.
    (b) Notice.--Subsection (a) of section 801 (21 U.S.C. 381), as 
amended by subsection (a), is further amended by inserting after the 
sixth sentence the following: ``The Secretary of Health and Human 
Services shall issue regulations providing for notice and an 
opportunity to appear before the Secretary of Health and Human Services 
and introduce testimony, as described in the first sentence of this 
subsection, on destruction of a drug under the sixth sentence of this 
subsection. The regulations shall provide that prior to destruction, 
appropriate due process is available to the owner or consignee seeking 
to challenge the decision to destroy the drug. Where the Secretary of 
Health and Human Services provides notice and an opportunity to appear 
and introduce testimony on the destruction of a drug, the Secretary of 
Health and Human Services shall store and, as applicable, dispose of 
the drug after the issuance of the notice, except that the owner and 
consignee shall remain liable for costs pursuant to subsection (c). 
Such process may be combined with the notice and opportunity to appear 
before the Secretary and introduce testimony, as described in the first 
sentence of this subsection, as long as appropriate notice is provided 
to the owner or consignee.''.
    (c) Applicability.--The amendment made by subsection (a) shall 
apply beginning on the effective date of the regulations promulgated 
pursuant to the amendment made by subsection (b).
    (d) Regulations.--
        (1) In general.--Not later than 2 years after the date of 
    enactment of this Act, the Secretary of Health and Human Services 
    shall adopt final regulations implementing the amendments made this 
    section.
        (2) Procedure.--In promulgating a regulation implementing the 
    amendments made by this section, the Secretary of Health and Human 
    Services shall--
            (A) issue a notice of proposed rulemaking that includes a 
        copy of 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 of Health and Human Services shall promulgate 
    regulations implementing the amendments made by this section only 
    as described in paragraph (2).
    SEC. 709. ADMINISTRATIVE DETENTION.
    (a) In General.--Section 304(g) (21 U.S.C. 335a(g)) is amended--
        (1) in paragraph (1), by inserting ``, drug,'' after 
    ``device'', each place it appears;
        (2) in paragraph (2)(A), by inserting ``, drug,'' after ``(B), 
    a device''; and
        (3) in paragraph (2)(B), by inserting ``or drug'' after 
    ``device'' each place it appears.
    (b) Regulations.--
        (1) In general.--Not later than 2 years after the date of the 
    enactment of this Act, the Secretary of Health and Human Services 
    shall promulgate regulations in accordance with section 304(i) of 
    the Federal Food, Drug, and Cosmetic Act, as added by paragraph (2) 
    of this subsection, to implement administrative detention authority 
    with respect to drugs, as authorized by the amendments made by 
    subsection (a). Before promulgating such regulations, the Secretary 
    shall consult with stakeholders, including manufacturers of drugs.
        (2) In general.--Section 304 (21 U.S.C. 334) is amended by 
    adding at the end the following:
    ``(i) Procedures for Promulgating Regulations.--
        ``(1) In general.--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.
        ``(2) Restrictions.--Notwithstanding any other provision of 
    Federal law, in implementing this section, the Secretary shall only 
    promulgate regulations as described in paragraph (1).''.
    (c) Effective Date.--The amendments made by subsection (a) shall 
not take effect until the Secretary has issued a final regulation under 
subsection (b).
    SEC. 710. EXCHANGE OF INFORMATION.
    Section 708 (21 U.S.C. 379) is amended--
        (1) by striking ``confidential information'' and all that 
    follows through ``The Secretary may provide'' and inserting the 
    following:
    ``SEC. 708. CONFIDENTIAL INFORMATION.
    ``(a) Contractors.--The Secretary may provide''; and
        (2) by adding at the end the following:
    ``(b) Ability To Receive and Protect Confidential Information 
Obtained From Foreign Governments.--
        ``(1) In general.--The Secretary shall not be required to 
    disclose under section 552 of title 5, United States Code (commonly 
    referred to as the `Freedom of Information Act'), or any other 
    provision of law, any information relating to drugs obtained from a 
    foreign government agency, if--
            ``(A) the information concerns the inspection of a 
        facility, is part of an investigation, alerts the United States 
        to the potential need for an investigation, or concerns a drug 
        that has a reasonable probability of causing serious adverse 
        health consequences or death to humans or animals;
            ``(B) the information is provided or made available to the 
        United States Government voluntarily on the condition that it 
        not be released to the public; and
            ``(C) the information is covered by, and subject to, a 
        written agreement between the Secretary and the foreign 
        government.
        ``(2) Time limitations.--The written agreement described in 
    paragraph (1)(C) shall specify the time period for which paragraph 
    (1) shall apply to the voluntarily disclosed information.   
    Paragraph (1) shall not apply with respect to such information 
    after the date specified in such agreement, but all other 
    applicable legal protections, including the provisions of section 
    552 of title 5, United States Code, and section 319L(e)(1) of the 
    Public Health Service Act, as applicable, shall continue to apply 
    to such information. If no date is specified in the written 
    agreement, paragraph (1) shall not apply with respect to such 
    information for a period of more than 36 months.
        ``(3) Disclosures not affected.--Nothing in this section 
    authorizes any official to withhold, or to authorize the 
    withholding of, information from Congress or information required 
    to be disclosed pursuant to an order of a court of the United 
    States.
        ``(4) Relation to other law.--For purposes of section 552 of 
    title 5, United States Code, this subsection shall be considered a 
    statute described in subsection (b)(3)(B) of such section 552.
    ``(c) Authority To Enter Into Memoranda of Understanding for 
Purposes of Information Exchange.--The Secretary may enter into written 
agreements to provide information referenced in section 301(j) to 
foreign governments subject to the following criteria:
        ``(1) Certification.--The Secretary may enter into a written 
    agreement to provide information under this subsection to a foreign 
    government only if the Secretary has certified such government as 
    having the authority and demonstrated ability to protect trade 
    secret information from disclosure. Responsibility for this 
    certification shall not be delegated to any officer or employee 
    other than the Commissioner of Food and Drugs.
        ``(2) Written agreement.--The written agreement to provide 
    information to the foreign government 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 only the following 
    circumstances:
            ``(A) Information concerning the inspection of a facility 
        may be provided to a foreign government if--
                ``(i) the Secretary reasonably believes, or the written 
            agreement described in paragraph (2) establishes, that the 
            government has authority to otherwise obtain such 
            information; and
                ``(ii) the written agreement executed under paragraph 
            (2) limits the recipient's use of the information to the 
            recipient's civil regulatory purposes.
            ``(B) Information not described in subparagraph (A) may be 
        provided as part of an investigation, or to alert the foreign 
        government to the potential need for an investigation, if the 
        Secretary has reasonable grounds to believe that a drug has a 
        reasonable probability of causing serious adverse health 
        consequences or death 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. 711. 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 paragraph (a)(2)(B), the term `current good 
manufacturing practice' includes the implementation of oversight and 
controls over the manufacture of drugs to ensure quality, including 
managing the risk of and establishing the safety of raw materials, 
materials used in the manufacturing of drugs, and finished drug 
products.''.
    SEC. 712. RECOGNITION OF FOREIGN GOVERNMENT INSPECTIONS.
    Chapter VIII (21 U.S.C. 381 et seq.) is amended by adding at the 
end the following:
    ``SEC. 809. RECOGNITION OF FOREIGN GOVERNMENT INSPECTIONS.
    ``(a) Inspection.--The Secretary--
        ``(1) may enter into arrangements and agreements with a foreign 
    government or an agency of a foreign government to recognize the 
    inspection of foreign establishments registered under section 
    510(i) in order to facilitate risk-based inspections in accordance 
    with the schedule established in section 510(h)(3);
        ``(2) may enter into arrangements and agreements with a foreign 
    government or an agency of a foreign government under this section 
    only with a foreign government or an agency of a foreign government 
    that the Secretary has determined as having the capability of 
    conduction inspections that meet the applicable requirements of 
    this Act; and
        ``(3) shall perform such reviews and audits of drug safety 
    programs, systems, and standards of a foreign government or agency 
    for the foreign government as the Secretary deems necessary to 
    determine that the foreign government or agency of the foreign 
    government is capable of conducting inspections that meet the 
    applicable requirements of this Act.
    ``(b) Results of Inspection.--The results of inspections performed 
by a foreign government or an agency of a foreign government under this 
section may be used as--
        ``(1) evidence of compliance with section 501(a)(2)(B) or 
    section 801(r); and
        ``(2) for any other purposes as determined appropriate by the 
    Secretary.''.
    SEC. 713. 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, pursuant to the regulations 
promulgated under paragraph (4)(A), 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) through representation by a foreign government, if an 
    inspection is conducted by a foreign government using standards and 
    practices as determined appropriate by the Secretary;
        ``(B) through representation by a foreign government or an 
    agency of a foreign government recognized under section 809; 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 under subparagraph (A), the 
Secretary--
        ``(i) may, as appropriate, take into account differences among 
    importers and types of imports, and, based on the level of risk 
    posed by the imported drug, provide for expedited clearance for 
    those importers that volunteer to participate in partnership 
    programs for highly compliant companies and pass a review of 
    internal controls, including sourcing of foreign manufacturing 
    inputs, and plant inspections; and
        ``(ii) 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. 714. REGISTRATION OF COMMERCIAL IMPORTERS.
    (a) Prohibitions.--Section 301 (21 U.S.C. 331) is amended by adding 
at the end the following:
    ``(aaa) The failure to register in accordance with section 
801(s).''.
    (b) Registration.--Section 801 (21 U.S.C. 381), as amended by 
section 713 of this Act, is further amended by adding at the end the 
following:
    ``(s) Registration of Commercial Importers.--
        ``(1) Registration.--The Secretary shall require a commercial 
    importer of drugs--
            ``(A) to be registered with the Secretary in a form and 
        manner specified by the Secretary; and
            ``(B) subject to paragraph (4), to submit, at the time of 
        registration, a unique identifier for the principal place of 
        business for which the importer is required to register under 
        this subsection.
        ``(2) Regulations.--
            ``(A) In general.--The Secretary, in consultation with the 
        Secretary of Homeland Security acting through U.S. Customs and 
        Border Protection, shall promulgate regulations to establish 
        good importer practices that specify the measures an importer 
        shall take to ensure imported drugs are in compliance with the 
        requirements of this Act and the Public Health Service Act.
            ``(B) Procedure.--In promulgating a regulation under 
        subparagraph (A), 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 regulation's effective date.
            ``(C) Restrictions.--Notwithstanding any other provision of 
        Federal law, in implementing this subsection, the Secretary 
        shall only promulgate regulations as described in subparagraph 
        (B).
        ``(3) Discontinuance of registration.--The Secretary shall 
    discontinue the registration of any commercial importer of drugs 
    that fails to comply with the regulations promulgated under this 
    subsection.
        ``(4) Unique facility identifier.--The Secretary shall specify 
    the unique facility identifier system that shall be used by 
    registrants under paragraph (1). The requirement to include a 
    unique facility identifier in a registration under paragraph (1) 
    shall not apply until the date that the identifier system is 
    specified by the Secretary under the preceding sentence.
        ``(5) Exemptions.--The Secretary, by notice in the Federal 
    Register, may establish exemptions from the requirements of this 
    subsection.''.
    (c) Misbranding.--Section 502(o) (21 U.S.C. 352) is amended by 
inserting ``if it is a drug and was imported or offered for import by a 
commercial importer of drugs not duly registered under section 
801(s),'' after ``not duly registered under section 510,''.
    (d) Regulations.--
        (1) In general.--Not later than 36 months after the date of the 
    enactment of this Act, the Secretary of Health and Human Services, 
    in consultation with the Secretary of Homeland Security acting 
    through U.S. Customs and Border Protection, shall promulgate the 
    regulations required to carry out section 801(s) of the Federal 
    Food, Drug, and Cosmetic Act, as added by subsection (b).
        (2) Procedures for promulgating regulations.--
            (A) In general.--In promulgating a regulation under 
        paragraph (1), 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 regulation's effective date.
            (B) Restrictions.--Notwithstanding any other provision of 
        Federal law, in implementing section 801(s) of the Federal 
        Food, Drug, and Cosmetic Act, as added by subsection (b), the 
        Secretary shall promulgate regulations only as described in 
        subparagraph (A).
        (3) Effective date.--In establishing the effective date of the 
    regulations under paragraph (1), the Secretary of Health and Human 
    Services shall, in consultation with the Secretary of Homeland 
    Security acting through U.S. Customs and Border Protection, as 
    determined appropriate by the Secretary of Health and Human 
    Services, provide a reasonable period of time for an importer of a 
    drug to comply with good importer practices, taking into account 
    differences among importers and types of imports, including based 
    on the level of risk posed by the imported product.
    SEC. 715. NOTIFICATION.
    (a) Prohibited Acts.--Section 301 (21 U.S.C. 331), as amended by 
section 714 of this Act, is further amended by adding at the end the 
following:
    ``(bbb) The failure to notify the Secretary in violation of section 
568.''.
    (b) Notification.--Subchapter E of chapter V (21 U.S.C. 360bbb et 
seq.) is amended by adding at the end the following:
    ``SEC. 568. NOTIFICATION.
    ``(a) Notification to Secretary.--With respect to a drug, the 
Secretary may require notification to the Secretary by a regulated 
person if the regulated person knows--
        ``(1) that the use of such drug in the United States may result 
    in serious injury or death;
        ``(2) of a significant loss or known theft of such drug 
    intended for use in the United States; or
        ``(3) that--
            ``(A) such drug has been or is being counterfeited; and
            ``(B)(i) the counterfeit product is in commerce in the 
        United States or could be reasonably expected to be introduced 
        into commerce in the United States; or
            ``(ii) such drug has been or is being imported into the 
        United States or may reasonably be expected to be offered for 
        import into the United States.
    ``(b) Manner of Notification.--Notification under this section 
shall be made in such manner and by such means as the Secretary may 
specify by regulation or guidance.
    ``(c) Savings Clause.--Nothing in this section shall be construed 
as limiting any other authority of the Secretary to require 
notifications related to a drug under any other provision of this Act 
or the Public Health Service Act.
    ``(d) Definition.--In this section, the term `regulated person' 
means--
        ``(1) a person who is required to register under section 510 or 
    801(s);
        ``(2) a wholesale distributor of a drug product; or
        ``(3) any other person that distributes drugs except a person 
    that distributes drugs exclusively for retail sale.''.
    SEC. 716. 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. 717. PENALTIES FOR COUNTERFEITING DRUGS.
    (a) Counterfeit Drug Penalty Enhancement.--
        (1) Offense.--Section 2320(a) of title 18, United States Code, 
    is amended--
            (A) by striking ``or'' at the end of paragraph (2);
            (B) by inserting ``or'' at the end of paragraph (3);
            (C) by inserting after paragraph (3) the following:
        ``(4) traffics in a counterfeit drug,''; and
            (D) by striking ``through (3)'' and inserting ``through 
        (4)''.
        (2) Penalties.--Section 2320(b)(3) of title 18, United States 
    Code, is amended--
            (A) in the heading, by inserting ``and counterfeit drugs'' 
        after ``services''; and
            (B) by inserting ``or counterfeit drug'' after ``service''.
        (3) Definition.--Section 2320(f) of title 18, United States 
    Code, is amended--
            (A) by striking ``and'' at the end of paragraph (4);
            (B) by striking the period at the end of paragraph (5) and 
        inserting ``; and''; and
            (C) by adding at the end the following:
        ``(6) the term `counterfeit drug' means a drug, as defined by 
    section 201 of the Federal Food, Drug, and Cosmetic Act, that uses 
    a counterfeit mark on or in connection with the drug.''.
        (4) Priority given to certain investigations and 
    prosecutions.--The Attorney General shall give increased priority 
    to efforts to investigate and prosecute offenses under section 2320 
    of title 18, United States Code, that involve counterfeit drugs.
    (b) Sentencing Commission Directive.--
        (1) Directive to sentencing commission.--Pursuant to its 
    authority under section 994(p) of title 28, United States Code, and 
    in accordance with this subsection, the United States Sentencing 
    Commission shall review and amend, if appropriate, its guidelines 
    and its policy statements applicable to persons convicted of an 
    offense described in section 2320(a)(4) of title 18, United States 
    Code, as amended by subsection (a), in order to reflect the intent 
    of Congress that such penalties be increased in comparison to those 
    currently provided by the guidelines and policy statements.
        (2) Requirements.--In carrying out this subsection, the 
    Commission shall--
            (A) ensure that the sentencing guidelines and policy 
        statements reflect the intent of Congress that the guidelines 
        and policy statements reflect the serious nature of the 
        offenses described in paragraph (1) and the need for an 
        effective deterrent and appropriate punishment to prevent such 
        offenses;
            (B) consider the extent to which the guidelines may or may 
        not appropriately account for the potential and actual harm to 
        the public resulting from the offense;
            (C) assure reasonable consistency with other relevant 
        directives and with other sentencing guidelines;
            (D) account for any additional aggravating or mitigating 
        circumstances that might justify exceptions to the generally 
        applicable sentencing ranges;
            (E) make any necessary conforming changes to the sentencing 
        guidelines; and
            (F) assure that the guidelines adequately meet the purposes 
        of sentencing as set forth in section 3553(a)(2) of title 18, 
        United States Code.
    SEC. 718. 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.''.

            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) a product that does not meet the definition of a 
    qualified infectious disease product under subsection (g) based 
    upon its approved uses.
    ``(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, including developing the list of qualifying pathogens 
    described in subsection (f).
        ``(2) Procedure.--In promulgating a regulation implementing 
    this section, the Secretary shall--
            ``(A) issue a notice of proposed rulemaking that includes 
        the proposed regulation;
            ``(B) provide a period of not less than 60 days for 
        comments on the proposed regulation; and
            ``(C) publish the final regulation not less than 30 days 
        before the effective date of the regulation.
        ``(3) Restrictions.--Notwithstanding any other provision of 
    law, the Secretary shall promulgate regulations implementing this 
    section only as described in paragraph (2), except that the 
    Secretary may issue interim guidance for sponsors seeking 
    designation under subsection (d) prior to the promulgation of such 
    regulations.
        ``(4) Designation prior to regulations.--The Secretary shall 
    designate drugs as qualified infectious disease products under 
    subsection (d) prior to the promulgation of regulations under this 
    subsection, if such drugs meet the definition of a qualified 
    infectious disease product described in subsection (g).
    ``(f) Qualifying Pathogen.--
        ``(1) Definition.--In this section, the term `qualifying 
    pathogen' means a pathogen identified and listed by the Secretary 
    under paragraph (2) that has the potential to pose a serious threat 
    to public health, such as--
            ``(A) resistant gram positive pathogens, including 
        methicillin-resistant Staphylococcus aureus, vancomycin-
        resistant Staphylococcus aureus, and vancomycin-resistant 
        enterococcus;
            ``(B) multi-drug resistant gram negative bacteria, 
        including Acinetobacter, Klebsiella, Pseudomonas, and E. coli 
        species;
            ``(C) multi-drug resistant tuberculosis; and
            ``(D) Clostridium difficile.
        ``(2) List of qualifying pathogens.--
            ``(A) In general.--The Secretary shall establish and 
        maintain a list of qualifying pathogens, and shall make public 
        the methodology for developing such list.
            ``(B) Considerations.--In establishing and maintaining the 
        list of pathogens described under this section, the Secretary 
        shall--
                ``(i) consider--

                    ``(I) the impact on the public health due to drug-
                resistant organisms in humans;
                    ``(II) the rate of growth of drug-resistant 
                organisms in humans;
                    ``(III) the increase in resistance rates in humans; 
                and
                    ``(IV) the morbidity and mortality in humans; and

                ``(ii) consult with experts in infectious diseases and 
            antibiotic resistance, including the Centers for Disease 
            Control and Prevention, the Food and Drug Administration, 
            medical professionals, and the clinical research community.
            ``(C) Review.--Every 5 years, or more often as needed, the 
        Secretary shall review, provide modifications to, and publish 
        the list of qualifying pathogens under subparagraph (A) and 
        shall by regulation revise the list as necessary, in accordance 
        with subsection (e).
    ``(g) Qualified Infectious Disease Product.--The term `qualified 
infectious disease product' means an antibacterial or antifungal drug 
for human use intended to treat serious or life-threatening infections, 
including those caused by--
        ``(1) an antibacterial or antifungal resistant pathogen, 
    including novel or emerging infectious pathogens; or
        ``(2) qualifying pathogens listed by the Secretary under 
    subsection (f).''.
    (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) of this Act, 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. 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 microbiological surrogate 
    markers, the use of noninferiority versus superiority trials, trial 
    enrollment, data requirements, and appropriate delta values for 
    noninferiority 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) 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 of this Act.
    SEC. 805. REASSESSMENT OF QUALIFIED INFECTIOUS DISEASE PRODUCT 
      INCENTIVES IN 5 YEARS.
    (a) In General.--Not later than 5 years after the date of enactment 
of this Act, the Secretary of Health and Human Services shall, in 
consultation with the Food and Drug Administration, the Centers for 
Disease Control and Prevention, and other appropriate agencies, submit 
to the Committee on Energy and Commerce of the House of Representatives 
and the Committee on Health, Education, Labor, and Pensions of the 
Senate a report that contains the following:
        (1)(A) The number of initial designations of drugs as qualified 
    infectious disease products under section 505E of the Federal Food, 
    Drug, and Cosmetic Act.
        (B) The number of qualified infectious disease products 
    approved under such section 505E.
        (C) Whether such products address the need for antibacterial 
    and antifungal drugs to treat serious and life-threatening 
    infections.
        (D) 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)).
        (E) The progress made regarding the review and revision of the 
    clinical trial guidance documents required under section 804 and 
    the impact such review and revision has had on the review and 
    approval of qualified infectious disease products.
        (F) The Federal contribution, if any, to funding of the 
    clinical trials for each qualified infectious disease product for 
    each phase.
        (2) Recommendations--
            (A) based on the information under paragraph (1) and any 
        other relevant data, on any changes that should be made to the 
        list of pathogens that are defined as qualifying pathogens 
        under section 505E(f)(2) of the Federal Food, Drug, and 
        Cosmetic Act, as added by section 801 of this Act; and
            (B) on whether any additional program (such as the 
        development of public-private collaborations to advance 
        antibacterial drug innovation) or changes to the incentives 
        under this subtitle may be needed to promote the development of 
        antibacterial drugs.
        (3) An examination of--
            (A) the adoption of programs to measure the use of 
        antibacterial drugs in health care settings; and
            (B) the implementation and effectiveness of antimicrobial 
        stewardship protocols across all health care settings.
        (4) Any recommendations for ways to encourage further 
    development and establishment of stewardship programs.
        (5) A description of the regulatory challenges and impediments 
    to clinical development, approval, and licensure of qualified 
    infectious disease products, and the steps the Secretary has taken 
    and will take to address such challenges and ensure regulatory 
    certainty and predictability with respect to qualified infectious 
    disease products.
    (b) Definition.--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 of this Act.
    SEC. 806. GUIDANCE ON PATHOGEN-FOCUSED ANTIBACTERIAL DRUG 
      DEVELOPMENT.
    (a) Draft Guidance.--Not later than June 30, 2013, in order to 
facilitate the development of antibacterial drugs for serious or life-
threatening bacterial infections, particularly in areas of unmet need, 
the Secretary of Health and Human Services shall publish draft guidance 
that--
        (1) specifies how preclinical and clinical data can be utilized 
    to inform an efficient and streamlined pathogen-focused 
    antibacterial drug development program that meets the approval 
    standards of the Food and Drug Administration; and
        (2) provides advice on approaches for the development of 
    antibacterial drugs that target a more limited spectrum of 
    pathogens.
    (b) Final Guidance.--Not later than December 31, 2014, after notice 
and opportunity for public comment on the draft guidance under 
subsection (a), the Secretary of Health and Human Services shall 
publish final guidance consistent with this section.

               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 postapproval 
        studies to verify and describe the predicted effect on 
        irreversible morbidity or mortality or other clinical benefit.
            ``(B) That the sponsor submit copies of all promotional 
        materials related to the product during the preapproval review 
        period and, following approval and for such period thereafter 
        as the Secretary determines to be appropriate, at least 30 days 
        prior to dissemination of the materials.
        ``(3) Expedited withdrawal of approval.--The Secretary may 
    withdraw approval of a product approved under accelerated approval 
    using expedited procedures (as prescribed by the Secretary in 
    regulations which shall include an opportunity for an informal 
    hearing) if--
            ``(A) the sponsor fails to conduct any required 
        postapproval study of the drug with due diligence;
            ``(B) a study required to verify and describe the predicted 
        effect on irreversible morbidity or mortality or other clinical 
        benefit of the product fails to verify and describe such effect 
        or benefit;
            ``(C) other evidence demonstrates that the product is not 
        safe or effective under the conditions of use; or
            ``(D) the sponsor disseminates false or misleading 
        promotional materials with respect to the product.
    ``(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--
            (A) issue final guidance; and
            (B) amend the regulations governing accelerated approval in 
        parts 314 and 601 of title 21, Code of Federal Regulations, as 
        necessary to conform such regulations with the amendment made 
        by subsection (b).
        (3) Consideration.--In developing the guidance under paragraphs 
    (1) and (2)(A) and the amendments under paragraph (2)(B), the 
    Secretary shall consider how to incorporate novel approaches to the 
    review of surrogate endpoints based on pathophysiologic and 
    pharmacologic evidence in such guidance, especially in instances 
    where the low prevalence of a disease renders the existence or 
    collection of other types of data unlikely or impractical.
        (4) Conforming changes.--The Secretary shall issue, as 
    necessary, conforming amendments to the applicable regulations 
    under title 21, Code of Federal Regulations, governing accelerated 
    approval.
        (5) No effect of inaction on requests.--The issuance (or 
    nonissuance) of guidance or conforming regulations implementing the 
    amendment made by subsection (b) 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 of this Act, 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 nonclinical and clinical data necessary for 
            approval is as efficient as practicable;
                ``(iii) involving senior managers and experienced 
            review staff, as appropriate, in a collaborative, cross-
            disciplinary review;
                ``(iv) assigning a cross-disciplinary project lead for 
            the Food and Drug Administration review team to facilitate 
            an efficient review of the development program and to serve 
            as a scientific liaison between the review team and the 
            sponsor; and
                ``(v) taking steps to ensure that the design of the 
            clinical trials is as efficient as practicable, when 
            scientifically appropriate, such as by minimizing the 
            number of patients exposed to a potentially less 
            efficacious treatment.''; and
        (4) in subsection (f)(1), as so redesignated, by striking 
    ``applicable to accelerated approval'' and inserting ``applicable 
    to breakthrough therapies, accelerated approval, and''.
    (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 this 
            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) 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 715 of this Act, is further amended by adding at the end the 
following:
    ``SEC. 569. CONSULTATION WITH EXTERNAL EXPERTS ON RARE DISEASES, 
      TARGETED THERAPIES, AND GENETIC TARGETING OF TREATMENTS.
    ``(a) In General.--For the purpose of promoting the efficiency of 
and informing the review by the Food and Drug Administration of new 
drugs and biological products for rare diseases and drugs and 
biological products that are genetically targeted, the following shall 
apply:
        ``(1) Consultation with stakeholders.--Consistent with sections 
    X.C and IX.E.4 of the PDUFA Reauthorization Performance Goals and 
    Procedures Fiscal Years 2013 through 2017, as referenced in the 
    letters described in section 101(b) of the Prescription Drug User 
    Fee Amendments of 2012, the Secretary shall ensure that 
    opportunities exist, at a time the Secretary determines 
    appropriate, for consultations with stakeholders on the topics 
    described in subsection (b).
        ``(2) Consultation with external experts.--
            ``(A) In general.--The Secretary shall develop and maintain 
        a list of external experts who, because of their special 
        expertise, are qualified to provide advice on rare disease 
        issues, including topics described in subsection (c). The 
        Secretary may, when appropriate to address a specific 
        regulatory question, consult such external experts on issues 
        related to the review of new drugs and biological products for 
        rare diseases and drugs and biological products that are 
        genetically targeted, including the topics described in 
        subsection (b), when such consultation is necessary because the 
        Secretary lacks the specific scientific, medical, or technical 
        expertise necessary for the performance of the Secretary's 
        regulatory responsibilities and the necessary expertise can be 
        provided by the external experts.
            ``(B) External experts.--For purposes of subparagraph (A), 
        external experts are individuals who possess scientific or 
        medical training that the Secretary lacks with respect to one 
        or more rare diseases.
    ``(b) Topics for Consultation.--Topics for consultation pursuant to 
this section may include--
        ``(1) rare diseases;
        ``(2) the severity of rare diseases;
        ``(3) the unmet medical need associated with rare diseases;
        ``(4) the willingness and ability of individuals with a rare 
    disease to participate in clinical trials;
        ``(5) an assessment of the benefits and risks of therapies to 
    treat rare diseases;
        ``(6) the general design of clinical trials for rare disease 
    populations and subpopulations; and
        ``(7) the demographics and the clinical description of patient 
    populations.
    ``(c) Classification as Special Government Employees.--The external 
experts who are consulted under this section may be considered special 
government employees, as defined under section 202 of title 18, United 
States Code.
    ``(d) Protection of Confidential Information and Trade Secrets.--
        ``(1) Rule of construction.--Nothing in this section shall be 
    construed to alter the protections offered by laws, regulations, 
    and policies governing disclosure of confidential commercial or 
    trade secret information, and any other information exempt from 
    disclosure pursuant to section 552(b) of title 5, United States 
    Code, as such provisions would be applied to consultation with 
    individuals and organizations prior to the date of enactment of 
    this section.
        ``(2) Consent required for disclosure.--The Secretary shall not 
    disclose confidential commercial or trade secret information to an 
    expert consulted under this section without the written consent of 
    the sponsor unless the expert is a special government employee (as 
    defined under section 202 of title 18, United States Code) or the 
    disclosure is otherwise authorized by law.
    ``(e) Other Consultation.--Nothing in this section shall be 
construed to limit the ability of the Secretary to consult with 
individuals and organizations as authorized prior to the date of 
enactment of this section.
    ``(f) No Right or Obligation.--
        ``(1) No right to consultation.--Nothing in this section shall 
    be construed to create a legal right for a consultation on any 
    matter or require the Secretary to meet with any particular expert 
    or stakeholder.
        ``(2) No altering of goals.--Nothing in this section shall be 
    construed to alter agreed upon goals and procedures identified in 
    the letters described in section 101(b) of the Prescription Drug 
    User Fee Amendments of 2012.
        ``(3) No change to number of review cycles.--Nothing in this 
    section is intended to increase the number of review cycles as in 
    effect before the date of enactment of this section.
    ``(g) No Delay in Product Review.--
        ``(1) In general.--Prior to a consultation with an external 
    expert, as described in this section, relating to an 
    investigational new drug application under section 505(i), a new 
    drug application under section 505(b), or a biologics license 
    application under section 351 of the Public Health Service Act, the 
    Director of the Center for Drug Evaluation and Research or the 
    Director of the Center for Biologics Evaluation and Research (or 
    appropriate Division Director), as appropriate, shall determine 
    that--
            ``(A) such consultation will--
                ``(i) facilitate the Secretary's ability to complete 
            the Secretary's review; and
                ``(ii) address outstanding deficiencies in the 
            application; or
            ``(B) the sponsor authorized such consultation.
        ``(2) Limitation.--The requirements of this subsection shall 
    apply only in instances where the consultation is undertaken solely 
    under the authority of this section. The requirements of this 
    subsection shall not apply to any consultation initiated under any 
    other authority.''.
    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-serif 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. GRANTS AND CONTRACTS FOR THE DEVELOPMENT OF ORPHAN DRUGS.
    (a) Qualified Testing Definition.--Section 5(b)(1)(A)(ii) of the 
Orphan Drug Act (21 U.S.C. 360ee(b)(1)(A)(ii)) is amended by striking 
``after the date such drug is designated under section 526 of such Act 
and''.
    (b) Authorization of Appropriations.--Section 5(c) of the Orphan 
Drug Act (21 U.S.C. 360ee(c)) is amended to read as follows:
    ``(c) Authorization of Appropriations.--For grants and contracts 
under subsection (a), there is authorized to be appropriated 
$30,000,000 for each of fiscal years 2013 through 2017.''.
    SEC. 907. REPORTING OF INCLUSION OF DEMOGRAPHIC SUBGROUPS IN 
      CLINICAL TRIALS AND DATA ANALYSIS IN APPLICATIONS FOR DRUGS, 
      BIOLOGICS, AND DEVICES.
    (a) Report.--
        (1) In general.--Not later than 1 year after the date of 
    enactment of this Act, the Secretary, acting through the 
    Commissioner, shall publish on the Internet Web site of the Food 
    and Drug Administration a report, consistent with the regulations 
    of the Food and Drug Administration pertaining to the protection of 
    sponsors' confidential commercial information as of the date of 
    enactment of this Act, addressing the extent to which clinical 
    trial participation and the inclusion of safety and effectiveness 
    data by demographic subgroups including sex, age, race, and 
    ethnicity, is included in applications submitted to the Food and 
    Drug Administration, and shall provide such publication to 
    Congress.
        (2) Contents of report.--The report described in paragraph (1) 
    shall contain the following:
            (A) A description of existing tools to ensure that data to 
        support demographic analyses are submitted in applications for 
        drugs, biological products, and devices, and that these 
        analyses are conducted by applicants consistent with applicable 
        Food and Drug Administration requirements and Guidance for 
        Industry. The report shall address how the Food and Drug 
        Administration makes available information about differences in 
        safety and effectiveness of medical products according to 
        demographic subgroups, such as sex, age, racial, and ethnic 
        subgroups, to health care providers, researchers, and patients.
            (B) An analysis of the extent to which demographic data 
        subset analyses on sex, age, race, and ethnicity is presented 
        in applications for new drug applications for new molecular 
        entities under section 505 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355), in biologics license applications 
        under section 351 of the Public Health Service Act (42 U.S.C. 
        262), and in premarket approval applications under section 515 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e) 
        for products approved or licensed by the Food and Drug 
        Administration, consistent with applicable requirements and 
        Guidance for Industry, and consistent with the regulations of 
        the Food and Drug Administration pertaining to the protection 
        of sponsors' confidential commercial information as of the date 
        of enactment of this Act.
            (C) An analysis of the extent to which demographic 
        subgroups, including sex, age, racial, and ethnic subgroups, 
        are represented in clinical studies to support applications for 
        approved or licensed new molecular entities, biological 
        products, and devices.
            (D) An analysis of the extent to which a summary of product 
        safety and effectiveness data by demographic subgroups 
        including sex, age, race, and ethnicity is readily available to 
        the public in a timely manner by means of the product labeling 
        or the Food and Drug Administration's Internet Web site.
    (b) Action Plan.--
        (1) In general.--Not later than 1 year after the publication of 
    the report described in subsection (a), the Secretary, acting 
    through the Commissioner, shall publish an action plan on the 
    Internet Web site of the Food and Drug Administration, and provide 
    such publication to Congress.
        (2) Content of action plan.--The plan described in paragraph 
    (1) shall include--
            (A) recommendations, as appropriate, to improve the 
        completeness and quality of analyses of data on demographic 
        subgroups in summaries of product safety and effectiveness data 
        and in labeling;
            (B) recommendations, as appropriate, on the inclusion of 
        such data, or the lack of availability of such data in 
        labeling;
            (C) recommendations, as appropriate, to otherwise improve 
        the public availability of such data to patients, health care 
        providers, and researchers; and
            (D) a determination with respect to each recommendation 
        identified in subparagraphs (A) through (C) that distinguishes 
        between product types referenced in subsection (a)(2)(B) 
        insofar as the applicability of each such recommendation to 
        each type of product.
    (c) Definitions.--In this section:
        (1) The term ``Commissioner'' means the Commissioner of Food 
    and Drugs.
        (2) The term ``device'' has the meaning given such term in 
    section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 
    U.S.C. 321(h)).
        (3) The term ``drug'' has the meaning given such term in 
    section 201(g) of the Federal Food, Drug, and Cosmetic Act (21 
    U.S.C. 321(g)).
        (4) The term ``biological product'' has the meaning given such 
    term in section 351(i) of the Public Health Service Act (42 U.S.C. 
    262(i)).
        (5) The term ``Secretary'' means the Secretary of Health and 
    Human Services.
    SEC. 908. RARE PEDIATRIC DISEASE PRIORITY REVIEW VOUCHER INCENTIVE 
      PROGRAM.
    Subchapter B of chapter V (21 U.S.C. 360aa et seq.) is amended by 
adding at the end the following:
    ``SEC. 529. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR RARE 
      PEDIATRIC DISEASES.
    ``(a) Definitions.--In this section:
        ``(1) Priority review.--The term `priority review', with 
    respect to a human drug application as defined in section 735(1), 
    means review and action by the Secretary on such application not 
    later than 6 months after receipt by the Secretary of such 
    application, as described in the Manual of Policies and Procedures 
    of the Food and Drug Administration and goals identified in the 
    letters described in section 101(b) of the Prescription Drug User 
    Fee Amendments of 2012.
        ``(2) Priority review voucher.--The term `priority review 
    voucher' means a voucher issued by the Secretary to the sponsor of 
    a rare pediatric disease product application that entitles the 
    holder of such voucher to priority review of a single human drug 
    application submitted under section 505(b)(1) or section 351(a) of 
    the Public Health Service Act after the date of approval of the 
    rare pediatric disease product application.
        ``(3) Rare pediatric disease.--The term `rare pediatric 
    disease' means a disease that meets each of the following criteria:
            ``(A) The disease primarily affects individuals aged from 
        birth to 18 years, including age groups often called neonates, 
        infants, children, and adolescents.
            ``(B) The disease is a rare disease or condition, within 
        the meaning of section 526.
        ``(4) Rare pediatric disease product application.--The term 
    `rare pediatric disease product application' means a human drug 
    application, as defined in section 735(1), that--
            ``(A) is for a drug or biological product--
                ``(i) that is for the prevention or treatment of a rare 
            pediatric disease; and
                ``(ii) that contains no active ingredient (including 
            any ester or salt of the active ingredient) that has been 
            previously approved in any other application under section 
            505(b)(1), 505(b)(2), or 505(j) of this Act or section 
            351(a) or 351(k) of the Public Health Service Act;
            ``(B) is submitted under section 505(b)(1) of this Act or 
        section 351(a) of the Public Health Service Act;
            ``(C) the Secretary deems eligible for priority review;
            ``(D) that relies on clinical data derived from studies 
        examining a pediatric population and dosages of the drug 
        intended for that population;
            ``(E) that does not seek approval for an adult indication 
        in the original rare pediatric disease product application; and
            ``(F) is approved after the date of the enactment of the 
        Prescription Drug User Fee Amendments of 2012.
    ``(b) Priority Review Voucher.--
        ``(1) In general.--The Secretary shall award a priority review 
    voucher to the sponsor of a rare pediatric disease product 
    application upon approval by the Secretary of such rare pediatric 
    disease product application.
        ``(2) Transferability.--
            ``(A) In general.--The sponsor of a rare pediatric disease 
        product application that receives a priority review voucher 
        under this section may transfer (including by sale) the 
        entitlement to such voucher. There is no limit on the number of 
        times a priority review voucher may be transferred before such 
        voucher is used.
            ``(B) Notification of transfer.--Each person to whom a 
        voucher is transferred shall notify the Secretary of such 
        change in ownership of the voucher not later than 30 days after 
        such transfer.
        ``(3) Limitation.--A sponsor of a rare pediatric disease 
    product application may not receive a priority review voucher under 
    this section if the rare pediatric disease product application was 
    submitted to the Secretary prior to the date that is 90 days after 
    the date of enactment of the Prescription Drug User Fee Amendments 
    of 2012.
        ``(4) Notification.--
            ``(A) In general.--The sponsor of a human drug application 
        shall notify the Secretary not later than 90 days prior to 
        submission of the human drug application that is the subject of 
        a priority review voucher of an intent to submit the human drug 
        application, including the date on which the sponsor intends to 
        submit the application. Such notification shall be a legally 
        binding commitment to pay for the user fee to be assessed in 
        accordance with this section.
            ``(B) Transfer after notice.--The sponsor of a human drug 
        application that provides notification of the intent of such 
        sponsor to use the voucher for the human drug application under 
        subparagraph (A) may transfer the voucher after such 
        notification is provided, if such sponsor has not yet submitted 
        the human drug application described in the notification.
        ``(5) Termination of authority.--The Secretary may not award 
    any priority review vouchers under paragraph (1) after the last day 
    of the 1-year period that begins on the date that the Secretary 
    awards the third rare pediatric disease priority voucher under this 
    section.
    ``(c) Priority Review User Fee.--
        ``(1) In general.--The Secretary shall establish a user fee 
    program under which a sponsor of a human drug application that is 
    the subject of a priority review voucher shall pay to the Secretary 
    a fee determined under paragraph (2). Such fee shall be in addition 
    to any fee required to be submitted by the sponsor under chapter 
    VII.
        ``(2) Fee amount.--The amount of the priority review user fee 
    shall be determined each fiscal year by the Secretary, based on the 
    difference between--
            ``(A) the average cost incurred by the Food and Drug 
        Administration in the review of a human drug application 
        subject to priority review in the previous fiscal year; and
            ``(B) the average cost incurred by the Food and Drug 
        Administration in the review of a human drug application that 
        is not subject to priority review in the previous fiscal year.
        ``(3) Annual fee setting.--The Secretary shall establish, 
    before the beginning of each fiscal year beginning after September 
    30, 2012, the amount of the priority review user fee for that 
    fiscal year.
        ``(4) Payment.--
            ``(A) In general.--The priority review user fee required by 
        this subsection shall be due upon the notification by a sponsor 
        of the intent of such sponsor to use the voucher, as specified 
        in subsection (b)(4)(A). All other user fees associated with 
        the human drug application shall be due as required by the 
        Secretary or under applicable law.
            ``(B) Complete application.--An application described under 
        subparagraph (A) for which the sponsor requests the use of a 
        priority review voucher shall be considered incomplete if the 
        fee required by this subsection and all other applicable user 
        fees are not paid in accordance with the Secretary's procedures 
        for paying such fees.
            ``(C) No waivers, exemptions, reductions, or refunds.--The 
        Secretary may not grant a waiver, exemption, reduction, or 
        refund of any fees due and payable under this section.
        ``(5) Offsetting collections.--Fees collected pursuant to this 
    subsection for any fiscal year--
            ``(A) shall be deposited and credited as offsetting 
        collections to the account providing appropriations to the Food 
        and Drug Administration; and
            ``(B) shall not be collected for any fiscal year except to 
        the extent provided in advance in appropriations Acts.
    ``(d) Designation Process.--
        ``(1) In general.--Upon the request of the manufacturer or the 
    sponsor of a new drug, the Secretary may designate--
            ``(A) the new drug as a drug for a rare pediatric disease; 
        and
            ``(B) the application for the new drug as a rare pediatric 
        disease product application.
        ``(2) Request for designation.--The request for a designation 
    under paragraph (1) shall be made at the same time a request for 
    designation of orphan disease status under section 526 or fast-
    track designation under section 506 is made. Requesting designation 
    under this subsection is not a prerequisite to receiving a priority 
    review voucher under this section.
        ``(3) Determination by secretary.--Not later than 60 days after 
    a request is submitted under paragraph (1), the Secretary shall 
    determine whether--
            ``(A) the disease or condition that is the subject of such 
        request is a rare pediatric disease; and
            ``(B) the application for the new drug is a rare pediatric 
        disease product application.
    ``(e) Marketing of Rare Pediatric Disease Products.--
        ``(1) Revocation.--The Secretary may revoke any priority review 
    voucher awarded under subsection (b) if the rare pediatric disease 
    product for which such voucher was awarded is not marketed in the 
    United States within the 365-day period beginning on the date of 
    the approval of such drug under section 505 of this Act or section 
    351 of the Public Health Service Act.
        ``(2) Postapproval production report.--The sponsor of an 
    approved rare pediatric disease product shall submit a report to 
    the Secretary not later than 5 years after the approval of the 
    applicable rare pediatric disease product application. Such report 
    shall provide the following information, with respect to each of 
    the first 4 years after approval of such product:
            ``(A) The estimated population in the United States 
        suffering from the rare pediatric disease.
            ``(B) The estimated demand in the United States for such 
        rare pediatric disease product.
            ``(C) The actual amount of such rare pediatric disease 
        product distributed in the United States.
    ``(f) Notice and Report.--
        ``(1) Notice of issuance of voucher and approval of products 
    under voucher.--The Secretary shall publish a notice in the Federal 
    Register and on the Internet Web site of the Food and Drug 
    Administration not later than 30 days after the occurrence of each 
    of the following:
            ``(A) The Secretary issues a priority review voucher under 
        this section.
            ``(B) The Secretary approves a drug pursuant to an 
        application submitted under section 505(b) of this Act or 
        section 351(a) of the Public Health Service Act for which the 
        sponsor of the application used a priority review voucher under 
        this section.
        ``(2) Notification.--If, after the last day of the 1-year 
    period that begins on the date that the Secretary awards the third 
    rare pediatric disease priority voucher under this section, a 
    sponsor of an application submitted under section 505(b) of this 
    Act or section 351(a) of the Public Health Service Act for a drug 
    uses a priority review voucher under this section for such 
    application, the Secretary shall submit to the Committee on Energy 
    and Commerce of the House of Representatives and the Committee on 
    Health, Education, Labor, and Pensions of the Senate a document--
            ``(A) notifying such Committees of the use of such voucher; 
        and
            ``(B) identifying the drug for which such priority review 
        voucher is used.
    ``(g) Eligibility for Other Programs.--Nothing in this section 
precludes a sponsor who seeks a priority review voucher under this 
section from participating in any other incentive program, including 
under this Act.
    ``(h) Relation to Other Provisions.--The provisions of this section 
shall supplement, not supplant, any other provisions of this Act or the 
Public Health Service Act that encourage the development of drugs for 
tropical diseases and rare pediatric diseases.
    ``(i) GAO Study and Report.--
        ``(1) Study.--
            ``(A) In general.--Beginning on the date that the Secretary 
        awards the third rare pediatric disease priority voucher under 
        this section, the Comptroller General of the United States 
        shall conduct a study of the effectiveness of awarding rare 
        pediatric disease priority vouchers under this section in the 
        development of human drug products that treat or prevent such 
        diseases.
            ``(B) Contents of study.--In conducting the study under 
        subparagraph (A), the Comptroller General shall examine the 
        following:
                ``(i) The indications for which each rare disease 
            product for which a priority review voucher was awarded was 
            approved under section 505 or section 351 of the Public 
            Health Service Act.
                ``(ii) Whether, and to what extent, an unmet need 
            related to the treatment or prevention of a rare pediatric 
            disease was met through the approval of such a rare disease 
            product.
                ``(iii) The value of the priority review voucher if 
            transferred.
                ``(iv) Identification of each drug for which a priority 
            review voucher was used.
                ``(v) The length of the period of time between the date 
            on which a priority review voucher was awarded and the date 
            on which it was used.
        ``(2) Report.--Not later than 1 year after the date under 
    paragraph (1)(A), the Comptroller General shall submit to the 
    Committee on Energy and Commerce of the House of Representatives 
    and the Committee on Health, Education, Labor, and Pensions of the 
    Senate, a report containing the results of the study under 
    paragraph (1).''.

                        TITLE X--DRUG SHORTAGES

SEC. 1001. DISCONTINUANCE OR INTERRUPTION IN THE PRODUCTION OF LIFE-
SAVING DRUGS.
    (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; or
            ``(C) intended for use in the prevention or treatment of a 
        debilitating disease or condition, including any such drug used 
        in emergency medical care or during surgery; and
        ``(2) that is not a radio pharmaceutical drug product 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 is likely to lead to a 
meaningful disruption in the supply of that drug in the United States, 
and the reasons for such discontinuance or interruption.
    ``(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) Distribution.--To the maximum extent practicable, the 
Secretary shall distribute, through such means as the Secretary deems 
appropriate, information on the discontinuation or interruption of the 
manufacture of the drugs described in subsection (a) to appropriate 
organizations, including physician, health provider, and patient 
organizations, as described in section 506E.
    ``(d) Confidentiality.--Nothing in this section shall be construed 
as authorizing the Secretary to disclose any information that is a 
trade secret or confidential information subject to section 552(b)(4) 
of title 5, United States Code, or section 1905 of title 18, United 
States Code.
    ``(e) Coordination With Attorney General.--Not later than 30 days 
after the receipt of a notification described in subsection (a), the 
Secretary shall--
        ``(1) determine whether the notification pertains to a 
    controlled substance subject to a production quota under section 
    306 of the Controlled Substances Act; and
        ``(2) if necessary, as determined by the Secretary--
            ``(A) notify the Attorney General that the Secretary has 
        received such a notification;
            ``(B) request that the Attorney General increase the 
        aggregate and individual production quotas under section 306 of 
        the Controlled Substances Act applicable to such controlled 
        substance and any ingredient therein to a level the Secretary 
        deems necessary to address a shortage of a controlled substance 
        based on the best available market data; and
            ``(C) if the Attorney General determines that the level 
        requested is not necessary to address a shortage of a 
        controlled substance, the Attorney General shall provide to the 
        Secretary a written response detailing the basis for the 
        Attorney General's determination.
    The Secretary shall make the written response provided under 
    subparagraph (C) available to the public on the Internet Web site 
    of the Food and Drug Administration.
    ``(f) Failure To Meet Requirements.--If a person fails to submit 
information required under subsection (a) in accordance with subsection 
(b)--
        ``(1) the Secretary shall issue a letter to such person 
    informing such person of such failure;
        ``(2) not later than 30 calendar days after the issuance of a 
    letter under paragraph (1), the person who receives such letter 
    shall submit to the Secretary a written response to such letter 
    setting forth the basis for noncompliance and providing information 
    required under subsection (a); and
        ``(3) not later than 45 calendar days after the issuance of a 
    letter under paragraph (1), the Secretary shall make such letter 
    and any response to such letter under paragraph (2) available to 
    the public on the Internet Web site of the Food and Drug 
    Administration, with appropriate redactions made to protect 
    information described in subsection (d), except that, if the 
    Secretary determines that the letter under paragraph (1) was issued 
    in error or, after review of such response, the person had a 
    reasonable basis for not notifying as required under subsection 
    (a), the requirements of this paragraph shall not apply.
    ``(g) 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.
    ``(h) 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 that is subject to section 
        503(b)(1); 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 (i);
        ``(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 affects 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.
    ``(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 a final regulation implementing this 
    section.
        ``(2) Contents.--Such regulation shall define, for purposes of 
    this section, the terms `life-supporting', `life-sustaining', and 
    `intended for use in the prevention or treatment of a debilitating 
    disease or condition'.
        ``(3) 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), including plasma products 
        derived from human plasma protein and their recombinant 
        analogs, if the Secretary determines such inclusion would 
        benefit the public health. Such regulation shall take into 
        account any supply reporting programs and shall aim to reduce 
        duplicative notification.
            ``(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.
        ``(4) 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.
        ``(5) Restrictions.--Notwithstanding any other provision of 
    Federal law, in implementing this section, the Secretary shall only 
    promulgate regulations as described in paragraph (4).''.
    (b) Effect of Notification.--The submission of a notification to 
the Secretary of Health and Human Services (referred to in this title 
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.
SEC. 1002. ANNUAL REPORTING ON DRUG SHORTAGES.
    Chapter V (21 U.S.C. 351 et seq.) is amended by inserting after 
section 506C, as amended by section 1001 of this Act, the following:
``SEC. 506C-1. ANNUAL REPORTING ON DRUG SHORTAGES.
    ``(a) Annual Reports to Congress.--Not later than the end of 
calendar year 2013, and not later than the end of each calendar year 
thereafter, the Secretary shall submit to the Committee on Energy and 
Commerce of the House of Representatives and the Committee on Health, 
Education, Labor, and Pensions of the Senate a report on drug shortages 
that--
        ``(1) specifies the number of manufacturers that submitted a 
    notification to the Secretary under section 506C(a) during such 
    calendar year;
        ``(2) describes the communication between the field 
    investigators of the Food and Drug Administration and the staff of 
    the Center for Drug Evaluation and Research's Office of Compliance 
    and Drug Shortage Program, including the Food and Drug 
    Administration's procedures for enabling and ensuring such 
    communication;
        ``(3)(A) lists the major actions taken by the Secretary to 
    prevent or mitigate the drug shortages described in paragraph (7);
        ``(B) in the list under subparagraph (A), includes--
            ``(i) the number of applications and supplements for which 
        the Secretary expedited review under section 506C(g)(1) during 
        such calendar year; and
            ``(ii) the number of establishment inspections or 
        reinspections that the Secretary expedited under section 
        506C(g)(2) during such calendar year;
        ``(4) describes the coordination between the Food and Drug 
    Administration and the Drug Enforcement Administration on efforts 
    to prevent or alleviate drug shortages;
        ``(5) identifies the number of and describes the instances in 
    which the Food and Drug Administration exercised regulatory 
    flexibility and discretion to prevent or alleviate a drug shortage;
        ``(6) lists the names of manufacturers that were issued letters 
    under section 506C(f); and
        ``(7) specifies the number of drug shortages occurring during 
    such calendar year, as identified by the Secretary.
    ``(b) Trend Analysis.--The Secretary is authorized to retain a 
third party to conduct a study, if the Secretary believes such a study 
would help clarify the causes, trends, or solutions related to drug 
shortages.
    ``(c) Definition.--In this section, the term `drug shortage' or 
`shortage' has the meaning given such term in section 506C.''.
SEC. 1003. COORDINATION; TASK FORCE AND STRATEGIC PLAN.
    Chapter V (21 U.S.C. 351 et seq.) is amended by inserting after 
section 506C-1, as added by section 1002 of this Act, the following:
``SEC. 506D. COORDINATION; TASK FORCE AND STRATEGIC PLAN.
    ``(a) Task Force and Strategic Plan.--
        ``(1) In general.--
            ``(A) Task force.--As soon as practicable after the date of 
        enactment of the Food and Drug Administration Safety and 
        Innovation Act, the Secretary shall establish a task force to 
        develop and implement a strategic plan for enhancing the 
        Secretary's response to preventing and mitigating drug 
        shortages.
            ``(B) Strategic plan.--The strategic plan described in 
        subparagraph (A) shall include--
                ``(i) plans for enhanced interagency and intra-agency 
            coordination, communication, and decisionmaking;
                ``(ii) plans for ensuring that drug shortages are 
            considered when the Secretary initiates a regulatory action 
            that could precipitate a drug shortage or exacerbate an 
            existing drug shortage;
                ``(iii) plans for effective communication with outside 
            stakeholders, including who the Secretary should alert 
            about potential or actual drug shortages, how the 
            communication should occur, and what types of information 
            should be shared;
                ``(iv) plans for considering the impact of drug 
            shortages on research and clinical trials; and
                ``(v) an examination of whether to establish a 
            `qualified manufacturing partner program', as described in 
            subparagraph (C).
            ``(C) Description of program.--In conducting the 
        examination of a `qualified manufacturing partner program' 
        under subparagraph (B)(v), the Secretary--
                ``(i) shall take into account that--

                    ``(I) a `qualified manufacturer', for purposes of 
                such program, would need to have the capability and 
                capacity to supply products determined or anticipated 
                to be in shortage; and
                    ``(II) in examining the capability and capacity to 
                supply products in shortage, the `qualified 
                manufacturer' could have a site that manufactures a 
                drug listed under section 506E or have the capacity to 
                produce drugs in response to a shortage within a rapid 
                timeframe; and

                ``(ii) shall examine whether incentives are necessary 
            to encourage the participation of `qualified manufacturers' 
            in such a program.
            ``(D) Consultation.--In carrying out this paragraph, the 
        task force shall ensure consultation with the appropriate 
        offices within the Food and Drug Administration, including the 
        Office of the Commissioner, the Center for Drug Evaluation and 
        Research, the Office of Regulatory Affairs, and employees 
        within the Department of Health and Human Services with 
        expertise regarding drug shortages. The Secretary shall engage 
        external stakeholders and experts as appropriate.
        ``(2) Timing.--Not later than 1 year after the date of 
    enactment of the Food and Drug Administration Safety and Innovation 
    Act, the task force shall--
            ``(A) publish the strategic plan described in paragraph 
        (1); and
            ``(B) submit such plan to Congress.
    ``(b) Communication.--The Secretary shall ensure that, prior to any 
enforcement action or issuance of a warning letter that the Secretary 
determines could reasonably be anticipated to lead to a meaningful 
disruption in the supply in the United States of a drug described under 
section 506C(a), there is communication with the appropriate office of 
the Food and Drug Administration with expertise regarding drug 
shortages regarding whether the action or letter could cause, or 
exacerbate, a shortage of the drug.
    ``(c) Action.--If the Secretary determines, after the communication 
described in subsection (b), that an enforcement action or a warning 
letter could reasonably cause or exacerbate a shortage of a drug 
described under section 506C(a), then the Secretary shall evaluate the 
risks associated with the impact of such shortage upon patients and 
those risks associated with the violation involved before taking such 
action or issuing such letter, unless there is imminent risk of serious 
adverse health consequences or death to humans.
    ``(d) Reporting by Other Entities.--The Secretary shall identify or 
establish a mechanism by which health care providers and other third-
party organizations may report to the Secretary evidence of a drug 
shortage.
    ``(e) Review and Construction.--No determination, finding, action, 
or omission of the Secretary under this section shall--
        ``(1) be subject to judicial review; or
        ``(2) be construed to establish a defense to an enforcement 
    action by the Secretary.
    ``(f) Sunset.--Subsections (a), (b), (c), and (e) shall cease to be 
effective on the date that is 5 years after the date of enactment of 
the Food and Drug Administration Safety and Innovation Act.''.
SEC. 1004. DRUG SHORTAGE LIST.
    Chapter V (21 U.S.C. 351 et seq.) is amended by inserting after 
section 506D, as added by section 1003 of this Act, the following:
``SEC. 506E. DRUG SHORTAGE LIST.
    ``(a) Establishment.--The Secretary shall maintain an up-to-date 
list of drugs that are determined by the Secretary to be in shortage in 
the United States.
    ``(b) Contents.--For each drug on such list, the Secretary shall 
include the following information:
        ``(1) The name of the drug in shortage, including the National 
    Drug Code number for such drug.
        ``(2) The name of each manufacturer of such drug.
        ``(3) The reason for the shortage, as determined by the 
    Secretary, selecting from the following categories:
            ``(A) Requirements related to complying with good 
        manufacturing practices.
            ``(B) Regulatory delay.
            ``(C) Shortage of an active ingredient.
            ``(D) Shortage of an inactive ingredient component.
            ``(E) Discontinuation of the manufacture of the drug.
            ``(F) Delay in shipping of the drug.
            ``(G) Demand increase for the drug.
        ``(4) The estimated duration of the shortage as determined by 
    the Secretary.
    ``(c) Public Availability.--
        ``(1) In general.--Subject to paragraphs (2) and (3), the 
    Secretary shall make the information in such list publicly 
    available.
        ``(2) Trade secrets and confidential information.--Nothing in 
    this section alters or amends section 1905 of title 18, United 
    States Code, or section 552(b)(4) of title 5 of such Code.
        ``(3) Public health exception.--The Secretary may choose not to 
    make information collected under this section publicly available 
    under paragraph (1) or section 506C(c) if the Secretary determines 
    that disclosure of such information would adversely affect the 
    public health (such as by increasing the possibility of hoarding or 
    other disruption of the availability of drug products to 
    patients).''.
SEC. 1005. QUOTAS APPLICABLE TO DRUGS IN SHORTAGE.
    Section 306 of the Controlled Substances Act (21 U.S.C. 826) is 
amended by adding at the end the following:
    ``(h)(1) Not later than 30 days after the receipt of a request 
described in paragraph (2), the Attorney General shall--
        ``(A) complete review of such request; and
        ``(B)(i) as necessary to address a shortage of a controlled 
    substance, increase the aggregate and individual production quotas 
    under this section applicable to such controlled substance and any 
    ingredient therein to the level requested; or
        ``(ii) if the Attorney General determines that the level 
    requested is not necessary to address a shortage of a controlled 
    substance, the Attorney General shall provide a written response 
    detailing the basis for the Attorney General's determination.
The Secretary shall make the written response provided under 
subparagraph (B)(ii) available to the public on the Internet Web site 
of the Food and Drug Administration.
    ``(2) A request is described in this paragraph if--
        ``(A) the request pertains to a controlled substance on the 
    list of drugs in shortage maintained under section 506E of the 
    Federal Food, Drug, and Cosmetic Act;
        ``(B) the request is submitted by the manufacturer of the 
    controlled substance; and
        ``(C) the controlled substance is in schedule II.''.
SEC. 1006. ATTORNEY GENERAL REPORT ON DRUG SHORTAGES.
    Not later than 6 months after the date of the enactment of this 
Act, and annually thereafter, the Attorney General shall submit to the 
Committee on Energy and Commerce of the House of Representatives and 
the Committee on the Judiciary of the Senate a report on drug shortages 
that--
        (1) identifies the number of requests received under section 
    306(h) of the Controlled Substances Act (as added by section 1005 
    of this Act), the average review time for such requests, the number 
    of requests granted and denied under such section, and, for each of 
    the requests denied under such section, the basis for such denial;
        (2) describes the coordination between the Drug Enforcement 
    Administration and Food and Drug Administration on efforts to 
    prevent or alleviate drug shortages; and
        (3) identifies drugs containing a controlled substance subject 
    to section 306 of the Controlled Substances Act when such a drug is 
    determined by the Secretary to be in shortage.
SEC. 1007. HOSPITAL REPACKAGING OF DRUGS IN SHORTAGE.
    Chapter V (21 U.S.C. 351 et seq.) is amended by inserting after 
section 506E, as added by section 1004 of this Act, the following:
``SEC. 506F. HOSPITAL REPACKAGING OF DRUGS IN SHORTAGE.
    ``(a) Definitions.--In this section:
        ``(1) Drug.--The term `drug' excludes any controlled substance 
    (as such term is defined in section 102 of the Controlled 
    Substances Act).
        ``(2) Health system.--The term `health system' means a 
    collection of hospitals that are owned and operated by the same 
    entity and that share access to databases with drug order 
    information for their patients.
        ``(3) Repackage.--For the purposes of this section only, the 
    term `repackage', with respect to a drug, means to divide the 
    volume of a drug into smaller amounts in order to--
            ``(A) extend the supply of a drug in response to the 
        placement of the drug on a drug shortage list under section 
        506E; and
            ``(B) facilitate access to the drug by hospitals within the 
        same health system.
    ``(b) Exclusion From Registration.--Notwithstanding any other 
provision of this Act, a hospital shall not be considered an 
establishment for which registration is required under section 510 
solely because it repackages a drug and transfers it to another 
hospital within the same health system in accordance with the 
conditions in subsection (c)--
        ``(1) during any period in which the drug is listed on the drug 
    shortage list under section 506E; or
        ``(2) during the 60-day period following any period described 
    in paragraph (1).
    ``(c) Conditions.--Subsection (b) shall only apply to a hospital, 
with respect to the repackaging of a drug for transfer to another 
hospital within the same health system, if the following conditions are 
met:
        ``(1) Drug for intrasystem use only.--In no case may a drug 
    that has been repackaged in accordance with this section be sold or 
    otherwise distributed by the health system or a hospital within the 
    system to an entity or individual that is not a hospital within 
    such health system.
        ``(2) Compliance with state rules.--Repackaging of a drug under 
    this section shall be done in compliance with applicable State 
    requirements of each State in which the drug is repackaged and 
    received.
    ``(d) Termination.--This section shall not apply on or after the 
date on which the Secretary issues final guidance that clarifies the 
policy of the Food and Drug Administration regarding hospital 
pharmacies repackaging and safely transferring repackaged drugs to 
other hospitals within the same health system during a drug 
shortage.''.
SEC. 1008. STUDY ON DRUG SHORTAGES.
    (a) Study.--The Comptroller General of the United States shall 
conduct a study to examine the cause of drug shortages and formulate 
recommendations on how to prevent or alleviate such shortages.
    (b) Consideration.--In conducting the study under this section, the 
Comptroller General shall consider the following questions:
        (1) What are the dominant characteristics of drugs that have 
    gone into a drug shortage over the preceding 3 years?
        (2) Are there systemic high-risk factors (such as drug pricing 
    structure, including Federal reimbursements, or the number of 
    manufacturers producing a drug product) that have led to the 
    concentration of drug shortages in certain drug products that have 
    made such products vulnerable to drug shortages?
        (3) Is there a reason why drug shortages have occurred 
    primarily in the sterile injectable market and in certain 
    therapeutic areas?
        (4)(A) How have regulations, guidance documents, regulatory 
    practices, policies, and other actions of Federal departments and 
    agencies (including the effectiveness of interagency and intra-
    agency coordination, communication, strategic planning, and 
    decisionmaking), including those used to enforce statutory 
    requirements, affected drug shortages?
        (B) Do any such regulations, guidances, policies, or practices 
    cause, exacerbate, prevent, or mitigate drug shortages?
        (C) How can regulations, guidances, policies, or practices be 
    modified, streamlined, expanded, or discontinued in order to reduce 
    or prevent such drug shortages?
        (D) What effect would the changes described in subparagraph (C) 
    have on the public health?
        (5) How does hoarding affect drug shortages?
        (6) How would incentives alleviate or prevent drug shortages?
        (7) To what extent are health care providers, including 
    hospitals and physicians responding to drug shortages, able to 
    adjust care effectively to compensate for such shortages, and what 
    impediments exist that hinder provider ability to adjust to such 
    shortages?
        (8)(A) Have drug shortages led market participants to stockpile 
    affected drugs or sell such drugs at inflated prices?
        (B) What has been the impact of any such activities described 
    in subparagraph (A) on Federal revenue, and are there any economic 
    factors that have exacerbated or created a market for such 
    activities?
        (C) Is there a need for any additional reporting or enforcement 
    actions to address such activities?
        (9)(A) How have the activities under section 506D of the 
    Federal Food, Drug, and Cosmetic Act (as added by section 1003 of 
    this Act) improved the efforts of the Food and Drug Administration 
    to mitigate and prevent drug shortages?
        (B) Is there a need to continue the task force and strategic 
    plan under such section 506D, or are there any other 
    recommendations to increase communication and coordination inside 
    the Food and Drug Administration, between the Food and Drug 
    Administration and other agencies, and between the Food and Drug 
    Administration and stakeholders?
    (c) Consultation With Stakeholders.--In conducting the study under 
this section, the Comptroller General shall consult with relevant 
stakeholders, including physicians, pharmacists, hospitals, patients, 
drug manufacturers, and other health providers.
    (d) Report.--Not later than 18 months after the date of the 
enactment of this Act, the Comptroller General shall submit a report to 
the Committee on Energy and Commerce of the House of Representatives 
and the Committee on Health, Education, Labor, and Pensions of the 
Senate on the results of the study under this section.

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

               Subtitle B--Medical Gas Product Regulation

SEC. 1111. REGULATION OF MEDICAL GASES.
    Chapter V (21 U.S.C. 351 et seq.) is amended by adding at the end 
the following:

                     ``Subchapter G--Medical Gases

    ``SEC. 575. DEFINITIONS.
    ``In this subchapter:
        ``(1) The term `designated medical gas' means any of the 
    following:
            ``(A) Oxygen that meets the standards set forth in an 
        official compendium.
            ``(B) Nitrogen that meets the standards set forth in an 
        official compendium.
            ``(C) Nitrous oxide that meets the standards set forth in 
        an official compendium.
            ``(D) Carbon dioxide that meets the standards set forth in 
        an official compendium.
            ``(E) Helium that meets the standards set forth in an 
        official compendium.
            ``(F) Carbon monoxide that meets the standards set forth in 
        an official compendium.
            ``(G) Medical air that meets the standards set forth in an 
        official compendium.
            ``(H) Any other medical gas deemed appropriate by the 
        Secretary, after taking into account any investigational new 
        drug application or investigational new animal drug application 
        for the same medical gas submitted in accordance with 
        regulations applicable to such applications in title 21 of the 
        Code of Federal Regulations, unless any period of exclusivity 
        under section 505(c)(3)(E)(ii) or section 505(j)(5)(F)(ii), or 
        the extension of any such period under section 505A, applicable 
        to such medical gas has not expired.
        ``(2) The term `medical gas' means a drug that--
            ``(A) is manufactured or stored in a liquefied, 
        nonliquefied, or cryogenic state; and
            ``(B) is administered as a gas.
    ``SEC. 576. REGULATION OF MEDICAL GASES.
    ``(a) Certification of Designated Medical Gases.--
        ``(1) Submission.--Beginning 180 days after the date of 
    enactment of this section, any person may file with the Secretary a 
    request for certification of a medical gas as a designated medical 
    gas. Any such request shall contain the following information:
            ``(A) A description of the medical gas.
            ``(B) The name and address of the sponsor.
            ``(C) The name and address of the facility or facilities 
        where the medical gas is or will be manufactured.
            ``(D) Any other information deemed appropriate by the 
        Secretary to determine whether the medical gas is a designated 
        medical gas.
        ``(2) Grant of certification.--The certification requested 
    under paragraph (1) is deemed to be granted unless, within 60 days 
    of the filing of such request, the Secretary finds that--
            ``(A) the medical gas subject to the certification is not a 
        designated medical gas;
            ``(B) the request does not contain the information required 
        under paragraph (1) or otherwise lacks sufficient information 
        to permit the Secretary to determine that the medical gas is a 
        designated medical gas; or
            ``(C) denying the request is necessary to protect the 
        public health.
        ``(3) Effect of certification.--
            ``(A) In general.--
                ``(i) Approved uses.--A designated medical gas for 
            which a certification is granted under paragraph (2) is 
            deemed, alone or in combination, as medically appropriate, 
            with another designated medical gas or gases for which a 
            certification or certifications have been granted, to have 
            in effect an approved application under section 505 or 512, 
            subject to all applicable postapproval requirements, for 
            the following indications for use:

                    ``(I) In the case of oxygen, the treatment or 
                prevention of hypoxemia or hypoxia.
                    ``(II) In the case of nitrogen, use in hypoxic 
                challenge testing.
                    ``(III) In the case of nitrous oxide, analgesia.
                    ``(IV) In the case of carbon dioxide, use in 
                extracorporeal membrane oxygenation therapy or 
                respiratory stimulation.
                    ``(V) In the case of helium, the treatment of upper 
                airway obstruction or increased airway resistance.
                    ``(VI) In the case of medical air, to reduce the 
                risk of hyperoxia.
                    ``(VII) In the case of carbon monoxide, use in lung 
                diffusion testing.
                    ``(VIII) Any other indication for use for a 
                designated medical gas or combination of designated 
                medical gases deemed appropriate by the Secretary, 
                unless any period of exclusivity under clause (iii) or 
                (iv) of section 505(c)(3)(E), clause (iii) or (iv) of 
                section 505(j)(5)(F), or section 527, or the extension 
                of any such period under section 505A, applicable to 
                such indication for use for such gas or combination of 
                gases has not expired.

                ``(ii) Labeling.--The requirements of sections 
            503(b)(4) and 502(f) are deemed to have been met for a 
            designated medical gas if the labeling on final use 
            container for such medical gas bears--

                    ``(I) the information required by section 
                503(b)(4);
                    ``(II) a warning statement concerning the use of 
                the medical gas as determined by the Secretary by 
                regulation; and
                    ``(III) appropriate directions and warnings 
                concerning storage and handling.

            ``(B) Inapplicability of exclusivity provisions.--
                ``(i) No exclusivity for a certified medical gas.--No 
            designated medical gas deemed under subparagraph (A)(i) to 
            have in effect an approved application is eligible for any 
            period of exclusivity under section 505(c), 505(j), or 527, 
            or the extension of any such period under section 505A, on 
            the basis of such deemed approval.
                ``(ii) Effect on certification.--No period of 
            exclusivity under section 505(c), 505(j), or section 527, 
            or the extension of any such period under section 505A, 
            with respect to an application for a drug product shall 
            prohibit, limit, or otherwise affect the submission, grant, 
            or effect of a certification under this section, except as 
            provided in subsection (a)(3)(A)(i)(VIII) and section 
            575(1)(H).
        ``(4) Withdrawal, suspension, or revocation of approval.--
            ``(A) Withdrawal, suspension of approval.--Nothing in this 
        subchapter limits the Secretary's authority to withdraw or 
        suspend approval of a drug product, including a designated 
        medical gas deemed under this section to have in effect an 
        approved application under section 505 or section 512 of this 
        Act.
            ``(B) Revocation of certification.--The Secretary may 
        revoke the grant of a certification under paragraph (2) if the 
        Secretary determines that the request for certification 
        contains any material omission or falsification.
    ``(b) Prescription Requirement.--
        ``(1) In general.--A designated medical gas shall be subject to 
    the requirements of section 503(b)(1) unless the Secretary 
    exercises the authority provided in section 503(b)(3) to remove 
    such medical gas from the requirements of section 503(b)(1), the 
    gas is approved for use without a prescription pursuant to an 
    application under section 505 or 512, or the use in question is 
    authorized pursuant to another provision of this Act relating to 
    use of medical products in emergencies.
        ``(2) Oxygen.--
            ``(A) No prescription required for certain uses.--
        Notwithstanding paragraph (1), oxygen may be provided without a 
        prescription for the following uses:
                ``(i) For use in the event of depressurization or other 
            environmental oxygen deficiency.
                ``(ii) For oxygen deficiency or for use in emergency 
            resuscitation, when administered by properly trained 
            personnel.
            ``(B) Labeling.--For oxygen provided pursuant to 
        subparagraph (A), the requirements of section 503(b)(4) shall 
        be deemed to have been met if its labeling bears a warning that 
        the oxygen can be used for emergency use only and for all other 
        medical applications a prescription is required.
    ``SEC. 577. INAPPLICABILITY OF DRUG FEES TO DESIGNATED MEDICAL 
      GASES.
    ``A designated medical gas, alone or in combination with another 
designated gas or gases (as medically appropriate) deemed under section 
576 to have in effect an approved application shall not be assessed 
fees under section 736(a) on the basis of such deemed approval.''.
SEC. 1112. CHANGES TO REGULATIONS.
    (a) Report.--Not later than 18 months after the date of the 
enactment of this Act, the Secretary, after obtaining input from 
medical gas manufacturers and any other interested members of the 
public, shall--
        (1) determine whether any changes to the Federal drug 
    regulations are necessary for medical gases; and
        (2) submit to the Committee on Health, Education, Labor, and 
    Pensions of the Senate and the Committee on Energy and Commerce of 
    the House of Representatives a report regarding any such changes.
    (b) Regulations.--If the Secretary determines under subsection (a) 
that changes to the Federal drug regulations are necessary for medical 
gases, the Secretary shall issue final regulations revising the Federal 
drug regulations with respect to medical gases not later than 48 months 
after the date of the enactment of this Act.
    (c) Definitions.--In this section:
        (1) The term ``Federal drug regulations'' means regulations in 
    title 21 of the Code of Federal Regulations pertaining to drugs.
        (2) The term ``medical gas'' has the meaning given to such term 
    in section 575 of the Federal Food, Drug, and Cosmetic Act, as 
    added by section 1111 of this Act.
        (3) The term ``Secretary'' means the Secretary of Health and 
    Human Services, acting through the Commissioner of Food and Drugs.
SEC. 1113. RULES OF CONSTRUCTION.
    Nothing in this subtitle and the amendments made by this subtitle 
applies with respect to--
        (1) a drug that is approved prior to May 1, 2012, pursuant to 
    an application submitted under section 505 or 512 of the Federal 
    Food, Drug, and Cosmetic Act (21 U.S.C. 355, 360b);
        (2) any gas listed in subparagraphs (A) through (G) of section 
    575(1) of the Federal Food, Drug, and Cosmetic Act, as added by 
    section 1111 of this Act, or any combination of any such gases, for 
    an indication that--
            (A) is not included in, or is different from, those 
        specified in subclauses (I) through (VII) of section 
        576(a)(3)(A)(i) of such Act; and
            (B) is approved on or after May 1, 2012, pursuant to an 
        application submitted under section 505 or 512; or
        (3) any designated medical gas added pursuant to subparagraph 
    (H) of section 575(1) of such Act for an indication that--
            (A) is not included in, or is different from, those 
        originally added pursuant to subparagraph (H) of section 575(1) 
        and section 576(a)(3)(A)(i)(VIII); and
            (B) is approved on or after May 1, 2012, pursuant to an 
        application submitted under section 505 or 512 of such Act.

                  Subtitle C--Miscellaneous Provisions

SEC. 1121. GUIDANCE DOCUMENT REGARDING PRODUCT PROMOTION USING THE 
INTERNET.
    Not later than 2 years after the date of enactment of 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. 1122. 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''), 
in coordination with other Federal agencies, as appropriate, shall 
review current Federal initiatives and identify gaps and opportunities 
with respect to--
        (1) ensuring the safe use of prescription drugs with the 
    potential for abuse; and
        (2) the treatment of prescription drug dependance.
    (b) Report.--Not later than 1 year after the date of enactment of 
this Act, the Secretary shall post on the Department of Health and 
Human Service's Internet Web site a report on the findings of the 
review under subsection (a). Such report shall include findings and 
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 provider 
    participation, producing standardized data on adverse events, 
    patient safety, and patient outcomes; and
        (3) how best to develop provider, pharmacist, and patient 
    education tools and a strategy to widely disseminate such tools and 
    assess the efficacy of such tools.
    (c) Guidance on Abuse-Deterrent Products.--Not later than 6 months 
after the date of enactment of this Act, the Secretary shall promulgate 
guidance on the development of abuse-deterrent drug products.
SEC. 1123. OPTIMIZING GLOBAL CLINICAL TRIALS.
    Subchapter E of chapter V (21 U.S.C. 360bbb et seq.), as amended by 
section 903 of this Act, 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 nonclinical 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. 1124. 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 toward 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) 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) Performance Reports.--The annual performance reports submitted 
to Congress under sections 736B(a) (as amended by section 104 of this 
Act), 738A(a) (as amended by section 204 of this Act), 744C(a) (as 
added by section 303 of this Act), and 744I(a) (as added by section 403 
of this Act) of the Federal Food, Drug, and Cosmetic Act for each of 
fiscal years 2014 and 2016, shall include a report from the Secretary 
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) 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. 1125. 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. 1126. NANOTECHNOLOGY.
    (a) In General.--The Secretary of Health and Human Services 
(referred to in this section as the ``Secretary'') shall intensify and 
expand activities related to enhancing scientific knowledge regarding 
nanomaterials included or intended for inclusion in products regulated 
under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) 
or other statutes administered by the Food and Drug Administration, to 
address issues relevant to the regulation of those products, including 
the potential toxicology of such nanomaterials, the potential benefit 
of new therapies derived from nanotechnology, the effects of such 
nanomaterials on biological systems, and the interaction of such 
nanomaterials with biological systems.
    (b) Activities.--In conducting activities related to 
nanotechnology, the Secretary may--
        (1) assess scientific literature and data on general 
    nanomaterials interactions with biological systems and on specific 
    nanomaterials of concern to the Food and Drug Administration;
        (2) in cooperation with other Federal agencies, develop and 
    organize information using databases and models that will 
    facilitate the identification of generalized principles and 
    characteristics regarding the behavior of classes of nanomaterials 
    with biological systems;
        (3) promote Food and Drug Administration programs and 
    participate in collaborative efforts, to further the understanding 
    of the science of novel properties of nanomaterials that might 
    contribute to toxicity;
        (4) promote and participate in collaborative efforts to further 
    the understanding of measurement and detection methods for 
    nanomaterials;
        (5) collect, synthesize, interpret, and disseminate scientific 
    information and data related to the interactions of nanomaterials 
    with biological systems;
        (6) build scientific expertise on nanomaterials within the Food 
    and Drug Administration, including field and laboratory expertise, 
    for monitoring the production and presence of nanomaterials in 
    domestic and imported products regulated under this Act;
        (7) ensure ongoing training, as well as dissemination of new 
    information within the centers of the Food and Drug Administration, 
    and more broadly across the Food and Drug Administration, to ensure 
    timely, informed consideration of the most current science 
    pertaining to nanomaterials;
        (8) encourage the Food and Drug Administration to participate 
    in international and national consensus standards activities 
    pertaining to nanomaterials; and
        (9) carry out other activities that the Secretary determines 
    are necessary and consistent with the purposes described in 
    paragraphs (1) through (8).
SEC. 1127. ONLINE PHARMACY REPORT TO CONGRESS.
    Not later than 1 year after the date of enactment of this Act, the 
Comptroller General of the United States 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 describes any problems posed by pharmacy Internet Web sites 
that violate Federal or State law, including--
        (1) the methods by which Internet Web sites are used to sell 
    prescription drugs in violation of Federal or State law or 
    established industry standards;
        (2) the harmful health effects that patients experience when 
    they consume prescription drugs purchased through such pharmacy 
    Internet Web sites;
        (3) efforts by the Federal Government and State and local 
    governments to investigate and prosecute the owners or operators of 
    pharmacy Internet Web sites, to address the threats such Web sites 
    pose, and to protect patients;
        (4) the level of success that Federal, State, and local 
    governments have experienced in investigating and prosecuting such 
    cases;
        (5) whether the law, as in effect on the date of the report, 
    provides sufficient authorities to Federal, State, and local 
    governments to investigate and prosecute the owners and operators 
    of pharmacy Internet Web sites that violate Federal or State law or 
    established industry standards;
        (6) additional authorities that could assist Federal, State, 
    and local governments in investigating and prosecuting the owners 
    and operators of pharmacy Internet Web sites that violate Federal 
    or State law or established industry standards;
        (7) laws, policies, and activities that would educate consumers 
    about how to distinguish pharmacy Internet Web sites that comply 
    with Federal and State laws and established industry standards from 
    those pharmacy Internet Web sites that do not comply with such laws 
    and standards; and
        (8) activities that private sector actors are taking to address 
    the prevalence of illegitimate pharmacy Internet Web sites, and any 
    policies to encourage further activities.
SEC. 1128. REPORT ON SMALL BUSINESSES.
    Not later than 1 year after the date of enactment of this Act, the 
Commissioner of Food and Drugs shall submit a report to Congress that 
includes--
        (1) a listing of and staffing levels of all small business 
    offices at the Food and Drug Administration, including the small 
    business liaison program;
        (2) the status of partnership efforts between the Food and Drug 
    Administration and the Small Business Administration;
        (3) a summary of outreach efforts to small businesses and small 
    business associations, including availability of toll-free 
    telephone help lines;
        (4) with respect to the program under the Orphan Drug Act 
    (Public Law 97-414), the number of applications made by small 
    businesses and number of applications approved for research grants 
    and the number of companies receiving protocol assistance for the 
    development of drugs for rare diseases and disorders;
        (5) the number of small businesses submitting applications and 
    receiving approval for unsolicited grant applications from the Food 
    and Drug Administration;
        (6) the number of small businesses submitting applications and 
    receiving approval for solicited grant applications from the Food 
    and Drug Administration; and
        (7) barriers small businesses encounter in the drug and medical 
    device approval process.
SEC. 1129. PROTECTIONS FOR THE COMMISSIONED CORPS OF THE PUBLIC HEALTH 
SERVICE ACT.
    (a) In General.--Section 221(a) of the Public Health Service Act 
(42 U.S.C. 213a(a)) is amended by adding at the end the following:
        ``(18) Section 1034, Protected Communications; Prohibition of 
    Retaliatory Personnel Actions.''.
    (b) Conforming Amendment.--Section 221(b) of the Public Health 
Service Act (42 U.S.C. 213a(b)) is amended by adding at the end the 
following: ``For purposes of paragraph (18) of subsection (a), the term 
`Inspector General' in section 1034 of such title 10 shall mean the 
Inspector General of the Department of Health and Human Services.''.
SEC. 1130. COMPLIANCE DATE FOR RULE RELATING TO SUNSCREEN DRUG PRODUCTS 
FOR OVER-THE-COUNTER HUMAN USE.
    In accordance with the final rule issued by the Commissioner of 
Food and Drug entitled ``Labeling and Effectiveness Testing; Sunscreen 
Drug Products for Over-the-Counter Human Use; Delay of Compliance 
Dates'' (77 Fed. Reg. 27591 (May 11, 2012)), a product subject to the 
final rule issued by the Commissioner entitled ``Labeling and 
Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter 
Human Use'' (76 Fed. Reg. 35620 (June 17, 2011)), shall comply with 
such rule not later than--
        (1) December 17, 2013, for products subject to such rule with 
    annual sales of less than $25,000 and
        (2) December 17, 2012, for all other products subject to such 
    rule.
SEC. 1131. STRATEGIC INTEGRATED MANAGEMENT PLAN.
    Not later than 1 year after the date of enactment of this Act, the 
Secretary of Health and Human Services 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, priorities, and 
    mechanisms to improve efficiency, 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, priorities, and mechanisms 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.).
SEC. 1132. ASSESSMENT AND MODIFICATION OF REMS.
    (a) Assessment and Modification of Approved Strategy.--Section 505-
1(g) (21 U.S.C. 355-1(g)) is amended--
        (1) in paragraph (1), by striking ``, and propose a 
    modification to,'';
        (2) in paragraph (2)--
            (A) in the matter before subparagraph (A)--
                (i) by striking ``, subject to paragraph (5),''; and
                (ii) by striking ``, and may propose a modification 
            to,'';
            (B) in subparagraph (C), by striking ``new safety or 
        effectiveness information indicates that'' and all that follows 
        and inserting the following: ``an assessment is needed to 
        evaluate whether the approved strategy should be modified to--
                ``(i) ensure the benefits of the drug outweigh the 
            risks of the drug; or
                ``(ii) minimize the burden on the health care delivery 
            system of complying with the strategy.''; and
            (C) by striking subparagraph (D);
        (3) in paragraph (3), by striking ``for a drug shall include--
    '' and all that follows and inserting the following ``for a drug 
    shall include, with respect to each goal included in the strategy, 
    an assessment of the extent to which the approved strategy, 
    including each element of the strategy, is meeting the goal or 
    whether 1 or more such goals or such elements should be 
    modified.''; and
        (4) by amending paragraph (4) to read as follows:
        ``(4) Modification.--
            ``(A) On initiative of responsible person.--After the 
        approval of a risk evaluation and mitigation strategy by the 
        Secretary, the responsible person may, at any time, submit to 
        the Secretary a proposal to modify the approved strategy. Such 
        proposal may propose the addition, modification, or removal of 
        any goal or element of the approved strategy and shall include 
        an adequate rationale to support such proposed addition, 
        modification, or removal of any goal or element of the 
        strategy.
            ``(B) On initiative of secretary.--After the approval of a 
        risk evaluation and mitigation strategy by the Secretary, the 
        Secretary may, at any time, require a responsible person to 
        submit a proposed modification to the strategy within 120 days 
        or within such reasonable time as the Secretary specifies, if 
        the Secretary, in consultation with the offices described in 
        subsection (c)(2), determines that 1 or more goals or elements 
        should be added, modified, or removed from the approved 
        strategy to--
                ``(i) ensure the benefits of the drug outweigh the 
            risks of the drug; or
                ``(ii) minimize the burden on the health care delivery 
            system of complying with the strategy.''.
    (b) Review of Proposed Strategies; Review of Assessments and 
Modifications of Approved Strategies.--Section 505-1(h) (21 U.S.C. 355-
1(h)) is amended--
        (1) in the subsection heading by inserting ``and 
    Modifications'' after ``Review of Assessments'';
        (2) in paragraph (1)--
            (A) by inserting ``and proposed modification to'' after 
        ``under subsection (a) and each assessment of''; and
            (B) by inserting ``, and, if necessary, promptly initiate 
        discussions with the responsible person about such proposed 
        strategy, assessment, or modification'' after ``subsection 
        (g)'';
        (3) by striking paragraph (2);
        (4) by redesignating paragraphs (3) through (9) as paragraphs 
    (2) through (8), respectively;
        (5) in paragraph (2), as redesignated by paragraph (4)--
            (A) by amending subparagraph (A) to read as follows:
            ``(A) In general.--
                ``(i) Timeframe.--Unless the dispute resolution process 
            described under paragraph (3) or (4) applies, and, except 
            as provided in clause (ii) or clause (iii) below, the 
            Secretary, in consultation with the offices described in 
            subsection (c)(2), shall review and act on the proposed 
            risk evaluation and mitigation strategy for a drug or any 
            proposed modification to any required strategy within 180 
            days of receipt of the proposed strategy or modification.
                ``(ii) Minor modifications.--The Secretary shall review 
            and act on a proposed minor modification, as defined by the 
            Secretary in guidance, within 60 days of receipt of such 
            modification.
                ``(iii) REMS modification due to safety label 
            changes.--Not later than 60 days after the Secretary 
            receives a proposed modification to an approved risk 
            evaluation and mitigation strategy to conform the strategy 
            to approved safety label changes, including safety labeling 
            changes initiated by the sponsor in accordance with FDA 
            regulatory requirements, or to a safety label change that 
            the Secretary has directed the holder of the application to 
            make pursuant to section 505(o)(4), the Secretary shall 
            review and act on such proposed modification to the 
            approved strategy.
                ``(iv) Guidance.--The Secretary shall establish, 
            through guidance, that responsible persons may implement 
            certain modifications to an approved risk evaluation and 
            mitigation strategy following notification to the 
            Secretary.''; and
            (B) by amending subparagraph (C) to read as follows:
            ``(C) Public availability.--Upon acting on a proposed risk 
        evaluation and mitigation strategy or proposed modification to 
        a risk evaluation and mitigation strategy under subparagraph 
        (A), the Secretary shall make publicly available an action 
        letter describing the actions taken by the Secretary under such 
        subparagraph (A).'';
        (6) in paragraph (4), as redesignated by paragraph (4)--
            (A) in subparagraph (A)(i)--
                (i) by striking ``Not earlier than 15 days, and not 
            later than 35 days, after discussions under paragraph (2) 
            have begun, the'' and inserting ``The''; and
                (ii) by inserting ``, after the sponsor is required to 
            make a submission under subsection (a)(2) or (g),'' before 
            ``request in writing''; and
            (B) in subparagraph (I)--
                (i) by striking clauses (i) and (ii); and
                (ii) by striking ``if the Secretary--'' and inserting 
            ``if the Secretary has complied with the timing 
            requirements of scheduling review by the Drug Safety 
            Oversight Board, providing a written recommendation, and 
            issuing an action letter under subparagraphs (B), (F), and 
            (G), respectively.'';
        (7) in paragraph (5), as redesignated by paragraph (4)--
            (A) in subparagraph (A), by striking ``any of subparagraphs 
        (B) through (D)'' and inserting ``subparagraph (B) or (C)''; 
        and
            (B) in subparagraph (C), by striking ``paragraph (4) or 
        (5)'' and inserting ``paragraph (3) or (4)''; and
        (8) in paragraph (8), as redesignated by paragraph (4), by 
    striking ``paragraphs (7) and (8)'' and inserting ``paragraphs (6) 
    and (7).''.
    (c) Guidance.--Not later than 1 year after the date of enactment of 
this Act, the Secretary of Health and Human Services shall issue 
guidance that, for purposes of section 505-1(h)(2)(A) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355-1(h)(2)(A)), describes the 
types of modifications to approved risk evaluation and mitigation 
strategies that shall be considered to be minor modifications of such 
strategies.
SEC. 1133. EXTENSION OF PERIOD FOR FIRST APPLICANT TO OBTAIN TENTATIVE 
APPROVAL WITHOUT FORFEITING 180-DAY-EXCLUSIVITY PERIOD.
    (a) Extension.--
        (1) In general.--If a first applicant files an application 
    during the 30-month period ending on the date of enactment of this 
    Act and such application initially contains a certification 
    described in paragraph (2)(A)(vii)(IV) of section 505(j) of the 
    Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)), or if a 
    first applicant files an application and the application is amended 
    during such period to first contain such a certification, the 
    phrase ``30 months'' in paragraph (5)(D)(i)(IV) of such section 
    shall, with respect to such application, be read as meaning--
            (A) during the period beginning on the date of enactment of 
        this Act, and ending on September 30, 2015, ``40 months''; and
            (B) during the period beginning on October 1, 2015, and 
        ending on September 30, 2016, ``36 months''.
        (2) Conforming amendment.--In the case of an application to 
    which an extended period under paragraph (1) applies, the reference 
    to the 30-month period under section 505(q)(1)(G) of the Federal 
    Food, Drug, and Cosmetic Act (21 U.S.C. 355(q)(1)(G)) shall be read 
    to be the applicable period under paragraph (1).
    (b) Period for Obtaining Tentative Approval of Certain 
Applications.--If an application is filed on or before the date of 
enactment of this Act and such application is amended during the period 
beginning on the day after the date of enactment of this Act and ending 
on September 30, 2017, to first contain a certification described in 
paragraph (2)(A)(vii)(IV) of section 505(j) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355(j)), the date of the filing of such 
amendment (rather than the date of the filing of such application) 
shall be treated as the beginning of the 30-month period described in 
paragraph (5)(D)(i)(IV) of such section 505(j).
    (c) Definitions.--For the purposes of this section, the terms 
``application'' and ``first applicant'' mean application and first 
applicant, as such terms are used in section 505(j)(5)(D)(i)(IV) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(D)(i)(IV)).
SEC. 1134. DEADLINE FOR DETERMINATION ON CERTAIN PETITIONS.
    (a) In General.--Section 505 (21 U.S.C. 355) is amended by adding 
at the end the following:
    ``(w) Deadline for Determination on Certain Petitions.--The 
Secretary shall issue a final, substantive determination on a petition 
submitted pursuant to subsection (b) of section 314.161 of title 21, 
Code of Federal Regulations (or any successor regulations), no later 
than 270 days after the date the petition is submitted.''.
    (b) Application.--The amendment made by subsection (a) shall apply 
to any petition that is submitted pursuant to subsection (b) of section 
314.161 of title 21, Code of Federal Regulations (or any successor 
regulations), on or after the date of enactment of this Act.
SEC. 1135. FINAL AGENCY ACTION RELATING TO PETITIONS AND CIVIL ACTIONS.
    Section 505(q) (21 U.S.C. 355(q)) is amended--
        (1) in paragraph (1)--
            (A) in subparagraph (A), by striking ``subsection (b)(2) or 
        (j)'' and inserting ``subsection (b)(2) or (j) of this section 
        or section 351(k) of the Public Health Service Act''; and
            (B) in subparagraph (F), by striking ``180 days'' and 
        inserting ``150 days'';
        (2) in paragraph (2)(A)--
            (A) in the subparagraph heading, by striking ``180'' and 
        inserting ``150''; and
            (B) in clause (i), by striking ``180-day'' and inserting 
        ``150-day'';
        (3) in paragraph (4)--
            (A) by redesignating subparagraphs (A) and (B) as clauses 
        (i) and (ii), respectively, and moving such clauses, as so 
        redesignated, 2 ems to the right;
            (B) by striking ``This subsection does not apply to--'' and 
        inserting the following:
            ``(A) This subsection does not apply to--''; and
            (C) by adding at the end the following:
            ``(B) Paragraph (2) does not apply to a petition addressing 
        issues concerning an application submitted pursuant to section 
        351(k) of the Public Health Service Act.''; and
        (4) in paragraph (5), by striking ``subsection (b)(2) or (j)'' 
    inserting ``subsection (b)(2) or (j) of the Act or 351(k) of the 
    Public Health Service Act''.
SEC. 1136. 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, presubmissions 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 
    presubmissions or submissions, shall include an electronic copy of 
    such presubmissions 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. 1137. PATIENT PARTICIPATION IN MEDICAL PRODUCT DISCUSSIONS.
    Subchapter E of chapter V (21 U.S.C. 360bbb et seq.), as amended by 
section 1123 of this Act, 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) Protection of Proprietary Information.--Nothing in this 
section shall be construed to alter the protections offered by laws, 
regulations, or 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 laws, regulations, or policies would apply to 
consultation with individuals and organizations prior to the date of 
enactment of this section.
    ``(c) 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.
    ``(d) 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.
    ``(e) Financial Interest.--In this section, the term `financial 
interest' means a financial interest under section 208(a) of title 18, 
United States Code.''.
SEC. 1138. ENSURING ADEQUATE INFORMATION REGARDING PHARMACEUTICALS FOR 
ALL POPULATIONS, PARTICULARLY UNDERREPRESENTED SUBPOPULATIONS, 
INCLUDING RACIAL SUBGROUPS.
    (a) Communication Plan.--The Secretary of Health and Human Services 
(referred to in this section as the ``Secretary''), acting through the 
Commissioner of Food and Drugs, shall review and modify, as necessary, 
the Food and Drug Administration's communication plan to inform and 
educate health care providers and patients on the benefits and risks of 
medical products, with particular focus on underrepresented 
subpopulations, including racial subgroups.
    (b) Content.--The communication plan described under subsection 
(a)--
        (1) shall take into account--
            (A) the goals and principles set forth in the Strategic 
        Action Plan to Reduce Racial and Ethnic Health Disparities 
        issued by the Department of Health and Human Services;
            (B) the nature of the medical product; and
            (C) health and disease information available from other 
        agencies within such Department, as well as any new means of 
        communicating health and safety benefits and risks related to 
        medical products;
        (2) taking into account the nature of the medical product, 
    shall address the best strategy for communicating safety alerts, 
    labeled indications for the medical products, changes to the label 
    or labeling of medical products (including black-box warnings, 
    health advisories, health and safety benefits and risks), 
    particular actions to be taken by health care professionals and 
    patients, any information identifying particular subpopulations, 
    and any other relevant information as determined appropriate to 
    enhance communication, including varied means of electronic 
    communication; and
        (3) shall include a process for implementation of any 
    improvements or other modifications determined to be necessary.
    (c) Issuance and Posting of Communication Plan.--
        (1) Communication plan.--Not later than 1 year after the date 
    of enactment of this Act, the Secretary, acting through the 
    Commissioner of Food and Drugs, shall issue the communication plan 
    described under this section.
        (2) Posting of communication plan on the office of minority 
    health web site.--The Secretary, acting through the Commissioner of 
    Food and Drugs, shall publicly post the communication plan on the 
    Internet Web site of the Office of Minority Health of the Food and 
    Drug Administration, and provide links to any other appropriate 
    Internet Web site, and seek public comment on the communication 
    plan.
SEC. 1139. SCHEDULING OF HYDROCODONE.
    (a) In General.--Not later than 60 days after the date of enactment 
of this Act, if practicable, the Secretary of Health and Human Services 
(referred to in this section as the ``Secretary'') shall hold a public 
meeting to solicit advice and recommendations to assist in conducting a 
scientific and medical evaluation in connection with a scheduling 
recommendation to the Drug Enforcement Administration regarding drug 
products containing hydrocodone, combined with other analgesics or as 
an antitussive.
    (b) Stakeholder Input.--In conducting the evaluation under 
subsection (a), the Secretary shall solicit input from a variety of 
stakeholders including patients, health care providers, harm prevention 
experts, the National Institute on Drug Abuse, the Centers for Disease 
Control and Prevention, and the Drug Enforcement Administration 
regarding the health benefits and risks, including the potential for 
abuse and the impact of up-scheduling of these products.
    (c) Transcript.--The transcript of any public meeting conducted 
pursuant to this section shall be published on the Internet Web site of 
the Food and Drug Administration.
SEC. 1140. STUDY ON DRUG LABELING BY ELECTRONIC MEANS.
    (a) Study.--The Comptroller General of the United States shall 
conduct a study on the benefits and efficiencies of electronic patient 
labeling of prescription drugs, as a complete or partial substitute for 
patient labeling in paper form. The study shall address the 
implementation costs to the different levels of the distribution 
system, logistical barriers to utilizing a system of electronic patient 
labeling, and any anticipated public health impact of movement to 
electronic labeling.
    (b) Report.--Not later than 1 year after the date of enactment of 
this Act, the Comptroller General shall submit to Congress a report on 
the results of the study under subsection (a).
SEC. 1141. RECOMMENDATIONS ON INTEROPERABILITY STANDARDS.
    (a) In General.--The Secretary of Health and Human Services may 
facilitate, and, as appropriate, may consult with the Attorney General 
to facilitate, the development of recommendations on interoperability 
standards to inform and facilitate the exchange of prescription drug 
information across State lines by States receiving grant funds under--
        (1) the Harold Rogers Prescription Drug Monitoring Program 
    established under the Departments of Commerce, Justice, and State, 
    the Judiciary, and Related Agencies Appropriations Act, 2002 
    (Public Law 107-77; 115 Stat. 748); and
        (2) the Controlled Substance Monitoring Program established 
    under section 399O of the Public Health Service Act (42 U.S.C. 
    280g-3).
    (b) Requirements.--The Secretary of Health and Human Services shall 
consider the following in facilitating the development of 
recommendations on interoperability of prescription drug monitoring 
programs under subsection (a)--
        (1) open standards that are freely available, without cost and 
    without restriction, in order to promote broad implementation;
        (2) the use of exchange intermediaries, or hubs, as necessary 
    to facilitate interstate interoperability by accommodating State-
    to-hub, hub-to-hub, and direct State-to-State communication;
        (3) the support of transmissions that are fully secured as 
    required, using industry standard methods of encryption, to ensure 
    that protected health information and personally identifiable 
    information are not compromised at any point during such 
    transmission;
        (4) access control methodologies to share protected information 
    solely in accordance with State laws and regulations; and
        (5) consider model interoperability standards developed by the 
    Alliance of States with Prescription Monitoring Programs.
    (c) Report.--
        (1) In general.--Not later than 1 year after the date of 
    enactment of this Act, the Secretary of Health and Human Services 
    shall submit to the Committee on Health, Education, Labor, and 
    Pensions of the Senate and the Committee on Energy and Commerce of 
    the House of Representatives a report on enhancing the 
    interoperability of State prescription drug monitoring programs 
    with other technologies and databases used for detecting and 
    reducing fraud, diversion, and abuse of prescription drugs.
        (2) Contents.--The report required under paragraph (1) shall 
    include--
            (A) an assessment of legal, technical, fiscal, privacy, or 
        security challenges that have an impact on interoperability;
            (B) a discussion of how State prescription drug monitoring 
        programs could increase the production and distribution of 
        unsolicited reports to prescribers and dispensers of 
        prescription drugs, law enforcement officials, and health 
        professional licensing agencies, including the enhancement of 
        such reporting through interoperability with other States and 
        relevant technology and databases;
            (C) any recommendations for addressing challenges that 
        impact interoperability of State prescription drug monitoring 
        programs in order to reduce fraud, diversion, and abuse of 
        prescription drugs; and
            (D) an assessment of the extent to which providers use 
        prescription drug management programs in delivering care and 
        preventing prescription drug abuse.
SEC. 1142. CONFLICTS OF INTEREST.
    (a) In General.--Section 712 (21 U.S.C. 379d-1) is amended--
        (1) by striking subsections (b) and (c) and inserting the 
    following subsections:
    ``(b) Recruitment for Advisory Committees.--
        ``(1) In general.--The Secretary shall--
            ``(A) develop and implement strategies on effective 
        outreach to potential members of advisory committees at 
        universities, colleges, other academic research centers, 
        professional and medical societies, and patient and consumer 
        groups;
            ``(B) seek input from professional medical and scientific 
        societies to determine the most effective informational and 
        recruitment activities;
            ``(C) at least every 180 days, request referrals for 
        potential members of advisory committees from a variety of 
        stakeholders, including--
                ``(i) product developers, patient groups, and disease 
            advocacy organizations; and
                ``(ii) relevant--

                    ``(I) professional societies;
                    ``(II) medical societies;
                    ``(III) academic organizations; and
                    ``(IV) governmental organizations; and

            ``(D) in carrying out subparagraphs (A) and (B), take into 
        account the levels of activity (including the numbers of annual 
        meetings) and the numbers of vacancies of the advisory 
        committees.
        ``(2) Recruitment activities.--The recruitment activities under 
    paragraph (1) may include--
            ``(A) advertising the process for becoming an advisory 
        committee member at medical and scientific society conferences;
            ``(B) making widely available, including by using existing 
        electronic communications channels, the contact information for 
        the Food and Drug Administration point of contact regarding 
        advisory committee nominations; and
            ``(C) developing a method through which an entity receiving 
        funding from the National Institutes of Health, the Agency for 
        Healthcare Research and Quality, the Centers for Disease 
        Control and Prevention, or the Veterans Health Administration 
        can identify a person whom the Food and Drug Administration can 
        contact regarding the nomination of individuals to serve on 
        advisory committees.
        ``(3) Expertise.--In carrying out this subsection, the 
    Secretary shall seek to ensure that the Secretary has access to the 
    most current expert advice.
    ``(c) Disclosure of Determinations and Certifications.--
Notwithstanding section 107(a)(2) of the Ethics in Government Act of 
1978, the following shall apply:
        ``(1) 15 or more days in advance.--As soon as practicable, but 
    (except as provided in paragraph (2)) not later than 15 days prior 
    to a meeting of an advisory committee to which a written 
    determination as referred to in section 208(b)(1) of title 18, 
    United States Code, or a written certification as referred to in 
    section 208(b)(3) of such title, applies, the Secretary shall 
    disclose (other than information exempted from disclosure under 
    section 552 or section 552a of title 5, United States Code 
    (popularly known as the Freedom of Information Act and the Privacy 
    Act of 1974, respectively)) on the Internet Web site of the Food 
    and Drug Administration--
            ``(A) the type, nature, and magnitude of the financial 
        interests of the advisory committee member to which such 
        determination or certification applies; and
            ``(B) the reasons of the Secretary for such determination 
        or certification, including, as appropriate, the public health 
        interest in having the expertise of the member with respect to 
        the particular matter before the advisory committee.
        ``(2) Less than 30 days in advance.--In the case of a financial 
    interest that becomes known to the Secretary less than 30 days 
    prior to a meeting of an advisory committee to which a written 
    determination as referred to in section 208(b)(1) of title 18, 
    United States Code, or a written certification as referred to in 
    section 208(b)(3) of such title applies, the Secretary shall 
    disclose (other than information exempted from disclosure under 
    section 552 or 552a of title 5, United States Code) on the Internet 
    Web site of the Food and Drug Administration, the information 
    described in subparagraphs (A) and (B) of paragraph (1) as soon as 
    practicable after the Secretary makes such determination or 
    certification, but in no case later than the date of such 
    meeting.'';
        (2) in subsection (d), by striking ``subsection (c)(3)'' and 
    inserting ``subsection (c)'';
        (3) by amending subsection (e) to read as follows:
    ``(e) Annual Report.--
        ``(1) In general.--Not later than February 1 of each year, the 
    Secretary shall submit to the Committee on Appropriations and the 
    Committee on Health, Education, Labor, and Pensions of the Senate, 
    and the Committee on Appropriations and the Committee on Energy and 
    Commerce of the House of Representatives, a report that describes--
            ``(A) with respect to the fiscal year that ended on 
        September 30 of the previous year, the number of persons 
        nominated for participation at meetings for each advisory 
        committee, the number of persons so nominated, and willing to 
        serve, the number of vacancies on each advisory committee, and 
        the number of persons contacted for service as members on each 
        advisory committee meeting for each advisory committee who did 
        not participate because of the potential for such participation 
        to constitute a disqualifying financial interest under section 
        208 of title 18, United States Code;
            ``(B) with respect to such year, the number of persons 
        contacted for services as members for each advisory committee 
        meeting for each advisory committee who did not participate 
        because of reasons other than the potential for such 
        participation to constitute a disqualifying financial interest 
        under section 208 of title 18, United States Code;
            ``(C) with respect to such year, the number of members 
        attending meetings for each advisory committee; and
            ``(D) with respect to such year, the aggregate number of 
        disclosures required under subsection (d) and the percentage of 
        individuals to whom such disclosures did not apply who served 
        on such committee.
        ``(2) Public availability.--Not later than 30 days after 
    submitting any report under paragraph (1) to the committees 
    specified in such paragraph, the Secretary shall make each such 
    report available to the public.'';
        (4) in subsection (f), by striking ``shall review guidance'' 
    and all that follows through the end of the subsection and 
    inserting the following: ``shall--
        ``(1) review guidance of the Food and Drug Administration with 
    respect to advisory committees regarding disclosure of conflicts of 
    interest and the application of section 208 of title 18, United 
    States Code; and
        ``(2) update such guidance as necessary to ensure that the Food 
    and Drug Administration receives appropriate access to needed 
    scientific expertise, with due consideration of the requirements of 
    such section 208.''; and
        (5) by adding at the end the following:
    ``(g) Guidance on Reported Disclosed 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 disclosed under subsection (c) 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.''.
    (b) Applicability.--The amendments made by subsection (a) apply 
beginning on October 1, 2012.
SEC. 1143. NOTIFICATION OF FDA INTENT TO REGULATE LABORATORY-DEVELOPED 
TESTS.
    (a) In General.--The Food and Drug Administration may not issue any 
draft or final guidance on the regulation of laboratory-developed tests 
under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) 
without, at least 60 days prior to such issuance--
        (1) notifying the Committee on Energy and Commerce of the House 
    of Representatives and the Committee on Health, Education, Labor, 
    and Pensions of the Senate of the Administration's intent to take 
    such action; and
        (2) including in such notification the anticipated details of 
    such action.
    (b) Sunset.--Subsection (a) shall cease to have force or effect on 
the date that is 5 years after the date of enactment of this Act.

                      Subtitle D--Synthetic Drugs

SEC. 1151. SHORT TITLE.
    This subtitle may be cited as the ``Synthetic Drug Abuse Prevention 
Act of 2012''.
SEC. 1152. ADDITION OF SYNTHETIC DRUGS TO SCHEDULE I OF THE CONTROLLED 
SUBSTANCES ACT.
    (a) Cannabimimetic Agents.--Schedule I, as set forth in section 
202(c) of the Controlled Substances Act (21 U.S.C. 812(c)) is amended 
by adding at the end the following:
    ``(d)(1) Unless specifically exempted or unless listed in another 
schedule, any material, compound, mixture, or preparation which 
contains any quantity of cannabimimetic agents, or which contains their 
salts, isomers, and salts of isomers whenever the existence of such 
salts, isomers, and salts of isomers is possible within the specific 
chemical designation.
    ``(2) In paragraph (1):
        ``(A) The term `cannabimimetic agents' means any substance that 
    is a cannabinoid receptor type 1 (CB1 receptor) agonist as 
    demonstrated by binding studies and functional assays within any of 
    the following structural classes:
            ``(i) 2-(3-hydroxycyclohexyl)phenol with substitution at 
        the 5-position of the phenolic ring by alkyl or alkenyl, 
        whether or not substituted on the cyclohexyl ring to any 
        extent.
            ``(ii) 3-(1-naphthoyl)indole or 3-(1-naphthylmethane)indole 
        by substitution at the nitrogen atom of the indole ring, 
        whether or not further substituted on the indole ring to any 
        extent, whether or not substituted on the naphthoyl or naphthyl 
        ring to any extent.
            ``(iii) 3-(1-naphthoyl)pyrrole by substitution at the 
        nitrogen atom of the pyrrole ring, whether or not further 
        substituted in the pyrrole ring to any extent, whether or not 
        substituted on the naphthoyl ring to any extent.
            ``(iv) 1-(1-naphthylmethylene)indene by substitution of the 
        3-position of the indene ring, whether or not further 
        substituted in the indene ring to any extent, whether or not 
        substituted on the naphthyl ring to any extent.
            ``(v) 3-phenylacetylindole or 3-benzoylindole by 
        substitution at the nitrogen atom of the indole ring, whether 
        or not further substituted in the indole ring to any extent, 
        whether or not substituted on the phenyl ring to any extent.
        ``(B) Such term includes--
            ``(i) 5-(1,1-dimethylheptyl)-2-[(1R,3S)-3-
        hydroxycyclohexyl]-phenol (CP-47,497);
            ``(ii) 5-(1,1-dimethyloctyl)-2-[(1R,3S)-3-
        hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP-47,497 C8-
        homolog);
            ``(iii) 1-pentyl-3-(1-naphthoyl)indole (JWH-018 and AM678);
            ``(iv) 1-butyl-3-(1-naphthoyl)indole (JWH-073);
            ``(v) 1-hexyl-3-(1-naphthoyl)indole (JWH-019);
            ``(vi) 1-[2-(4-morpholinyl)ethyl]-3-(1-naphthoyl)indole 
        (JWH-200);
            ``(vii) 1-pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250);
            ``(viii) 1-pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH-
        081);
            ``(ix) 1-pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122);
            ``(x) 1-pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398);
            ``(xi) 1-(5-fluoropentyl)-3-(1-naphthoyl)indole (AM2201);
            ``(xii) 1-(5-fluoropentyl)-3-(2-iodobenzoyl)indole (AM694);
            ``(xiii) 1-pentyl-3-[(4-methoxy)-benzoyl]indole (SR-19 and 
        RCS-4);
            ``(xiv) 1-cyclohexylethyl-3-(2-methoxyphenylacetyl)indole 
        (SR-18 and RCS-8); and
            ``(xv) 1-pentyl-3-(2-chlorophenylacetyl)indole (JWH-
        203).''.
    (b) Other Drugs.--Schedule I of section 202(c) of the Controlled 
Substances Act (21 U.S.C. 812(c)) is amended in subsection (c) by 
adding at the end the following:
        ``(18) 4-methylmethcathinone (Mephedrone).
        ``(19) 3,4-methylenedioxypyrovalerone (MDPV).
        ``(20) 2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E).
        ``(21) 2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D).
        ``(22) 2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C).
        ``(23) 2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I).
        ``(24) 2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-
    2).
        ``(25) 2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-
    T-4).
        ``(26) 2-(2,5-Dimethoxyphenyl)ethanamine (2C-H).
        ``(27) 2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N).
        ``(28) 2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine (2C-
    P).''.
SEC. 1153. TEMPORARY SCHEDULING TO AVOID IMMINENT HAZARDS TO PUBLIC 
SAFETY EXPANSION.
    Section 201(h)(2) of the Controlled Substances Act (21 U.S.C. 
811(h)(2)) is amended--
        (1) by striking ``one year'' and inserting ``2 years''; and
        (2) by striking ``six months'' and inserting ``1 year''.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.
```