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[112th Congress Public Law 144]
[From the U.S. Government Printing Office]

[[Page 126 STAT. 993]]

Public Law 112-144
112th Congress

                                 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. <<NOTE: July 9, 2012 -  [S. 3187]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, <<NOTE: Food and Drug 
Administration Safety and Innovation Act.>> 
SECTION 1. <<NOTE: 21 USC 301 note.>> 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.

[[Page 126 STAT. 994]]

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.

[[Page 126 STAT. 995]]

               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.

[[Page 126 STAT. 996]]

    (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 <<NOTE: Prescription Drug User Fee Amendments of 2012. 21 
USC 301 note.>> 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) <<NOTE: 21 USC 379g note.>>  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

[[Page 126 STAT. 997]]

                                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--

[[Page 126 STAT. 998]]

                          ``(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.-- <<NOTE: Notice. Federal 
        Register, publication.>> 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) <<NOTE: Determination. Time period.>> 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

[[Page 126 STAT. 999]]

                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. <<NOTE: Federal Register, publication.>> 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) <<NOTE: Contracts. Reviews. Deadlines.>> 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). <<NOTE: Reports.>> 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. <<NOTE: Publication. Public comments.>> 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. <<NOTE: Effective date.>> 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.-- <<NOTE: Deadline.>> 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

[[Page 126 STAT. 1000]]

        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.-- <<NOTE: Effective date.>> 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;

[[Page 126 STAT. 1001]]

                          ``(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.-- <<NOTE: 21 USC 379g note.>> 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.-- <<NOTE: 21 USC 379g-2 note.>> 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) <<NOTE: 21 USC 379g note, 379h-2 note.>> 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 <<NOTE: Repeals.>> 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) <<NOTE: 21 USC 379g note.>> 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) <<NOTE: 21 USC 379g notes.>> 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.

[[Page 126 STAT. 1002]]

            (3) Effective September 30, 1997, section 105 of the 
        Prescription Drug User Fee Act of 1992 (Public Law 102-
        571) <<NOTE: 21 USC 379g notes.>> is repealed.
SEC. 106. <<NOTE: 21 USC 379g note.>> 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. <<NOTE: 21 USC 379g note.>> SAVINGS CLAUSE.

     <<NOTE: Continuation. Time period.>> 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-- <<NOTE: Medical Device User Fee Amendments of 2012.>> FEES 
RELATING TO DEVICES
SEC. 201. SHORT TITLE; FINDINGS.

    (a) Short Title.-- <<NOTE: 21 USC 301 note.>> This title may be 
cited as the ``Medical Device User Fee Amendments of 2012''.

    (b) Findings.-- <<NOTE: 21 USC 379i note.>> 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'';

[[Page 126 STAT. 1003]]

            (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

[[Page 126 STAT. 1004]]

            (4) by inserting before paragraph (4), as so redesignated, 
        the following:
            ``(1) In general.-- <<NOTE: Time period. Federal Register, 
        publication.>> 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

[[Page 126 STAT. 1005]]

                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

[[Page 126 STAT. 1006]]

        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.-- <<NOTE: Effective 
                date.>> 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.-- <<NOTE: Public information. Web 
                site. Deadlines.>> 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,

[[Page 126 STAT. 1007]]

                supplements, and premarket notifications in the 
                cohort.''; and
            (2) in paragraph (2), by striking ``2008 through 2012'' and 
        inserting ``2013 through 2017''.
SEC. 205. <<NOTE: 21 USC 379i note.>> SAVINGS CLAUSE.

     <<NOTE: Continuation. Time period.>> 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. <<NOTE: 21 USC 379i note.>> 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.-- <<NOTE: 21 USC 379i note.>> 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.-- <<NOTE: Repeal.>> Section 217 of the Food 
        and Drug Administration Amendments Act of 2007 (Title II of 
        Public Law 110-85) <<NOTE: 21 USC 379i note.>> 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, <<NOTE: 121 Stat. 823.>> by 
        striking the item relating to section 217.

    (c) Technical Clarification.-- <<NOTE: Repeal.>> Effective September 
30, 2007--
            (1) section 107 of the Medical Device User Fee and 
        Modernization Act of 2002 (Public Law 107-250) <<NOTE: 21 USC 
        379i notes.>> 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. <<NOTE: 21 USC 379d-3.>> 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

[[Page 126 STAT. 1008]]

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-- <<NOTE: Generic Drug User Fee Amendments of 2012.>> FEES 
RELATING TO GENERIC DRUGS
SEC. 301. SHORT TITLE.

    (a) Short Title.-- <<NOTE: 21 USC 301 note.>> This title may be 
cited as the ``Generic Drug User Fee Amendments of 2012''.

    (b) Finding.-- <<NOTE: 21 USC 379j-41 note.>> 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. <<NOTE: 21 USC 379j-41.>> 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--

[[Page 126 STAT. 1009]]

                          ``(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

[[Page 126 STAT. 1010]]

        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

[[Page 126 STAT. 1011]]

        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. <<NOTE: 21 USC 379j-42.>> AUTHORITY TO ASSESS AND USE 
                          HUMAN GENERIC DRUG FEES.

    ``(a) Types of Fees.-- <<NOTE: Effective date.>> 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.-- <<NOTE: Deadline. Federal Register, 
                publication.>> 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

[[Page 126 STAT. 1012]]

                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.-- <<NOTE: Deadlines. Federal Register, 
                publication.>> 
                          ``(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.-- 
                      <<NOTE: Deadline. Criteria. Publication.>> 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.-- <<NOTE: Public 
                      information. Web 
                      site. Criteria. Publication.>> 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.

[[Page 126 STAT. 1013]]

            ``(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.-- <<NOTE: Deadlines. Federal Register, 
                publications.>> 
                          ``(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

[[Page 126 STAT. 1014]]

                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.-- <<NOTE: Federal Register, 
                publications.>> 
                          ``(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

[[Page 126 STAT. 1015]]

                      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).

[[Page 126 STAT. 1016]]

            ``(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.-- <<NOTE: Notice. Federal 
        Register, publication.>> 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

[[Page 126 STAT. 1017]]

                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.-- <<NOTE: Deadlines.>> 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.-- <<NOTE: Time 
        period.>> 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

[[Page 126 STAT. 1018]]

                    ``(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) <<NOTE: Federal Register, publication.>> 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) <<NOTE: Deadlines.>> 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.-- <<NOTE: Federal Register, 
                publication.>> The Secretary may, by notice published in 
                the Federal Register, specify the means and format

[[Page 126 STAT. 1019]]

                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.-- <<NOTE: Deadlines.>> 
            ``(1) Generic drug backlog fee.-- <<NOTE: Public 
        information.>> 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) <<NOTE: Notification.>> 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

[[Page 126 STAT. 1020]]

        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) <<NOTE: Public information.>> 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.-- <<NOTE: Effective date.>> 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.

[[Page 126 STAT. 1021]]

            ``(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) <<NOTE: Effective date.>> 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

[[Page 126 STAT. 1022]]

                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.-- <<NOTE: Deadline.>> 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.-- <<NOTE: Deadline.>> 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. <<NOTE: 21 USC 379j-43.>> REAUTHORIZATION; REPORTING 
                          REQUIREMENTS.

    ``(a) Performance Report.-- <<NOTE: Effective date.>> 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

[[Page 126 STAT. 1023]]

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.-- <<NOTE: Effective date.>> 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.-- <<NOTE: Web posting.>> 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) <<NOTE: Notice. Federal Register, 
                publication.>> 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) <<NOTE: Time period.>> provide a period of 30 
                days after the public meeting to obtain written comments 
                from the public suggesting changes to this part; and
                    ``(D) <<NOTE: Web posting.>> 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).

[[Page 126 STAT. 1024]]

            ``(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) <<NOTE: Federal Register, 
                publication.>> publish such recommendations in the 
                Federal Register;
                    ``(C) <<NOTE: Time period.>> 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.-- <<NOTE: Web 
                posting.>> 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.-- <<NOTE: 21 USC 379j-41 note.>> 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.-- <<NOTE: 21 USC 379j-43 note.>> 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. <<NOTE: 21 USC 379j-41 note.>> 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

[[Page 126 STAT. 1025]]

pharmaceutical ingredient that was manufactured, prepared, propagated, 
compounded, or processed in such a facility.''.
SEC. 307. <<NOTE: 21 USC 379d-3.>> 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. <<NOTE: 21 USC 379d-4.>> REPORTING REQUIREMENTS.

    ``(a) Generic Drugs.-- <<NOTE: Effective date.>> 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

[[Page 126 STAT. 1026]]

        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-- <<NOTE: Biosimilar User Fee Act of 2012.>> FEES RELATING TO 
BIOSIMILAR BIOLOGICAL PRODUCTS
SEC. 401. SHORT TITLE; FINDING.

    (a) Short Title.-- <<NOTE: 21 USC 301 note.>> This title may be 
cited as the ``Biosimilar User Fee Act of 2012''.

    (b) Finding.-- <<NOTE: 21 USC 379j-51 note.>> 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. <<NOTE: 21 USC 379j-51.>> 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;

[[Page 126 STAT. 1027]]

                    ``(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;

[[Page 126 STAT. 1028]]

                    ``(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.

[[Page 126 STAT. 1029]]

                          ``(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. <<NOTE: 21 USC 379j-52.>> AUTHORITY TO ASSESS AND USE 
                          BIOSIMILAR BIOLOGICAL PRODUCT FEES.

    ``(a) Types of Fees.-- <<NOTE: Effective date.>> 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

[[Page 126 STAT. 1030]]

                                to support a biosimilar biological 
                                product application.
                          ``(v) Transition rule.-- 
                      <<NOTE: Deadlines.>> 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.-- 
                <<NOTE: Deadline.>> 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

[[Page 126 STAT. 1031]]

                      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) <<NOTE: Deadline.>> 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

[[Page 126 STAT. 1032]]

                                    ``(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)

[[Page 126 STAT. 1033]]

                      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

[[Page 126 STAT. 1034]]

                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.-- <<NOTE: Time period.>> 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,

[[Page 126 STAT. 1035]]

        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

[[Page 126 STAT. 1036]]

                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

[[Page 126 STAT. 1037]]

                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.-- 
<<NOTE: Deadline.>> 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. <<NOTE: 21 USC 379j-53.>> REAUTHORIZATION; REPORTING 
                          REQUIREMENTS.

    ``(a) Performance Report.-- <<NOTE: Effective date.>> 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.-- <<NOTE: Web posting.>> The Secretary 
shall make the reports required under subsections (a) and (b) available 
to the

[[Page 126 STAT. 1038]]

public on the Internet Web site of the Food and Drug Administration.

    ``(d) Study.-- <<NOTE: Publications.>> 
            ``(1) In general.-- <<NOTE: Contracts.>> 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) <<NOTE: Federal Register, 
                publication.>> publish such recommendations in the 
                Federal Register;
                    ``(C) <<NOTE: Time period.>> 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.-- <<NOTE: 21 USC 379j-51 note.>> 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.-- <<NOTE: 21 USC 379j-53 note.>> 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.

[[Page 126 STAT. 1039]]

SEC. 405. <<NOTE: 21 USC 379j-51 note.>> 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. <<NOTE: 21 USC 379g note.>> SAVINGS CLAUSE.

    Notwithstanding <<NOTE: Continuation. Time period.>> 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, <<NOTE: 21 USC 379d-4.>> as added by section 308 of 
this Act, is amended by adding at the end the following:

    ``(b) Biosimilar Biological Products.--
            ``(1) In general.-- <<NOTE: Effective date.>> 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).

[[Page 126 STAT. 1040]]

    (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.-- <<NOTE: 21 USC 355a.>> 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. <<NOTE: 21 USC 355a note.>> COMMUNICATION WITH PEDIATRIC 
                        REVIEW COMMITTEE.

    Not <<NOTE: Deadline. Procedures.>>  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). <<NOTE: Public information. Web posting.>> Such internal standard 
operating procedures shall be made publicly available on the Internet 
Web site of the Food and Drug Administration.
SEC. 504. <<NOTE: 21 USC 355a note.>> ACCESS TO DATA.

    Not <<NOTE: Deadline. Public information. Web posting. Time 
period.>> 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--

[[Page 126 STAT. 1041]]

            (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), <<NOTE: Web posting.>> the 
                      Secretary shall make available to the public in an 
                      easily accessible manner, including through the

[[Page 126 STAT. 1042]]

                      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.-- <<NOTE: Applicability.>> 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) <<NOTE: Effective date. Deadlines.>> 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. <<NOTE: Notification.>> 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. <<NOTE: Public information. Web posting.>> 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

[[Page 126 STAT. 1043]]

        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. <<NOTE: Deadlines.>> 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--

[[Page 126 STAT. 1044]]

                          ``(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.-- 
        <<NOTE: Notification.>> 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.-- <<NOTE: Applicability.>> 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.-- <<NOTE: Consultation.>> 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,'';

[[Page 126 STAT. 1045]]

                    (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.-- <<NOTE: 21 USC 355c note.>> 
            (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. <<NOTE: 21 USC 355c-1.>> REPORT.

    (a) In General.-- <<NOTE: Public information. Web posting.>> 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

[[Page 126 STAT. 1046]]

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

[[Page 126 STAT. 1047]]

            (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.-- <<NOTE: Time period. Consultation.>> 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)--

[[Page 126 STAT. 1048]]

                                    (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)--

[[Page 126 STAT. 1049]]

                          (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

[[Page 126 STAT. 1050]]

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.-- <<NOTE: 21 USC 355a note.>> 
            (1) Application.-- <<NOTE: Effective date.>> 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) <<NOTE: Time period.>> 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.-- <<NOTE: Deadline.>> 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.-- <<NOTE: Strategic plan.>> 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.-- <<NOTE: Time period. Effective 
date.>> For the 5-year period beginning on the date of enactment of this 
subsection, at least one of the

[[Page 126 STAT. 1051]]

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) <<NOTE: Definition.>> 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) <<NOTE: Definition.>> 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.--

[[Page 126 STAT. 1052]]

            ``(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.-- <<NOTE: Deadline.>> 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. <<NOTE: Decision.>> 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) <<NOTE: Deadline. Reports.>> 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

[[Page 126 STAT. 1053]]

        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) <<NOTE: Continuation.>> 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. <<NOTE: 21 USC 360h-1.>> 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) <<NOTE: Procedures.>> clarify procedures for 
        conducting device recall audit checks to improve the ability of 
        investigators to perform those checks in a consistent manner;
            ``(3) <<NOTE: Criteria.>> 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--

[[Page 126 STAT. 1054]]

            ``(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) <<NOTE: Determination.>> 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) <<NOTE: Decision. Deadline.>> 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

[[Page 126 STAT. 1055]]

in subsection (i)), a person may submit a request under this clause for 
the Secretary to classify the device.
    ``(iii) <<NOTE: Classification. Deadline.>> 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) <<NOTE: Federal Register, publication.>> 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--

[[Page 126 STAT. 1056]]

            ``(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) <<NOTE: 21 USC 360c note.>> 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

[[Page 126 STAT. 1057]]

                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

[[Page 126 STAT. 1058]]

                                    (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

[[Page 126 STAT. 1059]]

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) <<NOTE: 21 USC 351 note.>> 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.--T <<NOTE: Web posting. 21 USC 360c-1.>> he 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.-- 
                <<NOTE: Deadlines.>> 
                          ``(i) Period.--Subject to suspension or 
                      withdrawal under subparagraph (B), any 
                      accreditation under this

[[Page 126 STAT. 1060]]

                      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. <<NOTE: Definition.>> 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. <<NOTE: Determination.>> 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.'';

[[Page 126 STAT. 1061]]

            (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.-- <<NOTE: Determination. 21 
USC 360j note.>> 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. <<NOTE: Deadlines.>> 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.-- 
                <<NOTE: Procedures.>> 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.

[[Page 126 STAT. 1062]]

            ``(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) <<NOTE: Deadline.>> 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

[[Page 126 STAT. 1063]]

                    ``(G) may have common, standardized design 
                characteristics, chemical and material compositions, and 
                manufacturing processes as commercially distributed 
                devices.
            ``(2) Limitations.-- <<NOTE: Applicability.>> 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) <<NOTE: Notification. Deadline.>> 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.-- <<NOTE: Deadline.>> 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.-- <<NOTE: Web posting.>> 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.-- <<NOTE: Determination.>> 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--

[[Page 126 STAT. 1064]]

            (1) by striking ``(C) For guidance documents'' and inserting 
        ``(C)(i) For guidance documents''; and
            (2) by adding at the end the following:
            ``(ii) <<NOTE: Notification.>> 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) <<NOTE: Deadlines. 21 USC 360e-1 note.>> 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) <<NOTE: Time period.>> 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) <<NOTE: Applicability.>> 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).''.

[[Page 126 STAT. 1065]]

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 <<NOTE: 21 USC 360.>> 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) <<NOTE: Time period.>> 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) <<NOTE: Applicability.>> 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:

[[Page 126 STAT. 1066]]

            ``(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.-- <<NOTE: Deadline.>> 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.

[[Page 126 STAT. 1067]]

            ``(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) <<NOTE: Effective date.>> 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:

[[Page 126 STAT. 1068]]

    ``(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) <<NOTE: Confirmation.>> 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) <<NOTE: Deadline. 21 USC 351 note.>> 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) <<NOTE: Regulations.>> 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

[[Page 126 STAT. 1069]]

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) <<NOTE: 21 USC 381 note.>> 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) <<NOTE: Deadlines. 21 USC 381 note.>> 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) <<NOTE: Notice.>> issue a notice of proposed 
                rulemaking that includes a copy of the proposed 
                regulation;
                    (B) <<NOTE: Time period.>> provide a period of not 
                less than 60 days for comments on the proposed 
                regulation; and
                    (C) <<NOTE: Publication.>> 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) <<NOTE: 21 USC 334.>> 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) <<NOTE: Deadlines. 21 USC 334 note.>> 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) <<NOTE: Notice.>> issue a notice of proposed 
                rulemaking that includes the proposed regulation;
                    ``(B) <<NOTE: Time period.>> provide a period of not 
                less than 60 days for comments on the proposed 
                regulation; and

[[Page 126 STAT. 1070]]

                    ``(C) <<NOTE: Publication.>> 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) <<NOTE: 21 USC 334 note.>> 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) <<NOTE: Applicability.>> 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.

[[Page 126 STAT. 1071]]

    ``(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 <<NOTE: Definition.>> 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.''.

[[Page 126 STAT. 1072]]

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. <<NOTE: 21 USC 384e.>> 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) <<NOTE: Reviews. Audits.>> 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.

[[Page 126 STAT. 1073]]

    ``(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) <<NOTE: Deadlines. Regulations.>> 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) <<NOTE: Notice.>> issue a notice of proposed 
                rulemaking that includes the proposed regulation;
                    ``(II) <<NOTE: Time period.>> provide a period of 
                not less than 60 days for comments on the proposed 
                regulation; and
                    ``(III) <<NOTE: Publication.>> 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) <<NOTE: Deadlines.>> Regulations.--
                    ``(A) In general.--The Secretary, in consultation 
                with the Secretary of Homeland Security acting through 
                U.S.

[[Page 126 STAT. 1074]]

                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) <<NOTE: Notice.>> issue a notice of 
                      proposed rulemaking that includes the proposed 
                      regulation;
                          ``(ii) <<NOTE: Time period.>> provide a period 
                      of not less than 60 days for comments on the 
                      proposed regulation; and
                          ``(iii) <<NOTE: Publication.>> 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). <<NOTE: Applicability.>> 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) <<NOTE: Federal Register, publication.>> 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) <<NOTE: Deadlines. 21 USC 381 note.>> 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) <<NOTE: Notice.>> issue a notice of 
                      proposed rulemaking that includes the proposed 
                      regulation;
                          (ii) <<NOTE: Time period.>> provide a period 
                      of not less than 60 days for comments on the 
                      proposed regulation; and
                          (iii) <<NOTE: Publication.>> 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).

[[Page 126 STAT. 1075]]

            (3) <<NOTE: Time period.>> 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. <<NOTE: 21 USC
                        360bbb-7.>> 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

[[Page 126 STAT. 1076]]

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) <<NOTE: 18 USC 2320 note.>> 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) <<NOTE: 28 USC 994 note.>> Sentencing Commission Directive.--
            (1) <<NOTE: Review. Guidelines.>> 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;

[[Page 126 STAT. 1077]]

                    (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. <<NOTE: 21 USC 337a.>> 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. <<NOTE: 21 USC 355f.>> 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

[[Page 126 STAT. 1078]]

        infectious disease product at any time before the submission of 
        an application under section 505(b) for such 
        drug. <<NOTE: Deadline. Determination.>> 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) <<NOTE: Deadlines.>> 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) <<NOTE: Notice.>> issue a notice of proposed 
                rulemaking that includes the proposed regulation;
                    ``(B) <<NOTE: Time period.>> provide a period of not 
                less than 60 days for comments on the proposed 
                regulation; and
                    ``(C) <<NOTE: Publication.>> 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) <<NOTE: Public information.>> In general.--The 
                Secretary shall establish and maintain a list of 
                qualifying pathogens, and shall make public the 
                methodology for developing such list.

[[Page 126 STAT. 1079]]

                    ``(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) <<NOTE: Consultation.>> 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) <<NOTE: Time 
                period. Publication. Regulations.>> 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) <<NOTE: Definition.>> 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) <<NOTE: 21 USC 355f note.>> 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. <<NOTE: 21 USC 360n-1.>> 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) <<NOTE: 21 USC 360n-1 note.>> 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.

[[Page 126 STAT. 1080]]

SEC. 804. <<NOTE: 21 USC 360a-1.>> 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) <<NOTE: Definition.>> 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) <<NOTE: Reports.>> 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

[[Page 126 STAT. 1081]]

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.

[[Page 126 STAT. 1082]]

SEC. 806. <<NOTE: Deadlines. Publication. 21 USC 355 
                        note.>> 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) <<NOTE: Public comments.>> 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) <<NOTE: 21 USC 356 note.>> 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

[[Page 126 STAT. 1083]]

                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) <<NOTE: Deadline. Determination.>> 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

[[Page 126 STAT. 1084]]

                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) <<NOTE: Records. Determination. Deadline.>> 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) <<NOTE: Regulations.>> 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) <<NOTE: Evaluation.>> 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

[[Page 126 STAT. 1085]]

                    ``(B) pays any fee that may be required under 
                section 736.
            ``(2) <<NOTE: Applicability.>> 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) <<NOTE: 21 USC 356 note.>> Guidance; Amended Regulations.--
            (1) <<NOTE: Deadline.>> 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.

[[Page 126 STAT. 1086]]

            (2) <<NOTE: Deadline. Public comments.>> 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

[[Page 126 STAT. 1087]]

        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) <<NOTE: Deadline. Determination.>> 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) <<NOTE: 21 USC 356 note.>> Guidance; Amended Regulations.--
            (1) <<NOTE: Deadlines.>> 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.

[[Page 126 STAT. 1088]]

                    (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) <<NOTE: Notice.>> issue a notice 
                                of proposed rulemaking that includes the 
                                proposed regulation;
                                    (II) <<NOTE: Time period.>> provide 
                                a period of not less than 60 days for 
                                comments on the proposed regulation; and
                                    (III) <<NOTE: Publication.>> 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. <<NOTE: 21 USC
                        360bbb-8.>> CONSULTATION WITH EXTERNAL 
                        EXPERTS ON RARE DISEASES, TARGETED 
                        THERAPIES, AND GENETIC TARGETING OF 
                        TREATMENTS.

    ``(a) <<NOTE: Applicability.>> 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.--

[[Page 126 STAT. 1089]]

                    ``(A) <<NOTE: Records.>> 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.--

[[Page 126 STAT. 1090]]

            ``(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) <<NOTE: Applicability.>> 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. <<NOTE: 29 USC 792 note.>> 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) <<NOTE: Deadline.>> 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

[[Page 126 STAT. 1091]]

                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) <<NOTE: Effective date.>> 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

[[Page 126 STAT. 1092]]

        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) <<NOTE: Web posting.>> 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

[[Page 126 STAT. 1093]]

        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) <<NOTE: Web posting.>> 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;

[[Page 126 STAT. 1094]]

                    (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. <<NOTE: 21 USC 360ff.>> PRIORITY REVIEW TO ENCOURAGE 
                        TREATMENTS FOR RARE PEDIATRIC DISEASES.

    ``(a) Definitions.--In this section:
            ``(1) <<NOTE: Deadline.>> 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--

[[Page 126 STAT. 1095]]

                          ``(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) <<NOTE: Deadline.>> 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) <<NOTE: Time period.>> 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) <<NOTE: Deadline.>> 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

[[Page 126 STAT. 1096]]

                has not yet submitted the human drug application 
                described in the notification.
            ``(5) <<NOTE: Time period.>> 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) <<NOTE: Effective date.>> 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--

[[Page 126 STAT. 1097]]

                    ``(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) <<NOTE: Deadline.>> 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) <<NOTE: Time period.>> 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) <<NOTE: Federal Register, publication. Web 
        posting.>> 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) <<NOTE: Time period.>> 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

[[Page 126 STAT. 1098]]

        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).''.

[[Page 126 STAT. 1099]]

                         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) <<NOTE: Notification.>> 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) <<NOTE: Deadline. Determination.>> 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) <<NOTE: Notification.>> 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

[[Page 126 STAT. 1100]]

                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 <<NOTE: Public information. Web posting.>> 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) <<NOTE: Notifications. Deadlines.>> 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'--

[[Page 126 STAT. 1101]]

                    ``(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) <<NOTE: Deadline.>> 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) <<NOTE: Definitions.>> 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) <<NOTE: Determination.>> 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) <<NOTE: Notice.>> issue a notice of proposed 
                rulemaking that includes the proposed regulation;
                    ``(B) <<NOTE: Time period.>> provide a period of not 
                less than 60 days for comments on the proposed 
                regulation; and
                    ``(C) <<NOTE: Publication.>> 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) <<NOTE: 21 USC 356c note.>> 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--

[[Page 126 STAT. 1102]]

            (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. <<NOTE: 21 USC 356c-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) <<NOTE: Study.>> 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.''.

[[Page 126 STAT. 1103]]

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. <<NOTE: 21 USC 356d.>> 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

[[Page 126 STAT. 1104]]

                and Human Services with expertise regarding drug 
                shortages. The Secretary shall engage external 
                stakeholders and experts as appropriate.
            ``(2) <<NOTE: Publication. Submission.>> 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) <<NOTE: Determination. Evaluation.>> 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. <<NOTE: 21 USC 356e.>> 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.

[[Page 126 STAT. 1105]]

                    ``(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) <<NOTE: Deadline.>> Not later than 30 days after the 
receipt of a request described in paragraph (2), the Attorney General 
shall--
            ``(A) <<NOTE: Review.>> 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) <<NOTE: Determination.>> 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 <<NOTE: Public information. Web posting.>> 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. <<NOTE: 21 USC 826a.>> 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,

[[Page 126 STAT. 1106]]

        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. <<NOTE: 21 USC 356f.>> 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

[[Page 126 STAT. 1107]]

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

[[Page 126 STAT. 1108]]

        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. <<NOTE: 21 USC 360ddd.>> 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.

[[Page 126 STAT. 1109]]

                    ``(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. <<NOTE: 21 USC
                        360ddd-1.>> REGULATION OF MEDICAL GASES.

    ``(a) Certification of Designated Medical Gases.--
            ``(1) <<NOTE: Effective date.>> 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) <<NOTE: Time period.>> 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:

[[Page 126 STAT. 1110]]

                                    ``(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

[[Page 126 STAT. 1111]]

                have in effect an approved application under section 505 
                or section 512 of this Act.
                    ``(B) <<NOTE: Determination.>> 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. <<NOTE: 21 USC 360ddd-2.>> 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. <<NOTE: 21 USC 360ddd note.>> CHANGES TO REGULATIONS.

    (a) <<NOTE: Determination.>> 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:

[[Page 126 STAT. 1112]]

            (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. <<NOTE: 21 USC 360ddd note.>> 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. <<NOTE: Deadline. 21 USC 379d-5.>> 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) <<NOTE: Web posting.>> 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

[[Page 126 STAT. 1113]]

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) <<NOTE: Deadline. 21 USC 355 note.>> 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. <<NOTE: 21 USC
                          360bbb-8a.>> 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. <<NOTE: 21 USC
                          360bbb-8b.>> 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

[[Page 126 STAT. 1114]]

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. <<NOTE: 21 USC 393 note.>> ADVANCING REGULATORY SCIENCE 
                          TO PROMOTE PUBLIC HEALTH INNOVATION.

    (a) <<NOTE: Deadline.>> 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

[[Page 126 STAT. 1115]]

        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) <<NOTE: Definition.>> 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. <<NOTE: 21 USC 393 note.>> 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;

[[Page 126 STAT. 1116]]

                    (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. <<NOTE: 21 USC 399e.>> 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--

[[Page 126 STAT. 1117]]

            (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;

[[Page 126 STAT. 1118]]

            (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.''.

[[Page 126 STAT. 1119]]

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 <<NOTE: Deadline.>> 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,'';

[[Page 126 STAT. 1120]]

                    (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) <<NOTE: Proposal.>> 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) <<NOTE: Deadline.>> 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)--

[[Page 126 STAT. 1121]]

                    (A) by amending subparagraph (A) to read as follows:
                    ``(A) <<NOTE: Deadlines.>> 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)--

[[Page 126 STAT. 1122]]

                    (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) <<NOTE: Deadline. 21 USC 355-1 note.>> 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. <<NOTE: 21 USC 355 note.>> 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)).

[[Page 126 STAT. 1123]]

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) <<NOTE: 21 USC 355 note.>> 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. <<NOTE: 21 USC 379k-1.>> ELECTRONIC FORMAT FOR 
                          SUBMISSIONS.

    ``(a) Drugs and Biologics.--
            ``(1) <<NOTE: Effective date.>> 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.

[[Page 126 STAT. 1124]]

            ``(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) <<NOTE: Effective date.>> 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. <<NOTE: 21 USC
                          360bbb-8c.>> 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

[[Page 126 STAT. 1125]]

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) <<NOTE: Definition.>> 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. <<NOTE: 21 USC 399f.>> 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) <<NOTE: Deadline.>> 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

[[Page 126 STAT. 1126]]

        provide links to any other appropriate Internet Web site, and 
        seek public comment on the communication plan.
SEC. 1139. SCHEDULING OF HYDROCODONE.

    (a) <<NOTE: Deadline. Public meeting. Evaluation.>> 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) <<NOTE: Web posting.>> 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;

[[Page 126 STAT. 1127]]

            (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;

[[Page 126 STAT. 1128]]

                    ``(C) <<NOTE: Time period.>> 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) <<NOTE: Applicability. Deadlines. Web posting.>> 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

[[Page 126 STAT. 1129]]

        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

[[Page 126 STAT. 1130]]

        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) <<NOTE: Effective date. 21 USC 379d-1 note.>> Applicability.--
The amendments made by subsection (a) apply beginning on October 1, 
2012.
SEC. 1143. <<NOTE: 21 USC 371 note.>> NOTIFICATION OF FDA INTENT 
                          TO REGULATE LABORATORY-DEVELOPED TESTS.

    (a) <<NOTE: Time period.>> 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-- <<NOTE: Synthetic Drug Abuse Prevention Act of 
2012.>> Synthetic Drugs
SEC. 1151. <<NOTE: 21 USC 801 note.>> 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) <<NOTE: Definition.>> 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.

[[Page 126 STAT. 1131]]

                    ``(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).

[[Page 126 STAT. 1132]]

            ``(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''.

    Approved July 9, 2012.

LEGISLATIVE HISTORY--S. 3187:
---------------------------------------------------------------------------

CONGRESSIONAL RECORD, Vol. 158 (2012):
            May 23, 24, considered and passed Senate.
            June 20, considered and passed House, amended.
            June 21, 25, 26, Senate considered and concurred in House 
                amendment.

                                  <all>
```