[Congressional Record (Bound Edition), Volume 158 (2012), Part 7]
[House]
[Pages 9476-9521]
[From the U.S. Government Publishing Office, www.gpo.gov]




         FOOD AND DRUG ADMINISTRATION SAFETY AND INNOVATION ACT

  Mr. UPTON. Mr. Speaker, I move to suspend the rules and pass the bill 
(S. 3187) to amend the Federal Food, Drug, and Cosmetic Act to revise 
and extend the user-fee programs for prescription drugs and medical 
devices, to establish user-fee programs for generic drugs and 
biosimilars, and for other purposes, as amended.
  The Clerk read the title of the bill.
  The text of the amendment is as follows:

       Amendment:
       Strike out all after the enacting clause and insert:

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Food and Drug Administration 
     Safety and Innovation Act''.

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

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

Sec. 1. Short title.
Sec. 2. Table of contents; references in Act.

                    TITLE I--FEES RELATING TO DRUGS

Sec. 101. Short title; finding.
Sec. 102. Definitions.
Sec. 103. Authority to assess and use drug fees.
Sec. 104. Reauthorization; reporting requirements.
Sec. 105. Sunset dates.
Sec. 106. Effective date.
Sec. 107. Savings clause.

                   TITLE II--FEES RELATING TO DEVICES

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

               TITLE III--FEES RELATING TO GENERIC DRUGS

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

       TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

Sec. 401. Short title; finding.
Sec. 402. Fees relating to biosimilar biological products.
Sec. 403. Reauthorization; reporting requirements.
Sec. 404. Sunset dates.
Sec. 405. Effective date.
Sec. 406. Savings clause.
Sec. 407. Conforming amendment.
Sec. 408. Additional reporting requirements.

                  TITLE V--PEDIATRIC DRUGS AND DEVICES

Sec. 501. Permanence.
Sec. 502. Written requests.
Sec. 503. Communication with Pediatric Review Committee.
Sec. 504. Access to data.
Sec. 505. Ensuring the completion of pediatric studies.
Sec. 506. Pediatric study plans.
Sec. 507. Reauthorizations.
Sec. 508. Report.
Sec. 509. Technical amendments.
Sec. 510. Pediatric rare diseases.
Sec. 511. Staff of Office of Pediatric Therapeutics.

            TITLE VI--MEDICAL DEVICE REGULATORY IMPROVEMENTS

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

                      TITLE VII--DRUG SUPPLY CHAIN

Sec. 701. Registration of domestic drug establishments.
Sec. 702. Registration of foreign establishments.
Sec. 703. Identification of drug excipient information with product 
              listing.
Sec. 704. Electronic system for registration and listing.
Sec. 705. Risk-based inspection frequency.
Sec. 706. Records for inspection.
Sec. 707. Prohibition against delaying, denying, limiting, or refusing 
              inspection.
Sec. 708. Destruction of adulterated, misbranded, or counterfeit drugs 
              offered for import.
Sec. 709. Administrative detention.
Sec. 710. Exchange of information.
Sec. 711. Enhancing the safety and quality of the drug supply.
Sec. 712. Recognition of foreign government inspections.
Sec. 713. Standards for admission of imported drugs.

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Sec. 714. Registration of commercial importers.
Sec. 715. Notification.
Sec. 716. Protection against intentional adulteration.
Sec. 717. Penalties for counterfeiting drugs.
Sec. 718. Extraterritorial jurisdiction.

            TITLE VIII--GENERATING ANTIBIOTIC INCENTIVES NOW

Sec. 801. Extension of exclusivity period for drugs.
Sec. 802. Priority review.
Sec. 803. Fast track product.
Sec. 804. Clinical trials.
Sec. 805. Reassessment of qualified infectious disease product 
              incentives in 5 years.
Sec. 806. Guidance on pathogen-focused antibacterial drug development.

               TITLE IX--DRUG APPROVAL AND PATIENT ACCESS

Sec. 901. Enhancement of accelerated patient access to new medical 
              treatments.
Sec. 902. Breakthrough therapies.
Sec. 903. Consultation with external experts on rare diseases, targeted 
              therapies, and genetic targeting of treatments.
Sec. 904. Accessibility of information on prescription drug container 
              labels by visually impaired and blind consumers.
Sec. 905. Risk-benefit framework.
Sec. 906. Grants and Contracts for the Development of Orphan Drugs.
Sec. 907. Reporting of inclusion of demographic subgroups in clinical 
              trials and data analysis in applications for drugs, 
              biologics, and devices.
Sec. 908. Rare pediatric disease priority review voucher incentive 
              program.

                        TITLE X--DRUG SHORTAGES

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

                       TITLE XI--OTHER PROVISIONS

                      Subtitle A--Reauthorizations

Sec. 1101. Reauthorization of provision relating to exclusivity of 
              certain drugs containing single enantiomers.
Sec. 1102. Reauthorization of the critical path public-private 
              partnerships.

               Subtitle B--Medical Gas Product Regulation

Sec. 1111. Regulation of medical gases.
Sec. 1112. Changes to regulations.
Sec. 1113. Rules of construction.

                  Subtitle C--Miscellaneous Provisions

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

                      Subtitle D--Synthetic Drugs

Sec. 1151. Short title.
Sec. 1152. Addition of synthetic drugs to schedule I of the Controlled 
              Substances Act.
Sec. 1153. Temporary scheduling to avoid imminent hazards to public 
              safety expansion.
       (b) References in Act.--Except as otherwise specified, 
     amendments made by this Act to a section or other provision 
     of law are amendments to such section or other provision of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
     seq.).

                    TITLE I--FEES RELATING TO DRUGS

     SEC. 101. SHORT TITLE; FINDING.

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

     SEC. 102. DEFINITIONS.

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

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

       Section 736 (21 U.S.C. 379h) is amended--
       (1) in subsection (a)--
       (A) in the matter preceding paragraph (1), by striking 
     ``fiscal year 2008'' and inserting ``fiscal year 2013'';
       (B) in paragraph (1)(A)--
       (i) in clause (i), by striking ``(c)(5)'' and inserting 
     ``(c)(4)''; and
       (ii) in clause (ii), by striking ``(c)(5)'' and inserting 
     ``(c)(4)'';
       (C) in the matter following clause (ii) in paragraph 
     (2)(A)--
       (i) by striking ``(c)(5)'' and inserting ``(c)(4)''; and
       (ii) by striking ``payable on or before October 1 of each 
     year'' and inserting ``due on the later of the first business 
     day on or after October 1 of each fiscal year or the first 
     business day after the enactment of an appropriations Act 
     providing for the collection and obligation of fees for such 
     fiscal year under this section'';
       (D) in paragraph (3)--
       (i) in subparagraph (A)--

       (I) by striking ``subsection (c)(5)'' and inserting 
     ``subsection (c)(4)''; and
       (II) by striking ``payable on or before October 1 of each 
     year.'' and inserting ``due on the later of the first 
     business day on or after October 1 of each fiscal year or the 
     first business day after the enactment of an appropriations 
     Act providing for the collection and obligation of fees for 
     such fiscal year under this section.''; and

       (ii) by amending subparagraph (B) to read as follows:
       ``(B) Exception.--A prescription drug product shall not be 
     assessed a fee under subparagraph (A) if such product is--
       ``(i) identified on the list compiled under section 
     505(j)(7) with a potency described in terms of per 100 mL;
       ``(ii) the same product as another product that--

       ``(I) was approved under an application filed under section 
     505(b) or 505(j); and
       ``(II) is not in the list of discontinued products compiled 
     under section 505(j)(7);

       ``(iii) the same product as another product that was 
     approved under an abbreviated application filed under section 
     507 (as in effect on the day before the date of enactment of 
     the Food and Drug Administration Modernization Act of 1997); 
     or
       ``(iv) the same product as another product that was 
     approved under an abbreviated new drug application pursuant 
     to regulations in effect prior to the implementation of the 
     Drug Price Competition and Patent Term Restoration Act of 
     1984.'';
       (2) in subsection (b)--
       (A) in paragraph (1)--
       (i) in the matter preceding subparagraph (A), by striking 
     ``fiscal years 2008 through 2012'' and inserting ``fiscal 
     years 2013 through 2017'';
       (ii) in subparagraph (A), by striking ``$392,783,000; and'' 
     and inserting ``$693,099,000;''; and
       (iii) by striking subparagraph (B) and inserting the 
     following:
       ``(B) the dollar amount equal to the inflation adjustment 
     for fiscal year 2013 (as determined under paragraph (3)(A)); 
     and
       ``(C) the dollar amount equal to the workload adjustment 
     for fiscal year 2013 (as determined under paragraph 
     (3)(B)).''; and
       (B) by striking paragraphs (3) and (4) and inserting the 
     following:
       ``(3) Fiscal year 2013 inflation and workload 
     adjustments.--For purposes of paragraph (1), the dollar 
     amount of the inflation and workload adjustments for fiscal 
     year 2013 shall be determined as follows:
       ``(A) Inflation adjustment.--The inflation adjustment for 
     fiscal year 2013 shall be the sum of--
       ``(i) $652,709,000 multiplied by the result of an inflation 
     adjustment calculation determined using the methodology 
     described in subsection (c)(1)(B); and
       ``(ii) $652,709,000 multiplied by the result of an 
     inflation adjustment calculation determined using the 
     methodology described in subsection (c)(1)(C).
       ``(B) Workload adjustment.--Subject to subparagraph (C), 
     the workload adjustment for fiscal 2013 shall be--
       ``(i) $652,709,000 plus the amount of the inflation 
     adjustment calculated under subparagraph (A); multiplied by
       ``(ii) the amount (if any) by which a percentage workload 
     adjustment for fiscal year 2013, as

[[Page 9478]]

     determined using the methodology described in subsection 
     (c)(2)(A), would exceed the percentage workload adjustment 
     (as so determined) for fiscal year 2012, if both such 
     adjustment percentages were calculated using the 5-year base 
     period consisting of fiscal years 2003 through 2007.
       ``(C) Limitation.--Under no circumstances shall the 
     adjustment under subparagraph (B) result in fee revenues for 
     fiscal year 2013 that are less than the sum of the amount 
     under paragraph (1)(A) and the amount under paragraph 
     (1)(B).'';
       (3) by striking subsection (c) and inserting the following:
       ``(c) Adjustments.--
       ``(1) Inflation adjustment.--For fiscal year 2014 and 
     subsequent fiscal years, the revenues established in 
     subsection (b) shall be adjusted by the Secretary by notice, 
     published in the Federal Register, for a fiscal year by the 
     amount equal to the sum of--
       ``(A) one;
       ``(B) the average annual percent change in the cost, per 
     full-time equivalent position of the Food and Drug 
     Administration, of all personnel compensation and benefits 
     paid with respect to such positions for the first 3 years of 
     the preceding 4 fiscal years, multiplied by the proportion of 
     personnel compensation and benefits costs to total costs of 
     the process for the review of human drug applications (as 
     defined in section 735(6)) for the first 3 years of the 
     preceding 4 fiscal years, and
       ``(C) the average annual percent change that occurred in 
     the Consumer Price Index for urban consumers (Washington-
     Baltimore, DC-MD-VA-WV; Not Seasonally Adjusted; All items; 
     Annual Index) for the first 3 years of the preceding 4 years 
     of available data multiplied by the proportion of all costs 
     other than personnel compensation and benefits costs to total 
     costs of the process for the review of human drug 
     applications (as defined in section 735(6)) for the first 3 
     years of the preceding 4 fiscal years.
     The adjustment made each fiscal year under this paragraph 
     shall be added on a compounded basis to the sum of all 
     adjustments made each fiscal year after fiscal year 2013 
     under this paragraph.
       ``(2) Workload adjustment.--For fiscal year 2014 and 
     subsequent fiscal years, after the fee revenues established 
     in subsection (b) are adjusted for a fiscal year for 
     inflation in accordance with paragraph (1), the fee revenues 
     shall be adjusted further for such fiscal year to reflect 
     changes in the workload of the Secretary for the process for 
     the review of human drug applications. With respect to such 
     adjustment:
       ``(A) The adjustment shall be determined by the Secretary 
     based on a weighted average of the change in the total number 
     of human drug applications (adjusted for changes in review 
     activities, as described in the notice that the Secretary is 
     required to publish in the Federal Register under this 
     subparagraph), efficacy supplements, and manufacturing 
     supplements submitted to the Secretary, and the change in the 
     total number of active commercial investigational new drug 
     applications (adjusted for changes in review activities, as 
     so described) during the most recent 12-month period for 
     which data on such submissions is available. The Secretary 
     shall publish in the Federal Register the fee revenues and 
     fees resulting from the adjustment and the supporting 
     methodologies.
       ``(B) Under no circumstances shall the adjustment result in 
     fee revenues for a fiscal year that are less than the sum of 
     the amount under subsection (b)(1)(A) and the amount under 
     subsection (b)(1)(B), as adjusted for inflation under 
     paragraph (1).
       ``(C) The Secretary shall contract with an independent 
     accounting or consulting firm to periodically review the 
     adequacy of the adjustment and publish the results of those 
     reviews. The first review shall be conducted and published by 
     the end of fiscal year 2013 (to examine the performance of 
     the adjustment since fiscal year 2009), and the second review 
     shall be conducted and published by the end of fiscal year 
     2015 (to examine the continued performance of the 
     adjustment). The reports shall evaluate whether the 
     adjustment reasonably represents actual changes in workload 
     volume and complexity and present options to discontinue, 
     retain, or modify any elements of the adjustment. The reports 
     shall be published for public comment. After review of the 
     reports and receipt of public comments, the Secretary shall, 
     if warranted, adopt appropriate changes to the methodology. 
     If the Secretary adopts changes to the methodology based on 
     the first report, the changes shall be effective for the 
     first fiscal year for which fees are set after the Secretary 
     adopts such changes and each subsequent fiscal year.
       ``(3) Final year adjustment.--For fiscal year 2017, the 
     Secretary may, in addition to adjustments under this 
     paragraph and paragraphs (1) and (2), further increase the 
     fee revenues and fees established in subsection (b) if such 
     an adjustment is necessary to provide for not more than 3 
     months of operating reserves of carryover user fees for the 
     process for the review of human drug applications for the 
     first 3 months of fiscal year 2018. If such an adjustment is 
     necessary, the rationale for the amount of the increase shall 
     be contained in the annual notice establishing fee revenues 
     and fees for fiscal year 2017. If the Secretary has carryover 
     balances for such process in excess of 3 months of such 
     operating reserves, the adjustment under this paragraph shall 
     not be made.
       ``(4) Annual fee setting.--The Secretary shall, not later 
     than 60 days before the start of each fiscal year that begins 
     after September 30, 2012, establish, for the next fiscal 
     year, application, product, and establishment fees under 
     subsection (a), based on the revenue amounts established 
     under subsection (b) and the adjustments provided under this 
     subsection.
       ``(5) Limit.--The total amount of fees charged, as adjusted 
     under this subsection, for a fiscal year may not exceed the 
     total costs for such fiscal year for the resources allocated 
     for the process for the review of human drug applications.''; 
     and
       (4) in subsection (g)--
       (A) in paragraph (1), by striking ``Fees authorized'' and 
     inserting ``Subject to paragraph (2)(C), fees authorized'';
       (B) in paragraph (2)--
       (i) in subparagraph (A)(i), by striking ``shall be 
     retained'' and inserting ``subject to subparagraph (C), shall 
     be collected and available'';
       (ii) in subparagraph (A)(ii), by striking ``shall only be 
     collected and available'' and inserting ``shall be 
     available''; and
       (iii) by adding at the end the following new subparagraph:
       ``(C) Provision for early payments.--Payment of fees 
     authorized under this section for a fiscal year, prior to the 
     due date for such fees, may be accepted by the Secretary in 
     accordance with authority provided in advance in a prior year 
     appropriations Act.'';
       (C) in paragraph (3), by striking ``fiscal years 2008 
     through 2012'' and inserting ``fiscal years 2013 through 
     2017''; and
       (D) in paragraph (4)--
       (i) by striking ``fiscal years 2008 through 2010'' and 
     inserting ``fiscal years 2013 through 2015'';
       (ii) by striking ``fiscal year 2011'' and inserting 
     ``fiscal year 2016'';
       (iii) by striking ``fiscal years 2008 through 2011'' and 
     inserting ``fiscal years 2013 through 2016''; and
       (iv) by striking ``fiscal year 2012'' and inserting 
     ``fiscal year 2017''.

     SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS.

       Section 736B (21 U.S.C. 379h-2) is amended--
       (1) by amending subsection (a) to read as follows:
       ``(a) Performance Report.--
       ``(1) In general.--Beginning with fiscal year 2013, not 
     later than 120 days after the end of each fiscal year for 
     which fees are collected under this part, the Secretary shall 
     prepare and submit to the Committee on Energy and Commerce of 
     the House of Representatives and the Committee on Health, 
     Education, Labor, and Pensions of the Senate a report 
     concerning--
       ``(A) the progress of the Food and Drug Administration in 
     achieving the goals identified in the letters described in 
     section 101(b) of the Prescription Drug User Fee Amendments 
     of 2012 during such fiscal year and the future plans of the 
     Food and Drug Administration for meeting the goals, including 
     the status of the independent assessment described in such 
     letters; and
       ``(B) the progress of the Center for Drug Evaluation and 
     Research and the Center for Biologics Evaluation and Research 
     in achieving the goals, and future plans for meeting the 
     goals, including, for each review division--
       ``(i) the number of original standard new drug applications 
     and biologics license applications filed per fiscal year for 
     each review division;
       ``(ii) the number of original priority new drug 
     applications and biologics license applications filed per 
     fiscal year for each review division;
       ``(iii) the number of standard efficacy supplements filed 
     per fiscal year for each review division;
       ``(iv) the number of priority efficacy supplements filed 
     per fiscal year for each review division;
       ``(v) the number of applications filed for review under 
     accelerated approval per fiscal year for each review 
     division;
       ``(vi) the number of applications filed for review as fast 
     track products per fiscal year for each review division;
       ``(vii) the number of applications filed for orphan-
     designated products per fiscal year for each review division; 
     and
       ``(viii) the number of breakthrough designations for a 
     fiscal year for each review division.
       ``(2) Inclusion.--The report under this subsection for a 
     fiscal year shall include information on all previous cohorts 
     for which the Secretary has not given a complete response on 
     all human drug applications and supplements in the cohort.''.
       (2) in subsection (b), by striking ``2008'' and inserting 
     ``2013''; and
       (3) in subsection (d), by striking ``2012'' each place it 
     appears and inserting ``2017''.

     SEC. 105. SUNSET DATES.

       (a) Authorization.--Sections 735 and 736 of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 379g; 379h) shall 
     cease to be effective October 1, 2017.
       (b) Reporting Requirements.--Section 736B of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 379h-2) shall cease 
     to be effective January 31, 2018.
       (c) Previous Sunset Provision.--
       (1) In general.--Section 106 of the Food and Drug 
     Administration Amendments Act of 2007 (Public Law 110-85) is 
     repealed.
       (2) Conforming amendment.--The Food and Drug Administration 
     Amendments Act of 2007 (Public Law 110-85) is amended in the 
     table of contents in section 2, by striking the item relating 
     to section 106.
       (d) Technical Clarifications.--
       (1) Effective September 30, 2007--
       (A) section 509 of the Prescription Drug User Fee 
     Amendments Act of 2002 (Title V of Public Law 107-188) is 
     repealed; and

[[Page 9479]]

       (B) the Public Health Security and Bioterrorism 
     Preparedness and Response Act of 2002 (Public Law 107-188) is 
     amended in the table of contents in section 1(b), by striking 
     the item relating to section 509.
       (2) Effective September 30, 2002--
       (A) section 107 of the Food and Drug Administration 
     Modernization Act of 1997 (Public Law 105-115) is repealed; 
     and
       (B) the table of contents in section 1(c) of such Act is 
     amended by striking the item related to section 107.
       (3) Effective September 30, 1997, section 105 of the 
     Prescription Drug User Fee Act of 1992 (Public Law 102-571) 
     is repealed.

     SEC. 106. EFFECTIVE DATE.

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

     SEC. 107. SAVINGS CLAUSE.

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

                   TITLE II--FEES RELATING TO DEVICES

     SEC. 201. SHORT TITLE; FINDINGS.

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

     SEC. 202. DEFINITIONS.

       Section 737 (21 U.S.C. 379i) is amended--
       (1) in paragraph (9), by striking ``incurred'' after 
     ``expenses'';
       (2) in paragraph (10), by striking ``October 2001'' and 
     inserting ``October 2011''; and
       (3) in paragraph (13), by striking ``is required to 
     register'' and all that follows through the end of paragraph 
     (13) and inserting the following: ``is registered (or is 
     required to register) with the Secretary under section 510 
     because such establishment is engaged in the manufacture, 
     preparation, propagation, compounding, or processing of a 
     device.''.

     SEC. 203. AUTHORITY TO ASSESS AND USE DEVICE FEES.

       (a) Types of Fees.--Section 738(a) (21 U.S.C. 379j(a)) is 
     amended--
       (1) in paragraph (1), by striking ``fiscal year 2008'' and 
     inserting ``fiscal year 2013'';
       (2) in paragraph (2)(A)--
       (A) in the matter preceding clause (i)--
       (i) by striking ``subsections (d) and (e)'' and inserting 
     ``subsections (d), (e), and (f)'';
       (ii) by striking ``October 1, 2002'' and inserting 
     ``October 1, 2012''; and
       (iii) by striking ``subsection (c)(1)'' and inserting 
     ``subsection (c)''; and
       (B) in clause (viii), by striking ``1.84'' and inserting 
     ``2''; and
       (3) in paragraph (3)--
       (A) in subparagraph (A), by inserting ``and subsection 
     (f)'' after ``subparagraph (B)''; and
       (B) in subparagraph (C), by striking ``initial 
     registration'' and all that follows through ``section 510.'' 
     and inserting ``later of--
       ``(i) the initial or annual registration (as applicable) of 
     the establishment under section 510; or
       ``(ii) the first business day after the date of enactment 
     of an appropriations Act providing for the collection and 
     obligation of fees for such year under this section.''.
       (b) Fee Amounts.--Section 738(b) (21 U.S.C. 379j(b)) is 
     amended to read as follows:
       ``(b) Fee Amounts.--
       ``(1) In general.--Subject to subsections (c), (d), (e), 
     (f), and (i), for each of fiscal years 2013 through 2017, 
     fees under subsection (a) shall be derived from the base fee 
     amounts specified in paragraph (2), to generate the total 
     revenue amounts specified in paragraph (3).
       ``(2) Base fee amounts specified.--For purposes of 
     paragraph (1), the base fee amounts specified in this 
     paragraph are as follows:

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

       ``(3) Total revenue amounts specified.--For purposes of 
     paragraph (1), the total revenue amounts specified in this 
     paragraph are as follows:
       ``(A) $97,722,301 for fiscal year 2013.
       ``(B) $112,580,497 for fiscal year 2014.
       ``(C) $125,767,107 for fiscal year 2015.
       ``(D) $129,339,949 for fiscal year 2016.
       ``(E) $130,184,348 for fiscal year 2017.''.
       (c) Annual Fee Setting; Adjustments.--Section 738(c) (21 
     U.S.C. 379j(c)) is amended--
       (1) in the subsection heading, by inserting ``; 
     Adjustments'' after ``Setting'';
       (2) by striking paragraphs (1) and (2);
       (3) by redesignating paragraphs (3) and (4) as paragraphs 
     (4) and (5), respectively; and
       (4) by inserting before paragraph (4), as so redesignated, 
     the following:
       ``(1) In general.--The Secretary shall, 60 days before the 
     start of each fiscal year after September 30, 2012, establish 
     fees under subsection (a), based on amounts specified under 
     subsection (b) and the adjustments provided under this 
     subsection, and publish such fees, and the rationale for any 
     adjustments to such fees, in the Federal Register.
       ``(2) Inflation adjustments.--
       ``(A) Adjustment to total revenue amounts.--For fiscal year 
     2014 and each subsequent fiscal year, the Secretary shall 
     adjust the total revenue amount specified in subsection 
     (b)(3) for such fiscal year by multiplying such amount by the 
     applicable inflation adjustment under subparagraph (B) for 
     such year.
       ``(B) Applicable inflation adjustment to total revenue 
     amounts.--The applicable inflation adjustment for a fiscal 
     year is--
       ``(i) for fiscal year 2014, the base inflation adjustment 
     under subparagraph (C) for such fiscal year; and
       ``(ii) for fiscal year 2015 and each subsequent fiscal 
     year, the product of--

       ``(I) the base inflation adjustment under subparagraph (C) 
     for such fiscal year; and
       ``(II) the product of the base inflation adjustment under 
     subparagraph (C) for each of the fiscal years preceding such 
     fiscal year, beginning with fiscal year 2014.

       ``(C) Base inflation adjustment to total revenue amounts.--
       ``(i) In general.--Subject to further adjustment under 
     clause (ii), the base inflation adjustment for a fiscal year 
     is the sum of one plus--

       ``(I) the average annual percent change in the cost, per 
     full-time equivalent position of the Food and Drug 
     Administration, of all personnel compensation and benefits 
     paid with respect to such positions for the first 3 years of 
     the preceding 4 fiscal years, multiplied by 0.60; and
       ``(II) the average annual percent change that occurred in 
     the Consumer Price Index for urban consumers (Washington-
     Baltimore, DC-MD-VA-WV; Not Seasonally Adjusted; All items; 
     Annual Index) for the first 3 years of the preceding 4 years 
     of available data multiplied by 0.40.

       ``(ii) Limitations.--For purposes of subparagraph (B), if 
     the base inflation adjustment for a fiscal year under clause 
     (i)--

       ``(I) is less than 1, such adjustment shall be considered 
     to be equal to 1; or
       ``(II) is greater than 1.04, such adjustment shall be 
     considered to be equal to 1.04.

       ``(D) Adjustment to base fee amounts.--For each of fiscal 
     years 2014 through 2017, the base fee amounts specified in 
     subsection (b)(2) shall be adjusted as needed, on a uniform 
     proportionate basis, to generate the total revenue amounts 
     under subsection (b)(3), as adjusted for inflation under 
     subparagraph (A).
       ``(3) Volume-based adjustments to establishment 
     registration base fees.--For each of fiscal years 2014 
     through 2017, after the base fee amounts specified in 
     subsection (b)(2) are adjusted under paragraph (2)(D), the 
     base establishment registration fee amounts specified in such 
     subsection shall be further adjusted, as the Secretary 
     estimates is necessary in order for total fee collections for 
     such fiscal year to generate the total revenue amounts, as 
     adjusted under paragraph (2).''.
       (d) Fee Waiver or Reduction.--Section 738 (21 U.S.C. 379j) 
     is amended by--
       (1) redesignating subsections (f) through (k) as 
     subsections (g) through (l), respectively; and
       (2) by inserting after subsection (e) the following new 
     subsection:
       ``(f) Fee Waiver or Reduction.--
       ``(1) In general.--The Secretary may, at the Secretary's 
     sole discretion, grant a waiver or reduction of fees under 
     subsection (a)(2) or (a)(3) if the Secretary finds that such 
     waiver or reduction is in the interest of public health.
       ``(2) Limitation.--The sum of all fee waivers or reductions 
     granted by the Secretary in any fiscal year under paragraph 
     (1) shall not exceed 2 percent of the total fee revenue 
     amounts established for such year under subsection (c).
       ``(3) Duration.--The authority provided by this subsection 
     terminates October 1, 2017.''.

[[Page 9480]]

       (e) Conditions.--Section 738(h)(1)(A) (21 U.S.C. 
     379j(h)(1)(A)), as redesignated by subsection (d)(1), is 
     amended by striking ``$205,720,000'' and inserting 
     ``$280,587,000''.
       (f) Crediting and Availability of Fees.--Section 738(i) (21 
     U.S.C. 379j(i)), as redesignated by subsection (d)(1), is 
     amended--
       (1) in paragraph (1), by striking ``Fees authorized'' and 
     inserting ``Subject to paragraph (2)(C), fees authorized'';
       (2) in paragraph (2)--
       (A) in subparagraph (A)--
       (i) in clause (i), by striking ``shall be retained'' and 
     inserting ``subject to subparagraph (C), shall be collected 
     and available''; and
       (ii) in clause (ii)--

       (I) by striking ``collected and'' after ``shall only be''; 
     and
       (II) by striking ``fiscal year 2002'' and inserting 
     ``fiscal year 2009''; and

       (B) by adding at the end, the following:
       ``(C) Provision for early payments.--Payment of fees 
     authorized under this section for a fiscal year, prior to the 
     due date for such fees, may be accepted by the Secretary in 
     accordance with authority provided in advance in a prior year 
     appropriations Act.'';
       (3) by amending paragraph (3) to read as follows:
       ``(3) Authorizations of appropriations.--For each of the 
     fiscal years 2013 through 2017, there is authorized to be 
     appropriated for fees under this section an amount equal to 
     the total revenue amount specified under subsection (b)(3) 
     for the fiscal year, as adjusted under subsection (c) and, 
     for fiscal year 2017 only, as further adjusted under 
     paragraph (4).''; and
       (4) in paragraph (4)--
       (A) by striking ``fiscal years 2008, 2009, and 2010'' and 
     inserting ``fiscal years 2013, 2014, and 2015'';
       (B) by striking ``fiscal year 2011'' and inserting ``fiscal 
     year 2016'';
       (C) by striking ``June 30, 2011'' and inserting ``June 30, 
     2016'';
       (D) by striking ``the amount of fees specified in aggregate 
     in'' and inserting ``the cumulative amount appropriated 
     pursuant to'';
       (E) by striking ``aggregate amount in'' before ``excess 
     shall be credited''; and
       (F) by striking ``fiscal year 2012'' and inserting ``fiscal 
     year 2017''.
       (g) Conforming Amendment.--Section 515(c)(4)(A) (21 U.S.C. 
     360e(c)(4)(A)) is amended by striking ``738(g)'' and 
     inserting ``738(h)''.

     SEC. 204. REAUTHORIZATION; REPORTING REQUIREMENTS.

       (a) Reauthorization.--Section 738A(b) (21 U.S.C. 379j-1(b)) 
     is amended--
       (1) in paragraph (1), by striking ``2012'' and inserting 
     ``2017''; and
       (2) in paragraph (5), by striking ``2012'' and inserting 
     ``2017''.
       (b) Performance Reports.--Section 738A(a) (21 U.S.C. 379j-
     1(a)) is amended--
       (1) by striking paragraph (1) and inserting the following:
       ``(1) Performance report.--
       ``(A) In general.--Beginning with fiscal year 2013, for 
     each fiscal year for which fees are collected under this 
     part, the Secretary shall prepare and submit to the Committee 
     on Health, Education, Labor, and Pensions of the Senate and 
     the Committee on Energy and Commerce of the House of 
     Representatives annual reports concerning the progress of the 
     Food and Drug Administration in achieving the goals 
     identified in the letters described in section 201(b) of the 
     Medical Device User Fee Amendments of 2012 during such fiscal 
     year and the future plans of the Food and Drug Administration 
     for meeting the goals.
       ``(B) Publication.--With regard to information to be 
     reported by the Food and Drug Administration to industry on a 
     quarterly and annual basis pursuant to the letters described 
     in section 201(b) of the Medical Device User Fee Amendments 
     Act of 2012, the Secretary shall make such information 
     publicly available on the Internet Web site of the Food and 
     Drug Administration not later than 60 days after the end of 
     each quarter or 120 days after the end of each fiscal year, 
     respectively, to which such information applies. This 
     information shall include the status of the independent 
     assessment identified in the letters described in such 
     section 201(b).
       ``(C) Updates.--The Secretary shall include in each report 
     under subparagraph (A) information on all previous cohorts 
     for which the Secretary has not given a complete response on 
     all device premarket applications and reports, supplements, 
     and premarket notifications in the cohort.''; and
       (2) in paragraph (2), by striking ``2008 through 2012'' and 
     inserting ``2013 through 2017''.

     SEC. 205. SAVINGS CLAUSE.

       Notwithstanding the amendments made by this title, part 3 
     of subchapter C of chapter VII of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the 
     day before the date of the enactment of this title, shall 
     continue to be in effect with respect to the submissions 
     listed in section 738(a)(2)(A) of such Act (in effect as of 
     such day) that on or after October 1, 2007, but before 
     October 1, 2012, were accepted by the Food and Drug 
     Administration for filing with respect to assessing and 
     collecting any fee required by such part for a fiscal year 
     prior to fiscal year 2013.

     SEC. 206. EFFECTIVE DATE.

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

     SEC. 207. SUNSET CLAUSE.

       (a) In General.--Sections 737 and 738 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 739i; 739j) shall cease to 
     be effective October 1, 2017. Section 738A (21 U.S.C. 739j-1) 
     of the Federal Food, Drug, and Cosmetic Act (regarding 
     reauthorization and reporting requirements) shall cease to be 
     effective January 31, 2018.
       (b) Previous Sunset Provision.--
       (1) In general.--Section 217 of the Food and Drug 
     Administration Amendments Act of 2007 (Title II of Public Law 
     110-85) is repealed.
       (2) Conforming amendment.--The Food and Drug Administration 
     Amendments Act of 2007 (Public Law 110-85) is amended in the 
     table of contents in section 2, by striking the item relating 
     to section 217.
       (c) Technical Clarification.--Effective September 30, 
     2007--
       (1) section 107 of the Medical Device User Fee and 
     Modernization Act of 2002 (Public Law 107-250) is repealed; 
     and
       (2) the table of contents in section 1(b) of such Act is 
     amended by striking the item related to section 107.

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

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

     ``SEC. 714. STREAMLINED HIRING AUTHORITY.

       ``(a) In General.--In addition to any other personnel 
     authorities under other provisions of law, the Secretary may, 
     without regard to the provisions of title 5, United States 
     Code, governing appointments in the competitive service, 
     appoint employees to positions in the Food and Drug 
     Administration to perform, administer, or support activities 
     described in subsection (b), if the Secretary determines that 
     such appointments are needed to achieve the objectives 
     specified in subsection (c).
       ``(b) Activities Described.--The activities described in 
     this subsection are activities under this Act related to the 
     process for the review of device applications (as defined in 
     section 737(8)).
       ``(c) Objectives Specified.--The objectives specified in 
     this subsection are with respect to the activities under 
     subsection (b), the goals referred to in section 738A(a)(1).
       ``(d) Internal Controls.--The Secretary shall institute 
     appropriate internal controls for appointments under this 
     section.
       ``(e) Sunset.--The authority to appoint employees under 
     this section shall terminate on the date that is 3 years 
     after the date of enactment of this section.''.

               TITLE III--FEES RELATING TO GENERIC DRUGS

     SEC. 301. SHORT TITLE.

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

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

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

                ``PART 7--FEES RELATING TO GENERIC DRUGS

     ``SEC. 744A. DEFINITIONS.

       ``For purposes of this part:
       ``(1) The term `abbreviated new drug application'--
       ``(A) means an application submitted under section 505(j), 
     an abbreviated application submitted under section 507 (as in 
     effect on the day before the date of enactment of the Food 
     and Drug Administration Modernization Act of 1997), or an 
     abbreviated new drug application submitted pursuant to 
     regulations in effect prior to the implementation of the Drug 
     Price Competition and Patent Term Restoration Act of 1984; 
     and
       ``(B) does not include an application for a positron 
     emission tomography drug.
       ``(2) The term `active pharmaceutical ingredient' means--
       ``(A) a substance, or a mixture when the substance is 
     unstable or cannot be transported on its own, intended--
       ``(i) to be used as a component of a drug; and
       ``(ii) to furnish pharmacological activity or other direct 
     effect in the diagnosis, cure, mitigation, treatment, or 
     prevention of disease, or to affect the structure or any 
     function of the human body; or
       ``(B) a substance intended for final crystallization, 
     purification, or salt formation, or any combination of those 
     activities, to become a substance or mixture described in 
     subparagraph (A).
       ``(3) The term `adjustment factor' means a factor 
     applicable to a fiscal year that is the Consumer Price Index 
     for all urban consumers (all

[[Page 9481]]

     items; United States city average) for October of the 
     preceding fiscal year divided by such Index for October 2011.
       ``(4) The term `affiliate' means a business entity that has 
     a relationship with a second business entity if, directly or 
     indirectly--
       ``(A) one business entity controls, or has the power to 
     control, the other business entity; or
       ``(B) a third party controls, or has power to control, both 
     of the business entities.
       ``(5)(A) The term `facility'--
       ``(i) means a business or other entity--
       ``(I) under one management, either direct or indirect; and
       ``(II) at one geographic location or address engaged in 
     manufacturing or processing an active pharmaceutical 
     ingredient or a finished dosage form; and
       ``(ii) does not include a business or other entity whose 
     only manufacturing or processing activities are one or more 
     of the following: repackaging, relabeling, or testing.
       ``(B) For purposes of subparagraph (A), separate buildings 
     within close proximity are considered to be at one geographic 
     location or address if the activities in them are--
       ``(i) closely related to the same business enterprise;
       ``(ii) under the supervision of the same local management; 
     and
       ``(iii) capable of being inspected by the Food and Drug 
     Administration during a single inspection.
       ``(C) If a business or other entity would meet the 
     definition of a facility under this paragraph but for being 
     under multiple management, the business or other entity is 
     deemed to constitute multiple facilities, one per management 
     entity, for purposes of this paragraph.
       ``(6) The term `finished dosage form' means--
       ``(A) a drug product in the form in which it will be 
     administered to a patient, such as a tablet, capsule, 
     solution, or topical application;
       ``(B) a drug product in a form in which reconstitution is 
     necessary prior to administration to a patient, such as oral 
     suspensions or lyophilized powders; or
       ``(C) any combination of an active pharmaceutical 
     ingredient with another component of a drug product for 
     purposes of production of a drug product described in 
     subparagraph (A) or (B).
       ``(7) The term `generic drug submission' means an 
     abbreviated new drug application, an amendment to an 
     abbreviated new drug application, or a prior approval 
     supplement to an abbreviated new drug application.
       ``(8) The term `human generic drug activities' means the 
     following activities of the Secretary associated with generic 
     drugs and inspection of facilities associated with generic 
     drugs:
       ``(A) The activities necessary for the review of generic 
     drug submissions, including review of drug master files 
     referenced in such submissions.
       ``(B) The issuance of--
       ``(i) approval letters which approve abbreviated new drug 
     applications or supplements to such applications; or
       ``(ii) complete response letters which set forth in detail 
     the specific deficiencies in such applications and, where 
     appropriate, the actions necessary to place such applications 
     in condition for approval.
       ``(C) The issuance of letters related to Type II active 
     pharmaceutical drug master files which--
       ``(i) set forth in detail the specific deficiencies in such 
     submissions, and where appropriate, the actions necessary to 
     resolve those deficiencies; or
       ``(ii) document that no deficiencies need to be addressed.
       ``(D) Inspections related to generic drugs.
       ``(E) Monitoring of research conducted in connection with 
     the review of generic drug submissions and drug master files.
       ``(F) Postmarket safety activities with respect to drugs 
     approved under abbreviated new drug applications or 
     supplements, including the following activities:
       ``(i) Collecting, developing, and reviewing safety 
     information on approved drugs, including adverse event 
     reports.
       ``(ii) Developing and using improved adverse-event data-
     collection systems, including information technology systems.
       ``(iii) Developing and using improved analytical tools to 
     assess potential safety problems, including access to 
     external data bases.
       ``(iv) Implementing and enforcing section 505(o) (relating 
     to postapproval studies and clinical trials and labeling 
     changes) and section 505(p) (relating to risk evaluation and 
     mitigation strategies) insofar as those activities relate to 
     abbreviated new drug applications.
       ``(v) Carrying out section 505(k)(5) (relating to adverse-
     event reports and postmarket safety activities).
       ``(G) Regulatory science activities related to generic 
     drugs.
       ``(9) The term `positron emission tomography drug' has the 
     meaning given to the term `compounded positron emission 
     tomography drug' in section 201(ii), except that paragraph 
     (1)(B) of such section shall not apply.
       ``(10) The term `prior approval supplement' means a request 
     to the Secretary to approve a change in the drug substance, 
     drug product, production process, quality controls, 
     equipment, or facilities covered by an approved abbreviated 
     new drug application when that change has a substantial 
     potential to have an adverse effect on the identity, 
     strength, quality, purity, or potency of the drug product as 
     these factors may relate to the safety or effectiveness of 
     the drug product.
       ``(11) The term `resources allocated for human generic drug 
     activities' means the expenses for--
       ``(A) officers and employees of the Food and Drug 
     Administration, contractors of the Food and Drug 
     Administration, advisory committees, and costs related to 
     such officers and employees and to contracts with such 
     contractors;
       ``(B) management of information, and the acquisition, 
     maintenance, and repair of computer resources;
       ``(C) leasing, maintenance, renovation, and repair of 
     facilities and acquisition, maintenance, and repair of 
     fixtures, furniture, scientific equipment, and other 
     necessary materials and supplies; and
       ``(D) collecting fees under subsection (a) and accounting 
     for resources allocated for the review of abbreviated new 
     drug applications and supplements and inspection related to 
     generic drugs.
       ``(12) The term `Type II active pharmaceutical ingredient 
     drug master file' means a submission of information to the 
     Secretary by a person that intends to authorize the Food and 
     Drug Administration to reference the information to support 
     approval of a generic drug submission without the submitter 
     having to disclose the information to the generic drug 
     submission applicant.

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

       ``(a) Types of Fees.--Beginning in fiscal year 2013, the 
     Secretary shall assess and collect fees in accordance with 
     this section as follows:
       ``(1) One-time backlog fee for abbreviated new drug 
     applications pending on october 1, 2012.--
       ``(A) In general.--Each person that owns an abbreviated new 
     drug application that is pending on October 1, 2012, and that 
     has not received a tentative approval prior to that date, 
     shall be subject to a fee for each such application, as 
     calculated under subparagraph (B).
       ``(B) Method of fee amount calculation.--The amount of each 
     one-time backlog fee shall be calculated by dividing 
     $50,000,000 by the total number of abbreviated new drug 
     applications pending on October 1, 2012, that have not 
     received a tentative approval as of that date.
       ``(C) Notice.--Not later than October 31, 2012, the 
     Secretary shall publish in the Federal Register a notice 
     announcing the amount of the fee required by subparagraph 
     (A).
       ``(D) Fee due date.--The fee required by subparagraph (A) 
     shall be due no later than 30 calendar days after the date of 
     the publication of the notice specified in subparagraph (C).
       ``(2) Drug master file fee.--
       ``(A) In general.--Each person that owns a Type II active 
     pharmaceutical ingredient drug master file that is referenced 
     on or after October 1, 2012, in a generic drug submission by 
     any initial letter of authorization shall be subject to a 
     drug master file fee.
       ``(B) One-time payment.--If a person has paid a drug master 
     file fee for a Type II active pharmaceutical ingredient drug 
     master file, the person shall not be required to pay a 
     subsequent drug master file fee when that Type II active 
     pharmaceutical ingredient drug master file is subsequently 
     referenced in generic drug submissions.
       ``(C) Notice.--
       ``(i) Fiscal year 2013.--Not later than October 31, 2012, 
     the Secretary shall publish in the Federal Register a notice 
     announcing the amount of the drug master file fee for fiscal 
     year 2013.
       ``(ii) Fiscal year 2014 through 2017.--Not later than 60 
     days before the start of each of fiscal years 2014 through 
     2017, the Secretary shall publish in the Federal Register the 
     amount of the drug master file fee established by this 
     paragraph for such fiscal year.
       ``(D) Availability for reference.--
       ``(i) In general.--Subject to subsection (g)(2)(C), for a 
     generic drug submission to reference a Type II active 
     pharmaceutical ingredient drug master file, the drug master 
     file must be deemed available for reference by the Secretary.
       ``(ii) Conditions.--A drug master file shall be deemed 
     available for reference by the Secretary if--

       ``(I) the person that owns a Type II active pharmaceutical 
     ingredient drug master file has paid the fee required under 
     subparagraph (A) within 20 calendar days after the applicable 
     due date under subparagraph (E); and
       ``(II) the drug master file has not failed an initial 
     completeness assessment by the Secretary, in accordance with 
     criteria to be published by the Secretary.

       ``(iii) List.--The Secretary shall make publicly available 
     on the Internet Web site of the Food and Drug Administration 
     a list of the drug master file numbers that correspond to 
     drug master files that have successfully undergone an initial 
     completeness assessment, in accordance with criteria to be 
     published by the Secretary, and are available for reference.
       ``(E) Fee due date.--
       ``(i) In general.--Subject to clause (ii), a drug master 
     file fee shall be due no later than the date on which the 
     first generic drug submission is submitted that references 
     the associated Type II active pharmaceutical ingredient drug 
     master file.
       ``(ii) Limitation.--No fee shall be due under subparagraph 
     (A) for a fiscal year until the later of--

       ``(I) 30 calendar days after publication of the notice 
     provided for in clause (i) or (ii) of subparagraph (C), as 
     applicable; or
       ``(II) 30 calendar days after the date of enactment of an 
     appropriations Act providing for the collection and 
     obligation of fees under this section.

       ``(3) Abbreviated new drug application and prior approval 
     supplement filing fee.--

[[Page 9482]]

       ``(A) In general.--Each applicant that submits, on or after 
     October 1, 2012, an abbreviated new drug application or a 
     prior approval supplement to an abbreviated new drug 
     application shall be subject to a fee for each such 
     submission in the amount established under subsection (d).
       ``(B) Notice.--
       ``(i) Fiscal year 2013.--Not later than October 31, 2012, 
     the Secretary shall publish in the Federal Register a notice 
     announcing the amount of the fees under subparagraph (A) for 
     fiscal year 2013.
       ``(ii) Fiscal years 2014 through 2017.--Not later than 60 
     days before the start of each of fiscal years 2014 through 
     2017, the Secretary shall publish in the Federal Register the 
     amount of the fees under subparagraph (A) for such fiscal 
     year.
       ``(C) Fee due date.--
       ``(i) In general.--Except as provided in clause (ii), the 
     fees required by subparagraphs (A) and (F) shall be due no 
     later than the date of submission of the abbreviated new drug 
     application or prior approval supplement for which such fee 
     applies.
       ``(ii) Special rule for 2013.--For fiscal year 2013, such 
     fees shall be due on the later of--

       ``(I) the date on which the fee is due under clause (i);
       ``(II) 30 calendar days after publication of the notice 
     referred to in subparagraph (B)(i); or
       ``(III) if an appropriations Act is not enacted providing 
     for the collection and obligation of fees under this section 
     by the date of submission of the application or prior 
     approval supplement for which the fees under subparagraphs 
     (A) and (F) apply, 30 calendar days after the date that such 
     an appropriations Act is enacted.

       ``(D) Refund of fee if abbreviated new drug application is 
     not considered to have been received.--The Secretary shall 
     refund 75 percent of the fee paid under subparagraph (A) for 
     any abbreviated new drug application or prior approval 
     supplement to an abbreviated new drug application that the 
     Secretary considers not to have been received within the 
     meaning of section 505(j)(5)(A) for a cause other than 
     failure to pay fees.
       ``(E) Fee for an application the secretary considers not to 
     have been received, or that has been withdrawn.--An 
     abbreviated new drug application or prior approval supplement 
     that was submitted on or after October 1, 2012, and that the 
     Secretary considers not to have been received, or that has 
     been withdrawn, shall, upon resubmission of the application 
     or a subsequent new submission following the applicant's 
     withdrawal of the application, be subject to a full fee under 
     subparagraph (A).
       ``(F) Additional fee for active pharmaceutical ingredient 
     information not included by reference to type ii active 
     pharmaceutical ingredient drug master file.--An applicant 
     that submits a generic drug submission on or after October 1, 
     2012, shall pay a fee, in the amount determined under 
     subsection (d)(3), in addition to the fee required under 
     subparagraph (A), if--
       ``(i) such submission contains information concerning the 
     manufacture of an active pharmaceutical ingredient at a 
     facility by means other than reference by a letter of 
     authorization to a Type II active pharmaceutical drug master 
     file; and
       ``(ii) a fee in the amount equal to the drug master file 
     fee established in paragraph (2) has not been previously paid 
     with respect to such information.
       ``(4) Generic drug facility fee and active pharmaceutical 
     ingredient facility fee.--
       ``(A) In general.--Facilities identified, or intended to be 
     identified, in at least one generic drug submission that is 
     pending or approved to produce a finished dosage form of a 
     human generic drug or an active pharmaceutical ingredient 
     contained in a human generic drug shall be subject to fees as 
     follows:
       ``(i) Generic drug facility.--Each person that owns a 
     facility which is identified or intended to be identified in 
     at least one generic drug submission that is pending or 
     approved to produce one or more finished dosage forms of a 
     human generic drug shall be assessed an annual fee for each 
     such facility.
       ``(ii) Active pharmaceutical ingredient facility.--Each 
     person that owns a facility which produces, or which is 
     pending review to produce, one or more active pharmaceutical 
     ingredients identified, or intended to be identified, in at 
     least one generic drug submission that is pending or approved 
     or in a Type II active pharmaceutical ingredient drug master 
     file referenced in such a generic drug submission, shall be 
     assessed an annual fee for each such facility.
       ``(iii) Facilities producing both active pharmaceutical 
     ingredients and finished dosage forms.--Each person that owns 
     a facility identified, or intended to be identified, in at 
     least one generic drug submission that is pending or approved 
     to produce both one or more finished dosage forms subject to 
     clause (i) and one or more active pharmaceutical ingredients 
     subject to clause (ii) shall be subject to fees under both 
     such clauses for that facility.
       ``(B) Amount.--The amount of fees established under 
     subparagraph (A) shall be established under subsection (d).
       ``(C) Notice.--
       ``(i) Fiscal year 2013.--For fiscal year 2013, the 
     Secretary shall publish in the Federal Register a notice 
     announcing the amount of the fees provided for in 
     subparagraph (A) within the timeframe specified in subsection 
     (d)(1)(B).
       ``(ii) Fiscal years 2014 through 2017.--Within the 
     timeframe specified in subsection (d)(2), the Secretary shall 
     publish in the Federal Register the amount of the fees under 
     subparagraph (A) for such fiscal year.
       ``(D) Fee due date.--
       ``(i) Fiscal year 2013.--For fiscal year 2013, the fees 
     under subparagraph (A) shall be due on the later of--

       ``(I) not later than 45 days after the publication of the 
     notice under subparagraph (B); or
       ``(II) if an appropriations Act is not enacted providing 
     for the collection and obligation of fees under this section 
     by the date of the publication of such notice, 30 days after 
     the date that such an appropriations Act is enacted.

       ``(ii) Fiscal years 2014 through 2017.--For each of fiscal 
     years 2014 through 2017, the fees under subparagraph (A) for 
     such fiscal year shall be due on the later of--

       ``(I) the first business day on or after October 1 of each 
     such year; or
       ``(II) the first business day after the enactment of an 
     appropriations Act providing for the collection and 
     obligation of fees under this section for such year.

       ``(5) Date of submission.--For purposes of this Act, a 
     generic drug submission or Type II pharmaceutical master file 
     is deemed to be `submitted' to the Food and Drug 
     Administration--
       ``(A) if it is submitted via a Food and Drug Administration 
     electronic gateway, on the day when transmission to that 
     electronic gateway is completed, except that a submission or 
     master file that arrives on a weekend, Federal holiday, or 
     day when the Food and Drug Administration office that will 
     review that submission is not otherwise open for business 
     shall be deemed to be submitted on the next day when that 
     office is open for business; or
       ``(B) if it is submitted in physical media form, on the day 
     it arrives at the appropriate designated document room of the 
     Food and Drug Administration.
       ``(b) Fee Revenue Amounts.--
       ``(1) In general.--
       ``(A) Fiscal year 2013.--For fiscal year 2013, fees under 
     subsection (a) shall be established to generate a total 
     estimated revenue amount under such subsection of 
     $299,000,000. Of that amount--
       ``(i) $50,000,000 shall be generated by the one-time 
     backlog fee for generic drug applications pending on October 
     1, 2012, established in subsection (a)(1); and
       ``(ii) $249,000,000 shall be generated by the fees under 
     paragraphs (2) through (4) of subsection (a).
       ``(B) Fiscal years 2014 through 2017.--For each of the 
     fiscal years 2014 through 2017, fees under paragraphs (2) 
     through (4) of subsection (a) shall be established to 
     generate a total estimated revenue amount under such 
     subsection that is equal to $299,000,000, as adjusted 
     pursuant to subsection (c).
       ``(2) Types of fees.--In establishing fees under paragraph 
     (1) to generate the revenue amounts specified in paragraph 
     (1)(A)(ii) for fiscal year 2013 and paragraph (1)(B) for each 
     of fiscal years 2014 through 2017, such fees shall be derived 
     from the fees under paragraphs (2) through (4) of subsection 
     (a) as follows:
       ``(A) Six percent shall be derived from fees under 
     subsection (a)(2) (relating to drug master files).
       ``(B) Twenty-four percent shall be derived from fees under 
     subsection (a)(3) (relating to abbreviated new drug 
     applications and supplements). The amount of a fee for a 
     prior approval supplement shall be half the amount of the fee 
     for an abbreviated new drug application.
       ``(C) Fifty-six percent shall be derived from fees under 
     subsection (a)(4)(A)(i) (relating to generic drug 
     facilities). The amount of the fee for a facility located 
     outside the United States and its territories and possessions 
     shall be not less than $15,000 and not more than $30,000 
     higher than the amount of the fee for a facility located in 
     the United States and its territories and possessions, as 
     determined by the Secretary on the basis of data concerning 
     the difference in cost between inspections of facilities 
     located in the United States, including its territories and 
     possessions, and those located outside of the United States 
     and its territories and possessions.
       ``(D) Fourteen percent shall be derived from fees under 
     subsection (a)(4)(A)(ii) (relating to active pharmaceutical 
     ingredient facilities). The amount of the fee for a facility 
     located outside the United States and its territories and 
     possessions shall be not less than $15,000 and not more than 
     $30,000 higher than the amount of the fee for a facility 
     located in the United States, including its territories and 
     possessions, as determined by the Secretary on the basis of 
     data concerning the difference in cost between inspections of 
     facilities located in the United States and its territories 
     and possessions and those located outside of the United 
     States and its territories and possessions.
       ``(c) Adjustments.--
       ``(1) Inflation adjustment.--For fiscal year 2014 and 
     subsequent fiscal years, the revenues established in 
     subsection (b) shall be adjusted by the Secretary by notice, 
     published in the Federal Register, for a fiscal year, by an 
     amount equal to the sum of--
       ``(A) one;
       ``(B) the average annual percent change in the cost, per 
     full-time equivalent position of the Food and Drug 
     Administration, of all personnel compensation and benefits 
     paid with respect to such positions for the first 3 years of 
     the preceding 4 fiscal years multiplied by the proportion of 
     personnel compensation and benefits costs to total costs of 
     human generic drug activities for the first 3 years of the 
     preceding 4 fiscal years; and

[[Page 9483]]

       ``(C) the average annual percent change that occurred in 
     the Consumer Price Index for urban consumers (Washington-
     Baltimore, DC-MD-VA-WV; Not Seasonally Adjusted; All items; 
     Annual Index) for the first 3 years of the preceding 4 years 
     of available data multiplied by the proportion of all costs 
     other than personnel compensation and benefits costs to total 
     costs of human generic drug activities for the first 3 years 
     of the preceding 4 fiscal years.
     The adjustment made each fiscal year under this subsection 
     shall be added on a compounded basis to the sum of all 
     adjustments made each fiscal year after fiscal year 2013 
     under this subsection.
       ``(2) Final year adjustment.--For fiscal year 2017, the 
     Secretary may, in addition to adjustments under paragraph 
     (1), further increase the fee revenues and fees established 
     in subsection (b) if such an adjustment is necessary to 
     provide for not more than 3 months of operating reserves of 
     carryover user fees for human generic drug activities for the 
     first 3 months of fiscal year 2018. Such fees may only be 
     used in fiscal year 2018. If such an adjustment is necessary, 
     the rationale for the amount of the increase shall be 
     contained in the annual notice establishing fee revenues and 
     fees for fiscal year 2017. If the Secretary has carryover 
     balances for such activities in excess of 3 months of such 
     operating reserves, the adjustment under this subparagraph 
     shall not be made.
       ``(d) Annual Fee Setting.--
       ``(1) Fiscal year 2013.--For fiscal year 2013--
       ``(A) the Secretary shall establish, by October 31, 2012, 
     the one-time generic drug backlog fee for generic drug 
     applications pending on October 1, 2012, the drug master file 
     fee, the abbreviated new drug application fee, and the prior 
     approval supplement fee under subsection (a), based on the 
     revenue amounts established under subsection (b); and
       ``(B) the Secretary shall establish, not later than 45 days 
     after the date to comply with the requirement for 
     identification of facilities in subsection (f)(2), the 
     generic drug facility fee and active pharmaceutical 
     ingredient facility fee under subsection (a) based on the 
     revenue amounts established under subsection (b).
       ``(2) Fiscal years 2014 through 2017.--Not more than 60 
     days before the first day of each of fiscal years 2014 
     through 2017, the Secretary shall establish the drug master 
     file fee, the abbreviated new drug application fee, the prior 
     approval supplement fee, the generic drug facility fee, and 
     the active pharmaceutical ingredient facility fee under 
     subsection (a) for such fiscal year, based on the revenue 
     amounts established under subsection (b) and the adjustments 
     provided under subsection (c).
       ``(3) Fee for active pharmaceutical ingredient information 
     not included by reference to type ii active pharmaceutical 
     ingredient drug master file.--In establishing the fees under 
     paragraphs (1) and (2), the amount of the fee under 
     subsection (a)(3)(F) shall be determined by multiplying--
       ``(A) the sum of--
       ``(i) the total number of such active pharmaceutical 
     ingredients in such submission; and
       ``(ii) for each such ingredient that is manufactured at 
     more than one such facility, the total number of such 
     additional facilities; and
       ``(B) the amount equal to the drug master file fee 
     established in subsection (a)(2) for such submission.
       ``(e) Limit.--The total amount of fees charged, as adjusted 
     under subsection (c), for a fiscal year may not exceed the 
     total costs for such fiscal year for the resources allocated 
     for human generic drug activities.
       ``(f) Identification of Facilities.--
       ``(1) Publication of notice; deadline for compliance.--Not 
     later than October 1, 2012, the Secretary shall publish in 
     the Federal Register a notice requiring each person that owns 
     a facility described in subsection (a)(4)(A), or a site or 
     organization required to be identified by paragraph (4), to 
     submit to the Secretary information on the identity of each 
     such facility, site, or organization. The notice required by 
     this paragraph shall specify the type of information to be 
     submitted and the means and format for submission of such 
     information.
       ``(2) Required submission of facility identification.--Each 
     person that owns a facility described in subsection (a)(4)(A) 
     or a site or organization required to be identified by 
     paragraph (4) shall submit to the Secretary the information 
     required under this subsection each year. Such information 
     shall--
       ``(A) for fiscal year 2013, be submitted not later than 60 
     days after the publication of the notice under paragraph (1); 
     and
       ``(B) for each subsequent fiscal year, be submitted, 
     updated, or reconfirmed on or before June 1 of the previous 
     year.
       ``(3) Contents of notice.--At a minimum, the submission 
     required by paragraph (2) shall include for each such 
     facility--
       ``(A) identification of a facility identified or intended 
     to be identified in an approved or pending generic drug 
     submission;
       ``(B) whether the facility manufactures active 
     pharmaceutical ingredients or finished dosage forms, or both;
       ``(C) whether or not the facility is located within the 
     United States and its territories and possessions;
       ``(D) whether the facility manufactures positron emission 
     tomography drugs solely, or in addition to other drugs; and
       ``(E) whether the facility manufactures drugs that are not 
     generic drugs.
       ``(4) Certain sites and organizations.--
       ``(A) In general.--Any person that owns or operates a site 
     or organization described in subparagraph (B) shall submit to 
     the Secretary information concerning the ownership, name, and 
     address of the site or organization.
       ``(B) Sites and organizations.--A site or organization is 
     described in this subparagraph if it is identified in a 
     generic drug submission and is--
       ``(i) a site in which a bioanalytical study is conducted;
       ``(ii) a clinical research organization;
       ``(iii) a contract analytical testing site; or
       ``(iv) a contract repackager site.
       ``(C) Notice.--The Secretary may, by notice published in 
     the Federal Register, specify the means and format for 
     submission of the information under subparagraph (A) and may 
     specify, as necessary for purposes of this section, any 
     additional information to be submitted.
       ``(D) Inspection authority.--The Secretary's inspection 
     authority under section 704(a)(1) shall extend to all such 
     sites and organizations.
       ``(g) Effect of Failure To Pay Fees.--
       ``(1) Generic drug backlog fee.--Failure to pay the fee 
     under subsection (a)(1) shall result in the Secretary placing 
     the person that owns the abbreviated new drug application 
     subject to that fee on a publicly available arrears list, 
     such that no new abbreviated new drug applications or 
     supplement submitted on or after October 1, 2012, from that 
     person, or any affiliate of that person, will be received 
     within the meaning of section 505(j)(5)(A) until such 
     outstanding fee is paid.
       ``(2) Drug master file fee.--
       ``(A) Failure to pay the fee under subsection (a)(2) within 
     20 calendar days after the applicable due date under 
     subparagraph (E) of such subsection (as described in 
     subsection (a)(2)(D)(ii)(I)) shall result in the Type II 
     active pharmaceutical ingredient drug master file not being 
     deemed available for reference.
       ``(B)(i) Any generic drug submission submitted on or after 
     October 1, 2012, that references, by a letter of 
     authorization, a Type II active pharmaceutical ingredient 
     drug master file that has not been deemed available for 
     reference shall not be received within the meaning of section 
     505(j)(5)(A) unless the condition specified in clause (ii) is 
     met.
       ``(ii) The condition specified in this clause is that the 
     fee established under subsection (a)(2) has been paid within 
     20 calendar days of the Secretary providing the notification 
     to the sponsor of the abbreviated new drug application or 
     supplement of the failure of the owner of the Type II active 
     pharmaceutical ingredient drug master file to pay the drug 
     master file fee as specified in subparagraph (C).
       ``(C)(i) If an abbreviated new drug application or 
     supplement to an abbreviated new drug application references 
     a Type II active pharmaceutical ingredient drug master file 
     for which a fee under subsection (a)(2)(A) has not been paid 
     by the applicable date under subsection (a)(2)(E), the 
     Secretary shall notify the sponsor of the abbreviated new 
     drug application or supplement of the failure of the owner of 
     the Type II active pharmaceutical ingredient drug master file 
     to pay the applicable fee.
       ``(ii) If such fee is not paid within 20 calendar days of 
     the Secretary providing the notification, the abbreviated new 
     drug application or supplement to an abbreviated new drug 
     application shall not be received within the meaning of 
     505(j)(5)(A).
       ``(3) Abbreviated new drug application fee and prior 
     approval supplement fee.--Failure to pay a fee under 
     subparagraph (A) or (F) of subsection (a)(3) within 20 
     calendar days of the applicable due date under subparagraph 
     (C) of such subsection shall result in the abbreviated new 
     drug application or the prior approval supplement to an 
     abbreviated new drug application not being received within 
     the meaning of section 505(j)(5)(A) until such outstanding 
     fee is paid.
       ``(4) Generic drug facility fee and active pharmaceutical 
     ingredient facility fee.--
       ``(A) In general.--Failure to pay the fee under subsection 
     (a)(4) within 20 calendar days of the due date as specified 
     in subparagraph (D) of such subsection shall result in the 
     following:
       ``(i) The Secretary shall place the facility on a publicly 
     available arrears list, such that no new abbreviated new drug 
     application or supplement submitted on or after October 1, 
     2012, from the person that is responsible for paying such 
     fee, or any affiliate of that person, will be received within 
     the meaning of section 505(j)(5)(A).
       ``(ii) Any new generic drug submission submitted on or 
     after October 1, 2012, that references such a facility shall 
     not be received, within the meaning of section 505(j)(5)(A) 
     if the outstanding facility fee is not paid within 20 
     calendar days of the Secretary providing the notification to 
     the sponsor of the failure of the owner of the facility to 
     pay the facility fee under subsection (a)(4)(C).
       ``(iii) All drugs or active pharmaceutical ingredients 
     manufactured in such a facility or containing an ingredient 
     manufactured in such a facility shall be deemed misbranded 
     under section 502(aa).
       ``(B) Application of penalties.--The penalties under this 
     paragraph shall apply until the fee established by subsection 
     (a)(4) is paid or the facility is removed from all generic 
     drug submissions that refer to the facility.
       ``(C) Nonreceival for nonpayment.--
       ``(i) Notice.--If an abbreviated new drug application or 
     supplement to an abbreviated new drug application submitted 
     on or after October 1, 2012, references a facility for which 
     a facility fee has not been paid by the applicable date under 
     subsection (a)(4)(C), the Secretary shall

[[Page 9484]]

     notify the sponsor of the generic drug submission of the 
     failure of the owner of the facility to pay the facility fee.
       ``(ii) Nonreceival.--If the facility fee is not paid within 
     20 calendar days of the Secretary providing the notification 
     under clause (i), the abbreviated new drug application or 
     supplement to an abbreviated new drug application shall not 
     be received within the meaning of section 505(j)(5)(A).
       ``(h) Limitations.--
       ``(1) In general.--Fees under subsection (a) shall be 
     refunded for a fiscal year beginning after fiscal year 2012, 
     unless appropriations for salaries and expenses of the Food 
     and Drug Administration for such fiscal year (excluding the 
     amount of fees appropriated for such fiscal year) are equal 
     to or greater than the amount of appropriations for the 
     salaries and expenses of the Food and Drug Administration for 
     fiscal year 2009 (excluding the amount of fees appropriated 
     for such fiscal year) multiplied by the adjustment factor (as 
     defined in section 744A) applicable to the fiscal year 
     involved.
       ``(2) Authority.--If the Secretary does not assess fees 
     under subsection (a) during any portion of a fiscal year and 
     if at a later date in such fiscal year the Secretary may 
     assess such fees, the Secretary may assess and collect such 
     fees, without any modification in the rate, for Type II 
     active pharmaceutical ingredient drug master files, 
     abbreviated new drug applications and prior approval 
     supplements, and generic drug facilities and active 
     pharmaceutical ingredient facilities at any time in such 
     fiscal year notwithstanding the provisions of subsection (a) 
     relating to the date fees are to be paid.
       ``(i) Crediting and Availability of Fees.--
       ``(1) In general.--Fees authorized under subsection (a) 
     shall be collected and available for obligation only to the 
     extent and in the amount provided in advance in 
     appropriations Acts, subject to paragraph (2). Such fees are 
     authorized to remain available until expended. Such sums as 
     may be necessary may be transferred from the Food and Drug 
     Administration salaries and expenses appropriation account 
     without fiscal year limitation to such appropriation account 
     for salaries and expenses with such fiscal year limitation. 
     The sums transferred shall be available solely for human 
     generic drug activities.
       ``(2) Collections and appropriation acts.--
       ``(A) In general.--The fees authorized by this section--
       ``(i) subject to subparagraphs (C) and (D), shall be 
     collected and available in each fiscal year in an amount not 
     to exceed the amount specified in appropriation Acts, or 
     otherwise made available for obligation for such fiscal year; 
     and
       ``(ii) shall be available for a fiscal year beginning after 
     fiscal year 2012 to defray the costs of human generic drug 
     activities (including such costs for an additional number of 
     full-time equivalent positions in the Department of Health 
     and Human Services to be engaged in such activities), only if 
     the Secretary allocates for such purpose an amount for such 
     fiscal year (excluding amounts from fees collected under this 
     section) no less than $97,000,000 multiplied by the 
     adjustment factor defined in section 744A(3) applicable to 
     the fiscal year involved.
       ``(B) Compliance.--The Secretary shall be considered to 
     have met the requirements of subparagraph (A)(ii) in any 
     fiscal year if the costs funded by appropriations and 
     allocated for human generic activities are not more than 10 
     percent below the level specified in such subparagraph.
       ``(C) Fee collection during first program year.--Until the 
     date of enactment of an Act making appropriations through 
     September 30, 2013 for the salaries and expenses account of 
     the Food and Drug Administration, fees authorized by this 
     section for fiscal year 2013, may be collected and shall be 
     credited to such account and remain available until expended.
       ``(D) Provision for early payments in subsequent years.--
     Payment of fees authorized under this section for a fiscal 
     year (after fiscal year 2013), prior to the due date for such 
     fees, may be accepted by the Secretary in accordance with 
     authority provided in advance in a prior year appropriations 
     Act.
       ``(3) Authorization of appropriations.--For each of the 
     fiscal years 2013 through 2017, there is authorized to be 
     appropriated for fees under this section an amount equivalent 
     to the total revenue amount determined under subsection (b) 
     for the fiscal year, as adjusted under subsection (c), if 
     applicable, or as otherwise affected under paragraph (2) of 
     this subsection.
       ``(j) Collection of Unpaid Fees.--In any case where the 
     Secretary does not receive payment of a fee assessed under 
     subsection (a) within 30 calendar days after it is due, such 
     fee shall be treated as a claim of the United States 
     Government subject to subchapter II of chapter 37 of title 
     31, United States Code.
       ``(k) Construction.--This section may not be construed to 
     require that the number of full-time equivalent positions in 
     the Department of Health and Human Services, for officers, 
     employees, and advisory committees not engaged in human 
     generic drug activities, be reduced to offset the number of 
     officers, employees, and advisory committees so engaged.
       ``(l) Positron Emission Tomography Drugs.--
       ``(1) Exemption from fees.--Submission of an application 
     for a positron emission tomography drug or active 
     pharmaceutical ingredient for a positron emission tomography 
     drug shall not require the payment of any fee under this 
     section. Facilities that solely produce positron emission 
     tomography drugs shall not be required to pay a facility fee 
     as established in subsection (a)(4).
       ``(2) Identification requirement.--Facilities that produce 
     positron emission tomography drugs or active pharmaceutical 
     ingredients of such drugs are required to be identified 
     pursuant to subsection (f).
       ``(m) Disputes Concerning Fees.--To qualify for the return 
     of a fee claimed to have been paid in error under this 
     section, a person shall submit to the Secretary a written 
     request justifying such return within 180 calendar days after 
     such fee was paid.
       ``(n) Substantially Complete Applications.--An abbreviated 
     new drug application that is not considered to be received 
     within the meaning of section 505(j)(5)(A) because of failure 
     to pay an applicable fee under this provision within the time 
     period specified in subsection (g) shall be deemed not to 
     have been `substantially complete' on the date of its 
     submission within the meaning of section 
     505(j)(5)(B)(iv)(II)(cc). An abbreviated new drug application 
     that is not substantially complete on the date of its 
     submission solely because of failure to pay an applicable fee 
     under the preceding sentence shall be deemed substantially 
     complete and received within the meaning of section 
     505(j)(5)(A) as of the date such applicable fee is 
     received.''.

     SEC. 303. REAUTHORIZATION; REPORTING REQUIREMENTS.

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

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

       ``(a) Performance Report.--Beginning with fiscal year 2013, 
     not later than 120 days after the end of each fiscal year for 
     which fees are collected under this part, the Secretary shall 
     prepare and submit to the Committee on Energy and Commerce of 
     the House of Representatives and the Committee on Health, 
     Education, Labor, and Pensions of the Senate a report 
     concerning the progress of the Food and Drug Administration 
     in achieving the goals identified in the letters described in 
     section 301(b) of the Generic Drug User Fee Amendments of 
     2012 during such fiscal year and the future plans of the Food 
     and Drug Administration for meeting the goals.
       ``(b) Fiscal Report.--Beginning with fiscal year 2013, not 
     later than 120 days after the end of each fiscal year for 
     which fees are collected under this part, the Secretary shall 
     prepare and submit to the Committee on Energy and Commerce of 
     the House of Representatives and the Committee on Health, 
     Education, Labor, and Pensions of the Senate a report on the 
     implementation of the authority for such fees during such 
     fiscal year and the use, by the Food and Drug Administration, 
     of the fees collected for such fiscal year.
       ``(c) Public Availability.--The Secretary shall make the 
     reports required under subsections (a) and (b) available to 
     the public on the Internet Web site of the Food and Drug 
     Administration.
       ``(d) Reauthorization.--
       ``(1) Consultation.--In developing recommendations to 
     present to the Congress with respect to the goals, and plans 
     for meeting the goals, for human generic drug activities for 
     the first 5 fiscal years after fiscal year 2017, and for the 
     reauthorization of this part for such fiscal years, the 
     Secretary shall consult with--
       ``(A) the Committee on Energy and Commerce of the House of 
     Representatives;
       ``(B) the Committee on Health, Education, Labor, and 
     Pensions of the Senate;
       ``(C) scientific and academic experts;
       ``(D) health care professionals;
       ``(E) representatives of patient and consumer advocacy 
     groups; and
       ``(F) the generic drug industry.
       ``(2) Prior public input.--Prior to beginning negotiations 
     with the generic drug industry on the reauthorization of this 
     part, the Secretary shall--
       ``(A) publish a notice in the Federal Register requesting 
     public input on the reauthorization;
       ``(B) hold a public meeting at which the public may present 
     its views on the reauthorization, including specific 
     suggestions for changes to the goals referred to in 
     subsection (a);
       ``(C) provide a period of 30 days after the public meeting 
     to obtain written comments from the public suggesting changes 
     to this part; and
       ``(D) publish the comments on the Food and Drug 
     Administration's Internet Web site.
       ``(3) Periodic consultation.--Not less frequently than once 
     every month during negotiations with the generic drug 
     industry, the Secretary shall hold discussions with 
     representatives of patient and consumer advocacy groups to 
     continue discussions of their views on the reauthorization 
     and their suggestions for changes to this part as expressed 
     under paragraph (2).
       ``(4) Public review of recommendations.--After negotiations 
     with the generic drug industry, the Secretary shall--
       ``(A) present the recommendations developed under paragraph 
     (1) to the congressional committees specified in such 
     paragraph;
       ``(B) publish such recommendations in the Federal Register;
       ``(C) provide for a period of 30 days for the public to 
     provide written comments on such recommendations;
       ``(D) hold a meeting at which the public may present its 
     views on such recommendations; and
       ``(E) after consideration of such public views and 
     comments, revise such recommendations as necessary.

[[Page 9485]]

       ``(5) Transmittal of recommendations.--Not later than 
     January 15, 2017, the Secretary shall transmit to the 
     Congress the revised recommendations under paragraph (4), a 
     summary of the views and comments received under such 
     paragraph, and any changes made to the recommendations in 
     response to such views and comments.
       ``(6) Minutes of negotiation meetings.--
       ``(A) Public availability.--Before presenting the 
     recommendations developed under paragraphs (1) through (5) to 
     the Congress, the Secretary shall make publicly available, on 
     the Internet Web site of the Food and Drug Administration, 
     minutes of all negotiation meetings conducted under this 
     subsection between the Food and Drug Administration and the 
     generic drug industry.
       ``(B) Content.--The minutes described under subparagraph 
     (A) shall summarize any substantive proposal made by any 
     party to the negotiations as well as significant 
     controversies or differences of opinion during the 
     negotiations and their resolution.''.

     SEC. 304. SUNSET DATES.

       (a) Authorization.--Sections 744A and 744B of the Federal 
     Food, Drug, and Cosmetic Act, as added by section 302 of this 
     Act, shall cease to be effective October 1, 2017.
       (b) Reporting Requirements.--Section 744C of the Federal 
     Food, Drug, and Cosmetic Act, as added by section 303 of this 
     Act, shall cease to be effective January 31, 2018.

     SEC. 305. EFFECTIVE DATE.

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

     SEC. 306. AMENDMENT WITH RESPECT TO MISBRANDING.

       Section 502 (21 U.S.C. 352) is amended by adding at the end 
     the following:
       ``(aa) If it is a drug, or an active pharmaceutical 
     ingredient, and it was manufactured, prepared, propagated, 
     compounded, or processed in a facility for which fees have 
     not been paid as required by section 744A(a)(4) or for which 
     identifying information required by section 744B(f) has not 
     been submitted, or it contains an active pharmaceutical 
     ingredient that was manufactured, prepared, propagated, 
     compounded, or processed in such a facility.''.

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

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

     SEC. 308. ADDITIONAL REPORTING REQUIREMENTS.

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

     ``SEC. 715. REPORTING REQUIREMENTS.

       ``(a) Generic Drugs.--Beginning with fiscal year 2013 and 
     ending after fiscal year 2017, not later than 120 days after 
     the end of each fiscal year for which fees are collected 
     under part 7 of subchapter C, the Secretary shall prepare and 
     submit to the Committee on Health, Education, Labor, and 
     Pensions of the Senate and the Committee on Energy and 
     Commerce of the House of Representatives a report concerning, 
     for all applications for approval of a generic drug under 
     section 505(j), amendments to such applications, and prior 
     approval supplements with respect to such applications filed 
     in the previous fiscal year--
       ``(1) the number of such applications that met the goals 
     identified for purposes of part 7 of subchapter C, in the 
     letters from the Secretary of Health and Human Services to 
     the Chairman of the Committee on Health, Education, Labor, 
     and Pensions of the Senate and the Chairman of the Committee 
     on Energy and Commerce of the House of Representatives, as 
     set forth in the Congressional Record;
       ``(2) the average total time to decision by the Secretary 
     for applications for approval of a generic drug under section 
     505(j), amendments to such applications, and prior approval 
     supplements with respect to such applications filed in the 
     previous fiscal year, including the number of calendar days 
     spent during the review by the Food and Drug Administration 
     and the number of calendar days spent by the sponsor 
     responding to a complete response letter;
       ``(3) the total number of applications under section 
     505(j), amendments to such applications, and prior approval 
     supplements with respect to such applications that were 
     pending with the Secretary for more than 10 months on the 
     date of enactment of the Food and Drug Administration Safety 
     and Innovation Act; and
       ``(4) the number of applications described in paragraph (3) 
     on which the Food and Drug Administration took final 
     regulatory action in the previous fiscal year.''.

       TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

     SEC. 401. SHORT TITLE; FINDING.

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

     SEC. 402. FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS.

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

       ``PART 8--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

     ``SEC. 744G. DEFINITIONS.

       ``For purposes of this part:
       ``(1) The term `adjustment factor' applicable to a fiscal 
     year that is the Consumer Price Index for all urban consumers 
     (Washington-Baltimore, DC-MD-VA-WV; Not Seasonally Adjusted; 
     All items) of the preceding fiscal year divided by such Index 
     for September 2011.
       ``(2) The term `affiliate' means a business entity that has 
     a relationship with a second business entity if, directly or 
     indirectly--
       ``(A) one business entity controls, or has the power to 
     control, the other business entity; or
       ``(B) a third party controls, or has power to control, both 
     of the business entities.
       ``(3) The term `biosimilar biological product' means a 
     product for which a biosimilar biological product application 
     has been approved.
       ``(4)(A) Subject to subparagraph (B), the term `biosimilar 
     biological product application' means an application for 
     licensure of a biological product under section 351(k) of the 
     Public Health Service Act.
       ``(B) Such term does not include--
       ``(i) a supplement to such an application;
       ``(ii) an application filed under section 351(k) of the 
     Public Health Service Act that cites as the reference product 
     a bovine blood product for topical application licensed 
     before September 1, 1992, or a large volume parenteral drug 
     product approved before such date;
       ``(iii) an application filed under section 351(k) of the 
     Public Health Service Act with respect to--
       ``(I) whole blood or a blood component for transfusion;
       ``(II) an allergenic extract product;
       ``(III) an in vitro diagnostic biological product; or
       ``(IV) a biological product for further manufacturing use 
     only; or
       ``(iv) an application for licensure under section 351(k) of 
     the Public Health Service Act that is submitted by a State or 
     Federal Government entity for a product that is not 
     distributed commercially.
       ``(5) The term `biosimilar biological product development 
     meeting' means any meeting, other than a biosimilar initial 
     advisory meeting, regarding the content of a development 
     program, including a proposed design for, or data from, a 
     study intended to support a biosimilar biological product 
     application.
       ``(6) The term `biosimilar biological product development 
     program' means the program under this part for expediting the 
     process for the review of submissions in connection with 
     biosimilar biological product development.
       ``(7)(A) The term `biosimilar biological product 
     establishment' means a foreign or domestic place of 
     business--
       ``(i) that is at one general physical location consisting 
     of one or more buildings, all of which are within 5 miles of 
     each other; and
       ``(ii) at which one or more biosimilar biological products 
     are manufactured in final dosage form.
       ``(B) For purposes of subparagraph (A)(ii), the term 
     `manufactured' does not include packaging.
       ``(8) The term `biosimilar initial advisory meeting'--
       ``(A) means a meeting, if requested, that is limited to--
       ``(i) a general discussion regarding whether licensure 
     under section 351(k) of the Public Health Service Act may be 
     feasible for a particular product; and
       ``(ii) if so, general advice on the expected content of the 
     development program; and
       ``(B) does not include any meeting that involves 
     substantive review of summary data or full study reports.
       ``(9) The term `costs of resources allocated for the 
     process for the review of biosimilar biological product 
     applications' means the expenses in connection with the 
     process for the review of biosimilar biological product 
     applications for--
       ``(A) officers and employees of the Food and Drug 
     Administration, contractors of the Food and Drug 
     Administration, advisory committees, and costs related to 
     such officers employees and committees and to contracts with 
     such contractors;
       ``(B) management of information, and the acquisition, 
     maintenance, and repair of computer resources;

[[Page 9486]]

       ``(C) leasing, maintenance, renovation, and repair of 
     facilities and acquisition, maintenance, and repair of 
     fixtures, furniture, scientific equipment, and other 
     necessary materials and supplies; and
       ``(D) collecting fees under section 744H and accounting for 
     resources allocated for the review of submissions in 
     connection with biosimilar biological product development, 
     biosimilar biological product applications, and supplements.
       ``(10) The term `final dosage form' means, with respect to 
     a biosimilar biological product, a finished dosage form which 
     is approved for administration to a patient without 
     substantial further manufacturing (such as lyophilized 
     products before reconstitution).
       ``(11) The term `financial hold'--
       ``(A) means an order issued by the Secretary to prohibit 
     the sponsor of a clinical investigation from continuing the 
     investigation if the Secretary determines that the 
     investigation is intended to support a biosimilar biological 
     product application and the sponsor has failed to pay any fee 
     for the product required under subparagraph (A), (B), or (D) 
     of section 744H(a)(1); and
       ``(B) does not mean that any of the bases for a `clinical 
     hold' under section 505(i)(3) have been determined by the 
     Secretary to exist concerning the investigation.
       ``(12) The term `person' includes an affiliate of such 
     person.
       ``(13) The term `process for the review of biosimilar 
     biological product applications' means the following 
     activities of the Secretary with respect to the review of 
     submissions in connection with biosimilar biological product 
     development, biosimilar biological product applications, and 
     supplements:
       ``(A) The activities necessary for the review of 
     submissions in connection with biosimilar biological product 
     development, biosimilar biological product applications, and 
     supplements.
       ``(B) Actions related to submissions in connection with 
     biosimilar biological product development, the issuance of 
     action letters which approve biosimilar biological product 
     applications or which set forth in detail the specific 
     deficiencies in such applications, and where appropriate, the 
     actions necessary to place such applications in condition for 
     approval.
       ``(C) The inspection of biosimilar biological product 
     establishments and other facilities undertaken as part of the 
     Secretary's review of pending biosimilar biological product 
     applications and supplements.
       ``(D) Activities necessary for the release of lots of 
     biosimilar biological products under section 351(k) of the 
     Public Health Service Act.
       ``(E) Monitoring of research conducted in connection with 
     the review of biosimilar biological product applications.
       ``(F) Postmarket safety activities with respect to 
     biologics approved under biosimilar biological product 
     applications or supplements, including the following 
     activities:
       ``(i) Collecting, developing, and reviewing safety 
     information on biosimilar biological products, including 
     adverse-event reports.
       ``(ii) Developing and using improved adverse-event data-
     collection systems, including information technology systems.
       ``(iii) Developing and using improved analytical tools to 
     assess potential safety problems, including access to 
     external data bases.
       ``(iv) Implementing and enforcing section 505(o) (relating 
     to postapproval studies and clinical trials and labeling 
     changes) and section 505(p) (relating to risk evaluation and 
     mitigation strategies).
       ``(v) Carrying out section 505(k)(5) (relating to adverse-
     event reports and postmarket safety activities).
       ``(14) The term `supplement' means a request to the 
     Secretary to approve a change in a biosimilar biological 
     product application which has been approved, including a 
     supplement requesting that the Secretary determine that the 
     biosimilar biological product meets the standards for 
     interchangeability described in section 351(k)(4) of the 
     Public Health Service Act.

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

       ``(a) Types of Fees.--Beginning in fiscal year 2013, the 
     Secretary shall assess and collect fees in accordance with 
     this section as follows:
       ``(1) Biosimilar development program fees.--
       ``(A) Initial biosimilar biological product development 
     fee.--
       ``(i) In general.--Each person that submits to the 
     Secretary a meeting request described under clause (ii) or a 
     clinical protocol for an investigational new drug protocol 
     described under clause (iii) shall pay for the product named 
     in the meeting request or the investigational new drug 
     application the initial biosimilar biological product 
     development fee established under subsection (b)(1)(A).
       ``(ii) Meeting request.--The meeting request described in 
     this clause is a request for a biosimilar biological product 
     development meeting for a product.
       ``(iii) Clinical protocol for ind.--A clinical protocol for 
     an investigational new drug protocol described in this clause 
     is a clinical protocol consistent with the provisions of 
     section 505(i), including any regulations promulgated under 
     section 505(i), (referred to in this section as 
     `investigational new drug application') describing an 
     investigation that the Secretary determines is intended to 
     support a biosimilar biological product application for a 
     product.
       ``(iv) Due date.--The initial biosimilar biological product 
     development fee shall be due by the earlier of the following:

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

       ``(v) Transition rule.--Each person that has submitted an 
     investigational new drug application prior to the date of 
     enactment of the Biosimilars User Fee Act of 2012 shall pay 
     the initial biosimilar biological product development fee by 
     the earlier of the following:

       ``(I) Not later than 60 days after the date of the 
     enactment of the Biosimilars User Fee Act of 2012, if the 
     Secretary determines that the investigational new drug 
     application describes an investigation that is intended to 
     support a biosimilar biological product application.
       ``(II) Not later than 5 days after the Secretary grants a 
     request for a biosimilar biological product development 
     meeting.

       ``(B) Annual biosimilar biological product development 
     fee.--
       ``(i) In general.--A person that pays an initial biosimilar 
     biological product development fee for a product shall pay 
     for such product, beginning in the fiscal year following the 
     fiscal year in which the initial biosimilar biological 
     product development fee was paid, an annual fee established 
     under subsection (b)(1)(B) for biosimilar biological product 
     development (referred to in this section as `annual 
     biosimilar biological product development fee').
       ``(ii) Due date.--The annual biosimilar biological product 
     development program fee for each fiscal year will be due on 
     the later of--

       ``(I) the first business day on or after October 1 of each 
     such year; or
       ``(II) the first business day after the enactment of an 
     appropriations Act providing for the collection and 
     obligation of fees for such year under this section.

       ``(iii) Exception.--The annual biosimilar development 
     program fee for each fiscal year will be due on the date 
     specified in clause (ii), unless the person has--

       ``(I) submitted a marketing application for the biological 
     product that was accepted for filing; or
       ``(II) discontinued participation in the biosimilar 
     biological product development program for the product under 
     subparagraph (C).

       ``(C) Discontinuation of fee obligation.--A person may 
     discontinue participation in the biosimilar biological 
     product development program for a product effective October 1 
     of a fiscal year by, not later than August 1 of the preceding 
     fiscal year--
       ``(i) if no investigational new drug application concerning 
     the product has been submitted, submitting to the Secretary a 
     written declaration that the person has no present intention 
     of further developing the product as a biosimilar biological 
     product; or
       ``(ii) if an investigational new drug application 
     concerning the product has been submitted, withdrawing the 
     investigational new drug application in accordance with part 
     312 of title 21, Code of Federal Regulations (or any 
     successor regulations).
       ``(D) Reactivation fee.--
       ``(i) In general.--A person that has discontinued 
     participation in the biosimilar biological product 
     development program for a product under subparagraph (C) 
     shall pay a fee (referred to in this section as `reactivation 
     fee') by the earlier of the following:

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

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

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

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

       ``(I) the Secretary determines that the investigation is 
     intended to support a biosimilar biological product 
     application; and

[[Page 9487]]

       ``(II) the sponsor has failed to pay an initial or annual 
     biosimilar biological product development fee for the product 
     as required under subparagraph (A) or (B), or a reactivation 
     fee for the product as required under subparagraph (D).

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

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

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

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

       ``(iii) A fee for a supplement for which clinical data 
     (other than comparative bioavailability studies) with respect 
     to safety or effectiveness are required, that is equal to 
     half of the amount of the fee established under subsection 
     (b)(1)(D) for a biosimilar biological product application.
       ``(B) Reduction in fees.--Notwithstanding section 404 of 
     the Biosimilars User Fee Act of 2012, any person who pays a 
     fee under subparagraph (A), (B), or (D) of paragraph (1) for 
     a product before October 1, 2017, but submits a biosimilar 
     biological product application for that product after such 
     date, shall be entitled to the reduction of any biosimilar 
     biological product application fees that may be assessed at 
     the time when such biosimilar biological product application 
     is submitted, by the cumulative amount of fees paid under 
     subparagraphs (A), (B), and (D) of paragraph (1) for that 
     product.
       ``(C) Payment due date.--Any fee required by subparagraph 
     (A) shall be due upon submission of the application or 
     supplement for which such fee applies.
       ``(D) Exception for previously filed application or 
     supplement.--If a biosimilar biological product application 
     or supplement was submitted by a person that paid the fee for 
     such application or supplement, was accepted for filing, and 
     was not approved or was withdrawn (without a waiver), the 
     submission of a biosimilar biological product application or 
     a supplement for the same product by the same person (or the 
     person's licensee, assignee, or successor) shall not be 
     subject to a fee under subparagraph (A).
       ``(E) Refund of application fee if application refused for 
     filing or withdrawn before filing.--The Secretary shall 
     refund 75 percent of the fee paid under this paragraph for 
     any application or supplement which is refused for filing or 
     withdrawn without a waiver before filing.
       ``(F) Fees for applications previously refused for filing 
     or withdrawn before filing.--A biosimilar biological product 
     application or supplement that was submitted but was refused 
     for filing, or was withdrawn before being accepted or refused 
     for filing, shall be subject to the full fee under 
     subparagraph (A) upon being resubmitted or filed over 
     protest, unless the fee is waived under subsection (c).
       ``(3) Biosimilar biological product establishment fee.--
       ``(A) In general.--Except as provided in subparagraph (E), 
     each person that is named as the applicant in a biosimilar 
     biological product application shall be assessed an annual 
     fee established under subsection (b)(1)(E) for each 
     biosimilar biological product establishment that is listed in 
     the approved biosimilar biological product application as an 
     establishment that manufactures the biosimilar biological 
     product named in such application.
       ``(B) Assessment in fiscal years.--The establishment fee 
     shall be assessed in each fiscal year for which the 
     biosimilar biological product named in the application is 
     assessed a fee under paragraph (4) unless the biosimilar 
     biological product establishment listed in the application 
     does not engage in the manufacture of the biosimilar 
     biological product during such fiscal year.
       ``(C) Due date.--The establishment fee for a fiscal year 
     shall be due on the later of--
       ``(i) the first business day on or after October 1 of such 
     fiscal year; or
       ``(ii) the first business day after the enactment of an 
     appropriations Act providing for the collection and 
     obligation of fees for such fiscal year under this section.
       ``(D) Application to establishment.--
       ``(i) Each biosimilar biological product establishment 
     shall be assessed only one fee per biosimilar biological 
     product establishment, notwithstanding the number of 
     biosimilar biological products manufactured at the 
     establishment, subject to clause (ii).
       ``(ii) In the event an establishment is listed in a 
     biosimilar biological product application by more than one 
     applicant, the establishment fee for the fiscal year shall be 
     divided equally and assessed among the applicants whose 
     biosimilar biological products are manufactured by the 
     establishment during the fiscal year and assessed biosimilar 
     biological product fees under paragraph (4).
       ``(E) Exception for new products.--If, during the fiscal 
     year, an applicant initiates or causes to be initiated the 
     manufacture of a biosimilar biological product at an 
     establishment listed in its biosimilar biological product 
     application--
       ``(i) that did not manufacture the biosimilar biological 
     product in the previous fiscal year; and
       ``(ii) for which the full biosimilar biological product 
     establishment fee has been assessed in the fiscal year at a 
     time before manufacture of the biosimilar biological product 
     was begun,
     the applicant shall not be assessed a share of the biosimilar 
     biological product establishment fee for the fiscal year in 
     which the manufacture of the product began.
       ``(4) Biosimilar biological product fee.--
       ``(A) In general.--Each person who is named as the 
     applicant in a biosimilar biological product application 
     shall pay for each such biosimilar biological product the 
     annual fee established under subsection (b)(1)(F).
       ``(B) Due date.--The biosimilar biological product fee for 
     a fiscal year shall be due on the later of--
       ``(i) the first business day on or after October 1 of each 
     such year; or
       ``(ii) the first business day after the enactment of an 
     appropriations Act providing for the collection and 
     obligation of fees for such year under this section.
       ``(C) One fee per product per year.--The biosimilar 
     biological product fee shall be paid only once for each 
     product for each fiscal year.
       ``(b) Fee Setting and Amounts.--
       ``(1) In general.--Subject to paragraph (2), the Secretary 
     shall, 60 days before the start of each fiscal year that 
     begins after September 30, 2012, establish, for the next 
     fiscal year, the fees under subsection (a). Except as 
     provided in subsection (c), such fees shall be in the 
     following amounts:
       ``(A) Initial biosimilar biological product development 
     fee.--The initial biosimilar biological product development 
     fee under subsection (a)(1)(A) for a fiscal year shall be 
     equal to 10 percent of the amount established under section 
     736(c)(4) for a human drug application described in section 
     736(a)(1)(A)(i) for that fiscal year.
       ``(B) Annual biosimilar biological product development 
     fee.--The annual biosimilar biological product development 
     fee under subsection (a)(1)(B) for a fiscal year shall be 
     equal to 10 percent of the amount established under section 
     736(c)(4) for a human drug application described in section 
     736(a)(1)(A)(i) for that fiscal year.
       ``(C) Reactivation fee.--The reactivation fee under 
     subsection (a)(1)(D) for a fiscal year shall be equal to 20 
     percent of the amount of the fee established under section 
     736(c)(4) for a human drug application described in section 
     736(a)(1)(A)(i) for that fiscal year.
       ``(D) Biosimilar biological product application fee.--The 
     biosimilar biological product application fee under 
     subsection (a)(2) for a fiscal year shall be equal to the 
     amount established under section 736(c)(4) for a human drug 
     application described in section 736(a)(1)(A)(i) for that 
     fiscal year.
       ``(E) Biosimilar biological product establishment fee.--The 
     biosimilar biological product establishment fee under 
     subsection (a)(3) for a fiscal year shall be equal to the 
     amount established under section 736(c)(4) for a prescription 
     drug establishment for that fiscal year.
       ``(F) Biosimilar biological product fee.--The biosimilar 
     biological product fee under subsection (a)(4) for a fiscal 
     year shall be equal to the amount established under section 
     736(c)(4) for a prescription drug product for that fiscal 
     year.
       ``(2) Limit.--The total amount of fees charged for a fiscal 
     year under this section may not exceed the total amount for 
     such fiscal year of the costs of resources allocated for the 
     process for the review of biosimilar biological product 
     applications.
       ``(c) Application Fee Waiver for Small Business.--
       ``(1) Waiver of application fee.--The Secretary shall grant 
     to a person who is named in a biosimilar biological product 
     application a waiver from the application fee assessed to 
     that person under subsection (a)(2)(A) for the first 
     biosimilar biological product application that a small 
     business or its affiliate submits to the Secretary for 
     review. After a small business or its

[[Page 9488]]

     affiliate is granted such a waiver, the small business or its 
     affiliate shall pay--
       ``(A) application fees for all subsequent biosimilar 
     biological product applications submitted to the Secretary 
     for review in the same manner as an entity that is not a 
     small business; and
       ``(B) all supplement fees for all supplements to biosimilar 
     biological product applications submitted to the Secretary 
     for review in the same manner as an entity that is not a 
     small business.
       ``(2) Considerations.--In determining whether to grant a 
     waiver of a fee under paragraph (1), the Secretary shall 
     consider only the circumstances and assets of the applicant 
     involved and any affiliate of the applicant.
       ``(3) Small business defined.--In this subsection, the term 
     `small business' means an entity that has fewer than 500 
     employees, including employees of affiliates, and does not 
     have a drug product that has been approved under a human drug 
     application (as defined in section 735) or a biosimilar 
     biological product application (as defined in section 
     744G(4)) and introduced or delivered for introduction into 
     interstate commerce.
       ``(d) Effect of Failure To Pay Fees.--A biosimilar 
     biological product application or supplement submitted by a 
     person subject to fees under subsection (a) shall be 
     considered incomplete and shall not be accepted for filing by 
     the Secretary until all fees owed by such person have been 
     paid.
       ``(e) Crediting and Availability of Fees.--
       ``(1) In general.--Subject to paragraph (2), fees 
     authorized under subsection (a) shall be collected and 
     available for obligation only to the extent and in the amount 
     provided in advance in appropriations Acts. Such fees are 
     authorized to remain available until expended. Such sums as 
     may be necessary may be transferred from the Food and Drug 
     Administration salaries and expenses appropriation account 
     without fiscal year limitation to such appropriation account 
     for salaries and expenses with such fiscal year limitation. 
     The sums transferred shall be available solely for the 
     process for the review of biosimilar biological product 
     applications.
       ``(2) Collections and appropriation acts.--
       ``(A) In general.--Subject to subparagraphs (C) and (D), 
     the fees authorized by this section shall be collected and 
     available in each fiscal year in an amount not to exceed the 
     amount specified in appropriation Acts, or otherwise made 
     available for obligation for such fiscal year.
       ``(B) Use of fees and limitation.--The fees authorized by 
     this section shall be available for a fiscal year beginning 
     after fiscal year 2012 to defray the costs of the process for 
     the review of biosimilar biological product applications 
     (including such costs for an additional number of full-time 
     equivalent positions in the Department of Health and Human 
     Services to be engaged in such process), only if the 
     Secretary allocates for such purpose an amount for such 
     fiscal year (excluding amounts from fees collected under this 
     section) no less than $20,000,000, multiplied by the 
     adjustment factor applicable to the fiscal year involved.
       ``(C) Fee collection during first program year.--Until the 
     date of enactment of an Act making appropriations through 
     September 30, 2013, for the salaries and expenses account of 
     the Food and Drug Administration, fees authorized by this 
     section for fiscal year 2013 may be collected and shall be 
     credited to such account and remain available until expended.
       ``(D) Provision for early payments in subsequent years.--
     Payment of fees authorized under this section for a fiscal 
     year (after fiscal year 2013), prior to the due date for such 
     fees, may be accepted by the Secretary in accordance with 
     authority provided in advance in a prior year appropriations 
     Act.
       ``(3) Authorization of appropriations.--For each of fiscal 
     years 2013 through 2017, there is authorized to be 
     appropriated for fees under this section an amount equivalent 
     to the total amount of fees assessed for such fiscal year 
     under this section.
       ``(f) Collection of Unpaid Fees.--In any case where the 
     Secretary does not receive payment of a fee assessed under 
     subsection (a) within 30 days after it is due, such fee shall 
     be treated as a claim of the United States Government subject 
     to subchapter II of chapter 37 of title 31, United States 
     Code.
       ``(g) Written Requests for Waivers and Refunds.--To qualify 
     for consideration for a waiver under subsection (c), or for a 
     refund of any fee collected in accordance with subsection 
     (a)(2)(A), a person shall submit to the Secretary a written 
     request for such waiver or refund not later than 180 days 
     after such fee is due.
       ``(h) Construction.--This section may not be construed to 
     require that the number of full-time equivalent positions in 
     the Department of Health and Human Services, for officers, 
     employers, and advisory committees not engaged in the process 
     of the review of biosimilar biological product applications, 
     be reduced to offset the number of officers, employees, and 
     advisory committees so engaged.''.

     SEC. 403. REAUTHORIZATION; REPORTING REQUIREMENTS.

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

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

       ``(a) Performance Report.--Beginning with fiscal year 2013, 
     not later than 120 days after the end of each fiscal year for 
     which fees are collected under this part, the Secretary shall 
     prepare and submit to the Committee on Energy and Commerce of 
     the House of Representatives and the Committee on Health, 
     Education, Labor, and Pensions of the Senate a report 
     concerning the progress of the Food and Drug Administration 
     in achieving the goals identified in the letters described in 
     section 401(b) of the Biosimilar User Fee Act of 2012 during 
     such fiscal year and the future plans of the Food and Drug 
     Administration for meeting such goals. The report for a 
     fiscal year shall include information on all previous cohorts 
     for which the Secretary has not given a complete response on 
     all biosimilar biological product applications and 
     supplements in the cohort.
       ``(b) Fiscal Report.--Not later than 120 days after the end 
     of fiscal year 2013 and each subsequent fiscal year for which 
     fees are collected under this part, the Secretary shall 
     prepare and submit to the Committee on Energy and Commerce of 
     the House of Representatives and the Committee on Health, 
     Education, Labor, and Pensions of the Senate a report on the 
     implementation of the authority for such fees during such 
     fiscal year and the use, by the Food and Drug Administration, 
     of the fees collected for such fiscal year.
       ``(c) Public Availability.--The Secretary shall make the 
     reports required under subsections (a) and (b) available to 
     the public on the Internet Web site of the Food and Drug 
     Administration.
       ``(d) Study.--
       ``(1) In general.--The Secretary shall contract with an 
     independent accounting or consulting firm to study the 
     workload volume and full costs associated with the process 
     for the review of biosimilar biological product applications.
       ``(2) Interim results.--Not later than June 1, 2015, the 
     Secretary shall publish, for public comment, interim results 
     of the study described under paragraph (1).
       ``(3) Final results.--Not later than September 30, 2016, 
     the Secretary shall publish, for public comment, the final 
     results of the study described under paragraph (1).
       ``(e) Reauthorization.--
       ``(1) Consultation.--In developing recommendations to 
     present to the Congress with respect to the goals described 
     in subsection (a), and plans for meeting the goals, for the 
     process for the review of biosimilar biological product 
     applications for the first 5 fiscal years after fiscal year 
     2017, and for the reauthorization of this part for such 
     fiscal years, the Secretary shall consult with--
       ``(A) the Committee on Energy and Commerce of the House of 
     Representatives;
       ``(B) the Committee on Health, Education, Labor, and 
     Pensions of the Senate;
       ``(C) scientific and academic experts;
       ``(D) health care professionals;
       ``(E) representatives of patient and consumer advocacy 
     groups; and
       ``(F) the regulated industry.
       ``(2) Public review of recommendations.--After negotiations 
     with the regulated industry, the Secretary shall--
       ``(A) present the recommendations developed under paragraph 
     (1) to the congressional committees specified in such 
     paragraph;
       ``(B) publish such recommendations in the Federal Register;
       ``(C) provide for a period of 30 days for the public to 
     provide written comments on such recommendations;
       ``(D) hold a meeting at which the public may present its 
     views on such recommendations; and
       ``(E) after consideration of such public views and 
     comments, revise such recommendations as necessary.
       ``(3) Transmittal of recommendations.--Not later than 
     January 15, 2017, the Secretary shall transmit to the 
     Congress the revised recommendations under paragraph (2), a 
     summary of the views and comments received under such 
     paragraph, and any changes made to the recommendations in 
     response to such views and comments.''.

     SEC. 404. SUNSET DATES.

       (a) Authorization.--Sections 744G and 744H of the Federal 
     Food, Drug, and Cosmetic Act, as added by section 402 of this 
     Act, shall cease to be effective October 1, 2017.
       (b) Reporting Requirements.--Section 744I of the Federal 
     Food, Drug, and Cosmetic Act, as added by section 403 of this 
     Act, shall cease to be effective January 31, 2018.

     SEC. 405. EFFECTIVE DATE.

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

     SEC. 406. SAVINGS CLAUSE.

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

     SEC. 407. CONFORMING AMENDMENT.

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

[[Page 9489]]



     SEC. 408. ADDITIONAL REPORTING REQUIREMENTS.

       Section 715, as added by section 308 of this Act, is 
     amended by adding at the end the following:
       ``(b) Biosimilar Biological Products.--
       ``(1) In general.--Beginning with fiscal year 2014, not 
     later than 120 days after the end of each fiscal year for 
     which fees are collected under part 8 of subchapter C, the 
     Secretary shall prepare and submit to the Committee on 
     Health, Education, Labor, and Pensions of the Senate and the 
     Committee on Energy and Commerce of the House of 
     Representatives a report concerning--
       ``(A) the number of applications for approval filed under 
     section 351(k) of the Public Health Service Act; and
       ``(B) the percentage of applications described in 
     subparagraph (A) that were approved by the Secretary.
       ``(2) Additional information.--As part of the performance 
     report described in paragraph (1), the Secretary shall 
     include an explanation of how the Food and Drug 
     Administration is managing the biological product review 
     program to ensure that the user fees collected under part 2 
     are not used to review an application under section 351(k) of 
     the Public Health Service Act.''.

                  TITLE V--PEDIATRIC DRUGS AND DEVICES

     SEC. 501. PERMANENCE.

       (a) Pediatric Studies of Drugs.--Section 505A (21 U.S.C. 
     355a) is amended by striking subsection (q) (relating to a 
     sunset).
       (b) Research Into Pediatric Uses for Drugs and Biological 
     Products.--Section 505B (21 U.S.C. 355c) is amended--
       (1) by striking subsection (m); and
       (2) by redesignating subsection (n) as subsection (m).

     SEC. 502. WRITTEN REQUESTS.

       (a) In General.--
       (1) Federal food, drug, and cosmetic act.--Subsection (h) 
     of section 505A (21 U.S.C. 355a) is amended to read as 
     follows:
       ``(h) Relationship to Pediatric Research Requirements.--
     Exclusivity under this section shall only be granted for the 
     completion of a study or studies that are the subject of a 
     written request and for which reports are submitted and 
     accepted in accordance with subsection (d)(3). Written 
     requests under this section may consist of a study or studies 
     required under section 505B.''.
       (2) Public health service act.--Section 351(m)(1) of the 
     Public Health Service Act (42 U.S.C. 262(m)(1)) is amended by 
     striking ``(f), (i), (j), (k), (l), (p), and (q)'' and 
     inserting ``(f), (h), (i), (j), (k), (l), (n), and (p)''.
       (b) Neonates.--Subparagraph (A) of section 505A(d)(1) is 
     amended by adding at the end the following: ``If a request 
     under this subparagraph does not request studies in neonates, 
     such request shall include a statement describing the 
     rationale for not requesting studies in neonates.''.

     SEC. 503. COMMUNICATION WITH PEDIATRIC REVIEW COMMITTEE.

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

     SEC. 504. ACCESS TO DATA.

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

     SEC. 505. ENSURING THE COMPLETION OF PEDIATRIC STUDIES.

       (a) Extension of Deadline for Deferred Studies.--Section 
     505B (21 U.S.C. 355c) is amended--
       (1) in subsection (a)(3)--
       (A) by redesignating subparagraph (B) as subparagraph (C);
       (B) by inserting after subparagraph (A) the following:
       ``(B) Deferral extension.--
       ``(i) In general.--On the initiative of the Secretary or at 
     the request of the applicant, the Secretary may grant an 
     extension of a deferral approved under subparagraph (A) for 
     submission of some or all assessments required under 
     paragraph (1) if--

       ``(I) the Secretary determines that the conditions 
     described in subclause (II) or (III) of subparagraph (A)(i) 
     continue to be met; and
       ``(II) the applicant submits a new timeline under 
     subparagraph (A)(ii)(IV) and any significant updates to the 
     information required under subparagraph (A)(ii).

       ``(ii) Timing and information.--If the deferral extension 
     under this subparagraph is requested by the applicant, the 
     applicant shall submit the deferral extension request 
     containing the information described in this subparagraph not 
     less than 90 days prior to the date that the deferral would 
     expire. The Secretary shall respond to such request not later 
     than 45 days after the receipt of such letter. If the 
     Secretary grants such an extension, the specified date shall 
     be the extended date. The sponsor of the required assessment 
     under paragraph (1) shall not be issued a letter described in 
     subsection (d) unless the specified or extended date of 
     submission for such required studies has passed or if the 
     request for an extension is pending. For a deferral that has 
     expired prior to the date of enactment of the Food and Drug 
     Administration Safety and Innovation Act or that will expire 
     prior to 270 days after the date of enactment of such Act, a 
     deferral extension shall be requested by an applicant not 
     later than 180 days after the date of enactment of such Act. 
     The Secretary shall respond to any such request as soon as 
     practicable, but not later than 1 year after the date of 
     enactment of such Act. Nothing in this clause shall prevent 
     the Secretary from updating the status of a study or studies 
     publicly if components of such study or studies are late or 
     delayed.''; and
       (C) in subparagraph (C), as so redesignated--
       (i) in clause (i), by adding at the end the following:

       ``(III) Projected completion date for pediatric studies.
       ``(IV) The reason or reasons why a deferral or deferral 
     extension continues to be necessary.''; and

       (ii) by amending clause (ii) to read as follows:
       ``(ii) Public availability.--Not later than 90 days after 
     the submission to the Secretary of the information submitted 
     through the annual review under clause (i), the Secretary 
     shall make available to the public in an easily accessible 
     manner, including through the Internet Web site of the Food 
     and Drug Administration--

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

       (2) in subsection (f)--
       (A) in the subsection heading, by inserting ``Deferral 
     Extensions,'' after ``Deferrals,'';
       (B) in paragraph (1), by inserting ``, deferral 
     extension,'' after ``deferral''; and
       (C) in paragraph (4)--
       (i) in the paragraph heading, by inserting ``deferral 
     extensions,'' after ``deferrals,''; and
       (ii) by inserting ``, deferral extensions,'' after 
     ``deferrals''.
       (b) Tracking of Extensions; Annual Information.--Section 
     505B(f)(6)(D) (21 U.S.C. 355c(f)(6)(D)) is amended to read as 
     follows:
       ``(D) aggregated on an annual basis--
       ``(i) the total number of deferrals and deferral extensions 
     requested and granted under this section and, if granted, the 
     reasons for each such deferral or deferral extension;
       ``(ii) the timeline for completion of the assessments; and
       ``(iii) the number of assessments completed and pending;''.
       (c) Action on Failure To Complete Studies.--
       (1) Issuance of letter.--Subsection (d) of section 505B (21 
     U.S.C. 355c) is amended to read as follows:
       ``(d) Submission of Assessments.--If a person fails to 
     submit a required assessment described in subsection (a)(2), 
     fails to meet the applicable requirements in subsection 
     (a)(3), or fails to submit a request for approval of a 
     pediatric formulation described in subsection (a) or (b), in 
     accordance with applicable provisions of subsections (a) and 
     (b), the following shall apply:
       ``(1) Beginning 270 days after the date of enactment of the 
     Food and Drug Administration Safety and Innovation Act, the 
     Secretary shall issue a non-compliance letter to such person 
     informing them of such failure to submit or meet the 
     requirements of the applicable subsection. Such letter shall 
     require the person to respond in writing within 45 calendar 
     days of issuance of such letter. Such response may include 
     the person's request for a deferral extension if applicable. 
     Such letter and the person's written response to such letter 
     shall be made publicly available on the Internet Web site of 
     the Food and Drug Administration 60 calendar days after 
     issuance, with redactions for any trade secrets and 
     confidential commercial information. If the Secretary 
     determines that the letter was issued in error, the 
     requirements of this paragraph shall not apply.
       ``(2) The drug or biological product that is the subject of 
     an assessment described in subsection (a)(2), applicable 
     requirements in subsection (a)(3), or request for approval of 
     a pediatric formulation, may be considered misbranded solely 
     because of that failure and subject to relevant enforcement 
     action (except that the drug or biological product shall not 
     be subject to action under section 303), but such failure 
     shall not be the basis for a proceeding--
       ``(A) to withdraw approval for a drug under section 505(e); 
     or
       ``(B) to revoke the license for a biological product under 
     section 351 of the Public Health Service Act.''.

[[Page 9490]]

       (2) Tracking of letters issued.--Subparagraph (D) of 
     section 505B(f)(6) (21 U.S.C. 355c(f)(6)), as amended by 
     subsection (b), is further amended--
       (A) in clause (ii), by striking ``; and'' and inserting a 
     semicolon;
       (B) in clause (iii), by adding ``and'' at the end; and
       (C) by adding at the end the following:
       ``(iv) the number of postmarket non-compliance letters 
     issued pursuant to subsection (d), and the recipients of such 
     letters;''.

     SEC. 506. PEDIATRIC STUDY PLANS.

       (a) In General.--Subsection (e) of section 505B (21 U.S.C. 
     355c) is amended to read as follows:
       ``(e) Pediatric Study Plans.--
       ``(1) In general.--An applicant subject to subsection (a) 
     shall submit to the Secretary an initial pediatric study plan 
     prior to the submission of the assessments described under 
     subsection (a)(2).
       ``(2) Timing; content; meeting.--
       ``(A) Timing.--An applicant shall submit the initial 
     pediatric plan under paragraph (1)--
       ``(i) before the date on which the applicant submits the 
     assessments under subsection (a)(2); and
       ``(ii) not later than--

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

     Nothing in this section shall preclude the Secretary from 
     accepting the submission of an initial pediatric plan earlier 
     than the date otherwise applicable under this subparagraph.
       ``(B) Content of initial plan.--The initial pediatric study 
     plan shall include--
       ``(i) an outline of the pediatric study or studies that the 
     applicant plans to conduct (including, to the extent 
     practicable study objectives and design, age groups, relevant 
     endpoints, and statistical approach);
       ``(ii) any request for a deferral, partial waiver, or 
     waiver under this section, if applicable, along with any 
     supporting information; and
       ``(iii) other information specified in the regulations 
     promulgated under paragraph (7).
       ``(C) Meeting.--The Secretary--
       ``(i) shall meet with the applicant to discuss the initial 
     pediatric study plan as soon as practicable, but not later 
     than 90 calendar days after the receipt of such plan under 
     subparagraph (A);
       ``(ii) may determine that a written response to the initial 
     pediatric study plan is sufficient to communicate comments on 
     the initial pediatric study plan, and that no meeting is 
     necessary; and
       ``(iii) if the Secretary determines that no meeting is 
     necessary, shall so notify the applicant and provide written 
     comments of the Secretary as soon as practicable, but not 
     later than 90 calendar days after the receipt of the initial 
     pediatric study plan.
       ``(3) Agreed initial pediatric study plan.--Not later than 
     90 calendar days following the meeting under paragraph 
     (2)(C)(i) or the receipt of a written response from the 
     Secretary under paragraph (2)(C)(iii), the applicant shall 
     document agreement on the initial pediatric study plan in a 
     submission to the Secretary marked `Agreed Initial Pediatric 
     Study Plan', and the Secretary shall confirm such agreement 
     to the applicant in writing not later than 30 calendar days 
     of receipt of such agreed initial pediatric study plan.
       ``(4) Deferral and waiver.--If the agreed initial pediatric 
     study plan contains a request from the applicant for a 
     deferral, partial waiver, or waiver under this section, the 
     written confirmation under paragraph (3) shall include a 
     recommendation from the Secretary as to whether such request 
     meets the standards under paragraphs (3) or (4) of subsection 
     (a).
       ``(5) Amendments to the plan.--At the initiative of the 
     Secretary or the applicant, the agreed initial pediatric 
     study plan may be amended at any time. The requirements of 
     paragraph (2)(C) shall apply to any such proposed amendment 
     in the same manner and to the same extent as such 
     requirements apply to an initial pediatric study plan under 
     paragraph (1). The requirements of paragraphs (3) and (4) 
     shall apply to any agreement resulting from such proposed 
     amendment in the same manner and to the same extent as such 
     requirements apply to an agreed initial pediatric study plan.
       ``(6) Internal committee.--The Secretary shall consult the 
     internal committee under section 505C on the review of the 
     initial pediatric study plan, agreed initial pediatric plan, 
     and any significant amendments to such plans.
       ``(7) Required rulemaking.--Not later than 1 year after the 
     date of enactment of the Food and Drug Administration Safety 
     and Innovation Act, the Secretary shall promulgate proposed 
     regulations and issue guidance to implement the provisions of 
     this subsection.''.
       (b) Conforming Amendments.--Section 505B (21 U.S.C. 355c) 
     is amended--
       (1) by amending subclause (II) of subsection (a)(3)(A)(ii) 
     to read as follows:

       ``(II) a pediatric study plan as described in subsection 
     (e);''; and

       (2) in subsection (f)--
       (A) in the subsection heading, by striking ``Pediatric 
     Plans,'' and inserting ``Pediatric Study Plans,'';
       (B) in paragraph (1), by striking ``all pediatric plans'' 
     and inserting ``initial pediatric study plans, agreed initial 
     pediatric study plans,''; and
       (C) in paragraph (4)--
       (i) in the paragraph heading, by striking ``Pediatric 
     Plans,'' and inserting ``Pediatric Study Plans,''; and
       (ii) by striking ``pediatric plans'' and inserting 
     ``initial pediatric study plans, agreed initial pediatric 
     study plans,''.
       (c) Effective Date.--
       (1) In general.--Subject to paragraph (2), the amendments 
     made by this section shall take effect 180 calendar days 
     after the date of enactment of this Act, irrespective of 
     whether the Secretary has promulgated final regulations to 
     carry out such amendments.
       (2) Rule of construction.--Paragraph (1) shall not be 
     construed to affect the deadline for promulgation of proposed 
     regulations under section 505B(e)(7) of the Federal Food, 
     Drug, and Cosmetic Act, as added by subsection (a) of this 
     section.

     SEC. 507. REAUTHORIZATIONS.

       (a) Pediatric Advisory Committee.--Section 14(d) of the 
     Best Pharmaceuticals for Children Act (42 U.S.C. 284m note) 
     is amended by striking ``during the five-year period 
     beginning on the date of the enactment of the Best 
     Pharmaceuticals for Children Act of 2007'' and inserting ``to 
     carry out the advisory committee's responsibilities under 
     sections 505A, 505B, and 520(m) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 355a, 355c, and 360j(m))''.
       (b) Pediatric Subcommittee of the Oncologic Drugs Advisory 
     Committee.--Section 15(a)(3) of the Best Pharmaceuticals for 
     Children Act (Public Law 107-109), as amended by section 
     502(e) of the Food and Drug Administration Amendments Act of 
     2007 (Public Law 110-85), is amended by striking ``during the 
     five-year period beginning on the date of the enactment of 
     the Best Pharmaceuticals for Children Act of 2007'' and 
     inserting ``for the duration of the operation of the 
     Oncologic Drugs Advisory Committee''.
       (c) Humanitarian Device Exemption Extension.--Section 
     520(m)(6)(A)(iv) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 360j(m)(6)(A)(iv)) is amended by striking ``2012'' 
     and inserting ``2017''.
       (d) Program for Pediatric Study of Drugs in PHSA.--Section 
     409I(e)(1) of the Public Health Service Act (42 U.S.C. 
     284m(e)(1)) is amended by striking ``to carry out this 
     section'' and all that follows through the end of paragraph 
     (1) and inserting ``to carry out this section, $25,000,000 
     for each of fiscal years 2013 through 2017.''.

     SEC. 508. REPORT.

       (a) In General.--Not later than four years after the date 
     of enactment of this Act and every five years thereafter, the 
     Secretary shall prepare and submit to the Committee on 
     Health, Education, Labor, and Pensions of the Senate and the 
     Committee on Energy and Commerce of the House of 
     Representatives, and make publicly available, including 
     through posting on the Internet Web site of the Food and Drug 
     Administration, a report on the implementation of sections 
     505A and 505B of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 355a, 355c).
       (b) Contents.--Each report under subsection (a) shall 
     include--
       (1) an assessment of the effectiveness of sections 505A and 
     505B of the Federal Food, Drug, and Cosmetic Act in improving 
     information about pediatric uses for approved drugs and 
     biological products, including the number and type of 
     labeling changes made since the date of enactment of this Act 
     and the importance of such uses in the improvement of the 
     health of children;
       (2) the number of required studies under such section 505B 
     that have not met the initial deadline provided under such 
     section 505B, including--
       (A) the number of deferrals and deferral extensions granted 
     and the reasons such extensions were granted;
       (B) the number of waivers and partial waivers granted; and
       (C) the number of letters issued under subsection (d) of 
     such section 505B;
       (3) an assessment of the timeliness and effectiveness of 
     pediatric study planning since the date of enactment of this 
     Act, including the number of initial pediatric study plans 
     not submitted in accordance with the requirements of 
     subsection (e) of such section 505B and any resulting 
     rulemaking;
       (4) the number of written requests issued, accepted, and 
     declined under such section 505A since the date of enactment 
     of this Act, and a listing of any important gaps in pediatric 
     information as a result of such declined requests;
       (5) a description and current status of referrals made 
     under subsection (n) of such section 505A;
       (6) an assessment of the effectiveness of studying 
     biological products in pediatric populations under such 
     sections 505A and 505B and section 409I of the Public Health 
     Service Act (42 U.S.C. 284m);
       (7)(A) the efforts made by the Secretary to increase the 
     number of studies conducted in the neonatal population 
     (including efforts made to encourage the conduct of 
     appropriate studies in neonates by companies with products 
     that have sufficient safety and other information to make the 
     conduct of the studies ethical and safe); and
       (B) the results of such efforts;
       (8)(A) the number and importance of drugs and biological 
     products for children with cancer that are being tested as a 
     result of the programs under such sections 505A and 505B and 
     under section 409I of the Public Health Service Act; and
       (B) any recommendations for modifications to such programs 
     that would lead to new and better therapies for children with 
     cancer, including a detailed rationale for each 
     recommendation;

[[Page 9491]]

       (9) any recommendations for modification to such programs 
     that would improve pediatric drug research and increase 
     pediatric labeling of drugs and biological products;
       (10) an assessment of the successes of and limitations to 
     studying drugs for rare diseases under such sections 505A and 
     505B; and
       (11) an assessment of the Secretary's efforts to address 
     the suggestions and options described in any prior report 
     issued by the Comptroller General, Institute of Medicine, or 
     the Secretary, and any subsequent reports, including 
     recommendations therein, regarding the topics addressed in 
     the reports under this section, including with respect to--
       (A) improving public access to information from pediatric 
     studies conducted under such sections 505A and 505B; and
       (B) improving the timeliness of pediatric studies and 
     pediatric study planning under such sections 505A and 505B.
       (c) Stakeholder Comment.--At least 180 days prior to the 
     submission of each report under subsection (a), the Secretary 
     shall consult with representatives of patient groups 
     (including pediatric patient groups), consumer groups, 
     regulated industry, academia, and other interested parties to 
     obtain any recommendations or information relevant to the 
     report including suggestions for modifications that would 
     improve pediatric drug research and pediatric labeling of 
     drugs and biological products.

     SEC. 509. TECHNICAL AMENDMENTS.

       (a) Pediatric Studies of Drugs in FFDCA.--Section 505A (21 
     U.S.C. 355a) is amended--
       (1) in subsection (k)(2), by striking ``subsection 
     (f)(3)(F)'' and inserting ``subsection (f)(6)(F)'';
       (2) in subsection (l)--
       (A) in paragraph (1)--
       (i) in the paragraph heading, by striking ``year one'' and 
     inserting ``first 18-month period''; and
       (ii) by striking ``one-year'' and inserting ``18-month'';
       (B) in paragraph (2)--
       (i) in the paragraph heading, by striking ``years'' and 
     inserting ``periods''; and
       (ii) by striking ``one-year period'' and inserting ``18-
     month period'';
       (C) by redesignating paragraph (3) as paragraph (4); and
       (D) by inserting after paragraph (2) the following:
       ``(3) Preservation of authority.--Nothing in this 
     subsection shall prohibit the Office of Pediatric 
     Therapeutics from providing for the review of adverse event 
     reports by the Pediatric Advisory Committee prior to the 18-
     month period referred to in paragraph (1), if such review is 
     necessary to ensure safe use of a drug in a pediatric 
     population.'';
       (3) in subsection (n)--
       (A) in the subsection heading, by striking ``Completed'' 
     and inserting ``Submitted''; and
       (B) in paragraph (1)--
       (i) in the matter preceding subparagraph (A), by striking 
     ``have not been completed'' and inserting ``have not been 
     submitted by the date specified in the written request issued 
     or if the applicant or holder does not agree to the 
     request'';
       (ii) in subparagraph (A)--

       (I) in the first sentence, by inserting ``, or for which a 
     period of exclusivity eligible for extension under subsection 
     (b)(1) or (c)(1) of this section or under subsection (m)(2) 
     or (m)(3) of section 351 of the Public Health Service Act has 
     not ended'' after ``expired''; and
       (II) by striking ``Prior to'' and all that follows through 
     the period at the end; and

       (iii) in subparagraph (B), by striking ``no listed patents 
     or has 1 or more listed patents that have expired,'' and 
     inserting ``no unexpired listed patents and for which no 
     unexpired periods of exclusivity eligible for extension under 
     subsection (b)(1) or (c)(1) of this section or under 
     subsection (m)(2) or (m)(3) of section 351 of the Public 
     Health Service Act apply,''; and
       (4) in subsection (o)(2), by amending subparagraph (B) to 
     read as follows:
       ``(B) a statement of any appropriate pediatric 
     contraindications, warnings, precautions, or other 
     information that the Secretary considers necessary to assure 
     safe use.''.
       (b) Research Into Pediatric Uses for Drugs and Biological 
     Projects in FFDCA.--Section 505B (21 U.S.C. 355c) is 
     amended--
       (1) in subsection (a)--
       (A) in paragraph (1), in the matter before subparagraph 
     (A), by inserting ``for a drug'' after ``(or supplement to an 
     application)''; and
       (B) in paragraph (4)(C)--
       (i) in the first sentence, by inserting ``partial'' before 
     ``waiver is granted''; and
       (ii) in the second sentence, by striking ``either a full 
     or'' and inserting ``such a'';
       (2) in subsection (b)(1), in the matter preceding 
     subparagraph (A), by striking ``After providing notice'' and 
     all that follows through ``studies), the'' and inserting 
     ``The'';
       (3) in subsection (g)--
       (A) in paragraph (1)(A), by inserting ``that receives a 
     priority review or 330 days after the date of the submission 
     of an application or supplement that receives a standard 
     review'' after ``after the date of the submission of the 
     application or supplement''; and
       (B) in paragraph (2), by striking ``the label of such 
     product'' and inserting ``the labeling of such product'';
       (4) in subsection (h)(1)--
       (A) by inserting ``an application (or supplement to an 
     application) that contains'' after ``date of submission of''; 
     and
       (B) by inserting ``if the application (or supplement) 
     receives a priority review, or not later than 330 days after 
     the date of submission of an application (or supplement to an 
     application) that contains a pediatric assessment under this 
     section, if the application (or supplement) receives a 
     standard review,'' after ``under this section,''; and
       (5) in subsection (i)--
       (A) in paragraph (1)--
       (i) in the paragraph heading, by striking ``year one'' and 
     inserting ``first 18-month period''; and
       (ii) by striking ``one-year'' and inserting ``18-month'';
       (B) in paragraph (2)--
       (i) in the paragraph heading, by striking ``years'' and 
     inserting ``periods''; and
       (ii) by striking ``one-year period'' and inserting ``18-
     month period'';
       (C) by redesignating paragraph (3) as paragraph (4); and
       (D) by inserting after paragraph (2) the following:
       ``(3) Preservation of authority.--Nothing in this 
     subsection shall prohibit the Office of Pediatric 
     Therapeutics from providing for the review of adverse event 
     reports by the Pediatric Advisory Committee prior to the 18-
     month period referred to in paragraph (1), if such review is 
     necessary to ensure safe use of a drug in a pediatric 
     population.''.
       (c) Internal Committee for Review of Pediatric Plans, 
     Assessments, Deferrals, Deferral Extensions, and Waivers.--
     Section 505C (21 U.S.C. 355d) is amended--
       (1) in the section heading, by inserting ``DEFERRAL 
     EXTENSIONS,'' after ``DEFERRALS,''; and
       (2) by inserting ``neonatology,'' after ``pediatric 
     ethics,''.
       (d) Program for Pediatric Studies of Drugs.--Section 
     409I(c) of the Public Health Service Act (42 U.S.C. 284m(c)) 
     is amended--
       (1) in paragraph (1)--
       (A) in the matter preceding subparagraph (A), by inserting 
     ``or section 351(m) of this Act,'' after ``Cosmetic Act,'';
       (B) in subparagraph (A)(i), by inserting ``or section 
     351(k) of this Act'' after ``Cosmetic Act''; and
       (C) by amending subparagraph (B) to read as follows:
       ``(B) there remains no patent listed pursuant to section 
     505(b)(1) of the Federal Food, Drug, and Cosmetic Act, and 
     every three-year and five-year period referred to in 
     subsection (c)(3)(E)(ii), (c)(3)(E)(iii), (c)(3)(E)(iv), 
     (j)(5)(F)(ii), (j)(5)(F)(iii), or (j)(5)(F)(iv) of section 
     505 of the Federal Food, Drug, and Cosmetic Act, or 
     applicable twelve-year period referred to in section 
     351(k)(7) of this Act, and any seven-year period referred to 
     in section 527 of the Federal Food, Drug, and Cosmetic Act 
     has ended for at least one form of the drug; and''; and
       (2) in paragraph (2)--
       (A) in the paragraph heading, by striking ``for drugs 
     lacking exclusivity'';
       (B) by striking ``under section 505 of the Federal Food, 
     Drug, and Cosmetic Act''; and
       (C) by striking ``505A of such Act'' and inserting ``505A 
     of the Federal Food, Drug, and Cosmetic Act or section 351(m) 
     of this Act''.
       (e) Pediatric Subcommittee of the Oncologic Advisory 
     Committee.--Section 15(a) of the Best Pharmaceuticals for 
     Children Act (Public Law 107-109), as amended by section 
     502(e) of the Food and Drug Administration Amendments Act of 
     2007 (Public Law 110-85), is amended in paragraph (1)(D), by 
     striking ``section 505B(f)'' and inserting ``section 505C''.
       (f) Foundation of National Institutes of Health.--Section 
     499(c)(1)(C) of the Public Health Service Act (42 U.S.C. 
     290b(c)(1)(C)) is amended by striking ``for which the 
     Secretary issues a certification in the affirmative under 
     section 505A(n)(1)(A) of the Federal Food, Drug, and Cosmetic 
     Act''.
       (g) Application; Transition Rule.--
       (1) Application.--Notwithstanding any provision of section 
     505A and 505B of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 355a, 355c) stating that a provision applies beginning 
     on the date of the enactment of the Best Pharmaceuticals for 
     Children Act of 2007 or the date of the enactment of the 
     Pediatric Research Equity Act of 2007, any amendment made by 
     this Act to such a provision applies beginning on the date of 
     the enactment of this Act.
       (2) Transitional rule for adverse event reporting.--With 
     respect to a drug for which a labeling change described under 
     section 505A(l)(1) or 505B(i)(1) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 355a(l)(1); 355c(i)(1)) is 
     approved or made, respectively, during the one-year period 
     that ends on the day before the date of enactment of this 
     Act, the Secretary shall apply section 505A(l) and section 
     505B(i), as applicable, to such drug, as such sections were 
     in effect on such day.

     SEC. 510. PEDIATRIC RARE DISEASES.

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

     SEC. 511. STAFF OF OFFICE OF PEDIATRIC THERAPEUTICS.

       Section 6 of the Best Pharmaceuticals for Children Act (21 
     U.S.C. 393a) is amended--

[[Page 9492]]

       (1) in subsection (c)--
       (A) in paragraph (1), by striking ``and'' at the end;
       (B) by redesignating paragraph (2) as paragraph (4); and
       (C) by inserting after paragraph (1) the following:
       ``(2) subject to subsection (d), one or more additional 
     individuals with necessary expertise in a pediatric 
     subpopulation that is, as determined through consideration of 
     the reports and recommendations issued by the Institute of 
     Medicine and the Comptroller General of the United States, 
     less likely to be studied as a part of a written request 
     issued under section 505A of the Federal Food, Drug, and 
     Cosmetic Act or an assessment under section 505B of such Act;
       ``(3) one or more additional individuals with expertise in 
     pediatric epidemiology; and''; and
       (2) by adding at the end the following:
       ``(d) Neonatology Expertise.--For the 5-year period 
     beginning on the date of enactment of this subsection, at 
     least one of the individuals described in subsection (c)(2) 
     shall have expertise in neonatology.''.

            TITLE VI--MEDICAL DEVICE REGULATORY IMPROVEMENTS

     SEC. 601. INVESTIGATIONAL DEVICE EXEMPTIONS.

       Section 520(g) (21 U.S.C. 360j(g)) is amended--
       (1) in paragraph (2)(B)(ii), by inserting ``safety or 
     effectiveness'' before ``data obtained''; and
       (2) in paragraph (4), by adding at the end the following:
       ``(C) Consistent with paragraph (1), the Secretary shall 
     not disapprove an application under this subsection because 
     the Secretary determines that--
       ``(i) the investigation may not support a substantial 
     equivalence or de novo classification determination or 
     approval of the device;
       ``(ii) the investigation may not meet a requirement, 
     including a data requirement, relating to the approval or 
     clearance of a device; or
       ``(iii) an additional or different investigation may be 
     necessary to support clearance or approval of the device.''.

     SEC. 602. CLARIFICATION OF LEAST BURDENSOME STANDARD.

       (a) Premarket Approval.--Section 513(a)(3)(D) (21 U.S.C. 
     360c(a)(3)(D)) is amended--
       (1) by redesignating clause (iii) as clause (v); and
       (2) by inserting after clause (ii) the following:
       ``(iii) For purposes of clause (ii), the term `necessary' 
     means the minimum required information that would support a 
     determination by the Secretary that an application provides 
     reasonable assurance of the effectiveness of the device.
       ``(iv) Nothing in this subparagraph shall alter the 
     criteria for evaluating an application for premarket approval 
     of a device.''.
       (b) Premarket Notification Under Section 510(k).--Section 
     513(i)(1)(D) (21 U.S.C. 360c(i)(1)(D)) is amended--
       (1) by striking ``(D) Whenever'' and inserting ``(D)(i) 
     Whenever''; and
       (2) by adding at the end the following:
       ``(ii) For purposes of clause (i), the term `necessary' 
     means the minimum required information that would support a 
     determination of substantial equivalence between a new device 
     and a predicate device.
       ``(iii) Nothing in this subparagraph shall alter the 
     standard for determining substantial equivalence between a 
     new device and a predicate device.''.

     SEC. 603. AGENCY DOCUMENTATION AND REVIEW OF SIGNIFICANT 
                   DECISIONS.

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

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

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

     SEC. 604. DEVICE MODIFICATIONS REQUIRING PREMARKET 
                   NOTIFICATION PRIOR TO MARKETING.

       Section 510(n) (21 U.S.C. 360(n)) is amended by--
       (1) striking ``(n) The Secretary'' and inserting ``(n)(1) 
     The Secretary''; and
       (2) by adding at the end the following:
       ``(2)(A) Not later than 18 months after the date of 
     enactment of this paragraph, the Secretary shall submit to 
     the Committee on Energy and Commerce of the House of 
     Representatives and the Committee on Health, Education, 
     Labor, and Pensions of the Senate a report regarding when a 
     premarket notification under subsection (k) should be 
     submitted for a modification or change to a legally marketed 
     device. The report shall include the Secretary's 
     interpretation of the following terms: `could significantly 
     affect the safety or effectiveness of the device', `a 
     significant change or modification in design, material, 
     chemical composition, energy source, or manufacturing 
     process', and `major change or modification in the intended 
     use of the device'. The report also shall discuss possible 
     processes for industry to use to determine whether a new 
     submission under subsection (k) is required and shall analyze 
     how to leverage existing quality system requirements to 
     reduce premarket burden, facilitate continual device 
     improvement, and provide reasonable assurance of safety and 
     effectiveness of modified devices. In developing such report, 
     the Secretary shall consider the input of interested 
     stakeholders.
       ``(B) The Secretary shall withdraw the Food and Drug 
     Administration draft guidance entitled `Guidance for Industry 
     and FDA Staff--510(k) Device Modifications: Deciding When to 
     Submit a 510(k) for a Change to an Existing Device', dated 
     July 27, 2011, and shall not use this draft guidance as part 
     of, or for the basis of, any premarket review or any 
     compliance or enforcement decisions or actions. The Secretary 
     shall not issue--
       ``(i) any draft guidance or proposed regulation that 
     addresses when to submit a premarket notification submission 
     for changes and modifications made to a manufacturer's 
     previously cleared device before the receipt by the Committee 
     on Energy and Commerce of the House of Representatives and 
     the Committee on Health, Education, Labor, and Pensions of 
     the Senate of the report required in subparagraph (A); and
       ``(ii) any final guidance or regulation on that topic for 
     one year after date of receipt of such report by the 
     Committee on Energy and Commerce of the House of 
     Representatives and the Committee on Health, Education, 
     Labor, and Pensions of the Senate.
       ``(C) The Food and Drug Administration guidance entitled 
     `Deciding When to Submit a 510(k) for a Change to an Existing 
     Device', dated January 10, 1997, shall be in effect until the 
     subsequent issuance of guidance or promulgation, if 
     appropriate, of a regulation described in subparagraph (B), 
     and the Secretary shall interpret such guidance in a manner 
     that is consistent with the manner in which the Secretary has 
     interpreted such guidance since 1997.''.

     SEC. 605. PROGRAM TO IMPROVE THE DEVICE RECALL SYSTEM.

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

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

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

     SEC. 606. CLINICAL HOLDS ON INVESTIGATIONAL DEVICE 
                   EXEMPTIONS.

       Section 520(g) (21 U.S.C. 360j(g)) is amended by adding at 
     the end the following:
       ``(8)(A) At any time, the Secretary may prohibit the 
     sponsor of an investigation from conducting the investigation 
     (referred to in this

[[Page 9493]]

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

     SEC. 607. MODIFICATION OF DE NOVO APPLICATION PROCESS.

       (a) In General.--Section 513(f)(2) (21 U.S.C. 360c(f)(2)) 
     is amended--
       (1) by inserting ``(i)'' after ``(2)(A)'';
       (2) in subparagraph (A)(i), as so designated by paragraph 
     (1), by striking ``under the criteria set forth'' and all 
     that follows through the end of subparagraph (A) and 
     inserting a period;
       (3) by adding at the end of subparagraph (A) the following:
       ``(ii) In lieu of submitting a report under section 510(k) 
     and submitting a request for classification under clause (i) 
     for a device, if a person determines there is no legally 
     marketed device upon which to base a determination of 
     substantial equivalence (as defined in subsection (i)), a 
     person may submit a request under this clause for the 
     Secretary to classify the device.
       ``(iii) Upon receipt of a request under clause (i) or (ii), 
     the Secretary shall classify the device subject to the 
     request under the criteria set forth in subparagraphs (A) 
     through (C) of subsection (a)(1) within 120 days.
       ``(iv) Notwithstanding clause (iii), the Secretary may 
     decline to undertake a classification request submitted under 
     clause (ii) if the Secretary identifies a legally marketed 
     device that could provide a reasonable basis for review of 
     substantial equivalence under paragraph (1), or when the 
     Secretary determines that the device submitted is not of low-
     moderate risk or that general controls would be inadequate to 
     control the risks and special controls to mitigate the risks 
     cannot be developed.
       ``(v) The person submitting the request for classification 
     under this subparagraph may recommend to the Secretary a 
     classification for the device and shall, if recommending 
     classification in class II, include in the request an initial 
     draft proposal for applicable special controls, as described 
     in subsection (a)(1)(B), that are necessary, in conjunction 
     with general controls, to provide reasonable assurance of 
     safety and effectiveness and a description of how the special 
     controls provide such assurance. Any such request shall 
     describe the device and provide detailed information and 
     reasons for the recommended classification.''; and
       (4) in subparagraph (B), by striking ``Not later than 60 
     days after the date of the submission of the request under 
     subparagraph (A), the Secretary'' and inserting ``The 
     Secretary''.
       (b) Conforming Amendments.--Section 513(f) (21 U.S.C. 
     360c(f)) is amended in paragraph (1)--
       (1) in subparagraph (A), by striking ``, or'' at the end 
     and inserting a semicolon;
       (2) in subparagraph (B), by striking the period and 
     inserting ``; or''; and
       (3) by inserting after subparagraph (B) the following:
       ``(C) the device is classified pursuant to a request 
     submitted under paragraph (2).''.

     SEC. 608. RECLASSIFICATION PROCEDURES.

       (a) Classification Changes.--
       (1) In general.--Section 513(e)(1) (21 U.S.C. 360c(e)(1)) 
     is amended to read as follows:
       ``(e)(1)(A)(i) Based on new information respecting a 
     device, the Secretary may, upon the initiative of the 
     Secretary or upon petition of an interested person, change 
     the classification of such device, and revoke, on account of 
     the change in classification, any regulation or requirement 
     in effect under section 514 or 515 with respect to such 
     device, by administrative order published in the Federal 
     Register following publication of a proposed reclassification 
     order in the Federal Register, a meeting of a device 
     classification panel described in subsection (b), and 
     consideration of comments to a public docket, notwithstanding 
     subchapter II of chapter 5 of title 5, United States Code. 
     The proposed reclassification order published in the Federal 
     Register shall set forth the proposed reclassification, and a 
     substantive summary of the valid scientific evidence 
     concerning the proposed reclassification, including--
       ``(I) the public health benefit of the use of the device, 
     and the nature and, if known, incidence of the risk of the 
     device;
       ``(II) in the case of a reclassification from class II to 
     class III, why general controls pursuant to subsection 
     (a)(1)(A) and special controls pursuant to subsection 
     (a)(1)(B) together are not sufficient to provide a reasonable 
     assurance of safety and effectiveness for such device; and
       ``(III) in the case of reclassification from class III to 
     class II, why general controls pursuant to subsection 
     (a)(1)(A) and special controls pursuant to subsection 
     (a)(1)(B) together are sufficient to provide a reasonable 
     assurance of safety and effectiveness for such device.
       ``(ii) An order under this subsection changing the 
     classification of a device from class III to class II may 
     provide that such classification shall not take effect until 
     the effective date of a performance standard established 
     under section 514 for such device.
       ``(B) Authority to issue such administrative order shall 
     not be delegated below the Director of the Center for Devices 
     and Radiological Health, acting in consultation with the 
     Commissioner.''.
       (2) Technical and conforming amendments.--
       (A) Section 513(e)(2) (21 U.S.C. 360c(e)(2)) is amended by 
     striking ``regulation promulgated'' and inserting ``an order 
     issued''.
       (B) Section 514(a)(1) (21 U.S.C. 360d(a)(1)) is amended by 
     striking ``under a regulation under section 513(e) but such 
     regulation'' and inserting ``under an administrative order 
     under section 513(e) (or a regulation promulgated under such 
     section prior to the date of enactment of the Food and Drug 
     Administration Safety and Innovation Act) but such order (or 
     regulation)''.
       (C) Section 517(a)(1) (21 U.S.C. 360g(a)(1)) is amended by 
     striking ``or changing the classification of a device to 
     class I'' and inserting ``, an administrative order changing 
     the classification of a device to class I,''.
       (3) Devices reclassified prior to the date of enactment of 
     this act.--
       (A) In general.--The amendments made by this subsection 
     shall have no effect on a regulation promulgated with respect 
     to the classification of a device under section 513(e) of the 
     Federal Food, Drug, and Cosmetic Act prior to the date of 
     enactment of this Act.
       (B) Applicability of other provisions.--In the case of a 
     device reclassified under section 513(e) of the Federal Food, 
     Drug, and Cosmetic Act by regulation prior to the date of 
     enactment of this Act, section 517(a)(1) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 360g(a)(1)) shall apply to 
     such regulation promulgated under section 513(e) of such Act 
     with respect to such device in the same manner such section 
     517(a)(1) applies to an administrative order issued with 
     respect to a device reclassified after the date of enactment 
     of this Act.
       (b) Devices Marketed Before May 28, 1976.--
       (1) Premarket approval.--Section 515 (21 U.S.C. 360e) is 
     amended--
       (A) in subsection (a), by striking ``regulation promulgated 
     under subsection (b)'' and inserting ``an order issued under 
     subsection (b) (or a regulation promulgated under such 
     subsection prior to the date of enactment of the Food and 
     Drug Administration Safety and Innovation Act)'';
       (B) in subsection (b)--
       (i) in paragraph (1)--

       (I) in the heading, by striking ``Regulation'' and 
     inserting ``Order''; and
       (II) in the matter following subparagraph (B)--

       (aa) by striking ``by regulation, promulgated in accordance 
     with this subsection'' and inserting ``by administrative 
     order following publication of a proposed order in the 
     Federal Register, a meeting of a device classification panel 
     described in section 513(b), and consideration of comments 
     from all affected stakeholders, including patients, payors, 
     and providers, notwithstanding subchapter II of chapter 5 of 
     title 5, United States Code''; and
       (bb) by adding at the end the following: ``Authority to 
     issue such administrative order shall not be delegated below 
     the Director of the Center for Devices and Radiological 
     Health, acting in consultation with the Commissioner.'';
       (ii) in paragraph (2)--

       (I) by striking subparagraph (B); and
       (II) in subparagraph (A)--

       (aa) by striking ``(2)(A) A proceeding for the promulgation 
     of a regulation under paragraph (1) respecting a device shall 
     be initiated by the publication in the Federal Register of a 
     notice of proposed rulemaking. Such notice shall contain--'' 
     and inserting ``(2) A proposed order required under paragraph 
     (1) shall contain--'';
       (bb) by redesignating clauses (i) through (iv) as 
     subparagraphs (A) through (D), respectively;
       (cc) in subparagraph (A), as so redesignated, by striking 
     ``regulation'' and inserting ``order''; and
       (dd) in subparagraph (C), as so redesignated, by striking 
     ``regulation'' and inserting ``order'';
       (iii) in paragraph (3)--

       (I) by striking ``proposed regulation'' each place such 
     term appears and inserting ``proposed order'';
       (II) by striking ``paragraph (2) and after'' and inserting 
     ``paragraph (2),'';
       (III) by inserting ``and a meeting of a device 
     classification panel described in section 513(b),'' after 
     ``such proposed regulation and findings,'';
       (IV) by striking ``(A) promulgate such regulation'' and 
     inserting ``(A) issue an administrative order under paragraph 
     (1)'';
       (V) by striking ``paragraph (2)(A)(ii)'' and inserting 
     ``paragraph (2)(B)''; and
       (VI) by striking ``promulgation of the regulation'' and 
     inserting ``issuance of the administrative order''; and

       (iv) by striking paragraph (4); and
       (C) in subsection (i)--
       (i) in paragraph (2)--

       (I) in the matter preceding subparagraph (A)--

       (aa) by striking ``December 1, 1995'' and inserting ``the 
     date that is 2 years after the date

[[Page 9494]]

     of enactment of the Food and Drug Administration Safety and 
     Innovation Act''; and
       (bb) by striking ``publish a regulation in the Federal 
     Register'' and inserting ``issue an administrative order 
     following publication of a proposed order in the Federal 
     Register, a meeting of a device classification panel 
     described in section 513(b), and consideration of comments 
     from all affected stakeholders, including patients, payors, 
     and providers, notwithstanding subchapter II of chapter 5 of 
     title 5, United States Code,'';

       (II) in subparagraph (B), by striking ``final regulation 
     has been promulgated under section 515(b)'' and inserting 
     ``administrative order has been issued under subsection (b) 
     (or no regulation has been promulgated under such subsection 
     prior to the date of enactment of the Food and Drug 
     Administration Safety and Innovation Act)'';
       (III) in the matter following subparagraph (B), by striking 
     ``regulation requires'' and inserting ``administrative order 
     issued under this paragraph requires''; and
       (IV) by striking the third and fourth sentences; and

       (ii) in paragraph (3)--

       (I) by striking ``regulation requiring'' each place such 
     term appears and inserting ``order requiring''; and
       (II) by striking ``promulgation of a section 515(b) 
     regulation'' and inserting ``issuance of an administrative 
     order under subsection (b)''.

       (2) Technical and conforming amendments.--Section 501(f) 
     (21 U.S.C. 351(f)) is amended--
       (A) in subparagraph (1)(A)--
       (i) in subclause (i), by striking ``a regulation 
     promulgated'' and inserting ``an order issued''; and
       (ii) in subclause (ii), by striking ``promulgation of such 
     regulation'' and inserting ``issuance of such order'';
       (B) in subparagraph (2)(B)--
       (i) by striking ``a regulation promulgated'' and inserting 
     ``an order issued''; and
       (ii) by striking ``promulgation of such regulation'' and 
     inserting ``issuance of such order''; and
       (C) by adding at the end the following:
       ``(3) In the case of a device with respect to which a 
     regulation was promulgated under section 515(b) prior to the 
     date of enactment of the Food and Drug Administration Safety 
     and Innovation Act, a reference in this subsection to an 
     order issued under section 515(b) shall be deemed to include 
     such regulation.''.
       (3) Approval by regulation prior to the date of enactment 
     of this act.--The amendments made by this subsection shall 
     have no effect on a regulation that was promulgated prior to 
     the date of enactment of this Act requiring that a device 
     have an approval under section 515 of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 360e) of an application for 
     premarket approval.
       (c) Reporting.--The Secretary of Health and Human Services 
     shall annually post on the Internet Web site of the Food and 
     Drug Administration--
       (1) the number and type of class I and class II devices 
     reclassified as class II or class III in the previous 
     calendar year under section 513(e)(1) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 360c(e)(1));
       (2) the number and type of class II and class III devices 
     reclassified as class I or class II in the previous calendar 
     year under such section 513(e)(1); and
       (3) the number and type of devices reclassified in the 
     previous calendar year under section 515 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 360e).

     SEC. 609. HARMONIZATION OF DEVICE PREMARKET REVIEW, 
                   INSPECTION, AND LABELING SYMBOLS.

       Paragraph (4) of section 803(c) (21 U.S.C. 383(c)) is 
     amended to read as follows:
       ``(4) With respect to devices, the Secretary may, when 
     appropriate, enter into arrangements with nations regarding 
     methods and approaches to harmonizing regulatory requirements 
     for activities, including inspections and common 
     international labeling symbols.''.

     SEC. 610. PARTICIPATION IN INTERNATIONAL FORA.

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

     SEC. 611. REAUTHORIZATION OF THIRD-PARTY REVIEW.

       (a) Periodic Reaccreditation.--Section 523(b)(2) (21 U.S.C. 
     360m(b)(2)) is amended by adding at the end of the following:
       ``(E) Periodic reaccreditation.--
       ``(i) Period.--Subject to suspension or withdrawal under 
     subparagraph (B), any accreditation under this section shall 
     be valid for a period of 3 years after its issuance.
       ``(ii) Response to reaccreditation request.--Upon the 
     submission of a request by an accredited person for 
     reaccreditation under this section, the Secretary shall 
     approve or deny such request not later than 60 days after 
     receipt of the request.
       ``(iii) Criteria.--Not later than 120 days after the date 
     of the enactment of this subparagraph, the Secretary shall 
     establish and publish in the Federal Register criteria to 
     reaccredit or deny reaccreditation to persons under this 
     section. The reaccreditation of persons under this section 
     shall specify the particular activities under subsection (a), 
     and the devices, for which such persons are reaccredited.''.
       (b) Duration of Authority.--Section 523(c) (21 U.S.C. 
     360m(c)) is amended by striking ``October 1, 2012'' and 
     inserting ``October 1, 2017''.

     SEC. 612. REAUTHORIZATION OF THIRD-PARTY INSPECTION.

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

     SEC. 613. HUMANITARIAN DEVICE EXEMPTIONS.

       (a) In General.--Section 520(m) (21 U.S.C. 360j(m)) is 
     amended--
       (1) in paragraph (6)--
       (A) in subparagraph (A)--
       (i) by striking clause (i) and inserting the following:
       ``(i) The device with respect to which the exemption is 
     granted--
       ``(I) is intended for the treatment or diagnosis of a 
     disease or condition that occurs in pediatric patients or in 
     a pediatric subpopulation, and such device is labeled for use 
     in pediatric patients or in a pediatric subpopulation in 
     which the disease or condition occurs; or
       ``(II) is intended for the treatment or diagnosis of a 
     disease or condition that does not occur in pediatric 
     patients or that occurs in pediatric patients in such numbers 
     that the development of the device for such patients is 
     impossible, highly impracticable, or unsafe.''; and
       (ii) by striking clause (ii) and inserting the following:
       ``(ii) During any calendar year, the number of such devices 
     distributed during that year under each exemption granted 
     under this subsection does not exceed the annual distribution 
     number for such device. In this paragraph, the term `annual 
     distribution number' means the number of such devices 
     reasonably needed to treat, diagnose, or cure a population of 
     4,000 individuals in the United States. The Secretary shall 
     determine the annual distribution number when the Secretary 
     grants such exemption.''; and
       (B) by amending subparagraph (C) to read as follows:
       ``(C) A person may petition the Secretary to modify the 
     annual distribution number determined by the Secretary under 
     subparagraph (A)(ii) with respect to a device if additional 
     information arises, and the Secretary may modify such annual 
     distribution number.'';
       (2) in paragraph (7), by striking ``regarding a device'' 
     and inserting ``regarding a device described in paragraph 
     (6)(A)(i)(I)''; and
       (3) in paragraph (8), by striking ``of all devices 
     described in paragraph (6)'' and inserting ``of all devices 
     described in paragraph (6)(A)(i)(I)''.
       (b) Applicability to Existing Devices.--A sponsor of a 
     device for which an exemption was approved under paragraph 
     (2) of section 520(m) of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 360j(m)) before the date of enactment of this 
     Act may seek a determination under subclause (I) or (II) of 
     section 520(m)(6)(A)(i) (as amended by subsection (a)). If 
     the Secretary of Health and Human Services determines that 
     such subclause (I) or (II) applies with respect to a device, 
     clauses (ii), (iii), and (iv) of subparagraph (A) and 
     subparagraphs (B), (C), (D), and (E) of paragraph (6) of such 
     section 520(m) shall apply to such device, and the Secretary 
     shall determine the annual distribution number for purposes 
     of clause (ii) of such subparagraph (A) when making the 
     determination under this subsection.

     SEC. 614. UNIQUE DEVICE IDENTIFIER.

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

     SEC. 615. SENTINEL.

       Section 519 (21 U.S.C. 360i) is amended by adding at the 
     end the following:
       ``(h) Inclusion of Devices in the Postmarket Risk 
     Identification and Analysis System.--
       ``(1) In general.--
       ``(A) Application to devices.--The Secretary shall amend 
     the procedures established and maintained under clauses (i), 
     (ii), (iii), and (v) of section 505(k)(3)(C) in order to 
     expand the postmarket risk identification and analysis system 
     established under such section to include and apply to 
     devices.
       ``(B) Exception.--Subclause (II) of clause (i) of section 
     505(k)(3)(C) shall not apply to devices.
       ``(C) Clarification.--With respect to devices, the private 
     sector health-related electronic data provided under section 
     505(k)(3)(C)(i)(III)(bb)

[[Page 9495]]

     may include medical device utilization data, health insurance 
     claims data, and procedure and device registries.
       ``(2) Data.--In expanding the system as described in 
     paragraph (1)(A), the Secretary shall use relevant data with 
     respect to devices cleared under section 510(k) or approved 
     under section 515, including claims data, patient survey 
     data, and any other data deemed appropriate by the Secretary.
       ``(3) Stakeholder input.--To help ensure effective 
     implementation of the system as described in paragraph (1) 
     with respect to devices, the Secretary shall engage outside 
     stakeholders in development of the system, and gather 
     information from outside stakeholders regarding the content 
     of an effective sentinel program, through a public hearing, 
     advisory committee meeting, maintenance of a public docket, 
     or other similar public measures.
       ``(4) Voluntary surveys.--Chapter 35 of title 44, United 
     States Code, shall not apply to the collection of voluntary 
     information from health care providers, such as voluntary 
     surveys or questionnaires, initiated by the Secretary for 
     purposes of postmarket risk identification, mitigation, and 
     analysis for devices.''.

     SEC. 616. POSTMARKET SURVEILLANCE.

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

     SEC. 617. CUSTOM DEVICES.

       Section 520(b) (21 U.S.C. 360j(b)) is amended to read as 
     follows:
       ``(b) Custom Devices.--
       ``(1) In general.--The requirements of sections 514 and 515 
     shall not apply to a device that--
       ``(A) is created or modified in order to comply with the 
     order of an individual physician or dentist (or any other 
     specially qualified person designated under regulations 
     promulgated by the Secretary after an opportunity for an oral 
     hearing);
       ``(B) in order to comply with an order described in 
     subparagraph (A), necessarily deviates from an otherwise 
     applicable performance standard under section 514 or 
     requirement under section 515;
       ``(C) is not generally available in the United States in 
     finished form through labeling or advertising by the 
     manufacturer, importer, or distributor for commercial 
     distribution;
       ``(D) is designed to treat a unique pathology or 
     physiological condition that no other device is domestically 
     available to treat;
       ``(E)(i) is intended to meet the special needs of such 
     physician or dentist (or other specially qualified person so 
     designated) in the course of the professional practice of 
     such physician or dentist (or other specially qualified 
     person so designated); or
       ``(ii) is intended for use by an individual patient named 
     in such order of such physician or dentist (or other 
     specially qualified person so designated);
       ``(F) is assembled from components or manufactured and 
     finished on a case-by-case basis to accommodate the unique 
     needs of individuals described in clause (i) or (ii) of 
     subparagraph (E); and
       ``(G) may have common, standardized design characteristics, 
     chemical and material compositions, and manufacturing 
     processes as commercially distributed devices.
       ``(2) Limitations.--Paragraph (1) shall apply to a device 
     only if--
       ``(A) such device is for the purpose of treating a 
     sufficiently rare condition, such that conducting clinical 
     investigations on such device would be impractical;
       ``(B) production of such device under paragraph (1) is 
     limited to no more than 5 units per year of a particular 
     device type, provided that such replication otherwise 
     complies with this section; and
       ``(C) the manufacturer of such device notifies the 
     Secretary on an annual basis, in a manner prescribed by the 
     Secretary, of the manufacture of such device.
       ``(3) Guidance.--Not later than 2 years after the date of 
     enactment of this section, the Secretary shall issue final 
     guidance on replication of multiple devices described in 
     paragraph (2)(B).''.

     SEC. 618. HEALTH INFORMATION TECHNOLOGY.

       (a) Report.--Not later than 18 months after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services (referred to in this section as the ``Secretary''), 
     acting through the Commissioner of Food and Drugs, and in 
     consultation with the National Coordinator for Health 
     Information Technology and the Chairman of the Federal 
     Communications Commission, shall post on the Internet Web 
     sites of the Food and Drug Administration, the Federal 
     Communications Commission, and the Office of the National 
     Coordinator for Health Information Technology, a report that 
     contains a proposed strategy and recommendations on an 
     appropriate, risk-based regulatory framework pertaining to 
     health information technology, including mobile medical 
     applications, that promotes innovation, protects patient 
     safety, and avoids regulatory duplication.
       (b) Working Group.--
       (1) In general.--In carrying out subsection (a), the 
     Secretary may convene a working group of external 
     stakeholders and experts to provide appropriate input on the 
     strategy and recommendations required for the report under 
     subsection (a).
       (2) Representatives.--If the Secretary convenes the working 
     group under paragraph (1), the Secretary, in consultation 
     with the Commissioner of Food and Drugs, the National 
     Coordinator for Health Information Technology, and the 
     Chairman of the Federal Communications Commission, shall 
     determine the number of representatives participating in the 
     working group, and shall, to the extent practicable, ensure 
     that the working group is geographically diverse and includes 
     representatives of patients, consumers, health care 
     providers, startup companies, health plans or other third-
     party payers, venture capital investors, information 
     technology vendors, health information technology vendors, 
     small businesses, purchasers, employers, and other 
     stakeholders with relevant expertise, as determined by the 
     Secretary.

     SEC. 619. GOOD GUIDANCE PRACTICES RELATING TO DEVICES.

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

     SEC. 620. PEDIATRIC DEVICE CONSORTIA.

       (a) In General.--Section 305(e) of Pediatric Medical Device 
     Safety and Improvement Act (Public Law 110-85; 42 U.S.C. 282 
     note)) is amended by striking ``$6,000,000 for each of fiscal 
     years 2008 through 2012'' and inserting ``$5,250,000 for each 
     of fiscal years 2013 through 2017''.
       (b) Final Rule Relating to Tracking of Pediatric Uses of 
     Devices.--The Secretary of Health and Human Services shall 
     issue--
       (1) a proposed rule implementing section 515A(a)(2) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e-1(a)(2)) 
     not later than December 31, 2012; and
       (2) a final rule implementing such section not later than 
     December 31, 2013.

                      TITLE VII--DRUG SUPPLY CHAIN

     SEC. 701. REGISTRATION OF DOMESTIC DRUG ESTABLISHMENTS.

       Section 510 (21 U.S.C. 360) is amended--
       (1) in subsection (b)--
       (A) in paragraph (1), by striking ``On or before'' and all 
     that follows through the period at the end and inserting the 
     following: ``During the period beginning on October 1 and 
     ending on December 31 of each year, every person who owns or 
     operates any establishment in any State engaged in the 
     manufacture, preparation, propagation, compounding, or 
     processing of a drug or drugs shall register with the 
     Secretary the name of such person, places of business of such 
     person, all such establishments, the unique facility 
     identifier of each such establishment, and a point of contact 
     e-mail address.; and
       (B) by adding at the end the following:
       ``(3) The Secretary shall specify the unique facility 
     identifier system that shall be used by registrants under 
     paragraph (1). The requirement to include a unique facility 
     identifier in a registration under paragraph (1) shall not 
     apply until the date that the identifier system is specified 
     by the Secretary under the preceding sentence.''; and
       (2) in subsection (c), by striking ``with the Secretary his 
     name, place of business, and such establishment'' and 
     inserting ``with the Secretary--
       ``(1) with respect to drugs, the information described 
     under subsection (b)(1); and
       ``(2) with respect to devices, the information described 
     under subsection (b)(2).''.

     SEC. 702. REGISTRATION OF FOREIGN ESTABLISHMENTS.

       (a) Enforcement of Registration of Foreign 
     Establishments.--Section 502(o) (21 U.S.C. 352(o)) is amended 
     by striking ``in any State''.
       (b) Registration of Foreign Drug Establishments.--Section 
     510(i) (U.S.C. 360(i)) is amended--
       (1) in paragraph (1)--
       (A) by amending the matter preceding subparagraph (A) to 
     read as follows: ``Every person who owns or operates any 
     establishment within any foreign country engaged in the 
     manufacture, preparation, propagation, compounding, or 
     processing of a drug or device that is imported or offered 
     for import into the United States shall, through electronic 
     means in accordance with the criteria of the Secretary--'';
       (B) by amending subparagraph (A) to read as follows:
       ``(A) upon first engaging in any such activity, immediately 
     submit a registration to the Secretary that includes--
       ``(i) with respect to drugs, the name and place of business 
     of such person, all such establishments, the unique facility 
     identifier of each such establishment, a point of contact e-
     mail address, the name of the United States agent of each 
     such establishment, the name of each importer of such drug in 
     the United States that is known to the establishment, and the 
     name of each person who imports or offers for import such 
     drug to the United States for purposes of importation; and
       ``(ii) with respect to devices, the name and place of 
     business of the establishment, the name of the United States 
     agent for the establishment,

[[Page 9496]]

     the name of each importer of such device in the United States 
     that is known to the establishment, and the name of each 
     person who imports or offers for import such device to the 
     United States for purposes of importation; and''; and
       (C) by amending subparagraph (B) to read as follows:
       ``(B) each establishment subject to the requirements of 
     subparagraph (A) shall thereafter register with the Secretary 
     during the period beginning on October 1 and ending on 
     December 31 of each year.''; and
       (2) by adding at the end the following:
       ``(4) The Secretary shall specify the unique facility 
     identifier system that shall be used by registrants under 
     paragraph (1) with respect to drugs. The requirement to 
     include a unique facility identifier in a registration under 
     paragraph (1) with respect to drugs shall not apply until the 
     date that the identifier system is specified by the Secretary 
     under the preceding sentence.''.

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

       Section 510(j) (21 U.S.C. 360(j)) is amended--
       (1) in paragraph (1)--
       (A) in subparagraph (C), by striking ``; and'' and 
     inserting a semicolon;
       (B) in subparagraph (D), by striking the period at the end 
     and inserting ``; and''; and
       (C) by adding at the end the following:
       ``(E) in the case of a drug contained in the applicable 
     list, the name and place of business of each manufacturer of 
     an excipient of the listed drug with which the person listing 
     the drug conducts business, including all establishments used 
     in the production of such excipient, the unique facility 
     identifier of each such establishment, and a point of contact 
     e-mail address for each such excipient manufacturer.''; and
       (2) by adding at the end the following:
       ``(4) The Secretary shall require persons subject to this 
     subsection to use, for purposes of this subsection, the 
     unique facility identifier systems specified under 
     subsections (b)(3) and (i)(4) with respect to drugs. Such 
     requirement shall not apply until the date that the 
     identifier system under subsection (b)(3) or (i)(4), as 
     applicable, is specified by the Secretary.''.

     SEC. 704. ELECTRONIC SYSTEM FOR REGISTRATION AND LISTING.

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

     SEC. 705. RISK-BASED INSPECTION FREQUENCY.

       Section 510(h) (21 U.S.C. 360(h)) is amended to read as 
     follows:
       ``(h) Inspections.--
       ``(1) In general.--Every establishment that is required to 
     be registered with the Secretary under this section shall be 
     subject to inspection pursuant to section 704.
       ``(2) Biennial inspections for devices.--Every 
     establishment described in paragraph (1), in any State, that 
     is engaged in the manufacture, propagation, compounding, or 
     processing of a device or devices classified in class II or 
     III shall be so inspected by one or more officers or 
     employees duly designated by the Secretary, or by persons 
     accredited to conduct inspections under section 704(g), at 
     least once in the 2-year period beginning with the date of 
     registration of such establishment pursuant to this section 
     and at least once in every successive 2-year period 
     thereafter.
       ``(3) Risk-based schedule for drugs.--The Secretary, acting 
     through one or more officers or employees duly designated by 
     the Secretary, shall inspect establishments described in 
     paragraph (1) that are engaged in the manufacture, 
     preparation, propagation, compounding, or processing of a 
     drug or drugs (referred to in this subsection as `drug 
     establishments') in accordance with a risk-based schedule 
     established by the Secretary.
       ``(4) Risk factors.--In establishing the risk-based 
     scheduled under paragraph (3), the Secretary shall inspect 
     establishments according to the known safety risks of such 
     establishments, which shall be based on the following 
     factors:
       ``(A) The compliance history of the establishment.
       ``(B) The record, history, and nature of recalls linked to 
     the establishment.
       ``(C) The inherent risk of the drug manufactured, prepared, 
     propagated, compounded, or processed at the establishment.
       ``(D) The inspection frequency and history of the 
     establishment, including whether the establishment has been 
     inspected pursuant to section 704 within the last 4 years.
       ``(E) Whether the establishment has been inspected by a 
     foreign government or an agency of a foreign government 
     recognized under section 809.
       ``(F) Any other criteria deemed necessary and appropriate 
     by the Secretary for purposes of allocating inspection 
     resources.
       ``(5) Effect of status.--In determining the risk associated 
     with an establishment for purposes of establishing a risk-
     based schedule under paragraph (3), the Secretary shall not 
     consider whether the drugs manufactured, prepared, 
     propagated, compounded, or processed by such establishment 
     are drugs described in section 503(b).
       ``(6) Annual report on inspections of establishments.--
     Beginning in 2014, not later than February 1 of each year, 
     the Secretary shall make available on the Internet Web site 
     of the Food and Drug Administration a report regarding--
       ``(A)(i) the number of domestic and foreign establishments 
     registered pursuant to this section in the previous fiscal 
     year; and
       ``(ii) the number of such domestic establishments and the 
     number of such foreign establishments that the Secretary 
     inspected in the previous fiscal year;
       ``(B) with respect to establishments that manufacture, 
     prepare, propagate, compound, or process an active ingredient 
     of a drug, a finished drug product, or an excipient of a 
     drug, the number of each such type of establishment; and
       ``(C) the percentage of the budget of the Food and Drug 
     Administration used to fund the inspections described under 
     subparagraph (A).''.

     SEC. 706. RECORDS FOR INSPECTION.

       Section 704(a) (21 U.S.C. 374(a)) is amended by adding at 
     the end the following:
       ``(4)(A) Any records or other information that the 
     Secretary may inspect under this section from a person that 
     owns or operates an establishment that is engaged in the 
     manufacture, preparation, propagation, compounding, or 
     processing of a drug shall, upon the request of the 
     Secretary, be provided to the Secretary by such person, in 
     advance of or in lieu of an inspection, within a reasonable 
     timeframe, within reasonable limits, and in a reasonable 
     manner, and in either electronic or physical form, at the 
     expense of such person. The Secretary's request shall include 
     a sufficient description of the records requested.
       ``(B) Upon receipt of the records requested under 
     subparagraph (A), the Secretary shall provide to the person 
     confirmation of receipt.
       ``(C) Nothing in this paragraph supplants the authority of 
     the Secretary to conduct inspections otherwise permitted 
     under this Act in order to ensure compliance with this 
     Act.''.

     SEC. 707. PROHIBITION AGAINST DELAYING, DENYING, LIMITING, OR 
                   REFUSING INSPECTION.

       (a) In General.--Section 501 (21 U.S.C. 351) is amended by 
     adding at the end the following:
       ``(j) If it is a drug and it has been manufactured, 
     processed, packed, or held in any factory, warehouse, or 
     establishment and the owner, operator, or agent of such 
     factory, warehouse, or establishment delays, denies, or 
     limits an inspection, or refuses to permit entry or 
     inspection.''.
       (b) Guidance.--Not later than 1 year after the date of 
     enactment of this section, the Secretary of Health and Human 
     Services shall issue guidance that defines the circumstances 
     that would constitute delaying, denying, or limiting 
     inspection, or refusing to permit entry or inspection, for 
     purposes of section 501(j) of the Federal Food, Drug, and 
     Cosmetic Act (as added by subsection (a)).

     SEC. 708. DESTRUCTION OF ADULTERATED, MISBRANDED, OR 
                   COUNTERFEIT DRUGS OFFERED FOR IMPORT.

       (a) In General.--The sixth sentence of section 801(a) (21 
     U.S.C. 381(a)) is amended by inserting before the period at 
     the end the following: ``, except that the Secretary of 
     Health and Human Services may destroy, without the 
     opportunity for export, any drug refused admission under this 
     section, if such drug is valued at an amount that is $2,500 
     or less (or such higher amount as the Secretary of the 
     Treasury may set by regulation pursuant to section 498(a)(1) 
     of the Tariff Act of 1930 (19 U.S.C. 1498(a)(1)) and was not 
     brought into compliance as described under subsection (b).''.
       (b) Notice.--Subsection (a) of section 801 (21 U.S.C. 381), 
     as amended by subsection (a), is further amended by inserting 
     after the sixth sentence the following: ``The Secretary of 
     Health and Human Services shall issue regulations providing 
     for notice and an opportunity to appear before the Secretary 
     of Health and Human Services and introduce testimony, as 
     described in the first sentence of this subsection, on 
     destruction of a drug under the sixth sentence of this 
     subsection. The regulations shall provide that prior to 
     destruction, appropriate due process is available to the 
     owner or consignee seeking to challenge the decision to 
     destroy the drug. Where the Secretary of Health and Human 
     Services provides notice and an opportunity to appear and 
     introduce testimony on the destruction of a drug, the 
     Secretary of Health and Human Services shall store and, as 
     applicable, dispose of the drug after the issuance of the 
     notice, except that the owner and consignee shall remain 
     liable for costs pursuant to subsection (c). Such process may 
     be combined with the notice and opportunity to appear before 
     the Secretary and introduce testimony, as described in the 
     first sentence of this

[[Page 9497]]

     subsection, as long as appropriate notice is provided to the 
     owner or consignee.''.
       (c) Applicability.--The amendment made by subsection (a) 
     shall apply beginning on the effective date of the 
     regulations promulgated pursuant to the amendment made by 
     subsection (b).
       (d) Regulations.--
       (1) In general.--Not later than 2 years after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services shall adopt final regulations implementing the 
     amendments made this section.
       (2) Procedure.--In promulgating a regulation implementing 
     the amendments made by this section, the Secretary of Health 
     and Human Services shall--
       (A) issue a notice of proposed rulemaking that includes a 
     copy of the proposed regulation;
       (B) provide a period of not less than 60 days for comments 
     on the proposed regulation; and
       (C) publish the final regulation not less than 30 days 
     before the effective date of the regulation.
       (3) Restrictions.--Notwithstanding any other provision of 
     law, the Secretary of Health and Human Services shall 
     promulgate regulations implementing the amendments made by 
     this section only as described in paragraph (2).

     SEC. 709. ADMINISTRATIVE DETENTION.

       (a) In General.--Section 304(g) (21 U.S.C. 335a(g)) is 
     amended--
       (1) in paragraph (1), by inserting ``, drug,'' after 
     ``device'', each place it appears;
       (2) in paragraph (2)(A), by inserting ``, drug,'' after 
     ``(B), a device''; and
       (3) in paragraph (2)(B), by inserting ``or drug'' after 
     ``device'' each place it appears.
       (b) Regulations.--
       (1) In general.--Not later than 2 years after the date of 
     the enactment of this Act, the Secretary of Health and Human 
     Services shall promulgate regulations in accordance with 
     section 304(i) of the Federal Food, Drug, and Cosmetic Act, 
     as added by paragraph (2) of this subsection, to implement 
     administrative detention authority with respect to drugs, as 
     authorized by the amendments made by subsection (a). Before 
     promulgating such regulations, the Secretary shall consult 
     with stakeholders, including manufacturers of drugs.
       (2) In general.--Section 304 (21 U.S.C. 334) is amended by 
     adding at the end the following:
       ``(i) Procedures for Promulgating Regulations.--
       ``(1) In general.--In promulgating a regulation 
     implementing this section, the Secretary shall--
       ``(A) issue a notice of proposed rulemaking that includes 
     the proposed regulation;
       ``(B) provide a period of not less than 60 days for 
     comments on the proposed regulation; and
       ``(C) publish the final regulation not less than 30 days 
     before the regulation's effective date.
       ``(2) Restrictions.--Notwithstanding any other provision of 
     Federal law, in implementing this section, the Secretary 
     shall only promulgate regulations as described in paragraph 
     (1).''.
       (c) Effective Date.--The amendments made by subsection (a) 
     shall not take effect until the Secretary has issued a final 
     regulation under subsection (b).

     SEC. 710. EXCHANGE OF INFORMATION.

       Section 708 (21 U.S.C. 379) is amended--
       (1) by striking ``confidential information'' and all that 
     follows through ``The Secretary may provide'' and inserting 
     the following:

     ``SEC. 708. CONFIDENTIAL INFORMATION.

       ``(a) Contractors.--The Secretary may provide''; and
       (2) by adding at the end the following:
       ``(b) Ability To Receive and Protect Confidential 
     Information Obtained From Foreign Governments.--
       ``(1) In general.--The Secretary shall not be required to 
     disclose under section 552 of title 5, United States Code 
     (commonly referred to as the `Freedom of Information Act'), 
     or any other provision of law, any information relating to 
     drugs obtained from a foreign government agency, if--
       ``(A) the information concerns the inspection of a 
     facility, is part of an investigation, alerts the United 
     States to the potential need for an investigation, or 
     concerns a drug that has a reasonable probability of causing 
     serious adverse health consequences or death to humans or 
     animals;
       ``(B) the information is provided or made available to the 
     United States Government voluntarily on the condition that it 
     not be released to the public; and
       ``(C) the information is covered by, and subject to, a 
     written agreement between the Secretary and the foreign 
     government.
       ``(2) Time limitations.--The written agreement described in 
     paragraph (1)(C) shall specify the time period for which 
     paragraph (1) shall apply to the voluntarily disclosed 
     information.   Paragraph (1) shall not apply with respect to 
     such information after the date specified in such agreement, 
     but all other applicable legal protections, including the 
     provisions of section 552 of title 5, United States Code, and 
     section 319L(e)(1) of the Public Health Service Act, as 
     applicable, shall continue to apply to such information. If 
     no date is specified in the written agreement, paragraph (1) 
     shall not apply with respect to such information for a period 
     of more than 36 months.
       ``(3) Disclosures not affected.--Nothing in this section 
     authorizes any official to withhold, or to authorize the 
     withholding of, information from Congress or information 
     required to be disclosed pursuant to an order of a court of 
     the United States.
       ``(4) Relation to other law.--For purposes of section 552 
     of title 5, United States Code, this subsection shall be 
     considered a statute described in subsection (b)(3)(B) of 
     such section 552.
       ``(c) Authority To Enter Into Memoranda of Understanding 
     for Purposes of Information Exchange.--The Secretary may 
     enter into written agreements to provide information 
     referenced in section 301(j) to foreign governments subject 
     to the following criteria:
       ``(1) Certification.--The Secretary may enter into a 
     written agreement to provide information under this 
     subsection to a foreign government only if the Secretary has 
     certified such government as having the authority and 
     demonstrated ability to protect trade secret information from 
     disclosure. Responsibility for this certification shall not 
     be delegated to any officer or employee other than the 
     Commissioner of Food and Drugs.
       ``(2) Written agreement.--The written agreement to provide 
     information to the foreign government under this subsection 
     shall include a commitment by the foreign government to 
     protect information exchanged under this subsection from 
     disclosure unless and until the sponsor gives written 
     permission for disclosure or the Secretary makes a 
     declaration of a public health emergency pursuant to section 
     319 of the Public Health Service Act that is relevant to the 
     information.
       ``(3) Information exchange.--The Secretary may provide to a 
     foreign government that has been certified under paragraph 
     (1) and that has executed a written agreement under paragraph 
     (2) information referenced in section 301(j) in only the 
     following circumstances:
       ``(A) Information concerning the inspection of a facility 
     may be provided to a foreign government if--
       ``(i) the Secretary reasonably believes, or the written 
     agreement described in paragraph (2) establishes, that the 
     government has authority to otherwise obtain such 
     information; and
       ``(ii) the written agreement executed under paragraph (2) 
     limits the recipient's use of the information to the 
     recipient's civil regulatory purposes.
       ``(B) Information not described in subparagraph (A) may be 
     provided as part of an investigation, or to alert the foreign 
     government to the potential need for an investigation, if the 
     Secretary has reasonable grounds to believe that a drug has a 
     reasonable probability of causing serious adverse health 
     consequences or death to humans or animals.
       ``(4) Effect of subsection.--Nothing in this subsection 
     affects the ability of the Secretary to enter into any 
     written agreement authorized by other provisions of law to 
     share confidential information.''.

     SEC. 711. ENHANCING THE SAFETY AND QUALITY OF THE DRUG 
                   SUPPLY.

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

     SEC. 712. RECOGNITION OF FOREIGN GOVERNMENT INSPECTIONS.

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

     ``SEC. 809. RECOGNITION OF FOREIGN GOVERNMENT INSPECTIONS.

       ``(a) Inspection.--The Secretary--
       ``(1) may enter into arrangements and agreements with a 
     foreign government or an agency of a foreign government to 
     recognize the inspection of foreign establishments registered 
     under section 510(i) in order to facilitate risk-based 
     inspections in accordance with the schedule established in 
     section 510(h)(3);
       ``(2) may enter into arrangements and agreements with a 
     foreign government or an agency of a foreign government under 
     this section only with a foreign government or an agency of a 
     foreign government that the Secretary has determined as 
     having the capability of conduction inspections that meet the 
     applicable requirements of this Act; and
       ``(3) shall perform such reviews and audits of drug safety 
     programs, systems, and standards of a foreign government or 
     agency for the foreign government as the Secretary deems 
     necessary to determine that the foreign government or agency 
     of the foreign government is capable of conducting 
     inspections that meet the applicable requirements of this 
     Act.
       ``(b) Results of Inspection.--The results of inspections 
     performed by a foreign government or an agency of a foreign 
     government under this section may be used as--
       ``(1) evidence of compliance with section 501(a)(2)(B) or 
     section 801(r); and
       ``(2) for any other purposes as determined appropriate by 
     the Secretary.''.

     SEC. 713. STANDARDS FOR ADMISSION OF IMPORTED DRUGS.

       Section 801 (21 U.S.C. 381) is amended--
       (1) in subsection (o), by striking ``drug or''; and
       (2) by adding at the end the following:
       ``(r)(1) The Secretary may require, pursuant to the 
     regulations promulgated under paragraph (4)(A), as a 
     condition of granting admission to a drug imported or offered 
     for import into the United States, that the importer 
     electronically submit information demonstrating that the drug 
     complies with applicable requirements of this Act.
       ``(2) The information described under paragraph (1) may 
     include--
       ``(A) information demonstrating the regulatory status of 
     the drug, such as the new drug

[[Page 9498]]

     application, abbreviated new drug application, or 
     investigational new drug or drug master file number;
       ``(B) facility information, such as proof of registration 
     and the unique facility identifier;
       ``(C) indication of compliance with current good 
     manufacturing practice, testing results, certifications 
     relating to satisfactory inspections, and compliance with the 
     country of export regulations; and
       ``(D) any other information deemed necessary and 
     appropriate by the Secretary to assess compliance of the 
     article being offered for import.
       ``(3) Information requirements referred to in paragraph 
     (2)(C) may, at the discretion of the Secretary, be 
     satisfied--
       ``(A) through representation by a foreign government, if an 
     inspection is conducted by a foreign government using 
     standards and practices as determined appropriate by the 
     Secretary;
       ``(B) through representation by a foreign government or an 
     agency of a foreign government recognized under section 809; 
     or
       ``(C) other appropriate documentation or evidence as 
     described by the Secretary.
       ``(4)(A) Not later than 18 months after the date of 
     enactment of the Food and Drug Administration Safety and 
     Innovation Act, the Secretary shall adopt final regulations 
     implementing this subsection. Such requirements shall be 
     appropriate for the type of import, such as whether the drug 
     is for import into the United States for use in preclinical 
     research or in a clinical investigation under an 
     investigational new drug exemption under 505(i).
       ``(B) In promulgating the regulations under subparagraph 
     (A), the Secretary--
       ``(i) may, as appropriate, take into account differences 
     among importers and types of imports, and, based on the level 
     of risk posed by the imported drug, provide for expedited 
     clearance for those importers that volunteer to participate 
     in partnership programs for highly compliant companies and 
     pass a review of internal controls, including sourcing of 
     foreign manufacturing inputs, and plant inspections; and
       ``(ii) shall--
       ``(I) issue a notice of proposed rulemaking that includes 
     the proposed regulation;
       ``(II) provide a period of not less than 60 days for 
     comments on the proposed regulation; and
       ``(III) publish the final regulation not less than 30 days 
     before the effective date of the regulation.
       ``(C) Notwithstanding any other provision of law, the 
     Secretary shall promulgate regulations implementing this 
     subsection only as described in subparagraph (B).''.

     SEC. 714. REGISTRATION OF COMMERCIAL IMPORTERS.

       (a) Prohibitions.--Section 301 (21 U.S.C. 331) is amended 
     by adding at the end the following:
       ``(aaa) The failure to register in accordance with section 
     801(s).''.
       (b) Registration.--Section 801 (21 U.S.C. 381), as amended 
     by section 713 of this Act, is further amended by adding at 
     the end the following:
       ``(s) Registration of Commercial Importers.--
       ``(1) Registration.--The Secretary shall require a 
     commercial importer of drugs--
       ``(A) to be registered with the Secretary in a form and 
     manner specified by the Secretary; and
       ``(B) subject to paragraph (4), to submit, at the time of 
     registration, a unique identifier for the principal place of 
     business for which the importer is required to register under 
     this subsection.
       ``(2) Regulations.--
       ``(A) In general.--The Secretary, in consultation with the 
     Secretary of Homeland Security acting through U.S. Customs 
     and Border Protection, shall promulgate regulations to 
     establish good importer practices that specify the measures 
     an importer shall take to ensure imported drugs are in 
     compliance with the requirements of this Act and the Public 
     Health Service Act.
       ``(B) Procedure.--In promulgating a regulation under 
     subparagraph (A), the Secretary shall--
       ``(i) issue a notice of proposed rulemaking that includes 
     the proposed regulation;
       ``(ii) provide a period of not less than 60 days for 
     comments on the proposed regulation; and
       ``(iii) publish the final regulation not less than 30 days 
     before the regulation's effective date.
       ``(C) Restrictions.--Notwithstanding any other provision of 
     Federal law, in implementing this subsection, the Secretary 
     shall only promulgate regulations as described in 
     subparagraph (B).
       ``(3) Discontinuance of registration.--The Secretary shall 
     discontinue the registration of any commercial importer of 
     drugs that fails to comply with the regulations promulgated 
     under this subsection.
       ``(4) Unique facility identifier.--The Secretary shall 
     specify the unique facility identifier system that shall be 
     used by registrants under paragraph (1). The requirement to 
     include a unique facility identifier in a registration under 
     paragraph (1) shall not apply until the date that the 
     identifier system is specified by the Secretary under the 
     preceding sentence.
       ``(5) Exemptions.--The Secretary, by notice in the Federal 
     Register, may establish exemptions from the requirements of 
     this subsection.''.
       (c) Misbranding.--Section 502(o) (21 U.S.C. 352) is amended 
     by inserting ``if it is a drug and was imported or offered 
     for import by a commercial importer of drugs not duly 
     registered under section 801(s),'' after ``not duly 
     registered under section 510,''.
       (d) Regulations.--
       (1) In general.--Not later than 36 months after the date of 
     the enactment of this Act, the Secretary of Health and Human 
     Services, in consultation with the Secretary of Homeland 
     Security acting through U.S. Customs and Border Protection, 
     shall promulgate the regulations required to carry out 
     section 801(s) of the Federal Food, Drug, and Cosmetic Act, 
     as added by subsection (b).
       (2) Procedures for promulgating regulations.--
       (A) In general.--In promulgating a regulation under 
     paragraph (1), the Secretary shall--
       (i) issue a notice of proposed rulemaking that includes the 
     proposed regulation;
       (ii) provide a period of not less than 60 days for comments 
     on the proposed regulation; and
       (iii) publish the final regulation not less than 30 days 
     before the regulation's effective date.
       (B) Restrictions.--Notwithstanding any other provision of 
     Federal law, in implementing section 801(s) of the Federal 
     Food, Drug, and Cosmetic Act, as added by subsection (b), the 
     Secretary shall promulgate regulations only as described in 
     subparagraph (A).
       (3) Effective date.--In establishing the effective date of 
     the regulations under paragraph (1), the Secretary of Health 
     and Human Services shall, in consultation with the Secretary 
     of Homeland Security acting through U.S. Customs and Border 
     Protection, as determined appropriate by the Secretary of 
     Health and Human Services, provide a reasonable period of 
     time for an importer of a drug to comply with good importer 
     practices, taking into account differences among importers 
     and types of imports, including based on the level of risk 
     posed by the imported product.

     SEC. 715. NOTIFICATION.

       (a) Prohibited Acts.--Section 301 (21 U.S.C. 331), as 
     amended by section 714 of this Act, is further amended by 
     adding at the end the following:
       ``(bbb) The failure to notify the Secretary in violation of 
     section 568.''.
       (b) Notification.--Subchapter E of chapter V (21 U.S.C. 
     360bbb et seq.) is amended by adding at the end the 
     following:

     ``SEC. 568. NOTIFICATION.

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

     SEC. 716. PROTECTION AGAINST INTENTIONAL ADULTERATION.

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

     SEC. 717. PENALTIES FOR COUNTERFEITING DRUGS.

       (a) Counterfeit Drug Penalty Enhancement.--
       (1) Offense.--Section 2320(a) of title 18, United States 
     Code, is amended--
       (A) by striking ``or'' at the end of paragraph (2);
       (B) by inserting ``or'' at the end of paragraph (3);
       (C) by inserting after paragraph (3) the following:
       ``(4) traffics in a counterfeit drug,''; and
       (D) by striking ``through (3)'' and inserting ``through 
     (4)''.
       (2) Penalties.--Section 2320(b)(3) of title 18, United 
     States Code, is amended--
       (A) in the heading, by inserting ``and counterfeit drugs'' 
     after ``services''; and
       (B) by inserting ``or counterfeit drug'' after ``service''.
       (3) Definition.--Section 2320(f) of title 18, United States 
     Code, is amended--
       (A) by striking ``and'' at the end of paragraph (4);

[[Page 9499]]

       (B) by striking the period at the end of paragraph (5) and 
     inserting ``; and''; and
       (C) by adding at the end the following:
       ``(6) the term `counterfeit drug' means a drug, as defined 
     by section 201 of the Federal Food, Drug, and Cosmetic Act, 
     that uses a counterfeit mark on or in connection with the 
     drug.''.
       (4) Priority given to certain investigations and 
     prosecutions.--The Attorney General shall give increased 
     priority to efforts to investigate and prosecute offenses 
     under section 2320 of title 18, United States Code, that 
     involve counterfeit drugs.
       (b) Sentencing Commission Directive.--
       (1) Directive to sentencing commission.--Pursuant to its 
     authority under section 994(p) of title 28, United States 
     Code, and in accordance with this subsection, the United 
     States Sentencing Commission shall review and amend, if 
     appropriate, its guidelines and its policy statements 
     applicable to persons convicted of an offense described in 
     section 2320(a)(4) of title 18, United States Code, as 
     amended by subsection (a), in order to reflect the intent of 
     Congress that such penalties be increased in comparison to 
     those currently provided by the guidelines and policy 
     statements.
       (2) Requirements.--In carrying out this subsection, the 
     Commission shall--
       (A) ensure that the sentencing guidelines and policy 
     statements reflect the intent of Congress that the guidelines 
     and policy statements reflect the serious nature of the 
     offenses described in paragraph (1) and the need for an 
     effective deterrent and appropriate punishment to prevent 
     such offenses;
       (B) consider the extent to which the guidelines may or may 
     not appropriately account for the potential and actual harm 
     to the public resulting from the offense;
       (C) assure reasonable consistency with other relevant 
     directives and with other sentencing guidelines;
       (D) account for any additional aggravating or mitigating 
     circumstances that might justify exceptions to the generally 
     applicable sentencing ranges;
       (E) make any necessary conforming changes to the sentencing 
     guidelines; and
       (F) assure that the guidelines adequately meet the purposes 
     of sentencing as set forth in section 3553(a)(2) of title 18, 
     United States Code.

     SEC. 718. EXTRATERRITORIAL JURISDICTION.

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

     ``SEC. 311. EXTRATERRITORIAL JURISDICTION.

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

            TITLE VIII--GENERATING ANTIBIOTIC INCENTIVES NOW

     SEC. 801. EXTENSION OF EXCLUSIVITY PERIOD FOR DRUGS.

       (a) In General.--Chapter V (21 U.S.C. 351 et seq.) is 
     amended by inserting after section 505D the following:

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

       ``(a) Extension.--If the Secretary approves an application 
     pursuant to section 505 for a drug that has been designated 
     as a qualified infectious disease product under subsection 
     (d), the 4- and 5-year periods described in subsections 
     (c)(3)(E)(ii) and (j)(5)(F)(ii) of section 505, the 3-year 
     periods described in clauses (iii) and (iv) of subsection 
     (c)(3)(E) and clauses (iii) and (iv) of subsection (j)(5)(F) 
     of section 505, or the 7-year period described in section 
     527, as applicable, shall be extended by 5 years.
       ``(b) Relation to Pediatric Exclusivity.--Any extension 
     under subsection (a) of a period shall be in addition to any 
     extension of the period under section 505A with respect to 
     the drug.
       ``(c) Limitations.--Subsection (a) does not apply to the 
     approval of--
       ``(1) a supplement to an application under section 505(b) 
     for any qualified infectious disease product for which an 
     extension described in subsection (a) is in effect or has 
     expired;
       ``(2) a subsequent application filed with respect to a 
     product approved under section 505 for a change that results 
     in a new indication, route of administration, dosing 
     schedule, dosage form, delivery system, delivery device, or 
     strength; or
       ``(3) a product that does not meet the definition of a 
     qualified infectious disease product under subsection (g) 
     based upon its approved uses.
       ``(d) Designation.--
       ``(1) In general.--The manufacturer or sponsor of a drug 
     may request the Secretary to designate a drug as a qualified 
     infectious disease product at any time before the submission 
     of an application under section 505(b) for such drug. The 
     Secretary shall, not later than 60 days after the submission 
     of such a request, determine whether the drug is a qualified 
     infectious disease product.
       ``(2) Limitation.--Except as provided in paragraph (3), a 
     designation under this subsection shall not be withdrawn for 
     any reason, including modifications to the list of qualifying 
     pathogens under subsection (f)(2)(C).
       ``(3) Revocation of designation.--The Secretary may revoke 
     a designation of a drug as a qualified infectious disease 
     product if the Secretary finds that the request for such 
     designation contained an untrue statement of material fact.
       ``(e) Regulations.--
       ``(1) In general.--Not later than 2 years after the date of 
     enactment of the Food and Drug Administration Safety and 
     Innovation Act, the Secretary shall adopt final regulations 
     implementing this section, including developing the list of 
     qualifying pathogens described in subsection (f).
       ``(2) Procedure.--In promulgating a regulation implementing 
     this section, the Secretary shall--
       ``(A) issue a notice of proposed rulemaking that includes 
     the proposed regulation;
       ``(B) provide a period of not less than 60 days for 
     comments on the proposed regulation; and
       ``(C) publish the final regulation not less than 30 days 
     before the effective date of the regulation.
       ``(3) Restrictions.--Notwithstanding any other provision of 
     law, the Secretary shall promulgate regulations implementing 
     this section only as described in paragraph (2), except that 
     the Secretary may issue interim guidance for sponsors seeking 
     designation under subsection (d) prior to the promulgation of 
     such regulations.
       ``(4) Designation prior to regulations.--The Secretary 
     shall designate drugs as qualified infectious disease 
     products under subsection (d) prior to the promulgation of 
     regulations under this subsection, if such drugs meet the 
     definition of a qualified infectious disease product 
     described in subsection (g).
       ``(f) Qualifying Pathogen.--
       ``(1) Definition.--In this section, the term `qualifying 
     pathogen' means a pathogen identified and listed by the 
     Secretary under paragraph (2) that has the potential to pose 
     a serious threat to public health, such as--
       ``(A) resistant gram positive pathogens, including 
     methicillin-resistant Staphylococcus aureus, vancomycin-
     resistant Staphylococcus aureus, and vancomycin-resistant 
     enterococcus;
       ``(B) multi-drug resistant gram negative bacteria, 
     including Acinetobacter, Klebsiella, Pseudomonas, and E. coli 
     species;
       ``(C) multi-drug resistant tuberculosis; and
       ``(D) Clostridium difficile.
       ``(2) List of qualifying pathogens.--
       ``(A) In general.--The Secretary shall establish and 
     maintain a list of qualifying pathogens, and shall make 
     public the methodology for developing such list.
       ``(B) Considerations.--In establishing and maintaining the 
     list of pathogens described under this section, the Secretary 
     shall--
       ``(i) consider--

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

       ``(ii) consult with experts in infectious diseases and 
     antibiotic resistance, including the Centers for Disease 
     Control and Prevention, the Food and Drug Administration, 
     medical professionals, and the clinical research community.
       ``(C) Review.--Every 5 years, or more often as needed, the 
     Secretary shall review, provide modifications to, and publish 
     the list of qualifying pathogens under subparagraph (A) and 
     shall by regulation revise the list as necessary, in 
     accordance with subsection (e).
       ``(g) Qualified Infectious Disease Product.--The term 
     `qualified infectious disease product' means an antibacterial 
     or antifungal drug for human use intended to treat serious or 
     life-threatening infections, including those caused by--
       ``(1) an antibacterial or antifungal resistant pathogen, 
     including novel or emerging infectious pathogens; or
       ``(2) qualifying pathogens listed by the Secretary under 
     subsection (f).''.
       (b) Application.--Section 505E of the Federal Food, Drug, 
     and Cosmetic Act, as added by subsection (a), applies only 
     with respect to a drug that is first approved under section 
     505(c) of such Act (21 U.S.C. 355(c)) on or after the date of 
     the enactment of this Act.

     SEC. 802. PRIORITY REVIEW.

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

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

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

     SEC. 803. FAST TRACK PRODUCT.

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

     SEC. 804. CLINICAL TRIALS.

       (a) Review and Revision of Guidance Documents.--
       (1) In general.--The Secretary of Health and Human Services 
     (referred to in this section as the ``Secretary'') shall 
     review and, as appropriate, revise not fewer than 3 guidance 
     documents per year, which shall include--
       (A) reviewing the guidance documents of the Food and Drug 
     Administration for the conduct

[[Page 9500]]

     of clinical trials with respect to antibacterial and 
     antifungal drugs; and
       (B) as appropriate, revising such guidance documents to 
     reflect developments in scientific and medical information 
     and technology and to ensure clarity regarding the procedures 
     and requirements for approval of antibacterial and antifungal 
     drugs under chapter V of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 351 et seq.).
       (2) Issues for review.--At a minimum, the review under 
     paragraph (1) shall address the appropriate animal models of 
     infection, in vitro techniques, valid microbiological 
     surrogate markers, the use of noninferiority versus 
     superiority trials, trial enrollment, data requirements, and 
     appropriate delta values for noninferiority trials.
       (3) Rule of construction.--Except to the extent to which 
     the Secretary makes revisions under paragraph (1)(B), nothing 
     in this section shall be construed to repeal or otherwise 
     effect the guidance documents of the Food and Drug 
     Administration.
       (b) Recommendations for Investigations.--
       (1) Request.--The sponsor of a drug intended to be 
     designated as a qualified infectious disease product may 
     request that the Secretary provide written recommendations 
     for nonclinical and clinical investigations which the 
     Secretary believes may be necessary to be conducted with the 
     drug before such drug may be approved under section 505 of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) for 
     use in treating, detecting, preventing, or identifying a 
     qualifying pathogen, as defined in section 505E of such Act.
       (2) Recommendations.--If the Secretary has reason to 
     believe that a drug for which a request is made under this 
     subsection is a qualified infectious disease product, the 
     Secretary shall provide the person making the request written 
     recommendations for the nonclinical and clinical 
     investigations which the Secretary believes, on the basis of 
     information available to the Secretary at the time of the 
     request, would be necessary for approval under section 505 of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) of 
     such drug for the use described in paragraph (1).
       (c) Qualified Infectious Disease Product.--For purposes of 
     this section, the term ``qualified infectious disease 
     product'' has the meaning given such term in section 505E(g) 
     of the Federal Food, Drug, and Cosmetic Act, as added by 
     section 801 of this Act.

     SEC. 805. REASSESSMENT OF QUALIFIED INFECTIOUS DISEASE 
                   PRODUCT INCENTIVES IN 5 YEARS.

       (a) In General.--Not later than 5 years after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services shall, in consultation with the Food and Drug 
     Administration, the Centers for Disease Control and 
     Prevention, and other appropriate agencies, submit to the 
     Committee on Energy and Commerce of the House of 
     Representatives and the Committee on Health, Education, 
     Labor, and Pensions of the Senate a report that contains the 
     following:
       (1)(A) The number of initial designations of drugs as 
     qualified infectious disease products under section 505E of 
     the Federal Food, Drug, and Cosmetic Act.
       (B) The number of qualified infectious disease products 
     approved under such section 505E.
       (C) Whether such products address the need for 
     antibacterial and antifungal drugs to treat serious and life-
     threatening infections.
       (D) A list of qualified infectious disease products with 
     information on the types of exclusivity granted for each 
     product, consistent with the information published under 
     section 505(j)(7)(A)(iii) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355(j)(7)(A)(iii)).
       (E) The progress made regarding the review and revision of 
     the clinical trial guidance documents required under section 
     804 and the impact such review and revision has had on the 
     review and approval of qualified infectious disease products.
       (F) The Federal contribution, if any, to funding of the 
     clinical trials for each qualified infectious disease product 
     for each phase.
       (2) Recommendations--
       (A) based on the information under paragraph (1) and any 
     other relevant data, on any changes that should be made to 
     the list of pathogens that are defined as qualifying 
     pathogens under section 505E(f)(2) of the Federal Food, Drug, 
     and Cosmetic Act, as added by section 801 of this Act; and
       (B) on whether any additional program (such as the 
     development of public-private collaborations to advance 
     antibacterial drug innovation) or changes to the incentives 
     under this subtitle may be needed to promote the development 
     of antibacterial drugs.
       (3) An examination of--
       (A) the adoption of programs to measure the use of 
     antibacterial drugs in health care settings; and
       (B) the implementation and effectiveness of antimicrobial 
     stewardship protocols across all health care settings.
       (4) Any recommendations for ways to encourage further 
     development and establishment of stewardship programs.
       (5) A description of the regulatory challenges and 
     impediments to clinical development, approval, and licensure 
     of qualified infectious disease products, and the steps the 
     Secretary has taken and will take to address such challenges 
     and ensure regulatory certainty and predictability with 
     respect to qualified infectious disease products.
       (b) Definition.--For purposes of this section, the term 
     ``qualified infectious disease product'' has the meaning 
     given such term in section 505E(g) of the Federal Food, Drug, 
     and Cosmetic Act, as added by section 801 of this Act.

     SEC. 806. GUIDANCE ON PATHOGEN-FOCUSED ANTIBACTERIAL DRUG 
                   DEVELOPMENT.

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

               TITLE IX--DRUG APPROVAL AND PATIENT ACCESS

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

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

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

       ``(a) Designation of Drug as Fast Track Product.--
       ``(1) In general.--The Secretary shall, at the request of 
     the sponsor of a new drug, facilitate the development and 
     expedite the review of such drug if it is intended, whether 
     alone or in combination with one or more other drugs, for the 
     treatment of a serious or life-threatening disease or 
     condition, and it demonstrates the potential to address unmet 
     medical needs for such a disease or condition. (In this 
     section, such a drug is referred to as a `fast track 
     product'.)
       ``(2) Request for designation.--The sponsor of a new drug 
     may request the Secretary to designate the drug as a fast 
     track product. A request for the designation may be made 
     concurrently with, or at any time after, submission of an 
     application for the investigation of the drug under section 
     505(i) or section 351(a)(3) of the Public Health Service Act.

[[Page 9501]]

       ``(3) Designation.--Within 60 calendar days after the 
     receipt of a request under paragraph (2), the Secretary shall 
     determine whether the drug that is the subject of the request 
     meets the criteria described in paragraph (1). If the 
     Secretary finds that the drug meets the criteria, the 
     Secretary shall designate the drug as a fast track product 
     and shall take such actions as are appropriate to expedite 
     the development and review of the application for approval of 
     such product.
       ``(b) Accelerated Approval of a Drug for a Serious or Life-
     Threatening Disease or Condition, Including a Fast Track 
     Product.--
       ``(1) In general.--
       ``(A) Accelerated approval.--The Secretary may approve an 
     application for approval of a product for a serious or life-
     threatening disease or condition, including a fast track 
     product, under section 505(c) or section 351(a) of the Public 
     Health Service Act upon a determination that the product has 
     an effect on a surrogate endpoint that is reasonably likely 
     to predict clinical benefit, or on a clinical endpoint that 
     can be measured earlier than irreversible morbidity or 
     mortality, that is reasonably likely to predict an effect on 
     irreversible morbidity or mortality or other clinical 
     benefit, taking into account the severity, rarity, or 
     prevalence of the condition and the availability or lack of 
     alternative treatments. The approval described in the 
     preceding sentence is referred to in this section as 
     `accelerated approval'.
       ``(B) Evidence.--The evidence to support that an endpoint 
     is reasonably likely to predict clinical benefit under 
     subparagraph (A) may include epidemiological, 
     pathophysiological, therapeutic, pharmacologic, or other 
     evidence developed using biomarkers, for example, or other 
     scientific methods or tools.
       ``(2) Limitation.--Approval of a product under this 
     subsection may be subject to 1 or both of the following 
     requirements:
       ``(A) That the sponsor conduct appropriate postapproval 
     studies to verify and describe the predicted effect on 
     irreversible morbidity or mortality or other clinical 
     benefit.
       ``(B) That the sponsor submit copies of all promotional 
     materials related to the product during the preapproval 
     review period and, following approval and for such period 
     thereafter as the Secretary determines to be appropriate, at 
     least 30 days prior to dissemination of the materials.
       ``(3) Expedited withdrawal of approval.--The Secretary may 
     withdraw approval of a product approved under accelerated 
     approval using expedited procedures (as prescribed by the 
     Secretary in regulations which shall include an opportunity 
     for an informal hearing) if--
       ``(A) the sponsor fails to conduct any required 
     postapproval study of the drug with due diligence;
       ``(B) a study required to verify and describe the predicted 
     effect on irreversible morbidity or mortality or other 
     clinical benefit of the product fails to verify and describe 
     such effect or benefit;
       ``(C) other evidence demonstrates that the product is not 
     safe or effective under the conditions of use; or
       ``(D) the sponsor disseminates false or misleading 
     promotional materials with respect to the product.
       ``(c) Review of Incomplete Applications for Approval of a 
     Fast Track Product.--
       ``(1) In general.--If the Secretary determines, after 
     preliminary evaluation of clinical data submitted by the 
     sponsor, that a fast track product may be effective, the 
     Secretary shall evaluate for filing, and may commence review 
     of portions of, an application for the approval of the 
     product before the sponsor submits a complete application. 
     The Secretary shall commence such review only if the 
     applicant--
       ``(A) provides a schedule for submission of information 
     necessary to make the application complete; and
       ``(B) pays any fee that may be required under section 736.
       ``(2) Exception.--Any time period for review of human drug 
     applications that has been agreed to by the Secretary and 
     that has been set forth in goals identified in letters of the 
     Secretary (relating to the use of fees collected under 
     section 736 to expedite the drug development process and the 
     review of human drug applications) shall not apply to an 
     application submitted under paragraph (1) until the date on 
     which the application is complete.
       ``(d) Awareness Efforts.--The Secretary shall--
       ``(1) develop and disseminate to physicians, patient 
     organizations, pharmaceutical and biotechnology companies, 
     and other appropriate persons a description of the provisions 
     of this section applicable to accelerated approval and fast 
     track products; and
       ``(2) establish a program to encourage the development of 
     surrogate and clinical endpoints, including biomarkers, and 
     other scientific methods and tools that can assist the 
     Secretary in determining whether the evidence submitted in an 
     application is reasonably likely to predict clinical benefit 
     for serious or life-threatening conditions for which 
     significant unmet medical needs exist.
       ``(e) Construction.--
       ``(1) Purpose.--The amendments made by the Food and Drug 
     Administration Safety and Innovation Act to this section are 
     intended to encourage the Secretary to utilize innovative and 
     flexible approaches to the assessment of products under 
     accelerated approval for treatments for patients with serious 
     or life-threatening diseases or conditions and unmet medical 
     needs.
       ``(2) Construction.--Nothing in this section shall be 
     construed to alter the standards of evidence under subsection 
     (c) or (d) of section 505 (including the substantial evidence 
     standard in section 505(d)) of this Act or under section 
     351(a) of the Public Health Service Act. Such sections and 
     standards of evidence apply to the review and approval of 
     products under this section, including whether a product is 
     safe and effective. Nothing in this section alters the 
     ability of the Secretary to rely on evidence that does not 
     come from adequate and well-controlled investigations for the 
     purpose of determining whether an endpoint is reasonably 
     likely to predict clinical benefit as described in subsection 
     (b)(1)(B).''.
       (c) Guidance; Amended Regulations.--
       (1) Draft guidance.--Not later than 1 year after the date 
     of enactment of this Act, the Secretary of Health and Human 
     Services (referred to in this section as the ``Secretary'') 
     shall issue draft guidance to implement the amendments made 
     by this section. In developing such guidance, the Secretary 
     shall specifically consider issues arising under the 
     accelerated approval and fast track processes under section 
     506 of the Federal Food, Drug, and Cosmetic Act, as amended 
     by subsection (b), for drugs designated for a rare disease or 
     condition under section 526 of such Act (21 U.S.C. 360bb) and 
     shall also consider any unique issues associated with very 
     rare diseases.
       (2) Final guidance.--Not later than 1 year after the 
     issuance of draft guidance under paragraph (1), and after an 
     opportunity for public comment, the Secretary shall--
       (A) issue final guidance; and
       (B) amend the regulations governing accelerated approval in 
     parts 314 and 601 of title 21, Code of Federal Regulations, 
     as necessary to conform such regulations with the amendment 
     made by subsection (b).
       (3) Consideration.--In developing the guidance under 
     paragraphs (1) and (2)(A) and the amendments under paragraph 
     (2)(B), the Secretary shall consider how to incorporate novel 
     approaches to the review of surrogate endpoints based on 
     pathophysiologic and pharmacologic evidence in such guidance, 
     especially in instances where the low prevalence of a disease 
     renders the existence or collection of other types of data 
     unlikely or impractical.
       (4) Conforming changes.--The Secretary shall issue, as 
     necessary, conforming amendments to the applicable 
     regulations under title 21, Code of Federal Regulations, 
     governing accelerated approval.
       (5) No effect of inaction on requests.--The issuance (or 
     nonissuance) of guidance or conforming regulations 
     implementing the amendment made by subsection (b) shall not 
     preclude the review of, or action on, a request for 
     designation or an application for approval submitted pursuant 
     to section 506 of the Federal Food, Drug, and Cosmetic Act, 
     as amended by subsection (b).
       (d) Independent Review.--The Secretary may, in conjunction 
     with other planned reviews, contract with an independent 
     entity with expertise in assessing the quality and efficiency 
     of biopharmaceutical development and regulatory review 
     programs to evaluate the Food and Drug Administration's 
     application of the processes described in section 506 of the 
     Federal Food, Drug, and Cosmetic Act, as amended by 
     subsection (b), and the impact of such processes on the 
     development and timely availability of innovative treatments 
     for patients suffering from serious or life-threatening 
     conditions. Any such evaluation shall include consultation 
     with regulated industries, patient advocacy and disease 
     research foundations, and relevant academic medical centers.

     SEC. 902. BREAKTHROUGH THERAPIES.

       (a) In General.--Section 506 (21 U.S.C. 356), as amended by 
     section 901 of this Act, is further amended--
       (1) by redesignating subsections (a) through (c) as 
     subsections (b) through (d), respectively;
       (2) by redesignating subsection (d) as subsection (f);
       (3) by inserting before subsection (b), as so redesignated, 
     the following:
       ``(a) Designation of a Drug as a Breakthrough Therapy.--
       ``(1) In general.--The Secretary shall, at the request of 
     the sponsor of a drug, expedite the development and review of 
     such drug if the drug is intended, alone or in combination 
     with 1 or more other drugs, to treat a serious or life-
     threatening disease or condition and preliminary clinical 
     evidence indicates that the drug may demonstrate substantial 
     improvement over existing therapies on 1 or more clinically 
     significant endpoints, such as substantial treatment effects 
     observed early in clinical development. (In this section, 
     such a drug is referred to as a `breakthrough therapy'.)
       ``(2) Request for designation.--The sponsor of a drug may 
     request the Secretary to designate the drug as a breakthrough 
     therapy. A request for the designation may be made 
     concurrently with, or at any time after, the submission of an 
     application for the investigation of the drug under section 
     505(i) or section 351(a)(3) of the Public Health Service Act.
       ``(3) Designation.--
       ``(A) In general.--Not later than 60 calendar days after 
     the receipt of a request under paragraph (2), the Secretary 
     shall determine whether the drug that is the subject of the 
     request meets the criteria described in paragraph (1). If the 
     Secretary finds that the drug meets the criteria, the 
     Secretary shall designate the drug as a

[[Page 9502]]

     breakthrough therapy and shall take such actions as are 
     appropriate to expedite the development and review of the 
     application for approval of such drug.
       ``(B) Actions.--The actions to expedite the development and 
     review of an application under subparagraph (A) may include, 
     as appropriate--
       ``(i) holding meetings with the sponsor and the review team 
     throughout the development of the drug;
       ``(ii) providing timely advice to, and interactive 
     communication with, the sponsor regarding the development of 
     the drug to ensure that the development program to gather the 
     nonclinical and clinical data necessary for approval is as 
     efficient as practicable;
       ``(iii) involving senior managers and experienced review 
     staff, as appropriate, in a collaborative, cross-disciplinary 
     review;
       ``(iv) assigning a cross-disciplinary project lead for the 
     Food and Drug Administration review team to facilitate an 
     efficient review of the development program and to serve as a 
     scientific liaison between the review team and the sponsor; 
     and
       ``(v) taking steps to ensure that the design of the 
     clinical trials is as efficient as practicable, when 
     scientifically appropriate, such as by minimizing the number 
     of patients exposed to a potentially less efficacious 
     treatment.''; and
       (4) in subsection (f)(1), as so redesignated, by striking 
     ``applicable to accelerated approval'' and inserting 
     ``applicable to breakthrough therapies, accelerated approval, 
     and''.
       (b) Guidance; Amended Regulations.--
       (1) In general.--
       (A) Guidance.--Not later than 18 months after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services (referred to in this section as the ``Secretary'') 
     shall issue draft guidance on implementing the requirements 
     with respect to breakthrough therapies, as set forth in 
     section 506(a) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 356(a)), as amended by this section. The Secretary 
     shall issue final guidance not later than 1 year after the 
     close of the comment period for the draft guidance.
       (B) Amended regulations.--
       (i) In general.--If the Secretary determines that it is 
     necessary to amend the regulations under title 21, Code of 
     Federal Regulations in order to implement the amendments made 
     by this section to section 506(a) of the Federal Food, Drug, 
     and Cosmetic Act, the Secretary shall amend such regulations 
     not later than 2 years after the date of enactment of this 
     Act.
       (ii) Procedure.--In amending regulations under clause (i), 
     the Secretary shall--

       (I) issue a notice of proposed rulemaking that includes the 
     proposed regulation;
       (II) provide a period of not less than 60 days for comments 
     on the proposed regulation; and
       (III) publish the final regulation not less than 30 days 
     before the effective date of the regulation.

       (iii) Restrictions.--Notwithstanding any other provision of 
     law, the Secretary shall promulgate regulations implementing 
     the amendments made by this section only as described in 
     clause (ii).
       (2) Requirements.--Guidance issued under this section 
     shall--
       (A) specify the process and criteria by which the Secretary 
     makes a designation under section 506(a)(3) of the Federal 
     Food, Drug, and Cosmetic Act; and
       (B) specify the actions the Secretary shall take to 
     expedite the development and review of a breakthrough therapy 
     pursuant to such designation under such section 506(a)(3), 
     including updating good review management practices to 
     reflect breakthrough therapies.
       (c) Conforming Amendments.--Section 506B(e) (21 U.S.C. 
     356b) is amended by striking ``section 506(b)(2)(A)'' each 
     place such term appears and inserting ``section 
     506(c)(2)(A)''.

     SEC. 903. CONSULTATION WITH EXTERNAL EXPERTS ON RARE 
                   DISEASES, TARGETED THERAPIES, AND GENETIC 
                   TARGETING OF TREATMENTS.

       Subchapter E of chapter V (21 U.S.C. 360bbb et seq.), as 
     amended by section 715 of this Act, is further amended by 
     adding at the end the following:

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

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

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

       (a) Establishment of Working Group.--
       (1) In general.--The Architectural and Transportation 
     Barriers Compliance Board (referred to in this section as the 
     ``Access Board'') shall convene a stakeholder working group 
     (referred to in this section as the ``working group'') to 
     develop best practices on access to information on 
     prescription drug container labels for individuals who are 
     blind or visually impaired.
       (2) Members.--The working group shall be comprised of 
     representatives of national organizations representing blind 
     and visually impaired individuals, national organizations 
     representing the elderly, and industry groups representing 
     stakeholders, including retail, mail-order, and independent 
     community pharmacies, who would be impacted by such best 
     practices. Representation within the working group shall be 
     divided equally between consumer and industry advocates.
       (3) Best practices.--
       (A) In general.--The working group shall develop, not later 
     than 1 year after the date of the

[[Page 9503]]

     enactment of this Act, best practices for pharmacies to 
     ensure that blind and visually impaired individuals have 
     safe, consistent, reliable, and independent access to the 
     information on prescription drug container labels.
       (B) Public availability.--The best practices developed 
     under subparagraph (A) may be made publicly available, 
     including through the Internet Web sites of the working group 
     participant organizations, and through other means, in a 
     manner that provides access to interested individuals, 
     including individuals with disabilities.
       (C) Limitations.--The best practices developed under 
     subparagraph (A) shall not be construed as accessibility 
     guidelines or standards of the Access Board, and shall not 
     confer any rights or impose any obligations on working group 
     participants or other persons. Nothing in this section shall 
     be construed to limit or condition any right, obligation, or 
     remedy available under the Americans with Disabilities Act of 
     1990 (42 U.S.C. 12101 et seq.) or any other Federal or State 
     law requiring effective communication, barrier removal, or 
     nondiscrimination on the basis of disability.
       (4) Considerations.--In developing and issuing the best 
     practices under paragraph (3)(A), the working group shall 
     consider--
       (A) the use of--
       (i) Braille;
       (ii) auditory means, such as--

       (I) ``talking bottles'' that provide audible container 
     label information;
       (II) digital voice recorders attached to the prescription 
     drug container; and
       (III) radio frequency identification tags;

       (iii) enhanced visual means, such as--

       (I) large font labels or large font ``duplicate'' labels 
     that are affixed or matched to a prescription drug container;
       (II) high-contrast printing; and
       (III) sans-serf font; and

       (iv) other relevant alternatives as determined by the 
     working group;
       (B) whether there are technical, financial, manpower, or 
     other factors unique to pharmacies with 20 or fewer retail 
     locations which may pose significant challenges to the 
     adoption of the best practices; and
       (C) such other factors as the working group determines to 
     be appropriate.
       (5) Information campaign.--Upon completion of development 
     of the best practices under subsection (a)(3), the National 
     Council on Disability, in consultation with the working 
     group, shall conduct an informational and educational 
     campaign designed to inform individuals with disabilities, 
     pharmacists, and the public about such best practices.
       (6) FACA waiver.--The Federal Advisory Committee Act (5 
     U.S.C. App.) shall not apply to the working group.
       (b) GAO Study.--
       (1) In general.--Beginning 18 months after the completion 
     of the development of best practices under subsection 
     (a)(3)(A), the Comptroller General of the United States shall 
     conduct a review of the extent to which pharmacies are 
     utilizing such best practices, and the extent to which 
     barriers to accessible information on prescription drug 
     container labels for blind and visually impaired individuals 
     continue.
       (2) Report.--Not later than September 30, 2016, the 
     Comptroller General of the United States shall submit to 
     Congress a report on the review conducted under paragraph 
     (1). Such report shall include recommendations about how best 
     to reduce the barriers experienced by blind and visually 
     impaired individuals to independently accessing information 
     on prescription drug container labels.
       (c) Definitions.--In this section--
       (1) the term ``pharmacy'' includes a pharmacy that receives 
     prescriptions and dispenses prescription drugs through an 
     Internet Web site or by mail;
       (2) the term ``prescription drug'' means a drug subject to 
     section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 353(b)(1)); and
       (3) the term ``prescription drug container label'' means 
     the label with the directions for use that is affixed to the 
     prescription drug container by the pharmacist and dispensed 
     to the consumer.

     SEC. 905. RISK-BENEFIT FRAMEWORK.

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

     SEC. 906. GRANTS AND CONTRACTS FOR THE DEVELOPMENT OF ORPHAN 
                   DRUGS.

       (a) Qualified Testing Definition.--Section 5(b)(1)(A)(ii) 
     of the Orphan Drug Act (21 U.S.C. 360ee(b)(1)(A)(ii)) is 
     amended by striking ``after the date such drug is designated 
     under section 526 of such Act and''.
       (b) Authorization of Appropriations.--Section 5(c) of the 
     Orphan Drug Act (21 U.S.C. 360ee(c)) is amended to read as 
     follows:
       ``(c) Authorization of Appropriations.--For grants and 
     contracts under subsection (a), there is authorized to be 
     appropriated $30,000,000 for each of fiscal years 2013 
     through 2017.''.

     SEC. 907. REPORTING OF INCLUSION OF DEMOGRAPHIC SUBGROUPS IN 
                   CLINICAL TRIALS AND DATA ANALYSIS IN 
                   APPLICATIONS FOR DRUGS, BIOLOGICS, AND DEVICES.

       (a) Report.--
       (1) In general.--Not later than 1 year after the date of 
     enactment of this Act, the Secretary, acting through the 
     Commissioner, shall publish on the Internet Web site of the 
     Food and Drug Administration a report, consistent with the 
     regulations of the Food and Drug Administration pertaining to 
     the protection of sponsors' confidential commercial 
     information as of the date of enactment of this Act, 
     addressing the extent to which clinical trial participation 
     and the inclusion of safety and effectiveness data by 
     demographic subgroups including sex, age, race, and 
     ethnicity, is included in applications submitted to the Food 
     and Drug Administration, and shall provide such publication 
     to Congress.
       (2) Contents of report.--The report described in paragraph 
     (1) shall contain the following:
       (A) A description of existing tools to ensure that data to 
     support demographic analyses are submitted in applications 
     for drugs, biological products, and devices, and that these 
     analyses are conducted by applicants consistent with 
     applicable Food and Drug Administration requirements and 
     Guidance for Industry. The report shall address how the Food 
     and Drug Administration makes available information about 
     differences in safety and effectiveness of medical products 
     according to demographic subgroups, such as sex, age, racial, 
     and ethnic subgroups, to health care providers, researchers, 
     and patients.
       (B) An analysis of the extent to which demographic data 
     subset analyses on sex, age, race, and ethnicity is presented 
     in applications for new drug applications for new molecular 
     entities under section 505 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355), in biologics license 
     applications under section 351 of the Public Health Service 
     Act (42 U.S.C. 262), and in premarket approval applications 
     under section 515 of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 360e) for products approved or licensed by the 
     Food and Drug Administration, consistent with applicable 
     requirements and Guidance for Industry, and consistent with 
     the regulations of the Food and Drug Administration 
     pertaining to the protection of sponsors' confidential 
     commercial information as of the date of enactment of this 
     Act.
       (C) An analysis of the extent to which demographic 
     subgroups, including sex, age, racial, and ethnic subgroups, 
     are represented in clinical studies to support applications 
     for approved or licensed new molecular entities, biological 
     products, and devices.
       (D) An analysis of the extent to which a summary of product 
     safety and effectiveness data by demographic subgroups 
     including sex, age, race, and ethnicity is readily available 
     to the public in a timely manner by means of the product 
     labeling or the Food and Drug Administration's Internet Web 
     site.
       (b) Action Plan.--
       (1) In general.--Not later than 1 year after the 
     publication of the report described in subsection (a), the 
     Secretary, acting through the Commissioner, shall publish an 
     action plan on the Internet Web site of the Food and Drug 
     Administration, and provide such publication to Congress.
       (2) Content of action plan.--The plan described in 
     paragraph (1) shall include--
       (A) recommendations, as appropriate, to improve the 
     completeness and quality of analyses of data on demographic 
     subgroups in summaries of product safety and effectiveness 
     data and in labeling;
       (B) recommendations, as appropriate, on the inclusion of 
     such data, or the lack of availability of such data in 
     labeling;
       (C) recommendations, as appropriate, to otherwise improve 
     the public availability of such data to patients, health care 
     providers, and researchers; and
       (D) a determination with respect to each recommendation 
     identified in subparagraphs (A) through (C) that 
     distinguishes between product types referenced in subsection 
     (a)(2)(B) insofar as the applicability of each such 
     recommendation to each type of product.
       (c) Definitions.--In this section:
       (1) The term ``Commissioner'' means the Commissioner of 
     Food and Drugs.
       (2) The term ``device'' has the meaning given such term in 
     section 201(h) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 321(h)).
       (3) The term ``drug'' has the meaning given such term in 
     section 201(g) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 321(g)).
       (4) The term ``biological product'' has the meaning given 
     such term in section 351(i) of the Public Health Service Act 
     (42 U.S.C. 262(i)).
       (5) The term ``Secretary'' means the Secretary of Health 
     and Human Services.

     SEC. 908. RARE PEDIATRIC DISEASE PRIORITY REVIEW VOUCHER 
                   INCENTIVE PROGRAM.

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

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

       ``(a) Definitions.--In this section:
       ``(1) Priority review.--The term `priority review', with 
     respect to a human drug application as defined in section 
     735(1), means review and action by the Secretary on such 
     application not later than 6 months after receipt by the 
     Secretary of such application, as described in the Manual of 
     Policies and Procedures of the Food and Drug Administration 
     and goals identified in

[[Page 9504]]

     the letters described in section 101(b) of the Prescription 
     Drug User Fee Amendments of 2012.
       ``(2) Priority review voucher.--The term `priority review 
     voucher' means a voucher issued by the Secretary to the 
     sponsor of a rare pediatric disease product application that 
     entitles the holder of such voucher to priority review of a 
     single human drug application submitted under section 
     505(b)(1) or section 351(a) of the Public Health Service Act 
     after the date of approval of the rare pediatric disease 
     product application.
       ``(3) Rare pediatric disease.--The term `rare pediatric 
     disease' means a disease that meets each of the following 
     criteria:
       ``(A) The disease primarily affects individuals aged from 
     birth to 18 years, including age groups often called 
     neonates, infants, children, and adolescents.
       ``(B) The disease is a rare disease or condition, within 
     the meaning of section 526.
       ``(4) Rare pediatric disease product application.--The term 
     `rare pediatric disease product application' means a human 
     drug application, as defined in section 735(1), that--
       ``(A) is for a drug or biological product--
       ``(i) that is for the prevention or treatment of a rare 
     pediatric disease; and
       ``(ii) that contains no active ingredient (including any 
     ester or salt of the active ingredient) that has been 
     previously approved in any other application under section 
     505(b)(1), 505(b)(2), or 505(j) of this Act or section 351(a) 
     or 351(k) of the Public Health Service Act;
       ``(B) is submitted under section 505(b)(1) of this Act or 
     section 351(a) of the Public Health Service Act;
       ``(C) the Secretary deems eligible for priority review;
       ``(D) that relies on clinical data derived from studies 
     examining a pediatric population and dosages of the drug 
     intended for that population;
       ``(E) that does not seek approval for an adult indication 
     in the original rare pediatric disease product application; 
     and
       ``(F) is approved after the date of the enactment of the 
     Prescription Drug User Fee Amendments of 2012.
       ``(b) Priority Review Voucher.--
       ``(1) In general.--The Secretary shall award a priority 
     review voucher to the sponsor of a rare pediatric disease 
     product application upon approval by the Secretary of such 
     rare pediatric disease product application.
       ``(2) Transferability.--
       ``(A) In general.--The sponsor of a rare pediatric disease 
     product application that receives a priority review voucher 
     under this section may transfer (including by sale) the 
     entitlement to such voucher. There is no limit on the number 
     of times a priority review voucher may be transferred before 
     such voucher is used.
       ``(B) Notification of transfer.--Each person to whom a 
     voucher is transferred shall notify the Secretary of such 
     change in ownership of the voucher not later than 30 days 
     after such transfer.
       ``(3) Limitation.--A sponsor of a rare pediatric disease 
     product application may not receive a priority review voucher 
     under this section if the rare pediatric disease product 
     application was submitted to the Secretary prior to the date 
     that is 90 days after the date of enactment of the 
     Prescription Drug User Fee Amendments of 2012.
       ``(4) Notification.--
       ``(A) In general.--The sponsor of a human drug application 
     shall notify the Secretary not later than 90 days prior to 
     submission of the human drug application that is the subject 
     of a priority review voucher of an intent to submit the human 
     drug application, including the date on which the sponsor 
     intends to submit the application. Such notification shall be 
     a legally binding commitment to pay for the user fee to be 
     assessed in accordance with this section.
       ``(B) Transfer after notice.--The sponsor of a human drug 
     application that provides notification of the intent of such 
     sponsor to use the voucher for the human drug application 
     under subparagraph (A) may transfer the voucher after such 
     notification is provided, if such sponsor has not yet 
     submitted the human drug application described in the 
     notification.
       ``(5) Termination of authority.--The Secretary may not 
     award any priority review vouchers under paragraph (1) after 
     the last day of the 1-year period that begins on the date 
     that the Secretary awards the third rare pediatric disease 
     priority voucher under this section.
       ``(c) Priority Review User Fee.--
       ``(1) In general.--The Secretary shall establish a user fee 
     program under which a sponsor of a human drug application 
     that is the subject of a priority review voucher shall pay to 
     the Secretary a fee determined under paragraph (2). Such fee 
     shall be in addition to any fee required to be submitted by 
     the sponsor under chapter VII.
       ``(2) Fee amount.--The amount of the priority review user 
     fee shall be determined each fiscal year by the Secretary, 
     based on the difference between--
       ``(A) the average cost incurred by the Food and Drug 
     Administration in the review of a human drug application 
     subject to priority review in the previous fiscal year; and
       ``(B) the average cost incurred by the Food and Drug 
     Administration in the review of a human drug application that 
     is not subject to priority review in the previous fiscal 
     year.
       ``(3) Annual fee setting.--The Secretary shall establish, 
     before the beginning of each fiscal year beginning after 
     September 30, 2012, the amount of the priority review user 
     fee for that fiscal year.
       ``(4) Payment.--
       ``(A) In general.--The priority review user fee required by 
     this subsection shall be due upon the notification by a 
     sponsor of the intent of such sponsor to use the voucher, as 
     specified in subsection (b)(4)(A). All other user fees 
     associated with the human drug application shall be due as 
     required by the Secretary or under applicable law.
       ``(B) Complete application.--An application described under 
     subparagraph (A) for which the sponsor requests the use of a 
     priority review voucher shall be considered incomplete if the 
     fee required by this subsection and all other applicable user 
     fees are not paid in accordance with the Secretary's 
     procedures for paying such fees.
       ``(C) No waivers, exemptions, reductions, or refunds.--The 
     Secretary may not grant a waiver, exemption, reduction, or 
     refund of any fees due and payable under this section.
       ``(5) Offsetting collections.--Fees collected pursuant to 
     this subsection for any fiscal year--
       ``(A) shall be deposited and credited as offsetting 
     collections to the account providing appropriations to the 
     Food and Drug Administration; and
       ``(B) shall not be collected for any fiscal year except to 
     the extent provided in advance in appropriations Acts.
       ``(d) Designation Process.--
       ``(1) In general.--Upon the request of the manufacturer or 
     the sponsor of a new drug, the Secretary may designate--
       ``(A) the new drug as a drug for a rare pediatric disease; 
     and
       ``(B) the application for the new drug as a rare pediatric 
     disease product application.
       ``(2) Request for designation.--The request for a 
     designation under paragraph (1) shall be made at the same 
     time a request for designation of orphan disease status under 
     section 526 or fast-track designation under section 506 is 
     made. Requesting designation under this subsection is not a 
     prerequisite to receiving a priority review voucher under 
     this section.
       ``(3) Determination by secretary.--Not later than 60 days 
     after a request is submitted under paragraph (1), the 
     Secretary shall determine whether--
       ``(A) the disease or condition that is the subject of such 
     request is a rare pediatric disease; and
       ``(B) the application for the new drug is a rare pediatric 
     disease product application.
       ``(e) Marketing of Rare Pediatric Disease Products.--
       ``(1) Revocation.--The Secretary may revoke any priority 
     review voucher awarded under subsection (b) if the rare 
     pediatric disease product for which such voucher was awarded 
     is not marketed in the United States within the 365-day 
     period beginning on the date of the approval of such drug 
     under section 505 of this Act or section 351 of the Public 
     Health Service Act.
       ``(2) Postapproval production report.--The sponsor of an 
     approved rare pediatric disease product shall submit a report 
     to the Secretary not later than 5 years after the approval of 
     the applicable rare pediatric disease product application. 
     Such report shall provide the following information, with 
     respect to each of the first 4 years after approval of such 
     product:
       ``(A) The estimated population in the United States 
     suffering from the rare pediatric disease.
       ``(B) The estimated demand in the United States for such 
     rare pediatric disease product.
       ``(C) The actual amount of such rare pediatric disease 
     product distributed in the United States.
       ``(f) Notice and Report.--
       ``(1) Notice of issuance of voucher and approval of 
     products under voucher.--The Secretary shall publish a notice 
     in the Federal Register and on the Internet Web site of the 
     Food and Drug Administration not later than 30 days after the 
     occurrence of each of the following:
       ``(A) The Secretary issues a priority review voucher under 
     this section.
       ``(B) The Secretary approves a drug pursuant to an 
     application submitted under section 505(b) of this Act or 
     section 351(a) of the Public Health Service Act for which the 
     sponsor of the application used a priority review voucher 
     under this section.
       ``(2) Notification.--If, after the last day of the 1-year 
     period that begins on the date that the Secretary awards the 
     third rare pediatric disease priority voucher under this 
     section, a sponsor of an application submitted under section 
     505(b) of this Act or section 351(a) of the Public Health 
     Service Act for a drug uses a priority review voucher under 
     this section for such application, the Secretary shall submit 
     to the Committee on Energy and Commerce of the House of 
     Representatives and the Committee on Health, Education, 
     Labor, and Pensions of the Senate a document--
       ``(A) notifying such Committees of the use of such voucher; 
     and
       ``(B) identifying the drug for which such priority review 
     voucher is used.
       ``(g) Eligibility for Other Programs.--Nothing in this 
     section precludes a sponsor who seeks a priority review 
     voucher under this section from participating in any other 
     incentive program, including under this Act.
       ``(h) Relation to Other Provisions.--The provisions of this 
     section shall supplement, not supplant, any other provisions 
     of this Act or the Public Health Service Act that encourage 
     the development of drugs for tropical diseases and rare 
     pediatric diseases.
       ``(i) GAO Study and Report.--
       ``(1) Study.--
       ``(A) In general.--Beginning on the date that the Secretary 
     awards the third rare pediatric

[[Page 9505]]

     disease priority voucher under this section, the Comptroller 
     General of the United States shall conduct a study of the 
     effectiveness of awarding rare pediatric disease priority 
     vouchers under this section in the development of human drug 
     products that treat or prevent such diseases.
       ``(B) Contents of study.--In conducting the study under 
     subparagraph (A), the Comptroller General shall examine the 
     following:
       ``(i) The indications for which each rare disease product 
     for which a priority review voucher was awarded was approved 
     under section 505 or section 351 of the Public Health Service 
     Act.
       ``(ii) Whether, and to what extent, an unmet need related 
     to the treatment or prevention of a rare pediatric disease 
     was met through the approval of such a rare disease product.
       ``(iii) The value of the priority review voucher if 
     transferred.
       ``(iv) Identification of each drug for which a priority 
     review voucher was used.
       ``(v) The length of the period of time between the date on 
     which a priority review voucher was awarded and the date on 
     which it was used.
       ``(2) Report.--Not later than 1 year after the date under 
     paragraph (1)(A), the Comptroller General shall submit to the 
     Committee on Energy and Commerce of the House of 
     Representatives and the Committee on Health, Education, 
     Labor, and Pensions of the Senate, a report containing the 
     results of the study under paragraph (1).''.

                        TITLE X--DRUG SHORTAGES

     SEC. 1001. DISCONTINUANCE OR INTERRUPTION IN THE PRODUCTION 
                   OF LIFE-SAVING DRUGS.

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

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

       ``(a) In General.--A manufacturer of a drug--
       ``(1) that is--
       ``(A) life-supporting;
       ``(B) life-sustaining; or
       ``(C) intended for use in the prevention or treatment of a 
     debilitating disease or condition, including any such drug 
     used in emergency medical care or during surgery; and
       ``(2) that is not a radio pharmaceutical drug product or 
     any other product as designated by the Secretary,

     shall notify the Secretary, in accordance with subsection 
     (b), of a permanent discontinuance in the manufacture of the 
     drug or an interruption of the manufacture of the drug that 
     is likely to lead to a meaningful disruption in the supply of 
     that drug in the United States, and the reasons for such 
     discontinuance or interruption.
       ``(b) Timing.--A notice required under subsection (a) shall 
     be submitted to the Secretary--
       ``(1) at least 6 months prior to the date of the 
     discontinuance or interruption; or
       ``(2) if compliance with paragraph (1) is not possible, as 
     soon as practicable.
       ``(c) Distribution.--To the maximum extent practicable, the 
     Secretary shall distribute, through such means as the 
     Secretary deems appropriate, information on the 
     discontinuation or interruption of the manufacture of the 
     drugs described in subsection (a) to appropriate 
     organizations, including physician, health provider, and 
     patient organizations, as described in section 506E.
       ``(d) Confidentiality.--Nothing in this section shall be 
     construed as authorizing the Secretary to disclose any 
     information that is a trade secret or confidential 
     information subject to section 552(b)(4) of title 5, United 
     States Code, or section 1905 of title 18, United States Code.
       ``(e) Coordination With Attorney General.--Not later than 
     30 days after the receipt of a notification described in 
     subsection (a), the Secretary shall--
       ``(1) determine whether the notification pertains to a 
     controlled substance subject to a production quota under 
     section 306 of the Controlled Substances Act; and
       ``(2) if necessary, as determined by the Secretary--
       ``(A) notify the Attorney General that the Secretary has 
     received such a notification;
       ``(B) request that the Attorney General increase the 
     aggregate and individual production quotas under section 306 
     of the Controlled Substances Act applicable to such 
     controlled substance and any ingredient therein to a level 
     the Secretary deems necessary to address a shortage of a 
     controlled substance based on the best available market data; 
     and
       ``(C) if the Attorney General determines that the level 
     requested is not necessary to address a shortage of a 
     controlled substance, the Attorney General shall provide to 
     the Secretary a written response detailing the basis for the 
     Attorney General's determination.

     The Secretary shall make the written response provided under 
     subparagraph (C) available to the public on the Internet Web 
     site of the Food and Drug Administration.
       ``(f) Failure To Meet Requirements.--If a person fails to 
     submit information required under subsection (a) in 
     accordance with subsection (b)--
       ``(1) the Secretary shall issue a letter to such person 
     informing such person of such failure;
       ``(2) not later than 30 calendar days after the issuance of 
     a letter under paragraph (1), the person who receives such 
     letter shall submit to the Secretary a written response to 
     such letter setting forth the basis for noncompliance and 
     providing information required under subsection (a); and
       ``(3) not later than 45 calendar days after the issuance of 
     a letter under paragraph (1), the Secretary shall make such 
     letter and any response to such letter under paragraph (2) 
     available to the public on the Internet Web site of the Food 
     and Drug Administration, with appropriate redactions made to 
     protect information described in subsection (d), except that, 
     if the Secretary determines that the letter under paragraph 
     (1) was issued in error or, after review of such response, 
     the person had a reasonable basis for not notifying as 
     required under subsection (a), the requirements of this 
     paragraph shall not apply.
       ``(g) Expedited Inspections and Reviews.--If, based on 
     notifications described in subsection (a) or any other 
     relevant information, the Secretary concludes that there is, 
     or is likely to be, a drug shortage of a drug described in 
     subsection (a), the Secretary may--
       ``(1) expedite the review of a supplement to a new drug 
     application submitted under section 505(b), an abbreviated 
     new drug application submitted under section 505(j), or a 
     supplement to such an application submitted under section 
     505(j) that could help mitigate or prevent such shortage; or
       ``(2) expedite an inspection or reinspection of an 
     establishment that could help mitigate or prevent such drug 
     shortage.
       ``(h) Definitions.--For purposes of this section--
       ``(1) the term `drug'--
       ``(A) means a drug (as defined in section 201(g)) that is 
     intended for human use and that is subject to section 
     503(b)(1); and
       ``(B) does not include biological products (as defined in 
     section 351 of the Public Health Service Act), unless 
     otherwise provided by the Secretary in the regulations 
     promulgated under subsection (i);
       ``(2) the term `drug shortage' or `shortage', with respect 
     to a drug, means a period of time when the demand or 
     projected demand for the drug within the United States 
     exceeds the supply of the drug; and
       ``(3) the term `meaningful disruption'--
       ``(A) means a change in production that is reasonably 
     likely to lead to a reduction in the supply of a drug by a 
     manufacturer that is more than negligible and affects the 
     ability of the manufacturer to fill orders or meet expected 
     demand for its product; and
       ``(B) does not include interruptions in manufacturing due 
     to matters such as routine maintenance or insignificant 
     changes in manufacturing so long as the manufacturer expects 
     to resume operations in a short period of time.
       ``(i) Regulations.--
       ``(1) In general.--Not later than 18 months after the date 
     of enactment of the Food and Drug Administration Safety and 
     Innovation Act, the Secretary shall adopt a final regulation 
     implementing this section.
       ``(2) Contents.--Such regulation shall define, for purposes 
     of this section, the terms `life-supporting', `life-
     sustaining', and `intended for use in the prevention or 
     treatment of a debilitating disease or condition'.
       ``(3) Inclusion of biological products.--
       ``(A) In general.--The Secretary may by regulation apply 
     this section to biological products (as defined in section 
     351 of the Public Health Service Act), including plasma 
     products derived from human plasma protein and their 
     recombinant analogs, if the Secretary determines such 
     inclusion would benefit the public health. Such regulation 
     shall take into account any supply reporting programs and 
     shall aim to reduce duplicative notification.
       ``(B) Rule for vaccines.--If the Secretary applies this 
     section to vaccines pursuant to subparagraph (A), the 
     Secretary shall--
       ``(i) consider whether the notification requirement under 
     subsection (a) may be satisfied by submitting a notification 
     to the Centers for Disease Control and Prevention under the 
     vaccine shortage notification program of such Centers; and
       ``(ii) explain the determination made by the Secretary 
     under clause (i) in the regulation.
       ``(4) Procedure.--In promulgating a regulation implementing 
     this section, the Secretary shall--
       ``(A) issue a notice of proposed rulemaking that includes 
     the proposed regulation;
       ``(B) provide a period of not less than 60 days for 
     comments on the proposed regulation; and
       ``(C) publish the final regulation not less than 30 days 
     before the regulation's effective date.
       ``(5) Restrictions.--Notwithstanding any other provision of 
     Federal law, in implementing this section, the Secretary 
     shall only promulgate regulations as described in paragraph 
     (4).''.
       (b) Effect of Notification.--The submission of a 
     notification to the Secretary of Health and Human Services 
     (referred to in this title as the ``Secretary'') for purposes 
     of complying with the requirement in section 506C(a) of the 
     Federal Food, Drug, and Cosmetic Act (as amended by 
     subsection (a)) shall not be construed--
       (1) as an admission that any product that is the subject of 
     such notification violates any provision of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); or
       (2) as evidence of an intention to promote or market the 
     product for an indication or use for which the product has 
     not been approved by the Secretary.

     SEC. 1002. ANNUAL REPORTING ON DRUG SHORTAGES.

       Chapter V (21 U.S.C. 351 et seq.) is amended by inserting 
     after section 506C, as amended by section 1001 of this Act, 
     the following:

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

       ``(a) Annual Reports to Congress.--Not later than the end 
     of calendar year 2013, and not later than the end of each 
     calendar year thereafter, the Secretary shall submit to the

[[Page 9506]]

     Committee on Energy and Commerce of the House of 
     Representatives and the Committee on Health, Education, 
     Labor, and Pensions of the Senate a report on drug shortages 
     that--
       ``(1) specifies the number of manufacturers that submitted 
     a notification to the Secretary under section 506C(a) during 
     such calendar year;
       ``(2) describes the communication between the field 
     investigators of the Food and Drug Administration and the 
     staff of the Center for Drug Evaluation and Research's Office 
     of Compliance and Drug Shortage Program, including the Food 
     and Drug Administration's procedures for enabling and 
     ensuring such communication;
       ``(3)(A) lists the major actions taken by the Secretary to 
     prevent or mitigate the drug shortages described in paragraph 
     (7);
       ``(B) in the list under subparagraph (A), includes--
       ``(i) the number of applications and supplements for which 
     the Secretary expedited review under section 506C(g)(1) 
     during such calendar year; and
       ``(ii) the number of establishment inspections or 
     reinspections that the Secretary expedited under section 
     506C(g)(2) during such calendar year;
       ``(4) describes the coordination between the Food and Drug 
     Administration and the Drug Enforcement Administration on 
     efforts to prevent or alleviate drug shortages;
       ``(5) identifies the number of and describes the instances 
     in which the Food and Drug Administration exercised 
     regulatory flexibility and discretion to prevent or alleviate 
     a drug shortage;
       ``(6) lists the names of manufacturers that were issued 
     letters under section 506C(f); and
       ``(7) specifies the number of drug shortages occurring 
     during such calendar year, as identified by the Secretary.
       ``(b) Trend Analysis.--The Secretary is authorized to 
     retain a third party to conduct a study, if the Secretary 
     believes such a study would help clarify the causes, trends, 
     or solutions related to drug shortages.
       ``(c) Definition.--In this section, the term `drug 
     shortage' or `shortage' has the meaning given such term in 
     section 506C.''.

     SEC. 1003. COORDINATION; TASK FORCE AND STRATEGIC PLAN.

       Chapter V (21 U.S.C. 351 et seq.) is amended by inserting 
     after section 506C-1, as added by section 1002 of this Act, 
     the following:

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

       ``(a) Task Force and Strategic Plan.--
       ``(1) In general.--
       ``(A) Task force.--As soon as practicable after the date of 
     enactment of the Food and Drug Administration Safety and 
     Innovation Act, the Secretary shall establish a task force to 
     develop and implement a strategic plan for enhancing the 
     Secretary's response to preventing and mitigating drug 
     shortages.
       ``(B) Strategic plan.--The strategic plan described in 
     subparagraph (A) shall include--
       ``(i) plans for enhanced interagency and intra-agency 
     coordination, communication, and decisionmaking;
       ``(ii) plans for ensuring that drug shortages are 
     considered when the Secretary initiates a regulatory action 
     that could precipitate a drug shortage or exacerbate an 
     existing drug shortage;
       ``(iii) plans for effective communication with outside 
     stakeholders, including who the Secretary should alert about 
     potential or actual drug shortages, how the communication 
     should occur, and what types of information should be shared;
       ``(iv) plans for considering the impact of drug shortages 
     on research and clinical trials; and
       ``(v) an examination of whether to establish a `qualified 
     manufacturing partner program', as described in subparagraph 
     (C).
       ``(C) Description of program.--In conducting the 
     examination of a `qualified manufacturing partner program' 
     under subparagraph (B)(v), the Secretary--
       ``(i) shall take into account that--

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

       ``(ii) shall examine whether incentives are necessary to 
     encourage the participation of `qualified manufacturers' in 
     such a program.
       ``(D) Consultation.--In carrying out this paragraph, the 
     task force shall ensure consultation with the appropriate 
     offices within the Food and Drug Administration, including 
     the Office of the Commissioner, the Center for Drug 
     Evaluation and Research, the Office of Regulatory Affairs, 
     and employees within the Department of Health and Human 
     Services with expertise regarding drug shortages. The 
     Secretary shall engage external stakeholders and experts as 
     appropriate.
       ``(2) Timing.--Not later than 1 year after the date of 
     enactment of the Food and Drug Administration Safety and 
     Innovation Act, the task force shall--
       ``(A) publish the strategic plan described in paragraph 
     (1); and
       ``(B) submit such plan to Congress.
       ``(b) Communication.--The Secretary shall ensure that, 
     prior to any enforcement action or issuance of a warning 
     letter that the Secretary determines could reasonably be 
     anticipated to lead to a meaningful disruption in the supply 
     in the United States of a drug described under section 
     506C(a), there is communication with the appropriate office 
     of the Food and Drug Administration with expertise regarding 
     drug shortages regarding whether the action or letter could 
     cause, or exacerbate, a shortage of the drug.
       ``(c) Action.--If the Secretary determines, after the 
     communication described in subsection (b), that an 
     enforcement action or a warning letter could reasonably cause 
     or exacerbate a shortage of a drug described under section 
     506C(a), then the Secretary shall evaluate the risks 
     associated with the impact of such shortage upon patients and 
     those risks associated with the violation involved before 
     taking such action or issuing such letter, unless there is 
     imminent risk of serious adverse health consequences or death 
     to humans.
       ``(d) Reporting by Other Entities.--The Secretary shall 
     identify or establish a mechanism by which health care 
     providers and other third-party organizations may report to 
     the Secretary evidence of a drug shortage.
       ``(e) Review and Construction.--No determination, finding, 
     action, or omission of the Secretary under this section 
     shall--
       ``(1) be subject to judicial review; or
       ``(2) be construed to establish a defense to an enforcement 
     action by the Secretary.
       ``(f) Sunset.--Subsections (a), (b), (c), and (e) shall 
     cease to be effective on the date that is 5 years after the 
     date of enactment of the Food and Drug Administration Safety 
     and Innovation Act.''.

     SEC. 1004. DRUG SHORTAGE LIST.

       Chapter V (21 U.S.C. 351 et seq.) is amended by inserting 
     after section 506D, as added by section 1003 of this Act, the 
     following:

     ``SEC. 506E. DRUG SHORTAGE LIST.

       ``(a) Establishment.--The Secretary shall maintain an up-
     to-date list of drugs that are determined by the Secretary to 
     be in shortage in the United States.
       ``(b) Contents.--For each drug on such list, the Secretary 
     shall include the following information:
       ``(1) The name of the drug in shortage, including the 
     National Drug Code number for such drug.
       ``(2) The name of each manufacturer of such drug.
       ``(3) The reason for the shortage, as determined by the 
     Secretary, selecting from the following categories:
       ``(A) Requirements related to complying with good 
     manufacturing practices.
       ``(B) Regulatory delay.
       ``(C) Shortage of an active ingredient.
       ``(D) Shortage of an inactive ingredient component.
       ``(E) Discontinuation of the manufacture of the drug.
       ``(F) Delay in shipping of the drug.
       ``(G) Demand increase for the drug.
       ``(4) The estimated duration of the shortage as determined 
     by the Secretary.
       ``(c) Public Availability.--
       ``(1) In general.--Subject to paragraphs (2) and (3), the 
     Secretary shall make the information in such list publicly 
     available.
       ``(2) Trade secrets and confidential information.--Nothing 
     in this section alters or amends section 1905 of title 18, 
     United States Code, or section 552(b)(4) of title 5 of such 
     Code.
       ``(3) Public health exception.--The Secretary may choose 
     not to make information collected under this section publicly 
     available under paragraph (1) or section 506C(c) if the 
     Secretary determines that disclosure of such information 
     would adversely affect the public health (such as by 
     increasing the possibility of hoarding or other disruption of 
     the availability of drug products to patients).''.

     SEC. 1005. QUOTAS APPLICABLE TO DRUGS IN SHORTAGE.

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

     SEC. 1006. ATTORNEY GENERAL REPORT ON DRUG SHORTAGES.

       Not later than 6 months after the date of the enactment of 
     this Act, and annually thereafter, the Attorney General shall 
     submit to the Committee on Energy and Commerce of the House 
     of Representatives and the Committee on the Judiciary of the 
     Senate a report on drug shortages that--

[[Page 9507]]

       (1) identifies the number of requests received under 
     section 306(h) of the Controlled Substances Act (as added by 
     section 1005 of this Act), the average review time for such 
     requests, the number of requests granted and denied under 
     such section, and, for each of the requests denied under such 
     section, the basis for such denial;
       (2) describes the coordination between the Drug Enforcement 
     Administration and Food and Drug Administration on efforts to 
     prevent or alleviate drug shortages; and
       (3) identifies drugs containing a controlled substance 
     subject to section 306 of the Controlled Substances Act when 
     such a drug is determined by the Secretary to be in shortage.

     SEC. 1007. HOSPITAL REPACKAGING OF DRUGS IN SHORTAGE.

       Chapter V (21 U.S.C. 351 et seq.) is amended by inserting 
     after section 506E, as added by section 1004 of this Act, the 
     following:

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

       ``(a) Definitions.--In this section:
       ``(1) Drug.--The term `drug' excludes any controlled 
     substance (as such term is defined in section 102 of the 
     Controlled Substances Act).
       ``(2) Health system.--The term `health system' means a 
     collection of hospitals that are owned and operated by the 
     same entity and that share access to databases with drug 
     order information for their patients.
       ``(3) Repackage.--For the purposes of this section only, 
     the term `repackage', with respect to a drug, means to divide 
     the volume of a drug into smaller amounts in order to--
       ``(A) extend the supply of a drug in response to the 
     placement of the drug on a drug shortage list under section 
     506E; and
       ``(B) facilitate access to the drug by hospitals within the 
     same health system.
       ``(b) Exclusion From Registration.--Notwithstanding any 
     other provision of this Act, a hospital shall not be 
     considered an establishment for which registration is 
     required under section 510 solely because it repackages a 
     drug and transfers it to another hospital within the same 
     health system in accordance with the conditions in subsection 
     (c)--
       ``(1) during any period in which the drug is listed on the 
     drug shortage list under section 506E; or
       ``(2) during the 60-day period following any period 
     described in paragraph (1).
       ``(c) Conditions.--Subsection (b) shall only apply to a 
     hospital, with respect to the repackaging of a drug for 
     transfer to another hospital within the same health system, 
     if the following conditions are met:
       ``(1) Drug for intrasystem use only.--In no case may a drug 
     that has been repackaged in accordance with this section be 
     sold or otherwise distributed by the health system or a 
     hospital within the system to an entity or individual that is 
     not a hospital within such health system.
       ``(2) Compliance with state rules.--Repackaging of a drug 
     under this section shall be done in compliance with 
     applicable State requirements of each State in which the drug 
     is repackaged and received.
       ``(d) Termination.--This section shall not apply on or 
     after the date on which the Secretary issues final guidance 
     that clarifies the policy of the Food and Drug Administration 
     regarding hospital pharmacies repackaging and safely 
     transferring repackaged drugs to other hospitals within the 
     same health system during a drug shortage.''.

     SEC. 1008. STUDY ON DRUG SHORTAGES.

       (a) Study.--The Comptroller General of the United States 
     shall conduct a study to examine the cause of drug shortages 
     and formulate recommendations on how to prevent or alleviate 
     such shortages.
       (b) Consideration.--In conducting the study under this 
     section, the Comptroller General shall consider the following 
     questions:
       (1) What are the dominant characteristics of drugs that 
     have gone into a drug shortage over the preceding 3 years?
       (2) Are there systemic high-risk factors (such as drug 
     pricing structure, including Federal reimbursements, or the 
     number of manufacturers producing a drug product) that have 
     led to the concentration of drug shortages in certain drug 
     products that have made such products vulnerable to drug 
     shortages?
       (3) Is there a reason why drug shortages have occurred 
     primarily in the sterile injectable market and in certain 
     therapeutic areas?
       (4)(A) How have regulations, guidance documents, regulatory 
     practices, policies, and other actions of Federal departments 
     and agencies (including the effectiveness of interagency and 
     intra-agency coordination, communication, strategic planning, 
     and decisionmaking), including those used to enforce 
     statutory requirements, affected drug shortages?
       (B) Do any such regulations, guidances, policies, or 
     practices cause, exacerbate, prevent, or mitigate drug 
     shortages?
       (C) How can regulations, guidances, policies, or practices 
     be modified, streamlined, expanded, or discontinued in order 
     to reduce or prevent such drug shortages?
       (D) What effect would the changes described in subparagraph 
     (C) have on the public health?
       (5) How does hoarding affect drug shortages?
       (6) How would incentives alleviate or prevent drug 
     shortages?
       (7) To what extent are health care providers, including 
     hospitals and physicians responding to drug shortages, able 
     to adjust care effectively to compensate for such shortages, 
     and what impediments exist that hinder provider ability to 
     adjust to such shortages?
       (8)(A) Have drug shortages led market participants to 
     stockpile affected drugs or sell such drugs at inflated 
     prices?
       (B) What has been the impact of any such activities 
     described in subparagraph (A) on Federal revenue, and are 
     there any economic factors that have exacerbated or created a 
     market for such activities?
       (C) Is there a need for any additional reporting or 
     enforcement actions to address such activities?
       (9)(A) How have the activities under section 506D of the 
     Federal Food, Drug, and Cosmetic Act (as added by section 
     1003 of this Act) improved the efforts of the Food and Drug 
     Administration to mitigate and prevent drug shortages?
       (B) Is there a need to continue the task force and 
     strategic plan under such section 506D, or are there any 
     other recommendations to increase communication and 
     coordination inside the Food and Drug Administration, between 
     the Food and Drug Administration and other agencies, and 
     between the Food and Drug Administration and stakeholders?
       (c) Consultation With Stakeholders.--In conducting the 
     study under this section, the Comptroller General shall 
     consult with relevant stakeholders, including physicians, 
     pharmacists, hospitals, patients, drug manufacturers, and 
     other health providers.
       (d) Report.--Not later than 18 months after the date of the 
     enactment of this Act, the Comptroller General shall submit a 
     report to the Committee on Energy and Commerce of the House 
     of Representatives and the Committee on Health, Education, 
     Labor, and Pensions of the Senate on the results of the study 
     under this section.

                       TITLE XI--OTHER PROVISIONS

                      Subtitle A--Reauthorizations

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

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

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

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

               Subtitle B--Medical Gas Product Regulation

     SEC. 1111. REGULATION OF MEDICAL GASES.

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

                     ``Subchapter G--Medical Gases

     ``SEC. 575. DEFINITIONS.

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

     ``SEC. 576. REGULATION OF MEDICAL GASES.

       ``(a) Certification of Designated Medical Gases.--
       ``(1) Submission.--Beginning 180 days after the date of 
     enactment of this section, any person may file with the 
     Secretary a request for certification of a medical gas as a 
     designated medical gas. Any such request shall contain the 
     following information:
       ``(A) A description of the medical gas.
       ``(B) The name and address of the sponsor.
       ``(C) The name and address of the facility or facilities 
     where the medical gas is or will be manufactured.
       ``(D) Any other information deemed appropriate by the 
     Secretary to determine whether the medical gas is a 
     designated medical gas.
       ``(2) Grant of certification.--The certification requested 
     under paragraph (1) is deemed to be granted unless, within 60 
     days of the filing of such request, the Secretary finds 
     that--
       ``(A) the medical gas subject to the certification is not a 
     designated medical gas;

[[Page 9508]]

       ``(B) the request does not contain the information required 
     under paragraph (1) or otherwise lacks sufficient information 
     to permit the Secretary to determine that the medical gas is 
     a designated medical gas; or
       ``(C) denying the request is necessary to protect the 
     public health.
       ``(3) Effect of certification.--
       ``(A) In general.--
       ``(i) Approved uses.--A designated medical gas for which a 
     certification is granted under paragraph (2) is deemed, alone 
     or in combination, as medically appropriate, with another 
     designated medical gas or gases for which a certification or 
     certifications have been granted, to have in effect an 
     approved application under section 505 or 512, subject to all 
     applicable postapproval requirements, for the following 
     indications for use:

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

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

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

       ``(B) Inapplicability of exclusivity provisions.--
       ``(i) No exclusivity for a certified medical gas.--No 
     designated medical gas deemed under subparagraph (A)(i) to 
     have in effect an approved application is eligible for any 
     period of exclusivity under section 505(c), 505(j), or 527, 
     or the extension of any such period under section 505A, on 
     the basis of such deemed approval.
       ``(ii) Effect on certification.--No period of exclusivity 
     under section 505(c), 505(j), or section 527, or the 
     extension of any such period under section 505A, with respect 
     to an application for a drug product shall prohibit, limit, 
     or otherwise affect the submission, grant, or effect of a 
     certification under this section, except as provided in 
     subsection (a)(3)(A)(i)(VIII) and section 575(1)(H).
       ``(4) Withdrawal, suspension, or revocation of approval.--
       ``(A) Withdrawal, suspension of approval.--Nothing in this 
     subchapter limits the Secretary's authority to withdraw or 
     suspend approval of a drug product, including a designated 
     medical gas deemed under this section to have in effect an 
     approved application under section 505 or section 512 of this 
     Act.
       ``(B) Revocation of certification.--The Secretary may 
     revoke the grant of a certification under paragraph (2) if 
     the Secretary determines that the request for certification 
     contains any material omission or falsification.
       ``(b) Prescription Requirement.--
       ``(1) In general.--A designated medical gas shall be 
     subject to the requirements of section 503(b)(1) unless the 
     Secretary exercises the authority provided in section 
     503(b)(3) to remove such medical gas from the requirements of 
     section 503(b)(1), the gas is approved for use without a 
     prescription pursuant to an application under section 505 or 
     512, or the use in question is authorized pursuant to another 
     provision of this Act relating to use of medical products in 
     emergencies.
       ``(2) Oxygen.--
       ``(A) No prescription required for certain uses.--
     Notwithstanding paragraph (1), oxygen may be provided without 
     a prescription for the following uses:
       ``(i) For use in the event of depressurization or other 
     environmental oxygen deficiency.
       ``(ii) For oxygen deficiency or for use in emergency 
     resuscitation, when administered by properly trained 
     personnel.
       ``(B) Labeling.--For oxygen provided pursuant to 
     subparagraph (A), the requirements of section 503(b)(4) shall 
     be deemed to have been met if its labeling bears a warning 
     that the oxygen can be used for emergency use only and for 
     all other medical applications a prescription is required.

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

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

     SEC. 1112. CHANGES TO REGULATIONS.

       (a) Report.--Not later than 18 months after the date of the 
     enactment of this Act, the Secretary, after obtaining input 
     from medical gas manufacturers and any other interested 
     members of the public, shall--
       (1) determine whether any changes to the Federal drug 
     regulations are necessary for medical gases; and
       (2) submit to the Committee on Health, Education, Labor, 
     and Pensions of the Senate and the Committee on Energy and 
     Commerce of the House of Representatives a report regarding 
     any such changes.
       (b) Regulations.--If the Secretary determines under 
     subsection (a) that changes to the Federal drug regulations 
     are necessary for medical gases, the Secretary shall issue 
     final regulations revising the Federal drug regulations with 
     respect to medical gases not later than 48 months after the 
     date of the enactment of this Act.
       (c) Definitions.--In this section:
       (1) The term ``Federal drug regulations'' means regulations 
     in title 21 of the Code of Federal Regulations pertaining to 
     drugs.
       (2) The term ``medical gas'' has the meaning given to such 
     term in section 575 of the Federal Food, Drug, and Cosmetic 
     Act, as added by section 1111 of this Act.
       (3) The term ``Secretary'' means the Secretary of Health 
     and Human Services, acting through the Commissioner of Food 
     and Drugs.

     SEC. 1113. RULES OF CONSTRUCTION.

       Nothing in this subtitle and the amendments made by this 
     subtitle applies with respect to--
       (1) a drug that is approved prior to May 1, 2012, pursuant 
     to an application submitted under section 505 or 512 of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355, 360b);
       (2) any gas listed in subparagraphs (A) through (G) of 
     section 575(1) of the Federal Food, Drug, and Cosmetic Act, 
     as added by section 1111 of this Act, or any combination of 
     any such gases, for an indication that--
       (A) is not included in, or is different from, those 
     specified in subclauses (I) through (VII) of section 
     576(a)(3)(A)(i) of such Act; and
       (B) is approved on or after May 1, 2012, pursuant to an 
     application submitted under section 505 or 512; or
       (3) any designated medical gas added pursuant to 
     subparagraph (H) of section 575(1) of such Act for an 
     indication that--
       (A) is not included in, or is different from, those 
     originally added pursuant to subparagraph (H) of section 
     575(1) and section 576(a)(3)(A)(i)(VIII); and
       (B) is approved on or after May 1, 2012, pursuant to an 
     application submitted under section 505 or 512 of such Act.

                  Subtitle C--Miscellaneous Provisions

     SEC. 1121. GUIDANCE DOCUMENT REGARDING PRODUCT PROMOTION 
                   USING THE INTERNET.

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

     SEC. 1122. COMBATING PRESCRIPTION DRUG ABUSE.

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

     SEC. 1123. OPTIMIZING GLOBAL CLINICAL TRIALS.

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

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

       ``(a) In General.--The Secretary shall--

[[Page 9509]]

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

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

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

     SEC. 1124. ADVANCING REGULATORY SCIENCE TO PROMOTE PUBLIC 
                   HEALTH INNOVATION.

       (a) In General.--Not later than 1 year after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services (referred to in this section as the ``Secretary'') 
     shall develop a strategy and implementation plan for 
     advancing regulatory science for medical products in order to 
     promote the public health and advance innovation in 
     regulatory decisionmaking.
       (b) Requirements.--The strategy and implementation plan 
     developed under subsection (a) shall be consistent with the 
     user fee performance goals in the Prescription Drug User Fee 
     Agreement commitment letter, the Generic Drug User Fee 
     Agreement commitment letter, and the Biosimilar User Fee 
     Agreement commitment letter transmitted by the Secretary to 
     Congress on January 13, 2012, and the Medical Device User Fee 
     Agreement commitment letter transmitted by the Secretary to 
     Congress on April 20, 2012, and shall--
       (1) identify a clear vision of the fundamental role of 
     efficient, consistent, and predictable, science-based 
     decisions throughout regulatory decisionmaking of the Food 
     and Drug Administration with respect to medical products;
       (2) identify the regulatory science priorities of the Food 
     and Drug Administration directly related to fulfilling the 
     mission of the agency with respect to decisionmaking 
     concerning medical products and allocation of resources 
     toward such regulatory science priorities;
       (3) identify regulatory and scientific gaps that impede the 
     timely development and review of, and regulatory certainty 
     with respect to, the approval, licensure, or clearance of 
     medical products, including with respect to companion 
     products and new technologies, and facilitating the timely 
     introduction and adoption of new technologies and 
     methodologies in a safe and effective manner;
       (4) identify clear, measurable metrics by which progress on 
     the priorities identified under paragraph (2) and gaps 
     identified under paragraph (3) will be measured by the Food 
     and Drug Administration, including metrics specific to the 
     integration and adoption of advances in regulatory science 
     described in paragraph (5) and improving medical product 
     decisionmaking, in a predictable and science-based manner; 
     and
       (5) set forth how the Food and Drug Administration will 
     ensure that advances in regulatory science for medical 
     products are adopted, as appropriate, on an ongoing basis and 
     in an manner integrated across centers, divisions, and 
     branches of the Food and Drug Administration, including by 
     senior managers and reviewers, including through the--
       (A) development, updating, and consistent application of 
     guidance documents that support medical product 
     decisionmaking; and
       (B) adoption of the tools, methods, and processes under 
     section 566 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 360bbb-5).
       (c) Performance Reports.--The annual performance reports 
     submitted to Congress under sections 736B(a) (as amended by 
     section 104 of this Act), 738A(a) (as amended by section 204 
     of this Act), 744C(a) (as added by section 303 of this Act), 
     and 744I(a) (as added by section 403 of this Act) of the 
     Federal Food, Drug, and Cosmetic Act for each of fiscal years 
     2014 and 2016, shall include a report from the Secretary on 
     the progress made with respect to--
       (1) advancing the regulatory science priorities identified 
     under paragraph (2) of subsection (b) and resolving the gaps 
     identified under paragraph (3) of such subsection, including 
     reporting on specific metrics identified under paragraph (4) 
     of such subsection;
       (2) the integration and adoption of advances in regulatory 
     science as set forth in paragraph (5) of such subsection; and
       (3) the progress made in advancing the regulatory science 
     goals outlined in the Prescription Drug User Fee Agreement 
     commitment letter, the Generic Drug User Fee Agreement 
     commitment letter, and the Biosimilar User Fee Agreement 
     commitment letter transmitted by the Secretary to Congress on 
     January 13, 2012, and the Medical Device User Fee Agreement 
     transmitted by the Secretary to Congress on April 20, 2012.
       (d) Medical Product.--In this section, the term ``medical 
     product'' means a drug, as defined in subsection (g) of 
     section 201 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 321), a device, as defined in subsection (h) of such 
     section, or a biological product, as defined in section 
     351(i) of the Public Health Service Act.

     SEC. 1125. INFORMATION TECHNOLOGY.

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

     SEC. 1126. NANOTECHNOLOGY.

       (a) In General.--The Secretary of Health and Human Services 
     (referred to in this section as the ``Secretary'') shall 
     intensify and expand activities related to enhancing 
     scientific knowledge regarding nanomaterials included or 
     intended for inclusion in products regulated under the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) 
     or other statutes administered by the Food and Drug 
     Administration, to address issues relevant to the regulation 
     of those products, including the potential toxicology of such 
     nanomaterials, the potential benefit of new therapies derived 
     from nanotechnology, the effects of such nanomaterials on 
     biological systems, and the interaction of such nanomaterials 
     with biological systems.
       (b) Activities.--In conducting activities related to 
     nanotechnology, the Secretary may--
       (1) assess scientific literature and data on general 
     nanomaterials interactions with biological systems and on 
     specific nanomaterials of concern to the Food and Drug 
     Administration;
       (2) in cooperation with other Federal agencies, develop and 
     organize information using databases and models that will 
     facilitate the identification of generalized principles and 
     characteristics regarding the behavior of classes of 
     nanomaterials with biological systems;
       (3) promote Food and Drug Administration programs and 
     participate in collaborative efforts, to further the 
     understanding of the

[[Page 9510]]

     science of novel properties of nanomaterials that might 
     contribute to toxicity;
       (4) promote and participate in collaborative efforts to 
     further the understanding of measurement and detection 
     methods for nanomaterials;
       (5) collect, synthesize, interpret, and disseminate 
     scientific information and data related to the interactions 
     of nanomaterials with biological systems;
       (6) build scientific expertise on nanomaterials within the 
     Food and Drug Administration, including field and laboratory 
     expertise, for monitoring the production and presence of 
     nanomaterials in domestic and imported products regulated 
     under this Act;
       (7) ensure ongoing training, as well as dissemination of 
     new information within the centers of the Food and Drug 
     Administration, and more broadly across the Food and Drug 
     Administration, to ensure timely, informed consideration of 
     the most current science pertaining to nanomaterials;
       (8) encourage the Food and Drug Administration to 
     participate in international and national consensus standards 
     activities pertaining to nanomaterials; and
       (9) carry out other activities that the Secretary 
     determines are necessary and consistent with the purposes 
     described in paragraphs (1) through (8).

     SEC. 1127. ONLINE PHARMACY REPORT TO CONGRESS.

       Not later than 1 year after the date of enactment of this 
     Act, the Comptroller General of the United States shall 
     submit to the Committee on Health, Education, Labor, and 
     Pensions of the Senate and the Committee on Energy and 
     Commerce of the House of Representatives a report that 
     describes any problems posed by pharmacy Internet Web sites 
     that violate Federal or State law, including--
       (1) the methods by which Internet Web sites are used to 
     sell prescription drugs in violation of Federal or State law 
     or established industry standards;
       (2) the harmful health effects that patients experience 
     when they consume prescription drugs purchased through such 
     pharmacy Internet Web sites;
       (3) efforts by the Federal Government and State and local 
     governments to investigate and prosecute the owners or 
     operators of pharmacy Internet Web sites, to address the 
     threats such Web sites pose, and to protect patients;
       (4) the level of success that Federal, State, and local 
     governments have experienced in investigating and prosecuting 
     such cases;
       (5) whether the law, as in effect on the date of the 
     report, provides sufficient authorities to Federal, State, 
     and local governments to investigate and prosecute the owners 
     and operators of pharmacy Internet Web sites that violate 
     Federal or State law or established industry standards;
       (6) additional authorities that could assist Federal, 
     State, and local governments in investigating and prosecuting 
     the owners and operators of pharmacy Internet Web sites that 
     violate Federal or State law or established industry 
     standards;
       (7) laws, policies, and activities that would educate 
     consumers about how to distinguish pharmacy Internet Web 
     sites that comply with Federal and State laws and established 
     industry standards from those pharmacy Internet Web sites 
     that do not comply with such laws and standards; and
       (8) activities that private sector actors are taking to 
     address the prevalence of illegitimate pharmacy Internet Web 
     sites, and any policies to encourage further activities.

     SEC. 1128. REPORT ON SMALL BUSINESSES.

       Not later than 1 year after the date of enactment of this 
     Act, the Commissioner of Food and Drugs shall submit a report 
     to Congress that includes--
       (1) a listing of and staffing levels of all small business 
     offices at the Food and Drug Administration, including the 
     small business liaison program;
       (2) the status of partnership efforts between the Food and 
     Drug Administration and the Small Business Administration;
       (3) a summary of outreach efforts to small businesses and 
     small business associations, including availability of toll-
     free telephone help lines;
       (4) with respect to the program under the Orphan Drug Act 
     (Public Law 97-414), the number of applications made by small 
     businesses and number of applications approved for research 
     grants and the number of companies receiving protocol 
     assistance for the development of drugs for rare diseases and 
     disorders;
       (5) the number of small businesses submitting applications 
     and receiving approval for unsolicited grant applications 
     from the Food and Drug Administration;
       (6) the number of small businesses submitting applications 
     and receiving approval for solicited grant applications from 
     the Food and Drug Administration; and
       (7) barriers small businesses encounter in the drug and 
     medical device approval process.

     SEC. 1129. PROTECTIONS FOR THE COMMISSIONED CORPS OF THE 
                   PUBLIC HEALTH SERVICE ACT.

       (a) In General.--Section 221(a) of the Public Health 
     Service Act (42 U.S.C. 213a(a)) is amended by adding at the 
     end the following:
       ``(18) Section 1034, Protected Communications; Prohibition 
     of Retaliatory Personnel Actions.''.
       (b) Conforming Amendment.--Section 221(b) of the Public 
     Health Service Act (42 U.S.C. 213a(b)) is amended by adding 
     at the end the following: ``For purposes of paragraph (18) of 
     subsection (a), the term `Inspector General' in section 1034 
     of such title 10 shall mean the Inspector General of the 
     Department of Health and Human Services.''.

     SEC. 1130. COMPLIANCE DATE FOR RULE RELATING TO SUNSCREEN 
                   DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE.

       In accordance with the final rule issued by the 
     Commissioner of Food and Drug entitled ``Labeling and 
     Effectiveness Testing; Sunscreen Drug Products for Over-the-
     Counter Human Use; Delay of Compliance Dates'' (77 Fed. Reg. 
     27591 (May 11, 2012)), a product subject to the final rule 
     issued by the Commissioner entitled ``Labeling and 
     Effectiveness Testing; Sunscreen Drug Products for Over-the-
     Counter Human Use'' (76 Fed. Reg. 35620 (June 17, 2011)), 
     shall comply with such rule not later than--
       (1) December 17, 2013, for products subject to such rule 
     with annual sales of less than $25,000 and
       (2) December 17, 2012, for all other products subject to 
     such rule.

     SEC. 1131. STRATEGIC INTEGRATED MANAGEMENT PLAN.

       Not later than 1 year after the date of enactment of this 
     Act, the Secretary of Health and Human Services shall submit 
     to Congress a strategic integrated management plan for the 
     Center for Drug Evaluation and Research, the Center for 
     Biologics Evaluation and Research, and the Center for Devices 
     and Radiological Health. Such strategic management plan 
     shall--
       (1) identify strategic institutional goals, priorities, and 
     mechanisms to improve efficiency, for the Center for Drug 
     Evaluation and Research, the Center for Biologics Evaluation 
     and Research, and the Center for Devices and Radiological 
     Health;
       (2) describe the actions the Secretary will take to 
     recruit, retain, train, and continue to develop the workforce 
     at the Center for Drug Evaluation and Research, the Center 
     for Biologics Evaluation and Research, and the Center for 
     Devices and Radiological Health to fulfill the public health 
     mission of the Food and Drug Administration; and
       (3) identify results-oriented, outcome-based measures that 
     the Secretary will use to measure the progress of achieving 
     the strategic goals, priorities, and mechanisms identified 
     under paragraph (1) and the effectiveness of the actions 
     identified under paragraph (2), including metrics to ensure 
     that managers and reviewers of the Center for Drug Evaluation 
     and Research, the Center for Biologics Evaluation and 
     Research, and the Center for Devices and Radiological Health 
     are familiar with and appropriately and consistently apply 
     the requirements under the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 301 et seq.), including new requirements under 
     parts 2, 3, 7, and 8 of subchapter C of title VII of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379f et 
     seq.).

     SEC. 1132. ASSESSMENT AND MODIFICATION OF REMS.

       (a) Assessment and Modification of Approved Strategy.--
     Section 505-1(g) (21 U.S.C. 355-1(g)) is amended--
       (1) in paragraph (1), by striking ``, and propose a 
     modification to,'';
       (2) in paragraph (2)--
       (A) in the matter before subparagraph (A)--
       (i) by striking ``, subject to paragraph (5),''; and
       (ii) by striking ``, and may propose a modification to,'';
       (B) in subparagraph (C), by striking ``new safety or 
     effectiveness information indicates that'' and all that 
     follows and inserting the following: ``an assessment is 
     needed to evaluate whether the approved strategy should be 
     modified to--
       ``(i) ensure the benefits of the drug outweigh the risks of 
     the drug; or
       ``(ii) minimize the burden on the health care delivery 
     system of complying with the strategy.''; and
       (C) by striking subparagraph (D);
       (3) in paragraph (3), by striking ``for a drug shall 
     include--'' and all that follows and inserting the following 
     ``for a drug shall include, with respect to each goal 
     included in the strategy, an assessment of the extent to 
     which the approved strategy, including each element of the 
     strategy, is meeting the goal or whether 1 or more such goals 
     or such elements should be modified.''; and
       (4) by amending paragraph (4) to read as follows:
       ``(4) Modification.--
       ``(A) On initiative of responsible person.--After the 
     approval of a risk evaluation and mitigation strategy by the 
     Secretary, the responsible person may, at any time, submit to 
     the Secretary a proposal to modify the approved strategy. 
     Such proposal may propose the addition, modification, or 
     removal of any goal or element of the approved strategy and 
     shall include an adequate rationale to support such proposed 
     addition, modification, or removal of any goal or element of 
     the strategy.
       ``(B) On initiative of secretary.--After the approval of a 
     risk evaluation and mitigation strategy by the Secretary, the 
     Secretary may, at any time, require a responsible person to 
     submit a proposed modification to the strategy within 120 
     days or within such reasonable time as the Secretary 
     specifies, if the Secretary, in consultation with the offices 
     described in subsection (c)(2), determines that 1 or more 
     goals or elements should be added, modified, or removed from 
     the approved strategy to--
       ``(i) ensure the benefits of the drug outweigh the risks of 
     the drug; or

[[Page 9511]]

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

     SEC. 1133. EXTENSION OF PERIOD FOR FIRST APPLICANT TO OBTAIN 
                   TENTATIVE APPROVAL WITHOUT FORFEITING 180-DAY-
                   EXCLUSIVITY PERIOD.

       (a) Extension.--
       (1) In general.--If a first applicant files an application 
     during the 30-month period ending on the date of enactment of 
     this Act and such application initially contains a 
     certification described in paragraph (2)(A)(vii)(IV) of 
     section 505(j) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355(j)), or if a first applicant files an 
     application and the application is amended during such period 
     to first contain such a certification, the phrase ``30 
     months'' in paragraph (5)(D)(i)(IV) of such section shall, 
     with respect to such application, be read as meaning--
       (A) during the period beginning on the date of enactment of 
     this Act, and ending on September 30, 2015, ``40 months''; 
     and
       (B) during the period beginning on October 1, 2015, and 
     ending on September 30, 2016, ``36 months''.
       (2) Conforming amendment.--In the case of an application to 
     which an extended period under paragraph (1) applies, the 
     reference to the 30-month period under section 505(q)(1)(G) 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     355(q)(1)(G)) shall be read to be the applicable period under 
     paragraph (1).
       (b) Period for Obtaining Tentative Approval of Certain 
     Applications.--If an application is filed on or before the 
     date of enactment of this Act and such application is amended 
     during the period beginning on the day after the date of 
     enactment of this Act and ending on September 30, 2017, to 
     first contain a certification described in paragraph 
     (2)(A)(vii)(IV) of section 505(j) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 355(j)), the date of the filing 
     of such amendment (rather than the date of the filing of such 
     application) shall be treated as the beginning of the 30-
     month period described in paragraph (5)(D)(i)(IV) of such 
     section 505(j).
       (c) Definitions.--For the purposes of this section, the 
     terms ``application'' and ``first applicant'' mean 
     application and first applicant, as such terms are used in 
     section 505(j)(5)(D)(i)(IV) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355(j)(5)(D)(i)(IV)).

     SEC. 1134. DEADLINE FOR DETERMINATION ON CERTAIN PETITIONS.

       (a) In General.--Section 505 (21 U.S.C. 355) is amended by 
     adding at the end the following:
       ``(w) Deadline for Determination on Certain Petitions.--The 
     Secretary shall issue a final, substantive determination on a 
     petition submitted pursuant to subsection (b) of section 
     314.161 of title 21, Code of Federal Regulations (or any 
     successor regulations), no later than 270 days after the date 
     the petition is submitted.''.
       (b) Application.--The amendment made by subsection (a) 
     shall apply to any petition that is submitted pursuant to 
     subsection (b) of section 314.161 of title 21, Code of 
     Federal Regulations (or any successor regulations), on or 
     after the date of enactment of this Act.

     SEC. 1135. FINAL AGENCY ACTION RELATING TO PETITIONS AND 
                   CIVIL ACTIONS.

       Section 505(q) (21 U.S.C. 355(q)) is amended--
       (1) in paragraph (1)--
       (A) in subparagraph (A), by striking ``subsection (b)(2) or 
     (j)'' and inserting ``subsection (b)(2) or (j) of this 
     section or section 351(k) of the Public Health Service Act''; 
     and
       (B) in subparagraph (F), by striking ``180 days'' and 
     inserting ``150 days'';
       (2) in paragraph (2)(A)--
       (A) in the subparagraph heading, by striking ``180'' and 
     inserting ``150''; and
       (B) in clause (i), by striking ``180-day'' and inserting 
     ``150-day'';
       (3) in paragraph (4)--
       (A) by redesignating subparagraphs (A) and (B) as clauses 
     (i) and (ii), respectively, and moving such clauses, as so 
     redesignated, 2 ems to the right;
       (B) by striking ``This subsection does not apply to--'' and 
     inserting the following:
       ``(A) This subsection does not apply to--''; and
       (C) by adding at the end the following:
       ``(B) Paragraph (2) does not apply to a petition addressing 
     issues concerning an application submitted pursuant to 
     section 351(k) of the Public Health Service Act.''; and
       (4) in paragraph (5), by striking ``subsection (b)(2) or 
     (j)'' inserting ``subsection (b)(2) or (j) of the Act or 
     351(k) of the Public Health Service Act''.

     SEC. 1136. ELECTRONIC SUBMISSION OF APPLICATIONS.

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

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

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

[[Page 9512]]



     SEC. 1137. PATIENT PARTICIPATION IN MEDICAL PRODUCT 
                   DISCUSSIONS.

       Subchapter E of chapter V (21 U.S.C. 360bbb et seq.), as 
     amended by section 1123 of this Act, is further amended by 
     adding at the end the following:

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

       ``(a) In General.--The Secretary shall develop and 
     implement strategies to solicit the views of patients during 
     the medical product development process and consider the 
     perspectives of patients during regulatory discussions, 
     including by--
       ``(1) fostering participation of a patient representative 
     who may serve as a special government employee in appropriate 
     agency meetings with medical product sponsors and 
     investigators; and
       ``(2) exploring means to provide for identification of 
     patient representatives who do not have any, or have minimal, 
     financial interests in the medical products industry.
       ``(b) Protection of Proprietary Information.--Nothing in 
     this section shall be construed to alter the protections 
     offered by laws, regulations, or policies governing 
     disclosure of confidential commercial or trade secret 
     information and any other information exempt from disclosure 
     pursuant to section 552(b) of title 5, United States Code, as 
     such laws, regulations, or policies would apply to 
     consultation with individuals and organizations prior to the 
     date of enactment of this section.
       ``(c) Other Consultation.--Nothing in this section shall be 
     construed to limit the ability of the Secretary to consult 
     with individuals and organizations as authorized prior to the 
     date of enactment of this section.
       ``(d) No Right or Obligation.--Nothing in this section 
     shall be construed to create a legal right for a consultation 
     on any matter or require the Secretary to meet with any 
     particular expert or stakeholder. Nothing in this section 
     shall be construed to alter agreed upon goals and procedures 
     identified in the letters described in section 101(b) of the 
     Prescription Drug User Fee Amendments of 2012. Nothing in 
     this section is intended to increase the number of review 
     cycles as in effect before the date of enactment of this 
     section.
       ``(e) Financial Interest.--In this section, the term 
     `financial interest' means a financial interest under section 
     208(a) of title 18, United States Code.''.

     SEC. 1138. ENSURING ADEQUATE INFORMATION REGARDING 
                   PHARMACEUTICALS FOR ALL POPULATIONS, 
                   PARTICULARLY UNDERREPRESENTED SUBPOPULATIONS, 
                   INCLUDING RACIAL SUBGROUPS.

       (a) Communication Plan.--The Secretary of Health and Human 
     Services (referred to in this section as the ``Secretary''), 
     acting through the Commissioner of Food and Drugs, shall 
     review and modify, as necessary, the Food and Drug 
     Administration's communication plan to inform and educate 
     health care providers and patients on the benefits and risks 
     of medical products, with particular focus on 
     underrepresented subpopulations, including racial subgroups.
       (b) Content.--The communication plan described under 
     subsection (a)--
       (1) shall take into account--
       (A) the goals and principles set forth in the Strategic 
     Action Plan to Reduce Racial and Ethnic Health Disparities 
     issued by the Department of Health and Human Services;
       (B) the nature of the medical product; and
       (C) health and disease information available from other 
     agencies within such Department, as well as any new means of 
     communicating health and safety benefits and risks related to 
     medical products;
       (2) taking into account the nature of the medical product, 
     shall address the best strategy for communicating safety 
     alerts, labeled indications for the medical products, changes 
     to the label or labeling of medical products (including 
     black-box warnings, health advisories, health and safety 
     benefits and risks), particular actions to be taken by health 
     care professionals and patients, any information identifying 
     particular subpopulations, and any other relevant information 
     as determined appropriate to enhance communication, including 
     varied means of electronic communication; and
       (3) shall include a process for implementation of any 
     improvements or other modifications determined to be 
     necessary.
       (c) Issuance and Posting of Communication Plan.--
       (1) Communication plan.--Not later than 1 year after the 
     date of enactment of this Act, the Secretary, acting through 
     the Commissioner of Food and Drugs, shall issue the 
     communication plan described under this section.
       (2) Posting of communication plan on the office of minority 
     health web site.--The Secretary, acting through the 
     Commissioner of Food and Drugs, shall publicly post the 
     communication plan on the Internet Web site of the Office of 
     Minority Health of the Food and Drug Administration, and 
     provide links to any other appropriate Internet Web site, and 
     seek public comment on the communication plan.

     SEC. 1139. SCHEDULING OF HYDROCODONE.

       (a) In General.--Not later than 60 days after the date of 
     enactment of this Act, if practicable, the Secretary of 
     Health and Human Services (referred to in this section as the 
     ``Secretary'') shall hold a public meeting to solicit advice 
     and recommendations to assist in conducting a scientific and 
     medical evaluation in connection with a scheduling 
     recommendation to the Drug Enforcement Administration 
     regarding drug products containing hydrocodone, combined with 
     other analgesics or as an antitussive.
       (b) Stakeholder Input.--In conducting the evaluation under 
     subsection (a), the Secretary shall solicit input from a 
     variety of stakeholders including patients, health care 
     providers, harm prevention experts, the National Institute on 
     Drug Abuse, the Centers for Disease Control and Prevention, 
     and the Drug Enforcement Administration regarding the health 
     benefits and risks, including the potential for abuse and the 
     impact of up-scheduling of these products.
       (c) Transcript.--The transcript of any public meeting 
     conducted pursuant to this section shall be published on the 
     Internet Web site of the Food and Drug Administration.

     SEC. 1140. STUDY ON DRUG LABELING BY ELECTRONIC MEANS.

       (a) Study.--The Comptroller General of the United States 
     shall conduct a study on the benefits and efficiencies of 
     electronic patient labeling of prescription drugs, as a 
     complete or partial substitute for patient labeling in paper 
     form. The study shall address the implementation costs to the 
     different levels of the distribution system, logistical 
     barriers to utilizing a system of electronic patient 
     labeling, and any anticipated public health impact of 
     movement to electronic labeling.
       (b) Report.--Not later than 1 year after the date of 
     enactment of this Act, the Comptroller General shall submit 
     to Congress a report on the results of the study under 
     subsection (a).

     SEC. 1141. RECOMMENDATIONS ON INTEROPERABILITY STANDARDS.

       (a) In General.--The Secretary of Health and Human Services 
     may facilitate, and, as appropriate, may consult with the 
     Attorney General to facilitate, the development of 
     recommendations on interoperability standards to inform and 
     facilitate the exchange of prescription drug information 
     across State lines by States receiving grant funds under--
       (1) the Harold Rogers Prescription Drug Monitoring Program 
     established under the Departments of Commerce, Justice, and 
     State, the Judiciary, and Related Agencies Appropriations 
     Act, 2002 (Public Law 107-77; 115 Stat. 748); and
       (2) the Controlled Substance Monitoring Program established 
     under section 399O of the Public Health Service Act (42 
     U.S.C. 280g-3).
       (b) Requirements.--The Secretary of Health and Human 
     Services shall consider the following in facilitating the 
     development of recommendations on interoperability of 
     prescription drug monitoring programs under subsection (a)--
       (1) open standards that are freely available, without cost 
     and without restriction, in order to promote broad 
     implementation;
       (2) the use of exchange intermediaries, or hubs, as 
     necessary to facilitate interstate interoperability by 
     accommodating State-to-hub, hub-to-hub, and direct State-to-
     State communication;
       (3) the support of transmissions that are fully secured as 
     required, using industry standard methods of encryption, to 
     ensure that protected health information and personally 
     identifiable information are not compromised at any point 
     during such transmission;
       (4) access control methodologies to share protected 
     information solely in accordance with State laws and 
     regulations; and
       (5) consider model interoperability standards developed by 
     the Alliance of States with Prescription Monitoring Programs.
       (c) Report.--
       (1) In general.--Not later than 1 year after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services shall submit to the Committee on Health, Education, 
     Labor, and Pensions of the Senate and the Committee on Energy 
     and Commerce of the House of Representatives a report on 
     enhancing the interoperability of State prescription drug 
     monitoring programs with other technologies and databases 
     used for detecting and reducing fraud, diversion, and abuse 
     of prescription drugs.
       (2) Contents.--The report required under paragraph (1) 
     shall include--
       (A) an assessment of legal, technical, fiscal, privacy, or 
     security challenges that have an impact on interoperability;
       (B) a discussion of how State prescription drug monitoring 
     programs could increase the production and distribution of 
     unsolicited reports to prescribers and dispensers of 
     prescription drugs, law enforcement officials, and health 
     professional licensing agencies, including the enhancement of 
     such reporting through interoperability with other States and 
     relevant technology and databases;
       (C) any recommendations for addressing challenges that 
     impact interoperability of State prescription drug monitoring 
     programs in order to reduce fraud, diversion, and abuse of 
     prescription drugs; and
       (D) an assessment of the extent to which providers use 
     prescription drug management programs in delivering care and 
     preventing prescription drug abuse.

     SEC. 1142. CONFLICTS OF INTEREST.

       (a) In General.--Section 712 (21 U.S.C. 379d-1) is 
     amended--
       (1) by striking subsections (b) and (c) and inserting the 
     following subsections:
       ``(b) Recruitment for Advisory Committees.--
       ``(1) In general.--The Secretary shall--
       ``(A) develop and implement strategies on effective 
     outreach to potential members of advisory committees at 
     universities, colleges, other academic research centers, 
     professional and medical societies, and patient and consumer 
     groups;
       ``(B) seek input from professional medical and scientific 
     societies to determine the most effective informational and 
     recruitment activities;
       ``(C) at least every 180 days, request referrals for 
     potential members of advisory committees from a variety of 
     stakeholders, including--

[[Page 9513]]

       ``(i) product developers, patient groups, and disease 
     advocacy organizations; and
       ``(ii) relevant--

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

       ``(D) in carrying out subparagraphs (A) and (B), take into 
     account the levels of activity (including the numbers of 
     annual meetings) and the numbers of vacancies of the advisory 
     committees.
       ``(2) Recruitment activities.--The recruitment activities 
     under paragraph (1) may include--
       ``(A) advertising the process for becoming an advisory 
     committee member at medical and scientific society 
     conferences;
       ``(B) making widely available, including by using existing 
     electronic communications channels, the contact information 
     for the Food and Drug Administration point of contact 
     regarding advisory committee nominations; and
       ``(C) developing a method through which an entity receiving 
     funding from the National Institutes of Health, the Agency 
     for Healthcare Research and Quality, the Centers for Disease 
     Control and Prevention, or the Veterans Health Administration 
     can identify a person whom the Food and Drug Administration 
     can contact regarding the nomination of individuals to serve 
     on advisory committees.
       ``(3) Expertise.--In carrying out this subsection, the 
     Secretary shall seek to ensure that the Secretary has access 
     to the most current expert advice.
       ``(c) Disclosure of Determinations and Certifications.--
     Notwithstanding section 107(a)(2) of the Ethics in Government 
     Act of 1978, the following shall apply:
       ``(1) 15 or more days in advance.--As soon as practicable, 
     but (except as provided in paragraph (2)) not later than 15 
     days prior to a meeting of an advisory committee to which a 
     written determination as referred to in section 208(b)(1) of 
     title 18, United States Code, or a written certification as 
     referred to in section 208(b)(3) of such title, applies, the 
     Secretary shall disclose (other than information exempted 
     from disclosure under section 552 or section 552a of title 5, 
     United States Code (popularly known as the Freedom of 
     Information Act and the Privacy Act of 1974, respectively)) 
     on the Internet Web site of the Food and Drug 
     Administration--
       ``(A) the type, nature, and magnitude of the financial 
     interests of the advisory committee member to which such 
     determination or certification applies; and
       ``(B) the reasons of the Secretary for such determination 
     or certification, including, as appropriate, the public 
     health interest in having the expertise of the member with 
     respect to the particular matter before the advisory 
     committee.
       ``(2) Less than 30 days in advance.--In the case of a 
     financial interest that becomes known to the Secretary less 
     than 30 days prior to a meeting of an advisory committee to 
     which a written determination as referred to in section 
     208(b)(1) of title 18, United States Code, or a written 
     certification as referred to in section 208(b)(3) of such 
     title applies, the Secretary shall disclose (other than 
     information exempted from disclosure under section 552 or 
     552a of title 5, United States Code) on the Internet Web site 
     of the Food and Drug Administration, the information 
     described in subparagraphs (A) and (B) of paragraph (1) as 
     soon as practicable after the Secretary makes such 
     determination or certification, but in no case later than the 
     date of such meeting.'';
       (2) in subsection (d), by striking ``subsection (c)(3)'' 
     and inserting ``subsection (c)'';
       (3) by amending subsection (e) to read as follows:
       ``(e) Annual Report.--
       ``(1) In general.--Not later than February 1 of each year, 
     the Secretary shall submit to the Committee on Appropriations 
     and the Committee on Health, Education, Labor, and Pensions 
     of the Senate, and the Committee on Appropriations and the 
     Committee on Energy and Commerce of the House of 
     Representatives, a report that describes--
       ``(A) with respect to the fiscal year that ended on 
     September 30 of the previous year, the number of persons 
     nominated for participation at meetings for each advisory 
     committee, the number of persons so nominated, and willing to 
     serve, the number of vacancies on each advisory committee, 
     and the number of persons contacted for service as members on 
     each advisory committee meeting for each advisory committee 
     who did not participate because of the potential for such 
     participation to constitute a disqualifying financial 
     interest under section 208 of title 18, United States Code;
       ``(B) with respect to such year, the number of persons 
     contacted for services as members for each advisory committee 
     meeting for each advisory committee who did not participate 
     because of reasons other than the potential for such 
     participation to constitute a disqualifying financial 
     interest under section 208 of title 18, United States Code;
       ``(C) with respect to such year, the number of members 
     attending meetings for each advisory committee; and
       ``(D) with respect to such year, the aggregate number of 
     disclosures required under subsection (d) and the percentage 
     of individuals to whom such disclosures did not apply who 
     served on such committee.
       ``(2) Public availability.--Not later than 30 days after 
     submitting any report under paragraph (1) to the committees 
     specified in such paragraph, the Secretary shall make each 
     such report available to the public.'';
       (4) in subsection (f), by striking ``shall review 
     guidance'' and all that follows through the end of the 
     subsection and inserting the following: ``shall--
       ``(1) review guidance of the Food and Drug Administration 
     with respect to advisory committees regarding disclosure of 
     conflicts of interest and the application of section 208 of 
     title 18, United States Code; and
       ``(2) update such guidance as necessary to ensure that the 
     Food and Drug Administration receives appropriate access to 
     needed scientific expertise, with due consideration of the 
     requirements of such section 208.''; and
       (5) by adding at the end the following:
       ``(g) Guidance on Reported Disclosed Financial Interest or 
     Involvement.--The Secretary shall issue guidance that 
     describes how the Secretary reviews the financial interests 
     and involvement of advisory committee members that are 
     disclosed under subsection (c) but that the Secretary 
     determines not to meet the definition of a disqualifying 
     interest under section 208 of title 18, United States Code 
     for the purposes of participating in a particular matter.''.
       (b) Applicability.--The amendments made by subsection (a) 
     apply beginning on October 1, 2012.

     SEC. 1143. NOTIFICATION OF FDA INTENT TO REGULATE LABORATORY-
                   DEVELOPED TESTS.

       (a) In General.--The Food and Drug Administration may not 
     issue any draft or final guidance on the regulation of 
     laboratory-developed tests under the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 301 et seq.) without, at least 60 
     days prior to such issuance--
       (1) notifying the Committee on Energy and Commerce of the 
     House of Representatives and the Committee on Health, 
     Education, Labor, and Pensions of the Senate of the 
     Administration's intent to take such action; and
       (2) including in such notification the anticipated details 
     of such action.
       (b) Sunset.--Subsection (a) shall cease to have force or 
     effect on the date that is 5 years after the date of 
     enactment of this Act.

                      Subtitle D--Synthetic Drugs

     SEC. 1151. SHORT TITLE.

       This subtitle may be cited as the ``Synthetic Drug Abuse 
     Prevention Act of 2012''.

     SEC. 1152. ADDITION OF SYNTHETIC DRUGS TO SCHEDULE I OF THE 
                   CONTROLLED SUBSTANCES ACT.

       (a) Cannabimimetic Agents.--Schedule I, as set forth in 
     section 202(c) of the Controlled Substances Act (21 U.S.C. 
     812(c)) is amended by adding at the end the following:
       ``(d)(1) Unless specifically exempted or unless listed in 
     another schedule, any material, compound, mixture, or 
     preparation which contains any quantity of cannabimimetic 
     agents, or which contains their salts, isomers, and salts of 
     isomers whenever the existence of such salts, isomers, and 
     salts of isomers is possible within the specific chemical 
     designation.
       ``(2) In paragraph (1):
       ``(A) The term `cannabimimetic agents' means any substance 
     that is a cannabinoid receptor type 1 (CB1 receptor) agonist 
     as demonstrated by binding studies and functional assays 
     within any of the following structural classes:
       ``(i) 2-(3-hydroxycyclohexyl)phenol with substitution at 
     the 5-position of the phenolic ring by alkyl or alkenyl, 
     whether or not substituted on the cyclohexyl ring to any 
     extent.
       ``(ii) 3-(1-naphthoyl)indole or 3-(1-naphthylmethane)indole 
     by substitution at the nitrogen atom of the indole ring, 
     whether or not further substituted on the indole ring to any 
     extent, whether or not substituted on the naphthoyl or 
     naphthyl ring to any extent.
       ``(iii) 3-(1-naphthoyl)pyrrole by substitution at the 
     nitrogen atom of the pyrrole ring, whether or not further 
     substituted in the pyrrole ring to any extent, whether or not 
     substituted on the naphthoyl ring to any extent.
       ``(iv) 1-(1-naphthylmethylene)indene by substitution of the 
     3-position of the indene ring, whether or not further 
     substituted in the indene ring to any extent, whether or not 
     substituted on the naphthyl ring to any extent.
       ``(v) 3-phenylacetylindole or 3-benzoylindole by 
     substitution at the nitrogen atom of the indole ring, whether 
     or not further substituted in the indole ring to any extent, 
     whether or not substituted on the phenyl ring to any extent.
       ``(B) Such term includes--
       ``(i) 5-(1,1-dimethylheptyl)-2-[(1R,3S)-3-
     hydroxycyclohexyl]-phenol (CP-47,497);
       ``(ii) 5-(1,1-dimethyloctyl)-2-[(1R,3S)-3-
     hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP-47,497 
     C8-homolog);
       ``(iii) 1-pentyl-3-(1-naphthoyl)indole (JWH-018 and AM678);
       ``(iv) 1-butyl-3-(1-naphthoyl)indole (JWH-073);
       ``(v) 1-hexyl-3-(1-naphthoyl)indole (JWH-019);
       ``(vi) 1-[2-(4-morpholinyl)ethyl]-3-(1-naphthoyl)indole 
     (JWH-200);
       ``(vii) 1-pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250);
       ``(viii) 1-pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH-
     081);
       ``(ix) 1-pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122);
       ``(x) 1-pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398);
       ``(xi) 1-(5-fluoropentyl)-3-(1-naphthoyl)indole (AM2201);
       ``(xii) 1-(5-fluoropentyl)-3-(2-iodobenzoyl)indole (AM694);
       ``(xiii) 1-pentyl-3-[(4-methoxy)-benzoyl]indole (SR-19 and 
     RCS-4);
       ``(xiv) 1-cyclohexylethyl-3-(2-methoxyphenylacetyl)indole 
     (SR-18 and RCS-8); and

[[Page 9514]]

       ``(xv) 1-pentyl-3-(2-chlorophenylacetyl)indole (JWH-
     203).''.
       (b) Other Drugs.--Schedule I of section 202(c) of the 
     Controlled Substances Act (21 U.S.C. 812(c)) is amended in 
     subsection (c) by adding at the end the following:
       ``(18) 4-methylmethcathinone (Mephedrone).
       ``(19) 3,4-methylenedioxypyrovalerone (MDPV).
       ``(20) 2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E).
       ``(21) 2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D).
       ``(22) 2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C).
       ``(23) 2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I).
       ``(24) 2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-
     T-2).
       ``(25) 2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine 
     (2C-T-4).
       ``(26) 2-(2,5-Dimethoxyphenyl)ethanamine (2C-H).
       ``(27) 2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N).
       ``(28) 2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine (2C-
     P).''.

     SEC. 1153. TEMPORARY SCHEDULING TO AVOID IMMINENT HAZARDS TO 
                   PUBLIC SAFETY EXPANSION.

       Section 201(h)(2) of the Controlled Substances Act (21 
     U.S.C. 811(h)(2)) is amended--
       (1) by striking ``one year'' and inserting ``2 years''; and
       (2) by striking ``six months'' and inserting ``1 year''.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Michigan (Mr. Upton) and the gentleman from California (Mr. Waxman) 
each will control 20 minutes.
  The Chair recognizes the gentleman from Michigan.


                             General Leave

  Mr. UPTON. Mr. Speaker, I ask unanimous consent that all Members may 
have 5 legislative days in which to revise and extend their remarks and 
insert extraneous material in the Record.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from California?
  There was no objection.
  Mr. UPTON. Mr. Speaker, I yield myself 2 minutes.
  Mr. Speaker, I want to thank Mr. Waxman, Chairman Harkin, Senator 
Enzi, and Members on both sides of the aisle in both the House and the 
Senate who played a role in this process. S. 3187 is a reflection of 
the hard work put in by both Members and staff, and of everyone's 
willingness to put partisanship aside to look at the issues together. 
Because of that outstanding dedication, we have a bill today that will 
make a real difference in the lives of so many patients and provide 
much-needed support for innovators across our great country.
  At the outset of this Congress, I set a goal of enacting this bill by 
the end of June--and here we are, well before the clock expires for 
this month--in order to provide certainty for American patients and 
innovators. I never lost confidence that we could deliver the 
bipartisan reforms we needed, and I am so proud that we will accomplish 
that goal.
  Mr. Speaker, this is a jobs bill, and it's a medical innovation bill. 
And as we put this package together, our goal was to improve the 
predictability, consistency, transparency, and efficiency of FDA 
regulation. These reforms will help get new treatments to patients more 
quickly. They will help us not only keep jobs in Michigan and all 
across the country, but also to create new ones. In order to get it 
right, we turned to patients, innovators, and job creators who provided 
firsthand experience of how the current system is broken. And we 
included many of their suggestions in the bill.
  This bill includes significant accountability and reform measures 
designed to hold the FDA responsible for its performance. The measure 
includes independent assessments of FDA's drug and device review 
process. It also includes requiring quarterly reporting from the device 
center so we don't have to wait a year to find out FDA's progress. The 
bill is about patients, and that's why so many patient advocates have 
spoken out in support of these reforms. Whether it is steps that we 
took to support treatments for rare diseases or mitigate drug shortages 
or speed up the approval of devices that will improve a patient's 
quality of life, these are steps that will make a real and significant 
difference.

                              {time}  1430

  They're going to keep the U.S. at the forefront of medical innovation 
where we belong.
  This bill is just the first step. This bill provides the resources 
and the game plans so that FDA can improve its performance.
  The SPEAKER pro tempore. The time of the gentleman has expired.
  Mr. UPTON. I yield myself an additional minute.
  It is now up to the FDA to execute that game plan. And I give my 
commitment today that our committee will continue to monitor and hold 
the FDA accountable for its performance. So, together, the Members of 
the House and the Senate have produced a bill that is a win for 
American patients, innovation, and job creation.
  Before I conclude, I would like to recognize Warren Burke and Megan 
Renfrew from the Legislative Counsel's Office for their tireless work. 
The role of Legislative Counsel often goes unnoticed. I also want to 
appreciate our staff, starting with our staff director, Gary Andres, 
for pushing this legislation over the finish line; Clay Alspach, on the 
majority staff; Rachel Sher, on the minority staff; and in particular, 
Ryan Long, the chief counsel for the Health Subcommittee.
  This bill, when it becomes law, patients will benefit from faster, 
newer, and better treatments, and American workers will keep us on the 
cutting edge of medical innovation.
  I reserve the balance of my time.
  Mr. WAXMAN. Mr. Speaker, I yield myself 3 minutes.
  Today, the House considers a bill that represents a significant 
bipartisan and bicameral achievement.
  On May 30 of this year, the House passed its user fee legislation by 
a dramatic vote of 387-5. That bill was a strong one, but through our 
collaborative process with the Senate, we have made it even better.
  It has been a pleasure to work not only with Mr. Upton, Mr. Pitts, 
Mr. Pallone, and Mr. Dingell, among many involved House colleagues, but 
also with our Senate colleagues, Senators Harkin and Enzi.
  When we began this process, there were divergent views on the various 
issues contained in this bill. But we worked together and found ways to 
bridge our differences in a fashion that protects patients and fosters 
innovation.
  This legislation contains many provisions that are critical to the 
functioning of major parts of the FDA. We reauthorize the FDA's drug 
and medical device user fee programs which will provide resources to 
enable the efficient review of applications and give patients rapid 
access to new therapies. We're also reauthorizing two pediatric 
programs which foster the development and safe use of prescription 
drugs in children.
  This year, we're establishing two new programs to help the FDA speed 
up their review of new generics and biosimilars. These provisions 
illustrate our bipartisan commitment to ensuring a vibrant generic 
marketplace. All of us will see the benefits when more low-cost 
generics are on the market.
  One of the most important improvements to the House-passed bill is in 
the area of antibiotics. We accepted the Senate language that directs 
incentives for the development of antibiotics toward serious and life-
threatening infections.
  This bill also includes provisions to modernize FDA's authorities 
with respect to the drug supply chain. Today, 80 percent of active 
ingredients and bulk chemicals used in U.S. drugs come from abroad and 
40 percent of finished drugs are manufactured abroad. FDA has been 
trying to keep pace with this increasingly globalized drug supply 
change using an outdated statute. This legislation will give the FDA 
critical new tools to police this dramatically different marketplace.
  We have also worked to address the area of drug shortages, which is a 
complex and multifaceted problem, but this legislation takes some 
sensible first steps.
  I want to thank my colleagues on both sides of the aisle and their 
staffs for the hard work they've put into

[[Page 9515]]

making this a strong bipartisan bill. I particularly want to thank Mr. 
Pallone and Mr. Dingell's staff members, Tiffany Guarascio and Kim 
Trzeciak, as well as Mr. Upton and Mr. Pitt's staff, Ryan Long and Clay 
Alspach.
  The SPEAKER pro tempore. The time of the gentleman has expired.
  Mr. WAXMAN. I yield myself an additional 30 seconds.
  Warren Burke and Megan Renfrew have done tremendous work on this 
bill. I'd like to express my appreciation for their efforts. I want to 
thank my own staff: Karen Nelson, Rachel Sher, Eric Flamm, and Arun 
Patel.
  The American public will benefit from the provisions of this bill. 
The FDA will have the resources to remain the gold standard for the 
future. This is an important bill, a good one. I urge its support.
  I reserve the balance of my time.
  Mr. UPTON. Mr. Speaker, I yield 1 minute to the chairman emeritus of 
the Energy and Commerce Committee, the gentleman from Texas (Mr. 
Barton).
  Mr. BARTON of Texas. I thank the distinguished chairman.
  Mr. Speaker, I rise in strong support of this bill. When the American 
public asks, ``Why can't Congress just work together?'' we should hold 
this bill up as Exhibit A that it is possible.
  As the ranking member just pointed out, this is a bipartisan, 
bicameral preconference agreement for a very complicated bill. We 
reauthorize the Food and Drug Administration user fee program for 5 
years. We also reauthorize the medical device user fee program for 5 
years, and, I believe for the first time, do one for generic and 
biosimilars. This is a complicated, complex piece of legislation, but 
it has been worked out in a bipartisan agreement.
  I have had some concerns about the extent and the cost of the user 
fees. I will continue to monitor that, Mr. Speaker. But this is a good 
piece of legislation. The chairman and ranking member and the 
subcommittee chairman and ranking member and all the others who have 
worked on this should be commended. This is an excellent bill, and I 
hope that the Congress will unanimously support it and the Senate will 
agree when we send it to the other body.
  Mr. WAXMAN. Mr. Speaker, at this time, I'd like to yield 3 minutes to 
the gentleman from New Jersey (Mr. Pallone), the ranking member of the 
Health Subcommittee, the subcommittee that was responsible for this 
legislation in its first instance.
  I ask unanimous consent that Mr. Pallone be permitted to manage the 
rest of the time on our side of the aisle.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from California?
  There was no objection.
  Mr. PALLONE. Thank you, Chairman Waxman.
  I want to say I'm very proud to support the bill before us, which 
would reauthorize and revitalize a number of different programs at the 
FDA.
  This bill really represents a great compromise between the House and 
the Senate and strikes the right balance by including strong provisions 
that will be good for both innovation and patient safety.
  When we passed the House version of this bill, I spoke highly of a 
great cordial process, and I'm happy to be able to echo those 
sentiments again here today. This process should be a model for 
congressional bipartisan cooperation in the future. Not only did we all 
work so well together, staffs were able to rectify the differences 
among the two Chambers' versions of the bill in a matter of 2 weeks. 
That's commendable. It's a clear indication that Congress is certainly 
capable of greatness if we just allow ourselves to set politics aside 
and simply legislate.
  I want to thank Chairman Upton and Ranking Member Waxman for your 
leadership. And to all the staff who worked around the clock--and of 
course particularly Tiffany Guarascio, who is my staff person--they 
were all dedicated to achieving a comprehensive and consensus product, 
and they've done just that.
  The bill before us today provides the FDA with more than $6 billion 
over 5 years to pay for the timely and efficient reviews of medical 
products. Together, these agreements will ensure that Americans have 
access to safe and effective new medicines and medical devices. It will 
reduce the drug costs for consumers by speeding the approval of lower 
cost generic drugs with the establishment of a new user fee program for 
generic drugs and for lower cost versions of biotech drugs as well.
  It also includes promising provisions that address the safety of the 
supply chain, help to foster the development and safe use of 
prescription drugs for children, increase efforts to address drug 
shortages, change conflict of interest rules so that the FDA has access 
to the best expertise on their advisory panels, and other provisions 
which are important to the pubic health of our Nation.
  This bill is good for the FDA; it's good for industry; it's good for 
patients alike. I'm confident we will pass this critical bill 
overwhelmingly today and that the Senate will act early next week so we 
can send it to the President for his signature as soon as possible.
  I urge all Members to support this bill, and I reserve the balance of 
my time.
  Mr. UPTON. Mr. Speaker, I yield 2 minutes to the distinguished 
chairman of the Health Subcommittee, the gentleman from Pennsylvania 
(Mr. Pitts).
  Mr. PITTS. Mr. Speaker, I stand to strongly support this legislation.
  This bipartisan agreement represents over 18 months of work from the 
Energy and Commerce Health Subcommittee, and I'm especially proud and 
appreciative of the hard work of Ryan Long and Clay Alspach for their 
diligent and tireless efforts in helping to make this bill possible.
  The FDA Safety and Innovation Act is critical to saving lives, 
improving regulatory operations, and sustaining a vital and dynamic 
American industry.

                              {time}  1440

  American companies are the leading developers of new medical devices 
and drugs to save and sustain life. To ensure that products are both 
safe and effective, we've tasked the Food and Drug Administration with 
reviewing products before they make their way into the market, and this 
is a critical responsibility.
  The device and drug industries are dynamic and innovative. Companies 
spend hundreds of millions of dollars and years of research and work to 
develop products. The review stage is a critical time for any company. 
Inconsistent reviews mean that the true cost of developing new products 
is hidden, making it difficult to properly prepare.
  When our Health Subcommittee began considering this legislation last 
year, we heard from a number of individuals about the increasing 
difficulty of working through the review process. American patients 
were waiting almost 4 years longer for new devices that had already 
been approved in Europe. And despite the slower U.S. review process, 
the safety outcomes were comparable.
  The FDA Safety and Innovation Act contains important reforms to the 
Medical Device User Fee Act and will hold the FDA accountable and keep 
reviews on schedule. There are many reforms in this bill.
  Finally, we include language to help patients and doctors and 
hospitals deal with drug shortages. Mr. Speaker, I'm proud of the work 
we've done. I'm proud that we have such a bipartisan effort.
  I'd like to especially thank Ranking Member Frank Pallone and his 
staff for patiently working with us, for Mr. Dingell, Mr. Waxman. We've 
accomplished much with this legislation, and it will help save lives, 
create jobs--two goals that we can all agree on. Thanks to our 
chairman, Mr. Upton.
  Mr. PALLONE. Mr. Speaker, I yield 3 minutes to our chairman emeritus, 
the gentleman from Michigan (Mr. Dingell), who worked so hard on this 
bill, particularly with regard to the safety provisions.
  Mr. DINGELL. Mr. Speaker, this is a good bill. I urge my colleagues 
to support it. I rise in strong support of it, and I urge my colleagues 
to join.
  This legislation enjoys broad bipartisan support on both sides of the 
Capitol and from industry and patient

[[Page 9516]]

groups. We should also be proud of the work we have done to get it here 
today.
  I would observe that it has been done because the Members worked 
together in the finest traditions of this body. And I'm also proud of 
the work that my colleagues on the committee and the staff have done on 
this matter. I was pleased to work with them to include strong upstream 
drug supply chain provisions, something that's been a long priority of 
mine.
  I'm also pleased that, for the first time, commercial importers will 
be required to register, so we'll know who's bringing what in and 
whether it's safe or not. There will also be parity between inspections 
of domestic and foreign drug facilities, something which is a major 
problem because foreign facilities and foreign manufacturers now import 
much into this country, much of which is unsafe and improperly 
inspected.
  FDA will be able to maintain a practice in which they will detain and 
destruct counterfeit drugs and those which are unsafe or intentionally 
or otherwise adulterated, and they will be able to impose increased 
penalties on those who adulterate these drugs and pharmaceuticals.
  These provisions, which mirror safety provisions in my drug safety 
bill, will equip FDA with the authorities it needs to better oversee 
our increasingly globalized drug supply chain and will give American 
families comfort that the pharmaceuticals that they are taking are 
safe, and help to deter and to respond to any future heparin-like 
incidents which killed some 80 Americans and hurt thousands more.
  While I am disappointed we were unable to come forward with a 
consensus on a national track-and-trace standard, it's my hope that we 
will continue to work on this in coming days. And I want to commend my 
colleagues, Mr. Matheson and Mr. Bilbray, for the fine work they have 
done on this matter.
  I've also been working on this issue for many years, and we've come 
closer than ever before to finding a consensus. Given additional time, 
I think we could have resolved this issue; but because of time 
pressures, we were not able to.
  I also want to thank my friends, Mr. Upton, Mr. Harkin, Ranking 
Members Waxman and Enzi, and their staff for the hard work they did to 
send this critical bill to the President before July 4. I also want to 
thank Kimberly Trzeciak of my staff for her diligence on the supply 
chain provisions and other matters.
  I urge my colleagues to support this bill. It will be something of 
which we will be proud. It will confer much safety on the American 
people in areas of very substantial danger; and it will see to it that, 
to a modest degree at least, the industry-supported provisions, 
including those which involved the collection of fees, will begin to 
work for the benefit of the American people.
  Mr. UPTON. Mr. Speaker, I yield 2 minutes to the gentleman from Texas 
(Mr. Burgess), the distinguished vice chair of the Health Subcommittee.
  Mr. BURGESS. I thank the chairman for yielding and the Speaker for 
the recognition.
  Today, we are considering the Food and Drug Administration's Safety 
Innovation Act, and I urge my colleagues to support it. This bill 
reauthorizes Food and Drug Administration's user fee programs. The bill 
will allow industry to continue to partner in providing our physicians 
the tools they need to prevent and alleviate human suffering.
  The legislation retains significant reforms that were made in our 
House bill and enhances other provisions, such as those on drug 
shortages. The bill will ensure that the Food and Drug Administration 
has the scientific and medical expertise they need when reviewing 
products utilizing emerging science, or for those populations with very 
rare diseases.
  This bill will spur innovation for antibiotics, will help those with 
rare diseases, and be particularly helpful to the community of 
physicians that takes care of our pediatric cancer patients.
  The Food and Drug Administration is now required to notify Congress 
before issuing guidance regarding the regulation of laboratory-
developed tests. I still believe we should strengthen and improve 
CLIA's oversight of laboratory-developed tests, instead of even 
contemplating any type of duplicative regulation.
  The bill avoids provisions added by the other Chamber that I thought 
crossed the line into the practice of medicine by Congress and actually 
threatened patient treatment. It will address numerous other issues to 
enhance the work of the FDA, while correcting missteps of the Agency in 
such areas as public input, good guidance practices, and the 
manufacture of custom devices.
  The process to this vote from the very beginning was respectful and 
resulted from hundreds of hours of negotiations. Chairman Upton, thank 
you, and Chairman Pitts, Ranking Members Waxman and Pallone. I 
specifically want to thank Ryan Long and Clay Alspach on the staff of 
the majority who sacrificed much to get this product to the floor 
today.
  This vote is really about patients who will be served by the passage 
of this bill, and I urge its expeditious passage.
  Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentlewoman from 
Colorado (Ms. DeGette), who worked very hard on the drug shortage 
provisions of the legislation.
  Ms. DeGETTE. Mr. Speaker, I'm delighted to support this bipartisan 
legislation which addresses critical problems affecting the safety of 
drugs and medical devices in this country. There are several highlights 
I'd like to talk about, like Dr. Gingrey's incentives for antibiotic 
development, or the supply chain legislation that Mr. Dingell has 
worked on tirelessly for years.
  But there's one issue that I've been working on on a bipartisan basis 
throughout this Congress that I want to discuss briefly. Drug shortages 
have rattled our hospitals, our doctors, and our families. Figures 
recently released by the University of Utah show there were 56 more 
newly reported drug shortages in the U.S. last year than in 2010 when 
there were 211.
  So, again, let me say 211 drugs in shortage. How can this be 
happening, and what can we do about it?
  Representative Tom Rooney from Florida and I introduced the 
bipartisan Preserving Access to Life-Saving Medications Act, which 
eventually had 85 cosponsors. The bill creates an early warning system 
between the FDA, drug companies, and providers so a community can 
respond to a drug shortage quickly and efficiently. It won't solve the 
root problems of the drug shortage crisis, but it will help providers 
and doctors and hospitals identify those crises and help with the 
patient.
  This February, for example, under a voluntary program, the FDA 
stepped in to allow for temporary emergency importation of the cancer 
drug, Doxil, which was in shortage. And at the same time, the FDA 
prioritized the review of a new manufacturer of the same drug when the 
cancer drug went into shortage.
  So what our bill will do is make this program mandatory. What we 
think it will do is it will help patients across the spectrum get the 
drugs they need. It will help the hospitals and the providers identify 
potential shortages, and it will help the manufacturers better make 
sure that they get the drugs to the patients that need them.
  I'm thrilled that this is contained, and I want to thank the 
chairman.

                              {time}  1450

  Mr. UPTON. Mr. Speaker, I yield 1 minute to the distinguished 
gentleman from Florida (Mr. Stearns).
  Mr. STEARNS. My colleagues, this reauthorization of the FDA's user 
fees will provide stability for the FDA's new product review as 
companies submit new and innovative drugs, medical devices, and 
biologics for approval.
  I am especially proud that my bill, the Faster Access to Specialized 
Treatments, H.R. 4132, FAST, was included in the FDA Reform Act. FAST 
modernizes the FDA's accelerated approval pathway to reflect scientific 
developments that have occurred over the past 20 years. This will allow 
for new drugs for people suffering from rare diseases.

[[Page 9517]]

There are 30 million Americans suffering from one of over 7,000 rare 
diseases, but only 250 currently have any treatment. FAST will save 
lives.
  I am pleased also that the bill includes the EXPERRT Act, H.R. 4156. 
This will help the FDA consult with medical experts when evaluating 
drugs designed for rare diseases, such as cystic fibrosis. As the 
cofounder of the Cystic Fibrosis Caucus, I am glad we are finally 
providing this tool to the FDA.
  I obviously support the passage of this bill.
  Mr. Speaker, the Food and Drug Administration Safety and Innovation 
Act (S. 3187) is based on user fee negotiations between FDA and the 
prescription drug, generic drug, biologic, and medical device industry. 
This reauthorization of the FDA user fees will provide stability with 
FDA's new product review as companies submit new and innovative devices 
and drugs for approval.
  This bill is the result of hard work and negotiations between 
industry and FDA, and the hard work between Republicans and Democrats, 
and between the House and the Senate. This bill is a true bipartisan, 
bicameral bill that will serve the American people well.
  In codifying the User Fee Agreement, this committee has included 
additional provisions designed to address some of the defects of the 
regulatory structure and overreach by the FDA. Under my Chairmanship of 
the Oversight and Investigation Subcommittee, we held a hearing into 
FDA's regulatory efforts in the medical device space. During our 
hearing, many of the witnesses talked about the reluctance of FDA to 
approve devices and how FDA continually moved the goalposts for 
approval. I am glad that Title VI of this bill includes a significant 
number of reform provisions designed to bring certainty to the medical 
device field.
  In addition to reforming approaches to medical devices through Title 
VI, the FDA's approach to rare diseases must also be modernized.
  I want to take this opportunity to thank Dr. Emil Kakkis, Julia 
Jenkins, Harry Sporidis, Tim Perrin, Steve Stranne, everyone at the 
EveryLife Foundation for Rare Diseases, Pat Furlong, Nick Manetto, 
everyone at the Parent Project Muscular Dystrophy, and the other 150 
rare disease groups that supported FAST and ULTRA. In 2011, I met with 
Dr. Kakkis who introduced me to two parents who had children with rare 
diseases and limited options as most rare diseases do not have 
treatments. One parent talked about his frustration at not having any 
treatments, except for a drug trial happening in Europe, not the United 
States. We talked about how we need FDA to properly address the issue 
of drug approval for the rare disease community, which led to examining 
the Accelerated Approval pathway and trying to modernize it. We 
developed the Unlocking Lifesaving Treatments for Rare-Diseases Act 
(ULTRA, H.R. 3737), which I introduced with my friend and colleague, 
Rep. Ed Towns, to nudge the FDA into using Accelerated Approval for 
rare diseases.
  However, after further review of the law, FDA's history of usage of 
Accelerated Approval and the feedback we received from stakeholders, we 
realized that amending the law was not sufficient. Instead, we worked 
with all the stakeholders to rewrite the entirety of the Accelerated 
Approval statute. In March, Representative Towns and I introduced the 
Faster Access to Specialized Treatments Act (FAST, H.R. 4132). FAST 
updates and modernizes Section 506 of the Food, Drug & Cosmetic Act, 
and updates the Accelerated Approval statute to reflect two decades 
worth of medical sciences that has occurred since Accelerated Approval 
was first created. FAST will help FDA implement 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 by using modern scientific tools.
  The use of surrogate endpoints may result in fewer, smaller or 
shorter clinical trials without compromising FDA's existing high 
standards for safety or efficacy. Surrogate and clinical endpoints only 
need to be reasonable predictors of clinical benefit to support 
accelerated approval. They do not need to be validated or proven first. 
The changes made to current law permitting the Secretary to require 
validation of surrogates following accelerated approval is not intended 
to change FDA's long history of granting accelerated approval based on 
unvalidated, but predictive, surrogate endpoints.
  Additionally, FAST includes explicit language for FDA to think about 
the challenges of rare diseases when developing their guidance and 
gives the rare disease community an opportunity to publically comment 
on FDA's draft guidance. FAST ensures that the voices of the 30 million 
Americans with a rare disease will be heard by FDA. There are about 
7,000 rare diseases and only about 250 have any treatment. FAST will 
save lives, and give a voice to the voiceless; and I am glad it is in 
the final bill.
  Lastly, the committee included the Expanding and Promoting Expertise 
in Review of Rare Treatments, (EXPERRT Act, H.R. 4156), a bill my 
fellow Co-Chairs of the Cystic Fibrosis Caucus and I introduced. 
EXPERRT will have the FDA consult with experts in rare diseases. This 
will ensure that FDA has access to the knowledge needed when dealing 
with drug approvals for diseases where FDA may lack subject matter 
expertise. As one of the Co-Founders of the Cystic Fibrosis Caucus, I 
am glad that we are giving this tool to the FDA. I also want to thank 
Stephanie Krenrich and the Cystic Fibrosis Foundation for all their 
hard work in developing EXPERRT.
  I would like to submit these letters from the EveryLife Foundation 
for Rare Diseases and the Parent Project Muscular Dystrophy into the 
Record.
  S. 3187 is a good bill that will help new drugs and new medicines get 
into the market and be available to patients. I support passage of the 
FDA Safety and Innovation Act.

                                                    Parent Project


                                           Muscular Dystrophy,

                                    Hackensack, NJ, June 20, 2012.
     Hon. Cliff Stearns,
     U.S. Congress, Washington, DC.
     Rayburn House Office Building,
       Dear Representative Stearns: On behalf of all patients and 
     families living with Duchenne muscular dystrophy--the most 
     common form of muscular dystrophy and the most common lethal 
     genetic condition diagnosed in childhood--Parent Project 
     Muscular Dystrophy (PPMD) would like to express its deep 
     gratitude for your efforts to include provisions of deep 
     interest to the rare disease community in S. 3187, the Food 
     and Drug Administration Safety and Innovation Act. The final 
     user fee reconciliation package between the House of 
     Representatives and Senate includes a number of measures that 
     will accelerate the Food and Drug Administration (FDA) 
     process of reviewing potential therapies for serious life-
     threatening conditions like Duchenne, will ensure that the 
     patient voice has a seat at the table when key decisions are 
     made, and will incent industry to develop treatments for 
     pediatric rare diseases.
       As you know, Duchenne muscular dystrophy exemplifies the 
     challenges faced by many patients and families afflicted by 
     rare diseases. It is a fatal condition with most patients not 
     living past their late 20s, and the only approved therapies 
     are steroids, which cause significant complications long-
     term. With nearly 20 potential therapies in various stages of 
     clinical trials, our community is hopeful that better times 
     are ahead, and we recognize that a more efficient FDA attuned 
     to the needs of the rare disease patient population is 
     critical to our success. Again, we are most appreciative of 
     your efforts to ensure that the above mentioned provisions 
     were included in the final legislation. On behalf of Duchenne 
     and the broader rare disease community, thank you for your 
     leadership and support.
           Sincerely,
                                                      Pat Furlong,
     Founding President and CEO.
                                  ____

                                              EveryLife Foundation


                                            for Rare Diseases,

                                        Novato, CA, June 19, 2012.
     Hon. Cliff Stearns,
     House of Representatives, Rayburn House Office Building, 
         Washington, DC.
     Hon. Edolphus Towns,
     House of Representatives, Rayburn House Office Building, 
         Washington, DC.
       Dear Representatives Stearns and Towns: On behalf of the 
     EveryLife Foundation for Rare Diseases and our 180 patient 
     organization partners, thank you for championing the FAST Act 
     which is included in The Food and Drug Administration Safety 
     and Innovation Act, S. 3187. This essential legislation will 
     improve access to the Accelerated Approval pathway for rare 
     diseases and spur the development of lifesaving treatments.
       Currently, there are fewer than 400 approved treatments for 
     7,000 rare diseases affecting more than 30 million Americans. 
     Without a treatment, diagnosis of a rare disease can be a 
     death sentence for these patients, many of whom are young 
     children. The science exists for many of these diseases to be 
     treated, and the inclusion of this legislation will provide a 
     more predictable development and regulatory pathway to unlock 
     the investment potential for rare disease treatments.
       The language from the FAST Act will fix a ``catch-22'' that 
     prevents very rare diseases from accessing the Accelerated 
     Approval pathway. We applaud you both for your tremendous 
     leadership in ensuring that this essential provision be 
     included in the FDA user fee legislation. This provision 
     provides FDA the ability to utilize all the tools available 
     to them to help bring new drugs to market

[[Page 9518]]

     to treat rare and ultra-rare diseases while maintaining the 
     FDA's strong safety and efficacy standards. Access to the 
     Accelerated Approval pathway will significantly decrease the 
     time and cost to develop a treatment and has been extremely 
     successful in getting treatments approved for cancer and AIDS 
     patients. Additionally, this provision has an added benefit 
     of promoting private investment in new biotechnology 
     companies and job growth in the United States.
       We thank you for your strong commitment to accelerating the 
     delivery of safe and effective therapies to patients in need. 
     We also would like to thank the more than 200 patient 
     organizations including Parent Project Muscular Dystrophy, 
     and the thousands of patient advocates who worked to support 
     this legislation. Passage of this legislation is testament of 
     perseverance of the rare disease community and the commitment 
     of the Congress to promote the development of lifesaving 
     treatments.
           Sincerely,
                                                      Emil Kakkis,
                                                        President.

  Mr. PALLONE. Mr. Speaker, I yield 1\1/2\ minutes to the gentlewoman 
from California (Mrs. Capps).
  Mrs. CAPPS. I thank my colleague for yielding.
  Mr. Speaker, I rise today in strong support of the FDA Safety and 
Innovation Act. This bipartisan effort will improve the health and 
safety of the American people; and at the same time, it will support 
good jobs and innovation in the health care industry. I am especially 
pleased that this bill includes two provisions which I authored:
  The first is modeled on my SAFE Devices Act, which will improve the 
post-market surveillance of medical devices and the implementation of 
the unique device identifier program. This essential provision will 
allow us to identify potential device problems early, thereby 
protecting patients and identifying issues when they are easier and 
less costly to address;
  The second provision I authored comes from my bipartisan HEART for 
Women Act, which the House has passed two times. It requires the FDA to 
report on the availability of new drug and device safety and efficacy 
data by sex, age, and racial and ethnic subgroups. Drugs and devices 
can have dissimilar effects among various populations, and this 
provision will help reduce substantial disparities in health care, 
especially for women and minorities.
  So I thank the chairmen and ranking members for their leadership on 
the FDA Safety and Innovation Act and for their support of these two 
provisions. I urge my colleagues to support this bipartisan bill.
  Mr. UPTON. Mr. Speaker, I yield 1 minute to the distinguished 
gentlewoman from North Carolina, the vice chair of the Energy and 
Commerce Committee, Mrs. Myrick.
  Mrs. MYRICK. Thank you, Mr. Chairman.
  The bill before us contains critical improvements to the current law. 
Among them is the creation of a priority review voucher program for 
companies that develop treatments for rare pediatric diseases. I am 
pleased with this and other advances.
  Yet the long-term success or failure of crucial drug and device 
approvals doesn't just depend on approving new funds and guidelines for 
the FDA. It also depends on instilling a culture at the FDA that seeks 
out practical solutions to the diseases that our constituents face. The 
FDA must recognize that patients, especially those with fatal 
illnesses, deserve to have potential treatments made available.
  Whenever possible, the FDA should use all the tools it has available 
to appropriately warn doctors and patients of risks associated with a 
treatment without removing patient access. Patients facing fatal 
diagnoses, whether it's metastatic cancer, ALS or others, should be 
given the benefit of the doubt unless treatments are very risky. This 
should be a guiding principle of the FDA and not simply a 
consideration.
  I urge the support of the bill.
  Mr. PALLONE. Mr. Speaker, I yield 1 minute to the gentleman from New 
York (Mr. Engel).
  Mr. ENGEL. I thank my friend for yielding to me.
  I rise in strong support of S. 3187, the Food and Drug Administration 
Safety and Innovation Act of 2012.
  This is one of these rare occasions these days when Congress is 
working in a bipartisan manner to get good things done. This 
bipartisan, bicameral agreement is something of which we can all be 
proud; and it is a prime example, again, of the good legislative work 
that can be done by this body when compromises are accepted.
  In particular, I would like to thank the chairmen and ranking members 
of the full Energy and Commerce Committee and of the Health 
Subcommittee for their hard work to finalize this bill in such a timely 
manner. I would also like to thank them for including the 
reauthorization of the Critical Path Public-Private Partnerships in 
this legislation, something for which I pushed for a long time so that 
needed improvements in regulatory science can continue.
  I believe this bill will help meet the needs of the FDA industry and, 
most importantly, of the patients. I look forward to its passage.
  Mr. UPTON. I yield 1 minute to the distinguished gentleman from 
Pennsylvania, Dr. Murphy.
  Mr. MURPHY of Pennsylvania. Mr. Speaker, what good are life-saving 
drugs if you can't afford them?
  That's why real reform of the Nation's health care system begins with 
promoting quality and affordability. I am excited this legislation is 
moving forward because the FDA will finally have a system for bringing 
more life-saving generic drugs to market.
  Today's bill authorizes the first generic drug user-fee program in 
order to expedite the approval of generics, which are only a fraction 
of the cost of brand-name drugs. Generic medications can save a patient 
$1,000 a year on medication alone, but it may well yield billions in 
savings across our Nation when affordable generic drugs are used to 
treat acute and chronic illness. Right now, consumers are spending 
millions, if not billions, more in out-of-pocket costs because the FDA 
doesn't have the resources to tackle 2,800 generic applications 
awaiting review.
  There will be fewer strokes, heart attacks, and cases of 
cardiovascular disease when this bill moves forward into law, and we 
will be assured the medicines our families take are of the highest 
quality. Under this bill, regulators will no longer be able to look 
past China's history of tainted drugs, like the 2007 heparin scare that 
killed 200 people.
  I would like to thank Congressmen Dingell and Waxman and Chairman 
Upton for moving forward with this bipartisan bill. I urge its 
adoption.
  Mr. PALLONE. Mr. Speaker, I inquire of how much time remains on both 
sides.
  The SPEAKER pro tempore. The gentleman from New Jersey has 6\1/2\ 
minutes remaining, and the gentleman from Michigan has 9 minutes 
remaining.
  Mr. PALLONE. I now yield 1\1/2\ minutes to the gentleman from North 
Carolina (Mr. Butterfield).
  Mr. BUTTERFIELD. Let me thank you, Mr. Pallone, for yielding the 
time, and I thank you so very much for your leadership on the Health 
Subcommittee. You do extraordinary work on our committee.
  Mr. Speaker, I rise today in support of S. 3187, the amended version 
of the Food and Drug Administration Safety and Innovation Act. I 
strongly support this bill, and I am particularly pleased that the 
intent of H.R. 3059, the Creating Hope Act, sponsored by my good friend 
from Texas (Mr. McCaul) and myself, was included in the final bill.
  I am thrilled to highlight section 908, the Rare Pediatric Disease 
Priority Review Voucher Incentive program. The program will incentivize 
pharmaceutical companies to develop new drugs for children with rare 
pediatric diseases, such as childhood cancers and sickle cell disease, 
by expanding the cost-neutral priority review voucher program. 
Expanding the voucher program will allow pharmaceutical companies to 
expedite the FDA review of more profitable drugs in return for 
developing treatments for rare pediatric diseases. I think that is a 
good trade-off.
  I would like to thank Mr. McCaul, Mr. Waxman, Mrs. Myrick, and all of 
those who have worked on this bill with us. I want to thank our Senate

[[Page 9519]]

colleagues, Messrs. Casey and Brown, for working diligently with me and 
our colleagues to see to its inclusion. Finally, I want to recognize 
Nancy Goodman, with Kids Versus Cancer, who continues to be a tireless 
advocate for this issue.
  Mr. UPTON. Mr. Speaker, I yield 1 minute to a member of the 
committee, the distinguished gentleman from California (Mr. Bilbray).
  Mr. BILBRAY. Mr. Speaker, I stand in support of this bill.
  I want to thank Chairman Upton and the leadership on both sides of 
the aisle for getting together and doing what's right for the American 
people.
  In this time that we talk about economic strife, we've got to 
remember that the FDA can be a friend or an enemy of not only our 
health but also of our jobs and our economic opportunities. In 
California alone, Mr. Speaker, we have over 267,000 people working in 
the pharmaceutical industry.

                              {time}  1500

  We have over 42,000 just working in San Diego County.
  This bill will not only help to protect jobs, but this bill is a 
bipartisan bill to save lives. What better message can we send to the 
American people than Washington is listening to the fact that they want 
bipartisan support and bipartisan efforts and bipartisan successes on 
things that matter?
  This bill is something that matters. We're talking about preserving 
the economic opportunities of our fellow citizens, and we're talking 
about saving the lives of our family members and our neighbors.
  Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentleman from 
Massachusetts (Mr. Markey).
  Mr. MARKEY. I would like to thank Chairman Upton and Chairman Pitts 
and Ranking Member Waxman and Ranking Member Pallone and their staffs 
for their work in bringing the FDA Safety and Innovation Act to the 
floor today.
  Passing this bill will allow the FDA to continue its critical mission 
of bringing safe and effective drugs and medical devices to the 
patients who need them. Reviewing drug and device applications has 
become increasingly challenging. Medical breakthroughs of today often 
target rare diseases or genetic subsets of those diseases. FDA 
reviewers must now assess a growing pipeline of very specialized 
treatments.
  I'm pleased that this bill includes language I helped author to 
improve collaboration between FDA and external experts in rare diseases 
like cystic fibrosis and sickle cell disease.
  The bill before us today also includes an important provision I 
helped author to ensure that the millions of Americans who are blind or 
visually impaired have safe and independent access to the information 
on prescription drug labels. No one should have to sacrifice their 
privacy or independence to access the vital information on these 
bottles, and I'm glad we're taking steps to address that here today.
  Finally, this bill helps increase the availability of pediatric 
medical devices and ensures that medications are tested and labeled 
appropriately for children. I was proud to work on these provisions 
with my colleagues, Congresswoman Eshoo and Congressman Rogers.
  I would have liked to have seen additional measures included in this 
bill to ensure the safety of medical devices based on defective models 
that have already been approved by the FDA, that unfortunately continue 
to be sold and jeopardize patients' health all across this country. I 
am going to continue to work on this critical issue. I believe it's a 
problem that we must solve. Once the FDA approves a device and then it 
turns out that there's a defect, there should be no excuse for allowing 
new companies to build their devices based upon the old approved 
defective model that the FDA had approved. Tens of thousands of 
Americans are put in jeopardy, and I would like to work to solve that 
problem.
  Nonetheless, this is an excellent piece of legislation, and I hope 
that the House gives it its overwhelming approval.
  Mr. UPTON. Mr. Speaker, I yield 2 minutes to the distinguished 
gentleman from Georgia, Dr. Gingrey, a member of the committee.
  Mr. GINGREY of Georgia. Mr. Speaker, I thank the gentleman for 
yielding.
  The FDA Safety and Innovation Act of 2012 may not be a great bill, 
but it is a darn good bill. And as a physician and a member of the 
Energy and Commerce Committee, I strongly support it.
  As my colleagues have said on both sides, this is a bicameral, 
bipartisan piece of legislation, and yes, we can get our work done. I 
want to particularly thank Chairman Upton, Ranking Member Waxman, 
Health Subcommittee Chairman Pitts, Ranking Member Pallone, and all of 
the Members that have worked so hard on this really vast, huge bill 
that covers a lot of things, not the least of which, of course, is to 
provide 65 percent of the funding for the FDA so they can, indeed, hire 
the best and brightest scientists so they get their work done in a 
timely manner, get new drugs to the market, medical devices, and bottom 
line, keep the health care system in this country the best in the world 
for our constituents and our patients.
  Mr. Speaker, I want to mention one particular aspect of the bill that 
I was very much involved in, and that's this issue of antibiotic 
shortage. The bill as it stood alone was called the GAIN Act, and I had 
a tremendous amount of help on both sides of the aisle. On the 
Democratic side, there was Congresswoman Eshoo, Congresswoman DeGette, 
and Congressman Gene Green. On my side of the aisle, there was Mike 
Rogers of Michigan, Mr. Shimkus, and Mr. Whitfield. What we do with 
that portion of the bill is to provide an opportunity for the 
manufacturers of antibiotics to have an additional 5 years of 
exclusivity so they can bring these innovative fifth- and sixth-
generation antibiotics to the market and still have an opportunity to 
recoup the investment and the expense of doing so.
  I want to just say to my colleagues on both sides of the aisle, it's 
a proud day, I think, for all of us, for Chairman Emeritus Dingell, the 
former chairman on our side of the aisle, Mr. Barton, and everybody 
involved in this bill. I thank all of you. Let's all unanimously 
support this bill.
  Mr. PALLONE. Mr. Speaker, I have no additional speakers, so I will 
reserve the balance of my time.
  Mr. UPTON. Mr. Speaker, I yield 1 minute to the gentleman from New 
Jersey (Mr. Lance), a member of the committee.
  Mr. LANCE. Thank you, Mr. Chairman.
  Mr. Speaker, such legislation will ensure that patients get improved 
access to innovative, lifesaving therapies and medical devices while 
protecting and creating U.S. jobs. The bill is critically important to 
New Jersey, where we have a high concentration of medical device, 
pharmaceutical, and life science employees.
  I'm pleased that the conference report contains provisions important 
to streamline and modernize FDA regulations while promoting patient 
safety. Just as important, today's measure is fiscally responsible, 
reducing the deficit by $311 billion over the next 10 years according 
to the CBO.
  I thank Chairman Upton, Chairman Pitts, Ranking Member Waxman, 
Ranking Member Pallone, and members of the Energy and Commerce 
Committee for working together in a bipartisan capacity on a final bill 
that protects patients and brings much needed certainty to the medical 
and biopharmaceutical industries. This is the way Congress should work.
  Mr. UPTON. Mr. Speaker, I yield 1 minute to the gentleman from 
Kentucky (Mr. Guthrie).
  Mr. GUTHRIE. Mr. Speaker, I appreciate the gentleman for yielding.
  I rise today in support of the legislation to reauthorize the 
Prescription Drug and Medical Device User Fee Act and authorize new 
user fee programs for generic drugs and biosimilars. The legislation 
also includes important reforms to grant patients improved access to 
new therapies and promotes innovation and job creation.
  Jobs and the economy are top issues for most Americans, and this bill 
focuses on that. As a manufacturer, I've

[[Page 9520]]

heard many stories from many device manufacturers across the country 
about problems they face with the FDA and how those struggles are 
making it harder for them to manufacture in America.
  This bill includes important changes, including one that I 
championed, to reform the FDA's guidance process that will inject 
certainty into the process and create more American jobs.
  This bill is an example of working in a bipartisan way to achieve a 
quality product that creates jobs. I thank the chairman and the ranking 
member for their work. And, Mr. Speaker, I urge my colleagues to 
support this bill.
  The SPEAKER pro tempore (Mr. Daniel E. Lungren of California). The 
gentleman from New Jersey has 3 minutes remaining, and the gentleman 
from Michigan has 4 minutes remaining.
  Mr. PALLONE. Mr. Speaker, I yield 30 seconds to the gentleman from 
Virginia (Mr. Moran).
  Mr. MORAN. Mr. Speaker, I don't oppose the bill, but I do have 
concerns about one element of this bill, and that is the provision that 
affects whistleblowers in the Public Health Service.
  The law that would apply to these employees is that of the military, 
the Defense Department, which, frankly, is weaker than that which 
applies to protecting whistleblowers who are in the civil service, 
civilian whistleblowers.
  I do think protection of whistleblowers needs to be a priority. In 
this case, I would hope that we could work in subsequent legislation to 
protect the rights of whistleblowers who are essential to our being 
able to do our job, as well as those people in the executive branch. I 
just wanted to make note of that point.

                              {time}  1510

  Mr. UPTON. Mr. Speaker, I yield 1 minute to the gentleman from New 
Hampshire (Mr. Bass), a member of the committee.
  Mr. BASS of New Hampshire. I thank the distinguished chairman of the 
committee for recognizing me for 1 minute.
  Mr. Speaker, I rise in strong support of the Food and Drug 
Administration Safety and Innovation Act.
  The user fee process at the FDA is a vital element in maintaining 
operations at the FDA to bring valuable drugs and devices through the 
approval pathway and to market. I am optimistic that, with the enhanced 
financial incentives and resources available to the FDA included in the 
user fee agreements, we will see shorter approval times and more 
products available to patients.
  Throughout this process, there has been a commitment to addressing 
the unique issues associated with the rare disease community and 
bringing it to the forefront of this debate. And I am proud to have had 
my bill, the Humanitarian Device Reform Act, included as a provision in 
this device regulatory section. This language will make it easier for 
medical device manufacturers to create devices specifically for the 
treatment of individuals, both children and adults, who are afflicted 
with very rare diseases.
  With this increased focus on providing incentives to manufacturers to 
invest in the development of these devices and drugs, it can be an 
attainable goal for an individual and family affected by rare diseases 
to not only improve the quality of life but possibly even find a cure.
  Mr. UPTON. Mr. Speaker, I yield 1 minute to the gentleman from 
Minnesota (Mr. Paulsen).
  Mr. PAULSEN. Mr. Speaker, I want to applaud, first of all, the 
chairman, the subcommittee chairman, and the ranking members for their 
leadership in bringing this bipartisan package to the floor.
  Mr. Speaker, nearly every week, I get a chance to tour a medical 
device company in my district. And almost every week, I hear a similar 
story from these companies that talk about how the FDA has become so 
burdensome and bureaucratic and inefficient that they move the goalpost 
in the process of the device approval process. As a result, some of 
these companies are closing their doors. Some of these companies are 
investing overseas and moving jobs, as opposed to keeping them in their 
home State of Minnesota or here in the United States.
  Unfortunately, it seems that Washington tends to thrive on these 
types of bureaucracies and inefficiencies. And I think the package that 
is before us today is designed to help correct that. The FDA review 
process needs to be rigorous, but it also needs to be relevant. You 
have heard that message time and time again: We have to find ways to 
streamline and modernize the FDA so that the United States can remain 
the leader in global medical innovation.
  This package absolutely moves us closer to meeting all of those 
goals. These reforms will make the device approval process much more 
transparent, much more consistent, and much more predictable. And 
specifically, I'm happy that my provisions to streamline the third-
party review process were included as well.
  I want to thank the chairman and Members for their bipartisan 
support, and I urge the support of my colleagues.
  Mr. UPTON. Mr. Speaker, may I ask how much time remains on each side?
  The SPEAKER pro tempore. The gentleman from Michigan has 2 minutes 
remaining, and the gentleman from New Jersey has 2\1/2\ minutes 
remaining.
  Mr. UPTON. Mr. Speaker, I have no further requests for time. So if 
the gentleman wants to close, then I will close.
  The SPEAKER pro tempore. The gentleman from New Jersey is recognized 
for 2\1/2\ minutes.
  Mr. PALLONE. Thank you, Mr. Speaker. I won't use all the time.
  I just want to stress, again, that the process of getting this bill 
passed and moved both here and in the Senate has been just a great 
model, if you will, for what we can do when we want to get together and 
work together on a bipartisan, bicameral basis. So I can't say enough 
about everyone who was involved on both sides of the aisle and staff 
for making this happen today.
  I also want to reiterate some of the things that some of my 
colleagues have said about how important this is. Because it's on a 
suspension, some people may say, Well, how important is it? It is 
extremely important. And some of those sentiments have been echoed by 
those who talk about the drug and medical device industry, which is 
really so important to this country.
  We pride ourselves on innovation. As some of you know, many of these 
companies are in my district. And we pride ourselves on the fact that 
Thomas Edison had his lab at Menlo Park, in my district, and that we 
are an innovative area in New Jersey, and New Jersey as a whole. But 
innovation can't continue to happen in this industry unless we continue 
to have an FDA process that runs smoothly and effectively.
  The fact of the matter is that this legislation is designed to make 
sure that that continues to happen, that the money is available so we 
can have an efficient process that continues to make the United States 
the innovator in the area of pharmaceuticals and medical devices.
  I'm very proud to have been part of this today. I urge everyone to 
support the bill. I thank my colleagues.
  I yield back the balance of my time.
  The SPEAKER pro tempore. The gentleman from Michigan is recognized 
for 2 minutes.
  Mr. UPTON. Thank you, Mr. Speaker.
  Mr. Speaker, I just want to say that with all of the positive 
comments here, this bill was not a piece of cake. There was a lot of 
hard work on both sides of the aisle, particularly by the staff on both 
sides of the aisle. Again, I want to cite Clay and Ryan on our staff.
  But let's face it: All of us particularly involved on the health side 
of the issues, as we meet with different folks afflicted with different 
diseases, we want to find a cure. And it would be great to find that 
cure here in America because we have outstanding pharmaceutical 
industries that have the talent and the staff to work with the 
different departments, whether it be the NIH, the CDC, certainly the 
FDA.
  So we really did set out last summer to embark on a good listening 
session to find out what it is that we needed to do not only to find 
the cures and the

[[Page 9521]]

prescriptions but the right process for them to be approved so that 
those companies that are willing to make that investment would stay 
here in America and not go overseas. Because we really do want it made 
in America. We have the best folks here. And that's what this bill 
does.
  The hard work in so many of the hearings that Joe Pitts led with Mr. 
Pallone, the work, the amendments, the subcommittee, the full 
committee, that whole process to get it done before it really expired 
later on this year is so important not only to the workers but, more 
importantly, to the patients.
  So dealing with the drug shortages and working with Mr. McCaul and 
the different rare diseases, all of those different elements, we were 
able to weave into what I think is a mighty fine, strong bill. And to 
then, of course, work with our counterparts in the Senate, whom we 
often bash here, but they actually stayed with us, and we were able to 
work in a very strong bipartisan way to get our two bills refined and 
done in order to bring up on the House floor this afternoon.
  I want to compliment everyone--and certainly Mr. Waxman, who is back 
on the floor--our leadership, the team that we had on both sides of the 
aisle and, again, our hardworking staff that really worked so hard to 
get this done, which impacts millions of lives.
  I urge my colleagues to support this bill, and I yield back the 
balance of my time.
  Mr. RAHALL. Mr. Speaker, I support the passage of the Food and Drug 
Administration Reform Act, which reauthorizes vital programs that will 
ensure the FDA continues to study and approve life-saving drugs and 
medical devices and work to prevent drug shortages of much needed 
medications.
  I am concerned, however, that the Congress is not doing more to fight 
prescription drug abuse. Members of the House were not permitted to 
offer amendments to address prescription drug addiction when this 
measure came before us last month, even though the FDA has a vital role 
in regulating the addictive qualities of drugs that are manufactured 
and ensuring sufficient education and awareness for health care 
providers and the general public.
  This conference report is a bittersweet pill to swallow. While it 
includes a provision that will ban the sale of dangerous synthetic 
drugs, which I support and the House of Representatives passed late 
last year, the FDA's programs could have been strengthened 
significantly to address substance abuse and its impact on our Nation's 
economic and security needs.
  If one reads any newspaper in southern West Virginia, you will 
undoubtedly find downright scary stories of families, children and 
seniors devastated by prescription drug abuse, and the crime that it 
engenders. As many of my colleagues know, fighting back against this 
unending wave of abuse will take the action of all--local, State and 
Federal Governments. I have introduced legislation, as have a number of 
my colleagues who serve in the Prescription Drug Abuse Caucus, which 
would arm our law enforcement, physicians, and local communities in 
this fight--making it harder for pills to get into the wrong hands and 
be misused, and ensuring that all prescriptions are properly monitored.
  Though this bill mentions the need to combat abuse of prescription 
drugs, it is not nearly strong enough, nor should we consider it 
sufficient, in addressing what has become a crisis in too many 
Appalachian communities. Our families and communities need more than 
recommendations--they need action, and they simply cannot wait any 
longer for help.
  I urge House leadership to work with members of this body who are 
committed to fighting back against this plague and saving our 
communities to consider legislation that will stop this scourge.
  Mr. DENT. Mr. Speaker, I rise in support of the Food and Drug 
Administration Safety and Innovation Act and particularly the 
provisions related to synthetic drugs.
  I introduced H.R. 1254, the Synthetic Drug Control Act, after the 
issue of synthetic or designer drugs was first brought to my attention 
by a constituent whose son had been abusing legal substitutes for 
marijuana.
  H.R. 1254 passed the House by a strong, bipartisan vote of 317 to 98 
this past December.
  After months of hard work, I am glad to see that similar language has 
been included in the House Amendment to the Senate-passed FDA reform 
bill. I would like to thank Chairmen Upton and Smith for their diligent 
efforts in advancing this legislation.
  This legislation will finally add a long list of dangerous drugs to 
Schedule I of the Controlled Substances Act.
  It covers synthetic cannabinoids, which affect the brain in a manner 
similar to marijuana but can actually be even more harmful, as well as 
many of the chemicals used in so-called ``bath salts,'' which have 
properties similar to cocaine, methamphetamine, LSD, and other hard 
street drugs.
  It will also double the amount of time that DEA may temporarily ban a 
new substance while working to prove that the drug in question should 
be banned permanently.
  As we speak, the proliferators of these deadly chemicals are working 
on new formulas to circumvent Federal law.
  This additional time will enhance DEA's ability to combat new and 
emerging substances.
  This legislation is especially timely given the recent reports of 
inhuman and psychotic acts committed by individuals high on bath salts.
  Last month, we all heard the horrifying story of a Miami man who 
stripped naked, assaulted another individual, and chewed his face off 
before being shot dead by the police.
  Last year, a man in my district was arrested after injecting himself 
with bath salts and firing a gun out of his window in a university 
neighborhood. He later attributed his actions to a drug-induced state 
of paranoia.
  Poison control centers nationwide have reported exponential increases 
in calls related to synthetic drugs, and far too many deaths have 
resulted both from overdoses and the Psychotic behavior that the drugs 
induce.
  For the inclusion of this important public safety language and for 
the many ways this legislation will spur economic growth and medical 
innovation, I urge all of my colleagues to vote in favor of the 
underlying bill.
  Mr. VAN HOLLEN. Mr. Speaker, I rise in support of S. 3187, as 
amended, the Food and Drug Administration Safety and Innovation Act.
  I am proud to represent many of the hard working employees at the 
Food and Drug Administration (FDA), and this legislation provides them 
with the resources to fulfill FDA's mission to protect and advance 
public health and safety. This bipartisan legislation enables FDA to 
review drugs and medical devices in a timely fashion, reduces costs by 
authorizing a new user fee program for generic drugs, and takes 
important steps to prevent and mitigate critical drug shortages.
  As the co-chairman of the Childhood Cancer Caucus, I am pleased that 
this legislation contains several provisions that will facilitate the 
development of safe and effective childhood cancer treatments. The 
legislation makes permanent two key complementary pediatric drug 
programs--the Best Pharmaceuticals for Children Act (BPCA) and the 
Pediatric Research Equity Act (PREA). Both of these programs foster the 
development of prescription drugs for children and the safe use of 
drugs by children. Finally, I am pleased that this legislation 
incorporates the Creating Hope Act, which I introduced with 
Representatives McCaul, Butterfield, and Myrick. Under this incentive 
program, a pharmaceutical company that develops a drug specifically to 
treat a rare pediatric disease will be rewarded with a priority review 
voucher for another drug. I'm hopeful that this program will kick start 
private sector investment in new and innovative treatments for children 
and families affected by cancer.
  I strongly urge my colleagues to support S. 3187 to provide FDA the 
resources it requires to guarantee the safety of American's 
prescription drugs and medical devices.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from Michigan (Mr. Upton) that the House suspend the rules 
and pass the bill, S. 3187, as amended.
  The question was taken; and (two-thirds being in the affirmative) the 
rules were suspended and the bill, as amended, was passed.
  A motion to reconsider was laid on the table.

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