112th CONGRESS 2d Session S. 3187 IN THE SENATE OF THE UNITED STATES AN ACT To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes.
1.
Short title
This Act may be cited as the Food and Drug Administration Safety and Innovation Act.
2.
Table of contents; references in Act
(a)
Table of contents
The table of contents of this Act is as follows: Sec. 1. Short title. Sec. 2. Table of contents; references in Act. TITLE I—Fees relating to drugs Sec. 101. Short title; finding. Sec. 102. Definitions. Sec. 103. Authority to assess and use drug fees. Sec. 104. Reauthorization; reporting requirements. Sec. 105. Sunset dates. Sec. 106. Effective date. Sec. 107. Savings clause. TITLE II—Fees relating to devices Sec. 201. Short title; findings. Sec. 202. Definitions. Sec. 203. Authority to assess and use device fees. Sec. 204. Reauthorization; reporting requirements. Sec. 205. Savings clause. Sec. 206. Effective date. Sec. 207. Sunset dates. Sec. 208. Streamlined hiring authority to support activities related to the process for the review of device applications. TITLE III—Fees relating to generic drugs Sec. 301. Short title. Sec. 302. Authority to assess and use human generic drug fees. Sec. 303. Reauthorization; reporting requirements. Sec. 304. Sunset dates. Sec. 305. Effective date. Sec. 306. Amendment with respect to misbranding. Sec. 307. Streamlined hiring authority of the Food and Drug Administration to support activities related to human generic drugs. TITLE IV—Fees relating to biosimilar biological products Sec. 401. Short title; finding. Sec. 402. Fees relating to biosimilar biological products. Sec. 403. Reauthorization; reporting requirements. Sec. 404. Sunset dates. Sec. 405. Effective date. Sec. 406. Savings clause. Sec. 407. Conforming amendment. TITLE V—Pediatric drugs and devices Sec. 501. Permanence. Sec. 502. Written requests. Sec. 503. Communication with Pediatric Review Committee. Sec. 504. Access to data. Sec. 505. Ensuring the completion of pediatric studies. Sec. 506. Pediatric study plans. Sec. 507. Reauthorizations. Sec. 508. Report. Sec. 509. Technical amendments. Sec. 510. Relationship between pediatric labeling and new clinical investigation exclusivity. Sec. 511. Pediatric rare diseases. TITLE VI—Medical device regulatory improvements Sec. 601. Reclassification procedures. Sec. 602. Condition of approval studies. Sec. 603. Postmarket surveillance. Sec. 604. Sentinel. Sec. 605. Recalls. Sec. 606. Clinical holds on investigational device exemptions. Sec. 607. Unique device identifier. Sec. 608. Clarification of least burdensome standard. Sec. 609. Custom devices. Sec. 610. Agency documentation and review of certain decisions regarding devices. Sec. 611. Good guidance practices relating to devices. Sec. 612. Modification of de novo application process. Sec. 613. Humanitarian device exemptions. Sec. 614. Reauthorization of third-party review and inspections. Sec. 615. 510(k) device modifications. Sec. 616. Health information technology. TITLE VII—Drug supply chain Subtitle A—Drug supply chain Sec. 701. Registration of domestic drug establishments. Sec. 702. Registration of foreign establishments. Sec. 703. Identification of drug excipient information with product listing. Sec. 704. Electronic system for registration and listing. Sec. 705. Risk-based inspection frequency. Sec. 706. Records for inspection. Sec. 707. Failure to allow foreign inspection. Sec. 708. Exchange of information. Sec. 709. Enhancing the safety and quality of the drug supply. Sec. 710. Accreditation of third-party auditors for drug establishments. Sec. 711. Standards for admission of imported drugs. Sec. 712. Notification. Sec. 713. Protection against intentional adulteration. Sec. 714. Enhanced criminal penalty for counterfeiting drugs. Sec. 715. Extraterritorial jurisdiction. Sec. 716. Compliance with international agreements. Subtitle B—Pharmaceutical distribution integrity Sec. 721. Short title. Sec. 722. Securing the pharmaceutical distribution supply chain. Sec. 723. Independent assessment. TITLE VIII—Generating Antibiotic Incentives Now Sec. 801. Extension of exclusivity period for drugs. Sec. 802. Priority review. Sec. 803. Fast track product. Sec. 804. GAO study. Sec. 805. Clinical trials. Sec. 806. Regulatory certainty and predictability. TITLE IX—Drug approval and patient access Sec. 901. Enhancement of accelerated patient access to new medical treatments. Sec. 902. Breakthrough therapies. Sec. 903. Consultation with external experts on rare diseases, targeted therapies, and genetic targeting of treatments. Sec. 904. Accessibility of information on prescription drug container labels by visually-impaired and blind consumers. Sec. 905. Risk-benefit framework. Sec. 906. Independent study on medical innovation inducement model. Sec. 907. Orphan product grants program. Sec. 908. Reporting of inclusion of demographic subgroups in clinical trials and data analysis in applications for drugs, biologics, and devices. TITLE X—Drug shortages Sec. 1001. Drug shortages. TITLE XI—Other provisions Subtitle A—Reauthorizations Sec. 1101. Reauthorization of provision relating to exclusivity of certain drugs containing single enantiomers. Sec. 1102. Reauthorization of the Critical Path Public-Private Partnerships. Subtitle B—Medical gas product regulation Sec. 1111. Regulation of medical gas products. Sec. 1112. Regulations. Sec. 1113. Applicability. Subtitle C—Miscellaneous provisions Sec. 1121. Advisory committee conflicts of interest. Sec. 1122. Guidance document regarding product promotion using the Internet. Sec. 1123. Electronic submission of applications. Sec. 1124. Combating prescription drug abuse. Sec. 1125. Tanning bed labeling. Sec. 1126. Optimizing global clinical trials. Sec. 1127. Advancing regulatory science to promote public health innovation. Sec. 1128. Information technology. Sec. 1129. Reporting requirements. Sec. 1130. Strategic integrated management plan. Sec. 1131. Drug development and testing. Sec. 1132. Patient participation in medical product discussions. Sec. 1133. Nanotechnology regulatory science program. Sec. 1134. Online pharmacy report to Congress. Sec. 1135. Medication and device errors. Sec. 1136. Compliance provision. Sec. 1137. Ensuring adequate information regarding pharmaceuticals for all populations, particularly underrepresented subpopulations, including racial subgroups. Sec. 1138. Report on small businesses. Sec. 1139. Protections for the commissioned corps of the public health service act. Sec. 1140. Regulations on clinical trial registration; GAO Study of clinical trial registration and reporting requirements. Sec. 1141. Hydrocodone amendment. Sec. 1142. Compliance date for rule relating to sunscreen drug products for over-the-counter human use. Sec. 1143. Recommendations on interoperability standards. 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. Sec. 1154. Prohibition on imposing mandatory minimum sentences. (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.).
<enum>I</enum><header display-inline="yes-display-inline">Fees relating to drugs</header> <section commented="no" display-inline="no-display-inline" id="H65CA085EBD7749D1997BF06E3BC0F25E" section-type="subsequent-section"><enum>101.</enum><header display-inline="yes-display-inline">Short title; finding</header> <subsection commented="no" display-inline="no-display-inline" id="HF2B6486813E74E888B4F7BBDF49601CC"><enum>(a)</enum><header display-inline="yes-display-inline">Short title</header><text display-inline="yes-display-inline">This title may be cited as the <quote><short-title>Prescription Drug User Fee Amendments of 2012</short-title></quote>.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="H4F93331326064657B5A2000DE30E5EF9"><enum>(b)</enum><header display-inline="yes-display-inline">Finding</header><text display-inline="yes-display-inline">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.</text> </subsection></section><section commented="no" display-inline="no-display-inline" id="HD7E3F76A2C5F411598FAD28476D0394E" section-type="subsequent-section"><enum>102.</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="no-display-inline">Paragraph (7) of section 735 (21 U.S.C. 379g) is amended, in the matter preceding subparagraph (A), by striking <quote>incurred</quote>.</text> </section><section commented="no" display-inline="no-display-inline" id="HF15FD79E391142C78953367796D703D6" section-type="subsequent-section"><enum>103.</enum><header display-inline="yes-display-inline">Authority to assess and use drug fees</header><text display-inline="no-display-inline">Section 736 (21 U.S.C. 379h) is amended—</text> <paragraph commented="no" display-inline="no-display-inline" id="HBE855BEC13E543DF99CF1612DDC6470C"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (a)—</text> <subparagraph commented="no" display-inline="no-display-inline" id="HC6CC678F58F747D0A046FC1C940D8FB5"><enum>(A)</enum><text display-inline="yes-display-inline">in the matter preceding paragraph (1), by striking <quote>fiscal year 2008</quote> and inserting <quote>fiscal year 2013</quote>;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H03BFDE5D8D7D4ADB8069ED44B9F35C87"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (1), in clauses (i) and (ii) of subparagraph (A), by striking <quote>subsection (c)(5)</quote> each place such term appears and inserting <quote>subsection (c)(4)</quote>;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HD05BA16EC3FB4060935ECA8A26CB78E4"><enum>(C)</enum><text display-inline="yes-display-inline">in the matter following clause (ii) in paragraph (2)(A)—</text> <clause commented="no" display-inline="no-display-inline" id="id42BFFC9F2CF24E29B4E491223D126D2D"><enum>(i)</enum><text display-inline="yes-display-inline">by striking <quote>subsection (c)(5)</quote> and inserting <quote>subsection (c)(4)</quote>; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="idDEA7FB7F28294E67ABC84B2374535007"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking <quote>payable on or before October 1 of each year</quote> and inserting <quote>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</quote>; and</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H6D9859CB8F934F80BFB288FF90EBE6F9"><enum>(D)</enum><text display-inline="yes-display-inline">in paragraph (3)—</text> <clause commented="no" display-inline="no-display-inline" id="H13434DF3A92540A38E445465CE29442D"><enum>(i)</enum><text display-inline="yes-display-inline">in subparagraph (A)—</text> <subclause commented="no" display-inline="no-display-inline" id="H5D9D764D99214E8FBAE0E15684C63AB8"><enum>(I)</enum><text display-inline="yes-display-inline">by striking <quote>subsection (c)(5)</quote> and inserting <quote>subsection (c)(4)</quote>; and</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="H46DFD4990E3346E1BCF223149B5F49D0"><enum>(II)</enum><text display-inline="yes-display-inline">by striking <quote>payable on or before October 1 of each year.</quote> and inserting <quote>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.</quote>; and</text> </subclause></clause><clause commented="no" display-inline="no-display-inline" id="H83D45C2A9F564449810B80BB47925900"><enum>(ii)</enum><text display-inline="yes-display-inline">by amending subparagraph (B) to read as follows:</text> <quoted-block display-inline="no-display-inline" id="H08E12ABE32A64BEABD8FD0BC48095347" style="OLC"> <subparagraph commented="no" display-inline="no-display-inline" id="H8012083131834EB0B271CB768D22E379"><enum>(B)</enum><header display-inline="yes-display-inline">Exception</header><text display-inline="yes-display-inline">A prescription drug product shall not be assessed a fee under subparagraph (A) if such product is—</text> <clause commented="no" display-inline="no-display-inline" id="H43095C9A683D4827834167F5575F7B18"><enum>(i)</enum><text display-inline="yes-display-inline">identified on the list compiled under section 505(j)(7) with a potency described in terms of per 100 mL;</text> </clause><clause commented="no" display-inline="no-display-inline" id="H69283E09172245E287E9F4C541D3BFFB"><enum>(ii)</enum><text display-inline="yes-display-inline">the same product as another product that—</text> <subclause commented="no" display-inline="no-display-inline" id="HBB631348CEFD480B83261A285F19B5ED"><enum>(I)</enum><text display-inline="yes-display-inline">was approved under an application filed under section 505(b) or 505(j); and</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="H81D540D7DB0E41F9BB7CD939FF6CD028"><enum>(II)</enum><text display-inline="yes-display-inline">is not in the list of discontinued products compiled under section 505(j)(7);</text> </subclause></clause><clause commented="no" display-inline="no-display-inline" id="H9C25F4FE392E4ED8A69BB236B52E921C"><enum>(iii)</enum><text display-inline="yes-display-inline">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</text> </clause><clause commented="no" display-inline="no-display-inline" id="HEC4701ECF3A24CC5970294869D99CCFF"><enum>(iv)</enum><text display-inline="yes-display-inline">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.</text> </clause></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block> </clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H492D1ED0CB84484B80F91CC1F0A0A06D"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (b)—</text> <subparagraph commented="no" display-inline="no-display-inline" id="H7F5EF6E5941C409EAA0936BF791D957C"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1)—</text> <clause commented="no" display-inline="no-display-inline" id="HB8B4459031784702B0A88C77B3C3BCC9"><enum>(i)</enum><text display-inline="yes-display-inline">in the matter preceding subparagraph (A), by striking <quote>fiscal years 2008 through 2012</quote> and inserting <quote>fiscal years 2013 through 2017</quote>;</text> </clause><clause commented="no" display-inline="no-display-inline" id="HA6B0016ABAEF4A67BFF11B6E5C83490E"><enum>(ii)</enum><text display-inline="yes-display-inline">in subparagraph (A), by striking <quote>$392,783,000; and</quote> and inserting <quote>$693,099,000;</quote>; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="H94EB5F7988D84A04900D3320BE99624C"><enum>(iii)</enum><text display-inline="yes-display-inline">by striking subparagraph (B) and inserting the following:</text> <quoted-block display-inline="no-display-inline" id="H9A77725788B244049957598E6A1785F3" style="OLC"> <subparagraph commented="no" display-inline="no-display-inline" id="H7108FB7DCDA44556BF355F78DE3F7760"><enum>(B)</enum><text display-inline="yes-display-inline">the dollar amount equal to the inflation adjustment for fiscal year 2013 (as determined under paragraph (3)(A)); and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H7DF87D10222A4A29B9AE014BDC187B0C"><enum>(C)</enum><text display-inline="yes-display-inline">the dollar amount equal to the workload adjustment for fiscal year 2013 (as determined under paragraph (3)(B)).</text> </subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H9CF7170585AA44A19F330015B6B20DA3"><enum>(B)</enum><text display-inline="yes-display-inline">by striking paragraphs (3) and (4) and inserting the following:</text> <quoted-block display-inline="no-display-inline" id="H24E2F99BCDB94F7D9B3A087EA446099C" style="OLC"> <paragraph commented="no" display-inline="no-display-inline" id="H751C6FF5D2344C8282B28C32780A79C1"><enum>(3)</enum><header display-inline="yes-display-inline">Fiscal year 2013 inflation and workload adjustments</header><text display-inline="yes-display-inline">For purposes of paragraph (1), the dollar amount of the inflation and workload adjustments for fiscal year 2013 shall be determined as follows:</text> <subparagraph commented="no" display-inline="no-display-inline" id="HB9A46BEA5D0F46559E8FBCD43C81EE0F"><enum>(A)</enum><header display-inline="yes-display-inline">Inflation adjustment</header><text display-inline="yes-display-inline">The inflation adjustment for fiscal year 2013 shall be the sum of—</text> <clause commented="no" display-inline="no-display-inline" id="HF99C1BA914CA4FDBA27F63B9BAD0F722"><enum>(i)</enum><text display-inline="yes-display-inline">$652,709,000 multiplied by the result of an inflation adjustment calculation determined using the methodology described in subsection (c)(1)(B); and</text> </clause><clause commented="no" display-inline="no-display-inline" id="HD9F87877AC464A16B08855BA35651A42"><enum>(ii)</enum><text display-inline="yes-display-inline">$652,709,000 multiplied by the result of an inflation adjustment calculation determined using the methodology described in subsection (c)(1)(C).</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HE21DD8486C694FF58A96F903168DC41A"><enum>(B)</enum><header display-inline="yes-display-inline">Workload adjustment</header><text display-inline="yes-display-inline">Subject to subparagraph (C), the workload adjustment for fiscal 2013 shall be—</text> <clause commented="no" display-inline="no-display-inline" id="H2AAC9B1AE13A44DFA720C2AFEB419AC1"><enum>(i)</enum><text display-inline="yes-display-inline">$652,709,000 plus the amount of the inflation adjustment calculated under subparagraph (A); multiplied by</text> </clause><clause commented="no" display-inline="no-display-inline" id="H1727DA9E954441BFA9EC03D302750250"><enum>(ii)</enum><text display-inline="yes-display-inline">the amount (if any) by which a percentage workload adjustment for fiscal year 2013, as determined using the methodology described in subsection (c)(2)(A), would exceed the percentage workload adjustment (as so determined) for fiscal year 2012, if both such adjustment percentages were calculated using the 5-year base period consisting of fiscal years 2003 through 2007.</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H7870DCFE07AB4855A5ACF928141D7567"><enum>(C)</enum><header display-inline="yes-display-inline">Limitation</header><text display-inline="yes-display-inline">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).</text> </subparagraph></paragraph><after-quoted-block>;</after-quoted-block></quoted-block> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H8E50584762F84DFD916331C6A175F213"><enum>(3)</enum><text display-inline="yes-display-inline">by striking subsection (c) and inserting the following:</text> <quoted-block display-inline="no-display-inline" id="H1DBFD1809D89485EB6D2353AACAE118F" style="OLC"> <subsection commented="no" display-inline="no-display-inline" id="HFC66220A58BA4E08AAACD332B7140763"><enum>(c)</enum><header display-inline="yes-display-inline">Adjustments</header> <paragraph commented="no" display-inline="no-display-inline" id="HDEC402F2913A46A9AF6C19581A7919F0"><enum>(1)</enum><header display-inline="yes-display-inline">Inflation adjustment</header><text display-inline="yes-display-inline">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—</text> <subparagraph commented="no" display-inline="no-display-inline" id="HD7E8B4781DB840F1A5AE8077B6B0D9B3"><enum>(A)</enum><text display-inline="yes-display-inline">one;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H348F60D8187A44619EBC10174DB5C65E"><enum>(B)</enum><text display-inline="yes-display-inline">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</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H27DD261A3F3E4770A728EB70CB6597AA"><enum>(C)</enum><text display-inline="yes-display-inline">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.</text> </subparagraph><continuation-text commented="no" continuation-text-level="paragraph">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.</continuation-text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H32650FA817B046E0884E72D0F6EBD612"><enum>(2)</enum><header display-inline="yes-display-inline">Workload adjustment</header><text display-inline="yes-display-inline">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:</text> <subparagraph commented="no" display-inline="no-display-inline" id="H7201AFE4B6364D4D8BCE4D9314CB4721"><enum>(A)</enum><text display-inline="yes-display-inline">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.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H92DDA10471CE416EBC34A27DE162FA85"><enum>(B)</enum><text display-inline="yes-display-inline">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).</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H6F276D31CD7C4BA98071B7D109242D36"><enum>(C)</enum><text display-inline="yes-display-inline">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.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H5D3D806D2C864E86A9D212AF170EB772"><enum>(3)</enum><header display-inline="yes-display-inline">Final year adjustment</header><text display-inline="yes-display-inline">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.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="H17EFBD1FD2B445A3B9A6D4AE4CCE8172"><enum>(4)</enum><header display-inline="yes-display-inline">Annual fee setting</header><text display-inline="yes-display-inline">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.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="H9A069ED1FC3F4DA48FD7635F88D01473"><enum>(5)</enum><header display-inline="yes-display-inline">Limit</header><text display-inline="yes-display-inline">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.</text> </paragraph></subsection><after-quoted-block>; and</after-quoted-block></quoted-block> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="HCDD390E347B546E8B11FFFFC9674ED1C"><enum>(4)</enum><text display-inline="yes-display-inline">in subsection (g)—</text> <subparagraph commented="no" display-inline="no-display-inline" id="H1A224273E9364C3095754B21E8BD572A"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1), by striking <quote>Fees authorized</quote> and inserting <quote>Subject to paragraph (2)(C), fees authorized</quote>;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H769D4A6489534A01AF17E2CF8B7F36CA"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (2)—</text> <clause commented="no" display-inline="no-display-inline" id="HC639C6869A414F1DA7CFA36FBEE2B148"><enum>(i)</enum><text display-inline="yes-display-inline">in subparagraph (A)—</text> <subclause commented="no" display-inline="no-display-inline" id="id62EC86FC16404924822A1FA470B61C0C"><enum>(I)</enum><text display-inline="yes-display-inline">in clause (i), by striking <quote>shall be retained</quote> and inserting <quote>subject to subparagraph (C), shall be collected and available</quote>; and</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="idC84EFFD697EB43969ABD018D17EEAD64"><enum>(II)</enum><text display-inline="yes-display-inline">in clause (ii), by striking <quote>shall only be collected and available</quote> and inserting <quote>shall be available</quote>; and</text> </subclause></clause><clause commented="no" display-inline="no-display-inline" id="H821F674A045A45C9BA56C9938B62AF6D"><enum>(ii)</enum><text display-inline="yes-display-inline">by adding at the end the following new subparagraph:</text> <quoted-block display-inline="no-display-inline" id="HD50EDEEED21F44C28B984A9E0204A5CB" style="OLC"> <subparagraph commented="no" display-inline="no-display-inline" id="H020AAB3795C24B1F87F837A4F6F674EF"><enum>(C)</enum><header display-inline="yes-display-inline">Provision for early payments</header><text display-inline="yes-display-inline">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.</text> </subparagraph><after-quoted-block>;</after-quoted-block></quoted-block> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H0E120F2360FE4E789FC1AEE65A5DFF74"><enum>(C)</enum><text display-inline="yes-display-inline">in paragraph (3), by striking <quote>fiscal years 2008 through 2012</quote> and inserting <quote>fiscal years 2013 through 2017</quote>; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HDE99B4451CDE4B5AA6CEFFC6AD92661E"><enum>(D)</enum><text display-inline="yes-display-inline">in paragraph (4)—</text> <clause commented="no" display-inline="no-display-inline" id="HF4C5A82D602E41CDB2004D14F24145CD"><enum>(i)</enum><text display-inline="yes-display-inline">by striking <quote>fiscal years 2008 through 2010</quote> and inserting <quote>fiscal years 2013 through 2015</quote>;</text> </clause><clause commented="no" display-inline="no-display-inline" id="HCA00076E19E64CA0A1E091751714A173"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking <quote>fiscal year 2011</quote> and inserting <quote>fiscal year 2016</quote>;</text> </clause><clause commented="no" display-inline="no-display-inline" id="H406846CAAE5C4119A4F9B156284C2D30"><enum>(iii)</enum><text display-inline="yes-display-inline">by striking <quote>fiscal years 2008 though 2011</quote> and inserting <quote>fiscal years 2013 through 2016</quote>; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="HA42513D907DC4131997C290338CA4EAD"><enum>(iv)</enum><text display-inline="yes-display-inline">by striking <quote>fiscal year 2012</quote> and inserting <quote>fiscal year 2017</quote>.</text> </clause></subparagraph></paragraph></section><section commented="no" display-inline="no-display-inline" id="HE06A8969CD3A486E8C4E8486A4227DD2" section-type="subsequent-section"><enum>104.</enum><header display-inline="yes-display-inline">Reauthorization; reporting requirements</header><text display-inline="no-display-inline">Section 736B (21 U.S.C. 379h–2) is amended—</text> <paragraph commented="no" display-inline="no-display-inline" id="HCFA22375C8C540A3BF095825F06A84E7"><enum>(1)</enum><text display-inline="yes-display-inline">by amending subsection (a) to read as follows:</text> <quoted-block display-inline="no-display-inline" id="HD253F6F7474B4733BB97DF63B79E9929" style="OLC"> <subsection commented="no" display-inline="no-display-inline" id="HE54E5C23B68843E983B54114CECAE3F1"><enum>(a)</enum><header display-inline="yes-display-inline">Performance report</header><text display-inline="yes-display-inline">Beginning with fiscal year 2013, not later than 120 days after the end of each fiscal year for which fees are collected under this part, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 101(b) of the <short-title>Prescription Drug User Fee Amendments of 2012</short-title> during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals. The report under this subsection for a fiscal year shall include information on all previous cohorts for which the Secretary has not given a complete response on all human drug applications and supplements in the cohort.</text> </subsection><after-quoted-block>;</after-quoted-block></quoted-block> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="H0822FE8C47B9403CA59537C795C5E790"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (b), by striking <quote>2008</quote> and inserting <quote>2013</quote>; and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="HCCEEE181DB624987BB3EB3445CC5DA5B"><enum>(3)</enum><text display-inline="yes-display-inline">in subsection (d), by striking <quote>2012</quote> each place it appears and inserting <quote>2017</quote>.</text> </paragraph></section><section commented="no" display-inline="no-display-inline" id="HF5BA124C60A64568A1B52CA8800904B8" section-type="subsequent-section"><enum>105.</enum><header display-inline="yes-display-inline">Sunset dates</header> <subsection commented="no" display-inline="no-display-inline" id="id0E85BB2CC9B9423991B3F1132BA4504E"><enum>(a)</enum><header display-inline="yes-display-inline">Authorization</header><text display-inline="yes-display-inline">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.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="H1B5AC39638C54B658308D3E7C335D385"><enum>(b)</enum><header display-inline="yes-display-inline">Reporting requirements</header><text display-inline="yes-display-inline">Section 736B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h–2) shall cease to be effective January 31, 2018.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="H7A34DB2AD9D34EC39DD370687404A334"><enum>(c)</enum><header display-inline="yes-display-inline">Previous sunset provision</header><text display-inline="yes-display-inline">Section 106 of the Prescription Drug User Fee Amendments of 2007 (Title I of Public Law 110–85) is repealed.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="idCB3EC33E241B44F79BC927F6016CB892"><enum>(d)</enum><header display-inline="yes-display-inline">Technical clarifications</header> <paragraph commented="no" display-inline="no-display-inline" id="id456cc1498b9a4482aa21f64ac269fef9"><enum>(1)</enum><text display-inline="yes-display-inline">Effective September 30, 2007, section 509 of the Prescription Drug User Fee Amendments Act of 2002 (Title V of Public Law 107–188) is repealed.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idaf99ee6e659f469287e93a308bba6096"><enum>(2)</enum><text display-inline="yes-display-inline">Effective September 30, 2002, section 107 of the Food and Drug Administration Modernization Act of 1997 (Public Law 105–115) is repealed.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id10dd1af0579a4a25b35a044af40877c2"><enum>(3)</enum><text display-inline="yes-display-inline">Effective September 30, 1997, section 105 of the Prescription Drug User Fee Act of 1992 (Public Law 102–571) is repealed.</text> </paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="H55AAF871BB384A20AC065F107080ECB8" section-type="subsequent-section"><enum>106.</enum><header display-inline="yes-display-inline">Effective date</header><text display-inline="no-display-inline">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.</text> </section><section commented="no" display-inline="no-display-inline" id="HF98F5783DCE74F9F9DBCAB071953C3F5" section-type="subsequent-section"><enum>107.</enum><header display-inline="yes-display-inline">Savings clause</header><text display-inline="no-display-inline">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.</text> </section><enum>II</enum><header display-inline="yes-display-inline">Fees relating to devices</header> <section commented="no" display-inline="no-display-inline" id="idF5871AC044BB4F3EA2FDAFB6DE7AF77E" section-type="subsequent-section"><enum>201.</enum><header display-inline="yes-display-inline">Short title; findings</header> <subsection commented="no" display-inline="no-display-inline" id="idAD70564ACAD845A78FCA7B723ABB9F21"><enum>(a)</enum><header display-inline="yes-display-inline">Short title</header><text display-inline="yes-display-inline">This title may be cited as the <quote><short-title>Medical Device User Fee Amendments of 2012</short-title></quote>.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="id56B30A874E724480826426FC0C0DDB70"><enum>(b)</enum><header display-inline="yes-display-inline">Findings</header><text display-inline="yes-display-inline">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.</text> </subsection></section><section commented="no" display-inline="no-display-inline" id="idA570CD605DE840E082821EAE8C7578B0" section-type="subsequent-section"><enum>202.</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="no-display-inline">Section 737 (21 U.S.C. 379i) is amended—</text> <paragraph commented="no" display-inline="no-display-inline" id="idAF356CFA2374437EBCD6971082CCA9A0"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (9), by striking <quote>incurred</quote> after <quote>expenses</quote>;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id41DF94F433BF4C5991062950CEEB3C20"><enum>(2)</enum><text display-inline="yes-display-inline">in paragraph (10), by striking <quote>October 2001</quote> and inserting <quote>October 2011</quote>; and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id8CC2762E00124937810C9ADEEE1FFB77"><enum>(3)</enum><text display-inline="yes-display-inline">in paragraph (13), by striking <quote>is required to register</quote> and all that follows through the end of paragraph (13) and inserting the following: <quote>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.</quote>.</text> </paragraph></section><section commented="no" display-inline="no-display-inline" id="idDD9907D6EAE5422B83ECFAB53848364C" section-type="subsequent-section"><enum>203.</enum><header display-inline="yes-display-inline">Authority to assess and use device fees</header> <subsection commented="no" display-inline="no-display-inline" id="id0E6E64E591ED49D696765FA72DECBF32"><enum>(a)</enum><header display-inline="yes-display-inline">Types of fees</header><text display-inline="yes-display-inline">Section 738(a) (21 U.S.C. 379j(a)) is amended—</text> <paragraph commented="no" display-inline="no-display-inline" id="idF581737AAFA8467C9AA7AE1C518C5205"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (1), by striking <quote>fiscal year 2008</quote> and inserting <quote>fiscal year 2013</quote>;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idE5A496F57DAE4D68BF69ACC333D04174"><enum>(2)</enum><text display-inline="yes-display-inline">in paragraph (2)(A)—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id6E1AF63D5331493392B4C7095F2AE58F"><enum>(A)</enum><text display-inline="yes-display-inline">in the matter preceding clause (i)—</text> <clause commented="no" display-inline="no-display-inline" id="id1D8C39ACA0B44B8C90952D2572BBDE71"><enum>(i)</enum><text display-inline="yes-display-inline">by striking <quote>subsections (d) and (e)</quote> and inserting <quote>subsections (d), (e), and (f)</quote>;</text> </clause><clause commented="no" display-inline="no-display-inline" id="id3343CCDEAF1E4BCBA6665663F7F11F8E"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking <quote>October 1, 2002</quote> and inserting <quote>October 1, 2012</quote>; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="id7452A8815850408D9B1E196CA3301BE4"><enum>(iii)</enum><text display-inline="yes-display-inline">by striking <quote>subsection (c)(1)</quote> and inserting <quote>subsection (c)</quote>; and</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id20DD8471B3AD4B4C8A3B722E13FCDEA3"><enum>(B)</enum><text display-inline="yes-display-inline">in clause (viii), by striking <quote>1.84</quote> and inserting <quote>2</quote>; and</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id9793BD60618F4A929C1B986DFCDD427D"><enum>(3)</enum><text display-inline="yes-display-inline">in paragraph (3)—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id5F5DD99ADB9A47B6816FAC39772C71B3"><enum>(A)</enum><text display-inline="yes-display-inline">in subparagraph (A)—</text> <clause commented="no" display-inline="no-display-inline" id="id778415818B9046D9B2A305B51E9EB469"><enum>(i)</enum><text display-inline="yes-display-inline">by inserting <quote>and subsection (f)</quote> after <quote>subparagraph (B)</quote>; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="id13B5531381EA4EB8B6694C55B7423C9A"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking <quote>2008</quote> and inserting <quote>2013</quote>; and</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idD9EF765E18AB4B6196996D48F4A7FBE2"><enum>(B)</enum><text display-inline="yes-display-inline">in subparagraph (C), by striking <quote>initial registration</quote> and all that follows through <quote>section 510.</quote> and inserting</text> <quoted-block display-inline="yes-display-inline" id="id3A3DFAFB1A9A432F8D11B4F8DD35C4DD" style="OLC"> <text>later of—</text><clause commented="no" display-inline="no-display-inline" id="idF5E23CEB6F024C4F93094CE9802A1E2E"><enum>(i)</enum><text display-inline="yes-display-inline">the initial or annual registration (as applicable) of the establishment under section 510; or</text> </clause><clause commented="no" display-inline="no-display-inline" id="id497B5D1C038949A3A141A126F7DF59AB"><enum>(ii)</enum><text display-inline="yes-display-inline">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.</text> </clause><after-quoted-block>.</after-quoted-block></quoted-block> </subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idAFF9197A49C94EC2B15C23CB2A035853"><enum>(b)</enum><header display-inline="yes-display-inline">Fee amounts</header><text display-inline="yes-display-inline">Section 738(b) (21 U.S.C. 379j(b)) is amended to read as follows:</text> <quoted-block display-inline="no-display-inline" id="idC2EAF42515A046DA9CCDC0DC39844DBC" style="OLC"> <subsection commented="no" display-inline="no-display-inline" id="id4881A3807B434581BA9BAA136FA0BEDA"><enum>(b)</enum><header display-inline="yes-display-inline">Fee amounts</header> <paragraph commented="no" display-inline="no-display-inline" id="id1885220DCDBC4806AA9E7C134458267C"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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).</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idEAA225A7D1164297B43F5B6D528ABBEA"><enum>(2)</enum><header display-inline="yes-display-inline">Base fee amounts</header><text display-inline="yes-display-inline">For purposes of paragraph (1), the base fee amounts specified in this paragraph are as follows:</text> <table blank-lines-after="0" blank-lines-before="0" line-rules="hor-ver" rule-weights="4.4.4.4.0.0"> <tgroup cols="6" grid-typeface="1.1" thead-tbody-ldg-size="8.8.8" ttitle-size="10"><colspec coldef="txt" colname="col1" min-data-value="60"></colspec><colspec coldef="fig" colname="col2" min-data-value="8"></colspec><colspec coldef="fig" colname="col3" min-data-value="8"></colspec><colspec coldef="fig" colname="col4" min-data-value="8"></colspec><colspec coldef="fig" colname="col5" min-data-value="8"></colspec><colspec coldef="fig" colname="col6" min-data-value="8"></colspec> <thead> <row><entry align="center" colname="col1">Fee Type</entry><entry align="center" colname="col2">Fiscal Year 2013</entry><entry align="center" colname="col3">Fiscal Year 2014</entry><entry align="center" colname="col4">Fiscal Year 2015</entry><entry align="center" colname="col5">Fiscal Year 2016</entry><entry align="center" colname="col6">Fiscal Year 2017</entry> </row> </thead> <tbody> <row><entry colname="col1" stub-definition="txt-ldr" stub-hierarchy="1">Premarket Application</entry><entry colname="col2">$248,000</entry><entry colname="col3">$252,960</entry><entry colname="col4">$258,019</entry><entry colname="col5">$263,180</entry><entry colname="col6">$268,443</entry> </row> <row><entry colname="col1" stub-definition="txt-ldr" stub-hierarchy="1">Establishment Registration</entry><entry colname="col2">$2,575</entry><entry colname="col3">$3,200</entry><entry colname="col4">$3,750</entry><entry colname="col5">$3,872</entry><entry colname="col6">$3,872</entry> </row> </tbody> </tgroup> </table> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id2A948F20016F42CEBBBF1D733970A17A"><enum>(3)</enum><header display-inline="yes-display-inline">Total revenue amounts</header><text display-inline="yes-display-inline">For purposes of paragraph (1), the total revenue amounts specified in this paragraph are as follows:</text> <subparagraph commented="no" display-inline="no-display-inline" id="id7E69FD621E604506AC22EB4BEB30E95F"><enum>(A)</enum><text display-inline="yes-display-inline">$97,722,301 for fiscal year 2013.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idF035DB7BBF0442E6AD5AA953C85F1944"><enum>(B)</enum><text display-inline="yes-display-inline">$112,580,497 for fiscal year 2014.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idC3C64EE01E584AB8A9171B4498579E62"><enum>(C)</enum><text display-inline="yes-display-inline">$125,767,107 for fiscal year 2015.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id5906184D115944BC9AE8013BE47C05C8"><enum>(D)</enum><text display-inline="yes-display-inline">$129,339,949 for fiscal year 2016.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idF931E4BEA12C4209AE2C5C9076065454"><enum>(E)</enum><text display-inline="yes-display-inline">$130,184,348 for fiscal year 2017.</text> </subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block> </subsection><subsection commented="no" display-inline="no-display-inline" id="id0A53A0C9151A4060A7AC02E0432D705E"><enum>(c)</enum><header display-inline="yes-display-inline">Annual fee setting; adjustments</header><text display-inline="yes-display-inline">Section 738(c) (21 U.S.C. 379j(c)) is amended—</text> <paragraph commented="no" display-inline="no-display-inline" id="id8EF16513D96B4F0A862FDD9F8930D5C1"><enum>(1)</enum><text display-inline="yes-display-inline">in the subsection heading, by inserting <quote><header-in-text level="subsection" style="OLC">; adjustments</header-in-text></quote> after <quote><header-in-text level="subsection" style="OLC">setting</header-in-text></quote>;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id4A45E53D16B4474C8958E778C2FDBB13"><enum>(2)</enum><text display-inline="yes-display-inline">by striking paragraphs (1) and (2);</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idCB8688E5CE33446480A2B33A5CEDB92E"><enum>(3)</enum><text display-inline="yes-display-inline">by redesignating paragraphs (3) and (4) as paragraphs (4) and (5), respectively; and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id49CAF9C64E054E11B2862D821C2D797C"><enum>(4)</enum><text display-inline="yes-display-inline">by inserting before paragraph (4), as so redesignated, the following:</text> <quoted-block display-inline="no-display-inline" id="id1F53288208A04AABBDFF2DB0F18479AD" style="OLC"> <paragraph commented="no" display-inline="no-display-inline" id="id0E296FCD01C44D64B60D344F8999C477"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id8E7015D94E0A43DE94D114878110B29B"><enum>(2)</enum><header display-inline="yes-display-inline">Inflation adjustments</header> <subparagraph commented="no" display-inline="no-display-inline" id="idEA5C6CB9B9654354A3A1A201371A4B69"><enum>(A)</enum><header display-inline="yes-display-inline">Adjustment to total revenue amounts</header><text display-inline="yes-display-inline">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 <internal-xref legis-path="(2)(B)">subparagraph (B)</internal-xref> for such year.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id4AB28D45A90C4C9EA428BB0DB6CE158F"><enum>(B)</enum><header display-inline="yes-display-inline">Applicable inflation adjustment to total revenue amounts</header><text display-inline="yes-display-inline">The applicable inflation adjustment for a fiscal year is—</text> <clause commented="no" display-inline="no-display-inline" id="id816618AD548C4432B689DC075429E52C"><enum>(i)</enum><text display-inline="yes-display-inline">for fiscal year 2014, the base inflation adjustment under <internal-xref legis-path="(2)(C)">subparagraph (C)</internal-xref> for such fiscal year; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="id43B84B0FA6D74992B269261693DCD771"><enum>(ii)</enum><text display-inline="yes-display-inline">for fiscal year 2015 and each subsequent fiscal year, the product of—</text> <subclause commented="no" display-inline="no-display-inline" id="id54DA1418B7BF4A20A13A2155C7734E7E"><enum>(I)</enum><text display-inline="yes-display-inline">the base inflation adjustment under <internal-xref legis-path="(2)(C)">subparagraph (C)</internal-xref> for such fiscal year; and</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="id274339F3CA844C27ADA9E1B2AED493D9"><enum>(II)</enum><text display-inline="yes-display-inline">the product of the base inflation adjustment under <internal-xref legis-path="(2)(C)">subparagraph (C)</internal-xref> for each of the fiscal years preceding such fiscal year, beginning with fiscal year 2014.</text> </subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idA5C986A2B76F41EC9DD25645E8BA2365"><enum>(C)</enum><header display-inline="yes-display-inline">Base inflation adjustment to total revenue amounts</header> <clause commented="no" display-inline="no-display-inline" id="id60CF531D39A84A58B0EDDE66097892EB"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Subject to further adjustment under clause (ii), the base inflation adjustment for a fiscal year is the sum of one plus—</text> <subclause commented="no" display-inline="no-display-inline" id="id3E81905B28724DE7947840EB0D285507"><enum>(I)</enum><text display-inline="yes-display-inline">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</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="idC297AB5110C144FB89097F1AC0331E5E"><enum>(II)</enum><text display-inline="yes-display-inline">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.</text> </subclause></clause><clause commented="no" display-inline="no-display-inline" id="id48A7FF5FD54F487B8D8C53E6773096D0"><enum>(ii)</enum><header display-inline="yes-display-inline">Limitations</header><text display-inline="yes-display-inline">For purposes of <internal-xref legis-path="(2)(B)">subparagraph (B)</internal-xref>, if the base inflation adjustment for a fiscal year under clause (i)—</text> <subclause commented="no" display-inline="no-display-inline" id="id83E62B4D04ED44BD89F42E3C63921EBA"><enum>(I)</enum><text display-inline="yes-display-inline">is less than 1, such adjustment shall be considered to be equal to 1; or</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="id29644530935B42548FAB5F6CEBBA7AD0"><enum>(II)</enum><text display-inline="yes-display-inline">is greater than 1.04, such adjustment shall be considered to be equal to 1.04.</text> </subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idD94999C21520454C97EF2F4EB604968E"><enum>(D)</enum><header display-inline="yes-display-inline">Adjustment to base fee amounts</header><text display-inline="yes-display-inline">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).</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id72C57F24EBD146B1B0D811ED1101F20E"><enum>(3)</enum><header display-inline="yes-display-inline">Volume-based adjustments to establishment registration base fees</header><text display-inline="yes-display-inline">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).</text> </paragraph><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id423F6D7AD50B476BA7154887402AC4DD"><enum>(d)</enum><header display-inline="yes-display-inline">Fee waiver or reduction</header><text display-inline="yes-display-inline">Section 738 (21 U.S.C. 379j) is amended by—</text> <paragraph commented="no" display-inline="no-display-inline" id="idA3428B7747614B0DA48E0F3FF5090D88"><enum>(1)</enum><text display-inline="yes-display-inline">redesignating subsections (f) through (k) as subsections (g) through (l), respectively; and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id7C8A94CD9A0F4E36951D672C9D93037B"><enum>(2)</enum><text display-inline="yes-display-inline">by inserting after subsection (e) the following new subsection:</text> <quoted-block display-inline="no-display-inline" id="id25C9B244EC9A4845B333129308B2D9D9" style="OLC"> <subsection commented="no" display-inline="no-display-inline" id="idDE0AA59690DB460A8A1093C6E1A7B1CE"><enum>(f)</enum><header display-inline="yes-display-inline">Fee waiver or reduction</header> <paragraph commented="no" display-inline="no-display-inline" id="id1B5F37FED80F49938C9F5792A5D05788"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idAB1391312578415A81159B362C22361F"><enum>(2)</enum><header display-inline="yes-display-inline">Limitation</header><text display-inline="yes-display-inline">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).</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idD10774846D574E96B8B8E5AC5C1EED35"><enum>(3)</enum><header display-inline="yes-display-inline">Duration</header><text display-inline="yes-display-inline">The authority provided by this subsection terminates October 1, 2017.</text> </paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id4267CD6EE8034B58A79000C8B2101F6D"><enum>(e)</enum><header display-inline="yes-display-inline">Conditions</header><text display-inline="yes-display-inline">Section 738(h)(1)(A) (21 U.S.C. 379j(h)(1)(A)), as redesignated by subsection (d)(1), is amended by striking <quote>$205,720,000</quote> and inserting <quote>$280,587,000</quote>.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="id9F58EC19B5B4465D8F4EF2CF24A23633"><enum>(f)</enum><header display-inline="yes-display-inline">Crediting and availability of fees</header><text display-inline="yes-display-inline">Section 738(i) (21 U.S.C. 379j(i)), as redesignated by subsection (d)(1), is amended—</text> <paragraph commented="no" display-inline="no-display-inline" id="idBEE54EED0BA94543AA401CBF10282653"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (1), by striking <quote>Fees authorized</quote> and inserting <quote>Subject to paragraph (2)(C), fees authorized</quote>;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id330B3649F4044618A73827A81CD90803"><enum>(2)</enum><text display-inline="yes-display-inline">in paragraph (2)—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id4166F7253E2B48088020AC6E28D2A0B5"><enum>(A)</enum><text display-inline="yes-display-inline">in subparagraph (A)—</text> <clause commented="no" display-inline="no-display-inline" id="idB0D54298FD9A4FA7BDCC4361C41FD40B"><enum>(i)</enum><text display-inline="yes-display-inline">in clause (i), by striking <quote>shall be retained</quote> and inserting <quote>subject to subparagraph (C), shall be collected and available</quote>; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="id98114942D81E42109F0A59C18B9A26A8"><enum>(ii)</enum><text display-inline="yes-display-inline">in clause (ii)—</text> <subclause commented="no" display-inline="no-display-inline" id="id1EAA9E6EDD9E41B0BC82F67759982EFE"><enum>(I)</enum><text display-inline="yes-display-inline">by striking <quote>collected and</quote> after <quote>shall only be</quote>; and</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="id3B271D94F6984C7A8BF2507821EF2DF1"><enum>(II)</enum><text display-inline="yes-display-inline">by striking <quote>fiscal year 2002</quote> and inserting <quote>fiscal year 2009</quote>; and</text> </subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id21CBADF5D0554FAC9DCA553025B57A33"><enum>(B)</enum><text display-inline="yes-display-inline">by adding at the end, the following:</text> <quoted-block display-inline="no-display-inline" id="idD8FA0DA422F34ADFB43FC3249D2FFAE7" style="OLC"> <subparagraph commented="no" display-inline="no-display-inline" id="id28C481B070D54EEAB62EBBEC9A7F6EF3"><enum>(C)</enum><header display-inline="yes-display-inline">Provision for early payments</header><text display-inline="yes-display-inline">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.</text> </subparagraph><after-quoted-block>;</after-quoted-block></quoted-block> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id4D1E0168F42744CEA18A5B883401F783"><enum>(3)</enum><text display-inline="yes-display-inline">by amending paragraph (3) to read as follows:</text> <quoted-block display-inline="no-display-inline" id="id33A52A6D88A34CE491E2D2C8184021EB" style="OLC"> <paragraph commented="no" display-inline="no-display-inline" id="idDC99B58E46894ED7954B562BC15AEA38"><enum>(3)</enum><header display-inline="yes-display-inline">Authorizations of appropriations</header><text display-inline="yes-display-inline">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).</text> </paragraph><after-quoted-block>; and</after-quoted-block></quoted-block> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id54F25FADDB8A4831A88684585A56CFD4"><enum>(4)</enum><text display-inline="yes-display-inline">in paragraph (4)—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id22A30C0D0C7344838CBEB08DD45ED983"><enum>(A)</enum><text display-inline="yes-display-inline">by striking <quote>fiscal years 2008, 2009, and 2010</quote> and inserting <quote>fiscal years 2013, 2014, and 2015</quote>;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idA8506B187BE04CBD81E50305C7C5CB14"><enum>(B)</enum><text display-inline="yes-display-inline">by striking <quote>fiscal year 2011</quote> and inserting <quote>fiscal year 2016</quote>;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id4F4DD520118D40038CDE953C92CF1973"><enum>(C)</enum><text display-inline="yes-display-inline">by striking <quote>June 30, 2011</quote> and inserting <quote>June 30, 2016</quote>;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id497A09E5BE0C49A28223F15F9972C29F"><enum>(D)</enum><text display-inline="yes-display-inline">by striking <quote>the amount of fees specified in aggregate in</quote> and inserting <quote>the cumulative amount appropriated pursuant to</quote>;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id5410021AA0594901AA8D0F541759F63C"><enum>(E)</enum><text display-inline="yes-display-inline">by striking <quote>aggregate amount in</quote> before <quote>excess shall be credited</quote>; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idD329CA085C2845F19A2348226938A716"><enum>(F)</enum><text display-inline="yes-display-inline">by striking <quote>fiscal year 2012</quote> and inserting <quote>fiscal year 2017</quote>.</text> </subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id6A02B67E924E47DF9CD3DD22077B2915"><enum>(g)</enum><header display-inline="yes-display-inline">Conforming amendment</header><text display-inline="yes-display-inline">Section 515(c)(4)(A) (21 U.S.C. 360e(c)(4)(A)) is amended by striking <quote>738(g)</quote> and inserting <quote>738(h)</quote>.</text> </subsection></section><section commented="no" display-inline="no-display-inline" id="idD9C51E5C9E8F47CDBA8D3AB5049B30C6" section-type="subsequent-section"><enum>204.</enum><header display-inline="yes-display-inline">Reauthorization; reporting requirements</header> <subsection commented="no" display-inline="no-display-inline" id="idEC17D1442CAD4E3188FB96196D398584"><enum>(a)</enum><header display-inline="yes-display-inline">Reauthorization</header><text display-inline="yes-display-inline">Section 738A(b) (21 U.S.C. 379j–1(b)) is amended—</text> <paragraph commented="no" display-inline="no-display-inline" id="idB33A53D334024FA5B6FEAD3E9FF2D5E9"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (1), by striking <quote>2012</quote> and inserting <quote>2017</quote>; and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id9AA2D3B214264D6F87B0A36674545AFA"><enum>(2)</enum><text display-inline="yes-display-inline">in paragraph (5), by striking <quote>2012</quote> and inserting <quote>2017</quote>.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idB2E46DCD4ABA479885D033F99C84428B"><enum>(b)</enum><header display-inline="yes-display-inline">Reports</header><text display-inline="yes-display-inline">Section 738A(a) (21 U.S.C. 379j–1(a)) is amended—</text> <paragraph commented="no" display-inline="no-display-inline" id="id63DBA1A68DDC4030A5A61EE3BFB3FEE5"><enum>(1)</enum><text display-inline="yes-display-inline">by striking <quote>2008 through 2012</quote> each place it appears and inserting <quote>2013 through 2017</quote>; and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id19C1A362158C490C9EBE32FB2B0CF662"><enum>(2)</enum><text display-inline="yes-display-inline">by striking <quote>section 201(c) of the Food and Drug Administration Amendments Act of 2007</quote> and inserting <quote>section 201(b) of the Medical Device User Fee Amendments of 2012</quote>.</text> </paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="idF02F5FD6EBF143F19428EF01CC639850" section-type="subsequent-section"><enum>205.</enum><header display-inline="yes-display-inline">Savings clause</header><text display-inline="no-display-inline">Notwithstanding the amendments made by this title, part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the day before the date of the enactment of this title, shall continue to be in effect with respect to submissions described in section 738(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act (as in effect as of such day) that on or after October 1, 2007, but before October 1, 2012, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2013.</text> </section><section commented="no" display-inline="no-display-inline" id="id24AB99F9E4CB4C4D9F3ADA9E8376FE67" section-type="subsequent-section"><enum>206.</enum><header display-inline="yes-display-inline">Effective date</header><text display-inline="no-display-inline">The amendments made by this title shall take effect on October 1, 2012, or the date of the enactment of this Act, whichever is later, except that fees under part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act shall be assessed for submissions described in section 738(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act received on or after October 1, 2012, regardless of the date of the enactment of this Act.</text> </section><section commented="no" display-inline="no-display-inline" id="id09808685B5F0447E925FCC304162DE1F" section-type="subsequent-section"><enum>207.</enum><header display-inline="yes-display-inline">Sunset dates</header> <subsection commented="no" display-inline="no-display-inline" id="H66F45C998C5942A6A4C2DFF73C34A806"><enum>(a)</enum><header display-inline="yes-display-inline">Authorizations</header><text display-inline="yes-display-inline">Sections 737 and 738 (21 U.S.C. 739i; 739j) shall cease to be effective October 1, 2017.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="id1927C875564147EB95523AF5A7F84076"><enum>(b)</enum><header display-inline="yes-display-inline">Reporting requirements</header><text display-inline="yes-display-inline">Section 738A (21 U.S.C. 739j–1) shall cease to be effective January 31, 2018.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="idCA1DE77FAF694B148579F041506179A7"><enum>(c)</enum><header display-inline="yes-display-inline">Previous sunset provision</header><text display-inline="yes-display-inline">Section 217 of the Medical Device User Fee Amendments of 2007 (Title II of Public Law 110–85) is repealed.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="id616CE66E9A104F55BB9A4EEBBFD50F49"><enum>(d)</enum><header display-inline="yes-display-inline">Technical clarification</header><text display-inline="yes-display-inline">Effective September 30, 2007, section 107 of the Medical Device User Fee and Modernization Act of 2002 (Public Law 107– 250) is repealed.</text> </subsection></section><section commented="no" display-inline="no-display-inline" id="idC1B484EA06564503A359156A31EA5A8E" section-type="subsequent-section"><enum>208.</enum><header display-inline="yes-display-inline">Streamlined hiring authority to support activities related to the process for the review of device applications</header><text display-inline="no-display-inline">Subchapter A of chapter VII (21 U.S.C. 371 et seq.) is amended by inserting after section 713 the following new section:</text> <quoted-block display-inline="no-display-inline" id="idD653055838B7406C88E17516233C86DC" style="OLC"> <section commented="no" display-inline="no-display-inline" id="idCC6B05C56DEF4E228B627CAFF1B084F3" section-type="subsequent-section"><enum>714.</enum><header display-inline="yes-display-inline">Streamlined hiring authority</header> <subsection commented="no" display-inline="no-display-inline" id="id1AB8CEB2B08845E29AC963358D51534A"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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).</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="idDA270033C3384CB5AC92BA6B19170E3A"><enum>(b)</enum><header display-inline="yes-display-inline">Activities described</header><text display-inline="yes-display-inline">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)).</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="id21ED26119AE44F9EAF48DEFF2DA4556B"><enum>(c)</enum><header display-inline="yes-display-inline">Objectives specified</header><text display-inline="yes-display-inline">The objectives specified in this subsection are with respect to the activities under <internal-xref legis-path="714.(b)(1)">subsection (b)</internal-xref>, the goals referred to in section 738A(a)(1).</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="id6F57DB7FFD234ECB868BB37E90726454"><enum>(d)</enum><header display-inline="yes-display-inline">Internal controls</header><text display-inline="yes-display-inline">The Secretary shall institute appropriate internal controls for appointments under this section.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="id28FD21BBB45C49C8A981D1A68149F9DB"><enum>(e)</enum><header display-inline="yes-display-inline">Sunset</header><text display-inline="yes-display-inline">The authority to appoint employees under this section shall terminate on the date that is three years after the date of enactment of this section.</text> </subsection></section><after-quoted-block>. </after-quoted-block></quoted-block> </section><enum>III</enum><header display-inline="yes-display-inline">Fees relating to generic drugs</header> <section commented="no" display-inline="no-display-inline" id="HD349199194574EFC838B5DE299CA63A5" section-type="subsequent-section"><enum>301.</enum><header display-inline="yes-display-inline">Short title</header> <subsection commented="no" display-inline="no-display-inline" id="HB14AD61E70C74231BB10055620478FEE"><enum>(a)</enum><header display-inline="yes-display-inline">Short title</header><text display-inline="yes-display-inline">This title may be cited as the <quote><short-title>Generic Drug User Fee Amendments of 2012</short-title></quote>.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="H473A4D10E9C44EA28DC4C4210D1C7B7B"><enum>(b)</enum><header display-inline="yes-display-inline">Finding</header><text display-inline="yes-display-inline">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.</text> </subsection></section><section commented="no" display-inline="no-display-inline" id="H4E7EB32BEA9E40E19013118DB55CAFAC" section-type="subsequent-section"><enum>302.</enum><header display-inline="yes-display-inline">Authority to assess and use human generic drug fees</header><text display-inline="no-display-inline">Subchapter C of chapter VII (21 U.S.C. 379f et seq.) is amended by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="HBD5E0901F5A149CB83D7B3BFABE0CAD0" style="OLC"> <part commented="no" id="id95A3ADE5EA3B4DE0955656928F399696" level-type="subsequent"><enum>7</enum><header display-inline="yes-display-inline">FEES RELATING TO GENERIC DRUGS </header> <section commented="no" display-inline="no-display-inline" id="HF16D3DA3F7D040F3BFCCAD5B12F5B7BF" section-type="subsequent-section"><enum>744A.</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="no-display-inline">For purposes of this part:</text> <paragraph commented="no" display-inline="no-display-inline" id="H10A620E9BFF647D6A91AA7D0A8257E3B"><enum>(1)</enum><text display-inline="yes-display-inline">The term <term>abbreviated new drug application</term>—</text> <subparagraph commented="no" display-inline="no-display-inline" id="HFF4BD41404B2487FBBE3310D049F9B59"><enum>(A)</enum><text display-inline="yes-display-inline">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</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H1A654080991E4488A2C45AC6095D38C6"><enum>(B)</enum><text display-inline="yes-display-inline">does not include an application for a positron emission tomography drug.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H53959F20EE3D410D9E3251345AB39FE7"><enum>(2)</enum><text display-inline="yes-display-inline">The term <term>active pharmaceutical ingredient</term> means—</text> <subparagraph commented="no" display-inline="no-display-inline" id="H85D709AB2B85474F8A51F20827D28328"><enum>(A)</enum><text display-inline="yes-display-inline">a substance, or a mixture when the substance is unstable or cannot be transported on its own, intended—</text> <clause commented="no" display-inline="no-display-inline" id="H0368276283DD4E4CBFE04C24A03C66F3"><enum>(i)</enum><text display-inline="yes-display-inline">to be used as a component of a drug; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="H5C016C19DCE9426CB43F5E9DB352D908"><enum>(ii)</enum><text display-inline="yes-display-inline">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</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HE4D5DBA3096C4C03B9597FF363211FF7"><enum>(B)</enum><text display-inline="yes-display-inline">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).</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H4078E21F684B40D1BB7C62CB88069189"><enum>(3)</enum><text display-inline="yes-display-inline">The term <term>adjustment factor</term> means a factor applicable to a fiscal year that is the Consumer Price Index for all urban consumers (all items; United States city average) for October of the preceding fiscal year divided by such Index for October 2011.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="H934C256632B541A893C64C3D9C533CF4"><enum>(4)</enum><text display-inline="yes-display-inline">The term <term>affiliate</term> means a business entity that has a relationship with a second business entity if, directly or indirectly—</text> <subparagraph commented="no" display-inline="no-display-inline" id="H650B8531C07048D2AE0C1EA14123ABEE"><enum>(A)</enum><text display-inline="yes-display-inline">one business entity controls, or has the power to control, the other business entity; or</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HF539DAF08A634F8A80514196D169F523"><enum>(B)</enum><text display-inline="yes-display-inline">a third party controls, or has power to control, both of the business entities.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H1B45A964F8CD4CB78AD8742386708390"><enum>(5)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="HB852DF28EA1B4769A1F1E5C5A3B6EF94"><enum>(A)</enum><text display-inline="yes-display-inline">The term <term>facility</term>—</text> <clause commented="no" display-inline="no-display-inline" id="HA08667547CD64C0BA1BF34236B1B668B" indent="up1"><enum>(i)</enum><text display-inline="yes-display-inline">means a business or other entity—</text> <subclause commented="no" display-inline="no-display-inline" id="H1FE7D124DF1248D1B106E932055AC771"><enum>(I)</enum><text display-inline="yes-display-inline">under one management, either direct or indirect; and</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="HDDB7EC5A603D4C6BB80194435D589E44"><enum>(II)</enum><text display-inline="yes-display-inline">at one geographic location or address engaged in manufacturing or processing an active pharmaceutical ingredient or a finished dosage form; and</text> </subclause></clause><clause commented="no" display-inline="no-display-inline" id="H90A4370DBA404E7CA20AF127CF98F368" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">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.</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HF04D2B2EAB3D42BCA578083721EF4AD8" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">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—</text> <clause commented="no" display-inline="no-display-inline" id="HB42511C8410B44A3ABCFC26BB9BF2543"><enum>(i)</enum><text display-inline="yes-display-inline">closely related to the same business enterprise;</text> </clause><clause commented="no" display-inline="no-display-inline" id="H8A4F8C7D7B6549588E9F949801155020"><enum>(ii)</enum><text display-inline="yes-display-inline">under the supervision of the same local management; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="H512EA89D784D41C8B7A7B35C3702BD84"><enum>(iii)</enum><text display-inline="yes-display-inline">capable of being inspected by the Food and Drug Administration during a single inspection.</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H6F0CCADA16E44ABBBB8E99F5868A3181" indent="up1"><enum>(C)</enum><text display-inline="yes-display-inline">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.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H8F23B50DD71D4A0CBCE176057F440550"><enum>(6)</enum><text display-inline="yes-display-inline">The term <term>finished dosage form</term> means—</text> <subparagraph commented="no" display-inline="no-display-inline" id="H17511E703B5545259518610782315401"><enum>(A)</enum><text display-inline="yes-display-inline">a drug product in the form in which it will be administered to a patient, such as a tablet, capsule, solution, or topical application;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HE76C91632DDC49FB89EF9BC24667EF8D"><enum>(B)</enum><text display-inline="yes-display-inline">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</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H84BBD7A01AD54A6D92946CE3C5111449"><enum>(C)</enum><text display-inline="yes-display-inline">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).</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H38C3696D7A9D4C5880A434E4D77A6142"><enum>(7)</enum><text display-inline="yes-display-inline">The term <term>generic drug submission</term> 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.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="HA6E1C54F073740379EDA119FC0BFB79A"><enum>(8)</enum><text display-inline="yes-display-inline">The term <term>human generic drug activities</term> means the following activities of the Secretary associated with generic drugs and inspection of facilities associated with generic drugs:</text> <subparagraph commented="no" display-inline="no-display-inline" id="H370C08B755C74451BBE8A6D6DB2BEC55"><enum>(A)</enum><text display-inline="yes-display-inline">The activities necessary for the review of generic drug submissions, including review of drug master files referenced in such submissions.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HECA01647FA754AD491B4D4101AED6AC4"><enum>(B)</enum><text display-inline="yes-display-inline">The issuance of—</text> <clause commented="no" display-inline="no-display-inline" id="HC62B7E475CB34B809648270BFBDFB611"><enum>(i)</enum><text display-inline="yes-display-inline">approval letters which approve abbreviated new drug applications or supplements to such applications; or</text> </clause><clause commented="no" display-inline="no-display-inline" id="H85270A4F351F4D6BB7BC4C0FD0E69BD7"><enum>(ii)</enum><text display-inline="yes-display-inline">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.</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H2F2EF173AA9144CAAF428EE4F204A195"><enum>(C)</enum><text display-inline="yes-display-inline">The issuance of letters related to Type II active pharmaceutical drug master files which—</text> <clause commented="no" display-inline="no-display-inline" id="H829D175907EF4471B6B12FA7125377DA"><enum>(i)</enum><text display-inline="yes-display-inline">set forth in detail the specific deficiencies in such submissions, and where appropriate, the actions necessary to resolve those deficiencies; or</text> </clause><clause commented="no" display-inline="no-display-inline" id="HF424C4DFE7C54A928A4F4DF4CFD5B233"><enum>(ii)</enum><text display-inline="yes-display-inline">document that no deficiencies need to be addressed.</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HB2D99A20E026404A88E3713A8BD26146"><enum>(D)</enum><text display-inline="yes-display-inline">Inspections related to generic drugs.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H453488A3B5D34702B1EF16126D562BD3"><enum>(E)</enum><text display-inline="yes-display-inline">Monitoring of research conducted in connection with the review of generic drug submissions and drug master files.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H0481C7A923574FEB9CA7B1FC83E47D86"><enum>(F)</enum><text display-inline="yes-display-inline">Postmarket safety activities with respect to drugs approved under abbreviated new drug applications or supplements, including the following activities:</text> <clause commented="no" display-inline="no-display-inline" id="HD7F99E214A3C42C697BCC3DCD8EACA04"><enum>(i)</enum><text display-inline="yes-display-inline">Collecting, developing, and reviewing safety information on approved drugs, including adverse event reports.</text> </clause><clause commented="no" display-inline="no-display-inline" id="H4203BB51239C4E27B491E12D1FD8DC16"><enum>(ii)</enum><text display-inline="yes-display-inline">Developing and using improved adverse-event data-collection systems, including information technology systems.</text> </clause><clause commented="no" display-inline="no-display-inline" id="HF09BAFF9DA744CC99CD29A340C9705FB"><enum>(iii)</enum><text display-inline="yes-display-inline">Developing and using improved analytical tools to assess potential safety problems, including access to external data bases.</text> </clause><clause commented="no" display-inline="no-display-inline" id="H8E59803AA3464BE0A11522BC08299A81"><enum>(iv)</enum><text display-inline="yes-display-inline">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.</text> </clause><clause commented="no" display-inline="no-display-inline" id="HE734BBDA9D8A4D53A7EF06762A5CAFE2"><enum>(v)</enum><text display-inline="yes-display-inline">Carrying out section 505(k)(5) (relating to adverse-event reports and postmarket safety activities).</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HDCA6EFAC62FF45C1AE712C4F6EF05C96"><enum>(G)</enum><text display-inline="yes-display-inline">Regulatory science activities related to generic drugs.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H1AADEE67F93C4CF1A8279C58692D682E"><enum>(9)</enum><text display-inline="yes-display-inline">The term <term>positron emission tomography drug</term> has the meaning given to the term <term>compounded positron emission tomography drug</term> in section 201(ii), except that paragraph (1)(B) of such section shall not apply.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="H55BB1478C3E7461D9974C3153D3308E7"><enum>(10)</enum><text display-inline="yes-display-inline">The term <term>prior approval supplement</term> 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.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="H733B73C4804540F5B78E2129DB9CBBB9"><enum>(11)</enum><text display-inline="yes-display-inline">The term <term>resources allocated for human generic drug activities</term> means the expenses for—</text> <subparagraph commented="no" display-inline="no-display-inline" id="H550BD00C21534D27AEB1D8FC15DFD8E5"><enum>(A)</enum><text display-inline="yes-display-inline">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;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H6B18BBF2DBBC4AC3A64FD38CF961A4A6"><enum>(B)</enum><text display-inline="yes-display-inline">management of information, and the acquisition, maintenance, and repair of computer resources;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HE5036556A5B94DC3AAA89A12F982744E"><enum>(C)</enum><text display-inline="yes-display-inline">leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H771320F59A924A56ADB9141045F0D745"><enum>(D)</enum><text display-inline="yes-display-inline">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.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H2DAEF59BA10140AF99CAEC0DF3598657"><enum>(12)</enum><text display-inline="yes-display-inline">The term <term>Type II active pharmaceutical ingredient drug master file</term> 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.</text> </paragraph></section><section commented="no" display-inline="no-display-inline" id="HAE0B86F930B74FBDB9D9DEA7BBAE5573" section-type="subsequent-section"><enum>744B.</enum><header display-inline="yes-display-inline">Authority to assess and use human generic drug fees</header> <subsection commented="no" display-inline="no-display-inline" id="H8E2E70F314A94D42B80C03CE43E72581"><enum>(a)</enum><header display-inline="yes-display-inline">Types of fees</header><text display-inline="yes-display-inline">Beginning in fiscal year 2013, the Secretary shall assess and collect fees in accordance with this section as follows:</text> <paragraph commented="no" display-inline="no-display-inline" id="H1C016252AE0B4D70872D78C1F0EA00C3"><enum>(1)</enum><header display-inline="yes-display-inline">One-Time Backlog Fee for Abbreviated New Drug Applications Pending on October 1, 2012</header> <subparagraph commented="no" display-inline="no-display-inline" id="H4B6C7647B74340C295D64624E787E446"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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).</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H5AEB09BC4F6E4EB38F02A2CEEA45B3D3"><enum>(B)</enum><header display-inline="yes-display-inline">Method of fee amount calculation</header><text display-inline="yes-display-inline">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.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H63C0F74A9EB445A9B5747DA6C5815C9C"><enum>(C)</enum><header display-inline="yes-display-inline">Notice</header><text display-inline="yes-display-inline">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).</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H23E84008BA6D472180E2487F8F6F96A8"><enum>(D)</enum><header display-inline="yes-display-inline">Fee due date</header><text display-inline="yes-display-inline">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).</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HFD250A6F09B647ABB8AF9C7088ED61BD"><enum>(2)</enum><header display-inline="yes-display-inline">Drug Master File Fee</header> <subparagraph commented="no" display-inline="no-display-inline" id="H1F794DCDEC7148848E829548D828486D"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H99E88221B0B040ACB106480B49F8FE00"><enum>(B)</enum><header display-inline="yes-display-inline">One-time payment</header><text display-inline="yes-display-inline">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.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H2D7DD0DB11FD41328CD208F9B43C2F58"><enum>(C)</enum><header display-inline="yes-display-inline">Notice</header> <clause commented="no" display-inline="no-display-inline" id="HD0E83E1D2CCD428DAE7B04616611EAE7"><enum>(i)</enum><header display-inline="yes-display-inline">Fiscal year 2013</header><text display-inline="yes-display-inline">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.</text> </clause><clause commented="no" display-inline="no-display-inline" id="HBC23B270F9754531A7205D5D414FD789"><enum>(ii)</enum><header display-inline="yes-display-inline">Fiscal year 2014 through 2017</header><text display-inline="yes-display-inline">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.</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HE602348AFA474D3496C2404AFE57C68A"><enum>(D)</enum><header display-inline="yes-display-inline">Availability for reference</header> <clause commented="no" display-inline="no-display-inline" id="H2317294003E04D96B74E447E7EE424BF"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text> </clause><clause commented="no" display-inline="no-display-inline" id="H2115E47E00B04DF1A5CCE151E10BF52B"><enum>(ii)</enum><header display-inline="yes-display-inline">Conditions</header><text display-inline="yes-display-inline">A drug master file shall be deemed available for reference by the Secretary if—</text> <subclause commented="no" display-inline="no-display-inline" id="H8A0C46630BED4ACDA765A1D384EA799B"><enum>(I)</enum><text display-inline="yes-display-inline">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</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="H1BD83BF2E826498C992728BA05AE05EA"><enum>(II)</enum><text display-inline="yes-display-inline">the drug master file has not failed an initial completeness assessment by the Secretary, in accordance with criteria to be published by the Secretary.</text> </subclause></clause><clause commented="no" display-inline="no-display-inline" id="H956FCD9F7A594526BAFA0481ADBB5F2B"><enum>(iii)</enum><header display-inline="yes-display-inline">List</header><text display-inline="yes-display-inline">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.</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HDB066DFB011D4BC59D948EE02D77B079"><enum>(E)</enum><header display-inline="yes-display-inline">Fee Due Date</header> <clause commented="no" display-inline="no-display-inline" id="HABDC1A3A3E9941F78D7F873376371C05"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text> </clause><clause commented="no" display-inline="no-display-inline" id="H9F3E86B0C0EE4B069D2F50DD1FBEC677"><enum>(ii)</enum><header display-inline="yes-display-inline">Limitation</header><text display-inline="yes-display-inline">No fee shall be due under subparagraph (A) for a fiscal year until the later of—</text> <subclause commented="no" display-inline="no-display-inline" id="H6EBE53FF563749CAB67FE1D6B1E078C1"><enum>(I)</enum><text display-inline="yes-display-inline">30 calendar days after publication of the notice provided for in clause (i) or (ii) of subparagraph (C), as applicable; or</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="H8115FC6E702F46999903E3B0D1433F8C"><enum>(II)</enum><text display-inline="yes-display-inline">30 calendar days after the date of enactment of an appropriations Act providing for the collection and obligation of fees under this section.</text> </subclause></clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H4B895ABD280C465A87D1F4977CEF5BE8"><enum>(3)</enum><header display-inline="yes-display-inline">Abbreviated New Drug Application and Prior Approval Supplement Filing Fee</header> <subparagraph commented="no" display-inline="no-display-inline" id="H86E5EC0FF31C498E97F1175FE97501CC"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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).</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HEFF43641ADF74F6EA25D44F08B0222F8"><enum>(B)</enum><header display-inline="yes-display-inline">Notice</header> <clause commented="no" display-inline="no-display-inline" id="H73A5A6F1EE31444CB59EC1C5CDF4BEDA"><enum>(i)</enum><header display-inline="yes-display-inline">Fiscal year 2013</header><text display-inline="yes-display-inline">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.</text> </clause><clause commented="no" display-inline="no-display-inline" id="H492268086559400580E51E288DF4FAB1"><enum>(ii)</enum><header display-inline="yes-display-inline">Fiscal years 2014 through 2017</header><text display-inline="yes-display-inline">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.</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H7C9B066A265140519D464767457049AE"><enum>(C)</enum><header display-inline="yes-display-inline">Fee Due Date</header> <clause commented="no" display-inline="no-display-inline" id="H840DB9EA33C5442494983600E0038D1D"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text> </clause><clause commented="no" display-inline="no-display-inline" id="HA85682F4BE7C4FC5937E826555E87D58"><enum>(ii)</enum><header display-inline="yes-display-inline">Special rule for 2013</header><text display-inline="yes-display-inline">For fiscal year 2013, such fees shall be due on the later of—</text> <subclause commented="no" display-inline="no-display-inline" id="HFE9E054D48844270A7FDA4A76FD4F10E"><enum>(I)</enum><text display-inline="yes-display-inline">the date on which the fee is due under clause (i);</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="HEA54E32F894C495AB3ED0D7FD4AAC0FD"><enum>(II)</enum><text display-inline="yes-display-inline">30 calendar days after publication of the notice referred to in subparagraph (B)(i); or</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="H0AA016F5B0FE4BC4977672EBC10C3B1C"><enum>(III)</enum><text display-inline="yes-display-inline">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.</text> </subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H006A5C1C8D1140428BEA57F807A833A7"><enum>(D)</enum><header display-inline="yes-display-inline">Refund of fee if abbreviated new drug application is not considered to have been received</header><text display-inline="yes-display-inline">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.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HD7B2F104A5D542E7B5A82C412A2AFF2D"><enum>(E)</enum><header display-inline="yes-display-inline">Fee for an application the secretary considers not to have been received, or that has been withdrawn</header><text display-inline="yes-display-inline">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).</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HC0643993137C45978A8654E721DA381E"><enum>(F)</enum><header display-inline="yes-display-inline">Additional fee for active pharmaceutical ingredient information not included by reference to Type II active pharmaceutical ingredient drug master file</header><text display-inline="yes-display-inline">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—</text> <clause commented="no" display-inline="no-display-inline" id="H9C3041FFADF747EBAFCDADD45023B521"><enum>(i)</enum><text display-inline="yes-display-inline">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</text> </clause><clause commented="no" display-inline="no-display-inline" id="HFD2DAF8C4AF24F15B6ADC9AC186B83BC"><enum>(ii)</enum><text display-inline="yes-display-inline">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.</text> </clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HB0D1F7340DAA44CB9AFD813C7E8AC8F1"><enum>(4)</enum><header display-inline="yes-display-inline">Generic Drug Facility Fee and Active Pharmaceutical Ingredient Facility Fee</header> <subparagraph commented="no" display-inline="no-display-inline" id="H96C39B13ECD44768A634DA4A37A90F7B"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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:</text> <clause commented="no" display-inline="no-display-inline" id="H0659C3A34E934D8FB637B29775F37EBB"><enum>(i)</enum><header display-inline="yes-display-inline">Generic drug facility</header><text display-inline="yes-display-inline">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.</text> </clause><clause commented="no" display-inline="no-display-inline" id="HD5D12EE7B2DE4C9E8C0BDD4C2229DDF8"><enum>(ii)</enum><header display-inline="yes-display-inline">Active pharmaceutical ingredient facility</header><text display-inline="yes-display-inline">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.</text> </clause><clause commented="no" display-inline="no-display-inline" id="HFF28DBBBEA2B4916B541B796D757E9C5"><enum>(iii)</enum><header display-inline="yes-display-inline">Facilities producing both active pharmaceutical ingredients and finished dosage forms</header><text display-inline="yes-display-inline">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.</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H763B34B70CB0489280BF1357E941D215"><enum>(B)</enum><header display-inline="yes-display-inline">Amount</header><text display-inline="yes-display-inline">The amount of fees established under subparagraph (A) shall be established under subsection (d).</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HDEBB94E285914CC19098B8DBA9545775"><enum>(C)</enum><header display-inline="yes-display-inline">Notice</header> <clause commented="no" display-inline="no-display-inline" id="HC2001C2A2D4B4539AB7405D139EF1848"><enum>(i)</enum><header display-inline="yes-display-inline">Fiscal year 2013</header><text display-inline="yes-display-inline">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).</text> </clause><clause commented="no" display-inline="no-display-inline" id="H8CE2DC2208FF4AF39BA2A9E15B27AB96"><enum>(ii)</enum><header display-inline="yes-display-inline">Fiscal years 2014 through 2017</header><text display-inline="yes-display-inline">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.</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H2F8147BBEE14470AA10B3079C38AF7AC"><enum>(D)</enum><header display-inline="yes-display-inline">Fee Due Date</header> <clause commented="no" display-inline="no-display-inline" id="H1AC69B4956A443DDB86533EB8EC14AB9"><enum>(i)</enum><header display-inline="yes-display-inline">Fiscal year 2013</header><text display-inline="yes-display-inline">For fiscal year 2013, the fees under subparagraph (A) shall be due on the later of—</text> <subclause commented="no" display-inline="no-display-inline" id="HDA9E5086E3C54FF8BF6A8D48B12221DF"><enum>(I)</enum><text display-inline="yes-display-inline">not later than 45 days after the publication of the notice under subparagraph (B); or</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="H283110945CA44C35841A3E0F75D254DB"><enum>(II)</enum><text display-inline="yes-display-inline">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.</text> </subclause></clause><clause commented="no" display-inline="no-display-inline" id="H00405333D9714A0BA62B5F8D8D9C8B3F"><enum>(ii)</enum><header display-inline="yes-display-inline">Fiscal years 2014 through 2017</header><text display-inline="yes-display-inline">For each of fiscal years 2014 through 2017, the fees under subparagraph (A) for such fiscal year shall be due on the later of—</text> <subclause commented="no" display-inline="no-display-inline" id="H40849EFB796641F3B505D8CF5DE6B60B"><enum>(I)</enum><text display-inline="yes-display-inline">the first business day on or after October 1 of each such year; or</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="H03383AA190C24528B1E94E2187CE6E25"><enum>(II)</enum><text display-inline="yes-display-inline">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.</text> </subclause></clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H02C84EED2D084A15BFE393EDF530E538"><enum>(5)</enum><header display-inline="yes-display-inline">Date of submission</header><text display-inline="yes-display-inline">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—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id6A02E90151224F08AA87C76571C22E6F"><enum>(A)</enum><text display-inline="yes-display-inline">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</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id7BC70311AC234936AB84DC87514D300F"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text> </subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HF34F96B2A0D64565B95209D47F94F2F5"><enum>(b)</enum><header display-inline="yes-display-inline">Fee revenue amounts</header> <paragraph commented="no" display-inline="no-display-inline" id="HD503A605D6814CB5B0C4754A198D1F9C"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header> <subparagraph commented="no" display-inline="no-display-inline" id="HE9B02AE997F34EF8A31DC113995A7826"><enum>(A)</enum><header display-inline="yes-display-inline">Fiscal year 2013</header><text display-inline="yes-display-inline">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—</text> <clause commented="no" display-inline="no-display-inline" id="HDC03E4F7F0DE474FA43EED86A58A2C6E"><enum>(i)</enum><text display-inline="yes-display-inline">$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</text> </clause><clause commented="no" display-inline="no-display-inline" id="H6E45217D4680430EBBEAD1B4C0428EC3"><enum>(ii)</enum><text display-inline="yes-display-inline">$249,000,000 shall be generated by the fees under paragraphs (2) through (4) of subsection (a).</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H0B105D16954647B1A99E403E787BFA00"><enum>(B)</enum><header display-inline="yes-display-inline">Fiscal years 2014 through 2017</header><text display-inline="yes-display-inline">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).</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H153F45FB8B0945F0AF38DFDFD6407BFD"><enum>(2)</enum><header display-inline="yes-display-inline">Types of fees</header><text display-inline="yes-display-inline">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:</text> <subparagraph commented="no" display-inline="no-display-inline" id="H690BA6C9CC9246E3B07DA47BDF87A011"><enum>(A)</enum><text display-inline="yes-display-inline">6 percent shall be derived from fees under subsection (a)(2) (relating to drug master files).</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H71BED88830FF49CA91D3D55D5DE4FA83"><enum>(B)</enum><text display-inline="yes-display-inline">24 percent shall be derived from fees under subsection (a)(3) (relating to abbreviated new drug applications and supplements). The amount of a fee for a prior approval supplement shall be half the amount of the fee for an abbreviated new drug application.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HA29C63264E484ABDB7C517460D0FBDE1"><enum>(C)</enum><text display-inline="yes-display-inline">56 percent shall be derived from fees under subsection (a)(4)(A)(i) (relating to generic drug facilities). The amount of the fee for a facility located outside the United States and its territories and possessions shall be not less than $15,000 and not more than $30,000 higher than the amount of the fee for a facility located in the United States and its territories and possessions, as determined by the Secretary on the basis of data concerning the difference in cost between inspections of facilities located in the United States, including its territories and possessions, and those located outside of the United States and its territories and possessions.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H28BD54C19369484FB9507AF648965CEA"><enum>(D)</enum><text display-inline="yes-display-inline">14 percent shall be derived from fees under subsection (a)(4)(A)(ii) (relating to active pharmaceutical ingredient facilities). The amount of the fee for a facility located outside the United States and its territories and possessions shall be not less than $15,000 and not more than $30,000 higher than the amount of the fee for a facility located in the United States, including its territories and possessions, as determined by the Secretary on the basis of data concerning the difference in cost between inspections of facilities located in the United States and its territories and possessions and those located outside of the United States and its territories and possessions.</text> </subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H36776C7F0C614DABB0EB6164679C34A4"><enum>(c)</enum><header display-inline="yes-display-inline">Adjustments</header> <paragraph commented="no" display-inline="no-display-inline" id="H2927A3F9FB754D56873537105560E1F6"><enum>(1)</enum><header display-inline="yes-display-inline">Inflation adjustment</header><text display-inline="yes-display-inline">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—</text> <subparagraph commented="no" display-inline="no-display-inline" id="HD42C74CC62984F17BAA79E86D9CE0091"><enum>(A)</enum><text display-inline="yes-display-inline">one;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H62EFB9AE2E924E54ACF013077D2E96AB"><enum>(B)</enum><text display-inline="yes-display-inline">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</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HA5CA859AC1354802BC55C53652476D7A"><enum>(C)</enum><text display-inline="yes-display-inline">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.</text> </subparagraph><continuation-text commented="no" continuation-text-level="paragraph">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.</continuation-text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H5B5A6B881F034D81AA1ABB4CD39A2990"><enum>(2)</enum><header display-inline="yes-display-inline">Final year adjustment</header><text display-inline="yes-display-inline">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.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HA54057A37B2A4CC4A79255530CFF9438"><enum>(d)</enum><header display-inline="yes-display-inline">Annual fee setting</header> <paragraph commented="no" display-inline="no-display-inline" id="H80B09CEEAF344EAF8A3C4D747025EDD5"><enum>(1)</enum><header display-inline="yes-display-inline">Fiscal year 2013</header><text display-inline="yes-display-inline">For fiscal year 2013—</text> <subparagraph commented="no" display-inline="no-display-inline" id="H4B11A39BB8404C4E87E35AC1B19AD1A9"><enum>(A)</enum><text display-inline="yes-display-inline">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</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HBAD57F25766349E7956AE1899DB78F6B"><enum>(B)</enum><text display-inline="yes-display-inline">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).</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H76CDCEE3A9F14081BAE69CC01C4EF651"><enum>(2)</enum><header display-inline="yes-display-inline">Fiscal years 2014 through 2017</header><text display-inline="yes-display-inline">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).</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="HE13C8AF1349C44B6BFFDA953E89EAC9B"><enum>(3)</enum><header display-inline="yes-display-inline">Fee for active pharmaceutical ingredient information not included by reference to Type II active pharmaceutical ingredient drug master file</header><text display-inline="yes-display-inline">In establishing the fees under paragraphs (1) and (2), the amount of the fee under subsection (a)(3)(F) shall be determined by multiplying—</text> <subparagraph commented="no" display-inline="no-display-inline" id="HB6552C2A89A64BA68EFF5E2C39214C87"><enum>(A)</enum><text display-inline="yes-display-inline">the sum of—</text> <clause commented="no" display-inline="no-display-inline" id="HCD3A9753FC344588BCDFC26579FE7FA4"><enum>(i)</enum><text display-inline="yes-display-inline">the total number of such active pharmaceutical ingredients in such submission; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="H472E12471D2B426FB223E144BAB33A30"><enum>(ii)</enum><text display-inline="yes-display-inline">for each such ingredient that is manufactured at more than one such facility, the total number of such additional facilities; and</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HAFFE9E51079A4A6897D56A930E66D802"><enum>(B)</enum><text display-inline="yes-display-inline">the amount equal to the drug master file fee established in subsection (a)(2) for such submission.</text> </subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HC8E508D7C32D4D1EA27E153321E5B565"><enum>(e)</enum><header display-inline="yes-display-inline">Limit</header><text display-inline="yes-display-inline">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.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="HE35D40AE9A6445D6908CF9452667EE81"><enum>(f)</enum><header display-inline="yes-display-inline">Identification of facilities</header> <paragraph commented="no" display-inline="no-display-inline" id="H73EBA345C35C430585BE58576F2F5377"><enum>(1)</enum><header display-inline="yes-display-inline">Publication of notice; deadline for compliance</header><text display-inline="yes-display-inline">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.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="H65C0847FB5024327A5C0968685D5014C"><enum>(2)</enum><header display-inline="yes-display-inline">Required submission of facility identification</header><text display-inline="yes-display-inline">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—</text> <subparagraph commented="no" display-inline="no-display-inline" id="H5F23468B46C74E279D75ABFC9D536F67"><enum>(A)</enum><text display-inline="yes-display-inline">for fiscal year 2013, be submitted not later than 60 days after the publication of the notice under paragraph (1); and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HCB32EA6429D14B1DAD28A82A1EBC9CF1"><enum>(B)</enum><text display-inline="yes-display-inline">for each subsequent fiscal year, be submitted, updated, or reconfirmed on or before June 1 of the previous year.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H53E93B2E5C2E474ABA448CD27DE4BEFA"><enum>(3)</enum><header display-inline="yes-display-inline">Contents of notice</header><text display-inline="yes-display-inline">At a minimum, the submission required by paragraph (2) shall include for each such facility—</text> <subparagraph commented="no" display-inline="no-display-inline" id="H98B97681239641309CA41633E27DCD93"><enum>(A)</enum><text display-inline="yes-display-inline">identification of a facility identified or intended to be identified in an approved or pending generic drug submission;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H27A0400F0D7E4140B3142096244EC1DA"><enum>(B)</enum><text display-inline="yes-display-inline">whether the facility manufactures active pharmaceutical ingredients or finished dosage forms, or both;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H48851B582F7A4AD2881C0BB4B1A0CB90"><enum>(C)</enum><text display-inline="yes-display-inline">whether or not the facility is located within the United States and its territories and possessions;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H1F71DBC26E8D4894A9469A720EBFAFF7"><enum>(D)</enum><text display-inline="yes-display-inline">whether the facility manufactures positron emission tomography drugs solely, or in addition to other drugs; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H20723E39FAA0496FBE723CC404BDE31C"><enum>(E)</enum><text display-inline="yes-display-inline">whether the facility manufactures drugs that are not generic drugs.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HB9ED05C81EFA469288F7C708D808D237"><enum>(4)</enum><header display-inline="yes-display-inline">Certain sites and organizations</header> <subparagraph commented="no" display-inline="no-display-inline" id="H7778DDE944684B8A80C6C363E55AF5EE"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H5012CBF0817D48EF9B6C259F97BEB698"><enum>(B)</enum><header display-inline="yes-display-inline">Sites and organizations</header><text display-inline="yes-display-inline">A site or organization is described in this subparagraph if it is identified in a generic drug submission and is—</text> <clause commented="no" display-inline="no-display-inline" id="H5FF9D520A4F14C76A99B49E1CB3A87EE"><enum>(i)</enum><text display-inline="yes-display-inline">a site in which a bioanalytical study is conducted;</text> </clause><clause commented="no" display-inline="no-display-inline" id="HE9AEF923029C4385A6203BB828024132"><enum>(ii)</enum><text display-inline="yes-display-inline">a clinical research organization;</text> </clause><clause commented="no" display-inline="no-display-inline" id="HF7F2DE2FF25C4530811C9DD051C49879"><enum>(iii)</enum><text display-inline="yes-display-inline">a contract analytical testing site; or</text> </clause><clause commented="no" display-inline="no-display-inline" id="HF872C1B873B24403A00DCA8019995ABE"><enum>(iv)</enum><text display-inline="yes-display-inline">a contract repackager site.</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H29F3DF437DA24D879F892139A6AA6C88"><enum>(C)</enum><header display-inline="yes-display-inline">Notice</header><text display-inline="yes-display-inline">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.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HABD82F96F3664D999D6AE04942F0C0D5"><enum>(D)</enum><header display-inline="yes-display-inline">Inspection authority</header><text display-inline="yes-display-inline">The Secretary’s inspection authority under section 704(a)(1) shall extend to all such sites and organizations.</text> </subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H12A466F5E5F24666A3AEB398FDD79C44"><enum>(g)</enum><header display-inline="yes-display-inline">Effect of failure To pay fees</header> <paragraph commented="no" display-inline="no-display-inline" id="H7EA06B749776486BB53E7CAFBF40545E"><enum>(1)</enum><header display-inline="yes-display-inline">Generic drug backlog fee</header><text display-inline="yes-display-inline">Failure to pay the fee under subsection (a)(1) shall result in the Secretary placing the person that owns the abbreviated new drug application subject to that fee on an arrears list, such that no new abbreviated new drug applications or supplement submitted on or after October 1, 2012, from that person, or any affiliate of that person, will be received within the meaning of section 505(j)(5)(A) until such outstanding fee is paid.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="H87F09DD3307B4CB4B8DC497F94E689B5"><enum>(2)</enum><header display-inline="yes-display-inline">Drug master file fee</header> <subparagraph commented="no" display-inline="no-display-inline" id="H9A72D7FF983746B9AE61BEBE5D98BA8F"><enum>(A)</enum><text display-inline="yes-display-inline">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.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H9D479991EB4F445DA8307AD06C31AC18"><enum>(B)</enum><clause commented="no" display-inline="yes-display-inline" id="H930A7F159306432D85660AD1390F516A"><enum>(i)</enum><text display-inline="yes-display-inline">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.</text> </clause><clause commented="no" display-inline="no-display-inline" id="H31B29ED2D25846FE8C93B0BFA55B877D" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">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).</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HDEA3317BA3E04E22B531D0AFDA6DFB76"><enum>(C)</enum><clause commented="no" display-inline="yes-display-inline" id="H081E6E99029C4AB8B6D3ED3D1008BBE2"><enum>(i)</enum><text display-inline="yes-display-inline">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.</text> </clause><clause commented="no" display-inline="no-display-inline" id="H41B60BF3EB0544A499536491C39BDD63" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">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).</text> </clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HBCD1EF2ECCAE4F5F8434739C43EDB4EC"><enum>(3)</enum><header display-inline="yes-display-inline">Abbreviated new drug application fee and prior approval supplement fee</header><text display-inline="yes-display-inline">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.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="H0083FA08F54843C299B9D676FE57A24A"><enum>(4)</enum><header display-inline="yes-display-inline">Generic drug facility fee and active pharmaceutical ingredient facility fee</header> <subparagraph commented="no" display-inline="no-display-inline" id="H91AD54770C5C4A38A979AC17E63DD407"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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:</text> <clause commented="no" display-inline="no-display-inline" id="H5F56475197B84934B3F97BE68F245800"><enum>(i)</enum><text display-inline="yes-display-inline">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).</text> </clause><clause commented="no" display-inline="no-display-inline" id="HC295B6D63F5148CE8098689322627EFA"><enum>(ii)</enum><text display-inline="yes-display-inline">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).</text> </clause><clause commented="no" display-inline="no-display-inline" id="H39B16283678045F09D6337D360EA42FE"><enum>(iii)</enum><text display-inline="yes-display-inline">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).</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H8A959CD864D64F4285FA28C38661B2F8"><enum>(B)</enum><header display-inline="yes-display-inline">Application of penalties</header><text display-inline="yes-display-inline">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.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HBBA6EFADE16D466E97EC652ACCBFF726"><enum>(C)</enum><header display-inline="yes-display-inline">Nonreceival for nonpayment</header> <clause commented="no" display-inline="no-display-inline" id="H150EC51F0F0642E28FAAF79201431262"><enum>(i)</enum><header display-inline="yes-display-inline">Notice</header><text display-inline="yes-display-inline">If an abbreviated new drug application or supplement to an abbreviated new drug application submitted on or after October 1, 2012, references a facility for which a facility fee has not been paid by the applicable date under subsection (a)(4)(C), the Secretary shall notify the sponsor of the generic drug submission of the failure of the owner of the facility to pay the facility fee.</text> </clause><clause commented="no" display-inline="no-display-inline" id="H4411617D145141CFA3A9F5E5C06EBF81"><enum>(ii)</enum><header display-inline="yes-display-inline">Nonreceival</header><text display-inline="yes-display-inline">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).</text> </clause></subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H43F35BC72DA64CF795B563A7758500F1"><enum>(h)</enum><header display-inline="yes-display-inline">Limitations</header> <paragraph commented="no" display-inline="no-display-inline" id="H5C059892D5824E3680AFD83C15AB5875"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Fees under subsection (a) shall be refunded for a fiscal year beginning after fiscal year 2012, unless appropriations for salaries and expenses of the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) are equal to or greater than the amount of appropriations for the salaries and expenses of the Food and Drug Administration for the fiscal year 2009 (excluding the amount of fees appropriated for such fiscal year) multiplied by the adjustment factor (as defined in section 744A) applicable to the fiscal year involved.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="HD2F9F1BCD4754B96A5A41F573F80DC2F"><enum>(2)</enum><header display-inline="yes-display-inline">Authority</header><text display-inline="yes-display-inline">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.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H7F8A6D8E424E4116B2E2845675B47E3B"><enum>(i)</enum><header display-inline="yes-display-inline">Crediting and availability of fees</header> <paragraph commented="no" display-inline="no-display-inline" id="HA46EAF7523E9427AB7D4A0DB18455D8F"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="H639565AA03EB4DFB9A78F4FD809AEB62"><enum>(2)</enum><header display-inline="yes-display-inline">Collections and appropriation acts</header> <subparagraph commented="no" display-inline="no-display-inline" id="HD8DE9489953B484F921A4622E449B864"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The fees authorized by this section—</text> <clause commented="no" display-inline="no-display-inline" id="H6C4616A3AC384D1CA4F1411B75C09791"><enum>(i)</enum><text display-inline="yes-display-inline">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</text> </clause><clause commented="no" display-inline="no-display-inline" id="H62B7090847EA490E86F8EC478D6968E4"><enum>(ii)</enum><text display-inline="yes-display-inline">shall be available for a fiscal year beginning after fiscal year 2012 to defray the costs of human generic drug activities (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such activities), only if the Secretary allocates for such purpose an amount for such fiscal year (excluding amounts from fees collected under this section) no less than $97,000,000 multiplied by the adjustment factor, as defined in section 744A(3), applicable to the fiscal year involved.</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H4F19ED57F4DD420C8377086161769024"><enum>(B)</enum><header display-inline="yes-display-inline">Compliance</header><text display-inline="yes-display-inline">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.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H60FEF01C96854076B76FEBC3C2681982"><enum>(C)</enum><header display-inline="yes-display-inline">Fee collection during first program year</header><text display-inline="yes-display-inline">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.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H9C8AA0D21E9A4E41AA8F7D3F5EB8EED3"><enum>(D)</enum><header display-inline="yes-display-inline">Provision for early payments in subsequent years</header><text display-inline="yes-display-inline">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.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H55D15C9C83F0422CA4DF87B9399FB9AB"><enum>(3)</enum><header display-inline="yes-display-inline">Authorization of appropriations</header><text display-inline="yes-display-inline">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.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H276E53F862E2402AA17119F5E6E76F65"><enum>(j)</enum><header display-inline="yes-display-inline">Collection of unpaid fees</header><text display-inline="yes-display-inline">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.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="HDED8CA49A1CF403D935A1D321E5C6C3F"><enum>(k)</enum><header display-inline="yes-display-inline">Construction</header><text display-inline="yes-display-inline">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.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="H3C895E463AF94B9AAC414F7CE7B64DD1"><enum>(l)</enum><header display-inline="yes-display-inline">Positron emission tomography drugs</header> <paragraph commented="no" display-inline="no-display-inline" id="HF6C475DBB44D4612BCCE8E5EC3F2D9EB"><enum>(1)</enum><header display-inline="yes-display-inline">Exemption from fees</header><text display-inline="yes-display-inline">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).</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="H908AD89B48CE4EB69762AEA2102F9148"><enum>(2)</enum><header display-inline="yes-display-inline">Identification requirement</header><text display-inline="yes-display-inline">Facilities that produce positron emission tomography drugs or active pharmaceutical ingredients of such drugs are required to be identified pursuant to subsection (f).</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H1E2084BA4B4849A3844799EB74FDA985"><enum>(m)</enum><header display-inline="yes-display-inline">Disputes concerning fees</header><text display-inline="yes-display-inline">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.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="HEF99BA7A7DF8421D939E636C5661001B"><enum>(n)</enum><header display-inline="yes-display-inline">Substantially complete applications</header><text display-inline="yes-display-inline">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 <quote>substantially complete</quote> 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.</text> </subsection></section></part><after-quoted-block>.</after-quoted-block></quoted-block> </section><section commented="no" display-inline="no-display-inline" id="H50BA12F7880B46C3B5F2503CC97F4EBA" section-type="subsequent-section"><enum>303.</enum><header display-inline="yes-display-inline">Reauthorization; reporting requirements</header><text display-inline="no-display-inline">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:</text> <quoted-block display-inline="no-display-inline" id="HF5D0A4F65A6B466699BBA23D43139219" style="OLC"> <section commented="no" display-inline="no-display-inline" id="H738651406D72462D80B4908444355F98" section-type="subsequent-section"><enum>744C.</enum><header display-inline="yes-display-inline">Reauthorization; reporting requirements</header> <subsection commented="no" display-inline="no-display-inline" id="H9F3F8EB99D8B49D28883D6528B55AFAB"><enum>(a)</enum><header display-inline="yes-display-inline">Performance report</header><text display-inline="yes-display-inline">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 <short-title>Generic Drug User Fee Amendments of 2012</short-title> during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="H03C97767C5F14CA38830FE176CBCCDEE"><enum>(b)</enum><header display-inline="yes-display-inline">Fiscal report</header><text display-inline="yes-display-inline">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.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="H52B725520D6B45B3B558C40DBC4A44F4"><enum>(c)</enum><header display-inline="yes-display-inline">Public availability</header><text display-inline="yes-display-inline">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.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="HBFC057964843484FAC610D1BD39F1EF7"><enum>(d)</enum><header display-inline="yes-display-inline">Reauthorization</header> <paragraph commented="no" display-inline="no-display-inline" id="HD2777F94C16C4CFC888DD1FFEDB1A317"><enum>(1)</enum><header display-inline="yes-display-inline">Consultation</header><text display-inline="yes-display-inline">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—</text> <subparagraph commented="no" display-inline="no-display-inline" id="H2A2EB8FEF3E144E4979BA7495690430D"><enum>(A)</enum><text display-inline="yes-display-inline">the Committee on Energy and Commerce of the House of Representatives;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HDD61E726B6C6432BB88C1B651DBFC670"><enum>(B)</enum><text display-inline="yes-display-inline">the Committee on Health, Education, Labor, and Pensions of the Senate;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HC2DB44ECA6974A81BE6C361A312D2F68"><enum>(C)</enum><text display-inline="yes-display-inline">scientific and academic experts;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H9B5A065B3EC7457C80064974B7E34EB6"><enum>(D)</enum><text display-inline="yes-display-inline">health care professionals;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H30183252BBC440A6A7E976552766D351"><enum>(E)</enum><text display-inline="yes-display-inline">representatives of patient and consumer advocacy groups; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HFB8673A7D62A44779109C443AE0DDBAA"><enum>(F)</enum><text display-inline="yes-display-inline">the generic drug industry.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H87E41123B3F6439C917C1932816FDC5D"><enum>(2)</enum><header display-inline="yes-display-inline">Prior public input</header><text display-inline="yes-display-inline">Prior to beginning negotiations with the generic drug industry on the reauthorization of this part, the Secretary shall—</text> <subparagraph commented="no" display-inline="no-display-inline" id="HFFE0EE17044B48BD8D7DDD5C0ECFF345"><enum>(A)</enum><text display-inline="yes-display-inline">publish a notice in the Federal Register requesting public input on the reauthorization;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H76152CB756F64ED6B75C905CE8D709AE"><enum>(B)</enum><text display-inline="yes-display-inline">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);</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HED6EF5DBDFB440BC90455219512FE6DA"><enum>(C)</enum><text display-inline="yes-display-inline">provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to this part; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HFF064201BA4B4566AEBC211C5661D093"><enum>(D)</enum><text display-inline="yes-display-inline">publish the comments on the Food and Drug Administration’s Internet Web site.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HDBF23DCD20C24066AC640C795116E053"><enum>(3)</enum><header display-inline="yes-display-inline">Periodic consultation</header><text display-inline="yes-display-inline">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).</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="H5C7BB89722734CBC8C2892AA5E1EA3E4"><enum>(4)</enum><header display-inline="yes-display-inline">Public review of recommendations</header><text display-inline="yes-display-inline">After negotiations with the generic drug industry, the Secretary shall—</text> <subparagraph commented="no" display-inline="no-display-inline" id="H77F18E02062C41B1B079229C172074F0"><enum>(A)</enum><text display-inline="yes-display-inline">present the recommendations developed under paragraph (1) to the congressional committees specified in such paragraph;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H9C97C4F114E54481920B74BF905092E5"><enum>(B)</enum><text display-inline="yes-display-inline">publish such recommendations in the Federal Register;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HEF2E847563AA410CAC908AC52632A203"><enum>(C)</enum><text display-inline="yes-display-inline">provide for a period of 30 days for the public to provide written comments on such recommendations;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H8763DF4950E24DED8DCC099B058930E0"><enum>(D)</enum><text display-inline="yes-display-inline">hold a meeting at which the public may present its views on such recommendations; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H8F3E00229E5D442CBBC67F36D6DEDE36"><enum>(E)</enum><text display-inline="yes-display-inline">after consideration of such public views and comments, revise such recommendations as necessary.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H52B28B412EE74C479CA539208BFF875E"><enum>(5)</enum><header display-inline="yes-display-inline">Transmittal of recommendations</header><text display-inline="yes-display-inline">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.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="H6B712C88640A4465982C28D9F8BD4F7D"><enum>(6)</enum><header display-inline="yes-display-inline">Minutes of negotiation meetings</header> <subparagraph commented="no" display-inline="no-display-inline" id="H6F780E3B826548AF9EC2D48D1F9F4DFF"><enum>(A)</enum><header display-inline="yes-display-inline">Public availability</header><text display-inline="yes-display-inline">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.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HC78E71E24AE7430D8E11BE16E114B79A"><enum>(B)</enum><header display-inline="yes-display-inline">Content</header><text display-inline="yes-display-inline">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.</text> </subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block> </section><section commented="no" display-inline="no-display-inline" id="H34E33EF8AAAB450682831A50B58F5D4C" section-type="subsequent-section"><enum>304.</enum><header display-inline="yes-display-inline">Sunset dates</header> <subsection commented="no" display-inline="no-display-inline" id="HC1E10E1A6DB1470E82852556D5102175"><enum>(a)</enum><header display-inline="yes-display-inline">Authorization</header><text display-inline="yes-display-inline">The amendments made by section 302 cease to be effective October 1, 2017.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="H65D668E69E574F94BA4F6BB6ED8681DA"><enum>(b)</enum><header display-inline="yes-display-inline">Reporting requirements</header><text display-inline="yes-display-inline">The amendments made by section 303 cease to be effective January 31, 2018.</text> </subsection></section><section commented="no" display-inline="no-display-inline" id="H46D7C2642256452697086C323E55792E" section-type="subsequent-section"><enum>305.</enum><header display-inline="yes-display-inline">Effective date</header><text display-inline="no-display-inline">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.</text> </section><section commented="no" display-inline="no-display-inline" id="HD3F93C32845744119539B4B70BB136BF" section-type="subsequent-section"><enum>306.</enum><header display-inline="yes-display-inline">Amendment with respect to misbranding</header><text display-inline="no-display-inline">Section 502 (21 U.S.C. 352) is amended by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="H75EC2FD6A4764CDBBE7E4B7A308C95C8" style="OLC"> <subsection commented="no" display-inline="no-display-inline" id="HBB7177D582804F51B3B272E713FC3E5C"><enum>(aa)</enum><text display-inline="yes-display-inline">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.</text> </subsection><after-quoted-block>.</after-quoted-block></quoted-block> </section><section commented="no" display-inline="no-display-inline" id="H3BC953D644B44CBB8B6C599B0483B626" section-type="subsequent-section"><enum>307.</enum><header display-inline="yes-display-inline">Streamlined hiring authority of the Food and Drug Administration to support activities related to human generic drugs</header><text display-inline="no-display-inline">Section 714 of the Federal Food, Drug, and Cosmetic Act, as added by section 208, is amended—</text> <paragraph commented="no" display-inline="no-display-inline" id="id07CDB1E05417441EA676FBA18B2C385C"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (b)—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id7C1743AA3D8949E3A39483E238939788"><enum>(A)</enum><text display-inline="yes-display-inline">by striking <quote>are activities</quote> and inserting “are—</text> <quoted-block display-inline="no-display-inline" id="idCDAC1AAAB3E64461AD3E907ADF4F61A0" style="OLC"> <paragraph commented="no" display-inline="no-display-inline" id="id4967DCB6E0CF428D993543F2D94A613E"><enum>(1)</enum><text display-inline="yes-display-inline">activities</text> </paragraph><after-quoted-block>;</after-quoted-block></quoted-block> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idD938F6C7EB1A4CB9A7D29A8D49A78F6C"><enum>(B)</enum><text display-inline="yes-display-inline">by striking the period at the end and inserting <quote>; and</quote>; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id2BE8935A4D714233ABB331A4068CD44A"><enum>(C)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="HCC00482686D74EAC8A262F587048203D" style="OLC"> <paragraph commented="no" display-inline="no-display-inline" id="id518BDC4CD8F64F52B81E583C51BCC956"><enum>(2)</enum><text display-inline="yes-display-inline">activities under this Act related to human generic drug activities (as defined in section 744A).</text> </paragraph><after-quoted-block>; and</after-quoted-block></quoted-block> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id1D47D8F4D1194C84AF48AD89A98E5ABE"><enum>(2)</enum><text display-inline="yes-display-inline">by amending subsection (c) to read as follows:</text> <quoted-block display-inline="no-display-inline" id="idCD824226F75F4C67825DB932D985D53B" style="OLC"> <subsection commented="no" display-inline="no-display-inline" id="HEF15466B0B474D7499B8F30C5B9742BB"><enum>(c)</enum><header display-inline="yes-display-inline">Objectives specified</header><text display-inline="yes-display-inline">The objectives specified in this subsection are—</text> <paragraph commented="no" display-inline="no-display-inline" id="id97DEBA62C5FB4E0EB47856D84517EA3F"><enum>(1)</enum><text display-inline="yes-display-inline">with respect to the activities under subsection (b)(1), the goals referred to in section 738A(a)(1); and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idD1AB4EB534914568856E3C6952388BF0"><enum>(2)</enum><text display-inline="yes-display-inline">with respect to the activities under subsection (b)(2), the performance goals with respect to section 744A (regarding assessment and use of human generic drug fees), as set forth in the letters described in section 301(b) of the <short-title>Generic Drug User Fee Amendments of 2012</short-title>.</text> </paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph></section><enum>IV</enum><header display-inline="yes-display-inline">Fees relating to biosimilar biological products</header> <section commented="no" display-inline="no-display-inline" id="H41FC53C9A3F148FCA92708774E7F58C5" section-type="subsequent-section"><enum>401.</enum><header display-inline="yes-display-inline">Short title; finding</header> <subsection commented="no" display-inline="no-display-inline" id="H2538D0B6E84943AD8EBDEAE0FD702130"><enum>(a)</enum><header display-inline="yes-display-inline">Short title</header><text display-inline="yes-display-inline">This title may be cited as the <quote><short-title>Biosimilar User Fee Act of 2012</short-title></quote>.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="H7379F26A2D7B426FB25CE4E4184B909F"><enum>(b)</enum><header display-inline="yes-display-inline">Finding</header><text display-inline="yes-display-inline">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.</text> </subsection></section><section commented="no" display-inline="no-display-inline" id="HAF8F2B2589424427A77174C57B5BA317" section-type="subsequent-section"><enum>402.</enum><header display-inline="yes-display-inline">Fees relating to biosimilar biological products</header><text display-inline="no-display-inline">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:</text> <quoted-block display-inline="no-display-inline" id="HFA8F7E7CA8CD4074B1859AB8EAEDF28C" style="OLC"> <part commented="no" id="HFDD9FCD553C746D5B07A011639F73595" level-type="subsequent"><enum>8</enum><header display-inline="yes-display-inline">FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS</header> <section commented="no" display-inline="no-display-inline" id="H0A56D97651FE4D18B3D8073F36BB56B6" section-type="subsequent-section"><enum>744G.</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="no-display-inline">For purposes of this part:</text> <paragraph commented="no" display-inline="no-display-inline" id="HC520158BB6FB46B89F621951FEE922BC"><enum>(1)</enum><text display-inline="yes-display-inline">The term <term>adjustment factor</term> 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.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="H2E2D783E2A21490EBA6DC959BB7D116B"><enum>(2)</enum><text display-inline="yes-display-inline">The term <term>affiliate</term> means a business entity that has a relationship with a second business entity if, directly or indirectly—</text> <subparagraph commented="no" display-inline="no-display-inline" id="H796589AF948C436AB885286F91D4962C"><enum>(A)</enum><text display-inline="yes-display-inline">one business entity controls, or has the power to control, the other business entity; or</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HC88673D835E148EEB9F66D39A9E92547"><enum>(B)</enum><text display-inline="yes-display-inline">a third party controls, or has power to control, both of the business entities.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HE56A9B876A184711AB53AD5E54ED1767"><enum>(3)</enum><text display-inline="yes-display-inline">The term <term>biosimilar biological product</term> means a product for which a biosimilar biological product application has been approved.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="H411E846D14B448F697B5D718991F5D23"><enum>(4)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="H71E00D610C894A44BE4D9E9A5CDAAC28"><enum>(A)</enum><text display-inline="yes-display-inline">Subject to subparagraph (B), the term <term>biosimilar biological product application</term> means an application for licensure of a biological product under section 351(k) of the Public Health Service Act.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H88735E75EC764D1FBF4084B2DFD632BD" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">Such term does not include—</text> <clause commented="no" display-inline="no-display-inline" id="H31C69ADF1E234470A3BB4FC19BCF8662"><enum>(i)</enum><text display-inline="yes-display-inline">a supplement to such an application;</text> </clause><clause commented="no" display-inline="no-display-inline" id="H60B6546623B34E7E8B740B924CE2EEC4"><enum>(ii)</enum><text display-inline="yes-display-inline">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;</text> </clause><clause commented="no" display-inline="no-display-inline" id="H73E2D2F9B6C8436DADCA7DBB245FFD13"><enum>(iii)</enum><text display-inline="yes-display-inline">an application filed under section 351(k) of the Public Health Service Act with respect to—</text> <subclause commented="no" display-inline="no-display-inline" id="H6C546E14CEE04D2CB2ACC462BA5C960C"><enum>(I)</enum><text display-inline="yes-display-inline">whole blood or a blood component for transfusion;</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="HA2CC3AD0568747E1870413D8552DB2D0"><enum>(II)</enum><text display-inline="yes-display-inline">an allergenic extract product;</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="HDA6535CA6DF8492688FEBA72E28B22F1"><enum>(III)</enum><text display-inline="yes-display-inline">an in vitro diagnostic biological product; or</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="H340CE1A9FE21454EB63EDF638CFD3A57"><enum>(IV)</enum><text display-inline="yes-display-inline">a biological product for further manufacturing use only; or</text> </subclause></clause><clause commented="no" display-inline="no-display-inline" id="H0B3DFA8FB51A403CB069BD7CC64016DB"><enum>(iv)</enum><text display-inline="yes-display-inline">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.</text> </clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H0EE40B8092F849CC931AD9764AB6219E"><enum>(5)</enum><text display-inline="yes-display-inline">The term <term>biosimilar biological product development meeting</term> 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.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="HA4C70998410F4190B9576C90CEFAFD46"><enum>(6)</enum><text display-inline="yes-display-inline">The term <term>biosimilar biological product development program</term> means the program under this part for expediting the process for the review of submissions in connection with biosimilar biological product development.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="HCDF1DAF2C02D4EC48245CF7630E573AA"><enum>(7)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="H279D41AC79A8424495E67E6B83B8EAD5"><enum>(A)</enum><text display-inline="yes-display-inline">The term <term>biosimilar biological product establishment</term> means a foreign or domestic place of business—</text> <clause commented="no" display-inline="no-display-inline" id="H3D6F0A33F0F04E68930F430E2278102E" indent="up1"><enum>(i)</enum><text display-inline="yes-display-inline">that is at one general physical location consisting of one or more buildings, all of which are within five miles of each other; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="HE2D067D738474941AFDEE3A1288DEDA1" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">at which one or more biosimilar biological products are manufactured in final dosage form.</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H20549EB6F95A40948F97E77ABB450983" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">For purposes of subparagraph (A)(ii), the term <term>manufactured</term> does not include packaging.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H2A6FB7FFCC33450E9F0B1F59DF84D883"><enum>(8)</enum><text display-inline="yes-display-inline">The term <term>biosimilar initial advisory meeting</term>—</text> <subparagraph commented="no" display-inline="no-display-inline" id="HA99F91ED336F475F83C7EB4F86E4C0E5"><enum>(A)</enum><text display-inline="yes-display-inline">means a meeting, if requested, that is limited to—</text> <clause commented="no" display-inline="no-display-inline" id="H7F40DAABFBCA44C5B2D6CAC787F7455F"><enum>(i)</enum><text display-inline="yes-display-inline">a general discussion regarding whether licensure under section 351(k) of the Public Health Service Act may be feasible for a particular product; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="HB6BDE47C2416411ABD8B6D49879402BA"><enum>(ii)</enum><text display-inline="yes-display-inline">if so, general advice on the expected content of the development program; and</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HD3EB5BBD04AF44F88989769616775EF5"><enum>(B)</enum><text display-inline="yes-display-inline">does not include any meeting that involves substantive review of summary data or full study reports.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H78F459E0977F4C498672B534449866D3"><enum>(9)</enum><text display-inline="yes-display-inline">The term <term>costs of resources allocated for the process for the review of biosimilar biological product applications</term> means the expenses in connection with the process for the review of biosimilar biological product applications for—</text> <subparagraph commented="no" display-inline="no-display-inline" id="H4ACE0C37321743829FA1AC110423057E"><enum>(A)</enum><text display-inline="yes-display-inline">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;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H8903914EE586446180DAA8DD6EB4317D"><enum>(B)</enum><text display-inline="yes-display-inline">management of information, and the acquisition, maintenance, and repair of computer resources;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H82ACC9FAE76544A5AEB1EA8E5AEA9994"><enum>(C)</enum><text display-inline="yes-display-inline">leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H0BE4B86773FE4EEA85F98DAE6A4490EF"><enum>(D)</enum><text display-inline="yes-display-inline">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.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H2CFA62627448450EB6009B9AD7E2FC6D"><enum>(10)</enum><text display-inline="yes-display-inline">The term <term>final dosage form</term> 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).</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="H12366526662E4404A561D8DED02989B5"><enum>(11)</enum><text display-inline="yes-display-inline">The term <term>financial hold</term>—</text> <subparagraph commented="no" display-inline="no-display-inline" id="HE345D8A8344F41B1BCD6B83C075C265A"><enum>(A)</enum><text display-inline="yes-display-inline">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</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H4E85E215213543C4BB0017A1F89565E8"><enum>(B)</enum><text display-inline="yes-display-inline">does not mean that any of the bases for a <quote>clinical hold</quote> under section 505(i)(3) have been determined by the Secretary to exist concerning the investigation.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H69A2A06D1B7043B8BF54D414ADDB772A"><enum>(12)</enum><text display-inline="yes-display-inline">The term <term>person</term> includes an affiliate of such person.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="H9C1E5384DB8D4761A974566BF8048840"><enum>(13)</enum><text display-inline="yes-display-inline">The term <term>process for the review of biosimilar biological product applications</term> 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:</text> <subparagraph commented="no" display-inline="no-display-inline" id="HF7763099E6F2407D80FCBC6491807EFA"><enum>(A)</enum><text display-inline="yes-display-inline">The activities necessary for the review of submissions in connection with biosimilar biological product development, biosimilar biological product applications, and supplements.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H6B7BC132FE6F4A05BCABBF52275FF43E"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HA6495BA7EC144E99BB16A8CCDDB299CE"><enum>(C)</enum><text display-inline="yes-display-inline">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.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HB83AF174F3F84B0498DB469EE491F51D"><enum>(D)</enum><text display-inline="yes-display-inline">Activities necessary for the release of lots of biosimilar biological products under section 351(k) of the Public Health Service Act.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H5B9A5D0D95F14C998C5A0153215F1A6F"><enum>(E)</enum><text display-inline="yes-display-inline">Monitoring of research conducted in connection with the review of biosimilar biological product applications.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H377C0208DE8C403081F38A16D8A7F487"><enum>(F)</enum><text display-inline="yes-display-inline">Postmarket safety activities with respect to biologics approved under biosimilar biological product applications or supplements, including the following activities:</text> <clause commented="no" display-inline="no-display-inline" id="H1B7C88DD5F904F73BA7D4BEA15152F3F"><enum>(i)</enum><text display-inline="yes-display-inline">Collecting, developing, and reviewing safety information on biosimilar biological products, including adverse-event reports.</text> </clause><clause commented="no" display-inline="no-display-inline" id="H1814EFE72F0E46B6AABF17E1B007C4DF"><enum>(ii)</enum><text display-inline="yes-display-inline">Developing and using improved adverse-event data-collection systems, including information technology systems.</text> </clause><clause commented="no" display-inline="no-display-inline" id="H1745F9031D88467E8DACCEA247E7F5C8"><enum>(iii)</enum><text display-inline="yes-display-inline">Developing and using improved analytical tools to assess potential safety problems, including access to external data bases.</text> </clause><clause commented="no" display-inline="no-display-inline" id="H43C8E41DB1EC4C89B4197A4BA23DB2D3"><enum>(iv)</enum><text display-inline="yes-display-inline">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).</text> </clause><clause commented="no" display-inline="no-display-inline" id="HA596102813A446F5BDF8E756A19918D8"><enum>(v)</enum><text display-inline="yes-display-inline">Carrying out section 505(k)(5) (relating to adverse-event reports and postmarket safety activities).</text> </clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HFA964895B88F4302AC2F7B7B8016FCD5"><enum>(14)</enum><text display-inline="yes-display-inline">The term <term>supplement</term> 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.</text> </paragraph></section><section commented="no" display-inline="no-display-inline" id="H2E4931C4A6AA4B97A92051BD5C8FF448" section-type="subsequent-section"><enum>744H.</enum><header display-inline="yes-display-inline">Authority to assess and use biosimilar biological product fees</header> <subsection commented="no" display-inline="no-display-inline" id="H888D063DA691488199873B5438C357F1"><enum>(a)</enum><header display-inline="yes-display-inline">Types of fees</header><text display-inline="yes-display-inline">Beginning in fiscal year 2013, the Secretary shall assess and collect fees in accordance with this section as follows:</text> <paragraph commented="no" display-inline="no-display-inline" id="H50088CD870C54E1D8D8914AC9172B2A0"><enum>(1)</enum><header display-inline="yes-display-inline">Biosimilar development program fees</header> <subparagraph commented="no" display-inline="no-display-inline" id="H1262A831B1914F4183DFA099E66FE5F2"><enum>(A)</enum><header display-inline="yes-display-inline">Initial biosimilar biological product development fee</header> <clause commented="no" display-inline="no-display-inline" id="HC257F9453ED347759358D20EAEF95AB3"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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).</text> </clause><clause commented="no" display-inline="no-display-inline" id="HC091AC54161F401FB14F7DFD92D1DCD7"><enum>(ii)</enum><header display-inline="yes-display-inline">Meeting request</header><text display-inline="yes-display-inline">The meeting request described in this clause is a request for a biosimilar biological product development meeting for a product.</text> </clause><clause commented="no" display-inline="no-display-inline" id="HC6EC90423CE64EF6819B9904CA04478D"><enum>(iii)</enum><header display-inline="yes-display-inline">Clinical protocol for IND</header><text display-inline="yes-display-inline">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 <quote>investigational new drug application</quote>) describing an investigation that the Secretary determines is intended to support a biosimilar biological product application for a product.</text> </clause><clause commented="no" display-inline="no-display-inline" id="H88098462DA7B4591957FD415467DEF77"><enum>(iv)</enum><header display-inline="yes-display-inline">Due Date</header><text display-inline="yes-display-inline">The initial biosimilar biological product development fee shall be due by the earlier of the following:</text> <subclause commented="no" display-inline="no-display-inline" id="H5A5B2EFF1BA3416EAF3D116FB729DF03"><enum>(I)</enum><text display-inline="yes-display-inline">Not later than 5 days after the Secretary grants a request for a biosimilar biological product development meeting.</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="HF4679468EE344300B3B381109A0C8DFA"><enum>(II)</enum><text display-inline="yes-display-inline">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.</text> </subclause></clause><clause commented="no" display-inline="no-display-inline" id="H7C958522F1F148A6B04BD0A30DB6F941"><enum>(v)</enum><header display-inline="yes-display-inline">Transition rule</header><text display-inline="yes-display-inline">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:</text> <subclause commented="no" display-inline="no-display-inline" id="H0696E38D607A489986399E7F24C5F244"><enum>(I)</enum><text display-inline="yes-display-inline">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.</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="H4BD844E7CC374D51B87A84C9AD742E37"><enum>(II)</enum><text display-inline="yes-display-inline">Not later than 5 days after the Secretary grants a request for a biosimilar biological product development meeting.</text> </subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H877E2390C2344518A3101BC1FA5073DE"><enum>(B)</enum><header display-inline="yes-display-inline">Annual biosimilar biological product development fee</header> <clause commented="no" display-inline="no-display-inline" id="H7A0D8FB143B146B2AFCCB436D55807BC"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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 <quote>annual biosimilar biological product development fee</quote>).</text> </clause><clause commented="no" display-inline="no-display-inline" id="H03B8CFA95F154418B1E73E76D35FCA92"><enum>(ii)</enum><header display-inline="yes-display-inline">Due date</header><text display-inline="yes-display-inline">The annual biosimilar biological product development program fee for each fiscal year will be due on the later of—</text> <subclause commented="no" display-inline="no-display-inline" id="H386C692517104B78A7B2424864B9393B"><enum>(I)</enum><text display-inline="yes-display-inline">the first business day on or after October 1 of each such year; or</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="HD249130809724717B603D9D01A489F36"><enum>(II)</enum><text display-inline="yes-display-inline">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.</text> </subclause></clause><clause commented="no" display-inline="no-display-inline" id="HF3702C53470C4ADD98D60BE1EE9DB7DB"><enum>(iii)</enum><header display-inline="yes-display-inline">Exception</header><text display-inline="yes-display-inline">The annual biosimilar development program fee for each fiscal year will be due on the date specified in clause (ii), unless the person has—</text> <subclause commented="no" display-inline="no-display-inline" id="HF3AA7E4C56774C51B83153C768E63967"><enum>(I)</enum><text display-inline="yes-display-inline">submitted a marketing application for the biological product that was accepted for filing; or</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="H55E900ADD3FF4141A4BDA212A2451647"><enum>(II)</enum><text display-inline="yes-display-inline">discontinued participation in the biosimilar biological product development program for the product under subparagraph (C).</text> </subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HCA1B53EEBFC94625A071A8A8F1BCCBA3"><enum>(C)</enum><header display-inline="yes-display-inline">Discontinuation of fee obligation</header><text display-inline="yes-display-inline">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—</text> <clause commented="no" display-inline="no-display-inline" id="HCB46DD4E0FB94F0EA324F8F0370EA4EB"><enum>(i)</enum><text display-inline="yes-display-inline">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</text> </clause><clause commented="no" display-inline="no-display-inline" id="HE908B5B2FB2D43F4869186E7283E443B"><enum>(ii)</enum><text display-inline="yes-display-inline">if an investigational new drug application concerning the product has been submitted, by withdrawing the investigational new drug application in accordance with part 312 of title 21, Code of Federal Regulations (or any successor regulations).</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H17E746F3068B43FC8D0CDB2CF82432FD"><enum>(D)</enum><header display-inline="yes-display-inline">Reactivation fee</header> <clause commented="no" display-inline="no-display-inline" id="HFF63C1C8A8DD44F8A8F31332BC3A5D4A"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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 <quote>reactivation fee</quote>) by the earlier of the following:</text> <subclause commented="no" display-inline="no-display-inline" id="H4C1223D7CCDF49FBA32A966E8A07BFCD"><enum>(I)</enum><text display-inline="yes-display-inline">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).</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="H1A86876CF2D24BD58E819E7BBC0F0147"><enum>(II)</enum><text display-inline="yes-display-inline">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.</text> </subclause></clause><clause commented="no" display-inline="no-display-inline" id="H3F7FC63F14264B12A45F067AAEF138C9"><enum>(ii)</enum><header display-inline="yes-display-inline">Application of annual fee</header><text display-inline="yes-display-inline">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).</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H871EF5E80F7B41C5A9F0FE5563C29C9C"><enum>(E)</enum><header display-inline="yes-display-inline">Effect of failure to pay biosimilar development program fees</header> <clause commented="no" display-inline="no-display-inline" id="HC336DFE758064344B2B34837AB1D82A0"><enum>(i)</enum><header display-inline="yes-display-inline">No biosimilar biological product development meetings</header><text display-inline="yes-display-inline">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.</text> </clause><clause commented="no" display-inline="no-display-inline" id="H3A495C991BC24A2E9DB9DC52F6092DC9"><enum>(ii)</enum><header display-inline="yes-display-inline">No receipt of investigational new drug applications</header><text display-inline="yes-display-inline">Except in extraordinary circumstances, the Secretary shall not consider an investigational new drug application to have been received under section 505(i)(2) if—</text> <subclause commented="no" display-inline="no-display-inline" id="H2FAD50511F2440A6B3000050993CF550"><enum>(I)</enum><text display-inline="yes-display-inline">the Secretary determines that the investigation is intended to support a biosimilar biological product application; and</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="HE8BE0A2EAD104727944FBA42065C24D5"><enum>(II)</enum><text display-inline="yes-display-inline">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).</text> </subclause></clause><clause commented="no" display-inline="no-display-inline" id="HCDCE872238704975BB3C0108C7E2B4D8"><enum>(iii)</enum><header display-inline="yes-display-inline">Financial hold</header><text display-inline="yes-display-inline">Notwithstanding section 505(i)(2), except in extraordinary circumstances, the Secretary shall prohibit the sponsor of a clinical investigation from continuing the investigation if—</text> <subclause commented="no" display-inline="no-display-inline" id="H96D933FF58BE45B28D41940B541D5FA7"><enum>(I)</enum><text display-inline="yes-display-inline">the Secretary determines that the investigation is intended to support a biosimilar biological product application; and</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="HDEEF064288FE4CFBBEFDBEC9CF6149CF"><enum>(II)</enum><text display-inline="yes-display-inline">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).</text> </subclause></clause><clause commented="no" display-inline="no-display-inline" id="HB49A9D8D9DCF452A9107CA7D7C28335D"><enum>(iv)</enum><header display-inline="yes-display-inline">No acceptance of biosimilar biological product applications or supplements</header><text display-inline="yes-display-inline">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.</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H8CCE4AFC23694A728B3251DFDABC8D30"><enum>(F)</enum><header display-inline="yes-display-inline">Limits regarding biosimilar development program fees</header> <clause commented="no" display-inline="no-display-inline" id="H7900DDBE34034A6FA90514E391EAE0B1"><enum>(i)</enum><header display-inline="yes-display-inline">No refunds</header><text display-inline="yes-display-inline">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).</text> </clause><clause commented="no" display-inline="no-display-inline" id="H9201F23C90C741D3B81D8A413DF54BCE"><enum>(ii)</enum><header display-inline="yes-display-inline">No waivers, exemptions, or reductions</header><text display-inline="yes-display-inline">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).</text> </clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H6DAF7A49A21E45CD86CB1DA159205AAD"><enum>(2)</enum><header display-inline="yes-display-inline">Biosimilar biological product application and supplement fee</header> <subparagraph commented="no" display-inline="no-display-inline" id="H147E49E613BC40E798832CA2A5D3E714"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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:</text> <clause commented="no" display-inline="no-display-inline" id="H8ED6E9D59BE749EDA58A952DA085444E"><enum>(i)</enum><text display-inline="yes-display-inline">A fee for a biosimilar biological product application that is equal to—</text> <subclause commented="no" display-inline="no-display-inline" id="H78088F62DF1C4ECA9B0B8CD318A26373"><enum>(I)</enum><text display-inline="yes-display-inline">the amount of the fee established under subsection (b)(1)(D) for a biosimilar biological product application; minus</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="H2621670B0130400882CDBCE4B866555C"><enum>(II)</enum><text display-inline="yes-display-inline">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.</text> </subclause></clause><clause commented="no" display-inline="no-display-inline" id="H899CB3FC455A4E3388255A85B0FBC54D"><enum>(ii)</enum><text display-inline="yes-display-inline">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—</text> <subclause commented="no" display-inline="no-display-inline" id="HABC7A4D7D47F4B37B6FEFBE8BCEA4D4C"><enum>(I)</enum><text display-inline="yes-display-inline">half of the amount of the fee established under subsection (b)(1)(D) for a biosimilar biological product application; minus</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="H096C1B11A97C4E3A9FAA5B67555E91E5"><enum>(II)</enum><text display-inline="yes-display-inline">the cumulative amount of fees paid, if any, under subparagraphs (A), (B), and (D) of paragraph (1) for that product.</text> </subclause></clause><clause commented="no" display-inline="no-display-inline" id="HBA385AE63D5449B0AD3BDB7AC0C46240"><enum>(iii)</enum><text display-inline="yes-display-inline">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.</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H2380BC6E45694E399857A4368F7DD0D5"><enum>(B)</enum><header display-inline="yes-display-inline">Reduction in fees</header><text display-inline="yes-display-inline">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.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HE2144AACBA1D4361BA17EEFFD015C5FE"><enum>(C)</enum><header display-inline="yes-display-inline">Payment due date</header><text display-inline="yes-display-inline">Any fee required by subparagraph (A) shall be due upon submission of the application or supplement for which such fee applies.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H610193E30EE0461BBD67FA5813F776A7"><enum>(D)</enum><header display-inline="yes-display-inline">Exception for previously filed application or supplement</header><text display-inline="yes-display-inline">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).</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H75718529BD1A47D9B6236C7DEFE3A4F2"><enum>(E)</enum><header display-inline="yes-display-inline">Refund of application fee if application refused for filing or withdrawn before filing</header><text display-inline="yes-display-inline">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.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H09DB9A0927424077AE0FF92E435EE9A4"><enum>(F)</enum><header display-inline="yes-display-inline">Fees for applications previously refused for filing or withdrawn before filing</header><text display-inline="yes-display-inline">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).</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H39A22AE5A303487181017B98C29A5BEE"><enum>(3)</enum><header display-inline="yes-display-inline">Biosimilar biological product establishment fee</header> <subparagraph commented="no" display-inline="no-display-inline" id="H746C8E53E3D140259A64A7450990B249"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H1C5D0497F80D4BC9AB94F380F62C3982"><enum>(B)</enum><header display-inline="yes-display-inline">Assessment in fiscal years</header><text display-inline="yes-display-inline">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.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H4B28F7ADE1B648028AF0BF2B1366BED9"><enum>(C)</enum><header display-inline="yes-display-inline">Due date</header><text display-inline="yes-display-inline">The establishment fee for a fiscal year shall be due on the later of—</text> <clause commented="no" display-inline="no-display-inline" id="H284FB26B91E44DD8A6560AA712023D89"><enum>(i)</enum><text display-inline="yes-display-inline">the first business day on or after October 1 of such fiscal year; or</text> </clause><clause commented="no" display-inline="no-display-inline" id="HAD820D9FA8514165B18B9268884D6E74"><enum>(ii)</enum><text display-inline="yes-display-inline">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.</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HC6B847A56ACF4800A3C22044C16C59CF"><enum>(D)</enum><header display-inline="yes-display-inline">Application to establishment</header> <clause commented="no" display-inline="no-display-inline" id="HB3F7DC5C2F95485782BC4C4B47FC0E7C"><enum>(i)</enum><text display-inline="yes-display-inline">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).</text> </clause><clause commented="no" display-inline="no-display-inline" id="H900AE5F79C18486CA3309EAF6689EFDC"><enum>(ii)</enum><text display-inline="yes-display-inline">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).</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H216C2F72A40B44E6AFE8DDCA97508B88"><enum>(E)</enum><header display-inline="yes-display-inline">Exception for new products</header><text display-inline="yes-display-inline">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—</text> <clause commented="no" display-inline="no-display-inline" id="HEA4FFF09559646D996746B1B77678E9E"><enum>(i)</enum><text display-inline="yes-display-inline">that did not manufacture the biosimilar biological product in the previous fiscal year; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="H49D219B219B74F86971134C9B5104DFA"><enum>(ii)</enum><text display-inline="yes-display-inline">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,</text> </clause><continuation-text commented="no" continuation-text-level="subparagraph">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.</continuation-text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H491CDA0378294E349C84A9A424F94742"><enum>(4)</enum><header display-inline="yes-display-inline">Biosimilar biological product fee</header> <subparagraph commented="no" display-inline="no-display-inline" id="HC362137B5FB94C04A2140B6467AB36BF"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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).</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H444DE69753104EC9AE0E6254FAD02F54"><enum>(B)</enum><header display-inline="yes-display-inline">Due date</header><text display-inline="yes-display-inline">The biosimilar biological product fee for a fiscal year shall be due on the later of—</text> <clause commented="no" display-inline="no-display-inline" id="HC15487EEEC1E47D78E548E107E642C11"><enum>(i)</enum><text display-inline="yes-display-inline">the first business day on or after October 1 of each such year; or</text> </clause><clause commented="no" display-inline="no-display-inline" id="H53B6FD13170B41CE885AC3A200955E6E"><enum>(ii)</enum><text display-inline="yes-display-inline">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.</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HF481D4FB7DD4415E86DDD353A3595FDA"><enum>(C)</enum><header display-inline="yes-display-inline">One fee per product per year</header><text display-inline="yes-display-inline">The biosimilar biological product fee shall be paid only once for each product for each fiscal year.</text> </subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H9CD23D1E5C384CFCA20C045494AFA596"><enum>(b)</enum><header display-inline="yes-display-inline">Fee setting and amounts</header> <paragraph commented="no" display-inline="no-display-inline" id="HF5D22757EE6749E4896C3D52FF7DC0DB"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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:</text> <subparagraph commented="no" display-inline="no-display-inline" id="H3B8E335078864FB7927AF8AD4988C108"><enum>(A)</enum><header display-inline="yes-display-inline">Initial biosimilar biological product development fee</header><text display-inline="yes-display-inline">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.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H3985C4BB1FF74A2B8BB222CC96DA31C1"><enum>(B)</enum><header display-inline="yes-display-inline">Annual biosimilar biological product development fee</header><text display-inline="yes-display-inline">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.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H70C2BE50765245CDA499E76D25299BB4"><enum>(C)</enum><header display-inline="yes-display-inline">Reactivation fee</header><text display-inline="yes-display-inline">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.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HD066F655646C45649F19C63000380974"><enum>(D)</enum><header display-inline="yes-display-inline">Biosimilar biological product application fee</header><text display-inline="yes-display-inline">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.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HE671526C1AF54BB6AA1FA23D3F6BF33C"><enum>(E)</enum><header display-inline="yes-display-inline">Biosimilar biological product establishment fee</header><text display-inline="yes-display-inline">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.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HD5B1C112A2634032A0AA6C242C2F6B81"><enum>(F)</enum><header display-inline="yes-display-inline">Biosimilar biological product fee</header><text display-inline="yes-display-inline">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.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H3527672A74AE41D19626AA80240CA5F7"><enum>(2)</enum><header display-inline="yes-display-inline">Limit</header><text display-inline="yes-display-inline">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.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H3977A06A8E404A51AF6E5EFF5E8ED006"><enum>(c)</enum><header display-inline="yes-display-inline">Application fee waiver for small business</header> <paragraph commented="no" display-inline="no-display-inline" id="HAA8D3089B0354369B9688067EA214BBC"><enum>(1)</enum><header display-inline="yes-display-inline">Waiver of application fee</header><text display-inline="yes-display-inline">The Secretary shall grant to a person who is named in a biosimilar biological product application a waiver from the application fee assessed to that person under subsection (a)(2)(A) for the first biosimilar biological product application that a small business or its affiliate submits to the Secretary for review. After a small business or its affiliate is granted such a waiver, the small business or its affiliate shall pay—</text> <subparagraph commented="no" display-inline="no-display-inline" id="H71BF763C73C54C5C9A83235C809CEDC8"><enum>(A)</enum><text display-inline="yes-display-inline">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</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HEBBC4B388C784F8B8A20DC052BD9465A"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H23F8C5CE96DD45BB87C6316F6C3F1CA0"><enum>(2)</enum><header display-inline="yes-display-inline">Considerations</header><text display-inline="yes-display-inline">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.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="HE8029BE1E89F42B68F71AEECD9490D48"><enum>(3)</enum><header display-inline="yes-display-inline">Small business defined</header><text display-inline="yes-display-inline">In this subsection, the term <term>small business</term> 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.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H1955E28F2E0840CCAF41738F10361FAD"><enum>(d)</enum><header display-inline="yes-display-inline">Effect of failure To pay fees</header><text display-inline="yes-display-inline">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.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="HFA6BC556A1924782A985CCC45D4EC776"><enum>(e)</enum><header display-inline="yes-display-inline">Crediting and availability of fees</header> <paragraph commented="no" display-inline="no-display-inline" id="HBA2D3D385BBB4B93962353BDAD7978B3"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="H30B1AB70B35241858E15D110D8433BF0"><enum>(2)</enum><header display-inline="yes-display-inline">Collections and appropriation acts</header> <subparagraph commented="no" display-inline="no-display-inline" id="HB701B69E9089456BB6300049A2836D0C"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H64AD730BD51C4674B10B9D7088BFCBAF"><enum>(B)</enum><header display-inline="yes-display-inline">Use of fees and limitation</header><text display-inline="yes-display-inline">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.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HD419B6E57A4941488FE1BC331EA48D34"><enum>(C)</enum><header display-inline="yes-display-inline">Fee collection during first program year</header><text display-inline="yes-display-inline">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.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H80C0324CC49948999C19665D93F8320C"><enum>(D)</enum><header display-inline="yes-display-inline">Provision for early payments in subsequent years</header><text display-inline="yes-display-inline">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.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HD1D863A7A15B4535A1F98FAE994237C4"><enum>(3)</enum><header display-inline="yes-display-inline">Authorization of appropriations</header><text display-inline="yes-display-inline">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.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H202626122BF34697AF37F50579B730B8"><enum>(f)</enum><header display-inline="yes-display-inline">Collection of unpaid fees</header><text display-inline="yes-display-inline">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.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="H6C26A172DC1B4E439EB676705BDE0729"><enum>(g)</enum><header display-inline="yes-display-inline">Written requests for waivers and refunds</header><text display-inline="yes-display-inline">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.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="H8C7E63ABADEE41DF8D96BF894B0061BD"><enum>(h)</enum><header display-inline="yes-display-inline">Construction</header><text display-inline="yes-display-inline">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.</text> </subsection></section></part><after-quoted-block>.</after-quoted-block></quoted-block> </section><section commented="no" display-inline="no-display-inline" id="HACD9687A64E04F2DB6B69D611A43A041" section-type="subsequent-section"><enum>403.</enum><header display-inline="yes-display-inline">Reauthorization; reporting requirements</header><text display-inline="no-display-inline">Part 8 of subchapter C of chapter VII, as added by section 402, is further amended by inserting after section 744H the following:</text> <quoted-block display-inline="no-display-inline" id="H090C682BF4C14644AC9C5C44928C130A" style="OLC"> <section commented="no" display-inline="no-display-inline" id="H8CA8B26FD95D407BAFED2916A9A11288" section-type="subsequent-section"><enum>744I.</enum><header display-inline="yes-display-inline">Reauthorization; reporting requirements</header> <subsection commented="no" display-inline="no-display-inline" id="H71C8D754607E4AEEB0B7D3BA990A9ECE"><enum>(a)</enum><header display-inline="yes-display-inline">Performance report</header><text display-inline="yes-display-inline">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 <short-title>Biosimilar User Fee Act of 2012</short-title> 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.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="HE04435F3791944E991BBCD5A7A3ED60B"><enum>(b)</enum><header display-inline="yes-display-inline">Fiscal report</header><text display-inline="yes-display-inline">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.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="H22E2654BACC644178C2AA9265A4D4865"><enum>(c)</enum><header display-inline="yes-display-inline">Public availability</header><text display-inline="yes-display-inline">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.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="HC1F8CD37EAEC451DA9F7EDF6ECF639CE"><enum>(d)</enum><header display-inline="yes-display-inline">Study</header> <paragraph commented="no" display-inline="no-display-inline" id="H902CD626A51C4EB8ABEFDCDC550F03A7"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="HDB2DA79FB0D8482CABE950F5D49A26F3"><enum>(2)</enum><header display-inline="yes-display-inline">Interim results</header><text display-inline="yes-display-inline">Not later than June 1, 2015, the Secretary shall publish, for public comment, interim results of the study described under paragraph (1).</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="H4B1D6DCFA5D64861919E532A10F53007"><enum>(3)</enum><header display-inline="yes-display-inline">Final results</header><text display-inline="yes-display-inline">Not later than September 30, 2016, the Secretary shall publish, for public comment, the final results of the study described under paragraph (1).</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H78189CA9915D4BB3B0E23120C327439A"><enum>(e)</enum><header display-inline="yes-display-inline">Reauthorization</header> <paragraph commented="no" display-inline="no-display-inline" id="HDCE746EBBE6449959565FB84EE805764"><enum>(1)</enum><header display-inline="yes-display-inline">Consultation</header><text display-inline="yes-display-inline">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—</text> <subparagraph commented="no" display-inline="no-display-inline" id="HB0348519CAE34AD19582AF9B8929DCC7"><enum>(A)</enum><text display-inline="yes-display-inline">the Committee on Energy and Commerce of the House of Representatives;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H80D8BF6632DA48AA88D557C572930CE2"><enum>(B)</enum><text display-inline="yes-display-inline">the Committee on Health, Education, Labor, and Pensions of the Senate;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HF9225A9F116C47C085B7409C9B410302"><enum>(C)</enum><text display-inline="yes-display-inline">scientific and academic experts;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HE58266F0CF77428D8E2D1F75B9437472"><enum>(D)</enum><text display-inline="yes-display-inline">health care professionals;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HE99582866C274530AA2CB46D75479171"><enum>(E)</enum><text display-inline="yes-display-inline">representatives of patient and consumer advocacy groups; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H92953FE3D7884EECAF03496F28AB353F"><enum>(F)</enum><text display-inline="yes-display-inline">the regulated industry.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HE21CEC85981345B2AE07C4F4AF08579F"><enum>(2)</enum><header display-inline="yes-display-inline">Public review of recommendations</header><text display-inline="yes-display-inline">After negotiations with the regulated industry, the Secretary shall—</text> <subparagraph commented="no" display-inline="no-display-inline" id="HA9B005B609C7422281C6F32AC656DE6C"><enum>(A)</enum><text display-inline="yes-display-inline">present the recommendations developed under paragraph (1) to the congressional committees specified in such paragraph;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H62245DB8C37E41F4803F947826E5D857"><enum>(B)</enum><text display-inline="yes-display-inline">publish such recommendations in the Federal Register;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HFD2DF0BAB3B34BB8B0EEE942C37917BA"><enum>(C)</enum><text display-inline="yes-display-inline">provide for a period of 30 days for the public to provide written comments on such recommendations;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H805A38151CE742F099DA6537D4788FAA"><enum>(D)</enum><text display-inline="yes-display-inline">hold a meeting at which the public may present its views on such recommendations; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H81693ED851554FD18F082B4A0BBF55EF"><enum>(E)</enum><text display-inline="yes-display-inline">after consideration of such public views and comments, revise such recommendations as necessary.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H3ED8166F0B97441B8EDF972AEB97503F"><enum>(3)</enum><header display-inline="yes-display-inline">Transmittal of recommendations</header><text display-inline="yes-display-inline">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.</text> </paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block> </section><section commented="no" display-inline="no-display-inline" id="HEAEF2C8D6F594D188CD8A71403536C6A" section-type="subsequent-section"><enum>404.</enum><header display-inline="yes-display-inline">Sunset dates</header> <subsection commented="no" display-inline="no-display-inline" id="H3CCA169AA7DF45018B3BF190707842C7"><enum>(a)</enum><header display-inline="yes-display-inline">Authorization</header><text display-inline="yes-display-inline">The amendment made by section 402 shall cease to be effective October 1, 2017.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="H05C229ECA442478BBEF645C8DCB5A6F9"><enum>(b)</enum><header display-inline="yes-display-inline">Reporting requirements</header><text display-inline="yes-display-inline">The amendment made by section 403 shall cease to be effective January 31, 2018.</text> </subsection></section><section commented="no" display-inline="no-display-inline" id="H135E60908606420796BC91950C9B770E" section-type="subsequent-section"><enum>405.</enum><header display-inline="yes-display-inline">Effective date</header> <subsection commented="no" display-inline="no-display-inline" id="H0C112084C2044709BD17D5381F0C46D8"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Except as provided under subsection (b), the amendments made by this title shall take effect on the later of—</text> <paragraph commented="no" display-inline="no-display-inline" id="HC5C3862C0A294196B54881F8B08AC019"><enum>(1)</enum><text display-inline="yes-display-inline">October 1, 2012; or</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="HFBC7BCAABA9C49EFBCC14AD89D86932D"><enum>(2)</enum><text display-inline="yes-display-inline">the date of the enactment of this title.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HFE4C98B2ED9B4F3F81AA1378CC403424"><enum>(b)</enum><header display-inline="yes-display-inline">Exception</header><text display-inline="yes-display-inline">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.</text> </subsection></section><section commented="no" display-inline="no-display-inline" id="H8D2B0D83A34F44EA93FC9A49451C16A8" section-type="subsequent-section"><enum>406.</enum><header display-inline="yes-display-inline">Savings clause</header><text display-inline="no-display-inline">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.</text> </section><section commented="no" display-inline="no-display-inline" id="HDD2C7D94D9694901ADB7D6BB5AC041FF" section-type="subsequent-section"><enum>407.</enum><header display-inline="yes-display-inline">Conforming amendment</header><text display-inline="no-display-inline">Section 735(1)(B) (21 U.S.C. 379g(1)(B)) is amended by striking <quote>or (k)</quote>.</text> </section><enum>V</enum><header display-inline="yes-display-inline">Pediatric drugs and devices</header> <section commented="no" display-inline="no-display-inline" id="idF2489FF8C6A34AF49E1D0609858A2585" section-type="subsequent-section"><enum>501.</enum><header display-inline="yes-display-inline">Permanence</header> <subsection commented="no" display-inline="no-display-inline" id="id5641257FBDDE4FB1B3F31944C5B03D3E"><enum>(a)</enum><header display-inline="yes-display-inline">Pediatric studies of drugs</header><text display-inline="yes-display-inline">Subsection (q) of section 505A (21 U.S.C. 355a) is amended—</text> <paragraph commented="no" display-inline="no-display-inline" id="idA1EF11F6C3554ACAB3DF218B320E0DF8"><enum>(1)</enum><text display-inline="yes-display-inline">in the subsection heading, by striking <quote><header-in-text level="subsection" style="OLC">Sunset</header-in-text></quote> and inserting <quote><header-in-text level="subsection" style="OLC">Permanence</header-in-text></quote>;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id955BA9A9C1D44A57A2934E19CA50FFE3"><enum>(2)</enum><text display-inline="yes-display-inline">in paragraph (1), by striking <quote>on or before October 1, 2012,</quote>; and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idAEA6A40A132F41F991A4829A4129FE51"><enum>(3)</enum><text display-inline="yes-display-inline">in paragraph (2), by striking <quote>on or before October 1, 2012,</quote>.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id4E53B7FA13C44B1591C9F64677E93D6A"><enum>(b)</enum><header display-inline="yes-display-inline">Research into pediatric uses for drugs and biological products</header><text display-inline="yes-display-inline">Section 505B (21 U.S.C. 355c) is amended—</text> <paragraph commented="no" display-inline="no-display-inline" id="idFE3ADA6D93E54EB481438433E0F4491D"><enum>(1)</enum><text display-inline="yes-display-inline">by striking subsection (m); and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id9EF2E50FA7994E5387E1B875CB0D1B75"><enum>(2)</enum><text display-inline="yes-display-inline">by redesignating subsection (n) as subsection (m).</text> </paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="idE402355083DC4B8D9CDA48075469F3FE" section-type="subsequent-section"><enum>502.</enum><header display-inline="yes-display-inline">Written requests</header> <subsection commented="no" display-inline="no-display-inline" id="id1D24AC1CAFD043A3AA20963B5F5DBE3C"><enum>(a)</enum><header display-inline="yes-display-inline">Federal Food, Drug, and Cosmetic Act</header><text display-inline="yes-display-inline">Subsection (h) of section 505A (21 U.S.C. 355a) is amended to read as follows:</text> <quoted-block display-inline="no-display-inline" id="idD0AB911A1B6D4279BA644CD3F1ECAEFB" style="OLC"> <subsection commented="no" display-inline="no-display-inline" id="id268FC0F388B54B5A9C3B922DFB2BBFC8"><enum>(h)</enum><header display-inline="yes-display-inline">Relationship to pediatric research requirements</header><text display-inline="yes-display-inline">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.</text> </subsection><after-quoted-block>.</after-quoted-block></quoted-block> </subsection><subsection commented="no" display-inline="no-display-inline" id="idD2D2069F307A45269467E78E88F156CA"><enum>(b)</enum><header display-inline="yes-display-inline">Public Health Service Act</header><text display-inline="yes-display-inline">Section 351(m)(1) of the Public Health Service Act (42 U.S.C. 262(m)(1)) is amended by striking <quote>(f), (i), (j), (k), (l), (p), and (q)</quote> and inserting <quote>(f), (h), (i), (j), (k), (l), (n), and (p)</quote>.</text> </subsection></section><section commented="no" display-inline="no-display-inline" id="id316E2DE0924D498D817DB4658E57BFA7" section-type="subsequent-section"><enum>503.</enum><header display-inline="yes-display-inline">Communication with Pediatric Review Committee</header><text display-inline="no-display-inline">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 <quote>Secretary</quote>) shall issue internal standard operating procedures that provide for the review by the internal review committee established under section 505C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355d) of any significant modifications to initial pediatric study plans, agreed initial pediatric study plans, and written requests under sections 505A and 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c). Such internal standard operating procedures shall be made publicly available on the Internet website of the Food and Drug Administration.</text> </section><section commented="no" display-inline="no-display-inline" id="idB5238D46693743CEA55A04E23BC5C47D" section-type="subsequent-section"><enum>504.</enum><header display-inline="yes-display-inline">Access to data</header><text display-inline="no-display-inline">Not later than 3 years after the date of enactment of this Act, the Secretary shall make available to the public, including through posting on the Internet website of the Food and Drug Administration, the medical, statistical, and clinical pharmacology reviews of, and corresponding written requests issued to an applicant, sponsor, or holder for, pediatric studies submitted between January 4, 2002 and September 27, 2007 under subsection (b) or (c) of section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) for which 6 months of market exclusivity was granted and that resulted in a labeling change. The Secretary shall make public the information described in the preceding sentence in a manner consistent with how the Secretary releases information under section 505A(k) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(k)).</text> </section><section commented="no" display-inline="no-display-inline" id="idD76B2ECBB79A47B0AF7CDB52EC14DF07" section-type="subsequent-section"><enum>505.</enum><header display-inline="yes-display-inline">Ensuring the completion of pediatric studies</header> <subsection commented="no" display-inline="no-display-inline" id="idEC7B2A9A471346C297B4831ADB38CB46"><enum>(a)</enum><header display-inline="yes-display-inline">Extension of deadline for deferred studies</header><text display-inline="yes-display-inline">Section 505B (21 U.S.C. 355c) is amended—</text> <paragraph commented="no" display-inline="no-display-inline" id="idC83AFF002BDD4DA993F48A8028C24368"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (a)(3)—</text> <subparagraph commented="no" display-inline="no-display-inline" id="idE9DB7A85B6794CE68380636F347AF5EE"><enum>(A)</enum><text display-inline="yes-display-inline">by redesignating subparagraph (B) as subparagraph (C);</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idEDDD85B268B6421DAC012DA005AFDA12"><enum>(B)</enum><text display-inline="yes-display-inline">by inserting after subparagraph (A) the following:</text> <quoted-block display-inline="no-display-inline" id="idC347F1DDAD3B4BF7B7452447E4C518E2" style="OLC"> <subparagraph commented="no" display-inline="no-display-inline" id="idE5385B780EF142508D6601489D5AC9F5"><enum>(B)</enum><header display-inline="yes-display-inline">Deferral extension</header> <clause commented="no" display-inline="no-display-inline" id="id73D4F54B068E4091872606363A1B3066"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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—</text> <subclause commented="no" display-inline="no-display-inline" id="idDF58DA708E7E44188762ABF1A184D3BC"><enum>(I)</enum><text display-inline="yes-display-inline">the Secretary determines that the conditions described in subclause (II) or (III) of subparagraph (A)(i) continue to be met; and</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="id5D1725F1A0334B818AE20B56B4A3CDAC"><enum>(II)</enum><text display-inline="yes-display-inline">the applicant submits a new timeline under subparagraph (A)(ii)(IV) and any significant updates to the information required under subparagraph (A)(ii).</text> </subclause></clause><clause commented="no" display-inline="no-display-inline" id="id4F2A851EC12143E0A107099D7876133A"><enum>(ii)</enum><header display-inline="yes-display-inline">Timing and information</header><text display-inline="yes-display-inline">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 <short-title>Food and Drug Administration Safety and Innovation Act</short-title> 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.</text> </clause></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id99EF70C338714EC7BF533AB974103C54"><enum>(C)</enum><text display-inline="yes-display-inline">in subparagraph (C), as so redesignated—</text> <clause commented="no" display-inline="no-display-inline" id="idFAFECE8CA1134D7FA6D9361BA9C16F5F"><enum>(i)</enum><text display-inline="yes-display-inline">in clause (i), by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="id2FF53D8F91D041D385F092AEAC42D65A" style="OLC"> <subclause commented="no" display-inline="no-display-inline" id="idCD2B3BF9B8CE4878B982A317960A26BA"><enum>(III)</enum><text display-inline="yes-display-inline">Projected completion date for pediatric studies.</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="id3FBFA25168E64C9DA78543ECB37C9D6E"><enum>(IV)</enum><text display-inline="yes-display-inline">The reason or reasons why a deferral or deferral extension continues to be necessary.</text> </subclause><after-quoted-block>; and</after-quoted-block></quoted-block> </clause><clause commented="no" display-inline="no-display-inline" id="id03BAED39FDC24ADCA3D96237BFADEF84"><enum>(ii)</enum><text display-inline="yes-display-inline">in clause (ii)—</text> <subclause commented="no" display-inline="no-display-inline" id="id05AF608E84AC444495F70D5EDD129B27"><enum>(I)</enum><text display-inline="yes-display-inline">by inserting <quote>, as well as the date of each deferral or deferral extension, as applicable,</quote> after <quote>clause (i)</quote>; and</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="id8E437486893144D3870041542FA78EAA"><enum>(II)</enum><text display-inline="yes-display-inline">by inserting <quote>not later than 90 days after submission to the Secretary or with the next routine quarterly update</quote> after <quote>Administration</quote>; and</text> </subclause></clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id97CE1E337CC0401EBDE5A64ED87280DC"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (f)—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id4F4CAB26260049BF901EB31DFB83FAAE"><enum>(A)</enum><text display-inline="yes-display-inline">in the subsection heading, by inserting <quote><header-in-text level="subsection" style="OLC">Deferral Extensions,</header-in-text></quote> after <quote><header-in-text level="subsection" style="OLC">Deferrals,</header-in-text></quote>;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idA997AF7754C844EE91271501848FDC2F"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (1), by inserting <quote>, deferral extension, </quote> after <quote>deferral</quote>; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id2135DD0231FB41428B968FA0FBBD9DC3"><enum>(C)</enum><text display-inline="yes-display-inline">in paragraph (4)—</text> <clause commented="no" display-inline="no-display-inline" id="id20E447B99EC047738ADF5C455893B14F"><enum>(i)</enum><text display-inline="yes-display-inline">in the paragraph heading, by inserting <quote><header-in-text level="paragraph" style="OLC">deferral extensions,</header-in-text></quote> after <quote><header-in-text level="paragraph" style="OLC">deferrals,</header-in-text></quote>; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="idF9CABFCFDA524FB695087FE10ADAB7AC"><enum>(ii)</enum><text display-inline="yes-display-inline">by inserting <quote>, deferral extensions, </quote> after <quote>deferrals</quote>.</text> </clause></subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id55660CAC16294FFAA41276AD025BD013"><enum>(b)</enum><header display-inline="yes-display-inline">Tracking of extensions; annual information</header><text display-inline="yes-display-inline">Section 505B(f)(6)(D) (21 U.S.C. 355c(f)(6)(D)) is amended to read as follows:</text> <quoted-block display-inline="no-display-inline" id="id12A2780D3CAE4C4A91034F337C89EDA9" style="OLC"> <subparagraph commented="no" display-inline="no-display-inline" id="id84793842BA3A4D16A36FA9AE214975CB"><enum>(D)</enum><text display-inline="yes-display-inline">aggregated on an annual basis—</text> <clause commented="no" display-inline="no-display-inline" id="id5D8AB0AA22764E8AA112A77C0A37AABF"><enum>(i)</enum><text display-inline="yes-display-inline">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;</text> </clause><clause commented="no" display-inline="no-display-inline" id="id02333096C0D94E90967E3D21462A7D57"><enum>(ii)</enum><text display-inline="yes-display-inline">the timeline for completion of the assessments; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="id0EAB086E4C11481B8D68AF9FCE8B7402"><enum>(iii)</enum><text display-inline="yes-display-inline">the number of assessments completed and pending;</text> </clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block> </subsection><subsection commented="no" display-inline="no-display-inline" id="idC4167A3BC0224D8AADCB7221B2EF4BC8"><enum>(c)</enum><header display-inline="yes-display-inline">Action on failure To complete studies</header> <paragraph commented="no" display-inline="no-display-inline" id="id080CB4C471F44465A9FED56A78BDC38A"><enum>(1)</enum><header display-inline="yes-display-inline">Issuance of letter</header><text display-inline="yes-display-inline">Subsection (d) of section 505B (21 U.S.C. 355c) is amended to read as follows:</text> <quoted-block display-inline="no-display-inline" id="idD140DFA4ACD1475CA39AB3807CB983CE" style="OLC"> <subsection commented="no" display-inline="no-display-inline" id="idAE871BEC4B4B4C72B8C93B00D1301E95"><enum>(d)</enum><header display-inline="yes-display-inline">Submission of assessments</header><text display-inline="yes-display-inline">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:</text> <paragraph commented="no" display-inline="no-display-inline" id="ida1d5fb2046194582818d783a49487b48"><enum>(1)</enum><text display-inline="yes-display-inline">Beginning 270 days after the date of enactment of the <short-title>Food and Drug Administration Safety and Innovation Act</short-title>, 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.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idcd98f89640d745d3a64c7dfd85e3f8d2"><enum>(2)</enum><text display-inline="yes-display-inline">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—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id571a08ff79394c6e8ddc3901526bed3a"><enum>(A)</enum><text display-inline="yes-display-inline">to withdraw approval for a drug under section 505(e); or</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id66cae100f4bc42cebc94e970aeedf9e1"><enum>(B)</enum><text display-inline="yes-display-inline">to revoke the license for a biological product under section 351 of the Public Health Service Act.</text> </subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id908944667A824064A77EB23A136E15A9"><enum>(2)</enum><header display-inline="yes-display-inline">Tracking of letters issued</header><text display-inline="yes-display-inline">Subparagraph (D) of section 505B(f)(6) (21 U.S.C. 355c(f)(6)), as amended by subsection (b), is further amended—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id8C7DF0DA622E432C99DF3EAB95CDF2CC"><enum>(A)</enum><text display-inline="yes-display-inline">in clause (ii), by striking <quote>; and</quote> and inserting a semicolon;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id78DFED440100465CBCC5713632EA35A1"><enum>(B)</enum><text display-inline="yes-display-inline">in clause (iii), by adding <quote>and</quote> at the end; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id8DDC4DE57A3E475FA5139CD3BE55C369"><enum>(C)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="id78EC752B35AE4777BCC9D377765967A8" style="OLC"> <clause commented="no" display-inline="no-display-inline" id="id9026287ED84649189197614691136233"><enum>(iv)</enum><text display-inline="yes-display-inline">the number of postmarket non-compliance letters issued pursuant to subsection (d), and the recipients of such letters;</text> </clause><after-quoted-block>.</after-quoted-block></quoted-block> </subparagraph></paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="id79C2AB289B3F4103A1584169A34079B2" section-type="subsequent-section"><enum>506.</enum><header display-inline="yes-display-inline">Pediatric study plans</header> <subsection commented="no" display-inline="no-display-inline" id="idC450AE4BA6374B3F958AD3CCD1FA1112"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Subsection (e) of section 505B (21 U.S.C. 355c) is amended to read as follows:</text> <quoted-block display-inline="no-display-inline" id="idEA23CEF023544EACA84318F9881C7129" style="OLC"> <subsection commented="no" display-inline="no-display-inline" id="ide1799d7984ca4e6cbbe077e2d374a3d2"><enum>(e)</enum><header display-inline="yes-display-inline">Pediatric study plans</header> <paragraph commented="no" display-inline="no-display-inline" id="id8c189a6e33f948f697dac5c00ef3a36d"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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).</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id9E3B1A66E0B34C058C86230A307AE8BD"><enum>(2)</enum><header display-inline="yes-display-inline">Timing; content; meeting</header> <subparagraph commented="no" display-inline="no-display-inline" id="idA5F15D074DBA44CAA7DD3DC0F509EF1F"><enum>(A)</enum><header display-inline="yes-display-inline">Timing</header><text display-inline="yes-display-inline">An applicant shall submit an initial pediatric study plan to the Secretary not later than 60 calendar days after the date of the end of phase II meeting or such other equivalent time agreed upon between the Secretary and the applicant. Nothing in this paragraph shall preclude the Secretary from accepting the submission of an initial pediatric study plan earlier than the date described under the preceding sentence.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idEBB02F77085941E6A7583D86796D89B4"><enum>(B)</enum><header display-inline="yes-display-inline">Content of initial plan</header><text display-inline="yes-display-inline">The initial pediatric study plan shall include—</text> <clause commented="no" display-inline="no-display-inline" id="ide92230f9ba2645199481e893111096a1"><enum>(i)</enum><text display-inline="yes-display-inline">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);</text> </clause><clause commented="no" display-inline="no-display-inline" id="idb55901726078480da4ddffc0807a2749"><enum>(ii)</enum><text display-inline="yes-display-inline">any request for a deferral, partial waiver, or waiver under this section, if applicable, along with any supporting information; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="id16d4c03b0d174f4e88a6de6591441994"><enum>(iii)</enum><text display-inline="yes-display-inline">other information specified in the regulations promulgated under paragraph (4).</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id582AF93383584E22AFB5FEF8E161073F"><enum>(C)</enum><header display-inline="yes-display-inline">Meeting</header><text display-inline="yes-display-inline">The Secretary—</text> <clause commented="no" display-inline="no-display-inline" id="id020834B12A784349AE105EA6D9C9F040"><enum>(i)</enum><text display-inline="yes-display-inline">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);</text> </clause><clause commented="no" display-inline="no-display-inline" id="id85433AF3680B4915A69BBF0BAE8C8428"><enum>(ii)</enum><text display-inline="yes-display-inline">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</text> </clause><clause commented="no" display-inline="no-display-inline" id="id910123E47ED74A2CBE03CD968E9A2E8B"><enum>(iii)</enum><text display-inline="yes-display-inline">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.</text> </clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id089FD577B432460A9361D8D7A3AF0A8F"><enum>(3)</enum><header display-inline="yes-display-inline">Agreed initial pediatric study plan</header><text display-inline="yes-display-inline">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 <quote>Agreed Initial Pediatric Study Plan</quote>, 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.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id177F09DC1BDC45A182E1750BFF12A4D0"><enum>(4)</enum><header display-inline="yes-display-inline">Deferral and waiver</header><text display-inline="yes-display-inline">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).</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idCB93CA1780DC41F085816F6DCEEB58C8"><enum>(5)</enum><header display-inline="yes-display-inline">Amendments to the plan</header><text display-inline="yes-display-inline">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.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id21970D6A77184CC58DA8ECC64C639BB9"><enum>(6)</enum><header display-inline="yes-display-inline">Internal committee</header><text display-inline="yes-display-inline">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.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id30256A1617C54F3EAAA638BEAB558DF7"><enum>(7)</enum><header display-inline="yes-display-inline">Required rulemaking</header><text display-inline="yes-display-inline">Not later than 1 year after the date of enactment of the <short-title>Food and Drug Administration Safety and Innovation Act</short-title>, the Secretary shall promulgate proposed regulations and issue proposed guidance to implement the provisions of this subsection.</text> </paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block> </subsection><subsection commented="no" display-inline="no-display-inline" id="idBA4AE74A8DDA44E8BA5852ED31F52F1C"><enum>(b)</enum><header display-inline="yes-display-inline">Conforming amendments</header><text display-inline="yes-display-inline">Section 505B (21 U.S.C. 355c)is amended—</text> <paragraph commented="no" display-inline="no-display-inline" id="id051F3B4265DF45CEB6C1ED9F9B127E7D"><enum>(1)</enum><text display-inline="yes-display-inline">by amending subclause (II) of subsection (a)(3)(A)(ii) to read as follows:</text> <quoted-block display-inline="no-display-inline" id="id6627CBDC610E42469C42AE2095BFECBD" style="OLC"> <subclause commented="no" display-inline="no-display-inline" id="id45173FCEF3754308A5199A4A7F7C5E58"><enum>(II)</enum><text display-inline="yes-display-inline">a pediatric study plan as described in subsection (e);</text> </subclause><after-quoted-block>; and</after-quoted-block></quoted-block> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id303425FDABD2453EB68E8DA16AC9FE40"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (f)—</text> <subparagraph commented="no" display-inline="no-display-inline" id="idEB4B1C4AF6B441FAB61669A826180265"><enum>(A)</enum><text display-inline="yes-display-inline">in the subsection heading, by striking <quote><header-in-text level="subsection" style="OLC">pediatric plans,</header-in-text></quote> and inserting <quote><header-in-text level="subsection" style="OLC">pediatric study plans,</header-in-text></quote>;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id59FD188F2C5B40958B72BBEF22654335"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (1), by striking <quote>all pediatric plans</quote> and inserting <quote>initial pediatric study plans, agreed initial pediatric study plans,</quote>; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id083CE222BDDF42F28D2F871B77F9E4D4"><enum>(C)</enum><text display-inline="yes-display-inline">in paragraph (4)—</text> <clause commented="no" display-inline="no-display-inline" id="idE187F0970E7E4C8CA8A9177D066E68CA"><enum>(i)</enum><text display-inline="yes-display-inline">in the paragraph heading, by striking <quote><header-in-text level="subsection" style="OLC">pediatric plans,</header-in-text></quote> and inserting <quote><header-in-text level="subsection" style="OLC">pediatric study plans,</header-in-text></quote>; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="id00F5FDA4D685431BA9B3008355F61E37"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking <quote>pediatric plans</quote> and inserting <quote>initial pediatric study plans, agreed initial pediatric study plans,</quote>.</text> </clause></subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id30D9E6C692674676867CA39004A0CF4D"><enum>(c)</enum><header display-inline="yes-display-inline">Effective dates</header> <paragraph commented="no" display-inline="no-display-inline" id="id75F6CAD77F0246A2850504252826FEFB"><enum>(1)</enum><header display-inline="yes-display-inline">Pediatric study plans</header><text display-inline="yes-display-inline">Subsection (e) of section 505B of the Federal Food, Drug, and Cosmetic Act (other than paragraph (4) of such subsection), as amended by subsection (a), shall take effect 180 days after the date of enactment of this Act, without regard to whether the Secretary has promulgated final regulations under paragraph (4) of such subsection by such date.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idAF357D935B5345708BE1D30478773304"><enum>(2)</enum><header display-inline="yes-display-inline">Conforming amendments</header><text display-inline="yes-display-inline">The amendments made by subsection (b) shall take effect 180 days after the date of enactment of this Act.</text> </paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="id03333CC21FD44B728BC6E95049F8F9F0" section-type="subsequent-section"><enum>507.</enum><header display-inline="yes-display-inline">Reauthorizations</header> <subsection commented="no" display-inline="no-display-inline" id="id8CD4B7496E5641569190FE563C930E8D"><enum>(a)</enum><header display-inline="yes-display-inline">Pediatric Advisory Committee</header><text display-inline="yes-display-inline">Section 14(d) of the Best Pharmaceuticals for Children Act (42 U.S.C. 284m note) is amended by striking <quote>Notwithstanding section 14 of the Federal Advisory Committee Act, the advisory committee shall continue to operate during the five-year period beginning on the date of the enactment of the Best Pharmaceuticals for Children Act of 2007</quote> and inserting <quote>Section 14 of the Federal Advisory Committee Act shall not apply to the advisory committee</quote>.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="id37D68AA0BE1748C794CD84AED2AC5532"><enum>(b)</enum><header display-inline="yes-display-inline">Pediatric Subcommittee of the Oncologic Drugs Advisory Committee</header><text display-inline="yes-display-inline">Section 15(a)(3) of the Best Pharmaceuticals for Children Act (42 U.S.C. 284m note) is amended by striking <quote>during the five-year period beginning on the date of the enactment of the Best Pharmaceuticals for Children Act of 2007</quote> and inserting <quote>for the duration of the operation of the Oncologic Drugs Advisory Committee</quote>.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="H165EC314854D42369108934DDC0E0BD1"><enum>(c)</enum><header display-inline="yes-display-inline">Humanitarian device exemption extension</header><text display-inline="yes-display-inline">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 <quote>2012</quote> and inserting <quote>2017</quote>.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="id95968C8C52D64BB4BCD305F99F810B7B"><enum>(d)</enum><header display-inline="yes-display-inline">Demonstration grants To improve pediatric device availability</header><text display-inline="yes-display-inline">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 <quote>$6,000,000 for each of fiscal years 2008 through 2012</quote> and inserting <quote>$4,500,000 for each of fiscal years 2013 through 2017</quote>.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="HFB7D80B7A26D40CE8E9926131E4F1DC2"><enum>(e)</enum><header display-inline="yes-display-inline">Program for pediatric study of drugs in PHSA</header><text display-inline="yes-display-inline">Section 409I(e)(1) of the Public Health Service Act (42 U.S.C. 284m(e)(1)) is amended by striking <quote>to carry out this section</quote> and all that follows through the end of paragraph (1) and inserting <quote>to carry out this section $25,000,000 for each of fiscal years 2012 through 2017.</quote>.</text> </subsection></section><section commented="no" display-inline="no-display-inline" id="id62686C1119184723B041062EC1D71956" section-type="subsequent-section"><enum>508.</enum><header display-inline="yes-display-inline">Report</header> <subsection commented="no" display-inline="no-display-inline" id="id9BDD6FADF5B84AB788B8BB9E13DDBE0E"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than October 31, 2016, and at the end of each subsequent 5-year period, the Secretary shall submit to Congress a report that evaluates the effectiveness of sections 505A and 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c) and section 409I of the Public Health Service Act (42 U.S.C. 284m) in ensuring that medicines used by children are tested in pediatric populations and properly labeled for use in children.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="id31394B6D181A48319293109E5C41C7F6"><enum>(b)</enum><header display-inline="yes-display-inline">Contents</header><text display-inline="yes-display-inline">The report under subsection (a) shall include—</text> <paragraph commented="no" display-inline="no-display-inline" id="id77e2b6c92fd540a8af0d42b6739c0690"><enum>(1)</enum><text display-inline="yes-display-inline">the number and importance of drugs and biological products for children for which studies have been requested or required (as of the date of such report) under 505A and 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c) and section 409I of the Public Health Service Act (42 U.S.C. 284m), including—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id4FB671C4C25E4A84A283BC231B561227"><enum>(A)</enum><text display-inline="yes-display-inline">the number of labeling changes made to drugs and biological products pursuant to such sections since the date of enactment of this Act; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idE51B4755BDEF494085517670BF5227A7"><enum>(B)</enum><text display-inline="yes-display-inline">the importance of such drugs and biological products in the improvement of the health of children;</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idd84cb9dabab84365b7a00d59d883bd97"><enum>(2)</enum><text display-inline="yes-display-inline">the number of required studies under such section 505B that have not met the initial deadline provided under such section, including—</text> <subparagraph commented="no" display-inline="no-display-inline" id="idbc0a2254097643689269f327a433119a"><enum>(A)</enum><text display-inline="yes-display-inline">the number of deferrals and deferral extensions granted and the reasons such extensions were granted;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ida1a28a5872b14c5fb9334f7faa0c1d67"><enum>(B)</enum><text display-inline="yes-display-inline">the number of waivers and partial waivers granted; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id7fd3bf7c5f6747e99d7d0cec601f3f8f"><enum>(C)</enum><text display-inline="yes-display-inline">the number of letters issued under subsection (d) of such section 505B;</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idfc402b2b463245178f37811e66836c39"><enum>(3)</enum><text display-inline="yes-display-inline">the number of written requests issued, declined, and referred to the National Institutes of Health under such section 505A since the date of enactment of this Act (including the reasons for such declination), and a description and status of referrals made under subsection (n) of such section 505A;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id35a379701cd141e19e4e8ba4046f1271"><enum>(4)</enum><text display-inline="yes-display-inline">the number of proposed pediatric study plans submitted and agreed to as identified in the marketing application under such section 505B;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id2E1923DA6CDC4DF89975D1BF572E9786"><enum>(5)</enum><text display-inline="yes-display-inline">any labeling changes recommended by the Pediatric Advisory Committee as a result of the review by such Committee of adverse events reports;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="ideb926f8f84f54e84bf02acb9e98c2867"><enum>(6)</enum><text display-inline="yes-display-inline">the number and current status of pediatric postmarketing requirements;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id79f9f4e57a3a4bbc83c36a28d3d79dd1"><enum>(7)</enum><text display-inline="yes-display-inline">the number and importance of drugs and biological products for children that are not being tested for use in pediatric populations, notwithstanding the existence of the programs under such sections 505A and 505B and section 409I of the Public Health Service Act;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idc5d276983e644b159b706651f94b8467"><enum>(8)</enum><text display-inline="yes-display-inline">the possible reasons for the lack of testing reported under paragraph (7);</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idf9c18e4b6efe429cae619a0956fe862c"><enum>(9)</enum><text display-inline="yes-display-inline">the number of drugs and biological products for which testing is being done (as of the date of the report) and for which a labeling change is required under the programs described in paragraph (7), including—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id94fa9657da0240218303c97aa98aa8bf"><enum>(A)</enum><text display-inline="yes-display-inline">the date labeling changes are made;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idfdac6f3a28dc4132af41f481029f0d55"><enum>(B)</enum><text display-inline="yes-display-inline">which labeling changes required the use of the dispute resolution process; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id811f59914798436187ddace8ead0f8af"><enum>(C)</enum><text display-inline="yes-display-inline">for labeling changes that required such dispute resolution process, a description of—</text> <clause commented="no" display-inline="no-display-inline" id="id00d44bd8226344a0b8e6f1a2215d4a11"><enum>(i)</enum><text display-inline="yes-display-inline">the disputes;</text> </clause><clause commented="no" display-inline="no-display-inline" id="idd0344684049d43a69bb9884e76eba9c0"><enum>(ii)</enum><text display-inline="yes-display-inline">the recommendations of the Pediatric Advisory Committee; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="idfb78002d56814dbe96bcc72ad5d5b77a"><enum>(iii)</enum><text display-inline="yes-display-inline">the outcomes of such process; and</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id6ad51cf9f2e044538e435874ba0bdfce"><enum>(D)</enum><text display-inline="yes-display-inline">an assessment of the effectiveness in improving information about pediatric uses of drugs and biological products;</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idDC17A2AFC9C34F4E9024489B146B3A0C"><enum>(10)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="idE5AC92A24C504202AEDF14FA57A22301"><enum>(A)</enum><text display-inline="yes-display-inline">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</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id3F67DBC036E541EDB5337967640D085A" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">the results of such efforts;</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id3FBB59CA6CAB42ACBCC08E25014A4422"><enum>(11)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="id007F9E5345F94D619B78FAA1823F89EB"><enum>(A)</enum><text display-inline="yes-display-inline">the number and importance of drugs and biological products for children with cancer that are being tested as a result of the programs described in paragraph (7); and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id91CBA3440D134250A13315C14E4EE07C" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">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;</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id2a533c8ee3da498482f318d8d9bb50b4"><enum>(12)</enum><text display-inline="yes-display-inline">an assessment of progress made in addressing the recommendations and findings of any prior report issued by the Comptroller General, the Institute of Medicine, or the Secretary regarding the topics addressed in the report under this section, including with respect to—</text> <subparagraph commented="no" display-inline="no-display-inline" id="ida8d1120e69ef4faba89d192b8b118ae7"><enum>(A)</enum><text display-inline="yes-display-inline">improving public access to information from pediatric studies conducted under such sections 505A and 505B; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id2fb767e2797148de9c6e5f18d7ff25bb"><enum>(B)</enum><text display-inline="yes-display-inline">improving the timeliness of pediatric studies and pediatric study planning under such sections 505A and 505B;</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ida76e5fdac0ea40d7b7742442b3f568ba"><enum>(13)</enum><text display-inline="yes-display-inline">any recommendations for modification to the programs that would improve pediatric drug research and increase pediatric labeling of drugs and biological products; and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id76B8331C19534CE39275E8769C72DA03"><enum>(14)</enum><text display-inline="yes-display-inline">an assessment of the successes of and limitations to studying drugs for rare diseases under such sections 505A and 505B.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id726B923667184F5BA1E0F231FF4942BC"><enum>(c)</enum><header display-inline="yes-display-inline">Consultation on recommendations</header><text display-inline="yes-display-inline">At least 180 days before the report is due under subsection (a), and no sooner than 4 years after the date of enactment of this Act, the Secretary shall consult with representatives of patient groups, including pediatric patient groups, consumer groups, regulated industry, scientific and medical communities, academia, and other interested parties to obtain any recommendations or information relevant to the effectiveness of the programs described in subsection (b)(7), including suggestions for modifications to such programs.</text> </subsection></section><section commented="no" display-inline="no-display-inline" id="idCDDFFFAF982A471582FB91E2204157DE" section-type="subsequent-section"><enum>509.</enum><header display-inline="yes-display-inline">Technical amendments</header> <subsection commented="no" display-inline="no-display-inline" id="H1BAC448E077547EFAFA3E2C9323A01F5"><enum>(a)</enum><header display-inline="yes-display-inline">Pediatric studies of drugs in FFDCA</header><text display-inline="yes-display-inline">Section 505A (21 U.S.C. 355a) is amended—</text> <paragraph commented="no" display-inline="no-display-inline" id="H17967E2BE279461FA32A97F36B8C6C50"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (k)(2), by striking <quote>subsection (f)(3)(F)</quote> and inserting <quote>subsection (f)(6)(F)</quote>;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="H91C8263BA7DD422A9E11182A0C70F74C"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (n)—</text> <subparagraph commented="no" display-inline="no-display-inline" id="H8D0D932C19C44D6CB9E198C2A2BE3F0A"><enum>(A)</enum><text display-inline="yes-display-inline">in the subsection heading, by striking <quote><header-in-text level="subsection" style="OLC">completed</header-in-text></quote> and inserting <quote><header-in-text level="subsection" style="OLC">submitted</header-in-text></quote>; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H3207DD39BBEF4EB59DFF58D66525C10C"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (1)—</text> <clause commented="no" display-inline="no-display-inline" id="H86FF35A2EC52473CAC9A0880FC7B84D3"><enum>(i)</enum><text display-inline="yes-display-inline">in the matter preceding subparagraph (A), by striking <quote>have not been completed</quote> and inserting <quote>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</quote>;</text> </clause><clause commented="no" display-inline="no-display-inline" id="H3A92A0DC15CC4A53A4A46001C63214B4"><enum>(ii)</enum><text display-inline="yes-display-inline">in subparagraph (A)—</text> <subclause commented="no" display-inline="no-display-inline" id="id8517CE5FB435402D9A927118316AC341"><enum>(I)</enum><text display-inline="yes-display-inline">in the first sentence, by inserting <quote>, 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</quote> after <quote>expired</quote>; and</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="idD15DA78DD59C4206A1001BE623B6521C"><enum>(II)</enum><text display-inline="yes-display-inline">by striking <quote>Prior to</quote> and all that follows through the period at the end; and</text> </subclause></clause><clause commented="no" display-inline="no-display-inline" id="H1D6CBD7FF36E4F579CA4A591ECEF88B2"><enum>(iii)</enum><text display-inline="yes-display-inline">in subparagraph (B), by striking <quote>no listed patents or has 1 or more listed patents that have expired,</quote> and inserting <quote>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,</quote>; and</text> </clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idF86E477413BB4D6EB2A2EB8E6A5B2834"><enum>(3)</enum><text display-inline="yes-display-inline">in subsection (o)(2), by amendment subparagraph (B) to read as follows:</text> <quoted-block display-inline="no-display-inline" id="id240960FF016644BE822537D3317D062F" style="OLC"> <subparagraph commented="no" display-inline="no-display-inline" id="idDF857E7FB0A445E584D036E8E5D339E9"><enum>(B)</enum><text display-inline="yes-display-inline">a statement of any appropriate pediatric contraindications, warnings, precautions, or other information that the Secretary considers necessary to assure safe use.</text> </subparagraph><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H34A31FD9600D4C0FA7A6939B1EF3EDC4"><enum>(b)</enum><header display-inline="yes-display-inline">Research into pediatric uses for drugs and biological projects in FFDCA</header><text display-inline="yes-display-inline">Section 505B (21 U.S.C. 355c) is amended—</text> <paragraph commented="no" display-inline="no-display-inline" id="H59801FBE2CA242A19D1B135E66B79DFB"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (a)—</text> <subparagraph commented="no" display-inline="no-display-inline" id="H6165418E7FF64E6EB4022D08BF171AEE"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1)—</text> <clause commented="no" display-inline="no-display-inline" id="H673B209D092340ED9FB89F3E86F6F0A0"><enum>(i)</enum><text display-inline="yes-display-inline">in the matter preceding subparagraph (A), by inserting <quote>for a drug</quote> after <quote>(or supplement to an application)</quote>;</text> </clause><clause commented="no" display-inline="no-display-inline" id="H83D7FF2F76EC429B869A16622861CCEE"><enum>(ii)</enum><text display-inline="yes-display-inline">in subparagraph (A), by striking <quote>for a</quote> and inserting <quote>, including, with respect to a drug, an application (or supplement to an application) for a</quote>;</text> </clause><clause commented="no" display-inline="no-display-inline" id="HE36A7D9C576E4DABBD1C538C5054AAE6"><enum>(iii)</enum><text display-inline="yes-display-inline">in subparagraph (B), by striking <quote>for a</quote> and inserting <quote>, including, with respect to a drug, an application (or supplement to an application) for a</quote>; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="id36F9EB7ECCE54D03A8D20A9B76C1A927"><enum>(iv)</enum><text display-inline="yes-display-inline">in the matter following subparagraph (B), by inserting <quote>(or supplement)</quote> after <quote>application</quote>; and</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HFD56E69D53A84111BDD9A942BF286418"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (4)(C)—</text> <clause commented="no" display-inline="no-display-inline" id="H3DEF49944001481E9429C095CCD6D59C"><enum>(i)</enum><text display-inline="yes-display-inline">in the first sentence, by inserting <quote>partial</quote> before <quote>waiver is granted</quote>; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="H8E256C3BD8464930B3BCB37994E82120"><enum>(ii)</enum><text display-inline="yes-display-inline">in the second sentence, by striking <quote>either a full or</quote> and inserting <quote>such a</quote>;</text> </clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id7F6218D188AC474381DCF56EFEF7167D"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (b)(1), in the matter preceding subparagraph (A), by striking <quote>After providing notice</quote> and all that follows through <quote>studies), the</quote> and inserting <quote>The</quote>;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="H09C6B78092314BB28AB0E00B51E5967D"><enum>(3)</enum><text display-inline="yes-display-inline">in subsection (g)—</text> <subparagraph commented="no" display-inline="no-display-inline" id="H289A4D3A7F3142E39FB3A8F1DC81635F"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1)(A), by inserting <quote>that receives a priority review or 330 days after the date of the submission of an application or supplement that receives a standard review</quote> after <quote>after the date of the submission of the application or supplement</quote>; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H1650B10F6CB14C2EA5A7081353CFDDCE"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (2), by striking <quote>the label of such product</quote> and inserting <quote>the labeling of such product</quote>; and</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF77C0C7DC6944FCAB1ACCCAD3765C82B"><enum>(4)</enum><text display-inline="yes-display-inline">in subsection (h)(1)—</text> <subparagraph commented="no" display-inline="no-display-inline" id="HA60FFF224F6C4E359B57D81449D075C9"><enum>(A)</enum><text display-inline="yes-display-inline">by inserting <quote>an application (or supplement to an application) that contains</quote> after <quote>date of submission of</quote>; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H694D8375821E423BBD4C3D3893F78778"><enum>(B)</enum><text display-inline="yes-display-inline">by inserting <quote>, 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,</quote> after <quote>under this section,</quote>.</text> </subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id1F4601CCCD79444D901EE4E044DC60CD"><enum>(c)</enum><header display-inline="yes-display-inline">Internal review committee</header><text display-inline="yes-display-inline">The heading of section 505C (21 U.S.C. 355d) is amended by inserting <quote><header-in-text level="section" style="OLC">and deferral extensions</header-in-text></quote> after <quote><header-in-text level="section" style="OLC">deferrals</header-in-text></quote>.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="idF235DF72D4BA41F7BFA5AD87BB4A4C36"><enum>(d)</enum><header display-inline="yes-display-inline">Program for pediatric studies of drugs</header><text display-inline="yes-display-inline">Section 409I(c) of the Public Health Service Act (42 U.S.C. 284m(c)) is amended—</text> <paragraph commented="no" display-inline="no-display-inline" id="id460C64975E3A45FAA132592FE82EFFFF"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (1)—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id2E92B99D13DC43D9ACC68EDAA5BC020A"><enum>(A)</enum><text display-inline="yes-display-inline">in the matter preceding subparagraph (A), by inserting <quote>or section 351(m) of this Act,</quote> after <quote>Cosmetic Act,</quote>;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id85A204CF0D8E42FB827A46FE2F762A87"><enum>(B)</enum><text display-inline="yes-display-inline">in subparagraph (A)(i), by inserting <quote>or section 351(k) of this Act</quote> after <quote>Cosmetic Act</quote>; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id0D37364964A046E89384F63B7680F79C"><enum>(C)</enum><text display-inline="yes-display-inline">by amending subparagraph (B) to read as follows:</text> <quoted-block display-inline="no-display-inline" id="id06B36A93FD4246BD9C1618EB7DAB3C8A" style="OLC"> <subparagraph commented="no" display-inline="no-display-inline" id="id6A4ACA1D46A64AC9A1DD1B228DBD2CE9"><enum>(B)</enum><text display-inline="yes-display-inline">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</text> </subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idDBAAA9DA0B2D4B5D841C4595BE3B19D2"><enum>(2)</enum><text display-inline="yes-display-inline">in paragraph (2)—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id7485FF3D2BCA4EBDA360220207D74BB7"><enum>(A)</enum><text display-inline="yes-display-inline">in the paragraph heading, by striking <quote><header-in-text level="paragraph" style="OLC">for drugs lacking exclusivity</header-in-text></quote>; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id249D2C05F6F74731B10BC926F1838A30"><enum>(B)</enum><text display-inline="yes-display-inline">by striking <quote>under section 505 of the Federal Food, Drug, and Cosmetic Act</quote>; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id67C0650880F2478AAC6DCF79FBE28EFB"><enum>(C)</enum><text display-inline="yes-display-inline">by striking <quote>505A of such Act</quote> and inserting <quote>505A of the Federal Food, Drug, and Cosmetic Act or section 351(m) of this Act</quote>.</text> </subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id80496A27E8DC4986B1F2809BEC85D714"><enum>(e)</enum><header display-inline="yes-display-inline">Pediatric subcommittee of the Oncologic Advisory Committee</header><text display-inline="yes-display-inline">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 <quote>‘section 505C’</quote>.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="idEAD0890751BD4FD8B369DEF7494555BA"><enum>(f)</enum><header display-inline="yes-display-inline">Foundation of national institutes of health</header><text display-inline="yes-display-inline">Section 499(c)(1)(C) of the Public Health Service Act (42 U.S.C. 290b(c)(1)(C)) is amended by striking <quote>for which the Secretary issues a certification in the affirmative under section 505A(n)(1)(A) of the Federal Food, Drug, and Cosmetic Act</quote>.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="id896808B765C349488B1F44209FF92C8E"><enum>(g)</enum><header display-inline="yes-display-inline">Application</header><text display-inline="yes-display-inline">Notwithstanding any provision of section 505A and 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c) stating that a provision applies beginning on the date of the enactment of the Best Pharmaceuticals for Children Act of 2007 or the date of the enactment of the Pediatric Research Equity Act of 2007, any amendment made by this title to such a provision applies beginning on the date of the enactment of this Act.</text> </subsection></section><section commented="no" display-inline="no-display-inline" id="id36C9322F0A5946839EA1C2529C4D7AF6" section-type="subsequent-section"><enum>510.</enum><header display-inline="yes-display-inline">Relationship between pediatric labeling and new clinical investigation exclusivity</header> <subsection commented="no" display-inline="no-display-inline" id="id9D9041C0916944E6BEFF89FC1496DF5C"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 505 (21 U.S.C. 351) is amended by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="idB4D80827280F4C7B8948C7018A53FFC3" style="OLC"> <subsection commented="no" display-inline="no-display-inline" id="id411C5B9BB876439986717C8E7B98174E"><enum>(w)</enum><header display-inline="yes-display-inline">Relationship Between Pediatric Labeling and New Clinical Investigation Exclusivity</header><text display-inline="yes-display-inline">The period of market exclusivity described in clauses (iii) and (iv) of subsection (c)(3)(E) and clauses (iii) and (iv) of subsection (j)(5)(F) shall not apply to a pediatric study conducted under section 505A or 505B that results, pursuant to section 505B(g)(2), in the inclusion in the labeling of the product a determination that the product is not indicated for use in pediatric populations or subpopulations or information indicating that the results of a study were inconclusive or did not demonstrate that the product is safe or effective in pediatric populations or subpopulations.</text> </subsection><after-quoted-block>.</after-quoted-block></quoted-block> </subsection><subsection commented="no" display-inline="no-display-inline" id="id7926971D829C481AAEFEC337ACED7506"><enum>(b)</enum><header display-inline="yes-display-inline">Pediatric studies of drugs</header><text display-inline="yes-display-inline">Section 505A(m) (21 U.S.C. 355a(m)) is amended—</text> <paragraph commented="no" display-inline="no-display-inline" id="id5B03F25A0C024B05952ACBE397333700"><enum>(1)</enum><text display-inline="yes-display-inline">by striking <quote>(m) <header-in-text level="subsection" style="OLC">Clarification of Interaction of Market Exclusivity Under This Section and Market Exclusivity Awarded to an Applicant for Approval of A Drug Under Section 505<enum-in-header>(j)</enum-in-header>.—</header-in-text>If a</quote> and all that follows through the end of the matter that precedes paragraph (1) and inserting the following:</text> <quoted-block display-inline="no-display-inline" id="id9B00F23F30EA45BDA443430157520B55" style="OLC"> <subsection commented="no" display-inline="no-display-inline" id="id109D616526C44E9DB8BB8E08D96379EB"><enum>(m)</enum><header display-inline="yes-display-inline">Clarification of Interaction of Market Exclusivity Under This Section and Market Exclusivity Awarded to an application or supplement under subsection (c) or (j) of Section 505</header> <paragraph commented="no" display-inline="no-display-inline" id="id9007CEABB7994A84BAF08AA4CAAA506C"><enum>(1)</enum><header display-inline="yes-display-inline">180-day exclusivity period</header><text display-inline="yes-display-inline">If a 180-day period under section 505(j)(5)(B)(iv) overlaps with a 6-month exclusivity period under this section, so that the applicant for approval of a drug under section 505(j) entitled to the 180-day period under that section loses a portion of the 180-day period to which the applicant is entitled for the drug, the 180-day period shall be extended from—</text> </paragraph></subsection><after-quoted-block>;</after-quoted-block></quoted-block> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id7F4DF7F8AC3E4AF3A8FA30AA03CD2C69"><enum>(2)</enum><text display-inline="yes-display-inline">by redesignating paragraphs (1) and (2) as subparagraphs (A) and (B) and moving such subparagraphs, as so redesignated, 2 ems to the right; and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id15853579B4D24A8CB2F177C47A24C221"><enum>(3)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="idF15B7509167B45FABEF5FABADBA3F8D1" style="OLC"> <paragraph commented="no" display-inline="no-display-inline" id="id351C8A5458D1424D8413E60897992A5F"><enum>(2)</enum><header display-inline="yes-display-inline">3-year exclusivity period</header><text display-inline="yes-display-inline">The 3-year period of exclusivity under clauses (iii) and (iv) of subsection 505(c)(3)(E) and clauses (iii) and (iv) of subsection 505(j)(5)(F) are not available for approval of applications or supplements to applications based on reports of pediatric studies conducted under sections 505A or 505B that resulted, pursuant to section 505A(j) or 505B(g)(2), in the inclusion in the labeling of the product a determination that the product is not indicated for use in pediatric populations or subpopulations or information indicating that the results of an assessment were inconclusive or did not demonstrate that the product is safe or effective in pediatric populations or subpopulation.</text> </paragraph><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id0138B06581DF47EDB2D7D6D404132814"><enum>(c)</enum><header display-inline="yes-display-inline">Prompt Approval of Drugs</header><text display-inline="yes-display-inline">Section 505A(o) (21 U.S.C. 355a(o)) is amended—</text> <paragraph commented="no" display-inline="no-display-inline" id="idF8FBE90EB6244470B1312E7830331858"><enum>(1)</enum><text display-inline="yes-display-inline">in the heading, by striking <quote><header-in-text level="subsection" style="OLC">section 505(j)</header-in-text></quote> and inserting <quote><header-in-text level="subsection" style="OLC">subsections (c) and (j) of section 505</header-in-text></quote>;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id9EFE5F5D84D141ECB66CB44C95C1E76A"><enum>(2)</enum><text display-inline="yes-display-inline">in paragraph (1), by striking <quote>under section 505(j)</quote> and inserting <quote>under subsection (b)(2), (c), or (j) of section 505</quote>;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idF7862F529FE042A3AE0A2E8F8769158F"><enum>(3)</enum><text display-inline="yes-display-inline">in paragraph (2), in the matter preceding subparagraph (A), by inserting <quote>clauses (iii) and (iv) of section 505(c)(3)(E) or</quote> after <quote>Notwithstanding</quote>; and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id23D42CBB7F88433D90C8C6A0D62399D3"><enum>(4)</enum><text display-inline="yes-display-inline">in paragraph (3)—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id525D70D2E3D94A59859486C8CB64F84C"><enum>(A)</enum><text display-inline="yes-display-inline">in subparagraph (B), by inserting <quote>that differ from adult formulations</quote> before the semicolon at the end; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id4BC19B19D3554E0BB096897BF6AD5190"><enum>(B)</enum><text display-inline="yes-display-inline">in subparagraph (C)—</text> <clause commented="no" display-inline="no-display-inline" id="idD1A98CF31C004FAFA821548A3E517BCE"><enum>(i)</enum><text display-inline="yes-display-inline">by striking <quote>under section 505(j)</quote> and inserting <quote>under subsection (c) or (j) of section 505</quote>; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="id288A70092464469D85C10A7571B9C5E9"><enum>(ii)</enum><text display-inline="yes-display-inline">by inserting <quote>clauses (iii) or (iv) of section 505(c)(3)(E) or</quote> after <quote>exclusivity under</quote>.</text> </clause></subparagraph></paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="id6A9717F5552D408296A59135329ADFB9" section-type="subsequent-section"><enum>511.</enum><header display-inline="yes-display-inline">Pediatric rare diseases</header> <subsection commented="no" display-inline="no-display-inline" id="id62C8390494EA4751B51AA81CB3254F3D"><enum>(a)</enum><header display-inline="yes-display-inline">Public meeting</header><text display-inline="yes-display-inline">Not later than 18 months after the date of enactment of this Act, the Secretary shall hold a public meeting to discuss ways to encourage and accelerate the development of new therapies for pediatric rare diseases.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="id66EB6F380A3E4AE597EE2305CFD3366C"><enum>(b)</enum><header display-inline="yes-display-inline">Report</header><text display-inline="yes-display-inline">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.</text> </subsection></section><enum>VI</enum><header display-inline="yes-display-inline">Medical device regulatory improvements</header> <section commented="no" display-inline="no-display-inline" id="idFEED59A4A3C5488988A92A438D21DC48" section-type="subsequent-section"><enum>601.</enum><header display-inline="yes-display-inline">Reclassification procedures</header> <subsection commented="no" display-inline="no-display-inline" id="id258D7E27D4C940938CF6D25766649F95"><enum>(a)</enum><header display-inline="yes-display-inline">Classification changes</header> <paragraph commented="no" display-inline="no-display-inline" id="idCACAF737D0884F46BA5FBD24FC8FEAA3"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 513(e)(1) (21 U.S.C. 360c(e)(1)) is amended to read as follows:</text> <quoted-block display-inline="no-display-inline" id="id9EDA4E3302EB4E35AC195DA26437AA90" style="OLC"> <subsection commented="no" display-inline="no-display-inline" id="id2F2E81065B1B4031934590CE37D09EFB"><enum>(e)</enum><paragraph commented="no" display-inline="yes-display-inline" id="id6B5A4F3CD92F4A8F9CA9E814697D09AB"><enum>(1)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="idFDCA754A988F41CAA3CEC9527E6097C7"><enum>(A)</enum><text display-inline="yes-display-inline">Based on new information respecting a device, the Secretary may, upon the initiative of the Secretary or upon petition of an interested person, change the classification of such device, and revoke, on account of the change in classification, any regulation or requirement in effect under section 514 or 515 with respect to such device, by administrative order published in the Federal Register following publication of a proposed reclassification order in the Federal Register, a meeting of a device classification panel described in subsection (b), and consideration of comments to a public docket, notwithstanding subchapter II of Chapter 5 of title 5 of the United States Code. An order under this subsection changing the classification of a device from class III to class II may provide that such classification shall not take effect until the effective date of a performance standard established under section 514 for such device.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id0D68A64601044F55A98874376A59DA4A" indent="up2"><enum>(B)</enum><text display-inline="yes-display-inline">Authority to issue such administrative order shall not be delegated below the Commissioner. The Commissioner shall issue such an order as proposed by the Director of the Center for Devices and Radiological Health unless the Commissioner, in consultation with the Office of the Secretary of Health and Human Services, concludes that the order exceeds the legal authority of the Food and Drug Administration or that the order would be lawful, but unlikely to advance the public health.</text> </subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id563F0DB957C643A59F65D7D84903E14C"><enum>(2)</enum><header display-inline="yes-display-inline">Technical and conforming amendments</header> <subparagraph commented="no" display-inline="no-display-inline" id="idA1883313A72B4F4EB154CF21ECD15380"><enum>(A)</enum><text display-inline="yes-display-inline">Section 513(e)(2) (21 U.S.C. 360c(e)(2)) is amended by striking <quote>regulation promulgated</quote> and inserting <quote>an order issued</quote>.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idA13F8D0E55DC46879409E0374F974D19"><enum>(B)</enum><text display-inline="yes-display-inline">Section 514(a)(1) (21 U.S.C. 360d(a)(1)) is amended by striking <quote>under a regulation under section 513(e) but such regulation</quote> and inserting <quote>under an administrative order under section 513(e) (or a regulation promulgated under such section prior to the date of enactment of the <short-title>Food and Drug Administration Safety and Innovation Act</short-title>) but such order (or regulation)</quote>;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id80A5C1B4010E400CBFBB39FFB26C487F"><enum>(C)</enum><text display-inline="yes-display-inline">Section 517(a)(1) (21 U.S.C. 360g(a)(1)) is amended by striking <quote>or changing the classification of a device to class I</quote> and inserting <quote>, an administrative order changing the classification of a device to class I,</quote>.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id0D4C7FC923DE4761A108B96E5F4C78D9"><enum>(3)</enum><header display-inline="yes-display-inline">Devices reclassified prior to the date of enactment of this Act</header> <subparagraph commented="no" display-inline="no-display-inline" id="idE3F9D9E365D04910A29C5807888D8820"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idF15AE49291954D76A4DCC247383BBF09"><enum>(B)</enum><header display-inline="yes-display-inline">Applicability of other provisions</header><text display-inline="yes-display-inline">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.</text> </subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idA2D63728F1AB4731BD6A167D231B3DED"><enum>(b)</enum><header display-inline="yes-display-inline">Devices marketed before May 28, 1976</header> <paragraph commented="no" display-inline="no-display-inline" id="idF03AC1BBD89F405190B8D68EF3D813A9"><enum>(1)</enum><header display-inline="yes-display-inline">Premarket approval</header><text display-inline="yes-display-inline">Section 515 (21 U.S.C. 360e) is amended—</text> <subparagraph commented="no" display-inline="no-display-inline" id="idD93EE5B03E0F4CAEB49F6F38F6A84B70"><enum>(A)</enum><text display-inline="yes-display-inline">in subsection (a), by striking <quote>regulation promulgated under subsection (b)</quote> and inserting <quote>an order issued under subsection (b) (or a regulation promulgated under such subsection prior to the date of enactment of the <short-title>Food and Drug Administration Safety and Innovation Act</short-title>)</quote>;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idB9AD224374FC4026BECDA0C279F897F8"><enum>(B)</enum><text display-inline="yes-display-inline">in subsection (b)—</text> <clause commented="no" display-inline="no-display-inline" id="id36608F9336DC458299A26967B18E1C75"><enum>(i)</enum><text display-inline="yes-display-inline">in paragraph (1)—</text> <subclause commented="no" display-inline="no-display-inline" id="id72835E038D7A4546BA0FC8C5E793D453"><enum>(I)</enum><text display-inline="yes-display-inline">in the heading, by striking <quote>Regulation</quote> and inserting <quote>Order</quote>; and</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="id086103721080430A8D512267C56C470D"><enum>(II)</enum><text display-inline="yes-display-inline">in the matter following subparagraph (B)—</text> <item commented="no" display-inline="no-display-inline" id="id3BF38A1E4834427AAA033CAE95C7AF40"><enum>(aa)</enum><text display-inline="yes-display-inline">by striking <quote>by regulation, promulgated in accordance with this subsection</quote> and inserting <quote>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</quote>; and</text> </item><item commented="no" display-inline="no-display-inline" id="idB41E8EBFF467434D8AA11DC51A114128"><enum>(bb)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text> </item></subclause></clause></subparagraph><continuation-text commented="no" continuation-text-level="paragraph" indent="subsection"><quote>Authority to issue such administrative order shall not be delegated below the Commissioner. Before publishing such administrative order, the Commissioner shall consult with the Office of the Secretary. The Commissioner shall issue such an order as proposed by the Director of the Center for Devices and Radiological Health unless the Commissioner, in consultation with the Office of the Secretary, concludes that the order exceeds the legal authority of the Food and Drug Administration or that the order would be lawful, but unlikely to advance the public health.</quote>;</continuation-text><subparagraph id="LEXA-RepairidD072C28FA72C4DDBB6E75C6B859B1FB7"><enum></enum><clause commented="no" display-inline="no-display-inline" id="idBE1DD4D3A51C42D7B473F5554276B134"><enum>(ii)</enum><text display-inline="yes-display-inline">in paragraph (2)—</text> <subclause commented="no" display-inline="no-display-inline" id="idED79473DB83C461487827CB1BA064BDA"><enum>(I)</enum><text display-inline="yes-display-inline">by striking subparagraph (B); and</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="id1567453C19774EA1839AFE3D2D10DAB7"><enum>(II)</enum><text display-inline="yes-display-inline">in subparagraph (A)—</text> <item commented="no" display-inline="no-display-inline" id="idD83D709644424DBB8945CBEDD836CB67"><enum>(aa)</enum><text display-inline="yes-display-inline">by striking <quote>(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—</quote> and inserting <quote>(2) A proposed order required under paragraph (1) shall contain—</quote>;</text> </item><item commented="no" display-inline="no-display-inline" id="idB09F214E96D74B0295A2A935C4CED908"><enum>(bb)</enum><text display-inline="yes-display-inline">by redesignating clauses (i) through (iv) as subparagraphs (A) through (D), respectively;</text> </item><item commented="no" display-inline="no-display-inline" id="id41E6D1F453334ADFA9FDCCF0AE4ED286"><enum>(cc)</enum><text display-inline="yes-display-inline">in subparagraph (A), as so redesignated, by striking <quote>regulation</quote> and inserting <quote>order</quote>; and</text> </item><item commented="no" display-inline="no-display-inline" id="id48BD3AC44D0E4D9CBF82D3C735F51382"><enum>(dd)</enum><text display-inline="yes-display-inline">in subparagraph (C), as so redesignated, by striking <quote>regulation</quote> and inserting <quote>order</quote>;</text> </item></subclause></clause><clause commented="no" display-inline="no-display-inline" id="id796166F4A09B4F118599AD02552B8B14"><enum>(iii)</enum><text display-inline="yes-display-inline">in paragraph (3)—</text> <subclause commented="no" display-inline="no-display-inline" id="id4B14226CD15E41DB9DFC761042B221CD"><enum>(I)</enum><text display-inline="yes-display-inline">by striking <quote>proposed regulation</quote> each place such term appears and inserting <quote>proposed order</quote>;</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="idDDF3930A21E04E0B899FBF3C8FF23549"><enum>(II)</enum><text display-inline="yes-display-inline">by striking <quote>paragraph (2) and after</quote> and inserting <quote>paragraph (2),</quote>;</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="id42C56CE619FF4912888FFAA5F6B4C64F"><enum>(III)</enum><text display-inline="yes-display-inline">by inserting <quote>and a meeting of a device classification panel described in section 513(b),</quote> after <quote>such proposed regulation and findings,</quote>;</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="id569CD1EE82604A8F914FCCD3C27039E9"><enum>(IV)</enum><text display-inline="yes-display-inline">by striking <quote>(A) promulgate such regulation</quote> and inserting <quote>(A) issue an administrative order under paragraph (1)</quote>;</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="id8374AC189E244DD99026FA0BF8E45A26"><enum>(V)</enum><text display-inline="yes-display-inline">by striking <quote>paragraph (2)(A)(ii)</quote> and inserting <quote>paragraph (2)(B)</quote>; and</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="id60CFDB9CF94E48A1AA6D8EA56D6A1B6B"><enum>(VI)</enum><text display-inline="yes-display-inline">by striking <quote>promulgation of the regulation</quote> and inserting <quote>issuance of the administrative order</quote>; and</text> </subclause></clause><clause commented="no" display-inline="no-display-inline" id="id98055A6F87924F30BF767270397CF4D8"><enum>(iv)</enum><text display-inline="yes-display-inline">by striking paragraph (4); and</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idDBAC5BDA73CD4459A95DC9787737CC61"><enum>(C)</enum><text display-inline="yes-display-inline">in subsection (i)—</text> <clause commented="no" display-inline="no-display-inline" id="id6322942401B14F4DA68F8A550FFD2AE6"><enum>(i)</enum><text display-inline="yes-display-inline">in paragraph (2)—</text> <subclause commented="no" display-inline="no-display-inline" id="id27CC962541E34900A4B6C514C46FF1BD"><enum>(I)</enum><text display-inline="yes-display-inline">in the matter preceding subparagraph (A)—</text> <item commented="no" display-inline="no-display-inline" id="id5EC3F3D910264CAFA25942ABCD4D1A4C"><enum>(aa)</enum><text display-inline="yes-display-inline">by striking <quote>December 1, 1995</quote> and inserting <quote>the date that is 2 years after the date of enactment of the <short-title>Food and Drug Administration Safety and Innovation Act</short-title></quote>; and</text> </item><item commented="no" display-inline="no-display-inline" id="idBDE3703398034DBCB682CE71435018EE"><enum>(bb)</enum><text display-inline="yes-display-inline">by striking <quote>publish a regulation in the Federal Register</quote> and inserting <quote>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,</quote>;</text> </item></subclause><subclause commented="no" display-inline="no-display-inline" id="idFA5FD76FEBCB477AA9F5BF54DD911483"><enum>(II)</enum><text display-inline="yes-display-inline">in subparagraph (B), by striking <quote>final regulation has been promulgated under section 515(b)</quote> and inserting <quote>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 <short-title>Food and Drug Administration Safety and Innovation Act</short-title>)</quote>;</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="id341BA7B5401141F48F3A1C425F463BED"><enum>(III)</enum><text display-inline="yes-display-inline">in the matter following subparagraph (B), by striking <quote>regulation requires</quote> and inserting <quote>administrative order issued under this paragraph requires</quote>; and</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="idFC7C5AEFF1F54C53BAB702ABDA42928E"><enum>(IV)</enum><text display-inline="yes-display-inline">by striking the third and fourth sentences; and</text> </subclause></clause><clause commented="no" display-inline="no-display-inline" id="id801F59A24CC5465886911DCADDF5C0BB"><enum>(ii)</enum><text display-inline="yes-display-inline">in paragraph (3)—</text> <subclause commented="no" display-inline="no-display-inline" id="id2929FABEA40E4F4FA6B2EBDAA08C9362"><enum>(I)</enum><text display-inline="yes-display-inline">by striking <quote>regulation requiring</quote> each place such term appears and inserting <quote>order requiring</quote>; and</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="id7F132220194243759973E6DA1471BAF8"><enum>(II)</enum><text display-inline="yes-display-inline">by striking <quote>promulgation of a section 515(b) regulation</quote> and inserting <quote>issuance of an administrative order under subsection (b)</quote>.</text> </subclause></clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id40374A15017143B691554EFF8D2CC19F"><enum>(2)</enum><header display-inline="yes-display-inline">Technical and conforming amendments</header><text display-inline="yes-display-inline">Section 501(f) (21 U.S.C. 351(f)) is amended—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id581EFD323554439ABA95E326BFAAA54D"><enum>(A)</enum><text display-inline="yes-display-inline">in subparagraph (1)(A)—</text> <clause commented="no" display-inline="no-display-inline" id="id0FA23730A2D34AB9B5BFF9DD182A5904"><enum>(i)</enum><text display-inline="yes-display-inline">in subclause (i), by striking <quote>a regulation promulgated</quote> and inserting <quote>an order issued</quote>; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="id860EB980F36F4611ACB2FC73575C62B0"><enum>(ii)</enum><text display-inline="yes-display-inline">in subclause (ii), by striking <quote>promulgation of such regulation</quote> and inserting <quote>issuance of such order</quote>;</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id39CE0784652B468FAFBE284A7FC53281"><enum>(B)</enum><text display-inline="yes-display-inline">in subparagraph (2)(B)—</text> <clause commented="no" display-inline="no-display-inline" id="idC9BBBD1EE600408F889B50D6AA6560F7"><enum>(i)</enum><text display-inline="yes-display-inline">by striking <quote>a regulation promulgated</quote> and inserting <quote>an order issued</quote>; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="id30E2D680EDF54D6087129CC89E01B8AA"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking <quote>promulgation of such regulation</quote> and inserting <quote>issuance of such order</quote>; and</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id87C742F2AD4A411CA5A99CE8622F7672"><enum>(C)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="id4B85E97B936B4A20857DF04710B5ADD0" style="OLC"> <paragraph commented="no" display-inline="no-display-inline" id="idE0F5786668B6460D826AEBE1506DB7F0" indent="up1"><enum>(3)</enum><text display-inline="yes-display-inline">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 <short-title>Food and Drug Administration Safety and Innovation Act</short-title>, a reference in this subsection to an order issued under section 515(b) shall be deemed to include such regulation.</text> </paragraph><after-quoted-block>.</after-quoted-block></quoted-block> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id5892375A4CD149D5A9EF9337EB672EE9"><enum>(3)</enum><header display-inline="yes-display-inline">Approval by regulation prior to the date of enactment of this Act</header><text display-inline="yes-display-inline">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.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id231E74D1578644C3BD795283B1919BAC"><enum>(c)</enum><header display-inline="yes-display-inline">Reporting</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services shall annually post on the Internet website of the Food and Drug Administration—</text> <paragraph commented="no" display-inline="no-display-inline" id="id9142b9d6699f4cc08c35a423b05f7799"><enum>(1)</enum><text display-inline="yes-display-inline">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));</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idd1e22e620d0f48a9a8194a8d5c4ca73f"><enum>(2)</enum><text display-inline="yes-display-inline">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</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id1275f5982be04466867e176a6e12e8fe"><enum>(3)</enum><text display-inline="yes-display-inline">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).</text> </paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="H5B4BD8FFF9B249DFB48557842AFC6A4B" section-type="subsequent-section"><enum>602.</enum><header display-inline="yes-display-inline">Condition of approval studies</header><text display-inline="no-display-inline">Section 515(d)(1)(B)(ii) (21 U.S.C. 360e(d)(1)(B)(ii)) is amended—</text> <paragraph commented="no" display-inline="no-display-inline" id="idE0439B83D804436493282D9EAD33B23D"><enum>(1)</enum><text display-inline="yes-display-inline">by striking <quote>(ii)</quote> and inserting <quote>(ii)(I)</quote>; and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id97F24A7FA62A4475A163CDB562014F18"><enum>(2)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="id814B9A15EEA24CE780157C46EEDC3A86" style="OLC"> <subclause commented="no" display-inline="no-display-inline" id="id8AE61B8802B1458FB28CB2B00A95B2F4" indent="up4"><enum>(II)</enum><text display-inline="yes-display-inline">An order approving an application for a device may require as a condition to such approval that the applicant conduct a postmarket study regarding the device.</text> </subclause><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph></section><section commented="no" display-inline="no-display-inline" id="id4F8825F8E585402085B465C90A9C982A" section-type="subsequent-section"><enum>603.</enum><header display-inline="yes-display-inline">Postmarket surveillance</header><text display-inline="no-display-inline">Section 522 (21 U.S.C. 360l) is amended—</text> <paragraph commented="no" display-inline="no-display-inline" id="idb584753e03784e29aada90c87624be55"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (a)(1)(A), in the matter preceding clause (i), by inserting <quote>, at the time of approval or clearance of a device or at any time thereafter,</quote> after <quote>by order</quote>; and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id23eb00a7b6b043a9a7dbb9568e0aeda3"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (b)(1), by inserting <quote>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.</quote> after the second sentence.</text> </paragraph></section><section commented="no" display-inline="no-display-inline" id="id7A5CCEB120014F51B8E5278B38049471" section-type="subsequent-section"><enum>604.</enum><header display-inline="yes-display-inline">Sentinel</header><text display-inline="no-display-inline">Section 519 (21 U.S.C. 360i) is amended by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="id7769A9DAC63C4B46B5E0D7BDA2D89AFD" style="OLC"> <subsection commented="no" display-inline="no-display-inline" id="id4ABFA21E3C2840C5965E79B79931CD13"><enum>(h)</enum><header display-inline="yes-display-inline">Inclusion of devices in the postmarket risk identification and analysis system</header> <paragraph commented="no" display-inline="no-display-inline" id="id47F97B1AC7B64F1DBE4A58661342396C"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header> <subparagraph commented="no" display-inline="no-display-inline" id="id219F78F38A5A42A09CF7B75C9D0DBC62"><enum>(A)</enum><header display-inline="yes-display-inline">Application to devices</header><text display-inline="yes-display-inline">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.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id06E82C72E4134311A9AD01E0CE59E814"><enum>(B)</enum><header display-inline="yes-display-inline">Exception</header><text display-inline="yes-display-inline">Subclause (II) of clause (i) of section 505(k)(3)(C) shall not apply to devices.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id2DEF2910EFC84CA5BEDE4739C86A47F7"><enum>(C)</enum><header display-inline="yes-display-inline">Clarification</header><text display-inline="yes-display-inline">With respect to devices, the private sector health-related electronic data provided under section 505(k)(3)(C)(i)(III)(bb) may include medical device utilization data, health insurance claims data, and procedure and device registries.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id4C3E0395978745F98DDE380D26A7D0AF"><enum>(2)</enum><header display-inline="yes-display-inline">Data</header><text display-inline="yes-display-inline">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.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idD8EA3C4A170E4F128ED8F24FA60AAE2C"><enum>(3)</enum><header display-inline="yes-display-inline">Stakeholder input</header><text display-inline="yes-display-inline">To help ensure effective implementation of the system described in paragraph (1)(A), the Secretary shall engage outside stakeholders in development of the system through a public hearing, advisory committee meeting, public docket, or other like public measures, as appropriate.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id75A82C1E25BE45E8A7D686855CAAD71B"><enum>(4)</enum><header display-inline="yes-display-inline">Voluntary surveys</header><text display-inline="yes-display-inline">Chapter 35 of title 44, United States Code, shall not apply to the collection of voluntary information from health care providers, such as voluntary surveys or questionnaires, initiated by the Secretary for purposes of postmarket risk identification for devices.</text> </paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block> </section><section commented="no" display-inline="no-display-inline" id="id94935B96AA68442A8ECFD9E2E36A3B55" section-type="subsequent-section"><enum>605.</enum><header display-inline="yes-display-inline">Recalls</header> <subsection commented="no" display-inline="no-display-inline" id="id7574B4BF3FB24DC5A0696DE518E714DA"><enum>(a)</enum><header display-inline="yes-display-inline">Assessment of device recall information</header> <paragraph commented="no" display-inline="no-display-inline" id="id2BDA70693A0B4311B99FA63AD11944C9"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header> <subparagraph commented="no" display-inline="no-display-inline" id="idDA597ACD8A134C15B25FDD8B18767520"><enum>(A)</enum><header display-inline="yes-display-inline">Assessment program</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services (referred to in this section as the <quote>Secretary</quote>) shall enhance the Food and Drug Administration's recall program to routinely and systematically assess—</text> <clause commented="no" display-inline="no-display-inline" id="id7B995417CC044D5387D478319DFBEED4"><enum>(i)</enum><text display-inline="yes-display-inline">information submitted to the Secretary pursuant to a device recall order under section 518(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360h(e)); and</text> </clause><clause commented="no" display-inline="no-display-inline" id="idB42BA307E66542F2ACB2D1E3581335BF"><enum>(ii)</enum><text display-inline="yes-display-inline">information required to be reported to the Secretary regarding a correction or removal of a device under section 519(g) of such Act (21 U.S.C. 360i(g)).</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idAB4758761C114CDE9017980E2747CCA0"><enum>(B)</enum><header display-inline="yes-display-inline">Use</header><text display-inline="yes-display-inline">The Secretary shall use the assessment of information described under subparagraph (A) to proactively identify strategies for mitigating health risks presented by defective or unsafe devices.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idCBD18E92D9DF4E72BD00730C91924BC4"><enum>(2)</enum><header display-inline="yes-display-inline">Design</header><text display-inline="yes-display-inline">The program under paragraph (1) shall, at a minimum, identify—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id6D4F9513FAB7433281BB28EA79EE6763"><enum>(A)</enum><text display-inline="yes-display-inline">trends in the numbers and types of device recalls;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id97BADB1607904D82A7885D997512BAD2"><enum>(B)</enum><text display-inline="yes-display-inline">the types of devices in each device class that are most frequently recalled;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id34385E8DC26D4488AE9A5804BD314E63"><enum>(C)</enum><text display-inline="yes-display-inline">the causes of device recalls; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idD649F47FCC294424A5443F7015C623E3"><enum>(D)</enum><text display-inline="yes-display-inline">any other information as the Secretary determines appropriate.</text> </subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idF9FAA18E33C541C38C289A424FDABF66"><enum>(b)</enum><header display-inline="yes-display-inline">Audit check procedures</header><text display-inline="yes-display-inline">The Secretary shall clarify procedures for conducting device recall audit checks to improve the ability of investigators to perform these checks in a consistent manner.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="idA94346BC53C547A7830D7CDCBCA98D3F"><enum>(c)</enum><header display-inline="yes-display-inline">Assessment criteria</header><text display-inline="yes-display-inline">The Secretary shall develop explicit criteria for assessing whether a person subject to a recall order under section 518(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360h(e)) or to a requirement under section 519(g) of such Act (21 U.S.C. 360i(g)) has performed an effective recall under such section 518(e) or an effective correction or removal action under such section 519(g), respectively.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="id55CC427188A844719F189D11D3C2E832"><enum>(d)</enum><header display-inline="yes-display-inline">Termination of recalls</header><text display-inline="yes-display-inline">The Secretary shall document the basis for the termination by the Food and Drug Administration of—</text> <paragraph commented="no" display-inline="no-display-inline" id="id8E480836F10C472AB58BC7177E1AEC83"><enum>(1)</enum><text display-inline="yes-display-inline">an individual device recall ordered under section 518(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360h(e)); and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id7C0783CE289F4E19BCFFE2EDD59C8E0B"><enum>(2)</enum><text display-inline="yes-display-inline">any correction or removal action for which a report is required to be submitted to the Secretary under section 519(g) of such Act (21 U.S.C. 360i(g)).</text> </paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="id85FA69F1D6DB427597EF237BF597FF56" section-type="subsequent-section"><enum>606.</enum><header display-inline="yes-display-inline">Clinical holds on investigational device exemptions</header><text display-inline="no-display-inline">Section 520(g) (21 U.S.C. 360j(g)) is amended by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="idB444F98447654E0698683D69127AF51E" style="OLC"> <paragraph commented="no" display-inline="no-display-inline" id="idD84163FF5DA145F38ABD0C15753B71D0" indent="up1"><enum>(8)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="idF122652A2D374D79942351596F2AB7AD"><enum>(A)</enum><text display-inline="yes-display-inline">At any time, the Secretary may prohibit the sponsor of an investigation from conducting the investigation (referred to in this paragraph as a <quote>clinical hold</quote>) 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.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id950876A9D24640168A0B504F61292DF1" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">For purposes of subparagraph (A), a determination described in this subparagraph with respect to a clinical hold is a determination that—</text> <clause commented="no" display-inline="no-display-inline" id="id08E46C78D083484FA2EA7FB2A3532938"><enum>(i)</enum><text display-inline="yes-display-inline">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</text> </clause><clause commented="no" display-inline="no-display-inline" id="idD353EE62560B49A595A0B0ACF3877E7D"><enum>(ii)</enum><text display-inline="yes-display-inline">the clinical hold should be issued for such other reasons as the Secretary may by regulation establish.</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idDFE9E38025F6463EB5575E459ECB42CE" indent="up1"><enum>(C)</enum><text display-inline="yes-display-inline">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.</text> </subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block> </section><section commented="no" display-inline="no-display-inline" id="idAC27D4D2A7404BE6A0182B125EA21359" section-type="subsequent-section"><enum>607.</enum><header display-inline="yes-display-inline">Unique device identifier</header><text display-inline="no-display-inline">Section 519(f) (21 U.S.C. 360i(f)) is amended—</text> <paragraph commented="no" display-inline="no-display-inline" id="id96F36CAE6F524A7497408E00DD389FB3"><enum>(1)</enum><text display-inline="yes-display-inline">by striking <quote>The Secretary shall promulgate</quote> and inserting <quote>Not later than December 31, 2012, the Secretary shall issue proposed</quote>; and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id44CFC9E5759949608E9E8B8F1163DCC9"><enum>(2)</enum><text display-inline="yes-display-inline">by adding at the end the following: <quote>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.</quote>.</text> </paragraph></section><section commented="no" display-inline="no-display-inline" id="idB2283E024CB8410D85307BBD430AAE09" section-type="subsequent-section"><enum>608.</enum><header display-inline="yes-display-inline">Clarification of least burdensome standard</header> <subsection commented="no" display-inline="no-display-inline" id="ID004d11d8635440fd9ca8164d3ea2abc8"><enum>(a)</enum><header display-inline="yes-display-inline">Premarket approval</header><text display-inline="yes-display-inline">Section 513(a)(3)(D) (21 U.S.C. 360c(a)(3)(D)) is amended—</text> <paragraph commented="no" display-inline="no-display-inline" id="id11299212E2C940B5B574732B93DC2776"><enum>(1)</enum><text display-inline="yes-display-inline">by redesignating clause (iii) as clause (v); and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id0A725A4D9CEB45A3BD10DE48AC59691E"><enum>(2)</enum><text display-inline="yes-display-inline">by inserting after clause (ii) the following:</text> <quoted-block display-inline="no-display-inline" id="id08EA84B4BCFF48D7866426F54283188F" style="OLC"> <clause commented="no" display-inline="no-display-inline" id="id107B4637E9D84EE795D3F9A66D371D2F" indent="up3"><enum>(iii)</enum><text display-inline="yes-display-inline">For purposes of clause (ii), the term <term>necessary</term> 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.</text> </clause><clause commented="no" display-inline="no-display-inline" id="id60B408C71E2B4DF2B9A40F914C5553C0" indent="up3"><enum>(iv)</enum><text display-inline="yes-display-inline">Nothing in this subparagraph shall alter the criteria for evaluating an application for premarket approval of a device.</text> </clause><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="IDeb8176f45d4946a59d1b046d6627d0b9"><enum>(b)</enum><header display-inline="yes-display-inline">Premarket notification under section 510(k)</header><text display-inline="yes-display-inline">Section 513(i)(1)(D) (21 U.S.C. 360c(i)(1)(D)) is amended—</text> <paragraph commented="no" display-inline="no-display-inline" id="ID9ee54a7001364d60b26186c9359cca51"><enum>(1)</enum><text display-inline="yes-display-inline">by striking <quote>(D) Whenever</quote> and inserting <quote>(D)(i) Whenever</quote>; and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID6b72835dad684048bf9fadbb04ca5ce8"><enum>(2)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="id8DD0085D28384DE6B1E612FE352FA3CC" style="OLC"> <clause commented="no" display-inline="no-display-inline" id="id5A240C1C38824D6DACC77DE45998E84D" indent="up3"><enum>(ii)</enum><text display-inline="yes-display-inline">For purposes of clause (i), the term <quote>necessary</quote> means the minimum required information that would support a determination of substantial equivalence between a new device and a predicate device.</text> </clause><clause commented="no" display-inline="no-display-inline" id="idF1E646A72DA040E993A47EC972F5F337" indent="up3"><enum>(iii)</enum><text display-inline="yes-display-inline">Nothing in this subparagraph shall alter the standard for determining substantial equivalence between a new device and a predicate device.</text> </clause><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="H74E76642A162469F8A9D5E657A590DA9" section-type="subsequent-section"><enum>609.</enum><header display-inline="yes-display-inline">Custom devices</header><text display-inline="no-display-inline">Section 520(b) (21 U.S.C. 360j(b)) is amended to read as follows:</text> <quoted-block display-inline="no-display-inline" id="idB3FA81BC661641349965C25D8BDE9511" style="OLC"> <subsection commented="no" display-inline="no-display-inline" id="idD397A78723B44733A284FFCFA147CF55"><enum>(b)</enum><header display-inline="yes-display-inline">Custom devices</header> <paragraph commented="no" display-inline="no-display-inline" id="id85448162DC2D45588CFC0FFA18DC73E0"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The requirements of sections 514 and 515 shall not apply to a device that—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id9E0D7873870B46008C23703577715BF6"><enum>(A)</enum><text display-inline="yes-display-inline">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);</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id134252A30FFE48A282881444AE3CA05F"><enum>(B)</enum><text display-inline="yes-display-inline">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;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id2216a50ea7e24dcfb68fd37b330169a4"><enum>(C)</enum><text display-inline="yes-display-inline">is not generally available in the United States in finished form through labeling or advertising by the manufacturer, importer, or distributor for commercial distribution;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id92B1769B6EC34F7A930B16F2C7164D3D"><enum>(D)</enum><text display-inline="yes-display-inline">is designed to treat a unique pathology or physiological condition that no other device is domestically available to treat;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idc142431cca8346b0a4b6306a736d218a"><enum>(E)</enum><clause commented="no" display-inline="yes-display-inline" id="idF8FD4BDD85D94218941C69344817FF75"><enum>(i)</enum><text display-inline="yes-display-inline">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</text> </clause><clause commented="no" display-inline="no-display-inline" id="idD00151D241C7437BB45E5FC0C9B734D0" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">is intended for use by an individual patient named in such order of such physician or dentist (or other specially qualified person so designated);</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id2D3894666C5E402EB89325E8809CA761"><enum>(F)</enum><text display-inline="yes-display-inline">is assembled from components or manufactured and finished on a case-by-case basis to accommodate the unique needs described in clause (i) or (ii) of subparagraph (E); and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id53C48165E6CE4A63AAEA3D923D47E4E8"><enum>(G)</enum><text display-inline="yes-display-inline">may have common, standardized design characteristics, chemical and material compositions, and manufacturing processes as commercially distributed devices.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id8F65C2D4A5594CEF8B9BE2B19619EE6E"><enum>(2)</enum><header display-inline="yes-display-inline">Limitations</header><text display-inline="yes-display-inline">Paragraph (1) shall apply to a device only if—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id8b75fb970d9a4d848fd19cef73a7999d"><enum>(A)</enum><text display-inline="yes-display-inline">such device is for the purpose of treating a sufficiently rare condition, such that conducting clinical investigations on such device would be impractical;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id2ca04780336540a393775f25fda7c7f2"><enum>(B)</enum><text display-inline="yes-display-inline">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</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id1D1286FCDCA3499089EECC7308E40A70"><enum>(C)</enum><text display-inline="yes-display-inline">the manufacturer of such device created or modified as described in paragraph (1) notifies the Secretary on an annual basis, in a manner prescribed by the Secretary, of the manufacture of such device.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idD9B48DF763414AEAB4287E52944F29A6"><enum>(3)</enum><header display-inline="yes-display-inline">Exception</header><text display-inline="yes-display-inline">Paragraph (1) shall not apply to oral facial devices.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id664640835bb945beb35d0ef428ea9967"><enum>(4)</enum><header display-inline="yes-display-inline">Guidance</header><text display-inline="yes-display-inline">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).</text> </paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block> </section><section commented="no" display-inline="no-display-inline" id="id3ACE621146F04D3AAB45AF6231FE5FCD" section-type="subsequent-section"><enum>610.</enum><header display-inline="yes-display-inline">Agency documentation and review of certain decisions regarding devices</header><text display-inline="no-display-inline">Chapter V (21 U.S.C. 351 et seq.) is amended by inserting after section 517 the following:</text> <quoted-block display-inline="no-display-inline" id="idA6E1A43A5B4D4F8DBB1BE8DA269A5A94" style="OLC"> <section commented="no" display-inline="no-display-inline" id="H4140E73E7A8940918D24D33CF825C035" section-type="subsequent-section"><enum>517A.</enum><header display-inline="yes-display-inline">Agency documentation and review of certain decisions regarding devices</header> <subsection commented="no" display-inline="no-display-inline" id="H31C675365E874EE69D914FD96CD69F0E"><enum>(a)</enum><header display-inline="yes-display-inline">Documentation of rationale for denial</header><text display-inline="yes-display-inline">If the Secretary renders a final decision to deny clearance of a premarket notification under section 510(k) or approval of a premarket application under section 515, or when the Secretary disapproves an application for an investigational exemption under 520(g), the written correspondence to the applicant communicating that decision shall provide a substantive summary of the scientific and regulatory rationale for the decision.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="id89A9B0F933D843AFA45B090F3FA6F9EA"><enum>(b)</enum><header display-inline="yes-display-inline">Review of denial</header> <paragraph commented="no" display-inline="no-display-inline" id="idF4A60C5603644476A0B1539D5FF94594"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">A person who has submitted a report under section 510(k), an application under section 515, or an application for an exemption under section 520(g) and for whom clearance of the report or approval of the application is denied may request a supervisory review of the decision to deny such clearance or approval. Such review shall be conducted by an individual at the organizational level above the organization level at which the decision to deny the clearance of the report or approval of the application is made.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id10258B9DAEEC4C0AB7C85118E0011BAC"><enum>(2)</enum><header display-inline="yes-display-inline">Submission of request</header><text display-inline="yes-display-inline">A person requesting a supervisory review under paragraph (1) shall submit such request to the Secretary not later than 30 days after such denial and shall indicate in the request whether such person seeks an in-person meeting or a teleconference review.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id36853995D0F34725966EFC08A0F4755B"><enum>(3)</enum><header display-inline="yes-display-inline">Timeframe</header> <subparagraph commented="no" display-inline="no-display-inline" id="id8803F6D7F79E4EC6AA686F415E0F5726"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id9996C880ED7742BDA46D5BF301AFB995"><enum>(B)</enum><header display-inline="yes-display-inline">Exception</header><text display-inline="yes-display-inline">Subparagraph (A) shall not apply in cases that involve consultation with experts outside of the Food and Drug Administration, or in cases in which the sponsor seeks to introduce evidence not already in the administrative record at the time the denial decision was made.</text> </subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block> </section><section commented="no" display-inline="no-display-inline" id="id4C7596BD649D4BBBACEB688F3F038F7E" section-type="subsequent-section"><enum>611.</enum><header display-inline="yes-display-inline">Good guidance practices relating to devices</header><text display-inline="no-display-inline">Subparagraph (C) of section 701(h)(1) (21 U.S.C. 371(h)(1)) is amended—</text> <paragraph commented="no" display-inline="no-display-inline" id="idC8E0BF51440C4AD8BE33BAC9D17DF58F"><enum>(1)</enum><text display-inline="yes-display-inline">by striking <quote>(C) For guidance documents</quote> and inserting <quote>(C)(i) For guidance documents</quote>; and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id6dc0e0ac7dd24a17b373eba91c7dc9f7"><enum>(2)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="id12130BA6DA6C4015B62FF9D6075BF051" style="OLC"> <clause commented="no" display-inline="no-display-inline" id="id13554E7B855C44DD8198B980CBFB55B4" indent="up2"><enum>(ii)</enum><text display-inline="yes-display-inline">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.</text> </clause><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph></section><section commented="no" display-inline="no-display-inline" id="idAA9A98F6D95040FEAB1AC9797CCB610D" section-type="subsequent-section"><enum>612.</enum><header display-inline="yes-display-inline">Modification of de novo application process</header> <subsection commented="no" display-inline="no-display-inline" id="H82D2A65503FE48D5A18DD1F0580ECF5A"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 513(f)(2) (21 U.S.C. 360c(f)(2)) is amended—</text> <paragraph commented="no" display-inline="no-display-inline" id="id760690EB130B410D907A3D1FDB9A5106"><enum>(1)</enum><text display-inline="yes-display-inline">by redesignating subparagraphs (B) and (C) as subparagraphs (C) and (D), respectively;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id393192464D00416E882FF7680C98B7D9"><enum>(2)</enum><text display-inline="yes-display-inline">by amending subparagraph (A) to read as follows:</text> <quoted-block display-inline="no-display-inline" id="id174A528B178141EBB6807014FD269C78" style="OLC"> <subparagraph commented="no" display-inline="no-display-inline" id="idF53C1C15A77E46BE850263D94E3B286C" indent="up2"><enum>(A)</enum><text display-inline="yes-display-inline">In the case of a type of device that has not previously been classified under this Act, a person may do one of the following:</text> <clause commented="no" display-inline="no-display-inline" id="id6E8D8B1AE4F0429ABEBC28EFC49DF8B5"><enum>(i)</enum><text display-inline="yes-display-inline">Submit a report under section 510(k), and, if the device is classified into class III under paragraph (1), such person may request, not later than 30 days after receiving written notice of such a classification, the Secretary to classify the device under the criteria set forth in subparagraphs (A) through (C) of subsection (a)(1). The person may, in the request, recommend to the Secretary a classification for the device. Any such request shall describe the device and provide detailed information and reasons for the recommended classification.</text> </clause><clause commented="no" display-inline="no-display-inline" id="id5BF91B40AFDB49A68186A19F76D8639B"><enum>(ii)</enum><text display-inline="yes-display-inline">Submit a request for initial classification of the device under this subparagraph, if the person declares that there is no legally marketed device upon which to base a substantial equivalence determination as that term is defined in subsection (i). Subject to subparagraph (B), the Secretary shall classify the device under the criteria set forth in subparagraphs (A) through (C) of subsection (a)(1). The person submitting the request for classification under this subparagraph may recommend to the Secretary a classification for the device and shall, if recommending classification in class II, include in the request an initial draft proposal for applicable special controls, as described in subsection (a)(1)(B), that are necessary, in conjunction with general controls, to provide reasonable assurance of safety and effectiveness and a description of how the special controls provide such assurance. Requests under this clause shall be subject to the electronic copy requirements of section 745A(b).</text> </clause></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id03471BC7F4804CA28BA2830602DAB754"><enum>(3)</enum><text display-inline="yes-display-inline">by inserting after subparagraph (A) the following:</text> <quoted-block display-inline="no-display-inline" id="idAFFAD84F9FEC4B9EBA99FAB25EA6914A" style="OLC"> <subparagraph commented="no" display-inline="no-display-inline" id="idAB3478F6BA654DB49D94790A3CE3757E" indent="up2"><enum>(B)</enum><text display-inline="yes-display-inline">The Secretary may decline to undertake a classification request submitted under clause (2)(A)(ii) if the Secretary identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence under paragraph (1), or when the Secretary determines that the device submitted is not of low-moderate risk or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed.</text> </subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id030F17A1AF38457B8359B56A4F9C89F1"><enum>(4)</enum><text display-inline="yes-display-inline">in subparagraph (C), as so redesignated—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id55C537068E4E4AEF8669B9DB1E55A5ED"><enum>(A)</enum><text display-inline="yes-display-inline">in clause (i), by striking <quote>Not later than 60 days after the date of the submission of the request under subparagraph (A),</quote> and inserting <quote>Not later than 120 days after the date of the submission of the request under subparagraph (A)(i) or 150 days after the date of the submission of the request under subparagraph (A)(ii),</quote>; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id369CD0D62BEA434EB1F1A05F8FCD8FA4"><enum>(B)</enum><text display-inline="yes-display-inline">in clause (ii), by inserting <quote>or is classified in</quote> after <quote>remains in</quote>.</text> </subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HCE68B301675547C89A40113E4662007A"><enum>(b)</enum><header display-inline="yes-display-inline">GAO report</header><text display-inline="yes-display-inline">Not later than 2 years after the date of enactment of this Act, the Comptroller General of the United States shall complete a study and submit to Congress a report on the effectiveness of the review pathway under section 513(f)(2)(A) of the Federal Food, Drug, and Cosmetic Act, as amended by this Act.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="id7AFFAB6BC3DD444299707E6B46E14C6A"><enum>(c)</enum><header display-inline="yes-display-inline">Conforming amendment</header><text display-inline="yes-display-inline">Section 513(f)(1)(B) (21 U.S.C. 360c(f)(1)(B)) is amended by inserting <quote>a request under paragraph (2) or</quote> after <quote>response to</quote>.</text> </subsection></section><section commented="no" display-inline="no-display-inline" id="id95EF5BDD30094F3BA0B9E1BBDC224083" section-type="subsequent-section"><enum>613.</enum><header display-inline="yes-display-inline">Humanitarian device exemptions</header> <subsection commented="no" display-inline="no-display-inline" id="id760274F5B2BB4816BFE8438DCD26660D"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 520(m) (21 U.S.C. 360j(m)) is amended—</text> <paragraph commented="no" display-inline="no-display-inline" id="id3ECCA0DB7D024D869756A3495BA3D5CA"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (6)—</text> <subparagraph commented="no" display-inline="no-display-inline" id="idDD8BE0F829F046A2A93C9E7552C26373"><enum>(A)</enum><text display-inline="yes-display-inline">in subparagraph (A)—</text> <clause commented="no" display-inline="no-display-inline" id="id2F0938A61D5D4A7B9C9E7AA7C3AED0EB"><enum>(i)</enum><text display-inline="yes-display-inline">by striking clause (i) and inserting the following:</text> <quoted-block display-inline="no-display-inline" id="id4C82F2158BF24AA9876591F3CD36A51E" style="OLC"> <clause commented="no" display-inline="no-display-inline" id="idAC59E8928BA2496ABDCD4B2D597B6D56" indent="up2"><enum>(i)</enum><text display-inline="yes-display-inline">The device with respect to which the exemption is granted—</text> <subclause commented="no" display-inline="no-display-inline" id="id16B8559ABE124C79AC45B62C6753F44B"><enum>(I)</enum><text display-inline="yes-display-inline">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</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="idD23E59AD59054FA693E276142D9503BB"><enum>(II)</enum><text display-inline="yes-display-inline">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.</text> </subclause></clause><after-quoted-block>; and</after-quoted-block></quoted-block> </clause><clause commented="no" display-inline="no-display-inline" id="idCEB94377D5A74EDF9918A2E00AF32A22"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking clause (ii) and inserting the following:</text> <quoted-block display-inline="no-display-inline" id="idF461CC0747604577882AAA58D470158B" style="OLC"> <clause commented="no" display-inline="no-display-inline" id="idDDAE5D9AA0B94DE4900D00B9D9A9004F" indent="up2"><enum>(ii)</enum><text display-inline="yes-display-inline">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 <term>annual distribution number</term> 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.</text> </clause><after-quoted-block>; and</after-quoted-block></quoted-block> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id2A45819D5EA245A886AA894A41AED3C8"><enum>(B)</enum><text display-inline="yes-display-inline">by amending subparagraph (C) to read as follows:</text> <quoted-block display-inline="no-display-inline" id="idC63D32FEF66A476380D9BBE00843DE91" style="OLC"> <subparagraph commented="no" display-inline="no-display-inline" id="id5e6801cff7d0446990ddf6bcced7ebd7" indent="up2"><enum>(C)</enum><text display-inline="yes-display-inline">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.</text> </subparagraph><after-quoted-block>;</after-quoted-block></quoted-block> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idC0D533A7CA424FEEB4BD6E7787B7B0DF"><enum>(2)</enum><text display-inline="yes-display-inline">in paragraph (7), by striking <quote>regarding a device</quote> and inserting <quote>regarding a device described in paragraph (6)(A)(i)(I)</quote>; and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id3A313BFF1AE649BDA86DFCFD4AECD2C8"><enum>(3)</enum><text display-inline="yes-display-inline">in paragraph (8), by striking <quote>of all devices described in paragraph (6)</quote> and inserting <quote>of all devices described in paragraph (6)(A)(i)(I)</quote>.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id09C9315FB1294045AE53DB75C5E1BA6E"><enum>(b)</enum><header display-inline="yes-display-inline">Applicability To existing devices</header><text display-inline="yes-display-inline">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.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="idA9A85B7DB4D3418D84FEE01DA0F259AC"><enum>(c)</enum><header display-inline="yes-display-inline">Report</header><text display-inline="yes-display-inline">Not later than January 1, 2017, the Comptroller General of the United States shall submit to Congress a report that evaluates and describes—</text> <paragraph commented="no" display-inline="no-display-inline" id="id2d7b9d27c80d4f72969bfee41d8c6e68"><enum>(1)</enum><text display-inline="yes-display-inline">the effectiveness of the amendments made by subsection (a) in stimulating innovation with respect to medical devices, including any favorable or adverse impact on pediatric device development;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idfda0a0e169934c93896326b5f8011a75"><enum>(2)</enum><text display-inline="yes-display-inline">the impact of such amendments on pediatric device approvals for devices that received a humanitarian use designation under section 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)) prior to the date of enactment of this Act;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id3a086b1aa3db4de3a48ddbf31f17422d"><enum>(3)</enum><text display-inline="yes-display-inline">the status of public and private insurance coverage of devices granted an exemption under paragraph (2) of such section 520(m) (as amended by subsection (a)) and costs to patients of such devices;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id51c53f7a6fde4b13b667ea2f2e019d3a"><enum>(4)</enum><text display-inline="yes-display-inline">the impact that paragraph (4) of such section 520(m) has had on access to and insurance coverage of devices granted an exemption under paragraph (2) of such section 520(m); and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id1951a223680449bcb0fa3edd792f92ed"><enum>(5)</enum><text display-inline="yes-display-inline">the effect of the amendments made by subsection (a) on patients described in such section 520(m).</text> </paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="id7C89DC8780B04462A21F0B94624B251B" section-type="subsequent-section"><enum>614.</enum><header display-inline="yes-display-inline">Reauthorization of third-party review and inspections</header> <subsection commented="no" display-inline="no-display-inline" id="id3F574DEBB8A64F6A85BC0560A0FEB017"><enum>(a)</enum><header display-inline="yes-display-inline">Third party review</header><text display-inline="yes-display-inline">Section 523(c) (21 U.S.C. 360m(c)) is amended by striking <quote>2012</quote> and inserting <quote>2017</quote>.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="id13AD21A50AEE462B97377343E127F74D"><enum>(b)</enum><header display-inline="yes-display-inline">Third party inspections</header><text display-inline="yes-display-inline">Section 704(g)(11) (21 U.S.C. 374(g)(11)) is amended by striking <quote>2012</quote> and inserting <quote>2017</quote>.</text> </subsection></section><section commented="no" display-inline="no-display-inline" id="id300F1D72A29644ED8115F10B48B959E6" section-type="subsequent-section"><enum>615.</enum><header display-inline="yes-display-inline">510(k) device modifications</header><text display-inline="no-display-inline">Having acknowledged to Congress potential unintended consequences that may result from the implementation of the Food and Drug Administration guidance entitled <quote>Guidance for Industry and FDA Staff—510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device</quote>, the Secretary of Health and Human Services shall withdraw such guidance promptly and ensure that, before any future guidance document on this issue is made final, affected stakeholders are provided with an opportunity to comment.</text> </section><section commented="no" display-inline="no-display-inline" id="id2F5BDE97EDA44298B3B8CD5A608FCB0D" section-type="subsequent-section"><enum>616.</enum><header display-inline="yes-display-inline">Health information technology</header> <subsection commented="no" display-inline="no-display-inline" id="id2511A34D6C7848BCB0BE4192373A7BED"><enum>(a)</enum><header display-inline="yes-display-inline">Limitation</header><text display-inline="yes-display-inline">Notwithstanding any other provision of law, the Secretary of Health and Human Services (referred to in this section as the <quote>Secretary</quote>) may issue final guidance on medical mobile applications only after the requirements under subsections (b) and (c) are met.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="id3AA9F527F00E475E817E3C56CC7A23F8"><enum>(b)</enum><header display-inline="yes-display-inline">Report</header><text display-inline="yes-display-inline">Not later than 18 months after the date of enactment of this Act, the Secretary, in consultation with the Commissioner of Food and Drugs, the National Coordinator for Health Information Technology, and the Chairman of the Federal Communications Commission, shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to medical device regulation and health information technology software, including mobile applications, that promotes innovation and protects patient safety.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="idBF02C56446A54DF1B496910C3D4502CD"><enum>(c)</enum><header display-inline="yes-display-inline">Working group</header> <paragraph commented="no" display-inline="no-display-inline" id="id160D38A464094EC4AE082BBBC5F9CC4C"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">In carrying out subsection (b), the Secretary shall convene a working group of external stakeholders and experts to provide appropriate input on the strategy and recommendations required for the report under subsection (b).</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idF26E9D4CC3FF4B45B1E9682C0CDB6957"><enum>(2)</enum><header display-inline="yes-display-inline">Representatives</header><text display-inline="yes-display-inline">The Secretary shall determine the number of representatives participating in the working group, and shall ensure that the working group is geographically diverse and includes representatives of patients, consumers, health care providers, startup companies, health plans or other third-party payers, venture capital investors, information technology vendors, small businesses, purchasers, employers, and other stakeholders with relevant expertise, as determined by the Secretary.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id39D9A7FD508946D3981B4D6993E80DBF"><enum>(3)</enum><header display-inline="yes-display-inline">Other requirements</header> <subparagraph commented="no" display-inline="no-display-inline" id="idAF8D3E1604784B9D957FD15CA8CE7B98"><enum>(A)</enum><header display-inline="yes-display-inline">FACA</header><text display-inline="yes-display-inline">The Federal Advisory Committee Act (5 U.S.C. App.) shall apply to the working group under this section.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id507683CCE0C74E16BB642A59BC870BA6"><enum>(B)</enum><header display-inline="yes-display-inline">FFDCA advisory committees</header><text display-inline="yes-display-inline">The requirements for advisory committees under section 712 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379d–1), as amended by section 1121, shall not apply to the working group under this section.</text> </subparagraph></paragraph></subsection></section><enum>VII</enum><header display-inline="yes-display-inline">Drug supply chain</header> <subtitle commented="no" id="idCAB7305209B34923BA3E9257924A2F21" level-type="subsequent"><enum>A</enum><header display-inline="yes-display-inline">Drug supply chain</header> <section commented="no" display-inline="no-display-inline" id="id5424BA20DC8A4EB7B61C5025D9008112" section-type="subsequent-section"><enum>701.</enum><header display-inline="yes-display-inline">Registration of domestic drug establishments</header><text display-inline="no-display-inline">Section 510 (21 U.S.C. 360) is amended—</text> <paragraph commented="no" display-inline="no-display-inline" id="id66C0835F84244A3F8E6C728A3BF35E82"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (b)—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id121DA592118C42F5A0174C4FDF37CE14"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1), by striking <quote>On or before</quote> 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—</text> <quoted-block display-inline="no-display-inline" id="id8C12EAB9619D49819254D4E025259133" style="OLC"> <subparagraph commented="no" display-inline="no-display-inline" id="id926D46A3CD044D9AAAE26BBD6866C790" indent="up1"><enum>(A)</enum><text display-inline="yes-display-inline">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</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idBC46BD766AE74A7B8F11D119F0B649EF" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">the name and place of business of each importer that takes physical possession of and supplies a drug (other than an excipient) to such person, including all establishments of each such drug importer, the unique facility identifier of each such drug importer establishment, and a point of contact e-mail address for each such drug importer.</text> </subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idFCFF9EEBA7244F66820D19C6C8B716B4"><enum>(B)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="id7D8CA6FCCD5149168E849D9F0B3F5E25" style="OLC"> <paragraph commented="no" display-inline="no-display-inline" id="id4C875743EB9D4DF984C77F6F41CFF69A" indent="up1"><enum>(3)</enum><text display-inline="yes-display-inline">The Secretary may specify the unique facility identifier system that shall be used by registrants under paragraph (1).</text> </paragraph><after-quoted-block>; and</after-quoted-block></quoted-block> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idAAD711C45EAF43F886B33024151BFE6C"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (c), by striking <quote>with the Secretary his name, place of business, and such establishment</quote> and inserting “with the Secretary—</text> <quoted-block display-inline="no-display-inline" id="id8ED1034D9DEF4E59A0732EE68AE055D5" style="OLC"> <paragraph commented="no" display-inline="no-display-inline" id="idE061B71598B24F1690362E5E8AB6B91C"><enum>(1)</enum><text display-inline="yes-display-inline">with respect to drugs, the information described under subsection (b)(1); and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idDE9786F15C9D4F8DAA3B2A5B52F4B8AB"><enum>(2)</enum><text display-inline="yes-display-inline">with respect to devices, the information described under subsection (b)(2).</text> </paragraph><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph></section><section commented="no" display-inline="no-display-inline" id="id81939C3005F24A1EA39675A1551AFAE6" section-type="subsequent-section"><enum>702.</enum><header display-inline="yes-display-inline">Registration of foreign establishments</header> <subsection commented="no" display-inline="no-display-inline" id="id1D5D99888FD74E439341E240A482C178"><enum>(a)</enum><header display-inline="yes-display-inline">Enforcement of registration of foreign establishments</header><text display-inline="yes-display-inline">Section 502(o) (21 U.S.C. 352(o)) is amended by striking <quote>in any State</quote>.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="idCC8BA99FCAD54CA3AD709C5CE64773E7"><enum>(b)</enum><header display-inline="yes-display-inline">Registration of foreign drug establishments</header><text display-inline="yes-display-inline">Section 510(i) (U.S.C. 360(i)) is amended—</text> <paragraph commented="no" display-inline="no-display-inline" id="id29DE0FE73DE0448E8249610AA1851AFE"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (1)—</text> <subparagraph commented="no" display-inline="no-display-inline" id="idA5992C35E2E8488390F4513AD3341AC0"><enum>(A)</enum><text display-inline="yes-display-inline">by amending the matter preceding subparagraph (A) to read as follows: <quote>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—</quote>;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idA146ADA2635845888B17BE026F3672B7"><enum>(B)</enum><text display-inline="yes-display-inline">by amending subparagraph (A) to read as follows:</text> <quoted-block display-inline="no-display-inline" id="idA2B73D5639014876B8B063CA29928916" style="OLC"> <subparagraph commented="no" display-inline="no-display-inline" id="id4329A054522440E0B49F403092F09037" indent="up1"><enum>(A)</enum><text display-inline="yes-display-inline">upon first engaging in any such activity, immediately submit a registration to the Secretary that includes—</text> <clause commented="no" display-inline="no-display-inline" id="idF6E87914D72A4F6090266D47C32F5082"><enum>(i)</enum><text display-inline="yes-display-inline">with respect to drugs, the name and place of business of such person, all such establishments, the unique facility identifier of each such establishment, a point of contact e-mail address, the name of the United States agent of each such establishment, the name and place of business of each drug importer with which such person conducts business to import or offer to import drugs into the United States, including all establishments of each such drug importer, the unique facility identifier of each such establishment, and a point of contact e-mail address for each such drug importer; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="id6B07894D9C2D41ACB7060629CB4ED560"><enum>(ii)</enum><text display-inline="yes-display-inline">with respect to devices, the name and place of business of the establishment, the name of the United States agent for the establishment, the name of each importer of such device in the United States that is known to the establishment, and the name of each person who imports or offers for import such device to the United States for purposes of importation; and</text> </clause></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id0194F9373FDB415BA0ED8F1A65C60A05"><enum>(C)</enum><text display-inline="yes-display-inline">by amending subparagraph (B) to read as follows:</text> <quoted-block display-inline="no-display-inline" id="id325B12E31AA34B2C882A0D79DC2AF61C" style="OLC"> <subparagraph commented="no" display-inline="no-display-inline" id="id140299CBE20043909A5A5288E45DDB4B" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text> </subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id8532BD0C36A24585A46C554C47E3F559"><enum>(2)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="idE5796CFB5D0B498DBDED7F53A5B8732A" style="OLC"> <paragraph commented="no" display-inline="no-display-inline" id="id68113216881247C3A4908D0200572238" indent="up1"><enum>(4)</enum><text display-inline="yes-display-inline">The Secretary may specify the unique facility identifier system that shall be used by registrants under paragraph (1) with respect to drugs.</text> </paragraph><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="idAFC21F44CE1D498CBA97EC7F25BAE67F" section-type="subsequent-section"><enum>703.</enum><header display-inline="yes-display-inline">Identification of drug excipient information with product listing</header><text display-inline="no-display-inline">Section 510(j)(1) (21 U.S.C. 360(j)(1)) is amended—</text> <paragraph commented="no" display-inline="no-display-inline" id="id3FC7EE59E3A0465489D2D60D4C80CDF4"><enum>(1)</enum><text display-inline="yes-display-inline">in subparagraph (C), by striking <quote>; and</quote> and inserting a semicolon;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idA544DC1295F94329A2AA144BE89F97F3"><enum>(2)</enum><text display-inline="yes-display-inline">in subparagraph (D), by striking the period at the end and inserting <quote>; and</quote>; and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id330638D23E8F4907A5B6898093D90FAE"><enum>(3)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="id5532B5ADCFF244B396FF8FF142ABFED5" style="OLC"> <subparagraph commented="no" display-inline="no-display-inline" id="idEBD89A74FF45416CA539D1FDD325D831" indent="up1"><enum>(E)</enum><text display-inline="yes-display-inline">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.</text> </subparagraph><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph></section><section commented="no" display-inline="no-display-inline" id="ID0004de7635dc455babdb1f4557a1f1a8" section-type="subsequent-section"><enum>704.</enum><header display-inline="yes-display-inline">Electronic system for registration and listing</header><text display-inline="no-display-inline">Section 510(p) (21 U.S.C. 360(p)) is amended—</text> <paragraph commented="no" display-inline="no-display-inline" id="id3A2A885ECF934D37B4431C1C8FAB5BC1"><enum>(1)</enum><text display-inline="yes-display-inline">by striking <quote>(p) Registrations and listings</quote> and inserting the following:</text> <quoted-block display-inline="no-display-inline" id="id5300ECAB773C476CB3EF12B06CD1D276" style="OLC"> <subsection commented="no" display-inline="no-display-inline" id="idBBAA462FB5984D1490055E1983BC0B95"><enum>(p)</enum><header display-inline="yes-display-inline">Electronic registration and listing</header> <paragraph commented="no" display-inline="no-display-inline" id="idA09798DE96144B1187C5194230D59978"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Registration and listing</text> </paragraph></subsection><after-quoted-block>; and</after-quoted-block></quoted-block> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idF51B205BC280459DAD979716EEF35E41"><enum>(2)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="id9F76231E32A94723B2D2DA2BF9BB66A0" style="OLC"> <paragraph commented="no" display-inline="no-display-inline" id="id532A92016CDD418BA5B99A6FB00E41C3"><enum>(2)</enum><header display-inline="yes-display-inline">Electronic database</header><text display-inline="yes-display-inline">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—</text> <subparagraph commented="no" display-inline="no-display-inline" id="idF518F310BAE44D38813DB09AAFC852BC"><enum>(A)</enum><text display-inline="yes-display-inline">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</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID3f36428a0047478daa7f4eb8d5b8ebe4"><enum>(B)</enum><text display-inline="yes-display-inline">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).</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id3F9E402080FA4088858D320DD2AB0B8E"><enum>(3)</enum><header display-inline="yes-display-inline">Risk-based information and coordination</header><text display-inline="yes-display-inline">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).</text> </paragraph><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph></section><section commented="no" display-inline="no-display-inline" id="id1AEEB52823154353BC171139C9AEF143" section-type="subsequent-section"><enum>705.</enum><header display-inline="yes-display-inline">Risk-based inspection frequency</header><text display-inline="no-display-inline">Section 510(h) (21 U.S.C. 360(h)) is amended to read as follows:</text> <quoted-block display-inline="no-display-inline" id="id167B346B876F49E6A49A93AD637BA5A4" style="OLC"> <subsection commented="no" display-inline="no-display-inline" id="idBD3A5047ADF9476C953E70DC3427C481"><enum>(h)</enum><header display-inline="yes-display-inline">Inspections</header> <paragraph commented="no" display-inline="no-display-inline" id="id69E3FD5FBE824993A45447898486E09A"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Every establishment that is required to be registered with the Secretary under this section shall be subject to inspection pursuant to section 704.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id9AE8AD1D15F14F749FBB85EE75780534"><enum>(2)</enum><header display-inline="yes-display-inline">Biennial inspections for devices</header><text display-inline="yes-display-inline">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.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idE826E7A431114BBFAB16253A116E3BB8"><enum>(3)</enum><header display-inline="yes-display-inline">Risk-based schedule for drugs</header><text display-inline="yes-display-inline">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 <quote>drug establishments</quote>) in accordance with a risk-based schedule established by the Secretary.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idE2E543D54FD74ABD837A7874DFC1F69A"><enum>(4)</enum><header display-inline="yes-display-inline">Risk factors</header><text display-inline="yes-display-inline">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:</text> <subparagraph commented="no" display-inline="no-display-inline" id="ID592610d836b244f795562b0f323d35cb"><enum>(A)</enum><text display-inline="yes-display-inline">The compliance history of the establishment.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID6c6f470600f346c39cc4e01be3ad8942"><enum>(B)</enum><text display-inline="yes-display-inline">The record, history, and nature of recalls linked to the establishment.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID41ee6daeed654fc4a1e8d2ac0234f0fc"><enum>(C)</enum><text display-inline="yes-display-inline">The inherent risk of the drug manufactured, prepared, propagated, compounded, or processed at the establishment.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id0204BDC800EE4990A0A3B4D421A87F2C"><enum>(D)</enum><text display-inline="yes-display-inline">The certifications described under sections 801(r) and 809 for the establishment.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id8D7BDE6B1A514D49A84737BD6682E239"><enum>(E)</enum><text display-inline="yes-display-inline">Whether the establishment has been inspected in the preceding 4-year period.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID014b8b8f095d434395ace6cdb1490a76"><enum>(F)</enum><text display-inline="yes-display-inline">Any other criteria deemed necessary and appropriate by the Secretary for purposes of allocating inspection resources.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idC66C27FE1FA54FE3A26C9A2975A63291"><enum>(5)</enum><header display-inline="yes-display-inline">Effect of status</header><text display-inline="yes-display-inline">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).</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID76a5c94bdf1c495caf33d500ebdfe26a"><enum>(6)</enum><header display-inline="yes-display-inline">Annual report on inspections of establishments</header><text display-inline="yes-display-inline">Not later than February 1 of each year, the Secretary shall submit a report to Congress regarding—</text> <subparagraph commented="no" display-inline="no-display-inline" id="IDc9c3d221d7bf4624b7952f3bd0ad223f"><enum>(A)</enum><clause commented="no" display-inline="yes-display-inline" id="id9C00BE7A538A4F7E82DC006E6A152CEA"><enum>(i)</enum><text display-inline="yes-display-inline">the number of domestic and foreign establishments registered pursuant to this section in the previous fiscal year; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="id4B4E84E331B24D9A98727CAF8943DB7C" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">the number of such domestic establishments and the number of such foreign establishments that the Secretary inspected in the previous fiscal year;</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idF4942D369C844D34B5C037A4852D9E90"><enum>(B)</enum><text display-inline="yes-display-inline">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</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id119E20DF2EDC465BACDAA54054AF8F94"><enum>(C)</enum><text display-inline="yes-display-inline">the percentage of the budget of the Food and Drug Administration used to fund the inspections described under subparagraph (A).</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idD99A9CB2EFD94B1BA38EEE58C1D6B879"><enum>(7)</enum><header display-inline="yes-display-inline">Public availability of annual reports</header><text display-inline="yes-display-inline">The Secretary shall make the report required under paragraph (6) available to the public on the Internet Web site of the Food and Drug Administration.</text> </paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block> </section><section commented="no" display-inline="no-display-inline" id="id6845CF0C38414BCFB65B562B083992FF" section-type="subsequent-section"><enum>706.</enum><header display-inline="yes-display-inline">Records for inspection</header><text display-inline="no-display-inline">Section 704(a) (21 U.S.C. 374(a)) is amended by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="idA25698D1F7A04BE9ACBA6C3078E46EB2" style="OLC"> <paragraph commented="no" display-inline="no-display-inline" id="id51726BE5984A40A48AC4183FA8114A70" indent="up1"><enum>(4)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="id95976670E028440786BF210733657F21"><enum>(A)</enum><text display-inline="yes-display-inline">Any records or other information that the Secretary is entitled to inspect under this section from a person that owns or operates an establishment that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug shall, upon the request of the Secretary, be provided to the Secretary by such person within a reasonable time frame, within reasonable limits and in a reasonable manner, and in electronic form, at the expense of such person. The Secretary’s request shall include a clear description of the records requested.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id201C3377BA5A447CB9491B5438B85182" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">Upon receipt of the records requested under subparagraph (A), the Secretary shall provide to the person confirmation of the receipt of such records.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id69553DDAADF2429895BD3B677500FE00" indent="up1"><enum>(C)</enum><text display-inline="yes-display-inline">Nothing in this paragraph supplants the authority of the Secretary to conduct inspections otherwise permitted under this Act in order to ensure compliance by an establishment with this Act.</text> </subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block> </section><section commented="no" display-inline="no-display-inline" id="id1969B59346AD41CEB55C4C8454AB1160" section-type="subsequent-section"><enum>707.</enum><header display-inline="yes-display-inline">Failure to allow foreign inspection</header><text display-inline="no-display-inline">Section 801(a) (21 U.S.C. 381(a)) is amended by adding at the end the following: <quote>Notwithstanding any other provision of this subsection, the Secretary of Homeland Security shall, upon request from the Secretary of Health and Human Services refuse to admit into the United States any article if the article was manufactured, prepared, propagated, compounded, processed, or held at an establishment that has refused to permit the Secretary of Health and Human Services to enter or inspect the establishment in the same manner and to the same extent as the Secretary may inspect establishments under section 704.</quote>.</text> </section><section commented="no" display-inline="no-display-inline" id="id4BDA3E224B87402185B5D761C34DD467" section-type="subsequent-section"><enum>708.</enum><header display-inline="yes-display-inline">Exchange of information</header><text display-inline="no-display-inline">Section 708 (21 U.S.C. 379) is amended—</text> <paragraph commented="no" display-inline="no-display-inline" id="IDbbdf075c81c74f269798cfa532609cd2"><enum>(1)</enum><text display-inline="yes-display-inline">by striking <quote><header-in-text level="section" style="traditional">Confidential information</header-in-text></quote> and all that follows through <quote>The Secretary</quote> and inserting <header-in-text level="section" style="OLC">“Confidential information.</header-in-text></text> <quoted-block display-inline="no-display-inline" id="id27F1C236241A4033A6DBC5628441695A" style="OLC"> <subsection commented="no" display-inline="no-display-inline" id="id21091D257EA04F21B893701EC8530E33"><enum>(a)</enum><header display-inline="yes-display-inline">Contractors</header><text display-inline="yes-display-inline">The Secretary</text> </subsection><after-quoted-block>; and</after-quoted-block></quoted-block> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idB9193C2464D0466FADA0C7B039DC01EF"><enum>(2)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="id7A3A94AE5C5841C6A77F707A4063AD1E" style="OLC"> <subsection id="idE0A51C7506014CA9AF5E5A2AF8C870F5"><enum>(b)</enum><header>Ability To receive and protect confidential information obtained from foreign governments</header> <paragraph id="id368a1ecc6bf545a5b2bce1eb45954363"><enum>(1)</enum><header>In general</header><text>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 described in subsection (c)(3) obtained from a foreign government agency, if—</text> <subparagraph id="idc77366049b334f82abcbeff9762207d2"><enum>(A)</enum><text>the information is provided or made available to the United States Government voluntarily and on the condition that the information not be released to the public; and</text> </subparagraph><subparagraph id="ida045c06d5d184c80a9c1241e4c5b2855"><enum>(B)</enum><text>the information is covered by, and subject to, a certification and written agreement under subsections (c)(1) and (c)(2).</text> </subparagraph></paragraph><paragraph id="idcb3401cf27554d3f8acf985413b3d664"><enum>(2)</enum><header>Time limitations</header><text>The written agreement described in subsection (c)(2) shall specify the time period for which the non-disclosure requirements under paragraph (1) shall apply to the voluntarily disclosed information. The non-disclosure requirements under paragraph (1) shall not apply after the date specified, but all other applicable legal protections, including section 552 of title 5, United States Code and section 319L(e)(1) of the Public Health Service Act, shall continue to apply to such information, as appropriate. If no date is specified in the written agreement, the non-disclosure protections described in paragraph (1) shall not exceed 3 years.</text> </paragraph><paragraph id="idf5cbfd92d8b74862a9e3457b41b18526"><enum>(3)</enum><header>Disclosures not affected</header><text>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.</text> </paragraph><paragraph id="idE022BEBC458743DE94F366A5ED69FF40"><enum>(4)</enum><header>Public information</header><text>For purposes of section 552 of title 5, United States Code, this subsection shall be considered a statute described in section 552(b)(3)(B).</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="IDd5b530ceb4b84152aa0ce7982ad47f4f"><enum>(c)</enum><header display-inline="yes-display-inline">Authority To enter into memoranda of understanding for purposes of information exchange</header><text display-inline="yes-display-inline">The Secretary may enter into written agreements regarding the exchange of information referenced in section 301(j) subject to the following criteria:</text> <paragraph commented="no" display-inline="no-display-inline" id="ID67c60c36a82848589ef54d6e5bb4d575"><enum>(1)</enum><header display-inline="yes-display-inline">Certification</header><text display-inline="yes-display-inline">The Secretary may only enter into written agreements under this subsection with foreign governments that the Secretary has certified as having the authority and demonstrated ability to protect trade secret information from disclosure. Responsibility for this certification shall not be delegated to any officer or employee other than the Commissioner.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID10890179e8e747ee8176025ca4251ce3"><enum>(2)</enum><header display-inline="yes-display-inline">Written agreement</header><text display-inline="yes-display-inline">The written agreement under this subsection shall include a commitment by the foreign government to protect information exchanged under this subsection from disclosure unless and until the sponsor gives written permission for disclosure or the Secretary makes a declaration of a public health emergency pursuant to section 319 of the Public Health Service Act that is relevant to the information.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDb7aee44cb87742a8a8c700f8c0aaccf4"><enum>(3)</enum><header display-inline="yes-display-inline">Information exchange</header><text display-inline="yes-display-inline">The Secretary may provide to a foreign government that has been certified under paragraph (1) and that has executed a written agreement under paragraph (2) information referenced in section 301(j) in the following circumstances:</text> <subparagraph commented="no" display-inline="no-display-inline" id="IDeedb27cbb3a542a4a64abf18cdc575b1"><enum>(A)</enum><text display-inline="yes-display-inline">Information concerning the inspection of a facility may be provided if—</text> <clause commented="no" display-inline="no-display-inline" id="IDbb551facf30a4a3ea1080466b0913ba7"><enum>(i)</enum><text display-inline="yes-display-inline">the Secretary reasonably believes, or that the written agreement described in paragraph (2) establishes, that the government has authority to otherwise obtain such information; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="ID6076a08201b94228b5a4f284e29c6526"><enum>(ii)</enum><text display-inline="yes-display-inline">the written agreement executed under paragraph (2) limits the recipient’s use of the information to the recipient’s civil regulatory purposes.</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID1efe1ae0eae240699867a7e74150e4a3"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id7AB95BD63E9341058F23BA77D2C8C649"><enum>(4)</enum><header display-inline="yes-display-inline">Effect of subsection</header><text display-inline="yes-display-inline">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.</text> </paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph></section><section commented="no" display-inline="no-display-inline" id="idFDB0F873DBA446B982F129C85551419E" section-type="subsequent-section"><enum>709.</enum><header display-inline="yes-display-inline">Enhancing the safety and quality of the drug supply</header><text display-inline="no-display-inline">Section 501 (21 U.S.C. 351) is amended by adding at the end the following flush text:</text> <quoted-block display-inline="no-display-inline" id="idB692EBA6B993449C92D9407E2BD026F6" style="OLC"> <quoted-block-continuation-text commented="no" quoted-block-continuation-text-level="section">For purposes of subsection (a)(2)(B), the term <term>current good manufacturing practice</term> 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.</quoted-block-continuation-text><after-quoted-block>.</after-quoted-block></quoted-block> </section><section commented="no" display-inline="no-display-inline" id="IDe16dc6c0251d4dbfb305d352e9a36854" section-type="subsequent-section"><enum>710.</enum><header display-inline="yes-display-inline">Accreditation of third-party auditors for drug establishments</header> <subsection commented="no" display-inline="no-display-inline" id="IDfcdfaa700d9542269646726d8ac8f523"><enum>(a)</enum><header display-inline="yes-display-inline">In General</header><text display-inline="yes-display-inline">Chapter VIII (21 U.S.C. 381 et seq.) is amended by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="idEFA132996BB2479B8656E3E2692241A4" style="OLC"> <section commented="no" display-inline="no-display-inline" id="ID67346e7d223844bbbac1be430107e296" section-type="subsequent-section"><enum>809.</enum><header display-inline="yes-display-inline">Accreditation of third-party auditors for drug establishments</header> <subsection commented="no" display-inline="no-display-inline" id="IDbb470d8b90f1473081885ef67e0503b6"><enum>(a)</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="yes-display-inline">In this section:</text> <paragraph commented="no" display-inline="no-display-inline" id="ID8d067997bf7d464c879b1462f0c03d7a"><enum>(1)</enum><header display-inline="yes-display-inline">Accreditation body</header><text display-inline="yes-display-inline">The term <term>accreditation body</term> means an authority that performs accreditation of third-party auditors.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDe826003eabce45cd9f69d2eb5c15a523"><enum>(2)</enum><header display-inline="yes-display-inline">Accredited third-party auditor</header><text display-inline="yes-display-inline">The term <term>accredited third-party auditor</term> means a third-party auditor (which may be an individual) accredited by an accreditation body to conduct drug safety and quality audits.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDdb018b6e096845da872d9a972fbe9714"><enum>(3)</enum><header display-inline="yes-display-inline">Audit agent</header><text display-inline="yes-display-inline">The term <term>audit agent</term> means an individual who is an employee or agent of an accredited third-party auditor and, although not individually accredited, is qualified to conduct drug safety and quality audits on behalf of an accredited third-party auditor.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idCA9B7E92070C4229A0476BC5F306D683"><enum>(4)</enum><header display-inline="yes-display-inline">Consultative audit</header><text display-inline="yes-display-inline">The term <term>consultative audit</term> means an audit of an eligible entity intended for internal purposes only to determine whether an establishment is in compliance with the provisions of this Act and applicable industry practices, or any other such service.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDcc2508c78c2a46d492635204ebdb7d56"><enum>(5)</enum><header display-inline="yes-display-inline">Drug safety and quality audit</header><text display-inline="yes-display-inline">The term <term>drug safety and quality audit</term>—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id4EF44155297A49F5ABC03B06A8F21FD5"><enum>(A)</enum><text display-inline="yes-display-inline">means an audit of an eligible entity to certify that the eligible entity meets the requirements of this Act applicable to drugs, including the requirements of section 501 with respect to drugs; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idCE65D4098121405DAC2EBADDC947DCD0"><enum>(B)</enum><text display-inline="yes-display-inline">is not a consultative audit.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDee2a932a8ea1485c87ad0627f61e32b2"><enum>(6)</enum><header display-inline="yes-display-inline">Eligible entity</header><text display-inline="yes-display-inline">The term <term>eligible entity</term> means an entity, including a foreign drug establishment registered under section 510(c), in the drug supply chain that chooses to be audited by an accredited third-party auditor or the audit agent of such accredited third-party auditor.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID149d5d263f29469a92836f10c04af2d7"><enum>(7)</enum><header display-inline="yes-display-inline">Third-party auditor</header><text display-inline="yes-display-inline">The term <term>third-party auditor</term> means a foreign government, agency of a foreign government or any other third party (which may be an individual), as the Secretary determines appropriate in accordance with the criteria described in subsection (c)(1), that is eligible to be considered for accreditation to conduct drug safety and quality audits.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID000f34a9360f4bda8dc309f40091fef0"><enum>(b)</enum><header display-inline="yes-display-inline">Accreditation system</header> <paragraph commented="no" display-inline="no-display-inline" id="ID83c7e30ca97d41d0871747c8912ac917"><enum>(1)</enum><header display-inline="yes-display-inline">Recognition of accreditation bodies</header> <subparagraph commented="no" display-inline="no-display-inline" id="IDbceeb950667a41d08bed3c7b3a2534df"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than 2 years after date of enactment of the <short-title>Food and Drug Administration Safety and Innovation Act</short-title>, the Secretary shall establish a system for the recognition of accreditation bodies that accredit third-party auditors to conduct drug safety and quality audits.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID13b3ade667074c6f9099f1c83eb2a5b9"><enum>(B)</enum><header display-inline="yes-display-inline">Direct accreditation</header> <clause commented="no" display-inline="no-display-inline" id="id94C8282AFC0B4F7AB8F99B7A54EB5316"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">If, by the date that is 2 years after the date of establishment of the system described in subparagraph (A), the Secretary has not identified and recognized an accreditation body to meet the requirements of this section, the Secretary may directly accredit third-party auditors.</text> </clause><clause commented="no" display-inline="no-display-inline" id="IDfbde40d26a274f4aa208e594b8089975"><enum>(ii)</enum><header display-inline="yes-display-inline">Certain direct accreditations</header><text display-inline="yes-display-inline">Notwithstanding subparagraph (A) or clause (i), the Secretary may directly accredit any foreign government or any agency of a foreign government as a third-party auditor at any time after the date of enactment of the <short-title>Food and Drug Administration Safety and Innovation Act</short-title>.</text> </clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDe84d5d05edf4481cb44c02ce60fbc0a6"><enum>(2)</enum><header display-inline="yes-display-inline">Notification</header><text display-inline="yes-display-inline">Each accreditation body recognized by the Secretary shall submit to the Secretary—</text> <subparagraph commented="no" display-inline="no-display-inline" id="ID3178839bfe5f4e02acd90c6d0bc47392"><enum>(A)</enum><text display-inline="yes-display-inline">a list of all accredited third-party auditors accredited by such body (including the name, contact information, and scope and duration of accreditation for each such auditor), and the audit agents of such auditors; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID37400af82a4848de9649eab69602b373"><enum>(B)</enum><text display-inline="yes-display-inline">updated lists as needed to ensure the list held by the Secretary is accurate.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID247667a7fe694cc89e2c93de93bc10c0"><enum>(3)</enum><header display-inline="yes-display-inline">Revocation of recognition as an accreditation body</header><text display-inline="yes-display-inline">The Secretary shall promptly revoke, after the opportunity for an informal hearing, the recognition of any accreditation body found not to be in compliance with the requirements of this section.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID120a9082a97f4fc8a71b512ece063dab"><enum>(4)</enum><header display-inline="yes-display-inline">Reinstatement</header><text display-inline="yes-display-inline">The Secretary shall establish procedures to reinstate recognition of an accreditation body if the Secretary determines, based on evidence presented by such accreditation body, that revocation was inappropriate or that the body meets the requirements for recognition under this section.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID6113ebef71ae4e44a3a23211aa28c372"><enum>(5)</enum><header display-inline="yes-display-inline">Model accreditation standards</header> <subparagraph commented="no" display-inline="no-display-inline" id="ID11fed5b7dd2046f793768ef9f440c2ee"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than 18 months after the date of enactment of the <short-title>Food and Drug Administration Safety and Innovation Act</short-title>, the Secretary shall develop model standards, including standards for drug safety and quality audit results, reports, and certifications, and each recognized accreditation body shall ensure that third-party auditors and audit agents of such auditors meet such standards in order to qualify such third-party auditors as accredited third-party auditors under this section.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id08428D4344514F3B8E6C1911952F2AFC"><enum>(B)</enum><header display-inline="yes-display-inline">Content</header><text display-inline="yes-display-inline">The standards developed under subparagraph (A) may—</text> <clause commented="no" display-inline="no-display-inline" id="ID2cdc1ec0cb484db1a9a378e8ee0507db"><enum>(i)</enum><text display-inline="yes-display-inline">include a description of required standards relating to the training procedures, competency, management responsibilities, quality control, and conflict of interest requirements of accredited third-party auditors; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="IDd4891ec3380c400dae97a7416591d7ff"><enum>(ii)</enum><text display-inline="yes-display-inline">set forth procedures for the periodic renewal of the accreditation of accredited third-party auditors.</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDed7b8fe4ced44560aa8fef1148bc763d"><enum>(C)</enum><header display-inline="yes-display-inline">Requirement to provide results and reports to the Secretary</header><text display-inline="yes-display-inline">An accreditation body (or, in the case of direct accreditation under subsection (b)(1)(B), the Secretary) may not accredit a third-party auditor unless such third-party auditor agrees to provide to the Secretary, upon request, the results and reports of any drug safety and quality audit conducted pursuant to the accreditation provided under this section.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID70cbe274c0654aba94159f0c4689362c"><enum>(6)</enum><header display-inline="yes-display-inline">Disclosure</header><text display-inline="yes-display-inline">The Secretary shall maintain on the Internet Web site of the Food and Drug Administration a list of recognized accreditation bodies and accredited third-party auditors under this section.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID0f3f97b1095a4854b2c04aa5ce032f20"><enum>(c)</enum><header display-inline="yes-display-inline">Accredited third-party auditors</header> <paragraph commented="no" display-inline="no-display-inline" id="ID057936debabf4496beadf133b220ec9d"><enum>(1)</enum><header display-inline="yes-display-inline">Requirements for accreditation as a third-party auditor</header> <subparagraph commented="no" display-inline="no-display-inline" id="ID2930d6f0d51846d58b49afc8e7471552"><enum>(A)</enum><header display-inline="yes-display-inline">Foreign governments</header><text display-inline="yes-display-inline">Prior to accrediting a foreign government or an agency of a foreign government as an accredited third-party auditor, the accreditation body (or, in the case of direct accreditation under subsection (b)(1)(B), the Secretary) shall perform such reviews and audits of drug safety programs, systems, and standards of the government or agency of the government as the Secretary deems necessary, including requirements under the standards developed under subsection (b)(5), to determine that the foreign government or agency of the foreign government is capable of adequately ensuring that eligible entities or drugs certified by such government or agency meet the requirements of this Act.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID8a96ae3b22504767a3e1fbf0fa9711b1"><enum>(B)</enum><header display-inline="yes-display-inline">Other third parties</header><text display-inline="yes-display-inline">Prior to accrediting any other third party to be an accredited third-party auditor, the accreditation body (or, in the case of direct accreditation under subsection (b)(1)(B), the Secretary) shall perform such reviews and audits of the training and qualifications of audit agents used by that party and conduct such reviews of internal systems and such other investigation of the party as the Secretary deems necessary, including requirements under the standards developed under subsection (b)(5), to determine that the third-party auditor is capable of adequately ensuring that an eligible entity or drug certified by such third-party auditor meets the requirements of this Act.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID4c2e491db1354e02ade1ea7bfbbe0bd5"><enum>(2)</enum><header display-inline="yes-display-inline">Use of audit agents</header><text display-inline="yes-display-inline">An accredited third-party auditor may conduct drug safety and quality audits and may employ or use audit agents to conduct drug safety and quality audits, but must ensure that such audit agents comply with all requirements the Secretary deems necessary, including requirements under paragraph (1) and subsection (b)(5).</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID9dab0779dd5d45f296a1f16475af0479"><enum>(3)</enum><header display-inline="yes-display-inline">Revocation of accreditation</header> <subparagraph commented="no" display-inline="no-display-inline" id="ID82b36c9dd11a4638a62b61bb524f8954"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary shall promptly revoke, after the opportunity for an informal hearing, the accreditation of an accredited third-party auditor—</text> <clause commented="no" display-inline="no-display-inline" id="ID1fa26199fd4f41babbf168a2afdd6a40"><enum>(i)</enum><text display-inline="yes-display-inline">if, following an evaluation, the Secretary finds that the accredited third-party auditor is not in compliance with the requirements of this section; or</text> </clause><clause commented="no" display-inline="no-display-inline" id="IDe7c246a0a2dc473eac288e84bafafacf"><enum>(ii)</enum><text display-inline="yes-display-inline">following a refusal to allow United States officials to conduct such audits and investigations as may be necessary to determine compliance with the requirements set forth in this section.</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID727c553e0ae9445f8b36bb120a81bfc6"><enum>(B)</enum><header display-inline="yes-display-inline">Additional basis for revocation of accreditation</header><text display-inline="yes-display-inline">The Secretary may revoke accreditation from an accredited third-party auditor in the case that such third-party auditor is accredited by an accreditation body for which recognition as an accreditation body under subsection (b)(3) is revoked, if the Secretary determines that there is good cause for the revocation of accreditation.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID3ecb7c07abf84a45acac5e1741e7520a"><enum>(4)</enum><header display-inline="yes-display-inline">Reaccreditation</header><text display-inline="yes-display-inline">The Secretary shall establish procedures to reinstate the accreditation of a third-party auditor for which accreditation has been revoked under paragraph (3)—</text> <subparagraph commented="no" display-inline="no-display-inline" id="IDe15b99dfdaf0484f858d0fb465678418"><enum>(A)</enum><text display-inline="yes-display-inline">if the Secretary determines, based on evidence presented, that—</text> <clause commented="no" display-inline="no-display-inline" id="ID192e60a93e2f4bda920654a86712fe2b"><enum>(i)</enum><text display-inline="yes-display-inline">the third-party auditor satisfies the requirements of this section; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="ID185c206149844085901399f487b82444"><enum>(ii)</enum><text display-inline="yes-display-inline">adequate grounds for revocation no longer exist; and</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDc3e23be6e2e540c0ab459ae220f53028"><enum>(B)</enum><text display-inline="yes-display-inline">in the case of a third-party auditor accredited by an accreditation body for which recognition as an accreditation body is revoked under subsection (b)(3)—</text> <clause commented="no" display-inline="no-display-inline" id="ID8114d34cef7f425c9f00f01ce1a82b17"><enum>(i)</enum><text display-inline="yes-display-inline">if the third-party auditor becomes accredited not later than 1 year after revocation of accreditation under paragraph (3), through direct accreditation under subsection (b)(1)(B), or by an accreditation body in good standing; or</text> </clause><clause commented="no" display-inline="no-display-inline" id="IDe8e2cc378d8d49c29733735a3b53903d"><enum>(ii)</enum><text display-inline="yes-display-inline">under such other conditions as the Secretary may require.</text> </clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID88e37b5e327642db9c1889eaccb77489"><enum>(5)</enum><header display-inline="yes-display-inline">Requirement to issue certification of eligible entities for compliance with current good manufacturing practice</header> <subparagraph commented="no" display-inline="no-display-inline" id="ID8059865cf67f419ca7bbaaf0805561f4"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">An accreditation body (or, in the case of direct accreditation under subsection (b)(1)(B), the Secretary) may not accredit a third-party auditor unless such third-party auditor agrees to issue a written and, as appropriate, electronic, document or certification, as the Secretary may require under this Act, regarding compliance with section 501. The Secretary may consider any such document or certification to satisfy requirements under section 801(r) and to target inspection resources under section 510(h).</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID68aafcd00cc44d9b9e57c77f14838776"><enum>(B)</enum><header display-inline="yes-display-inline">Requirements for issuing certification</header> <clause commented="no" display-inline="no-display-inline" id="ID16a87cc0d28e4ff4a398a70147bf8e05"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">An accredited third-party auditor shall issue a drug certification described in subparagraph (A) only after conducting a drug safety and quality audit and such other activities that may be necessary to establish compliance with the provisions of section 501.</text> </clause><clause commented="no" display-inline="no-display-inline" id="ID2a3ca59ebea74fc084b24c8fc5a4b007"><enum>(ii)</enum><header display-inline="yes-display-inline">Provision of certification</header><text display-inline="yes-display-inline">Only an accredited third-party auditor or the Secretary may provide a drug certification described in subparagraph (A).</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDc4f9ae18832a4965b34f3bbaf97bf971"><enum>(C)</enum><header display-inline="yes-display-inline">Records</header><text display-inline="yes-display-inline">Following any accreditation of a third-party auditor, the Secretary may, at any time, require the accredited third-party auditor or any audit agent of such auditor to submit to the Secretary a drug safety and quality audit report and such other reports or documents required as part of the drug safety and quality audit process, for any eligible entity for which the accredited third-party auditor or audit agent of such auditor performed a drug safety and quality audit. The Secretary may require documentation that the eligible entity is in compliance with any applicable registration requirements.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDa076bdac08224ac697e36be3896d8536"><enum>(D)</enum><header display-inline="yes-display-inline">Limitation</header><text display-inline="yes-display-inline">The requirement under subparagraph (C) shall not include any report or other documents resulting from a consultative audit, except that the Secretary may access the results of a consultative audit in accordance with section 704.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID6955cc1642ae4fef915d77c62908701c"><enum>(E)</enum><header display-inline="yes-display-inline">Declaration of audit type</header><text display-inline="yes-display-inline">Before an accredited third-party auditor begins any audit or provides any consultative service to an eligible entity, both the accredited third-party auditor and eligible entity shall establish in writing whether the audit is intended to be a drug safety and quality audit. Any audit, inspection, or consultative service of any type provided by an accredited third-party auditor on behalf of an eligible entity shall be presumed to be a drug safety and quality audit in the absence of such a written agreement. Once a drug safety and quality audit is initiated, it shall be subject to the requirements of this section, and no person may withhold from the Secretary any document subject to subparagraph (C) on the grounds that the audit was a consultative audit or otherwise not a drug safety and quality audit.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID63d3266dfe60442090daf5a2d692baf9"><enum>(F)</enum><header display-inline="yes-display-inline">Rule of Construction</header><text display-inline="yes-display-inline">Nothing in this section shall be construed to limit the authority of the Secretary under section 704.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID275e42a9de704ab8885e6bce870dcfa2"><enum>(6)</enum><header display-inline="yes-display-inline">Requirements regarding serious risks to the public health</header><text display-inline="yes-display-inline">If, at any time during a drug safety and quality audit, an accredited third-party auditor or an audit agent of such auditor discovers a condition that could cause or contribute to a serious risk to the public health, such auditor shall immediately notify the Secretary of—</text> <subparagraph commented="no" display-inline="no-display-inline" id="ID52f9758f175a40498876e60a9351a040"><enum>(A)</enum><text display-inline="yes-display-inline">the identity and location of the eligible entity subject to the drug safety and quality audit; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID17206c90cef2441a8737fc7c41e95265"><enum>(B)</enum><text display-inline="yes-display-inline">such condition.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID061c69bd10f64c0a87d8ad1c948fbe24"><enum>(7)</enum><header display-inline="yes-display-inline">Limitations</header> <subparagraph commented="no" display-inline="no-display-inline" id="IDfad161dc5ced4892a0e72a314160de55"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">An audit agent of an accredited third-party auditor may not perform a drug safety and quality audit of an eligible entity if such audit agent has performed a drug safety and quality audit or consultative audit of such eligible entity during the previous 13-month period.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID2f9345b690c84ad3a3c3f072f96179bd"><enum>(B)</enum><header display-inline="yes-display-inline">Waiver</header><text display-inline="yes-display-inline">The Secretary may waive the application of subparagraph (A) if the Secretary determines that there is insufficient access to accredited third-party auditors in a country or region or that the use of the same audit agent or accredited third-party auditor is otherwise necessary.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDd6f0d426ca8f469aa849152ca7e79c0a"><enum>(8)</enum><header display-inline="yes-display-inline">Conflicts of interest</header> <subparagraph commented="no" display-inline="no-display-inline" id="id49F89B3949644537A769DCB57DC4536A"><enum>(A)</enum><header display-inline="yes-display-inline">Accreditation bodies</header><text display-inline="yes-display-inline">A recognized accreditation body shall—</text> <clause commented="no" display-inline="no-display-inline" id="id7094A5736D174AEB9F852E42D78E9E8F"><enum>(i)</enum><text display-inline="yes-display-inline">not be owned, managed, or controlled by any person that owns or operates a third-party auditor to be accredited by such body;</text> </clause><clause commented="no" display-inline="no-display-inline" id="idE855A25E1712428A94E214C6843742D8"><enum>(ii)</enum><text display-inline="yes-display-inline">in carrying out accreditation of third-party auditors under this section, have procedures to ensure against the use of any officer or employee of such body that has a financial conflict of interest regarding a third-party auditor to be accredited by such body; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="id57DB93A3C1624634B7D660D2C51E6031"><enum>(iii)</enum><text display-inline="yes-display-inline">annually make available to the Secretary disclosures of the extent to which such body and the officers and employees of such body have maintained compliance with clauses (i) and (ii) relating to financial conflicts of interest.</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID64d1a06fedfa47c9a0719f81e6e150f7"><enum>(B)</enum><header display-inline="yes-display-inline">Accredited third-party auditors</header><text display-inline="yes-display-inline">An accredited third-party auditor shall—</text> <clause commented="no" display-inline="no-display-inline" id="IDeec59cee230f4829a52ce2dc3c0545af"><enum>(i)</enum><text display-inline="yes-display-inline">not be owned, managed, or controlled by any person that owns or operates an eligible entity to be certified by such auditor;</text> </clause><clause commented="no" display-inline="no-display-inline" id="ID9dd226de76984e14b2c6fdefdc1432b3"><enum>(ii)</enum><text display-inline="yes-display-inline">in carrying out drug safety and quality audits of eligible entities under this section, have procedures to ensure against the use of any officer or employee of such auditor that has a financial conflict of interest regarding an eligible entity to be certified by such auditor; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="IDcc4bda33428041d59b1c28fec8ef1f5e"><enum>(iii)</enum><text display-inline="yes-display-inline">annually make available to the Secretary disclosures of the extent to which such auditor and the officers and employees of such auditor have maintained compliance with clauses (i) and (ii) relating to financial conflicts of interest.</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDe6c487f371aa4e70a1d667bd052a1975"><enum>(C)</enum><header display-inline="yes-display-inline">Audit agents</header><text display-inline="yes-display-inline">An audit agent shall—</text> <clause commented="no" display-inline="no-display-inline" id="ID906f36d904b04a2188345e71d0a2ba81"><enum>(i)</enum><text display-inline="yes-display-inline">not own or operate an eligible entity to be audited by such agent;</text> </clause><clause commented="no" display-inline="no-display-inline" id="ID1ea2af2230624410ae83d9e65fb9d91c"><enum>(ii)</enum><text display-inline="yes-display-inline">in carrying out audits of eligible entities under this section, have procedures to ensure that such agent does not have a financial conflict of interest regarding an eligible entity to be audited by such agent; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="IDc2bff19e5ccb4822899dc8d7ebdad38a"><enum>(iii)</enum><text display-inline="yes-display-inline">annually make available to the Secretary disclosures of the extent to which such agent has maintained compliance with clauses (i) and (ii) relating to financial conflicts of interest.</text> </clause></subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID6902e60d669a490286629a3e0dbf585b"><enum>(d)</enum><header display-inline="yes-display-inline">False statements</header><text display-inline="yes-display-inline">Any statement or representation made—</text> <paragraph commented="no" display-inline="no-display-inline" id="ID23b08a52e506439d950bb765194c0cea"><enum>(1)</enum><text display-inline="yes-display-inline">by an employee or agent of an eligible entity to an accredited third-party auditor or audit agent; or</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDb28596ba80d54d2f8b2c875cdd81ec81"><enum>(2)</enum><text display-inline="yes-display-inline">by an accreditation body, accredited third-party auditor, or audit agent of such auditor to the Secretary, shall be subject to section 1001 of title 18, United States Code.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID81ad2713395947ec9928e9a9decee910"><enum>(e)</enum><header display-inline="yes-display-inline">Monitoring</header><text display-inline="yes-display-inline">To ensure compliance with the requirements of this section, the Secretary—</text> <paragraph commented="no" display-inline="no-display-inline" id="ID0b0a1c31456e4504bc9872e255b0dfc6"><enum>(1)</enum><text display-inline="yes-display-inline">shall periodically, or at least once every 4 years, reevaluate the accreditation bodies described in subsection (b)(1);</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDaf6f49ed81494bc4a29a0e048b84e608"><enum>(2)</enum><text display-inline="yes-display-inline">shall periodically, or at least once every 4 years, evaluate the performance of each accredited third-party auditor, through the review of regulatory audit reports by such auditors, the compliance history as available of eligible entities certified by such auditors, and any other measures deemed necessary by the Secretary;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDfbebed70aecc4a8b963cde3ac217834a"><enum>(3)</enum><text display-inline="yes-display-inline">may at any time, conduct an onsite audit of any eligible entity certified by an accredited third-party auditor, with or without the auditor present; and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID29578104bdf842759d439e2207769e27"><enum>(4)</enum><text display-inline="yes-display-inline">shall take any other measures deemed necessary by the Secretary.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID08f577b7d0ee41c4a1289a3d27624018"><enum>(f)</enum><header display-inline="yes-display-inline">Effect of Audit</header><text display-inline="yes-display-inline">The results of a drug safety and quality audit by an accredited third-party auditor under this section—</text> <paragraph commented="no" display-inline="no-display-inline" id="IDaaeb83302f67419d9a5c15e6448df835"><enum>(1)</enum><text display-inline="yes-display-inline">may be used by the eligible entity—</text> <subparagraph commented="no" display-inline="no-display-inline" id="ID3adcf940e3bd4276944fe0ab4a8e265f"><enum>(A)</enum><text display-inline="yes-display-inline">as documentation of compliance with section 501(a)(2)(B) or section 801(r); and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDd27cf76fadf84f8ba443ee62aa62e1dd"><enum>(B)</enum><text display-inline="yes-display-inline">for other purposes as determined appropriate by the Secretary; and</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID56a51b6f31ec4f95b8760175edf60abb"><enum>(2)</enum><text display-inline="yes-display-inline">shall be used by the Secretary in establishing the risk-based inspection schedules under section 510(h).</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID433500e2382e4d708300afd8152d8be0"><enum>(g)</enum><header display-inline="yes-display-inline">Costs</header> <paragraph commented="no" display-inline="no-display-inline" id="idE97B8612C74746E881D7AE0BC207F86C"><enum>(1)</enum><header display-inline="yes-display-inline">Authorized fees of Secretary</header><text display-inline="yes-display-inline">The Secretary may assess fees on accreditation bodies and accredited third-party auditors in such an amount necessary to establish and administer the recognition and accreditation program under this section. The Secretary may require accredited third-party auditors and audit agents to reimburse the Food and Drug Administration for the work performed to carry out this section. The Secretary shall not generate surplus revenue from such a reimbursement mechanism. Fees authorized under this paragraph shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriation Acts. Such fees are authorized to remain available until expended.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id3763F8B9598643518210BB6C28FF7F65"><enum>(2)</enum><header display-inline="yes-display-inline">Authorized fees for recognized accreditation bodies</header><text display-inline="yes-display-inline">An accreditation body recognized by the Secretary under subsection (b) may assess a reasonable fee to accredit third-party auditors.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="IDe04e7a87efb748eba77d14957e951b91"><enum>(h)</enum><header display-inline="yes-display-inline">Limitations</header> <paragraph commented="no" display-inline="no-display-inline" id="ID6b8dec22800e481681b971b4e1edd747"><enum>(1)</enum><header display-inline="yes-display-inline">No effect on Section 704 inspections</header><text display-inline="yes-display-inline">The drug safety and quality audits performed under this section shall not be considered inspections under section 704.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID07031aee73ec481f8a85f5ce9c626b68"><enum>(2)</enum><header display-inline="yes-display-inline">No effect on inspection authority</header><text display-inline="yes-display-inline">Nothing in this section affects the authority of the Secretary to inspect any eligible entity pursuant to this Act.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id9378023F09FD4462B95B63EE8136F5EF"><enum>(i)</enum><header display-inline="yes-display-inline">Regulations</header> <paragraph commented="no" display-inline="no-display-inline" id="idBFEB694C95214132B38635C34F214B14"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than 18 months after the date of enactment of the <short-title>Food and Drug Administration Safety and Innovation Act</short-title>, the Secretary shall adopt final regulations implementing this section.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id3866460178304E13ADEE1B8CC7A306DC"><enum>(2)</enum><header display-inline="yes-display-inline">Procedure</header><text display-inline="yes-display-inline">In promulgating the regulations implementing this section, the Secretary shall—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id93e511827f9e4aecb1319057c092a931"><enum>(A)</enum><text display-inline="yes-display-inline">issue a notice of proposed rulemaking that includes the proposed regulation;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id5a4ad5e2254c4b53a60c98f01cd995c0"><enum>(B)</enum><text display-inline="yes-display-inline">provide a period of not less than 60 days for comments on the proposed regulation; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id454a5a33afff4bb5b0e36abd73c3afe3"><enum>(C)</enum><text display-inline="yes-display-inline">publish the final regulation not less than 30 days before the effective date of the regulation.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idD7F44AD739FC40B3BE2BFE4C75025E1D"><enum>(3)</enum><header display-inline="yes-display-inline">Content</header><text display-inline="yes-display-inline">Such regulations shall include—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id2fe1ccab7b2e45bcb1a69979143516b8"><enum>(A)</enum><text display-inline="yes-display-inline">requirements that, to the extent practicable, drug safety and quality audits performed under this section be unannounced;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id0872a9544cc94fe39b05d0d54ab460ee"><enum>(B)</enum><text display-inline="yes-display-inline">a structure to decrease the potential for conflicts of interest, including timing and public disclosure, for fees paid by eligible entities to accredited third-party auditors; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idcae4e53c5f62480499da76dbd8a39363"><enum>(C)</enum><text display-inline="yes-display-inline">appropriate limits on financial affiliations between an accredited third-party auditor or audit agents of such auditor and any person that owns or operates an eligible entity to be audited by such auditor, as described in subparagraphs (A) and (B).</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id73541F7E068B4C049BA0BAF78A13B4A0"><enum>(4)</enum><header display-inline="yes-display-inline">Restrictions</header><text display-inline="yes-display-inline">Notwithstanding any other provision of law, the Secretary shall promulgate regulations implementing this section only as described in paragraph (2).</text> </paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block> </subsection><subsection commented="no" display-inline="no-display-inline" id="IDf6f59bb9d0f14ab38d8ac8aa8e9b2d7b"><enum>(b)</enum><header display-inline="yes-display-inline">Report on accredited third-party auditors</header><text display-inline="yes-display-inline">Not later than January 20, 2017, the Comptroller General of the United States shall submit to Congress a report that addresses the following, with respect to the period beginning on the date of implementation of section 809 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)) and ending on the date of such report:</text> <paragraph commented="no" display-inline="no-display-inline" id="IDad99d4a09cd44673a91d17d4cd607147"><enum>(1)</enum><text display-inline="yes-display-inline">The extent to which drug safety and quality audits completed by accredited third-party auditors under such section 809 are being used by the Secretary of Health and Human Services (referred to in this subsection as the <quote>Secretary</quote>) in establishing or applying the risk-based inspection schedules under section 510(h) of such Act (as amended by section 705).</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDa483cd70629d41e2ab59c6efec913d17"><enum>(2)</enum><text display-inline="yes-display-inline">The extent to which drug safety and quality audits completed by accredited third-party auditors or agents are assisting the Food and Drug Administration in evaluating compliance with sections 501(a)(2)(B) of such Act (21 U.S.C. 351(a)(2)(B)) and 801(r) of such Act (as added by section 711).</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID2ec7a6b81560468ab58bb56244977823"><enum>(3)</enum><text display-inline="yes-display-inline">Whether the Secretary has been able to access drug safety and quality audit reports completed by accredited third-party auditors under such section 809.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID1eba10d5d47c470d9b69f51119a3045c"><enum>(4)</enum><text display-inline="yes-display-inline">Whether accredited third-party auditors accredited under such section 809 have adhered to the conflict of interest provisions set forth in such section.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDa9422dd2c9da4798a2127525c3f3df27"><enum>(5)</enum><text display-inline="yes-display-inline">The extent to which the Secretary has audited recognized accreditation bodies or accredited third-party auditors to ensure compliance with the requirements of such section 809.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDb369fc16b31243e5906371d559633af5"><enum>(6)</enum><text display-inline="yes-display-inline">The number of waivers under subsection (c)(7)(B) of such section 809 issued during the most recent 12-month period and the official justification by the Secretary for each determination that there was insufficient access to an accredited third-party auditor.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID5eecba5b5439464c9edd626c683c45e7"><enum>(7)</enum><text display-inline="yes-display-inline">The number of times a manufacturer has used the same accredited third-party auditor for 2 or more consecutive drug safety and quality audits under such section 809.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDcb3c0a19cac648ce9b30bbc09ec03746"><enum>(8)</enum><text display-inline="yes-display-inline">Recommendations to Congress regarding the accreditation program under such section 809, including whether Congress should continue, modify, or terminate the program.</text> </paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="idA1D22A7EC1B64FC8898B6B75C14E264A" section-type="subsequent-section"><enum>711.</enum><header display-inline="yes-display-inline">Standards for admission of imported drugs</header><text display-inline="no-display-inline">Section 801 (21 U.S.C. 381) is amended—</text> <paragraph commented="no" display-inline="no-display-inline" id="IDb825945ea2dd43cda0f6fae5218efa17"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (o), by striking <quote>drug or</quote>; and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID11701596f70a4624bb3566322d8f16bd"><enum>(2)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="idE8FC6D02F5D84AE0AA3B97D5B59364AE" style="OLC"> <subsection commented="no" display-inline="no-display-inline" id="ID7cbf27fae2574bc18497b9996d083a76"><enum>(r)</enum><paragraph commented="no" display-inline="yes-display-inline" id="id9EE749E1C53D4C678EB9A90BCE4EA0AD"><enum>(1)</enum><text display-inline="yes-display-inline">The Secretary may require, as a condition of granting admission to a drug imported or offered for import into the United States, that the importer electronically submit information demonstrating that the drug complies with applicable requirements of this Act.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idC69F816584D047B4BEDD686C821BBB68" indent="up1"><enum>(2)</enum><text display-inline="yes-display-inline">The information described under paragraph (1) may include—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id8F22B4290CDB47468FE808C529998155"><enum>(A)</enum><text display-inline="yes-display-inline">information demonstrating the regulatory status of the drug, such as the new drug application, abbreviated new drug application, or investigational new drug or drug master file number;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idB7CE4E94666342F39F129E2178B96CB0"><enum>(B)</enum><text display-inline="yes-display-inline">facility information, such as proof of registration and the unique facility identifier;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id70837CE379F5451489CC149EDCEC78A6"><enum>(C)</enum><text display-inline="yes-display-inline">indication of compliance with current good manufacturing practice, testing results, certifications relating to satisfactory inspections, and compliance with the country of export regulations; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id357B89D8CC7A45CDB34C71F90301B05F"><enum>(D)</enum><text display-inline="yes-display-inline">any other information deemed necessary and appropriate by the Secretary to assess compliance of the article being offered for import.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idE25E46B1739B492281D7B2947D4EEC26" indent="up1"><enum>(3)</enum><text display-inline="yes-display-inline">Information requirements referred to in paragraph (2)(C) may, at the discretion of the Secretary, be satisfied—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id278498F1039E4085809DDCA0FABFF66C"><enum>(A)</enum><text display-inline="yes-display-inline">by certifications from accredited third parties, as described under section 809;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id83167F75D94241829CDADE5E0011BD16"><enum>(B)</enum><text display-inline="yes-display-inline">through representation by a foreign government, if such inspection is conducted using standards and practices as determined appropriate by the Secretary; or</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id45ACF498F3A04D3B95F3E33A1058D342"><enum>(C)</enum><text display-inline="yes-display-inline">other appropriate documentation or evidence as described by the Secretary.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id372F15B2E715464E8CFC9AC861F78203" indent="up1"><enum>(4)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="idE1A2DFE6675B44E5A7BDA62404B56648"><enum>(A)</enum><text display-inline="yes-display-inline">Not later than 18 months after the date of enactment of the <short-title>Food and Drug Administration Safety and Innovation Act</short-title>, 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).</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id443037FB3B6343F1A6C1CFBDEECF178A" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">In promulgating the regulations implementing this subsection, the Secretary shall—</text> <clause commented="no" display-inline="no-display-inline" id="id6B9EE8B8144B43179B1054CA5C137F70"><enum>(i)</enum><text display-inline="yes-display-inline">issue a notice of proposed rulemaking that includes the proposed regulation;</text> </clause><clause commented="no" display-inline="no-display-inline" id="id308CCFA4BEF047D48E525F8116A988A5"><enum>(ii)</enum><text display-inline="yes-display-inline">provide a period of not less than 60 days for comments on the proposed regulation; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="id3069A3CCB4D54F248EA98F13452CC656"><enum>(iii)</enum><text display-inline="yes-display-inline">publish the final regulation not less than 30 days before the effective date of the regulation.</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idD86B762C49DD4F64AB48390AE59F48BF" indent="up1"><enum>(C)</enum><text display-inline="yes-display-inline">Notwithstanding any other provision of law, the Secretary shall promulgate regulations implementing this subsection only as described in subparagraph (B).</text> </subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph></section><section commented="no" display-inline="no-display-inline" id="id2D7DA711089C46E4BBF4A4BD072E0FA3" section-type="subsequent-section"><enum>712.</enum><header display-inline="yes-display-inline">Notification</header> <subsection commented="no" display-inline="no-display-inline" id="H7D098237617F42D6AF988FDB401AD70B"><enum>(a)</enum><header display-inline="yes-display-inline">Prohibited acts</header><text display-inline="yes-display-inline">Section 301 (21 U.S.C. 331) is amended by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="HA39872E5EAB047418893B3F32BF58B0F" style="OLC"> <subsection commented="no" display-inline="no-display-inline" id="H444AFF2BBD0047458056EB6BC8CD5D93"><enum>(aaa)</enum><text display-inline="yes-display-inline">The failure to notify the Secretary in violation of section 568.</text> </subsection><after-quoted-block>.</after-quoted-block></quoted-block> </subsection><subsection commented="no" display-inline="no-display-inline" id="HD75AEC2B9CDB4C32B5561E4F4D14CF57"><enum>(b)</enum><header display-inline="yes-display-inline">Notification</header> <paragraph commented="no" display-inline="no-display-inline" id="id443E0DF494C145F5A8DC55D5239459B2"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Subchapter E of chapter V (21 U.S.C. 360bbb et seq.) is amended by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="H33ED3FD3815744ECBB2470548FDD2AFB" style="OLC"> <section commented="no" display-inline="no-display-inline" id="H722B56F4840544B0BCBDAC1D0E23047B" section-type="subsequent-section"><enum>568.</enum><header display-inline="yes-display-inline">Notification</header> <subsection commented="no" display-inline="no-display-inline" id="H2B5E8C0DA52C47938E957EA6DE632BCC"><enum>(a)</enum><header display-inline="yes-display-inline">Notification to Secretary</header><text display-inline="yes-display-inline">With respect to a drug, the Secretary may require notification to the Secretary by a covered person if the covered person knows—</text> <paragraph commented="no" display-inline="no-display-inline" id="HC7BB6C5F7B3D4356B7B3836DE6D09FF0"><enum>(1)</enum><text display-inline="yes-display-inline">of a substantial loss or theft of such drug; or</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF3D540AC187E4B92B44EFD220EA7B709"><enum>(2)</enum><text display-inline="yes-display-inline">that such drug—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id632102726F884791B2D31588316A6641"><enum>(A)</enum><text display-inline="yes-display-inline">has been or is being counterfeited; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id163BB1E673984E3DA784AAB360C101CA"><enum>(B)</enum><clause commented="no" display-inline="yes-display-inline" id="id14858433CDAC4C77B1FC9BDA4FC1F867"><enum>(i)</enum><text display-inline="yes-display-inline">is a counterfeit product in commerce in the United States; or</text> </clause><clause commented="no" display-inline="no-display-inline" id="id0CCECCB2BA4C4AEF8E100A593BC93A10" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">is offered for import into the United States.</text> </clause></subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HAF173351C71E4A4AA4384E3F43DA5AAC"><enum>(b)</enum><header display-inline="yes-display-inline">Manner of notification</header><text display-inline="yes-display-inline">Notification under this section shall be made in a reasonable time, in such reasonable manner, and by such reasonable means as the Secretary may require by regulation or specify in guidance.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="HBCEE3B93F44649E58961F9212441737F"><enum>(c)</enum><header display-inline="yes-display-inline">Definition</header><text display-inline="yes-display-inline">In this section, the term <term>covered person</term> means—</text> <paragraph commented="no" display-inline="no-display-inline" id="id25625F74B9944042A53D2BDF89DB4BB0"><enum>(1)</enum><text display-inline="yes-display-inline">a person who is required to register under section 510 with respect to an establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a drug; or</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idB32BBCAD10B547769EA046A48C7689EB"><enum>(2)</enum><text display-inline="yes-display-inline">a person engaged in the wholesale distribution (as defined in section 503(e)(3)(B)) of a drug.</text> </paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id3C75B365F96B4B7D8709C8EE95A40642"><enum>(2)</enum><header display-inline="yes-display-inline">Applicability</header><text display-inline="yes-display-inline">Notifications under section 568 of the Federal Food, Drug, and Cosmetic Act (as added by paragraph (1)) apply to losses, thefts, or counterfeiting, as described in subsection (a) of such section 568, that occur on or after the date of enactment of this Act.</text> </paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="idB29873BB00D148C98B2DED704C6928D7" section-type="subsequent-section"><enum>713.</enum><header display-inline="yes-display-inline">Protection against intentional adulteration</header><text display-inline="no-display-inline">Section 303(b) (21 U.S.C. 333(b)) is amended by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="idE561C5425CD6464D93ED053490B7E773" style="OLC"> <paragraph commented="no" display-inline="no-display-inline" id="id29A494F28B004AD69E12FA8070F04508" indent="up1"><enum>(7)</enum><text display-inline="yes-display-inline">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.</text> </paragraph><after-quoted-block>.</after-quoted-block></quoted-block> </section><section commented="no" display-inline="no-display-inline" id="id1F340342123043B7B584EF1728E23CDF" section-type="subsequent-section"><enum>714.</enum><header display-inline="yes-display-inline">Enhanced criminal penalty for counterfeiting drugs</header> <subsection commented="no" display-inline="no-display-inline" id="id02C286B22B984D94B15F4BFCE7B128D8"><enum>(a)</enum><header display-inline="yes-display-inline">FFDCA</header><text display-inline="yes-display-inline">Section 303(b) (21 U.S.C. 333(b)), as amended by section 713, is further amended by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="id8214019E0FFB452CAD242967557217FD" style="OLC"> <paragraph commented="no" display-inline="no-display-inline" id="id62AC972AC2824EDE8567B7F8AEAC7E05" indent="up1"><enum>(8)</enum><text display-inline="yes-display-inline">Notwithstanding subsection (a)(2), any person who knowingly and intentionally violates section 301(i) shall be imprisoned for not more than 20 years or fined not more than $4,000,000 or both.</text> </paragraph><after-quoted-block>.</after-quoted-block></quoted-block> </subsection><subsection commented="no" display-inline="no-display-inline" id="id0574DB7D87934A3986A71E346B5C330F"><enum>(b)</enum><header display-inline="yes-display-inline">Title 18</header><text display-inline="yes-display-inline">Section 2320(b) of title 18, United States Code, is amended—</text> <paragraph commented="no" display-inline="no-display-inline" id="idE5C2776ECB3144F4BE1A3702636BB412"><enum>(1)</enum><text display-inline="yes-display-inline">by redesignating paragraphs (2) and (3) as paragraphs (3) and (4), respectively; and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id743E633907CC4A418C645561A60DED1C"><enum>(2)</enum><text display-inline="yes-display-inline">by inserting after paragraph (1) the following:</text> <quoted-block display-inline="no-display-inline" id="idE038BA47C1534297B71A03AA60621CCC" style="OLC"> <paragraph commented="no" display-inline="no-display-inline" id="idAFFCF960E86F4E8D9CA095EAEF26E0FA"><enum>(2)</enum><header display-inline="yes-display-inline">Counterfeit drugs</header> <subparagraph commented="no" display-inline="no-display-inline" id="id96AFC8134A7C40398C7EB5544ADBB10B"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Whoever commits an offense under subsection (a) with respect to a drug (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)) shall—</text> <clause commented="no" display-inline="no-display-inline" id="idEBD35E3B0E314D4C8C2DA1097B15A875"><enum>(i)</enum><text display-inline="yes-display-inline">if an individual, be fined not more than $4,000,000, imprisoned not more than 20 years, or both; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="idD5416B9148884A7290C8EBC9308342FF"><enum>(ii)</enum><text display-inline="yes-display-inline">if a person other than an individual, be fined not more than $10,000,000.</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idDE818A1CDBEB49EBAF5355C802D589C7"><enum>(B)</enum><header display-inline="yes-display-inline">Multiple offenses</header><text display-inline="yes-display-inline">In the case of an offense by a person under this paragraph that occurs after that person is convicted of another offense under this paragraph, the person convicted—</text> <clause commented="no" display-inline="no-display-inline" id="id29D602D876D54AC5A57B2553E220A18C"><enum>(i)</enum><text display-inline="yes-display-inline">if an individual, shall be fined not more than $8,000,000, imprisoned not more than 20 years, or both; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="id1A1C36530E874DE9A79266F0ADFFEFAB"><enum>(ii)</enum><text display-inline="yes-display-inline">if other than an individual, shall be fined not more than $20,000,000.</text> </clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id90F63A4604F7475FBC4B96BA83073FD7"><enum>(c)</enum><header display-inline="yes-display-inline">Sentencing</header> <paragraph commented="no" display-inline="no-display-inline" id="ID750a1b64682a4110a3bd167a19a88e0e"><enum>(1)</enum><header display-inline="yes-display-inline">Directive to sentencing commission</header><text display-inline="yes-display-inline">Pursuant to its authority under section 994(p) of title 28, United States Code, and in accordance with this section, 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(b)(2) of title 18, United States Code, as amended by subsection (b), 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.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDd4e434f546f64e67b4991f9233f74219"><enum>(2)</enum><header display-inline="yes-display-inline">Requirements</header><text display-inline="yes-display-inline">In carrying out this subsection, the Commission shall—</text> <subparagraph commented="no" display-inline="no-display-inline" id="IDe7adc515130b4e9cb807241da530213c"><enum>(A)</enum><text display-inline="yes-display-inline">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;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDd045b0b0769147e48c0718afcf2863ca"><enum>(B)</enum><text display-inline="yes-display-inline">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;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID121585d970f04e1fa8cabdfcb9708012"><enum>(C)</enum><text display-inline="yes-display-inline">assure reasonable consistency with other relevant directives and with other sentencing guidelines;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID5391e51ecd24468490a917f046018ad8"><enum>(D)</enum><text display-inline="yes-display-inline">account for any additional aggravating or mitigating circumstances that might justify exceptions to the generally applicable sentencing ranges;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDb1ce68cae4a44ba28a4bd118a2929d60"><enum>(E)</enum><text display-inline="yes-display-inline">make any necessary conforming changes to the sentencing guidelines; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID0403fea699364924ae89aa772de31c10"><enum>(F)</enum><text display-inline="yes-display-inline">assure that the guidelines adequately meet the purposes of sentencing as set forth in section 3553(a)(2) of title 18, United States Code.</text> </subparagraph></paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="H9BB01346CF6B479788E476946D65B29B" section-type="subsequent-section"><enum>715.</enum><header display-inline="yes-display-inline">Extraterritorial jurisdiction</header><text display-inline="no-display-inline">Chapter III (21 U.S.C. 331 et seq.) is amended by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="H0A9F924258E943DEA93A098799090A44" style="OLC"> <section commented="no" display-inline="no-display-inline" id="H754929EDBB8E4C8F942BB85110FB6691" section-type="subsequent-section"><enum>311.</enum><header display-inline="yes-display-inline">Extraterritorial jurisdiction</header><text display-inline="no-display-inline">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.</text> </section><after-quoted-block>.</after-quoted-block></quoted-block> </section><section commented="no" display-inline="no-display-inline" id="id83EB9A7397164AEE8474588B80FFE927" section-type="subsequent-section"><enum>716.</enum><header display-inline="yes-display-inline">Compliance with international agreements</header><text display-inline="no-display-inline">Nothing in this title (or an amendment made by this title) shall be construed in a manner inconsistent with the obligations of the United States under the Agreement Establishing the World Trade Organization, or any other treaty or international agreement to which the United States is a party.</text> </section></subtitle><subtitle commented="no" id="id5DFEBFB7BF1A4E8B81AEC74815104286" level-type="subsequent"><enum>B</enum><header display-inline="yes-display-inline">Pharmaceutical distribution integrity</header> <section commented="no" display-inline="no-display-inline" id="idACFFDAA0FDC843E58D7A2EDB94F57A6E" section-type="subsequent-section"><enum>721.</enum><header display-inline="yes-display-inline">Short title</header><text display-inline="no-display-inline">This subtitle may be referred to as the <quote><short-title>Securing Pharmaceutical Distribution Integrity to Protect the Public Health Act of 2012</short-title></quote> or the <quote>Securing Pharmaceutical Distribution Integrity Act of 2012</quote>.</text> </section><section commented="no" display-inline="no-display-inline" id="idC6F0754653EC496B99C1088C93322042" section-type="subsequent-section"><enum>722.</enum><header display-inline="yes-display-inline">Securing the pharmaceutical distribution supply chain</header> <subsection commented="no" display-inline="no-display-inline" id="id9071319BB8224B0797BCF7067A9796A0"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Chapter V (21 U.S.C. 351 et seq.) is amended by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="idc600ce851a9145cbae2e465d2c3e0e57" style="OLC"> <subchapter commented="no" id="id48297C7E349242449828B318544ED993" level-type="subsequent"><enum>H</enum><header display-inline="yes-display-inline">Pharmaceutical distribution integrity</header> <section commented="no" display-inline="no-display-inline" id="id2e92b9cb7aff4c4ca8b240e0d8e3c9c6" section-type="subsequent-section"><enum>581.</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="no-display-inline">In this subchapter:</text> <paragraph commented="no" display-inline="no-display-inline" id="idac3402a0d9124e4cbe30b0863e51d50b"><enum>(1)</enum><header display-inline="yes-display-inline">Data carrier</header><text display-inline="yes-display-inline">The term <term>data carrier</term> means a machine-readable graphic that is intended to be affixed to, or imprinted upon, an individual saleable unit and a homogeneous case of product. The data carrier shall comply with a form and format developed by a widely recognized international standards development organization to ensure interoperability among distribution chain participants.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id19ad6669afdf4d7198e9153688bfde8d"><enum>(2)</enum><header display-inline="yes-display-inline">Individual saleable unit</header><text display-inline="yes-display-inline">The term <term>individual saleable unit</term> means the smallest container of product put into interstate commerce by the manufacturer that is intended by the manufacturer for individual sale to a pharmacy or other dispenser of such product.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id872e2b798d564848a915f3503365dce7"><enum>(3)</enum><header display-inline="yes-display-inline">Product</header><text display-inline="yes-display-inline">The term <term>product</term> means a finished drug subject to section 503(b)(1).</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id0493cee28c514a75b4ec0ac411e661bf"><enum>(4)</enum><header display-inline="yes-display-inline">Product tracing</header><text display-inline="yes-display-inline">The term <term>product tracing</term> means—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id8CD0CA4E6A354C7583548DB61934061F"><enum>(A)</enum><text display-inline="yes-display-inline">identifying the immediate previous source and immediate subsequent recipient of a product in wholesale distribution at the lot level where a change of ownership of such product has occurred between non-affiliated entities, except as otherwise described in this subchapter;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id1EE437CCF16C413B97EF7A135E79EC5E"><enum>(B)</enum><text display-inline="yes-display-inline">identifying the immediate subsequent recipient of the product at the lot level when a manufacturer or repackager introduces such product into interstate commerce;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idD4864E96D95F4C7EAEF5D8D9EA2A0D9E"><enum>(C)</enum><text display-inline="yes-display-inline">identifying that manufacturer and dispenser of a product at the lot level when a manufacturer ships a product at the lot level, without regard to the change in ownership involving the wholesale distributor; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id91ED8ED2B2DE41B8818D51898E3932C5"><enum>(D)</enum><text display-inline="yes-display-inline">identifying the immediate previous source of a product at the lot level for dispensers.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id32c498f69dee406fa3ff089887f97bd1"><enum>(5)</enum><header display-inline="yes-display-inline">Rxtec</header><text display-inline="yes-display-inline">The term <term>RxTEC</term> means a data carrier that includes the standardized numerical identifier (SNI), the lot number, and the expiration date of a product. The standard data carrier RxTEC shall be a 2D data matrix barcode affixed to each individual saleable unit of a product and a linear or 2D data matrix barcode on a homogenous case of a product. Such information shall be both machine readable and human readable.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id59da435d36034220a8229494db55d788"><enum>(6)</enum><header display-inline="yes-display-inline">Suspect product</header><text display-inline="yes-display-inline">The term <term>suspect product</term> means a product that, based on credible evidence—</text> <subparagraph commented="no" display-inline="no-display-inline" id="idE762BA9338CA4852BE9BA27B5C83A291"><enum>(A)</enum><text display-inline="yes-display-inline">is potentially counterfeit, diverted, or stolen;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idfb012c0986ea4324b43ce85b2ba8bded"><enum>(B)</enum><text display-inline="yes-display-inline">is reasonably likely to be intentionally adulterated such that the product would result in serious adverse health consequences or death to humans; or</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idcf993bc879b94243bf61bf5d96627c26"><enum>(C)</enum><text display-inline="yes-display-inline">appears otherwise unfit for distribution such that the product would result in serious adverse health consequence or death to humans.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idf8023cdec12748dfa47f412fe0062d4b"><enum>(7)</enum><header display-inline="yes-display-inline">Verification</header><text display-inline="yes-display-inline">The term <term>verification</term> means the process of determining whether a product has the standardized numerical identifier or lot number, consistent with section 582, and expiration date assigned by the manufacturer, or the repackager as applicable, and identifying whether a product has the appearance of being a counterfeit, diverted, or stolen product, or a product otherwise unfit for distribution. Verification of the RxTEC data may occur by using either a human-readable, machine-readable, or other method such as through purchase records or invoices.</text> </paragraph></section><section commented="no" display-inline="no-display-inline" id="id670d3be9555548daaadd91329c7ff7ea" section-type="subsequent-section"><enum>582.</enum><header display-inline="yes-display-inline">Ensuring the safety of the pharmaceutical distribution supply chain through the establishment of an RxTEC system</header> <subsection commented="no" display-inline="no-display-inline" id="id32ff3524a06f4759862830dfcfde3025"><enum>(a)</enum><header display-inline="yes-display-inline">Manufacturer requirements</header> <paragraph commented="no" display-inline="no-display-inline" id="id342D1B100733453D97EBC6D0DC57DABC"><enum>(1)</enum><header display-inline="yes-display-inline">Product tracing</header><text display-inline="yes-display-inline">A manufacturer, not later than 4<fraction>1/2</fraction> years after the date of enactment of the Securing Pharmaceutical Distribution Integrity Act of 2012 and in accordance with this section, shall—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id137764f5993b4494bfbde9dc41688a43"><enum>(A)</enum><text display-inline="yes-display-inline">apply RxTEC to the individual saleable units and homogeneous case of all products intended to be introduced into interstate commerce;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idc7e4c7597ea04e33a41bfda4b37137b4"><enum>(B)</enum><text display-inline="yes-display-inline">maintain change of ownership and transaction information, including RxTEC data that associate unit and lot level data for each individual saleable unit of product and homogenous case introduced in interstate commerce; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id22fd0ac3f8ff459da0ab083489222fda"><enum>(C)</enum><text display-inline="yes-display-inline">maintain, where a change of ownership has occurred between non-affiliated entities or, in the case of a return from the immediate previous source, change of ownership and transaction information relating to a product, including—</text> <clause commented="no" display-inline="no-display-inline" id="idB1C047A125DF4B1FA8EA8CD8F204E8DC"><enum>(i)</enum><text display-inline="yes-display-inline">RxTEC data;</text> </clause><clause commented="no" display-inline="no-display-inline" id="idB500C625A67549AC954ED156143D07DB"><enum>(ii)</enum><text display-inline="yes-display-inline">the business name and address of the immediate previous source, if applicable, and the immediate subsequent recipient of the product;</text> </clause><clause commented="no" display-inline="no-display-inline" id="id9ABD82BE3BDF46BC9F165D439D1B72F5"><enum>(iii)</enum><text display-inline="yes-display-inline">the proprietary or established name or names of the product;</text> </clause><clause commented="no" display-inline="no-display-inline" id="id70FAAE1751DD4B5ABC423B940E3EC9D8"><enum>(iv)</enum><text display-inline="yes-display-inline">the National Drug Code number of the product;</text> </clause><clause commented="no" display-inline="no-display-inline" id="idEA36AE01ACAF49EEAD1F37A7E7CA8DB1"><enum>(v)</enum><text display-inline="yes-display-inline">container size;</text> </clause><clause commented="no" display-inline="no-display-inline" id="id38261F4A50764D75BE25AB12A892FCA0"><enum>(vi)</enum><text display-inline="yes-display-inline">number of containers;</text> </clause><clause commented="no" display-inline="no-display-inline" id="idF192828BC60A4F20A0FA400612835928"><enum>(vii)</enum><text display-inline="yes-display-inline">the lot number or numbers of the product; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="id6E65152DD7E54E83B54ADF502C316D8B"><enum>(viii)</enum><text display-inline="yes-display-inline">the date of the transaction;</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id438C03F9D5C34DB39893E075C52583F2"><enum>(D)</enum><text display-inline="yes-display-inline">provide the following change of ownership and trans action information to the immediate subsequent recipient of such product—</text> <clause commented="no" display-inline="no-display-inline" id="id2DA60492E6334D4CA6223641DD4376D0"><enum>(i)</enum><text display-inline="yes-display-inline">the proprietary or established name or names of the product;</text> </clause><clause commented="no" display-inline="no-display-inline" id="id8C9546FBB4FD49B199C98B1F52DC6877"><enum>(ii)</enum><text display-inline="yes-display-inline">the National Drug Code number of the product;</text> </clause><clause commented="no" display-inline="no-display-inline" id="idE9FDD8E255D147C79953D92B8C319E92"><enum>(iii)</enum><text display-inline="yes-display-inline">container size;</text> </clause><clause commented="no" display-inline="no-display-inline" id="idBA7FCF9630824893BBA552419EFD14CE"><enum>(iv)</enum><text display-inline="yes-display-inline">number of containers;</text> </clause><clause commented="no" display-inline="no-display-inline" id="idCD1D04A56BE34723B597F5902FE1406F"><enum>(v)</enum><text display-inline="yes-display-inline">the lot number or numbers of the product; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="id4B8F37324A884E48AB3C5256314A540B"><enum>(vi)</enum><text display-inline="yes-display-inline">a signed statement that the manufacturer did not knowingly and intentionally adulterate or knowingly and intentionally counterfeit such product; and</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id0DD1BEDA778D4D508F6A6C178E8845E9"><enum>(E)</enum><text display-inline="yes-display-inline">upon request by the Secretary, other appropriate Federal official, or State official, in the event of a recall or as determined necessary by the Secretary, or such other Federal or State official, to investigate a suspect product, provide in a reasonable time and in a reasonable manner—</text> <clause commented="no" display-inline="no-display-inline" id="id4a6b5507cb784297aeb0e3bd6b8da45d"><enum>(i)</enum><text display-inline="yes-display-inline">RxTEC data by lot; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="id7befdf1e7f01417caf71be6b750ad89c"><enum>(ii)</enum><text display-inline="yes-display-inline">change of ownership and transaction information pursuant to subparagraphs (C) and (D) necessary to identify the immediate previous source or immediate subsequent recipient of such product, as applicable.</text> </clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id31E8C671B09E4420A642A4572710A1C5"><enum>(2)</enum><header display-inline="yes-display-inline">Verification requirements</header><text display-inline="yes-display-inline">A manufacturer, not later than 4<fraction>1/2</fraction> years after the date of enactment of the Securing Pharmaceutical Distribution Integrity Act of 2012 and in accordance with this section, shall—</text> <subparagraph commented="no" display-inline="no-display-inline" id="idA4CD2FA963D2496087C50CF28897FCBD"><enum>(A)</enum><text display-inline="yes-display-inline">utilize RxTEC data at the lot level, as part of ongoing activities to significantly minimize or prevent the incidences of a suspect product in the pharmaceutical distribution supply chain, as applicable and appropriate, which—</text> <clause commented="no" display-inline="no-display-inline" id="id5f8662f4f3a64a798d46dfb2ff438bb7"><enum>(i)</enum><text display-inline="yes-display-inline">may include responding to an alert regarding a suspect product from a trading partner or the Secretary, routine monitoring of a suspect product at the lot level while such product is in the possession of the manufacturer, and checking inventory for a suspect product at the request of a trading partner or the Secretary in case of returns; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="id3f499eb8141447119f636c95f2473735"><enum>(ii)</enum><text display-inline="yes-display-inline">shall take into consideration—</text> <subclause commented="no" display-inline="no-display-inline" id="idce6e283385c843b5a58591aa3e973528"><enum>(I)</enum><text display-inline="yes-display-inline">the likelihood that a particular product has a high potential risk with respect to pharmaceutical distribution supply chain security;</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="id01f867a64d134e868c9ff71216b2146e"><enum>(II)</enum><text display-inline="yes-display-inline">the history and severity of incidences of counterfeit, diversion, and theft of such product;</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="id4bfbff63aaf34b59a7beda7dbb28a9b9"><enum>(III)</enum><text display-inline="yes-display-inline">the point in the pharmaceutical distribution supply chain where counterfeit, diversion, or theft has occurred or is most likely to occur;</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="id8f91155bae5647a4affd4b00c229bd35"><enum>(IV)</enum><text display-inline="yes-display-inline">the likelihood that such activities will reduce the possibility of the counterfeit, diversion, and theft of such product;</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="id6d4091a61d4745f9b37eb8c58411114b"><enum>(V)</enum><text display-inline="yes-display-inline">whether the product could mitigate or prevent a drug shortage as defined in section 506C; and</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="id7c0209bd01394ef1a82484144c002ff7"><enum>(VI)</enum><text display-inline="yes-display-inline">any guidance the Secretary issues regarding high-risk scenarios that could increase the risk of a suspect product entering the pharmaceutical distribution supply chain; and</text> </subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ida02e09a128f54846ad23ec3687667a4e"><enum>(B)</enum><text display-inline="yes-display-inline">conduct unit level verification upon the request of a licensed or registered repackager, wholesale distributor, dispenser, or the Secretary, regarding such product.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id18698493865D449E9BD24863A94708F7"><enum>(3)</enum><header display-inline="yes-display-inline">Notification of product removal</header> <subparagraph commented="no" display-inline="no-display-inline" id="id3DA21281476845BC8C4C30E8AC89FBC9"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than 4<fraction>1/2</fraction> years after the date of enactment of the Securing Pharmaceutical Distribution Integrity Act of 2012 and in accordance with this section, a manufacturer, upon confirming that a product does not have the standardized numerical identifier or lot number, consistent with this section, and expiration date assigned by the manufacturer, or has the appearance of being a counterfeit, diverted, or stolen product, or a product otherwise unfit for distribution such that the product would result in serious adverse health consequences or death to humans, shall—</text> <clause commented="no" display-inline="no-display-inline" id="id4dd6f1af97c5484095a7752a08672d8c"><enum>(i)</enum><text display-inline="yes-display-inline">promptly notify the Secretary and impacted trading partners, as applicable and appropriate; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="idf4b91e1406394bcdb520ede32eec842f"><enum>(ii)</enum><text display-inline="yes-display-inline">take steps to remove such product from the pharmaceutical distribution supply chain.</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idd0abc68349c54da9b57adf8d21d91b90"><enum>(B)</enum><header display-inline="yes-display-inline">Redistribution</header><text display-inline="yes-display-inline">Any product subject to a notification under this subsection may not be redistributed as a saleable product unless the manufacturer, in consultation with the Secretary, determines such product may reenter the pharmaceutical distribution supply chain.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id1251A2C2AD6B45A0A9BEDC660B0AD4DC"><enum>(4)</enum><header display-inline="yes-display-inline">Limitation</header><text display-inline="yes-display-inline">Nothing in this section shall require a manufacturer to aggregate unit level data to cases or pallets.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id6cb7ff53c76d402f9851e1a549cf8fa5"><enum>(b)</enum><header display-inline="yes-display-inline">Repackager Requirements</header> <paragraph commented="no" display-inline="no-display-inline" id="id2BFF180FA0AE401F9AC0AA7B0C7A9D39"><enum>(1)</enum><header display-inline="yes-display-inline">Product tracing</header><text display-inline="yes-display-inline">A repackager, not later than 5<fraction>1/2</fraction> years after the date of enactment of the Securing Pharmaceutical Distribution Integrity Act of 2012 and in accordance with this section, shall—</text> <subparagraph commented="no" display-inline="no-display-inline" id="idb1914c4457c24d89a41c4b5cb53d1e0f"><enum>(A)</enum><text display-inline="yes-display-inline">apply RxTEC to the individual saleable unit and the homogenous case of all product intended to be introduced into interstate commerce;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idd151b4a803284ef09374ff24b22a3db4"><enum>(B)</enum><text display-inline="yes-display-inline">maintain change of ownership and transaction information, including RxTEC data, that associate unit and lot level data for each individual saleable unit of product and each homogenous case of product introduced in interstate commerce, including RxTEC data received for such products and for which a repackager applies a new RxTEC;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ida8aa525df7bd447cb66d773b593319c6"><enum>(C)</enum><text display-inline="yes-display-inline">receive only products encoded with RxTEC data from a licensed or registered manufacturer or wholesaler;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idb1734a737ba34cc0917b144c82b0bf2d"><enum>(D)</enum><text display-inline="yes-display-inline">maintain, where a change of ownership has occurred between non-affiliated entities in wholesale distribution, change of ownership and transaction information relating to a product, including—</text> <clause commented="no" display-inline="no-display-inline" id="ide06f620c9b5149c78b8cb27a6dc2b064"><enum>(i)</enum><text display-inline="yes-display-inline">RxTEC data;</text> </clause><clause commented="no" display-inline="no-display-inline" id="id497e3899b4cf4d3d8d898467ec79d40e"><enum>(ii)</enum><text display-inline="yes-display-inline">the business name and address of the immediate previous source and the immediate subsequent recipient of the product;</text> </clause><clause commented="no" display-inline="no-display-inline" id="idc991c78a0a84460ea51391ba107d34c9"><enum>(iii)</enum><text display-inline="yes-display-inline">the proprietary or established name or names of the product;</text> </clause><clause commented="no" display-inline="no-display-inline" id="idcf15e32ae0d04d12a3fca841c106add4"><enum>(iv)</enum><text display-inline="yes-display-inline">the National Drug Code number of the product;</text> </clause><clause commented="no" display-inline="no-display-inline" id="idf0243fd512f345bb83344b387b2db9fb"><enum>(v)</enum><text display-inline="yes-display-inline">container size;</text> </clause><clause commented="no" display-inline="no-display-inline" id="id38278e8b304842988581009a45102a67"><enum>(vi)</enum><text display-inline="yes-display-inline">number of containers;</text> </clause><clause commented="no" display-inline="no-display-inline" id="id2ff5ce9287da4c3d89d566387cc5c6ab"><enum>(vii)</enum><text display-inline="yes-display-inline">the lot number or numbers of the product; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="idcb196c80bd9140be9134b1dff0d27334"><enum>(viii)</enum><text display-inline="yes-display-inline">the date of the transaction;</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idB0EEE8D602FF4E9097972DCBB4BDB611"><enum>(E)</enum><text display-inline="yes-display-inline">provide the following change of ownership and transaction information to the immediate subsequent recipient of such product—</text> <clause commented="no" display-inline="no-display-inline" id="ida173eaf072614010b663d430549f908e"><enum>(i)</enum><text display-inline="yes-display-inline">the proprietary or established name or names of the product;</text> </clause><clause commented="no" display-inline="no-display-inline" id="id417f551fca9143e39910b85fbe41897d"><enum>(ii)</enum><text display-inline="yes-display-inline">the National Drug Code number of the product;</text> </clause><clause commented="no" display-inline="no-display-inline" id="id24e09051710543f8bee6bbbe22ed6f2e"><enum>(iii)</enum><text display-inline="yes-display-inline">container size;</text> </clause><clause commented="no" display-inline="no-display-inline" id="id9b5071a54fcc48dcb80f083fd3e9a2c5"><enum>(iv)</enum><text display-inline="yes-display-inline">number of containers;</text> </clause><clause commented="no" display-inline="no-display-inline" id="idd9ce584b157a4ad5b3025dffbc80df9d"><enum>(v)</enum><text display-inline="yes-display-inline">the lot number or numbers of the product; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="idf3bf8b7962c3480aa7c3f68186ead764"><enum>(vi)</enum><text display-inline="yes-display-inline">a signed statement that the repackager—</text> <subclause commented="no" display-inline="no-display-inline" id="id30ABE10C3CA44B1CA966CE1B71291432"><enum>(I)</enum><text display-inline="yes-display-inline">is licensed or registered;</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="id81f9537d172a4feda9b0edbbb9b7be6e"><enum>(II)</enum><text display-inline="yes-display-inline">received the product from a manufacturer that is licensed or registered;</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="id8957bbd4452040559b5c9eb9ea4f8316"><enum>(III)</enum><text display-inline="yes-display-inline">received a signed statement from the manufacturer of such product consistent with subsection (a)(1)(D)(vi); and</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="id04dd2eced505450baa4ef6473a3e4791"><enum>(IV)</enum><text display-inline="yes-display-inline">did not knowingly and intentionally adulterate or knowingly and intentionally counterfeit such product; and</text> </subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id2CE2795177384EEAA765B7467223D8A0"><enum>(F)</enum><text display-inline="yes-display-inline">upon request by the Secretary, other appropriate Federal official, or State official, in the event of a recall, or as determined necessary by the Secretary or such other Federal or State official to investigate a suspect product, provide in a reasonable time and in a reasonable manner—</text> <clause commented="no" display-inline="no-display-inline" id="id1cb1a4a5786a4228a3c94df8d3bef776"><enum>(i)</enum><text display-inline="yes-display-inline">RxTEC data by lot; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="id3f86f74e25074d1d9af1dcc729d0759c"><enum>(ii)</enum><text display-inline="yes-display-inline">change of ownership and transaction information pursuant to subparagraph (C) or (E) necessary to identify the immediate previous source or the immediate subsequent recipient of such product, as applicable.</text> </clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idEFDA8A05FE7D48BE9F8DBB49D6FD767E"><enum>(2)</enum><header display-inline="yes-display-inline">Verification requirements</header><text display-inline="yes-display-inline">A repackager, not later than 5<fraction>1/2</fraction> years after the date of enactment of the Securing Pharmaceutical Distribution Integrity Act of 2012 and in accordance with this section, shall—</text> <subparagraph commented="no" display-inline="no-display-inline" id="idb18af9887d914f5b95d3637e0a05989b"><enum>(A)</enum><text display-inline="yes-display-inline">utilize RxTEC data at the lot level, as part of ongoing activities to significantly minimize or prevent the incidences of suspect product in the pharmaceutical distribution supply chain, as applicable and appropriate, which—</text> <clause commented="no" display-inline="no-display-inline" id="id434fc92f281541d682bb5dd18701a8a4"><enum>(i)</enum><text display-inline="yes-display-inline">may include—</text> <subclause commented="no" display-inline="no-display-inline" id="idEE08DC53BEF04765B6E9F7A51075526A"><enum>(I)</enum><text display-inline="yes-display-inline">responding to alerts regarding a suspect product from a trading partner or the Secretary, routine monitoring of a suspect product at the lot level while such product is in the possession of the repackager; and</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="id4496A8F27858480C86909F0C7BF4EF5A"><enum>(II)</enum><text display-inline="yes-display-inline">checking inventory for a suspect product at the request of a trading partner or the Secretary in the case of returns; and</text> </subclause></clause><clause commented="no" display-inline="no-display-inline" id="id5812c9af513f4e558a8bab90352e709a"><enum>(ii)</enum><text display-inline="yes-display-inline">shall take into consideration—</text> <subclause commented="no" display-inline="no-display-inline" id="ida9d8b5c8da85452b83642bc54e32d8be"><enum>(I)</enum><text display-inline="yes-display-inline">the likelihood that a particular product has a high potential risk with respect to pharmaceutical distribution supply chain security;</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="id591953f03eea4c788f3f4ef2ef84a3a0"><enum>(II)</enum><text display-inline="yes-display-inline">the history and severity of incidences of counterfeit, diversion, and theft of such product;</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="idfa321fede8c649c0a65e14fd3a244711"><enum>(III)</enum><text display-inline="yes-display-inline">the point in the pharmaceutical distribution supply chain where counterfeit, diversion, and theft has occurred or is most likely to occur;</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="id7082e93086ca4e639455cae574d20a6e"><enum>(IV)</enum><text display-inline="yes-display-inline">the likelihood that such activities will reduce the possibility of counterfeit, diversion, and theft of such product;</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="id1871de6d23ba48ed987f092a6794ab97"><enum>(V)</enum><text display-inline="yes-display-inline">whether the product could mitigate or prevent a drug shortage as defined in section 506C; and</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="idf1d7fdb39c5e436ba809593cec13ee0e"><enum>(VI)</enum><text display-inline="yes-display-inline">any guidance the Secretary issues regarding high-risk scenarios that could increase the risk of a suspect product entering the pharmaceutical distribution supply chain; and</text> </subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idEFEDFB24DF214A239FEC10F73260F192"><enum>(B)</enum><text display-inline="yes-display-inline">conduct unit level verification upon the request of a licensed or registered manufacturer, wholesale distributor, dispenser, or the Secretary, regarding such product.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id947D4E1DDD0143CB9645D45231788AC9"><enum>(3)</enum><header display-inline="yes-display-inline">Notification and product removal</header> <subparagraph commented="no" display-inline="no-display-inline" id="id0F19E22B6D6544BF8EAC561EF89AA203"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than 5<fraction>1/2</fraction> years after the date of enactment of the Securing Pharmaceutical Distribution Integrity Act of 2012 and in accordance with this section, a repackager, upon confirming that a product does not have the standardized numerical identifier or lot number, consistent with this section, and expiration date assigned by the manufacturer, or has the appearance of being a counterfeit, diverted, or stolen product, or a product otherwise unfit for distribution such that it would result in serious adverse health consequences or death to humans, shall—</text> <clause commented="no" display-inline="no-display-inline" id="ide022941cc13b4db4bb2df78dc7f6577d"><enum>(i)</enum><text display-inline="yes-display-inline">promptly notify the Secretary and impacted trading partners, as applicable and appropriate; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="id1d73a0ef81cd4af38b4b0428cd131ad9"><enum>(ii)</enum><text display-inline="yes-display-inline">take steps to remove such product from the pharmaceutical distribution supply chain.</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id680172cea48142ac9e0206aeb1361c89"><enum>(B)</enum><header display-inline="yes-display-inline">Redistribution</header><text display-inline="yes-display-inline">Any product subject to a notification under this subsection may not be redistributed as a saleable product unless the repackager, in consultation with the Secretary, and manufacturer as applicable, determines such product may reenter the pharmaceutical distribution supply chain.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idB1D2F732E6A345548B66477F2F5A8DB7"><enum>(4)</enum><header display-inline="yes-display-inline">Limitation</header><text display-inline="yes-display-inline">Nothing in this section shall require a repackager to aggregate unit level data to cases or pallets.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ideaf1c46cac0048478295e464459727ed"><enum>(c)</enum><header display-inline="yes-display-inline">Wholesale Distributor Requirements</header> <paragraph commented="no" display-inline="no-display-inline" id="idd081152d0a4c4ca994ce3c96f58415eb"><enum>(1)</enum><header display-inline="yes-display-inline">Product Tracing Requirements</header><text display-inline="yes-display-inline">A wholesale distributor engaged in wholesale distribution, not later than 6<fraction>1/2</fraction> years after the date of enactment of the Securing Pharmaceutical Distribution Integrity Act of 2012 and in accordance with this section, shall—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id8d76335806b14f128caf2cec2b6af6c3"><enum>(A)</enum><text display-inline="yes-display-inline">receive only products encoded with RxTEC from a licensed or registered manufacturer, wholesaler, or repackager;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id59c71c4cf03e4ec4a301d0f837dada4f"><enum>(B)</enum><text display-inline="yes-display-inline">maintain, in wholesale distribution where a change of ownership has occurred between non-affiliated entities, change of ownership and transaction information, including—</text> <clause commented="no" display-inline="no-display-inline" id="idb4c3902fa8de43629f395aa64ab22822"><enum>(i)</enum><text display-inline="yes-display-inline">RxTEC data by lot;</text> </clause><clause commented="no" display-inline="no-display-inline" id="id315eac66173b4b6fa59513a7085b0484"><enum>(ii)</enum><text display-inline="yes-display-inline">the business name and address of the immediate previous source and the immediate subsequent recipient of the product;</text> </clause><clause commented="no" display-inline="no-display-inline" id="idc92d718f36f24e6baf562de735aca4ae"><enum>(iii)</enum><text display-inline="yes-display-inline">the proprietary or established name or names of the product;</text> </clause><clause commented="no" display-inline="no-display-inline" id="idbdc3af081caf44a0b2967eff924a5b6b"><enum>(iv)</enum><text display-inline="yes-display-inline">the National Drug Code number of the product;</text> </clause><clause commented="no" display-inline="no-display-inline" id="id51191ce5b1f04e6e8923484e4102f7e5"><enum>(v)</enum><text display-inline="yes-display-inline">container size;</text> </clause><clause commented="no" display-inline="no-display-inline" id="id37eb25bed286475abc6d0b09ac9868f6"><enum>(vi)</enum><text display-inline="yes-display-inline">number of containers;</text> </clause><clause commented="no" display-inline="no-display-inline" id="idd0682c3392854c20a690ad893ad574c0"><enum>(vii)</enum><text display-inline="yes-display-inline">the lot number or numbers of the product; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="idc26d000ac0b44f05a5217ef08a0d04ad"><enum>(viii)</enum><text display-inline="yes-display-inline">the date of the transaction;</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idDBC61DF1FBEA4F94A2C324D5510859F4"><enum>(C)</enum><text display-inline="yes-display-inline">provide the following change of ownership and transaction information to the immediate subsequent recipient of such product—</text> <clause commented="no" display-inline="no-display-inline" id="ideb156b24b4124fb68e4e4ca322ae8cf3"><enum>(i)</enum><text display-inline="yes-display-inline">the proprietary or established name or names of the product;</text> </clause><clause commented="no" display-inline="no-display-inline" id="idae950bfa5a0f4e128bb6709d5a41435c"><enum>(ii)</enum><text display-inline="yes-display-inline">the National Drug Code number of the product;</text> </clause><clause commented="no" display-inline="no-display-inline" id="id18899e5a8ee8444897dd0b0350a37e74"><enum>(iii)</enum><text display-inline="yes-display-inline">container size;</text> </clause><clause commented="no" display-inline="no-display-inline" id="id1e01f1ab0c584d45ba4aaa91efe73f72"><enum>(iv)</enum><text display-inline="yes-display-inline">number of containers;</text> </clause><clause commented="no" display-inline="no-display-inline" id="idfee73859603a4c1e8e4e60ac23001810"><enum>(v)</enum><text display-inline="yes-display-inline">the lot number or numbers of the product;</text> </clause><clause commented="no" display-inline="no-display-inline" id="idbf101b25f41e4e7c9a4ce953c189f3bb"><enum>(vi)</enum><text display-inline="yes-display-inline">the date of the transaction; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="idccb39fe2c002454ba061299f6bda459b"><enum>(vii)</enum><text display-inline="yes-display-inline">a signed statement that the wholesale distributor—</text> <subclause commented="no" display-inline="no-display-inline" id="id7ddd873944264a4fb82d29d54cc5c869"><enum>(I)</enum><text display-inline="yes-display-inline">is licensed or registered;</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="id0a5527f861744d70ab96f7d3fa1b1db7"><enum>(II)</enum><text display-inline="yes-display-inline">received the product from a registered or licensed manufacturer, repackager, or wholesale distributor, as applicable;</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="id86ef8aeca4894f58a1fe3da91dbe28e5"><enum>(III)</enum><text display-inline="yes-display-inline">received a signed statement from the immediate subsequent recipient of such product that such trading partner did not knowingly and intentionally adulterate or knowingly and intentionally counterfeit such product; and</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="id4f30144f9b544d478438d4647d32bd55"><enum>(IV)</enum><text display-inline="yes-display-inline">did not knowingly and intentionally adulterate or knowingly and intentionally counterfeit such product; and</text> </subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id9db6b4855ed0444092ec5bb560b2109c"><enum>(D)</enum><text display-inline="yes-display-inline">upon request by the Secretary, other appropriate Federal official, or State official, in the event of a recall, return, or as determined necessary by the Secretary, or such other Federal or State official, to investigate a suspect product, provide in a reasonable time and in a reasonable manner—</text> <clause commented="no" display-inline="no-display-inline" id="iddfcd061ded13499e9302f9fdb67418a5"><enum>(i)</enum><text display-inline="yes-display-inline">RxTEC data by lot; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="id1fb89b40cd064f3c82a27849e99345cc"><enum>(ii)</enum><text display-inline="yes-display-inline">change of ownership and transaction information pursuant to subparagraphs (B) and (C), as necessary to identify the immediate previous source or the immediate subsequent recipient of such product.</text> </clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idB056BF853A2447D09AF575799B528F75"><enum>(2)</enum><header display-inline="yes-display-inline">Verification requirements</header> <subparagraph commented="no" display-inline="no-display-inline" id="id40D9C5019D414327BAE4DF0CBDD3D756"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">A wholesale distributor engaged in wholesale distribution, not later than 6<fraction>1/2</fraction> years after the date of enactment of the Securing Pharmaceutical Distribution Integrity Act of 2012 and in accordance with this section, shall—</text> <clause commented="no" display-inline="no-display-inline" id="ide437e4f8415548ab969fe6b33a47b54e"><enum>(i)</enum><text display-inline="yes-display-inline">utilize RxTEC data at the lot level, as part of ongoing activities to significantly minimize or prevent the incidence of suspect product in the pharmaceutical distribution supply chain, as applicable and appropriate, which—</text> <subclause commented="no" display-inline="no-display-inline" id="idaa916aa6b6a448999c3edbdfb04a71fa"><enum>(I)</enum><text display-inline="yes-display-inline">may include responding to an alert regarding a suspect product from a trading partner or the Secretary, routine monitoring of a suspect product at the lot level while such product is in the possession of the wholesale distributor, and checking inventory for a suspect product at the request of a trading partner or the Secretary; and</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="idb1f1c27dea9b4540b801443f8ea70e3d"><enum>(II)</enum><text display-inline="yes-display-inline">shall take into consideration—</text> <item commented="no" display-inline="no-display-inline" id="id568561c1d0274d8792b2857d8a9dac62"><enum>(aa)</enum><text display-inline="yes-display-inline">the likelihood that a particular product has a high potential risk with respect to pharmaceutical distribution supply chain security;</text> </item><item commented="no" display-inline="no-display-inline" id="id8683161919f242459b406ede5577f5c6"><enum>(bb)</enum><text display-inline="yes-display-inline">the history and severity of incidences of counterfeit, diversion, and theft of such product;</text> </item><item commented="no" display-inline="no-display-inline" id="id98a71cdc629048acb67681fee83138af"><enum>(cc)</enum><text display-inline="yes-display-inline">the point in the pharmaceutical distribution supply chain where counterfeit, diversion, and theft has occurred or is most likely to occur;</text> </item><item commented="no" display-inline="no-display-inline" id="id3b566ac8dfde4d38a922579fec499662"><enum>(dd)</enum><text display-inline="yes-display-inline">the likelihood that such activities will reduce the possibility of counterfeit, diversion, and theft of such product;</text> </item><item commented="no" display-inline="no-display-inline" id="id00c2911bc58249f9996e18dd118e2fa0"><enum>(ee)</enum><text display-inline="yes-display-inline">whether the product could mitigate or prevent a drug shortage as defined in section 506C; and</text> </item><item commented="no" display-inline="no-display-inline" id="ide4bbde2a832f468cb3bfe0558d4f25e5"><enum>(ff)</enum><text display-inline="yes-display-inline">any guidance the Secretary issues regarding high-risk scenarios that could increase the risk of suspect product entering the pharmaceutical distribution supply chain;</text> </item></subclause></clause><clause commented="no" display-inline="no-display-inline" id="ida171a7dd7c834e8aaf9aa4d2351d4a6d"><enum>(ii)</enum><text display-inline="yes-display-inline">conduct lot-level verification in the event of a recall, including upon the request of a licensed or registered manufacturer, repackager, dispenser, or the Secretary, regarding such product and recall;</text> </clause><clause commented="no" display-inline="no-display-inline" id="id1eb7b9be566f4de1b9629a1470372969"><enum>(iii)</enum><text display-inline="yes-display-inline">conduct verification of a returned product to validate the return at the lot level for a sealed homogenous case of such product or at the individual saleable unit of such product if the unit is not in a sealed homogenous case; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="id20b2ad4290814ebc8696f0b2aa0a4688"><enum>(iv)</enum><text display-inline="yes-display-inline">conduct unit level verification of a suspect product—</text> <subclause commented="no" display-inline="no-display-inline" id="id12b8331ead324005a572971eaa011235"><enum>(I)</enum><text display-inline="yes-display-inline">upon the request of a licensed or registered manufacturer, repackager, wholesaler, dispenser, or the Secretary, regarding such product; or</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="id6a7718b62d2941a48888525761cfb54f"><enum>(II)</enum><text display-inline="yes-display-inline">upon the determination that a product is a suspect product.</text> </subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id71e84be4990a43b8a21e6d7127c2ab84"><enum>(B)</enum><header display-inline="yes-display-inline">Limitation</header><text display-inline="yes-display-inline">Nothing in this paragraph shall require a wholesale distributor to verify product at the unit level except as required under clauses (iii) and (iv) of subparagraph (A).</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id465B8B04A0F043ED93AA94D30D1BFC1A"><enum>(3)</enum><header display-inline="yes-display-inline">Notification and product removal</header> <subparagraph commented="no" display-inline="no-display-inline" id="idACAACADEADD74942B1B5DCC058E5C1AA"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than 6<fraction>1/2</fraction> years after the date of enactment of the Securing Pharmaceutical Distribution Integrity Act of 2012 and in accordance with this section, a wholesale distributor, upon confirming that a product does not have the standardized numerical identifier or lot number, consistent with this section, and expiration date assigned by the manufacturer, or has the appearance of being a counterfeit, diverted, or stolen product, or a product otherwise unfit for distribution such that the product would result in serious adverse health consequences or death to humans, shall—</text> <clause commented="no" display-inline="no-display-inline" id="id0303cb84ccfd475191253d7133b7354e"><enum>(i)</enum><text display-inline="yes-display-inline">promptly notify the Secretary and impacted trading partners, as applicable and appropriate; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="id4027285f969a41fea1e0658220ae5ceb"><enum>(ii)</enum><text display-inline="yes-display-inline">take steps to remove such product from the pharmaceutical distribution supply chain.</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idc6d612aed06441cd81e8e61c11e799d6"><enum>(B)</enum><header display-inline="yes-display-inline">Redistribution</header><text display-inline="yes-display-inline">Any product subject to a notification under this subsection may not be redistributed as a saleable product unless the wholesaler, in consultation with the Secretary, and manufacturer or repackager as applicable, determines such product may reenter the pharmaceutical distribution supply chain.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idE6159F015CE944A98E8B6AE3AA83FE08"><enum>(C)</enum><header display-inline="yes-display-inline">Confidential data</header><text display-inline="yes-display-inline">A wholesale distributor may confidentially maintain RxTEC data for a direct trading partner and provide access to such information to such trading partner in lieu of data transmission, if mutually agreed upon by such trading partners.</text> </subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id827DF2B9CB20449791F2890232AD735F"><enum>(d)</enum><header display-inline="yes-display-inline">Dispenser requirements</header> <paragraph commented="no" display-inline="no-display-inline" id="idEEF67906D4574AB783953FFD27916427"><enum>(1)</enum><header display-inline="yes-display-inline">Product tracing requirements</header><text display-inline="yes-display-inline">A dispenser, not later than 7<fraction>1/2</fraction> years after the date of enactment of the Securing Pharmaceutical Distribution Integrity Act of 2012 and in accordance with this section, shall—</text> <subparagraph commented="no" display-inline="no-display-inline" id="idc9be6e0bf0c44e7aaa513e38f5329346"><enum>(A)</enum><text display-inline="yes-display-inline">receive product only from a licensed or registered manufacturer, repackager, or wholesale distributor;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id68f41d2f5b8a47c5b23dd4e0a23a040f"><enum>(B)</enum><text display-inline="yes-display-inline">receive only products encoded with RxTEC lot level data from a manufacturer, repackager, or wholesale distributor selling the drug product to the dispenser;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idbfb9414909a64fb5ac30657028181175"><enum>(C)</enum><text display-inline="yes-display-inline">maintain RxTEC lot level data or allow the wholesale distributor to confidentially maintain and store the RxTEC lot level data sufficient to identify the product provided to the dispenser from the immediate previous source where a change of ownership has occurred between non-affiliated entities (if such arrangement is mutually agreed upon by the dispenser and the wholesale distributor);</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id0874a0cddb2c4019a15c96fb7e6edbba"><enum>(D)</enum><text display-inline="yes-display-inline">use the RxTEC lot level data maintained by the dispenser or maintained by the wholesale distributor on behalf of the dispenser (if such arrangement is mutually agreed upon by the dispenser and the wholesale distributor), as necessary to respond to a request from the Secretary in the event of a suspect product or recall;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id1942da588b61420dbd35f1489769ea71"><enum>(E)</enum><text display-inline="yes-display-inline">maintain lot level data upon change of ownership between non-affiliated entities and for recalled product; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idd6c2d63ef77a4970a8141822c111602a"><enum>(F)</enum><text display-inline="yes-display-inline">for investigation purposes only, and upon request by the Secretary, other appropriate Federal official, or State official, for the purpose of investigating a suspect or recalled product, provide the RxTEC data by lot and the immediate previous source or immediate subsequent receipt of the suspect or recalled product, as applicable.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idA299CB0BB8C249B287AECBCAA810BDF6"><enum>(2)</enum><header display-inline="yes-display-inline">Verification requirements</header><text display-inline="yes-display-inline">Not later than 7<fraction>1/2</fraction> years after the date of enactment of the Securing Pharmaceutical Distribution Integrity Act of 2012 and in accordance with this section, a dispenser shall be required to conduct lot level verification of suspect product only.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id82A00C81F9AD45688D263E1EC0F58EA7"><enum>(3)</enum><header display-inline="yes-display-inline">Notification and product removal</header> <subparagraph commented="no" display-inline="no-display-inline" id="idEE086BCA93634B8BB664A8EB43E6D544"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than 7<fraction>1/2</fraction> years after the date of enactment of the Securing Pharmaceutical Distribution Integrity Act of 2012 and in accordance with this section, a dispenser, upon confirming that a product is a suspect product or a product otherwise unfit for distribution, shall—</text> <clause commented="no" display-inline="no-display-inline" id="id8a0bb580c28e4cccb3e0f4ab4acd1ad0"><enum>(i)</enum><text display-inline="yes-display-inline">promptly notify the Secretary and impacted trading partners, as applicable and appropriate; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="idb00ee2f8e23240cf8c0d8e5c5fe51f9b"><enum>(ii)</enum><text display-inline="yes-display-inline">take steps to remove such product from the pharmaceutical distribution supply chain.</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id3590da02189f4bb38df9484ec075a342"><enum>(B)</enum><header display-inline="yes-display-inline">Redistribution</header><text display-inline="yes-display-inline">Any product subject to a notification under this paragraph may not be redistributed as a saleable product unless the dispenser, in consultation with the Secretary, and manufacturer, repackager, or wholesaler as applicable, determines such product may reenter the pharmaceutical distribution supply chain.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idd7888e3f05d74bfe81f72243e1d593ea"><enum>(C)</enum><header display-inline="yes-display-inline">Limitations</header><text display-inline="yes-display-inline">Nothing in this section shall—</text> <clause commented="no" display-inline="no-display-inline" id="id6CC2CF5110DC4568A1842B3270275B72"><enum>(i)</enum><text display-inline="yes-display-inline">require a dispenser to verify product at the unit level; or</text> </clause><clause commented="no" display-inline="no-display-inline" id="id6cfc8d42e0a54cd0b416fd0f3d9c47ee"><enum>(ii)</enum><text display-inline="yes-display-inline">require a dispenser to adopt specific technologies or business systems for compliance with this section.</text> </clause></subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id347194eee21e478f81d2a856acb4d6c0"><enum>(e)</enum><header display-inline="yes-display-inline">Ensuring flexibility</header><text display-inline="yes-display-inline">The requirements under this section shall—</text> <paragraph commented="no" display-inline="no-display-inline" id="id58f6c4d94bad4c0894b5f172a4c91699"><enum>(1)</enum><text display-inline="yes-display-inline">require the maintenance and transmission only of information that is reasonably available and appropriate;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id8b30f7764fd54e7bb0de5b1315c1d3b8"><enum>(2)</enum><text display-inline="yes-display-inline">be based on current scientific and technological capabilities and shall neither require nor restrict the use of additional data carrier technologies;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idc4a76449083e49988158cb456547e3ef"><enum>(3)</enum><text display-inline="yes-display-inline">not prescribe or proscribe specific technologies or systems for the maintenance and transmission of data other than the standard data carrier for RxTEC or specific methods of verification;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id33be2567750447ca903d34e05960b79b"><enum>(4)</enum><text display-inline="yes-display-inline">not require a record of the complete previous distribution history of the drug from the point of origin of such drug;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id67e99add766e45458cf9ca2b7b92b7de"><enum>(5)</enum><text display-inline="yes-display-inline">take into consideration whether the public health benefits of imposing any additional regulations outweigh the cost of compliance with such requirements;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idfa683d617e344e34a4cd000ad7a84c4b"><enum>(6)</enum><text display-inline="yes-display-inline">be scale-appropriate and practicable for entities of varying sizes and capabilities;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id87c274b603ba400991998a4e8783dd59"><enum>(7)</enum><text display-inline="yes-display-inline">with respect to cost and recordkeeping burdens, not require the creation and maintenance of duplicative records where the information is contained in other company records kept in the normal course of business;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idFF262066A3E74CC89C6AF948C3D16901"><enum>(8)</enum><text display-inline="yes-display-inline">to the extent practicable, not require specific business systems for compliance with such requirements;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idC7C0110B8A3A43008B1D754A3ACD824F"><enum>(9)</enum><text display-inline="yes-display-inline">include a process by which the Secretary may issue a waiver of such regulations for an individual entity if the Secretary determines that such requirements would result in an economic hardship or for emergency medical reasons, including a public health emergency declaration pursuant to section 319 of the Public Health Service Act; and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="ide74427e12fe74d8682d41b2f507f5adb"><enum>(10)</enum><text display-inline="yes-display-inline">include a process by which the Secretary may determine exceptions to the standard data carrier RxTEC requirement if a drug is packaged in a container too small or otherwise unable to accommodate a label with sufficient space to bear the information required for compliance with this section.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id3f39c5e06cb04575b9f74bbad8db0b3a"><enum>(f)</enum><header display-inline="yes-display-inline">Regulations and guidance</header> <paragraph commented="no" display-inline="no-display-inline" id="idDB2E2D115A2442548165073983B283C9"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary may issue guidance consistent with this section regarding the circumstances surrounding suspect product and verification practices.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id2A7954C371484FEEB1270F78897F7D77"><enum>(2)</enum><header display-inline="yes-display-inline">Procedure</header><text display-inline="yes-display-inline">The Secretary, in promulgating any regulation pursuant to this section, shall—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id93BBF1E58DBD4CAE814AFBDD56B8097A"><enum>(A)</enum><text display-inline="yes-display-inline">issue a notice of proposed rulemaking that includes a copy of the proposed regulation;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id35F07F2C5F0947049F724C9BB2C2B86F"><enum>(B)</enum><text display-inline="yes-display-inline">provide a period of not less than 60 days for comments on the proposed regulation; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idF007721A95D844BEBC3130B736153D6B"><enum>(C)</enum><text display-inline="yes-display-inline">publish the final regulation not less than 30 days before the effective date of the regulation.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id185E861CAEE64B1BAD73DD4AD9719C55"><enum>(3)</enum><header display-inline="yes-display-inline">Restrictions</header><text display-inline="yes-display-inline">Notwithstanding any other provision of law, the Secretary shall promulgate regulations implementing this section only as described in paragraph (2).</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ide64a394cb9384adb95d6c460bf54355c"><enum>(g)</enum><header display-inline="yes-display-inline">Standards</header><text display-inline="yes-display-inline">The Secretary shall, in consultation with other appropriate Federal officials, manufacturers, repackagers, wholesale distributors, dispensers, and other supply chain stakeholders, prioritize and develop standards for the interoperable exchange of ownership and transaction information for tracking and tracing prescription drugs.</text> </subsection></section></subchapter><after-quoted-block>.</after-quoted-block></quoted-block> </subsection><subsection commented="no" display-inline="no-display-inline" id="idd5eb640187fe4e9d8fcd81de4d05aed1"><enum>(b)</enum><header display-inline="yes-display-inline">Prohibited Act</header><text display-inline="yes-display-inline">Section 301 (21 U.S.C. 331), as amended by section 712, is further amended by inserting at the end the following:</text> <quoted-block display-inline="no-display-inline" id="idC954373E92734AEDAB73F31C755782A4" style="OLC"> <subsection commented="no" display-inline="no-display-inline" id="idAF08CD4015D04035AD17EF775F4BEEE3"><enum>(bbb)</enum><text display-inline="yes-display-inline">The violation of any requirement under section 582.</text> </subsection><after-quoted-block>.</after-quoted-block></quoted-block> </subsection><subsection commented="no" display-inline="no-display-inline" id="id78a81d55c82d41e29a323e93ec96ddd8"><enum>(c)</enum><header display-inline="yes-display-inline">Small entity compliance guide</header><text display-inline="yes-display-inline">Not later than 180 days after enactment of this Act, the Secretary of Health and Human Services (referred to in this title as the <quote>Secretary</quote>) shall issue a compliance guide setting forth in plain language the requirements under section 582 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), in order to assist small entities in complying with such section.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="id16DB9BB80C0143E4B663B6F256B9C795"><enum>(d)</enum><header display-inline="yes-display-inline">Limitations</header> <paragraph commented="no" display-inline="no-display-inline" id="idEADB2000422540A39D56170CCD037F39"><enum>(1)</enum><header display-inline="yes-display-inline">Savings clause</header><text display-inline="yes-display-inline">Nothing in this subtitle or the amendments made by this subtitle shall preempt any State or local law or regulation.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idA5413333090A499BABE2115179CCFF6F"><enum>(2)</enum><header display-inline="yes-display-inline">Effect on California law</header><text display-inline="yes-display-inline">Notwithstanding any other provision of Federal or State law, including any provision of this subtitle or of subchapter H of chapter V of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), such subchapter H shall not trigger California Business and Professions Code, section 4034.1.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idC3CCF461527A4918A65C1FB546C04470"><enum>(3)</enum><header display-inline="yes-display-inline">Effective date</header><text display-inline="yes-display-inline">Subsection (c) and the amendments made by subsections (a) and (b) shall take effect on January 1, 2022, or on the date on which Congress enacts a law providing for express preemption of any State law regulating the distribution of drugs, whichever is later.</text> </paragraph></subsection></section><section id="id9770EB5F81B543B2B992E06620EC1F13"><enum>723.</enum><header>Independent assessment</header> <subsection id="id1465D8CD0A7B44D6843BCE5522DCCF8E"><enum>(a)</enum><header>In general</header><text>The Secretary shall contract with a private, independent consulting firm capable of performing the technical analysis, management assessment, and program evaluation tasks required to conduct a comprehensive assessment of the process for the review of drug applications under subsections (b) and (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b), (j)) and subsections (a) and (k) of section 351 of the Public Health Service Act (42 U.S.C. 262(a), (k)). The assessment shall address the premarket review process of drugs by the Food and Drug Administration, using an assessment framework that draws from appropriate quality system standards, including management responsibility, documents controls and records management, and corrective and preventive action.</text> </subsection><subsection id="id6D82FC653A844B3CB30338BF62F7CBE3"><enum>(b)</enum><header>Participation</header><text>Representatives of the Food and Drug Administration and manufacturers of drugs subject to user fees under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.) shall participate in a comprehensive assessment of the process for the review of drug applications under section 505 of the Federal Food, Drug, and Cosmetic Act and section 351 of the Public Health Service Act. The assessment shall be conducted in phases.</text> </subsection><subsection id="id5EB923B7C5B44688AAE698D2ADB4F475"><enum>(c)</enum><header>First contract</header><text>The Secretary shall award the contract for the first assessment under this section not later than March 31, 2013. Such contractor shall evaluate the implementation of recommendations and publish a written assessment not later than February 1, 2016.</text> </subsection><subsection id="id3EDFD24444894E85BCE30757B2F907FB"><enum>(d)</enum><header>Findings and recommendations</header> <paragraph id="id3D4D7DC3790A4F3BACE6C0749C05B25A"><enum>(1)</enum><header>In general</header><text>The Secretary shall publish the findings and recommendations under this section that are likely to have a significant impact on review times not later than 6 months after the contract is awarded. Final comprehensive findings and recommendations shall be published not later than 1 year after the contract is awarded.</text> </paragraph><paragraph id="idF17E5E9004884D349F023EC76F92A26A"><enum>(2)</enum><header>Implementation plan</header><text>The Food and Drug Administration shall publish an implementation plan not later than 6 months after the date of receipt of each set of recommendation.</text> </paragraph></subsection><subsection id="id487B5D5D449144F484A51339D0B9D2F9"><enum>(e)</enum><header>Scope of assessment</header><text>The assessment under this section shall include the following:</text> <paragraph id="id4E0231A048DC467AB0250DDA59AFE769"><enum>(1)</enum><text>Identification of process improvements and best practices for conducting predictable, efficient, and consistent premarket reviews that meet regulatory review standards.</text> </paragraph><paragraph id="idAC55930B9F764674BBFB51E31E7B7ADA"><enum>(2)</enum><text>Analysis of elements of the review process that consume or save time to facilitate a more efficient process. Such analysis shall include—</text> <subparagraph id="id94C9614D8E574E0DAF0F32088B035001"><enum>(A)</enum><text>consideration of root causes for inefficiencies that may affect review performance and total time to decision;</text> </subparagraph><subparagraph id="id725AA18C3A1F4817826CFAFEFC7700AC"><enum>(B)</enum><text>recommended actions to correct any failures to meet user fee program goals; and</text> </subparagraph><subparagraph id="id5E1580F977514149A35BC5AF6D313A53"><enum>(C)</enum><text>consideration of the impact of combination products on the review process.</text> </subparagraph></paragraph><paragraph id="id904E4CD203F74FB3869D148E92F56475"><enum>(3)</enum><text>Assessment of methods and controls of the Food and Drug Administration for collecting and reporting information on premarket review process resource use and performance.</text> </paragraph><paragraph id="id7FD2C6E016A543D6B595AD7A56A30F19"><enum>(4)</enum><text>Assessment of effectiveness of the reviewer training program of the Food and Drug Administration.</text> </paragraph><paragraph id="id45C909DBD6AA4E51AB28AA381C5AB118"><enum>(5)</enum><text>Recommendations for ongoing periodic assessments and any additional, more detailed or focused assessments.</text> </paragraph></subsection><subsection id="id1CAB1923833B4C56874B86C0A99FCB9F"><enum>(f)</enum><header>Requirements</header><text>The Secretary shall—</text> <paragraph id="id00CCF733BB394D1F80AE93817B1EFE77"><enum>(1)</enum><text>analyze the recommendations for improvement opportunities identified in the assessment, develop and implement a corrective action plan, and ensure it effectiveness;</text> </paragraph><paragraph id="id1B2A8F57D1984A8F9CD90BB127CFA97A"><enum>(2)</enum><text>incorporate the findings and recommendations of the contractors, as appropriate, into the management of the premarket review program of the Food and Drug Administration; and</text> </paragraph><paragraph id="idB63DEA8CF79A495A944A6AA37DE0B408"><enum>(3)</enum><text>incorporate the results of the assessment in a Good Review Management Practices guidance document, which shall include initial and ongoing training of Food and Drug Administration staff, and periodic audits of compliance with the guidance.</text> </paragraph></subsection></section></subtitle><enum>VIII</enum><header display-inline="yes-display-inline">Generating Antibiotic Incentives Now </header> <section commented="no" display-inline="no-display-inline" id="HC986BF0659A14F07A290324F4BACCDB5" section-type="subsequent-section"><enum>801.</enum><header display-inline="yes-display-inline">Extension of exclusivity period for drugs</header> <subsection commented="no" display-inline="no-display-inline" id="HA102724C96334802A8A78053102BB108"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Chapter V (21 U.S.C. 351 et seq.) is amended by inserting after section 505D the following:</text> <quoted-block display-inline="no-display-inline" id="H284DF96D9A8848C591E5E07F8377E82D" style="OLC"> <section commented="no" display-inline="no-display-inline" id="HABFAE1B4194C4518B6627042AF78AA7D" section-type="subsequent-section"><enum>505E.</enum><header display-inline="yes-display-inline">Extension of exclusivity period for new qualified infectious disease products</header> <subsection commented="no" display-inline="no-display-inline" id="HED04EE26C8D644DB99A825C196E6CDD0"><enum>(a)</enum><header display-inline="yes-display-inline">Extension</header><text display-inline="yes-display-inline">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.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="H37057B05A8144ED7B32C5B4E6BFDBE50"><enum>(b)</enum><header display-inline="yes-display-inline">Relation to pediatric exclusivity</header><text display-inline="yes-display-inline">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.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="H8CE65356987F4656B7AE357425B68FA0"><enum>(c)</enum><header display-inline="yes-display-inline">Limitations</header><text display-inline="yes-display-inline">Subsection (a) does not apply to the approval of—</text> <paragraph commented="no" display-inline="no-display-inline" id="HAC4AF468A900415B8B8CD4F378F049A3"><enum>(1)</enum><text display-inline="yes-display-inline">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;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="H5D79D3C3273B4E998BAE22A26BA4A58D"><enum>(2)</enum><text display-inline="yes-display-inline">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</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id540904D3F4E74EF5860CC781203EED0D"><enum>(3)</enum><text display-inline="yes-display-inline">an application for a product that is not approved for the use for which it received a designation under subsection (d).</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HBE3CBF2896164C38AF49C8476D5CB400"><enum>(d)</enum><header display-inline="yes-display-inline">Designation</header> <paragraph commented="no" display-inline="no-display-inline" id="id57407AB4650042A385664080D07567B4"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idFC10E49BAC964CCB980904B4AA9F6AC7"><enum>(2)</enum><header display-inline="yes-display-inline">Limitation</header><text display-inline="yes-display-inline">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).</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idBDB75ABE44964A5485F14AA61CB5D0B7"><enum>(3)</enum><header display-inline="yes-display-inline">Revocation of designation</header><text display-inline="yes-display-inline">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.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HD1A24DDF73604F0998365FB5D4D59852"><enum>(e)</enum><header display-inline="yes-display-inline">Regulations</header> <paragraph commented="no" display-inline="no-display-inline" id="id09A9450C9FC1460081673D41E094D6DC"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than 2 years after the date of enactment of the <short-title>Food and Drug Administration Safety and Innovation Act</short-title>, the Secretary shall adopt final regulations implementing this section.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id06EDA4BBF75F460E945B3A53A9405348"><enum>(2)</enum><header display-inline="yes-display-inline">Procedure</header><text display-inline="yes-display-inline">In promulgating a regulation implementing this section, the Secretary shall—</text> <subparagraph commented="no" display-inline="no-display-inline" id="iddacc561555a2461cbd0d109ad8a2587c"><enum>(A)</enum><text display-inline="yes-display-inline">issue a notice of proposed rulemaking that includes the proposed regulation;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id09a9988be2d74bbdac21221fff1c4565"><enum>(B)</enum><text display-inline="yes-display-inline">provide a period of not less than 60 days for comments on the proposed regulation; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id1f8f9739e75d4da19c4314223c6657e4"><enum>(C)</enum><text display-inline="yes-display-inline">publish the final regulation not less than 30 days before the effective date of the regulation.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id3B8692D95296471C92772EE892E638FB"><enum>(3)</enum><header display-inline="yes-display-inline">Restrictions</header><text display-inline="yes-display-inline">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.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idE70223B9EE9F4150A749F8214AC3AC93"><enum>(4)</enum><header display-inline="yes-display-inline">Designation prior to regulations</header><text display-inline="yes-display-inline">The Secretary may designate drugs as qualified infectious disease products under subsection (d) prior to the promulgation of regulations under this subsection.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H84A1621F08E54C07AF9CAFF0D0B76763"><enum>(f)</enum><header display-inline="yes-display-inline">Qualifying pathogen</header> <paragraph commented="no" display-inline="no-display-inline" id="id3847cd585d8c42a6ba23e61448d53031"><enum>(1)</enum><header display-inline="yes-display-inline">Definition</header><text display-inline="yes-display-inline">In this section, the term <term>qualifying pathogen</term> 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—</text> <subparagraph commented="no" display-inline="no-display-inline" id="idccc047896dca4ba495c434bcdbe1397e"><enum>(A)</enum><text display-inline="yes-display-inline">resistant gram positive pathogens, including methicillin-resistant Staphylococcus aureus, vancomycin-resistant Staphylococcus aureus, and vancomycin-resistant enterococcus;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id164D910AF6574E6DBD01E6B3FC1133CF"><enum>(B)</enum><text display-inline="yes-display-inline">multi-drug resistant gram negative bacteria, including Acinetobacter, Klebsiella, Pseudomonas, and E. coli species;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id3568E4C10E4C49159DF90162915E49C5"><enum>(C)</enum><text display-inline="yes-display-inline">multi-drug resistant tuberculosis; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idac4c62a8b3054073b48bd7b5586ae126"><enum>(D)</enum><text display-inline="yes-display-inline">Clostridium difficile.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id0766311a84fc4f67817a8020b298d3b7"><enum>(2)</enum><header display-inline="yes-display-inline">List of qualifying pathogens</header> <subparagraph commented="no" display-inline="no-display-inline" id="id2CA4D853332B4EFC9D7A3515DF26E270"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary shall establish and maintain a list of qualifying pathogens, and shall make public the methodology for developing such list.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id789970BED3604EC6B69466A47DD1CCDB"><enum>(B)</enum><header display-inline="yes-display-inline">Considerations</header><text display-inline="yes-display-inline">In establishing and maintaining the list of pathogens described under this section the Secretary shall—</text> <clause commented="no" display-inline="no-display-inline" id="id070794be2e424df2883c5517b5397f13"><enum>(i)</enum><text display-inline="yes-display-inline">consider—</text> <subclause commented="no" display-inline="no-display-inline" id="id909bd2b0d9174ba0a0e2d902d4f85c3e"><enum>(I)</enum><text display-inline="yes-display-inline">the impact on the public health due to drug-resistant organisms in humans;</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="idb01d6ff7f48943159d2b8cd7ed5f75fe"><enum>(II)</enum><text display-inline="yes-display-inline">the rate of growth of drug-resistant organisms in humans;</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="id105a0bd9765f433595776eb8c9e34fc0"><enum>(III)</enum><text display-inline="yes-display-inline">the increase in resistance rates in humans; and</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="idc18cb0f7c8b744fa877405f6a57011f6"><enum>(IV)</enum><text display-inline="yes-display-inline">the morbidity and mortality in humans; and</text> </subclause></clause><clause commented="no" display-inline="no-display-inline" id="id5a9da34c349b418abe76abe613bff599"><enum>(ii)</enum><text display-inline="yes-display-inline">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.</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id9ef5b67a22924b7f9d5a39593da6ac25"><enum>(C)</enum><header display-inline="yes-display-inline">Review</header><text display-inline="yes-display-inline">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).</text> </subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id9F4048AACE5A4A2CA41917CEF5B091DA"><enum>(g)</enum><header display-inline="yes-display-inline">Qualified infectious disease product</header><text display-inline="yes-display-inline">The term <term>qualified infectious disease product</term> means an antibacterial or antifungal drug for human use intended to treat serious or life-threatening infections, including those caused by—</text> <paragraph commented="no" display-inline="no-display-inline" id="id7917C3A0C9CD4707A540A91B4BC01CDC"><enum>(1)</enum><text display-inline="yes-display-inline">an antibacterial or antifungal resistant pathogen, including novel or emerging infectious pathogens; or</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idFDC26827C5A2417580496CFDF0EAFD76"><enum>(2)</enum><text display-inline="yes-display-inline">qualifying pathogens listed by the Secretary under subsection (f).</text> </paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block> </subsection><subsection commented="no" display-inline="no-display-inline" id="H6786C7D1DFEF4A9EB1A3C585DD80FC73"><enum>(b)</enum><header display-inline="yes-display-inline">Application</header><text display-inline="yes-display-inline">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.</text> </subsection></section><section commented="no" display-inline="no-display-inline" id="HA97B0566708B44E4BA403E2562E038A0" section-type="subsequent-section"><enum>802.</enum><header display-inline="yes-display-inline">Priority review</header> <subsection commented="no" display-inline="no-display-inline" id="H1B13A240DC3A461FBD7C4636397EDDF1"><enum>(a)</enum><header display-inline="yes-display-inline">Amendment</header><text display-inline="yes-display-inline">Chapter V (21 U.S.C. 351 et seq.) is amended by inserting after section 524 the following:</text> <quoted-block display-inline="no-display-inline" id="H415A857D92D1484AA98322EB2052CCBA" style="OLC"> <section commented="no" display-inline="no-display-inline" id="HC1C9F3B79C44460AB6A04143DDEA57F9" section-type="subsequent-section"><enum>524A.</enum><header display-inline="yes-display-inline">Priority review for qualified infectious disease products</header> <subsection commented="no" display-inline="no-display-inline" id="HC7718EE06353449B8E81B55337049781"><enum></enum><text display-inline="yes-display-inline">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).</text> </subsection></section><after-quoted-block>.</after-quoted-block></quoted-block> </subsection><subsection commented="no" display-inline="no-display-inline" id="HFA0CF6A2DB8D441D933EACECEED54E4C"><enum>(b)</enum><header display-inline="yes-display-inline">Application</header><text display-inline="yes-display-inline">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.</text> </subsection></section><section commented="no" display-inline="no-display-inline" id="HFA79EA0D5532414A852F0A7D7B277E1B" section-type="subsequent-section"><enum>803.</enum><header display-inline="yes-display-inline">Fast track product</header><text display-inline="no-display-inline">Section 506(a)(1) (21 U.S.C. 356(a)(1)), as amended by section 901(b), is amended by inserting <quote>, or if the Secretary designates the drug as a qualified infectious disease product under section 505E(d)</quote> before the period at the end of the first sentence.</text> </section><section commented="no" display-inline="no-display-inline" id="H8EBCA8724AF64CA0B676BA002F70E74B" section-type="subsequent-section"><enum>804.</enum><header display-inline="yes-display-inline">GAO study</header> <subsection commented="no" display-inline="no-display-inline" id="H161D17275D004ACBB3ABD95A17DF0EB3"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Comptroller General of the United States shall—</text> <paragraph commented="no" display-inline="no-display-inline" id="HE96F3F6EDFE8496795141735D2EB0FA3"><enum>(1)</enum><text display-inline="yes-display-inline">conduct a study—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id6FE1168261F04DCA9022E6E0711FC3DA"><enum>(A)</enum><text display-inline="yes-display-inline">on the need for, and public health impact of, incentives to encourage the research, development, and marketing of qualified infectious disease biological products and antifungal products; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id7E716510332C44ED93D6071D71D13C76"><enum>(B)</enum><text display-inline="yes-display-inline">consistent with trade and confidentiality data protections, assessing, for all antibacterial and antifungal drugs, including biological products, the average or aggregate—</text> <clause commented="no" display-inline="no-display-inline" id="idA5975858040C4442BBD0F81EC2B5427D"><enum>(i)</enum><text display-inline="yes-display-inline">costs of all clinical trials for each phase;</text> </clause><clause commented="no" display-inline="no-display-inline" id="id8418223FD3AB4CD683E9F7217525DB49"><enum>(ii)</enum><text display-inline="yes-display-inline">percentage of success or failure at each phase of clinical trials; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="id9BCCBCE70D3E4FB2B847D534E986D0CA"><enum>(iii)</enum><text display-inline="yes-display-inline">public versus private funding levels of the trials for each phase; and</text> </clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H2778D9C1BC294F518B92645E05E8BB22"><enum>(2)</enum><text display-inline="yes-display-inline">not later than 1 year after the date of enactment of this Act, submit a report to Congress on the results of such study, including any recommendations of the Comptroller General on appropriate incentives for addressing such need.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idFD131C8567124E6BAFD22BA679BEE4C4"><enum>(b)</enum><header display-inline="yes-display-inline">Contents</header><text display-inline="yes-display-inline">The part of the study described in subsection (a)(1)(A) shall include—</text> <paragraph commented="no" display-inline="no-display-inline" id="id63C962F4AC2F462DABBC6D9E186C8901"><enum>(1)</enum><text display-inline="yes-display-inline">an assessment of any underlying regulatory issues related to qualified infectious disease products, including qualified infectious disease biological products;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id60B46C9FF3924A768CD1365269BD144D"><enum>(2)</enum><text display-inline="yes-display-inline">an assessment of the management by the Food and Drug Administration of the review of qualified infectious disease products, including qualified infectious disease biological products and the regulatory certainty of related regulatory pathways for such products;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id81B65DEBA56A43D48AF31237C0010537"><enum>(3)</enum><text display-inline="yes-display-inline">a description of any regulatory impediments to the clinical development of new qualified infectious disease products, including qualified infectious disease biological products, and the efforts of the Food and Drug Administration to address such impediments; and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id1AAC63529AE24984B60A912F6FD02ED0"><enum>(4)</enum><text display-inline="yes-display-inline">recommendations with respect to—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id49FA6E7AFD1D4505A8F26BC6EAFBE146"><enum>(A)</enum><text display-inline="yes-display-inline">improving the review and predictability of regulatory pathways for such products; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idD2140B51B5A64808B8807701C647FC94"><enum>(B)</enum><text display-inline="yes-display-inline">overcoming any regulatory impediments identified in paragraph (3).</text> </subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H0E584B3AC17146C096EDD1F97A954BCF"><enum>(c)</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="yes-display-inline">In this section:</text> <paragraph commented="no" display-inline="no-display-inline" id="H735B1BCEC5A14F54AAED608FA62DCD60"><enum>(1)</enum><text display-inline="yes-display-inline">The term <term>biological product</term> has the meaning given to such term in section 351 of the Public Health Service Act (42 U.S.C. 262).</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idE01D81B326BA4D4A8DA1164D4CEF026E"><enum>(2)</enum><text display-inline="yes-display-inline">The term <term>qualified infectious disease biological product</term> means a biological product intended to treat a serious or life-threatening infection described in section 505E(g) of the Federal Food, Drug, and Cosmetic Act, as added by section 801.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="H596F1E4EEB504D8DB988A133E5747F12"><enum>(3)</enum><text display-inline="yes-display-inline">The term <term>qualified infectious disease product</term> has the meaning given such term in section 505E(g) of the Federal Food, Drug, and Cosmetic Act, as added by section 801.</text> </paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="H152795DE48754C8D8AC778BCEFFF17E6" section-type="subsequent-section"><enum>805.</enum><header display-inline="yes-display-inline">Clinical trials</header> <subsection commented="no" display-inline="no-display-inline" id="H5EC8E1789F48498187A2364FAF51F88E"><enum>(a)</enum><header display-inline="yes-display-inline">Review and revision of guidance documents</header> <paragraph commented="no" display-inline="no-display-inline" id="H01CF879027BC451BBAD0F079842F3A92"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services (referred to in this section as the <quote>Secretary</quote>) shall review and, as appropriate, revise not fewer than 3 guidance documents per year, which shall include—</text> <subparagraph commented="no" display-inline="no-display-inline" id="H611C9E252564497E8C24D71666334764"><enum>(A)</enum><text display-inline="yes-display-inline">reviewing the guidance documents of the Food and Drug Administration for the conduct of clinical trials with respect to antibacterial and antifungal drugs; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H6FEAE7AF78E649B7A6AAE8E8BDFD3E59"><enum>(B)</enum><text display-inline="yes-display-inline">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.).</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H558347E1B6D44E16BCD7419BC9867CDA"><enum>(2)</enum><header display-inline="yes-display-inline">Issues for review</header><text display-inline="yes-display-inline">At a minimum, the review under paragraph (1) shall address the appropriate animal models of infection, in vitro techniques, valid micro-biological surrogate markers, the use of non-inferiority versus superiority trials, trial enrollment, data requirements, and appropriate delta values for non-inferiority trials.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="HECE3B52526E5486E96FA8760683AF4D7"><enum>(3)</enum><header display-inline="yes-display-inline">Rule of construction</header><text display-inline="yes-display-inline">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.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H1CF6958BB23342B982CC6ECB34AC66F7"><enum>(b)</enum><header display-inline="yes-display-inline">Recommendations for investigations</header> <paragraph commented="no" display-inline="no-display-inline" id="H7FFACA4710B342B6A6105D7F3DED825A"><enum>(1)</enum><header display-inline="yes-display-inline">Request</header><text display-inline="yes-display-inline">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.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="HB9EA5750403942C4A335C632C2A9DCCA"><enum>(2)</enum><header display-inline="yes-display-inline">Recommendations</header><text display-inline="yes-display-inline">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).</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H917C78DAF1424072B1FACE9EE65825B4"><enum>(c)</enum><header display-inline="yes-display-inline">GAO study</header><text display-inline="yes-display-inline">Not later than January 1, 2016, the Comptroller General of the United States shall submit to Congress a report—</text> <paragraph commented="no" display-inline="no-display-inline" id="id36e33c1b7e764c8eaa262a3db090383c"><enum>(1)</enum><text display-inline="yes-display-inline">regarding the review and revision of the clinical trial guidance documents required under subsection (a) and the impact such review and revision has had on the review and approval of qualified infectious disease products;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="ida3f255ffb86a48d69d9c10b141ac86d7"><enum>(2)</enum><text display-inline="yes-display-inline">assessing—</text> <subparagraph commented="no" display-inline="no-display-inline" id="idF7D335300A894545B6AFA4B170EAC4F7"><enum>(A)</enum><text display-inline="yes-display-inline">the effectiveness of the results-oriented metrics managers employ to ensure that reviewers of such products are familiar with, and consistently applying, clinical trial guidance documents; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id713F3167631C455082F01451206830DC"><enum>(B)</enum><text display-inline="yes-display-inline">the predictability of related regulatory pathways and review;</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id96ae5d9beddd4dd7bd0ec97d41f38de8"><enum>(3)</enum><text display-inline="yes-display-inline">identifying any outstanding regulatory impediments to the clinical development of qualified infectious disease products;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id50369e7bcf7f4ed199c46c9e5cb077c9"><enum>(4)</enum><text display-inline="yes-display-inline">reporting on the progress the Food and Drug Administration has made in addressing the impediments identified under paragraph (3); and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id4b073858a254496eaf8fded40d55ecd5"><enum>(5)</enum><text display-inline="yes-display-inline">containing recommendations regarding how to improve the review of, and regulatory pathway for, such products.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id44B02AD9EF4745A48ABBE9FBF404FCD8"><enum>(d)</enum><header display-inline="yes-display-inline">Qualified infectious disease product</header><text display-inline="yes-display-inline">For purposes of this section, the term <term>qualified infectious disease product</term> has the meaning given such term in section 505E(g) of the Federal Food, Drug, and Cosmetic Act, as added by section 801.</text> </subsection></section><section commented="no" display-inline="no-display-inline" id="idD340067CCDDF4AF59A9C022A8F5A5A98" section-type="subsequent-section"><enum>806.</enum><header display-inline="yes-display-inline">Regulatory certainty and predictability</header> <subsection commented="no" display-inline="no-display-inline" id="id4AC3FD1D844D4F16B30D52CFA4D0FBAF"><enum>(a)</enum><header display-inline="yes-display-inline">Initial strategy and implementation plan</header><text display-inline="yes-display-inline">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 <quote>Secretary</quote>) shall submit to Congress a strategy and implementation plan with respect to the requirements of this Act. The strategy and implementation plan shall include—</text> <paragraph commented="no" display-inline="no-display-inline" id="idf4bd0999d2e94563b4288c924ecb9d78"><enum>(1)</enum><text display-inline="yes-display-inline">a description of the regulatory challenges to clinical development, approval, and licensure of qualified infectious disease products;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id7796247116384b63ab4d4c55dcd3bb67"><enum>(2)</enum><text display-inline="yes-display-inline">the regulatory and scientific priorities of the Secretary with respect to such challenges; and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id5ec22d0877164dd08e644b883cb955fe"><enum>(3)</enum><text display-inline="yes-display-inline">the steps the Secretary will take to ensure regulatory certainty and predictability with respect to qualified infectious disease products, including steps the Secretary will take to ensure managers and reviewers are familiar with related regulatory pathways, requirements of the Food and Drug Administration, guidance documents related to such products, and applying such requirements consistently.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id1d4ff48d2c474dcab41deb4c2a20515b"><enum>(b)</enum><header display-inline="yes-display-inline">Subsequent report</header><text display-inline="yes-display-inline">Not later than 3 years after the date of enactment of this Act, the Secretary shall submit to Congress a report on—</text> <paragraph commented="no" display-inline="no-display-inline" id="idfbb9f36c8ec549ca8c3cde5edcbdd166"><enum>(1)</enum><text display-inline="yes-display-inline">the progress made toward the priorities identified under subsection (a)(2);</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id46b9e9825beb4ba98be1f2a0f91820e9"><enum>(2)</enum><text display-inline="yes-display-inline">the number of qualified infectious disease products that have been submitted for approval or licensure on or after the date of enactment of this Act;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id4dcc1a7c2a0d4bacb939c343b7e303fc"><enum>(3)</enum><text display-inline="yes-display-inline">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));</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idf66a1b6d16414f7f8919eac8ced794cc"><enum>(4)</enum><text display-inline="yes-display-inline">the number of such qualified infectious disease products and that have been approved or licensed on or after the date of enactment of this Act; and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="ida8724dcc287c48468ef5f0100db8e1b3"><enum>(5)</enum><text display-inline="yes-display-inline">the number of calendar days it took for the approval or licensure of the qualified infectious disease products approved or licensed on or after the date of enactment of this Act.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idC790550915A842B5AE99CEB818CDCFA9"><enum>(c)</enum><header display-inline="yes-display-inline">Qualified infectious disease product</header><text display-inline="yes-display-inline">For purposes of this section, the term <term>qualified infectious disease product</term> has the meaning given such term in section 505E(g) of the Federal Food, Drug, and Cosmetic Act, as added by section 801.</text> </subsection></section><enum>IX</enum><header display-inline="yes-display-inline">Drug approval and patient access</header> <section commented="no" display-inline="no-display-inline" id="id546198B563BF47D1803CC3D2A9B0FED3" section-type="subsequent-section"><enum>901.</enum><header display-inline="yes-display-inline">Enhancement of accelerated patient access to new medical treatments</header> <subsection commented="no" display-inline="no-display-inline" id="id25E9603603DE4CACAEB2E594A613BCA9"><enum>(a)</enum><header display-inline="yes-display-inline">Findings; Sense of Congress</header> <paragraph commented="no" display-inline="no-display-inline" id="id4B9E699945E34E9CAAB0042B80E471D9"><enum>(1)</enum><header display-inline="yes-display-inline">Findings</header><text display-inline="yes-display-inline">Congress finds as follows:</text> <subparagraph commented="no" display-inline="no-display-inline" id="ID8b06ecf8a5774ac59cfcd19f56f1a8ae"><enum>(A)</enum><text display-inline="yes-display-inline">The Food and Drug Administration (referred to in this section as the <quote>FDA</quote>) 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.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDd843aa53e7ba4edda26a80c67ae94c45"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID199d3f8ab85a43f5a45518d954b4a3f1"><enum>(C)</enum><text display-inline="yes-display-inline">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.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID4850b263b89f4f2f8a360b984a0b1d3e"><enum>(D)</enum><text display-inline="yes-display-inline">Patients benefit from expedited access to safe and effective innovative therapies to treat unmet medical needs for serious or life-threatening diseases or conditions.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID2947b9b1ebfa4c33afb4990a2c947a9a"><enum>(E)</enum><text display-inline="yes-display-inline">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.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idC9302FD150D8445E8301FDF81D9B959C"><enum>(2)</enum><header display-inline="yes-display-inline">Sense of Congress</header><text display-inline="yes-display-inline">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.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idC6652EFA71744A3EA9D88092F22D1C63"><enum>(b)</enum><header display-inline="yes-display-inline">Expedited approval of drugs for serious or life-Threatening diseases or conditions</header><text display-inline="yes-display-inline">Section 506 (21 U.S.C. 356) is amended to read as follows:</text> <quoted-block display-inline="no-display-inline" id="idE67B2E2906EC427E95DAA35C0BDD02C2" style="OLC"> <section commented="no" display-inline="no-display-inline" id="idCD9480451A254EDFB8CBE652D84620F6" section-type="subsequent-section"><enum>506.</enum><header display-inline="yes-display-inline">Expedited approval of drugs for serious or life-threatening diseases or conditions</header> <subsection commented="no" display-inline="no-display-inline" id="idC237C07D608E44D78E0E43773923825E"><enum>(a)</enum><header display-inline="yes-display-inline">Designation of drug as fast track product</header> <paragraph commented="no" display-inline="no-display-inline" id="id749DD557C2DB4B7B890103BCF8ED7B21"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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 <quote>fast track product</quote>.)</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDf252eb570dd74afb9810887ccbf242e3"><enum>(2)</enum><header display-inline="yes-display-inline">Request for designation</header><text display-inline="yes-display-inline">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.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID984b3cfcc9a041e0bb19415ad1bf2091"><enum>(3)</enum><header display-inline="yes-display-inline">Designation</header><text display-inline="yes-display-inline">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.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idBC75AD2A1F9E406DA9078D543BEDF21B"><enum>(b)</enum><header display-inline="yes-display-inline">Accelerated approval of a drug for a serious or life-Threatening disease or condition, including a fast track product</header> <paragraph commented="no" display-inline="no-display-inline" id="idA46FCF2291414A6D85D37080D1E9A3A6"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header> <subparagraph commented="no" display-inline="no-display-inline" id="id23F084F0ABEF4403814AB093A37E4ED3"><enum>(A)</enum><header display-inline="yes-display-inline">Accelerated approval</header><text display-inline="yes-display-inline">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 <quote>accelerated approval</quote>.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idA8B820E670D841389899F9A56E6672A9"><enum>(B)</enum><header display-inline="yes-display-inline">Evidence</header><text display-inline="yes-display-inline">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.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idDE597B668F7446A2B14A24F826F39438"><enum>(2)</enum><header display-inline="yes-display-inline">Limitation</header><text display-inline="yes-display-inline">Approval of a product under this subsection may be subject to 1 or both of the following requirements:</text> <subparagraph commented="no" display-inline="no-display-inline" id="IDd8850ce52e634ad0af4a57d4d19d3fa5"><enum>(A)</enum><text display-inline="yes-display-inline">That the sponsor conduct appropriate post-approval studies to verify and describe the predicted effect on irreversible morbidity or mortality or other clinical benefit.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDe45f3d51fd784e50af6d98f3c6bdd99e"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id3CFC9F47B55B407A9CA5ED497B17B0DD"><enum>(3)</enum><header display-inline="yes-display-inline">Expedited withdrawal of approval</header><text display-inline="yes-display-inline">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—</text> <subparagraph commented="no" display-inline="no-display-inline" id="IDad1fc860e0e54f699ceccfa9e5ab8f8a"><enum>(A)</enum><text display-inline="yes-display-inline">the sponsor fails to conduct any required post-approval study of the drug with due diligence;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID48f0fed8277c455c9eafab4f348324df"><enum>(B)</enum><text display-inline="yes-display-inline">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;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID4ec84decfa244aee8acf742d852e3103"><enum>(C)</enum><text display-inline="yes-display-inline">other evidence demonstrates that the product is not safe or effective under the conditions of use; or</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID9aeb9e5e7609431892feabf2d474a9b0"><enum>(D)</enum><text display-inline="yes-display-inline">the sponsor disseminates false or misleading promotional materials with respect to the product.</text> </subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id12E4475CBBC84C95912559D39BB01D10"><enum>(c)</enum><header display-inline="yes-display-inline">Review of incomplete applications for approval of a fast track product</header> <paragraph commented="no" display-inline="no-display-inline" id="idC6B33E0CD60B48B29D620F7D3787C578"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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—</text> <subparagraph commented="no" display-inline="no-display-inline" id="ID4b120e782844458da9476bcbf6031e7b"><enum>(A)</enum><text display-inline="yes-display-inline">provides a schedule for submission of information necessary to make the application complete; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID55a23a2dc83648bfb56642fa64b751fa"><enum>(B)</enum><text display-inline="yes-display-inline">pays any fee that may be required under section 736.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id713103005A534B68885BF7F2BC66BE41"><enum>(2)</enum><header display-inline="yes-display-inline">Exception</header><text display-inline="yes-display-inline">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.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idBD5779746B61422A9C4BEE6B8F74F142"><enum>(d)</enum><header display-inline="yes-display-inline">Awareness efforts</header><text display-inline="yes-display-inline">The Secretary shall—</text> <paragraph commented="no" display-inline="no-display-inline" id="IDa5dccd99fdd84f84a21480e7576509b5"><enum>(1)</enum><text display-inline="yes-display-inline">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</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDe04a5d3e0cad4c12a48641824866f5f6"><enum>(2)</enum><text display-inline="yes-display-inline">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.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idD71ECE9ABBD14F0180220B05C29400B7"><enum>(e)</enum><header display-inline="yes-display-inline">Construction</header> <paragraph commented="no" display-inline="no-display-inline" id="id37D1BEEB1CA24DC395B7A2F58AF78CC1"><enum>(1)</enum><header display-inline="yes-display-inline">Purpose</header><text display-inline="yes-display-inline">The amendments made by the <short-title>Food and Drug Administration Safety and Innovation Act</short-title> 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.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idA69135F40E2E45A68742132E40D9F0CD"><enum>(2)</enum><header display-inline="yes-display-inline">Construction</header><text display-inline="yes-display-inline">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).</text> </paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block> </subsection><subsection commented="no" display-inline="no-display-inline" id="id25A4D91E395D4209A68BFD6190913254"><enum>(c)</enum><header display-inline="yes-display-inline">Guidance; amended regulations</header> <paragraph commented="no" display-inline="no-display-inline" id="id2250DB4AE0AF47AEBCF8731553671A96"><enum>(1)</enum><header display-inline="yes-display-inline">Draft guidance</header><text display-inline="yes-display-inline">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 <quote>Secretary</quote>) 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.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id9CCEAAAE524C48D196D3C169F4F54A61"><enum>(2)</enum><header display-inline="yes-display-inline">Final guidance</header><text display-inline="yes-display-inline">Not later than 1 year after the issuance of draft guidance under paragraph (1), and after an opportunity for public comment, the Secretary shall issue final guidance.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idFA31A8BEAD714D879F0C220F8A49D73D"><enum>(3)</enum><header display-inline="yes-display-inline">Conforming changes</header><text display-inline="yes-display-inline">The Secretary shall issue, as necessary, conforming amendments to the applicable regulations under title 21, Code of Federal Regulations, governing accelerated approval.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idB9E73ABCAD644931BB611AA463E1ABE6"><enum>(4)</enum><header display-inline="yes-display-inline">No effect of inaction on requests</header><text display-inline="yes-display-inline">If the Secretary fails to issue final guidance or amended regulations as required by this subsection, such failure shall not preclude the review of, or action on, a request for designation or an application for approval submitted pursuant to section 506 of the Federal Food, Drug, and Cosmetic Act, as amended by subsection (b).</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id39AC1403DD044667AF7C5F60166165A8"><enum>(d)</enum><header display-inline="yes-display-inline">Independent review</header><text display-inline="yes-display-inline">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.</text> </subsection></section><section commented="no" display-inline="no-display-inline" id="idE187C1928F134846B1ABD8555A341E6A" section-type="subsequent-section"><enum>902.</enum><header display-inline="yes-display-inline">Breakthrough therapies</header> <subsection commented="no" display-inline="no-display-inline" id="idA4D892C3347C44219BF32B091A8B2D5D"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 506 (21 U.S.C. 356), as amended by section 901, is further amended—</text> <paragraph commented="no" display-inline="no-display-inline" id="id3393ED8FE8634D19816A634166DAC350"><enum>(1)</enum><text display-inline="yes-display-inline">by redesignating subsections (a) through (c) as subsections (b) through (d), respectively;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id190517AA791F469DA954FD55F5C674FE"><enum>(2)</enum><text display-inline="yes-display-inline">by redesignating subsection (d) as subsection (f);</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idB6B28E719AC54BF6804362BA2AC44CFA"><enum>(3)</enum><text display-inline="yes-display-inline">by inserting before subsection (b), as so redesignated, the following:</text> <quoted-block display-inline="no-display-inline" id="id61E905894AC5441D8C94A2A160343AEE" style="OLC"> <subsection commented="no" display-inline="no-display-inline" id="idA5F5BACD6B8F4B85B19CC4FF42C05CF5"><enum>(a)</enum><header display-inline="yes-display-inline">Designation of a drug as a breakthrough therapy</header> <paragraph commented="no" display-inline="no-display-inline" id="idD3F30C5C5E72488FB3212A88A358310C"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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 <term>breakthrough therapy</term>.)</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idD046823B9B534C82A17315CE5D645A1A"><enum>(2)</enum><header display-inline="yes-display-inline">Request for designation</header><text display-inline="yes-display-inline">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.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idA06862D5BE714EA2BC74CA38C94B79D2"><enum>(3)</enum><header display-inline="yes-display-inline">Designation</header> <subparagraph commented="no" display-inline="no-display-inline" id="id74AB210DAA594D9D9A4B43DB43EDAE5B"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than 60 calendar days after the receipt of a request under paragraph (2), the Secretary shall determine whether the drug that is the subject of the request meets the criteria described in paragraph (1). If the Secretary finds that the drug meets the criteria, the Secretary shall designate the drug as a breakthrough therapy and shall take such actions as are appropriate to expedite the development and review of the application for approval of such drug.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idEDB4A3E3FE284CDD99B59557531FD2B6"><enum>(B)</enum><header display-inline="yes-display-inline">Actions</header><text display-inline="yes-display-inline">The actions to expedite the development and review of an application under subparagraph (A) may include, as appropriate—</text> <clause commented="no" display-inline="no-display-inline" id="id9624A0946B8C49BCA383E085D749F489"><enum>(i)</enum><text display-inline="yes-display-inline">holding meetings with the sponsor and the review team throughout the development of the drug;</text> </clause><clause commented="no" display-inline="no-display-inline" id="id55b9a49b44664b29ba694cfac0e9d270"><enum>(ii)</enum><text display-inline="yes-display-inline">providing timely advice to, and interactive communication with, the sponsor regarding the development of the drug to ensure that the development program to gather the non-clinical and clinical data necessary for approval is as efficient as practicable;</text> </clause><clause commented="no" display-inline="no-display-inline" id="id559f1ae57b4b447db254fc80d56855f0"><enum>(iii)</enum><text display-inline="yes-display-inline">involving senior managers and experienced review staff, as appropriate, in a collaborative, cross-disciplinary review;</text> </clause><clause commented="no" display-inline="no-display-inline" id="ide27b7187dbe84fe9ac841fa2945487ce"><enum>(iv)</enum><text display-inline="yes-display-inline">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</text> </clause><clause commented="no" display-inline="no-display-inline" id="id2d874e6ea7cb4475861fb34742b8dfda"><enum>(v)</enum><text display-inline="yes-display-inline">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.</text> </clause></subparagraph></paragraph></subsection><after-quoted-block>;</after-quoted-block></quoted-block> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idC9A7E05772474E91AD149BAFF7C08DD5"><enum>(4)</enum><text display-inline="yes-display-inline">in subsection (f)(1), as so redesignated, by striking <quote>applicable to accelerated approval</quote> and inserting <quote>applicable to breakthrough therapies, accelerated approval, and</quote>; and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id393F009AB77B4A2F9B2C099AFF9B8E09"><enum>(5)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="id19E0D8139C2D4750B448346857A9BF9A" style="OLC"> <subsection commented="no" display-inline="no-display-inline" id="id3FA826473ABE4247B226480C70D6C43E"><enum>(g)</enum><header display-inline="yes-display-inline">Report</header><text display-inline="yes-display-inline">Beginning in fiscal year 2013, the Secretary shall annually prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, and make publicly available, with respect to this section for the previous fiscal year—</text> <paragraph commented="no" display-inline="no-display-inline" id="id7d24ad153ed34b55bdb22259ecbfdfc4"><enum>(1)</enum><text display-inline="yes-display-inline">the number of drugs for which a sponsor requested designation as a breakthrough therapy;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idac9b378193a743aebae5d9a47396b63c"><enum>(2)</enum><text display-inline="yes-display-inline">the number of products designated as a breakthrough therapy; and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id37799d414e694ae3ad61eb78e43aea04"><enum>(3)</enum><text display-inline="yes-display-inline">for each product designated as a breakthrough therapy, a summary of the actions taken under subsection (a)(3).</text> </paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id9227968B6DD94F698498D246606B6574"><enum>(b)</enum><header display-inline="yes-display-inline">Guidance; amended regulations</header> <paragraph commented="no" display-inline="no-display-inline" id="id7ad186de8da345b1b94b4a215e2cf725"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header> <subparagraph commented="no" display-inline="no-display-inline" id="idE525EEC00FA5487BBA662D7A32A34453"><enum>(A)</enum><header display-inline="yes-display-inline">Guidance</header><text display-inline="yes-display-inline">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 <quote>Secretary</quote>) 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.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idc8323bf1b22847298042d9c4d4c1e47f"><enum>(B)</enum><header display-inline="yes-display-inline">Amended regulations</header> <clause commented="no" display-inline="no-display-inline" id="id5ED27D66EB85405B9880FDF873B391B7"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text> </clause><clause commented="no" display-inline="no-display-inline" id="idBEF71D6B44824E599419EAF83BE1949A"><enum>(ii)</enum><header display-inline="yes-display-inline">Procedure</header><text display-inline="yes-display-inline">In amending regulations under clause (i), the Secretary shall—</text> <subclause commented="no" display-inline="no-display-inline" id="id52c84432c0bd42919cc3cff46d609292"><enum>(I)</enum><text display-inline="yes-display-inline">issue a notice of proposed rulemaking that includes the proposed regulation;</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="idb22dab367f0a43a3b6ba1beeca0cf62c"><enum>(II)</enum><text display-inline="yes-display-inline">provide a period of not less than 60 days for comments on the proposed regulation; and</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="id08c1b1e9b3a745ea8fa8e83ada76991e"><enum>(III)</enum><text display-inline="yes-display-inline">publish the final regulation not less than 30 days before the effective date of the regulation.</text> </subclause></clause><clause commented="no" display-inline="no-display-inline" id="idb23060d1c8714369bba60315a6cd4f6a"><enum>(iii)</enum><header display-inline="yes-display-inline">Restrictions</header><text display-inline="yes-display-inline">Notwithstanding any other provision of law, the Secretary shall promulgate regulations implementing the amendments made by section only as described in clause (ii).</text> </clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idcd37cf70be7e42c089f36cf150b87579"><enum>(2)</enum><header display-inline="yes-display-inline">Requirements</header><text display-inline="yes-display-inline">Guidance issued under this section shall—</text> <subparagraph commented="no" display-inline="no-display-inline" id="idC7E2494BD9644F14BDA38345BB973A84"><enum>(A)</enum><text display-inline="yes-display-inline">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</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id06e85daf61024f1581ccff3bcf47a741"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text> </subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idD29450F940C046AEA95F1B5DC18F5B27"><enum>(c)</enum><header display-inline="yes-display-inline">Independent review</header><text display-inline="yes-display-inline">Not later than 3 years after the date of enactment of this Act, the Comptroller General of the United States, in consultation with appropriate experts, shall assess the manner by which the Food and Drug Administration has applied the processes described in section 506(a) of the Federal Food, Drug, and Cosmetic Act, as amended by this section, and the impact of such processes on the development and timely availability of innovative treatments for patients affected by serious or life-threatening conditions. Such assessment shall be made publicly available upon completion.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="idA048349C3D09461A8512ABCFC2641CDD"><enum>(d)</enum><header display-inline="yes-display-inline">Conforming amendments</header><text display-inline="yes-display-inline">Section 506B(e) (21 U.S.C. 356b) is amended by striking <quote>section 506(b)(2)(A)</quote> each place such term appears and inserting <quote>section 506(c)(2)(A)</quote>.</text> </subsection></section><section commented="no" display-inline="no-display-inline" id="HFFC74674B79C4211868620D596C306FA" section-type="subsequent-section"><enum>903.</enum><header display-inline="yes-display-inline">Consultation with external experts on rare diseases, targeted therapies, and genetic targeting of treatments</header><text display-inline="no-display-inline">Subchapter E of chapter V (21 U.S.C. 360bbb et seq.), as amended by section 712, is further amended by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="HF56F66B17F7D43B7AA7526A5167C5F6C" style="OLC"> <section commented="no" display-inline="no-display-inline" id="HF225883E2A034D8C904922928E1BF91A" section-type="subsequent-section"><enum>569.</enum><header display-inline="yes-display-inline">Consultation with external experts on rare diseases, targeted therapies, and genetic targeting of treatments</header> <subsection commented="no" display-inline="no-display-inline" id="idA258BC5907BE4D439D599820E4C06B19"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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:</text> <paragraph commented="no" display-inline="no-display-inline" id="idd544435ceb234dae9ab229f452ff792c"><enum>(1)</enum><header display-inline="yes-display-inline">Consultation with stakeholders</header><text display-inline="yes-display-inline">Consistent with sections X.C and IX.E.4 of the PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2013 through 2017, as referenced in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2012, the Secretary shall ensure that opportunities exist, at a time the Secretary determines appropriate, for consultations with stakeholders on the topics described in subsection (c).</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id975d2cbf5c7a4e399abf0df6dc0aa609"><enum>(2)</enum><header display-inline="yes-display-inline">Consultation with external experts</header><text display-inline="yes-display-inline">The Secretary shall develop and maintain a list of external experts who, because of their special expertise, are qualified to provide advice on rare disease issues, including topics described in subsection (c). The Secretary may, when appropriate to address a specific regulatory question, consult such external experts on issues related to the review of new drugs and biological products for rare diseases and drugs and biological products that are genetically targeted, including the topics described in subsection (c), when such consultation is necessary because the Secretary lacks specific scientific, medical, or technical expertise necessary for the performance of its regulatory responsibilities and the necessary expertise can be provided by the external experts.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id61575929DF60476E9ABD218E761BB90F"><enum>(b)</enum><header display-inline="yes-display-inline">External experts</header><text display-inline="yes-display-inline">For purposes of subsection (a)(2), external experts are those who possess scientific or medical training that the Secretary lacks with respect to one or more rare diseases.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="id29DC87B354844F42B8DA2B334EC5DA9C"><enum>(c)</enum><header display-inline="yes-display-inline">Topics for consultation</header><text display-inline="yes-display-inline">Topics for consultation pursuant to this section may include—</text> <paragraph commented="no" display-inline="no-display-inline" id="ide21a93d26f6f4ff586ee7d125dba5e1d"><enum>(1)</enum><text display-inline="yes-display-inline">rare diseases;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idddf5d49e3b8b47b7a4bdaafe23dbfd2e"><enum>(2)</enum><text display-inline="yes-display-inline">the severity of rare diseases;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id4da1a99840034a13aca1072aa89d25a3"><enum>(3)</enum><text display-inline="yes-display-inline">the unmet medical need associated with rare diseases;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id41d71488536942a89efe624bf9f2cda6"><enum>(4)</enum><text display-inline="yes-display-inline">the willingness and ability of individuals with a rare disease to participate in clinical trials;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idf1dbad786b1944f995ba745ead2ef004"><enum>(5)</enum><text display-inline="yes-display-inline">an assessment of the benefits and risks of therapies to treat rare diseases;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="ideed60a835f95447c8ede97a5cb14de36"><enum>(6)</enum><text display-inline="yes-display-inline">the general design of clinical trials for rare disease populations and subpopulations; and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idb92edcba6bc14fa2b2513cec541a43de"><enum>(7)</enum><text display-inline="yes-display-inline">demographics and the clinical description of patient populations.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id1249E09A1CD44942A789A14AD1E2CDD5"><enum>(d)</enum><header display-inline="yes-display-inline">Classification as special government employees</header><text display-inline="yes-display-inline">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.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="id3BD3FE5B6F78429AB8CEED96A6D32B3D"><enum>(e)</enum><header display-inline="yes-display-inline">Protection of proprietary information</header><text display-inline="yes-display-inline">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.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="idCA7FD6612C4C489B962D152916BC21C3"><enum>(f)</enum><header display-inline="yes-display-inline">Other consultation</header><text display-inline="yes-display-inline">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.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="id5AA4400A918C4313A9CD1A7BFFC7308E"><enum>(g)</enum><header display-inline="yes-display-inline">No right or obligation</header><text display-inline="yes-display-inline">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.</text> </subsection></section><after-quoted-block>.</after-quoted-block></quoted-block> </section><section commented="no" display-inline="no-display-inline" id="id930D8B15A5314157B84695F141DF30D2" section-type="subsequent-section"><enum>904.</enum><header display-inline="yes-display-inline">Accessibility of information on prescription drug container labels by visually-impaired and blind consumers</header> <subsection commented="no" display-inline="no-display-inline" id="id6706437709b64cf7923697604a70821f"><enum>(a)</enum><header display-inline="yes-display-inline">Establishment of Working Group</header> <paragraph commented="no" display-inline="no-display-inline" id="id6cf18fe961e9483c839c231171f8500e"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Architectural and Transportation Barriers Compliance Board (referred to in this section as the <quote>Access Board</quote>) shall convene a stakeholder working group (referred to in this section as the <quote>working group</quote>) to develop best practices on access to information on prescription drug container labels for individuals who are blind or visually impaired.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id4f4309dffcf143338a91bf639c607c30"><enum>(2)</enum><header display-inline="yes-display-inline">Members</header><text display-inline="yes-display-inline">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.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idccfebd61e4fe43469ec5f7698bc35629"><enum>(3)</enum><header display-inline="yes-display-inline">Best practices</header> <subparagraph commented="no" display-inline="no-display-inline" id="id9B2D1CC480BF4646B7B9461C53A9EE71"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The working group shall develop, not later than 1 year after the date of the enactment of this Act, best practices for pharmacies to ensure that blind and visually-impaired individuals have safe, consistent, reliable, and independent access to the information on prescription drug container labels.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id44B19632FAF6495DADB68DB28930F117"><enum>(B)</enum><header display-inline="yes-display-inline">Public availability</header><text display-inline="yes-display-inline">The best practices developed under subparagraph (A) may be made publicly available, including through the Internet websites of the working group participant organizations, and through other means, in a manner that provides access to interested individuals, including individuals with disabilities.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id864C3A54F6CD4328BB028A20DE2BC4E2"><enum>(C)</enum><header display-inline="yes-display-inline">Limitations</header><text display-inline="yes-display-inline">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.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id6dfb0ab84bd74edba6978944fe52afb6"><enum>(4)</enum><header display-inline="yes-display-inline">Considerations</header><text display-inline="yes-display-inline">In developing and issuing the best practices under paragraph (3)(A), the working group shall consider—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id1dd9f8a3888a421ab528aac58fdf8195"><enum>(A)</enum><text display-inline="yes-display-inline">the use of—</text> <clause commented="no" display-inline="no-display-inline" id="id9b53215a40924e989fee6665edbbf820"><enum>(i)</enum><text display-inline="yes-display-inline">Braille;</text> </clause><clause commented="no" display-inline="no-display-inline" id="id4e7855c855f94c608d5e6d61dbfb94ce"><enum>(ii)</enum><text display-inline="yes-display-inline">auditory means, such as—</text> <subclause commented="no" display-inline="no-display-inline" id="id488a20696645492aad26c8f8b6183aa4"><enum>(I)</enum><text display-inline="yes-display-inline"><quote>talking bottles</quote> that provide audible container label information;</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="id424152039e814d87b9bdd082e89891c9"><enum>(II)</enum><text display-inline="yes-display-inline">digital voice recorders attached to the prescription drug container; and</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="id1454ca6094874e19a4ef4b2083493ebd"><enum>(III)</enum><text display-inline="yes-display-inline">radio frequency identification tags;</text> </subclause></clause><clause commented="no" display-inline="no-display-inline" id="idbb731ddfda064aff9ab4b866897011c6"><enum>(iii)</enum><text display-inline="yes-display-inline">enhanced visual means, such as—</text> <subclause commented="no" display-inline="no-display-inline" id="id43744ee5d4534f249b161a65b82812b9"><enum>(I)</enum><text display-inline="yes-display-inline">large font labels or large font <quote>duplicate</quote> labels that are affixed or matched to a prescription drug container;</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="ide0577d4850c54aba99092882ac8313a8"><enum>(II)</enum><text display-inline="yes-display-inline">high-contrast printing; and</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="id454db0b00d2347a29940d19dde3426d3"><enum>(III)</enum><text display-inline="yes-display-inline">sans-serf font; and</text> </subclause></clause><clause commented="no" display-inline="no-display-inline" id="idb39265bb11f44ea4898663643d1e7b6f"><enum>(iv)</enum><text display-inline="yes-display-inline">other relevant alternatives as determined by the working group;</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id57fbc2258797483ba350ff81a0e653ae"><enum>(B)</enum><text display-inline="yes-display-inline">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</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idf6e75660305b4b6199c866684da867af"><enum>(C)</enum><text display-inline="yes-display-inline">such other factors as the working group determines to be appropriate.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idadcebf97d6cf41c7a896a2b570129958"><enum>(5)</enum><header display-inline="yes-display-inline">Information campaign</header><text display-inline="yes-display-inline">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.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id8FC2C11F5FDC40D29DE4613355B4C48C"><enum>(6)</enum><header display-inline="yes-display-inline">FACA waiver</header><text display-inline="yes-display-inline">The Federal Advisory Committee Act (5 U.S.C. App.) shall not apply to the working group.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idb8752fc5cae642dc90af3d7fc5ff6642"><enum>(b)</enum><header display-inline="yes-display-inline">GAO Study</header> <paragraph commented="no" display-inline="no-display-inline" id="idacc80e6e7be74a538077c06ff7d5e253"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id77b44d4b68fd4eda81fa58cf4f55a6ee"><enum>(2)</enum><header display-inline="yes-display-inline">Report</header><text display-inline="yes-display-inline">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.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id132214b24fd44ab39ebfef1c91394e50"><enum>(c)</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="yes-display-inline">In this section—</text> <paragraph commented="no" display-inline="no-display-inline" id="ida21121be91e846e680a9e17933b0f780"><enum>(1)</enum><text display-inline="yes-display-inline">the term <term>pharmacy</term> includes a pharmacy that receives prescriptions and dispenses prescription drugs through an Internet website or by mail;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id3cccb3fc24274d098b71b1fda112fd30"><enum>(2)</enum><text display-inline="yes-display-inline">the term <term>prescription drug</term> 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</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id973392F295354F8EB4524F1F09AC46B5"><enum>(3)</enum><text display-inline="yes-display-inline">the term <term>prescription drug container label</term> means the label with the directions for use that is affixed to the prescription drug container by the pharmacist and dispensed to the consumer.</text> </paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="id22CD509C09804E3DAC6BCAC4500752D1" section-type="subsequent-section"><enum>905.</enum><header display-inline="yes-display-inline">Risk-benefit framework</header><text display-inline="no-display-inline">Section 505(d) (21 U.S.C. 355(d)) is amended by adding at the end the following: <quote>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.</quote>.</text> </section><section commented="no" display-inline="no-display-inline" id="id6E282F929C2A4B65AA5227787D5E978E" section-type="subsequent-section"><enum>906.</enum><header display-inline="yes-display-inline">Independent study on medical innovation inducement model</header> <subsection commented="no" display-inline="no-display-inline" id="id2880AA89F757496EAF00895FB45A64FC"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services shall enter into an agreement with the National Academies to provide expert consultation and conduct a study that evaluates the feasibility and possible consequences of the use of innovation inducement prizes to reward successful medical innovations. Under the agreement, the National Academies shall submit to the Secretary a report on such study not later than 15 months after the date of enactment of this Act.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="idB857ED182E4945D28AEC6723C72453BB"><enum>(b)</enum><header display-inline="yes-display-inline">Requirements</header> <paragraph commented="no" display-inline="no-display-inline" id="id51450944A35B4DA5AF5AD24E25E61EC3"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The study conducted under subsection (a) shall model at least 3 separate segments on the medical technologies market as candidate targets for the new incentive system and consider different medical innovation inducement prize design issues, including the challenges presented in the implementation of prizes for end products, open source dividend prizes, and prizes for upstream research.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idC2E03C58E02E442A9FF5AE75A8DBBAAE"><enum>(2)</enum><header display-inline="yes-display-inline">Market segments</header><text display-inline="yes-display-inline">The segments on the medical technologies market that shall be considered under paragraph (1) include—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id449287a6e30444c5ae09b291d2ab77f3"><enum>(A)</enum><text display-inline="yes-display-inline">all pharmaceutical and biologic drugs and vaccines;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idb81a72db7c344d0bbef6f7c1c4e47ab9"><enum>(B)</enum><text display-inline="yes-display-inline">drugs and vaccines used solely for the treatment of HIV/AIDS; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ida391b63a3cc049ef9e841bd1327e4412"><enum>(C)</enum><text display-inline="yes-display-inline">antibiotics.</text> </subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idFE854B6C8B204DAF83B9FA469A4625FD"><enum>(c)</enum><header display-inline="yes-display-inline">Elements</header><text display-inline="yes-display-inline">The study conducted under subsection (a) shall include consideration of each of the following:</text> <paragraph commented="no" display-inline="no-display-inline" id="id8cff4bdc2a594031bec24d5c557ec9cd"><enum>(1)</enum><text display-inline="yes-display-inline">Whether a system of large innovation inducement prizes could work as a replacement for the existing product monopoly/patent-based system, as in effect on the date of enactment of this Act.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id5cf2f586f72d479798435871479f27d2"><enum>(2)</enum><text display-inline="yes-display-inline">How large the innovation prize funds would have to be in order to induce at least as much research and development investment in innovation as is induced under the current system of time-limited market exclusivity, as in effect on the date of enactment of this Act.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id18f7edba8dd74e738335e72e72fdeaea"><enum>(3)</enum><text display-inline="yes-display-inline">Whether a system of large innovation inducement prizes would be more or less expensive than the current system of time-limited market exclusivity, as in effect on the date of enactment of this Act, calculated over different time periods.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id2d83d2895b234d7593e4c7acc316058c"><enum>(4)</enum><text display-inline="yes-display-inline">Whether a system of large innovation inducement prizes would expand access to new products and improve health outcomes.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="ide4a54002e0714abb8d191397ccb48723"><enum>(5)</enum><text display-inline="yes-display-inline">The type of information and decisionmaking skills that would be necessary to manage end product prizes.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id05bd4f6b23124d9c9877507d027de939"><enum>(6)</enum><text display-inline="yes-display-inline">Whether there would there be major advantages in rewarding the incremental impact of innovations, as benchmarked against existing products.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id789f1c4279f64420a9dfe0c4eb11acc7"><enum>(7)</enum><text display-inline="yes-display-inline">How open-source dividend prizes could be managed, and whether such prizes would increase access to knowledge, materials, data and technologies.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id6e6f8c8a3b554204b90078bfc80f91a7"><enum>(8)</enum><text display-inline="yes-display-inline">Whether a system of competitive intermediaries for interim research prizes would provide an acceptable solution to the valuation challenges for interim prizes.</text> </paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="id10FAF74D678A4334BD47DE25B15E77A8" section-type="subsequent-section"><enum>907.</enum><header display-inline="yes-display-inline">Orphan product grants program</header> <subsection commented="no" display-inline="no-display-inline" id="id9076E66C73234D56B1FA4A57B831AAEE"><enum>(a)</enum><header display-inline="yes-display-inline">Reauthorization of program</header><text display-inline="yes-display-inline">Section 5(c) of the Orphan Drug Act (21 U.S.C. 360ee(c)) is amended by striking <quote>2008 through 2012</quote> and inserting <quote>2013 through 2017</quote>.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="id1A46EAA5CB9A4054AA3EEC0DF741D8D3"><enum>(b)</enum><header display-inline="yes-display-inline">Human clinical testing</header><text display-inline="yes-display-inline">Section 5(b)(1)(A)(ii)) of the Orphan Drug Act (21 U.S.C. 360ee(b)(1)(A)(ii)) is amended by striking <quote>after the date such drug is designated under section 526 of such Act and</quote>.</text> </subsection></section><section commented="no" display-inline="no-display-inline" id="H45C0769D4A5741769323DB25D623894F" section-type="subsequent-section"><enum>908.</enum><header display-inline="yes-display-inline">Reporting of inclusion of demographic subgroups in clinical trials and data analysis in applications for drugs, biologics, and devices</header> <subsection commented="no" display-inline="no-display-inline" id="id4F8187B10DE64C5A811847E70DC54009"><enum>(a)</enum><header display-inline="yes-display-inline">Report</header> <paragraph commented="no" display-inline="no-display-inline" id="id5D2FC5108BD8477080470CCD90765AA9"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than 1 year after the date of enactment of this Act, the Secretary, acting through the Commissioner, shall publish on the Internet website 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.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idA823A59F0A8644E1AE4940DF65B17F77"><enum>(2)</enum><header display-inline="yes-display-inline">Contents of report</header><text display-inline="yes-display-inline">The report described in paragraph (1) shall contain the following:</text> <subparagraph commented="no" display-inline="no-display-inline" id="id397319cdf09d4a5786b2e0c4f23a23dc"><enum>(A)</enum><text display-inline="yes-display-inline">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 healthcare providers, researchers, and patients.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id6668cc810e1f4c38b2974170dbd9daf2"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id7c45223be5b446099b420d7bf12d2474"><enum>(C)</enum><text display-inline="yes-display-inline">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.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idae30c5c60c6e4b26923fe4770133d0a9"><enum>(D)</enum><text display-inline="yes-display-inline">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 website.</text> </subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id054A6B80984C487FB0D462062EDEEAA4"><enum>(b)</enum><header display-inline="yes-display-inline">Action plan</header> <paragraph commented="no" display-inline="no-display-inline" id="idCF9B119E454D4761B9A2BFA910A16952"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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 website of the Food and Drug Administration, and provide such publication to Congress.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id301C2BFCEB5C427EB8E7F2057ED062C3"><enum>(2)</enum><header display-inline="yes-display-inline">Content of action plan</header><text display-inline="yes-display-inline">The plan described in paragraph (1) shall include—</text> <subparagraph commented="no" display-inline="no-display-inline" id="ided9ff42f79df443caffa46dd66a660f3"><enum>(A)</enum><text display-inline="yes-display-inline">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;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id9f43b193f6ba4facb6cbf4dcab71f428"><enum>(B)</enum><text display-inline="yes-display-inline">recommendations, as appropriate, on the inclusion of such data, or the lack of availability of such data in labeling;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id7978cd8652d54c1fb3895d067a85b8dc"><enum>(C)</enum><text display-inline="yes-display-inline">recommendations, as appropriate, to otherwise improve the public availability of such data to patients, healthcare providers, and researchers; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id1962f9932f5248d89c1dc71c2957da66"><enum>(D)</enum><text display-inline="yes-display-inline">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.</text> </subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id627AF479004A40A3BC551380A136070E"><enum>(c)</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="yes-display-inline">In this section:</text> <paragraph commented="no" display-inline="no-display-inline" id="idab5f545b588e4574b6c3d91a23a8fcc4"><enum>(1)</enum><text display-inline="yes-display-inline">The term <term>Commissioner</term> means the Commissioner of Food and Drugs.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id92da26aa9c4241e2b5177c6524cb22ad"><enum>(2)</enum><text display-inline="yes-display-inline">The term <term>device</term> has the meaning given such term in section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)).</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="ide08ae8c8b8db44949683280a8b79009a"><enum>(3)</enum><text display-inline="yes-display-inline">The term <term>drug</term> has the meaning given such term in section 201(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)).</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id26f68a21ed4d4b0f9050cff239df44b7"><enum>(4)</enum><text display-inline="yes-display-inline">The term <term>biological product</term> has the meaning given such term in section 351(i) of the Public Health Service Act (42 U.S.C. 262(i)).</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id1e19e9be20d34d13b5cf6884994927eb"><enum>(5)</enum><text display-inline="yes-display-inline">The term <term>Secretary</term> means the Secretary of Health and Human Services.</text> </paragraph></subsection></section><enum>X</enum><header display-inline="yes-display-inline">Drug shortages</header> <section commented="no" display-inline="no-display-inline" id="id6530F8CD0BF4473D940B20FAA3BC159A" section-type="subsequent-section"><enum>1001.</enum><header display-inline="yes-display-inline">Drug shortages</header> <subsection commented="no" display-inline="no-display-inline" id="id08FDBE9B4F034EE5B18F88D33ADC6E65"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 506C (21 U.S.C. 356c) is amended to read as follows:</text> <quoted-block display-inline="no-display-inline" id="id612A494ED87C4456BF6F202ABB71C65B" style="OLC"> <section commented="no" display-inline="no-display-inline" id="idF3FCB5016B3F489298E2FB222F01C1B2" section-type="subsequent-section"><enum>506C.</enum><header display-inline="yes-display-inline">Discontinuance or interruption in the production of life-saving drugs</header> <subsection commented="no" display-inline="no-display-inline" id="idbdf59971d70547369b4fdef70f20cabf"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">A manufacturer of a drug—</text> <paragraph commented="no" display-inline="no-display-inline" id="idf37b6ed1d20c420e955549debe2974a6"><enum>(1)</enum><text display-inline="yes-display-inline">that is—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id98c014cfacf147bf8080588e30257d6c"><enum>(A)</enum><text display-inline="yes-display-inline">life-supporting;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id4bdbce1c654c46409e3a2539f1f3c599"><enum>(B)</enum><text display-inline="yes-display-inline">life-sustaining;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ida1a9367155084b1c9e9943fddbce8469"><enum>(C)</enum><text display-inline="yes-display-inline">intended for use in the prevention of a debilitating disease or condition;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id277A66CA39ED446AB7CA2A99B12D24B2"><enum>(D)</enum><text display-inline="yes-display-inline">a sterile injectable product; or</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idD05E9267BCCD4A559A4D293233C0D6D2"><enum>(E)</enum><text display-inline="yes-display-inline">used in emergency medical care or during surgery; and</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id789ad14ca32143e8ac0ed91bcef21ad1"><enum>(2)</enum><text display-inline="yes-display-inline">that is not a radio pharmaceutical drug product, a human tissue replaced by a recombinant product, a product derived from human plasma protein, or any other product as designated by the Secretary,</text> </paragraph><continuation-text commented="no" continuation-text-level="subsection">shall notify the Secretary, in accordance with subsection (b), of a permanent discontinuance in the manufacture of the drug or an interruption of the manufacture of the drug that could lead to a meaningful disruption in the supply of that drug in the United States.</continuation-text></subsection><subsection commented="no" display-inline="no-display-inline" id="id3B2885CA969C474E8970F7616E999B0A"><enum>(b)</enum><header display-inline="yes-display-inline">Timing</header><text display-inline="yes-display-inline">A notice required under subsection (a) shall be submitted to the Secretary—</text> <paragraph commented="no" display-inline="no-display-inline" id="id9A60E741FED74F798B4B48BC847329D4"><enum>(1)</enum><text display-inline="yes-display-inline">at least 6 months prior to the date of the discontinuance or interruption; or</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id3745ED4E0896480AB2A3B8182338725E"><enum>(2)</enum><text display-inline="yes-display-inline">if compliance with paragraph (1) is not possible, as soon as practicable.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id63d17fcbcca741618bbbf8c91a8df22c"><enum>(c)</enum><header display-inline="yes-display-inline">Expedited inspections and reviews</header><text display-inline="yes-display-inline">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—</text> <paragraph commented="no" display-inline="no-display-inline" id="id311993f6f0c840deafeca578cc0034ba"><enum>(1)</enum><text display-inline="yes-display-inline">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</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idd4f0b484423b4ef09e83cbc72b93ad90"><enum>(2)</enum><text display-inline="yes-display-inline">expedite an inspection or reinspection of an establishment that could help mitigate or prevent such drug shortage.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idfa8b1a9a2e384afa9886d2aa8e7a6fa8"><enum>(d)</enum><header display-inline="yes-display-inline">Coordination</header> <paragraph commented="no" display-inline="no-display-inline" id="id6e0732e876674b34a5213445cc8d8369"><enum>(1)</enum><header display-inline="yes-display-inline">Task force and strategic plan</header> <subparagraph commented="no" display-inline="no-display-inline" id="idAAE3C651A4FA4890BC062B88CF0844BF"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header> <clause commented="no" display-inline="no-display-inline" id="id958A14BA1EA94681B6468A9D2E04BDAB"><enum>(i)</enum><header display-inline="yes-display-inline">Task Force</header><text display-inline="yes-display-inline">As soon as practicable after the date of enactment of the <short-title>Food and Drug Administration Safety and Innovation Act</short-title>, 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.</text> </clause><clause commented="no" display-inline="no-display-inline" id="id4A7197A262DE4B2CA637E1E4BFC50E1B"><enum>(ii)</enum><header display-inline="yes-display-inline">Strategic plan</header><text display-inline="yes-display-inline">The strategic plan described in clause (i) shall include—</text> <subclause commented="no" display-inline="no-display-inline" id="idd7a985b534714e3d9551a524cd26cc9f"><enum>(I)</enum><text display-inline="yes-display-inline">plans for enhanced interagency and intraagency coordination, communication, and decisionmaking;</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="idd6e8f615a56d4a2f92d5bc54ff5bc923"><enum>(II)</enum><text display-inline="yes-display-inline">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;</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="id9a03e77138fe48338cb62bed6d4197f5"><enum>(III)</enum><text display-inline="yes-display-inline">plans for effective communication with outside stakeholders, including who the Secretary should alert about potential or actual drug shortages, how the communication should occur, and what types of information should be shared; and</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="id9C34ACA8840740089A9E43CC0AF1635E"><enum>(IV)</enum><text display-inline="yes-display-inline">plans for considering the impact of drug shortages on research and clinical trials.</text> </subclause></clause><clause commented="no" display-inline="no-display-inline" id="idD0686225917B4C8DA8027FE049721A1D"><enum>(iii)</enum><header display-inline="yes-display-inline">Consultation</header><text display-inline="yes-display-inline">In carrying out this subparagraph, the Task Force shall ensure consultation with the appropriate offices within the Food and Drug Administration, including the Office of the Commissioner, the Center for Drug Evaluation and Research, the Office of Regulatory Affairs, and employees within the Department of Health and Human Services with expertise regarding drug shortages. The Secretary shall engage external stakeholders and experts as appropriate.</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id7A740275EB5340589FB372C385346897"><enum>(B)</enum><header display-inline="yes-display-inline">Timing</header><text display-inline="yes-display-inline">Not later than 1 year after the date of enactment <short-title>Food and Drug Administration Safety and Innovation Act</short-title>, the Task Force shall—</text> <clause commented="no" display-inline="no-display-inline" id="id5771DB7A69CE4E2DB20339F1AADAC8A7"><enum>(i)</enum><text display-inline="yes-display-inline">publish the strategic plan described in subparagraph (A); and</text> </clause><clause commented="no" display-inline="no-display-inline" id="id3F207C921F3F42ECBB3450EFDDF38B41"><enum>(ii)</enum><text display-inline="yes-display-inline">submit such plan to Congress.</text> </clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idc0a024e3a2b84c6080d0fdbb79ffc401"><enum>(2)</enum><header display-inline="yes-display-inline">Communication</header><text display-inline="yes-display-inline">The Secretary shall ensure that, prior to any enforcement action or issuance of a warning letter that the Secretary determines could reasonably be anticipated to lead to a meaningful disruption in the supply in the United States of a drug described under subsection (a), there is communication with the appropriate office of the Food and Drug Administration with expertise regarding drug shortages regarding whether the action or letter could cause, or exacerbate, a shortage of the drug.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id81ed5840a8d64d01b3dc11535abbfc0c"><enum>(3)</enum><header display-inline="yes-display-inline">Action</header><text display-inline="yes-display-inline">If the Secretary determines, after the communication described in paragraph (2), that an enforcement action or a warning letter could reasonably cause or exacerbate a shortage of a drug described under subsection (a), then the Secretary shall evaluate the risks associated with the impact of such shortage upon patients and those risks associated with the violation involved before taking such action or issuing such letter, unless there is imminent risk of serious adverse health consequences or death to humans.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id8B76A22DA1284EF4A314662DA562A331"><enum>(4)</enum><header display-inline="yes-display-inline">Reporting by other entities</header><text display-inline="yes-display-inline">The Secretary shall identify or establish a mechanism by which healthcare providers and other third-party organizations may report to the Secretary evidence of a drug shortage.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id8904eb7140ab4bec963ec046c63d41e9"><enum>(5)</enum><header display-inline="yes-display-inline">Review and construction</header><text display-inline="yes-display-inline">No determination, finding, action, or omission of the Secretary under this subsection shall—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id66c2ae3a776041fdb139de443c805043"><enum>(A)</enum><text display-inline="yes-display-inline">be subject to judicial review; or</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id64d0e1fad0d54013a22dc433947ff654"><enum>(B)</enum><text display-inline="yes-display-inline">be construed to establish a defense to an enforcement action by the Secretary.</text> </subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id34449166d5414e3a8b9194a7446c842e"><enum>(e)</enum><header display-inline="yes-display-inline">Recordkeeping and reporting</header> <paragraph commented="no" display-inline="no-display-inline" id="id62EF006B76984183BA4FE4BDA7CF66A5"><enum>(1)</enum><header display-inline="yes-display-inline">Recordkeeping</header><text display-inline="yes-display-inline">The Secretary shall maintain records related to drug shortages, including with respect to each of the following:</text> <subparagraph commented="no" display-inline="no-display-inline" id="id7b07f87326d6429c9f8f3de858c6cf46"><enum>(A)</enum><text display-inline="yes-display-inline">The number of manufacturers that submitted a notification to the Secretary under subsection (a) in each calendar year.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id805933a023334236a7aafd9c409cf5c0"><enum>(B)</enum><text display-inline="yes-display-inline">The number of drug shortages that occurred in each calendar year and a list of drug names, drug types, and classes that were the subject of such shortages.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idea25a6e31fce43f7bc64fdf6c02c3539"><enum>(C)</enum><text display-inline="yes-display-inline">A list of the known factors contributing to the drug shortages described in subparagraph (B).</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idff0cac9017144712a1dd52d5e576d26e"><enum>(D)</enum><clause commented="no" display-inline="yes-display-inline" id="id7112A8BCA29A4169B62C9916CB72908D"><enum>(i)</enum><text display-inline="yes-display-inline">A list of major actions taken by the Secretary to prevent or mitigate the drug shortages described in subparagraph (B).</text> </clause><clause commented="no" display-inline="no-display-inline" id="idD009DE7D96D842118909CB3931069509" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">The Secretary shall include in the list under clause (i) the following:</text> <subclause commented="no" display-inline="no-display-inline" id="id8F4EE6685AC44A30B4316F43D9D3DAA0"><enum>(I)</enum><text display-inline="yes-display-inline">The number of applications for which the Secretary expedited review under subsection (c)(1) in each calendar year.</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="idB15902DFB2B94A72B8221308C4269F72"><enum>(II)</enum><text display-inline="yes-display-inline">The number of establishment inspections or reinspections that the Secretary expedited under subsection (c)(2) in each calendar year.</text> </subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id5f1cb03a54eb434e8d99fc89c9ed52b6"><enum>(E)</enum><text display-inline="yes-display-inline">The number of notifications submitted to the Secretary under subsection (a) in each calendar year.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="iddd0b160024d045e588d46bb409e4fd48"><enum>(F)</enum><text display-inline="yes-display-inline">The names of manufacturers that the Secretary has learned did not comply with the notification requirement under subsection (a) in each calendar year.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idB461D06403CB4945AFF598B78A0C80F1"><enum>(G)</enum><text display-inline="yes-display-inline">The number of times in each calendar year that the Secretary determined under subsection (d)(3) that an enforcement action or a warning letter could reasonably cause or exacerbate a shortage of a drug described under subsection (a), but did not evaluate the risks associated with the impact of such shortage upon patients and those risks associated with the violation involved before taking such action or issuing such letter on the grounds that there was imminent risk of serious adverse health consequences or death to humans, and a summary of the determinations.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ide6225fb9538c4f7f9dcdaf76d95431a5"><enum>(H)</enum><text display-inline="yes-display-inline">A summary of the communications made and actions taken under subsection (d) in each calendar year.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idFAF1080D9A604AF2B83396AB63167029"><enum>(I)</enum><text display-inline="yes-display-inline">Any other information the Secretary deems appropriate to better prevent and mitigate drug shortages.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id5384b9b9afef4c72b7a2c1f8ff932454"><enum>(2)</enum><header display-inline="yes-display-inline">Trend analysis</header><text display-inline="yes-display-inline">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.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idbff66f44530843dbb50a4ad4f8ec299f"><enum>(3)</enum><header display-inline="yes-display-inline">Annual summary</header><text display-inline="yes-display-inline">Not later than 18 months after the date of enactment of the <short-title>Food and Drug Administration Safety and Innovation Act</short-title>, and annually thereafter, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report summarizing, with respect to the 1-year period preceding such report, the information described in paragraph (1). Such report shall not include any information that is exempt from disclosure under subsection (a) of section 552 of title 5, United States Code, by reason of subsection (b)(4) of such section.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id74440a711dc64d00bf0452ee667976f8"><enum>(f)</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="yes-display-inline">For purposes of this section—</text> <paragraph commented="no" display-inline="no-display-inline" id="id187216f24bb94d56856a77352ddbe5f1"><enum>(1)</enum><text display-inline="yes-display-inline">the term <term>drug</term>—</text> <subparagraph commented="no" display-inline="no-display-inline" id="idDF4DD2C774B14B3B80587CB3A89F9E8A"><enum>(A)</enum><text display-inline="yes-display-inline">means a drug (as defined in section 201(g)) that is intended for human use; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id05BEE130B3CD410ABF0966B07617F7AC"><enum>(B)</enum><text display-inline="yes-display-inline">does not include biological products (as defined in section 351 of the Public Health Service Act), unless otherwise provided by the Secretary in the regulations promulgated under subsection (h);</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id175e2b03ac244b2db3e76e7d7fa173e6"><enum>(2)</enum><text display-inline="yes-display-inline">the term <term>drug shortage</term> or <term>shortage</term>, 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</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id6ba0b502de3f415fb1104b044f043c5d"><enum>(3)</enum><text display-inline="yes-display-inline">the term <term>meaningful disruption</term>—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id1CEB5F1CE68740049587B7C6ACDD95D3"><enum>(A)</enum><text display-inline="yes-display-inline">means a change in production that is reasonably likely to lead to a reduction in the supply of a drug by a manufacturer that is more than negligible and impacts the ability of the manufacturer to fill orders or meet expected demand for its product; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id109DD46EF1D14DF781EF8A7A13B9804D"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text> </subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id6e5f9fbe9c404939ba89965969cac89d"><enum>(g)</enum><header display-inline="yes-display-inline">Distribution</header><text display-inline="yes-display-inline">To the maximum extent practicable, the Secretary may distribute information on drug shortages and on the permanent discontinuation of the drugs described in this section to appropriate provider and patient organizations, except that any such distribution shall not include any information that is exempt from disclosure under section 552 of title 5, United States Code, by reason of subsection (b)(4) of such section.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="idc92c906d13d14c7b9c751a3d335b3eec"><enum>(h)</enum><header display-inline="yes-display-inline">Regulations</header> <paragraph commented="no" display-inline="no-display-inline" id="id8160a0f9a5d9418eb725d00fc36f2d01"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than 18 months after the date of enactment of the <short-title>Food and Drug Administration Safety and Innovation Act</short-title>, the Secretary shall adopt a final regulation implementing this section.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idA24073A7FF3340D290EB1D7CF1926B5E"><enum>(2)</enum><header display-inline="yes-display-inline">Inclusion of biological products</header> <subparagraph commented="no" display-inline="no-display-inline" id="idF9CB04DF9047451CA0A401F4C1A58FFD"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary may by regulation apply this section to biological products (as defined in section 351 of the Public Health Service Act) if the Secretary determines such inclusion would benefit the public health.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id7FA84FFB76F0487494B267585E5D9310"><enum>(B)</enum><header display-inline="yes-display-inline">Rule for vaccines</header><text display-inline="yes-display-inline">If the Secretary applies this section to vaccines pursuant to subparagraph (A), the Secretary shall—</text> <clause commented="no" display-inline="no-display-inline" id="id43EF9D56750E415384E1DFBAD184B3A3"><enum>(i)</enum><text display-inline="yes-display-inline">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</text> </clause><clause commented="no" display-inline="no-display-inline" id="id9DDD73A497554B808C92617580B1C086"><enum>(ii)</enum><text display-inline="yes-display-inline">explain the determination made by the Secretary under clause (i) in the regulation.</text> </clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idD3B7B6CFB16C4236B33A518E63D1B6F9"><enum>(3)</enum><header display-inline="yes-display-inline">Procedure</header><text display-inline="yes-display-inline">In promulgating a regulation implementing this section, the Secretary shall—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id1EDEA83B955C4BDC825203158DC80F20"><enum>(A)</enum><text display-inline="yes-display-inline">issue a notice of proposed rulemaking that includes the proposed regulation;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idF610C319E2394414B5D0E2A17390AE26"><enum>(B)</enum><text display-inline="yes-display-inline">provide a period of not less than 60 days for comments on the proposed regulation; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id652A2DF5F4FF49EDA6877112633B6A08"><enum>(C)</enum><text display-inline="yes-display-inline">publish the final regulation not less than 30 days before the regulation’s effective date.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id5eb9d43427a24c269a0be92b0e0cc769"><enum>(4)</enum><header display-inline="yes-display-inline">Restrictions</header><text display-inline="yes-display-inline">Notwithstanding any other provision of Federal law, in implementing this section, the Secretary shall only promulgate regulations as described in paragraph (3).</text> </paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block> </subsection><subsection commented="no" display-inline="no-display-inline" id="ide6c5a032ec7a4ab594f8f896e1fdb42c"><enum>(b)</enum><header display-inline="yes-display-inline">Effect of notification</header><text display-inline="yes-display-inline">The submission of a notification to the Secretary of Health and Human Services (referred to in this section as the <quote>Secretary</quote>) 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—</text> <paragraph commented="no" display-inline="no-display-inline" id="id2eb773dbfe474115a04b61305eac1c98"><enum>(1)</enum><text display-inline="yes-display-inline">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</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id165b9c7f997e4141baf50023427ae6a7"><enum>(2)</enum><text display-inline="yes-display-inline">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.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id05B89D197F1B4CA1813E86BB6922B769"><enum>(c)</enum><header display-inline="yes-display-inline">Internal review</header><text display-inline="yes-display-inline">Not later than 2 years after the date of enactment of this Act, the Secretary shall—</text> <paragraph commented="no" display-inline="no-display-inline" id="id4e83b09640b6473a9b539347f3137b9c"><enum>(1)</enum><text display-inline="yes-display-inline">analyze and review the regulations promulgated under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), the guidances or policies issued under such Act related to drugs intended for human use, and the practices of the Food and Drug Administration regarding enforcing such Act related to manufacturing of such drugs, to identify any such regulations, guidances, policies, or practices that cause, exacerbate, prevent, or mitigate drug shortages (as defined in section 506C of the Federal Food, Drug, and Cosmetic Act (as amended by subsection (a)); and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idd93ea9392a224bb9b8ff0665eb2dc3da"><enum>(2)</enum><text display-inline="yes-display-inline">determine how regulations, guidances, policies, or practices identified under paragraph (1) should be modified, streamlined, expanded, or discontinued in order to reduce or prevent such drug shortages, taking into consideration the effect of any changes on the public health.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idAEE883448BE04DE9ADEF6CE2BED75E41"><enum>(d)</enum><header display-inline="yes-display-inline">Study on Market Factors Contributing to Drug Shortages and Stockpiling</header> <paragraph commented="no" display-inline="no-display-inline" id="id335e49b39fba438299450445f9db51f9"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than 1 year after the date of enactment of this Act, the Comptroller General of the United States, in consultation with the Secretary, the Department of Health and Human Services Office of the Inspector General, the Attorney General, and Chairman of the Federal Trade Commission, shall publish a report reviewing any findings that drug shortages (as so defined) have led market participants to stockpile affected drugs or sell them at significantly increased prices, the impact of such activities on Federal revenue, and any economic factors that have exacerbated or created a market for such actions.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idf4fc7840281c4b1480bab39e14984207"><enum>(2)</enum><header display-inline="yes-display-inline">Content</header><text display-inline="yes-display-inline">The report under paragraph (1) shall include—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id4e3390293a4443e5bd80ec2a9834ca95"><enum>(A)</enum><text display-inline="yes-display-inline">an analysis of the incidence of any of the activities described in paragraph (1) and the effect of such activities on the public health;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id51b41e9897c746f09e54eb3498fc46e2"><enum>(B)</enum><text display-inline="yes-display-inline">an evaluation of whether in such cases there is a correlation between drugs in shortage and—</text> <clause commented="no" display-inline="no-display-inline" id="id6c1b2a7920af4e3488df1f45f74c4f15"><enum>(i)</enum><text display-inline="yes-display-inline">the number of manufacturers producing such drugs;</text> </clause><clause commented="no" display-inline="no-display-inline" id="id729465eda424468ca9a8259cf90c19cd"><enum>(ii)</enum><text display-inline="yes-display-inline">the pricing structure, including Federal reimbursements, for such drugs before such drugs were in shortage, and to the extent possible, revenue received by each such manufacturer of such drugs;</text> </clause><clause commented="no" display-inline="no-display-inline" id="id751f9c16738841d78ec4812f642941b0"><enum>(iii)</enum><text display-inline="yes-display-inline">pricing structure and revenue, to the extent possible, for the same drugs when sold under the conditions described in paragraph (1); and</text> </clause><clause commented="no" display-inline="no-display-inline" id="id6b172d9f208c4935ac6bb85ec0631be5"><enum>(iv)</enum><text display-inline="yes-display-inline">the impact of contracting practices by market participants (including manufacturers, distributors, group purchasing organizations, and providers) on competition, access to drugs, and pricing of drugs;</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id06c43fe51bbc4a52a8de1efba6cea8f6"><enum>(C)</enum><text display-inline="yes-display-inline">whether the activities described in paragraph (1) are consistent with applicable law; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id43f26ae34e0a486c882991c137f1bec8"><enum>(D)</enum><text display-inline="yes-display-inline">recommendations to Congress on what, if any, additional reporting or enforcement actions are necessary.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id0F6ABA2D59E4448480AC6DB87D137980"><enum>(3)</enum><header display-inline="yes-display-inline">Trade Secret and Confidential information</header><text display-inline="yes-display-inline">Nothing in this subsection alters or amends section 1905 of title 18, United States Code, or section 552(b)(4) of title 5, United States Code.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id0E7A43D41D4F4EC2BDE4C39C5B6540C8"><enum>(e)</enum><header display-inline="yes-display-inline">Guidance regarding repackaging</header><text display-inline="yes-display-inline">Not later than 1 year after the date of enactment of this Act, the Secretary shall issue guidance that clarifies the policy of the Food and Drug Administration regarding hospital pharmacies repackaging and safely transferring repackaged drugs among hospitals within a common health system during a drug shortage, as identified by the Secretary.</text> </subsection></section><enum>XI</enum><header display-inline="yes-display-inline">Other provisions</header> <subtitle commented="no" id="id87A865E471104B4B9463E01E64741046" level-type="subsequent"><enum>A</enum><header display-inline="yes-display-inline">Reauthorizations</header> <section commented="no" display-inline="no-display-inline" id="idE2A2E8D7378D4053A316D472E6B8040E" section-type="subsequent-section"><enum>1101.</enum><header display-inline="yes-display-inline">Reauthorization of provision relating to exclusivity of certain drugs containing single enantiomers</header> <subsection commented="no" display-inline="no-display-inline" id="idCF5A553B05DA41939735945E6261B60C"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 505(u)(4) (21 U.S.C. 355(u)(4)) is amended by striking <quote>2012</quote> and inserting <quote>2017</quote>.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="id43BD784FD25F406CB581BC8E4247A58E"><enum>(b)</enum><header display-inline="yes-display-inline">Amendment</header><text display-inline="yes-display-inline">Section 505(u)(1)(A)(ii)(II) (21 U.S.C. 355(u)(1)(A)(ii)(II)) is amended by inserting <quote>clinical</quote> after <quote>any</quote>.</text> </subsection></section><section commented="no" display-inline="no-display-inline" id="id9F9C6C576B5A4318A0FCD17095AE3D63" section-type="subsequent-section"><enum>1102.</enum><header display-inline="yes-display-inline">Reauthorization of the Critical Path Public-Private Partnerships</header><text display-inline="no-display-inline">Section 566(f) (21 U.S.C. 360bbb–5(f)) is amended by striking <quote>2012</quote> and inserting <quote>2017</quote>.</text> </section></subtitle><subtitle commented="no" id="idAD1D15FE471A480DA47B667625563870" level-type="subsequent"><enum>B</enum><header display-inline="yes-display-inline">Medical gas product regulation</header> <section commented="no" display-inline="no-display-inline" id="idBD64415869DA400BA07E0A32B02BF1E4" section-type="subsequent-section"><enum>1111.</enum><header display-inline="yes-display-inline">Regulation of medical gas products</header> <subsection commented="no" display-inline="no-display-inline" id="idE07E9776306D4483BCC3BBF275D9BEF8"><enum>(a)</enum><header display-inline="yes-display-inline">Regulation</header><text display-inline="yes-display-inline">Chapter V (21 U.S.C. 351 et seq.) is amended by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="id3BAB2B7FFB16440D91D8751950507669" style="OLC"> <subchapter commented="no" id="id0ddd74da31c845759136add270aca056" level-type="subsequent"><enum>G</enum><header display-inline="yes-display-inline">Medical gas products</header> <section commented="no" display-inline="no-display-inline" id="idc60ddbf08133401cb8a3ff6e1c5b9126" section-type="subsequent-section"><enum>575.</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="no-display-inline">In this subchapter:</text> <paragraph commented="no" display-inline="no-display-inline" id="idb4acc10f13d9428dbce9e0eaaac9132f"><enum>(1)</enum><text display-inline="yes-display-inline">The term <term>designated medical gas product</term> means any of the following:</text> <subparagraph commented="no" display-inline="no-display-inline" id="idd63404e790d6456b9ac97197bf6b5b7a"><enum>(A)</enum><text display-inline="yes-display-inline">Oxygen, that meets the standards set forth in an official compendium.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ide4ddc2158fe24831b6745c92e55a9b95"><enum>(B)</enum><text display-inline="yes-display-inline">Nitrogen, that meets the standards set forth in an official compendium.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id41037d90678543eb851c7075d9280f13"><enum>(C)</enum><text display-inline="yes-display-inline">Nitrous oxide, that meets the standards set forth in an official compendium.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id03ca2e7566c343d7a5312a46073b9807"><enum>(D)</enum><text display-inline="yes-display-inline">Carbon dioxide, that meets the standards set forth in an official compendium.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idd78c997d9d4d465bb6b2eae07080a36e"><enum>(E)</enum><text display-inline="yes-display-inline">Helium, that meets the standards set forth in an official compendium.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idb04188bb63774d0ab73ba3a5a8964b02"><enum>(F)</enum><text display-inline="yes-display-inline">Carbon monoxide, that meets the standards set forth in an official compendium.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id712b675d0e7444729ff98f5942fe4684"><enum>(G)</enum><text display-inline="yes-display-inline">Medical air, that meets the standards set forth in an official compendium.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id4587425ef3954d02986912c52b0074f0"><enum>(H)</enum><text display-inline="yes-display-inline">Any other medical gas product deemed appropriate by the Secretary, unless any period of exclusivity under section 505(c)(3)(E)(ii) or 505(j)(5)(F)(ii), or the extension of any such period under section 505A, applicable to such medical gas product has not expired.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id807979E68F12444E9670D32780B7C044"><enum>(2)</enum><text display-inline="yes-display-inline">The term <term>medical gas product</term> means a drug that—</text> <subparagraph commented="no" display-inline="no-display-inline" id="idd820c395c33b449ba960c3e177777d3b"><enum>(A)</enum><text display-inline="yes-display-inline">is manufactured or stored in a liquefied, nonliquefied, or cryogenic state; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id86b922c0784f4ba1982eba2324462709"><enum>(B)</enum><text display-inline="yes-display-inline">is administered as a gas.</text> </subparagraph></paragraph></section><section commented="no" display-inline="no-display-inline" id="idC7E5601A848F4BAE9DA08B628C1295BC" section-type="subsequent-section"><enum>576.</enum><header display-inline="yes-display-inline">Regulation of medical gas products</header> <subsection commented="no" display-inline="no-display-inline" id="idD9BD4AD5685D41D785E10690EC3755C1"><enum>(a)</enum><header display-inline="yes-display-inline">Certification of designated medical gas products</header> <paragraph commented="no" display-inline="no-display-inline" id="idF10AAB0C43444EEE8BD5E685A7AA1647"><enum>(1)</enum><header display-inline="yes-display-inline">Submission</header> <subparagraph commented="no" display-inline="no-display-inline" id="idBCE376E3FAB94D65A90A66E5C3DE3836"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Beginning on the date of enactment of this section, any person may file with the Secretary a request for a certification of a designated medical gas product.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id1F4D66AA3FBF40C7AF7439CAE3F4B680"><enum>(B)</enum><header display-inline="yes-display-inline">Content</header><text display-inline="yes-display-inline">A request under subparagraph (A) shall contain—</text> <clause commented="no" display-inline="no-display-inline" id="idEC3E36FEFD474E6B885850F3A15BBB47"><enum>(i)</enum><text display-inline="yes-display-inline">a description of the medical gas product;</text> </clause><clause commented="no" display-inline="no-display-inline" id="id7543394AB847415F9A7EA51C27E0984D"><enum>(ii)</enum><text display-inline="yes-display-inline">the name and address of the sponsor;</text> </clause><clause commented="no" display-inline="no-display-inline" id="idA316B58F1B7E4D9E9CC1DC3C28398143"><enum>(iii)</enum><text display-inline="yes-display-inline">the name and address of the facility or facilities where the gas product is or will be manufactured; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="id88CCF9ED41674ED695C6C4F637020460"><enum>(iv)</enum><text display-inline="yes-display-inline">any other information deemed appropriate by the Secretary to determine whether the medical gas product is a designated medical gas product.</text> </clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idBAA54F098B8446EE85A560C778CF5BC0"><enum>(2)</enum><header display-inline="yes-display-inline">Grant of certification</header><text display-inline="yes-display-inline">A certification described under paragraph (1)(A) shall be determined to have been granted unless, not later than 60 days after the filing of a request under paragraph (1), the Secretary finds that—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id1B136508DB154EAA99B93C7A0289BB46"><enum>(A)</enum><text display-inline="yes-display-inline">the medical gas product subject to the certification is not a designated medical gas product;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idA5C49F0BE9464D85A3D3284BD5C27B02"><enum>(B)</enum><text display-inline="yes-display-inline">the request does not contain the information required under paragraph (1) or otherwise lacks sufficient information to permit the Secretary to determine that the gas product is a designated medical gas product; or</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id6C0F7C423DCB4E44A9C48889E4322839"><enum>(C)</enum><text display-inline="yes-display-inline">granting the request would be contrary to public health.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id7E5398BAE7024AEAB4CD40858AAD1131"><enum>(3)</enum><header display-inline="yes-display-inline">Effect of certification</header> <subparagraph commented="no" display-inline="no-display-inline" id="id317C172FF6584BEC886FDAE146C7C2BD"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header> <clause commented="no" display-inline="no-display-inline" id="id55A56E908480446CB0D136F8E9194B53"><enum>(i)</enum><header display-inline="yes-display-inline">Approved uses</header><text display-inline="yes-display-inline">A designated medical gas product for which a certification is granted under paragraph (2) is deemed, alone or in combination with another designated gas product or products as medically appropriate, to have in effect an approved application under section 505 or 512, subject to all applicable postapproval requirements, for the following indications for use:</text> <subclause commented="no" display-inline="no-display-inline" id="id8ca882a0c1b745efa41a6d7b385ed137"><enum>(I)</enum><text display-inline="yes-display-inline">Oxygen for the treatment or prevention of hypoxemia or hypoxia.</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="id7bee2d615edb415394e26a4eb577efbe"><enum>(II)</enum><text display-inline="yes-display-inline">Nitrogen for use in hypoxic challenge testing.</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="id06beb06f9ee54d7f8beffe8ed14d93ad"><enum>(III)</enum><text display-inline="yes-display-inline">Nitrous oxide for analgesia.</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="iddb2e62a13ad54b139e55ee89daa0d576"><enum>(IV)</enum><text display-inline="yes-display-inline">Carbon dioxide for use in extracorporeal membrane oxygenation therapy or respiratory stimulation.</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="id7870fac0f5f84aec9a012f90e6853c4a"><enum>(V)</enum><text display-inline="yes-display-inline">Helium for the treatment of upper airway obstruction or increased airway resistance.</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="id5f3b274761b34972951fdadb02764775"><enum>(VI)</enum><text display-inline="yes-display-inline">Medical air to reduce the risk of hyperoxia.</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="idcf461d74dab845d4bad17a59ff93cdf2"><enum>(VII)</enum><text display-inline="yes-display-inline">Carbon monoxide for use in lung diffusion testing.</text> </subclause><subclause commented="no" display-inline="no-display-inline" id="idc0e75371c6164bdab7c6760db31da06b"><enum>(VIII)</enum><text display-inline="yes-display-inline">Any other indication for use for a designated medical gas product or combination of designated medical gas products deemed appropriate by the Secretary, unless any period of exclusivity under clause (iii) or (iv) of section 505(c)(3)(E), under clause (iii) or (iv) of section 505(j)(5)(F), or under section 527, or the extension of any such period under section 505A, applicable to such indication for use for such gas product or combination of products has not expired.</text> </subclause></clause><clause commented="no" display-inline="no-display-inline" id="id9DDA9007F5064806B21C55C9D23E6ECF"><enum>(ii)</enum><header display-inline="yes-display-inline">Labeling</header><text display-inline="yes-display-inline">The requirements established in sections 503(b)(4) and 502(f) shall be deemed to have been met for a designated medical gas product if the labeling on final use containers of such gas product bears the information required by section 503(b)(4) and a warning statement concerning the use of the gas product, as determined by the Secretary by regulation, as well as appropriate directions and warnings concerning storage and handling.</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id6C72BF55A57B4212A44C514114743CD3"><enum>(B)</enum><header display-inline="yes-display-inline">Inapplicability of exclusivity provisions</header> <clause commented="no" display-inline="no-display-inline" id="id84B61D3E107342D787E43CC673EFA265"><enum>(i)</enum><header display-inline="yes-display-inline">Effect on ineligibility</header><text display-inline="yes-display-inline">No designated medical gas product deemed under paragraph (3)(A)(i) to have in effect an approved application shall be eligible for any periods of exclusivity under sections 505(c), 505(j), or 527, or the extension of any such period under section 505A, on the basis of such deemed approval.</text> </clause><clause commented="no" display-inline="no-display-inline" id="id1830A02155BE4F4D8EEECF123A7D28E2"><enum>(ii)</enum><header display-inline="yes-display-inline">Effect on certification</header><text display-inline="yes-display-inline">No period of exclusivity under sections 505(c), 505(j), or section 527, or the extension of any such period under section 505A, with respect to an application for a drug shall prohibit, limit, or otherwise affect the submission, grant, or effect of a certification under this section, except as provided in paragraph (3)(A)(i)(VIII).</text> </clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id2352177DD88C4A7CAA7A2073EBCD5655"><enum>(4)</enum><header display-inline="yes-display-inline">Withdrawal, suspension, or revocation of approval</header> <subparagraph commented="no" display-inline="no-display-inline" id="id7812DC70C04C4EEC9903C8E363932ABA"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Nothing in this subchapter limits the authority of the Secretary to withdraw or suspend approval of a drug, including a designated medical gas product deemed under this section to have in effect an approved application, under section 505 or section 512.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id2A6B8F2D79D944F8985E7627025353A5"><enum>(B)</enum><header display-inline="yes-display-inline">Revocation</header><text display-inline="yes-display-inline">The Secretary may revoke the grant of a certification under this section if the Secretary determines that the request for certification contains any material omission or falsification.</text> </subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idF710C89D75434D08ACC1BDE09AEC2663"><enum>(b)</enum><header display-inline="yes-display-inline">Prescription requirement</header> <paragraph commented="no" display-inline="no-display-inline" id="id64176DED651345818E6492AFFD5FE6FA"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">A designated medical gas product shall be subject to section 503(b)(1) unless the Secretary exercises the authority provided in section 503(b)(3) to remove such gas product from the requirements of section 503(b)(1) or the use in question is authorized pursuant to another provision of this Act relating to use of medical products in emergencies.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id0750B1237A5149068EDDD0B918C522A6"><enum>(2)</enum><header display-inline="yes-display-inline">Exception for oxygen</header> <subparagraph commented="no" display-inline="no-display-inline" id="id7C2A4FFD12584AF5BB8B7AC4A7C973CD"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Notwithstanding paragraph (1), oxygen may be provided without a prescription for the following uses:</text> <clause commented="no" display-inline="no-display-inline" id="id5311F6FE134D4EB39507ECE0F4A2537C"><enum>(i)</enum><text display-inline="yes-display-inline">The use in the event of depressurization or other environmental oxygen deficiency.</text> </clause><clause commented="no" display-inline="no-display-inline" id="idA29D4A2A8FE040AE98A283840AA7122E"><enum>(ii)</enum><text display-inline="yes-display-inline">The use in the event of oxygen deficiency or use in emergency resuscitation, when administered by properly trained personnel.</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id26AB5EE91577416AB3B4421348162C34"><enum>(B)</enum><header display-inline="yes-display-inline">Labeling</header><text display-inline="yes-display-inline">For oxygen provided pursuant to subparagraph (A), the requirements established in section 503(b)(4) shall be deemed to have been met if the labeling of the oxygen bears a warning that the medical gas product can be used for emergency use only and for all other medical applications a prescription is required.</text> </subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idCA1A7DB45BDD4173BFFA67291A9E5932"><enum>(c)</enum><header display-inline="yes-display-inline">Inapplicability of drugs fees to designated medical gas products</header><text display-inline="yes-display-inline">A designated medical gas product deemed under this section to have in effect an approved application shall not be assessed fees under section 736(a) on the basis of such deemed approval.</text> </subsection></section></subchapter><after-quoted-block>.</after-quoted-block></quoted-block> </subsection></section><section commented="no" display-inline="no-display-inline" id="id306876222DDD4056B59F8B3680D34563" section-type="subsequent-section"><enum>1112.</enum><header display-inline="yes-display-inline">Regulations</header> <subsection commented="no" display-inline="no-display-inline" id="id6373f247bf59479ba502369fcde59806"><enum>(a)</enum><header display-inline="yes-display-inline">Review of regulations</header><text display-inline="yes-display-inline">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 <quote>Secretary</quote>) shall, after obtaining input from medical gas product manufacturers, and any other interested members of the public, submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives regarding any changes to the Federal drug regulations in title 21, Code of Federal Regulations that the Secretary determines to be necessary.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="id60192cfa61394b39abbdf6acce638288"><enum>(b)</enum><header display-inline="yes-display-inline">Amended regulations</header><text display-inline="yes-display-inline">If the Secretary determines that changes to the Federal drug regulations in title 21, Code of Federal Regulations are necessary under subsection (a), the Secretary shall issue final regulations implementing such changes not later than 4 years after the date of enactment of this Act.</text> </subsection></section><section commented="no" display-inline="no-display-inline" id="id83B58209F2744BC2858B2E9F1D2A317B" section-type="subsequent-section"><enum>1113.</enum><header display-inline="yes-display-inline">Applicability</header><text display-inline="no-display-inline">Nothing in this subtitle or the amendments made by this subtitle shall apply to—</text> <paragraph commented="no" display-inline="no-display-inline" id="id3A71B83C100E4D119BD586360BEB0E18"><enum>(1)</enum><text display-inline="yes-display-inline">a drug that is covered by an application under section 505 or 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355, 360b) approved prior to May 1, 2012; or</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id74A50E3F14544131B6BE65D31584246F"><enum>(2)</enum><text display-inline="yes-display-inline">any of the gases listed in subparagraphs (A) through (G) of section 575(1) of such Act (as added by section 1111), or any mixture of any such gases, for an indication that—</text> <subparagraph commented="no" display-inline="no-display-inline" id="idF0EDEEAC36744A53B1F2F43181E7B1C9"><enum>(A)</enum><text display-inline="yes-display-inline">is not included in, or is different from, those specified in subclauses (I) through (VII) of section 576(a)(3)(i) of such Act (as added by section 1111); and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id80C5594329D84527B3883F82DDA77959"><enum>(B)</enum><text display-inline="yes-display-inline">is approved on or after May 1, 2012, pursuant to an application submitted under section 505 or 512 of such Act.</text> </subparagraph></paragraph></section></subtitle><subtitle commented="no" id="id03F405C9EC664DF38F472E90E63D433B" level-type="subsequent"><enum>C</enum><header display-inline="yes-display-inline">Miscellaneous provisions</header> <section commented="no" display-inline="no-display-inline" id="idD77994E096464DF5AFE29E3B6D6ACCAD" section-type="subsequent-section"><enum>1121.</enum><header display-inline="yes-display-inline">Advisory committee conflicts of interest</header><text display-inline="no-display-inline">Section 712 (21 U.S.C. 379d–1) is amended—</text> <paragraph commented="no" display-inline="no-display-inline" id="id179C685F1C6B42DE915FF1C535834414"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (b)—</text> <subparagraph commented="no" display-inline="no-display-inline" id="idBB73E0DF276C4E92B5C43CDD5BD7AF0A"><enum>(A)</enum><text display-inline="yes-display-inline">by striking paragraph (2); and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idAB733082C87B40758996EEB65D4DE1C8"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (1)—</text> <clause commented="no" display-inline="no-display-inline" id="idCD35E68554B44C719E93D202340729E1"><enum>(i)</enum><text display-inline="yes-display-inline">by redesignating subparagraph (B) as paragraph (2) and moving such paragraph, as so redesignated, 2 ems to the left;</text> </clause><clause commented="no" display-inline="no-display-inline" id="idBABE7085A3F64A058F3D900BD2C99159"><enum>(ii)</enum><text display-inline="yes-display-inline">in subparagraph (A), by redesignating clauses (i) through (iii) as subparagraphs (A) through (C), respectively, and moving such subparagraphs, as so redesignated, 2 ems to the left;</text> </clause><clause commented="no" display-inline="no-display-inline" id="id54C895197607477C907D615F3A70DD82"><enum>(iii)</enum><text display-inline="yes-display-inline">in subparagraph (A), as so redesignated, by inserting <quote>, including strategies to increase the number of special Government employees across medical and scientific specialties in areas where the Secretary would benefit from specific scientific, medical, or technical expertise necessary for the performance of its regulatory responsibilities</quote> before the semicolon at the end;</text> </clause><clause commented="no" display-inline="no-display-inline" id="idFA0E9E1551BD435DB25FEBA2387D1EE1"><enum>(iv)</enum><text display-inline="yes-display-inline">by striking <quote>(1) <header-in-text level="paragraph" style="OLC">Recruitment.—</header-in-text></quote> and inserting <quote>(1) <header-in-text level="paragraph" style="OLC">Recruitment in general.</header-in-text>—The Secretary shall—</quote>;</text> </clause><clause commented="no" display-inline="no-display-inline" id="idC340ACC62B794536B0D9E5B778505995"><enum>(v)</enum><text display-inline="yes-display-inline">by striking <quote>(A) <header-in-text level="subparagraph" style="OLC">In general.</header-in-text>—The Secretary shall—</quote>;</text> </clause><clause commented="no" display-inline="no-display-inline" id="id9475DFBD05D844B8AF33DD6E9A454031"><enum>(vi)</enum><text display-inline="yes-display-inline">by redesignating clauses (i) through (iii) of paragraph (2) (as so redesignated) as subparagraphs (A) through (C), respectively, and moving such subparagraphs, as so redesignated, 2 ems to the left;</text> </clause><clause commented="no" display-inline="no-display-inline" id="idCB33B5C3BBC041888E3DDC0C94A1EF3E"><enum>(vii)</enum><text display-inline="yes-display-inline">in paragraph (2) (as so redesignated), in the matter before subparagraph (A) (as so redesignated), by striking <quote>subparagraph (A)</quote> and inserting <quote>paragraph (1)</quote>; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="id6CE0A0022E8645B387BFCD284AA16B84"><enum>(viii)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="id661AC2AE6A0744BE9A589BE603273E08" style="OLC"> <paragraph commented="no" display-inline="no-display-inline" id="id6BB935E9CC0E4BDA9644725A79193A93"><enum>(3)</enum><header display-inline="yes-display-inline">Recruitment through referrals</header><text display-inline="yes-display-inline">In carrying out paragraph (1), the Secretary shall, in order to further the goal of including in advisory committees highly qualified and specialized experts in the specific diseases to be considered by such advisory committees, at least every 180 days, request referrals from a variety of stakeholders, such as the Institute of Medicine, the National Institutes of Health, product developers, patient groups, disease advocacy organizations, professional societies, medical societies, including the American Academy of Medical Colleges, and other governmental organizations.</text> </paragraph><after-quoted-block>;</after-quoted-block></quoted-block> </clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id8E8E0FE822BD4BAFB16DB6BE4F53E6A9"><enum>(2)</enum><text display-inline="yes-display-inline">by amending subsection (c)(2)(C) to read as follows:</text> <quoted-block display-inline="no-display-inline" id="idC6A5367E3E104A33B6E916BD70DA344A" style="OLC"> <subparagraph commented="no" display-inline="no-display-inline" id="id912A49EB320B4DF0AE50F329A1DD4B5A"><enum>(C)</enum><header display-inline="yes-display-inline">Consideration by Secretary</header><text display-inline="yes-display-inline">The Secretary shall ensure that each determination made under subparagraph (B) considers the type, nature, and magnitude of the financial interests at issue and the public health interest in having the expertise of the member with respect to the particular matter before the advisory committee.</text> </subparagraph><after-quoted-block>;</after-quoted-block></quoted-block> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id4CF79B78C8204F4EB7644401F1D0786F"><enum>(3)</enum><text display-inline="yes-display-inline">in subsection (e), by inserting <quote>, and shall make publicly available,</quote> after <quote>House of Representatives</quote>; and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idC627C3201AE44E37BD67C5EEA652B13E"><enum>(4)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="id8C7BE84ABA7442679E3FE7108449DACA" style="OLC"> <subsection commented="no" display-inline="no-display-inline" id="idD49EDB40627B4FA18A55CEFB5CD777D5"><enum>(g)</enum><header display-inline="yes-display-inline">Guidance on reported financial interest or involvement</header><text display-inline="yes-display-inline">The Secretary shall issue guidance that describes how the Secretary reviews the financial interests and involvement of advisory committee members that are reported under subsection (c)(1) but that the Secretary determines not to meet the definition of a disqualifying interest under section 208 of title 18, United States Code for the purposes of participating in a particular matter.</text> </subsection><after-quoted-block>. </after-quoted-block></quoted-block> </paragraph></section><section commented="no" display-inline="no-display-inline" id="id25DE34E7D5AC479AAA4921FDFA039BBB" section-type="subsequent-section"><enum>1122.</enum><header display-inline="yes-display-inline">Guidance document regarding product promotion using the Internet</header><text display-inline="no-display-inline">Not later than 2 years after the date of enactment this Act, the Secretary of Health and Human Services shall issue guidance that describes Food and Drug Administration policy regarding the promotion, using the Internet (including social media), of medical products that are regulated by such Administration.</text> </section><section commented="no" display-inline="no-display-inline" id="id3055B0FC8BF64AE0BA5F66F0FEFDC0E4" section-type="subsequent-section"><enum>1123.</enum><header display-inline="yes-display-inline">Electronic submission of applications</header><text display-inline="no-display-inline">Subchapter D of chapter VII (21 U.S.C. 379k et seq.) is amended by inserting after section 745 the following:</text> <quoted-block display-inline="no-display-inline" id="HEFB610AA93864058B6F3B5F1E486DF5B" style="OLC"> <section commented="no" display-inline="no-display-inline" id="H0CE455385DA2463297E7A1CF426B3330" section-type="subsequent-section"><enum>745A.</enum><header display-inline="yes-display-inline">Electronic format for submissions</header> <subsection commented="no" display-inline="no-display-inline" id="H1AABA6E15B61402286F483887F8E4815"><enum>(a)</enum><header display-inline="yes-display-inline">Drugs and biologics</header> <paragraph commented="no" display-inline="no-display-inline" id="HCFEC138A92304E5AB614A8018F66666A"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="H1AFF29FF5E2E41AD9F1FCAFD2F082B7F"><enum>(2)</enum><header display-inline="yes-display-inline">Guidance contents</header><text display-inline="yes-display-inline">In the guidance under <internal-xref idref="HCFEC138A92304E5AB614A8018F66666A" legis-path="745A.(a)(1)">paragraph (1)</internal-xref>, the Secretary may—</text> <subparagraph commented="no" display-inline="no-display-inline" id="H16089D6D46D940028BFB86D5F071B745"><enum>(A)</enum><text display-inline="yes-display-inline">provide a timetable for establishment by the Secretary of further standards for electronic submission as required by such paragraph; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H8E20B6DBF84F4350A8BC7C577F2F348C"><enum>(B)</enum><text display-inline="yes-display-inline">set forth criteria for waivers of and exemptions from the requirements of this subsection.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H3AF7A784108540E6BADC2F4BD91FBDB2"><enum>(3)</enum><header display-inline="yes-display-inline">Exception</header><text display-inline="yes-display-inline">This subsection shall not apply to submissions described in section 561.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H18B58BA150EE456CB5D4A1DE78888311"><enum>(b)</enum><header display-inline="yes-display-inline">Devices</header> <paragraph commented="no" display-inline="no-display-inline" id="H07CF305AAE864A6BB8D4D89F0DE7E6AF"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Beginning after the issuance of final guidance implementing this paragraph, pre-submissions and submissions for devices under section 510(k), 513(f)(2)(A), 515(c), 515(d), 515(f), 520(g), 520(m), or 564 of this Act or section 351 of the Public Health Service Act, and any supplements to such pre-submissions or submissions, shall include an electronic copy of such pre-submissions or submissions.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="H4F19CDF8D5154CD9A8F968515248ACBB"><enum>(2)</enum><header display-inline="yes-display-inline">Guidance contents</header><text display-inline="yes-display-inline">In the guidance under <internal-xref idref="H07CF305AAE864A6BB8D4D89F0DE7E6AF" legis-path="745A.(b)(1)">paragraph (1)</internal-xref>, the Secretary may—</text> <subparagraph commented="no" display-inline="no-display-inline" id="H3B8B9115153440FDB2F8E23CAFFCE396"><enum>(A)</enum><text display-inline="yes-display-inline">provide standards for the electronic copy required under such paragraph; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H6734FF0BCBD6414D8975A8BE4CFA31F4"><enum>(B)</enum><text display-inline="yes-display-inline">set forth criteria for waivers of and exemptions from the requirements of this subsection.</text> </subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block> </section><section commented="no" display-inline="no-display-inline" id="id155D1D35A3B2401CAA5E338BD27444D1" section-type="subsequent-section"><enum>1124.</enum><header display-inline="yes-display-inline">Combating prescription drug abuse</header> <subsection commented="no" display-inline="no-display-inline" id="id4F739C7BB7E44F27AA058FFDE4A4E4B2"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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 <quote>Secretary</quote>), acting through the Commissioner of Food and Drugs (referred to in this section as the <quote>Commissioner</quote>) and in coordination with other Federal agencies, as appropriate, shall review current Federal initiatives and identify gaps and opportunities with respect to ensuring the safe use and disposal of prescription drugs with the potential for abuse.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="id2D8B576B44A64810AA14E32D6EA97CF6"><enum>(b)</enum><header display-inline="yes-display-inline">Report</header><text display-inline="yes-display-inline">Not later than 1 year after the date of enactment of this Act, the Secretary shall post a report on the Internet website of the Food and Drug Administration on the findings of the review under subsection (a). Such report shall include findings and recommendations on—</text> <paragraph commented="no" display-inline="no-display-inline" id="idd0a986854c9a4bf0a5a7bcef1a7db76e"><enum>(1)</enum><text display-inline="yes-display-inline">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;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idaea0e91b6f754f94bf4764c8e362afc6"><enum>(2)</enum><text display-inline="yes-display-inline">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</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id211f1a8a2ce8499c9b97224b68be83fc"><enum>(3)</enum><text display-inline="yes-display-inline">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.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ideb7bf7205b934a44b5085985cd7d98a6"><enum>(c)</enum><header display-inline="yes-display-inline">Guidance on abuse-deterrent products</header><text display-inline="yes-display-inline">Not later than 6 months after the date of enactment of this Act, the Secretary, acting through the Commissioner, shall promulgate guidance on the development of abuse-deterrent drug products.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="id136B508F6B1246F98F29BDC42907923B"><enum>(d)</enum><header display-inline="yes-display-inline">Study and report on prescription drug abuse</header><text display-inline="yes-display-inline">Not later than 1 year after the date of enactment of this Act, the Secretary shall seek to enter into an agreement with the Institute of Medicine to conduct a study and report on prescription drug abuse. Such report shall evaluate trends in prescription drug abuse, assess opportunities to inform and educate the public, patients, and health care providers on issues related to prescription drug abuse and misuse, and identify potential barriers, if any, to prescription drug monitoring program participation and implementation.</text> </subsection></section><section commented="no" display-inline="no-display-inline" id="id3C64B597B05F4571B8777FE6EE6B3E13" section-type="subsequent-section"><enum>1125.</enum><header display-inline="yes-display-inline">Tanning bed labeling</header><text display-inline="no-display-inline">Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services shall determine whether to amend the warning label requirements for sunlamp products to include specific requirements to more clearly and effectively convey the risks that such products pose for the development of irreversible damage to the eyes and skin, including skin cancer.</text> </section><section commented="no" display-inline="no-display-inline" id="id661991AEE8384F73BA9268BC0CA65E4B" section-type="subsequent-section"><enum>1126.</enum><header display-inline="yes-display-inline">Optimizing global clinical trials</header><text display-inline="no-display-inline">Subchapter E of chapter V (21 U.S.C. 360bbb et seq.), as amended by section 903, is further amended by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="id48990462b42d4536831aef1d034a1dc6" style="OLC"> <section commented="no" display-inline="no-display-inline" id="id3D9EAF6ABAD84CD8BB35893315BDF5EE" section-type="subsequent-section"><enum>569A.</enum><header display-inline="yes-display-inline">Optimizing global clinical trials</header> <subsection commented="no" display-inline="no-display-inline" id="idC67323617E444D40993CFF1A1CF5CB4C"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary shall—</text> <paragraph commented="no" display-inline="no-display-inline" id="id9998094c8832488ebbc6a68b801a1bf8"><enum>(1)</enum><text display-inline="yes-display-inline">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</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idac79dc8f7e1a4e2dba331b5955bdedce"><enum>(2)</enum><text display-inline="yes-display-inline">enhance the commitment to provide consistent parallel scientific advice to manufacturers seeking simultaneous global development of new medical products in order to—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id48b12e388e9848dabc861f3c78031080"><enum>(A)</enum><text display-inline="yes-display-inline">enhance medical product development;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id2e8c0486c11b4282960355966e1f22e2"><enum>(B)</enum><text display-inline="yes-display-inline">facilitate the use of foreign data; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id959255a6117449b397d3afdf6720dde6"><enum>(C)</enum><text display-inline="yes-display-inline">minimize the need to conduct duplicative clinical studies, preclinical studies, or non-clinical studies.</text> </subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idDD7670EDD5C04671B6456181B4402B28"><enum>(b)</enum><header display-inline="yes-display-inline">Medical product</header><text display-inline="yes-display-inline">In this section, the term <term>medical product</term> 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.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="id4F12EC53855A402FA776DFDD17EB3FC0"><enum>(c)</enum><header display-inline="yes-display-inline">Savings clause</header><text display-inline="yes-display-inline">Nothing in this section shall alter the criteria for evaluating the safety or effectiveness of a medical product under this Act.</text> </subsection></section><section commented="no" display-inline="no-display-inline" id="id5DFDA31F35444D228D4E9DBFFDE5FDAA" section-type="subsequent-section"><enum>569B.</enum><header display-inline="yes-display-inline">Use of clinical investigation data from outside the United States</header> <subsection commented="no" display-inline="no-display-inline" id="idC6C8A61F92D84491AC3914434BCEB77A"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="id569db769ebe94fb9929060647bef20e6"><enum>(b)</enum><header display-inline="yes-display-inline">Notice to sponsor</header><text display-inline="yes-display-inline">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.</text> </subsection></section><after-quoted-block>.</after-quoted-block></quoted-block> </section><section commented="no" display-inline="no-display-inline" id="idBDFCAB6460E3460097F94247B276CB96" section-type="subsequent-section"><enum>1127.</enum><header display-inline="yes-display-inline">Advancing regulatory science to promote public health innovation</header> <subsection commented="no" display-inline="no-display-inline" id="id24CDB6C90DE945CDA5935FA5CFF815CE"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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 <quote>Secretary</quote>) 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.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="idDCA9C4460E964206B2C4EFAA5267592B"><enum>(b)</enum><header display-inline="yes-display-inline">Requirements</header><text display-inline="yes-display-inline">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—</text> <paragraph commented="no" display-inline="no-display-inline" id="id4b0b46349a934276ba70ac501a0d2f59"><enum>(1)</enum><text display-inline="yes-display-inline">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;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id68901a114df24a4b893bd1c8c358445a"><enum>(2)</enum><text display-inline="yes-display-inline">identify the regulatory science priorities of the Food and Drug Administration directly related to fulfilling the mission of the agency with respect to decisionmaking concerning medical products and allocation of resources towards such regulatory science priorities;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id4efea3af4f4748f1ac3c88dbc3ed6c86"><enum>(3)</enum><text display-inline="yes-display-inline">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;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id146b1a840bb84494b22ae5c1c3bb31a0"><enum>(4)</enum><text display-inline="yes-display-inline">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</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id59f2eeede45d425897eda9095a2aaaff"><enum>(5)</enum><text display-inline="yes-display-inline">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—</text> <subparagraph commented="no" display-inline="no-display-inline" id="idd64d3cf6ad5a43bbad04d2c664fbbe68"><enum>(A)</enum><text display-inline="yes-display-inline">development, updating, and consistent application of guidance documents that support medical product decisionmaking; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id7f464dca7ac14e87b18c9ad1e0f3c89b"><enum>(B)</enum><text display-inline="yes-display-inline">the adoption of the tools, methods, and processes under section 566 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–5).</text> </subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idB4267386747D4A7FB4C99084A33AD30D"><enum>(c)</enum><header display-inline="yes-display-inline">Annual performance reports</header><text display-inline="yes-display-inline">As part of the annual performance reports submitted to Congress under sections 736B(a) (as amended by section 104), 738A(a) (as amended by section 204), 744C(a) (as added by section 303), and 744I(a) (as added by section 403) of the Federal Food, Drug, and Cosmetic Act for each of fiscal years 2013 through 2017, the Secretary shall annually report on the progress made with respect to—</text> <paragraph commented="no" display-inline="no-display-inline" id="id659fa2e5d91b4b53bc277a9e16263dd1"><enum>(1)</enum><text display-inline="yes-display-inline">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;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="ida439ace6919349878d6be019124ca214"><enum>(2)</enum><text display-inline="yes-display-inline">the integration and adoption of advances in regulatory science as set forth in paragraph (5) of such subsection; and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idb42f52f13f054f0b931d0432bd49ae89"><enum>(3)</enum><text display-inline="yes-display-inline">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.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idbc94bd0da73e481dbbae989d9e73b53f"><enum>(d)</enum><header display-inline="yes-display-inline">Independent assessment</header><text display-inline="yes-display-inline">Not later than January 1, 2016, the Comptroller General of the United States shall submit to Congress a report—</text> <paragraph commented="no" display-inline="no-display-inline" id="idc363fc8322e44d1c9d119836e256d510"><enum>(1)</enum><text display-inline="yes-display-inline">detailing the progress made by the Food and Drug Administration in meeting the priorities and addressing the gaps identified in subsection (b), including any outstanding gaps; and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idc8c185c65ece42bdbf9e41e072c8d27b"><enum>(2)</enum><text display-inline="yes-display-inline">containing recommendations, as appropriate, on how regulatory science initiatives for medical products can be strengthened and improved to promote the public health and advance innovation in regulatory decisionmaking.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id936633B695504A95962D06ED549C1D5D"><enum>(e)</enum><header display-inline="yes-display-inline">Medical product</header><text display-inline="yes-display-inline">In this section, the term <term>medical product</term> 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.</text> </subsection></section><section commented="no" display-inline="no-display-inline" id="id181161DBB8C84C229A6A95827F1D59D9" section-type="subsequent-section"><enum>1128.</enum><header display-inline="yes-display-inline">Information technology</header> <subsection commented="no" display-inline="no-display-inline" id="id79FD936E927C4A7083BBED1629BA5E3C"><enum>(a)</enum><header display-inline="yes-display-inline">HHS report</header><text display-inline="yes-display-inline">Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services shall—</text> <paragraph commented="no" display-inline="no-display-inline" id="id7ead688dc2f848159a0cdfc6ce3afebb"><enum>(1)</enum><text display-inline="yes-display-inline">report to Congress on—</text> <subparagraph commented="no" display-inline="no-display-inline" id="idfe9e2888f136483695b77522788d243e"><enum>(A)</enum><text display-inline="yes-display-inline">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;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idc2210d11b21c4a55896b1363e82ef685"><enum>(B)</enum><text display-inline="yes-display-inline">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;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idaec5a2ea9eca44fb8b0b67bba2a208f0"><enum>(C)</enum><text display-inline="yes-display-inline">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</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id3775f2cecaf64db196255a2b8ea80123"><enum>(D)</enum><text display-inline="yes-display-inline">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</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id83ea1a0a3a864574b89dfa01c541225d"><enum>(2)</enum><text display-inline="yes-display-inline">develop—</text> <subparagraph commented="no" display-inline="no-display-inline" id="iddcde10265de5467ab9429f9da196937f"><enum>(A)</enum><text display-inline="yes-display-inline">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</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id3c2ed3c25fb548f2975217763a73034d"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text> </subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idB9F559EC8122403F8D70BF8F7932BA72"><enum>(b)</enum><header display-inline="yes-display-inline">GAO report</header><text display-inline="yes-display-inline">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—</text> <paragraph commented="no" display-inline="no-display-inline" id="id6c8cca0939a247a6879031cb8edf8991"><enum>(1)</enum><text display-inline="yes-display-inline">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);</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idde3b7eb6fcd341e692b1701a1a1ab6a6"><enum>(2)</enum><text display-inline="yes-display-inline">the effectiveness of the comprehensive information technology strategic plan described in subsection (a)(1)(A), including the results-oriented goals and performance measures; and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idc2a1641b30f0476ea101158a68187e2a"><enum>(3)</enum><text display-inline="yes-display-inline">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.</text> </paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="id7BF93CEE866046198C105A91FAEF36AA" section-type="subsequent-section"><enum>1129.</enum><header display-inline="yes-display-inline">Reporting requirements</header><text display-inline="no-display-inline">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:</text> <quoted-block display-inline="no-display-inline" id="id5e39afcd70b042d18e1378261d278c73" style="OLC"> <section commented="no" display-inline="no-display-inline" id="id1BA9EA50C45E42298010948B9B870D40" section-type="subsequent-section"><enum>715.</enum><header display-inline="yes-display-inline">Reporting requirements</header> <subsection commented="no" display-inline="no-display-inline" id="id522314D806F2407D922A1ACE467613C8"><enum>(a)</enum><header display-inline="yes-display-inline">New drugs</header><text display-inline="yes-display-inline">Beginning with fiscal year 2013 and ending with fiscal year 2017, not later than 120 days after the end of each fiscal year for which fees are collected under part 2 of subchapter C, the Secretary shall prepare and submit to the Committee on Health Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report concerning, for all applications for approval of a new drug under section 505(b) of this Act or a new biological product under section 351(a) of the Public Health Service Act filed in the previous fiscal year—</text> <paragraph commented="no" display-inline="no-display-inline" id="ide940ce19bbef4827bc58498926455133"><enum>(1)</enum><text display-inline="yes-display-inline">the number of such applications that met the goals identified for purposes of part 2 of subchapter C in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idb9d317dbf56c4cfe85269700ad507345"><enum>(2)</enum><text display-inline="yes-display-inline">the percentage of such applications that were approved;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="ide742636fb12f4d948053bd328f626a7c"><enum>(3)</enum><text display-inline="yes-display-inline">the percentage of such applications that were issued complete response letters;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idd86aabf117bb4718bcc25e66cdb66205"><enum>(4)</enum><text display-inline="yes-display-inline">the percentage of such applications that were subject to a refuse-to-file action;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id988d00bcd36a453eb8fce15d40896959"><enum>(5)</enum><text display-inline="yes-display-inline">the percentage of such applications that were withdrawn; and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id784cc7dbad7d40d689798899335bbf6f"><enum>(6)</enum><text display-inline="yes-display-inline">the average total time to decision by the Secretary for all applications for approval of a new drug under section 505(b) of this Act or a new biological product under section 351(a) of the Public Health Service Act filed in the previous fiscal year, including the number of calendar days spent during the review by the Food and Drug Administration and the number of calendar days spent by the sponsor responding to a complete response letter.</text> </paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block> <quoted-block display-inline="no-display-inline" id="ide8b0de49c855470583068cb026c5e04a" style="OLC"> <subsection commented="no" display-inline="no-display-inline" id="id3fdf131048684a369de7824f2a2abb33"><enum>(b)</enum><header display-inline="yes-display-inline">Generic drugs</header><text display-inline="yes-display-inline">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—</text> <paragraph commented="no" display-inline="no-display-inline" id="id7f074a9b31fa4e69ad771521aaced4b5"><enum>(1)</enum><text display-inline="yes-display-inline">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;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id5b30369d6bb94109a0f27fbe3a1b6138"><enum>(2)</enum><text display-inline="yes-display-inline">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;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id753e35b331404f268b219d9d00fe3738"><enum>(3)</enum><text display-inline="yes-display-inline">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 <short-title>Food and Drug Administration Safety and Innovation Act</short-title>; and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idc2df9cfc0b2c492fbd098ebf40c37b9c"><enum>(4)</enum><text display-inline="yes-display-inline">the number of applications described in paragraph (3) on which the Food and Drug Administration took final regulatory action in the previous fiscal year.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id11EDEA326EE4475E917279053ECD6760"><enum>(c)</enum><header display-inline="yes-display-inline">Biosimilar biological products</header> <paragraph commented="no" display-inline="no-display-inline" id="idD8C2D319F8444DF9842A69AC6C117185"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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—</text> <subparagraph commented="no" display-inline="no-display-inline" id="idfd15304625804865845c660406d1fec3"><enum>(A)</enum><text display-inline="yes-display-inline">the number of applications for approval filed under section 351(k) of the Public Health Service Act; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id04c0642ff20c47bd85746b442812addc"><enum>(B)</enum><text display-inline="yes-display-inline">the percentage of applications described in subparagraph (A) that were approved by the Secretary.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idaf45372e42954eaa841ca9370a3f65ae"><enum>(2)</enum><header display-inline="yes-display-inline">Additional information</header><text display-inline="yes-display-inline">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.</text> </paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block> </section><section commented="no" display-inline="no-display-inline" id="idBAC37FAED291465599AED244F3CF9833" section-type="subsequent-section"><enum>1130.</enum><header display-inline="yes-display-inline">Strategic integrated management plan</header> <subsection commented="no" display-inline="no-display-inline" id="id51A2CC47ACA048A8BF8369AC36821E97"><enum>(a)</enum><header display-inline="yes-display-inline">Strategic integrated management plan</header><text display-inline="yes-display-inline">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 <quote>Secretary</quote>) 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—</text> <paragraph commented="no" display-inline="no-display-inline" id="id12d39be232bc4bb59ac0af18d3bfb6e4"><enum>(1)</enum><text display-inline="yes-display-inline">identify strategic institutional goals and priorities for the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id1a2cac617e0046ecb082cd9f1d113bd7"><enum>(2)</enum><text display-inline="yes-display-inline">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</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idd7658a5ea02c4d95b3b1d611df8c3f49"><enum>(3)</enum><text display-inline="yes-display-inline">identify results-oriented, outcome-based measures that the Secretary will use to measure the progress of achieving the strategic goals and priorities identified under paragraph (1) and the effectiveness of the actions identified under paragraph (2), including metrics to ensure that managers and reviewers of the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health are familiar with and appropriately and consistently apply the requirements under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), including new requirements under parts 2, 3, 7, and 8 of subchapter C of title VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379f et seq.).</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idd1e834f975174001ada2e63204eb0eb1"><enum>(b)</enum><header display-inline="yes-display-inline">Report</header><text display-inline="yes-display-inline">Not later than January 1, 2016, the Comptroller General of the United States shall issue a report regarding the strategic management plan described in subsection (a) and related actions carried out by the Food and Drug Administration. Such report shall—</text> <paragraph commented="no" display-inline="no-display-inline" id="id9c36a47e8762494ab294884282ca2715"><enum>(1)</enum><text display-inline="yes-display-inline">assess the effectiveness of the actions described in subsection (a)(2) in recruiting, retaining, training, and developing the workforce at the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health in fulfilling the public health mission of the Food and Drug Administration;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id7d29cf2230f34bfdb285eff801a1988f"><enum>(2)</enum><text display-inline="yes-display-inline">assess the effectiveness of the measures identified under subsection (a)(3) in gauging progress against the strategic goals and priorities identified under subsection (a)(1);</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id68c1ed8b232940bfb5cf53afa4fb7db0"><enum>(3)</enum><text display-inline="yes-display-inline">assess the extent to which the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health are using the identified results-oriented set of performance measures in tracking their workload by strategic goals and the effectiveness of such measures;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idab055e3d536f48d18ede231b198f34cf"><enum>(4)</enum><text display-inline="yes-display-inline">assess the extent to which performance information is collected, analyzed, and acted on by managers; and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id1c851927b6574b49b138722dd3d38f83"><enum>(5)</enum><text display-inline="yes-display-inline">make recommendations, as appropriate, regarding how the strategic management plan and related actions of the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health could be improved to fulfill the public health mission of the Food and Drug Administration in as efficient and effective manner as possible.</text> </paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="id98AA948567AB4F1596CEDDBF28F6CB82" section-type="subsequent-section"><enum>1131.</enum><header display-inline="yes-display-inline">Drug development and testing</header> <subsection commented="no" display-inline="no-display-inline" id="id5FA5D67B56A847099285AD1729B20E04"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 505–1 (21 U.S.C. 355–1) is amended by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="id7ff74c5d00894f3197d7a666cad2ed8c" style="OLC"> <subsection commented="no" display-inline="no-display-inline" id="id60FAAC6001AF4DDC8CCB322F49FFF38F"><enum>(k)</enum><header display-inline="yes-display-inline">Drug development and testing</header> <paragraph commented="no" display-inline="no-display-inline" id="id642a5bfa3aeb44898d7edd2e8c2d5cad"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Notwithstanding any other provision of law, if a drug is a covered drug, no elements to ensure safe use shall prohibit, or be construed or applied to prohibit, supply of such drug to any eligible drug developer for the purpose of conducting testing necessary to support an application under subsection (b)(2) or (j) of section 505 of this Act or section 351(k) of the Public Health Service Act, if the Secretary has issued a written notice described in paragraph (2), and the eligible drug developer has agreed to comply with the terms of the notice.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id7ec27007723f490fba949d5fa79d5b83"><enum>(2)</enum><header display-inline="yes-display-inline">Written notice</header><text display-inline="yes-display-inline">For purposes of this subsection, the Secretary shall, within a reasonable period of time, consider and respond to a request by an eligible drug developer for a written notice authorizing the supply of a covered drug for purposes of testing as described in paragraph (1), and the Secretary shall issue a written notice to such eligible drug developer and the holder of an application for a covered drug authorizing the supply of such drug to such eligible drug developer for purposes of testing if—</text> <subparagraph commented="no" display-inline="no-display-inline" id="iddc43d2ad3cc042359320fcc43448ae70"><enum>(A)</enum><text display-inline="yes-display-inline">the eligible drug developer has agreed to comply with any conditions the Secretary considers necessary;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id878d5d23ffaa451eba24aee65c38afda"><enum>(B)</enum><text display-inline="yes-display-inline">in the event the eligible drug developer is conducting bioequivalence or other clinical testing, the eligible drug developer has submitted, and the Secretary has approved, a protocol that includes protections that the Secretary finds will provide assurance of safety comparable to the assurance of safety provided by the elements to ensure safe use in the risk evaluation and mitigation strategy for the covered drug as applicable to such testing; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ided99527155f04dc79aa4db93926427d2"><enum>(C)</enum><text display-inline="yes-display-inline">the eligible drug developer is in compliance with applicable laws and regulations related to such testing, including any applicable requirements related to Investigational New Drug Applications or informed consent.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idf2a5026dabdc48bda8e84475af3821a0"><enum>(3)</enum><header display-inline="yes-display-inline">Additional required element</header><text display-inline="yes-display-inline">The Secretary shall require as an element of each risk evaluation and mitigation strategy with elements to ensure safe use approved by the Secretary that the holder of an application for a covered drug shall not restrict the resale of the covered drug to an eligible drug developer that receives a written notice from the Secretary under paragraph (2) unless, at any time, the Secretary provides written notice to the holder of the application directing otherwise based on a shortage of such drug for patients, national security concerns related to access to such drug, or such other reason as the Secretary may specify.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id63ab5c82ba024aa1b61805800a225c53"><enum>(4)</enum><header display-inline="yes-display-inline">Violation and penalties</header><text display-inline="yes-display-inline">For purposes of subsection (f)(8) and sections 301, 303(f)(4), 502(y), and 505(p), it shall be a violation of the risk evaluation and mitigation strategy for the holder of the application for a covered drug to violate the element described in paragraph (3), or in the case of a holder of an application that is a sole distributor or supplier of a covered drug, to prevent the sale thereof after receipt of a written notice by the Secretary issued under paragraph (2). The Secretary shall provide written notice to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives within 30 days of the Secretary becoming aware that a holder of an application of a covered drug has restricted the sale of such a covered drug to any eligible drug developer after receipt of written notice as provided in paragraph (2).</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id84b79d54324b4994b1d83ce178c47d22"><enum>(5)</enum><header display-inline="yes-display-inline">Liability</header><text display-inline="yes-display-inline">Unless the holder of the application for a covered drug and the eligible developer are the same entity, the holder of an application for a covered drug shall not be liable for any claim arising out of the eligible drug developer’s testing necessary to support an application under subsection (b)(2) or (j) of section 505 of this Act or section 351(k) of the Public Health Service Act for a drug obtained under this subsection. Nothing in this subsection shall be construed to expand or limit the liability of the eligible drug developer or the holder of an application for a covered drug for any other claim.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="ide29db4fa897c455c8baf176f22d30aaa"><enum>(6)</enum><header display-inline="yes-display-inline">Certification</header><text display-inline="yes-display-inline">In any request for supply of a covered drug for purposes of testing as described in paragraph (1), an eligible drug developer shall certify to the Secretary that—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id440bf81bae2e4a95becb32343a4a8c06"><enum>(A)</enum><text display-inline="yes-display-inline">the eligible drug developer will comply with all conditions the Secretary considers necessary, any protocol approved by the Secretary, and all applicable laws and regulations pertaining to such testing; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idfdff9fd15ac24772866c4f9ec56ee953"><enum>(B)</enum><text display-inline="yes-display-inline">the eligible drug developer intends to submit an application under subsection (b)(2) or (j) of section 505 of this Act or section 351(k) of the Public Health Service Act for the drug for which it is requesting written notice pursuant to paragraph (2), and will use the covered drug only for the purpose of conducting testing to support such an application.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idec9b8f802642479b8e04c4c259fef190"><enum>(7)</enum><header display-inline="yes-display-inline">Definitions</header> <subparagraph commented="no" display-inline="no-display-inline" id="id715a898c7ea640cfb7e92673ab6565f1"><enum>(A)</enum><header display-inline="yes-display-inline">Covered drug</header><text display-inline="yes-display-inline">Notwithstanding subsection (b)(2), for purposes of this subsection, the term <term>covered drug</term> means a drug, including a biological product licensed under section 351(a) of the Public Health Service Act, that is subject to a risk evaluation and mitigation strategy with elements to ensure safe use under subsection (f), or a drug, including a biological product licensed under section 351(a) of the Public Health Service Act, required to have a risk evaluation and mitigation strategy with elements to ensure safe use under section 909(b) of the Food and Drug Administration Amendments Act of 2007.</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id4eec44302cc144c5b896fa5cb82ffcbd"><enum>(B)</enum><header display-inline="yes-display-inline">Eligible drug developer</header><text display-inline="yes-display-inline">For purposes of this subsection, the term <term>eligible drug developer</term> means a sponsor that has submitted, or intends to submit, an application under subsection (b)(2) or (j) of section 505 of this Act or section 351(k) of the Public Health Service Act to market a version of the covered drug in the United States.</text> </subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id5c820c492d3042e2af4d8e3840240b30"><enum>(8)</enum><header display-inline="yes-display-inline">Effect on other law</header><text display-inline="yes-display-inline">Notwithstanding the provisions of this subsection, the antitrust statutes enforced by the Federal Trade Commission, including the Federal Trade Commission Act (15 U.S.C. 41–58), the Sherman Act (15 U.S.C. 1–7), and any other statute properly under such Commission’s jurisdiction, shall apply to the conduct described in this subsection to the same extent as such statutes did on the day before the date of enactment of this subsection.</text> </paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block> </subsection><subsection commented="no" display-inline="no-display-inline" id="idc0f3f87b9937429eba93587321e1fe4f"><enum>(b)</enum><header display-inline="yes-display-inline">Technical and conforming amendments</header> <paragraph commented="no" display-inline="no-display-inline" id="id45f41968cd554ca6a64e5f7309a158bb"><enum>(1)</enum><text display-inline="yes-display-inline">Section 505–1(c)(2) (21 U.S.C. 355–1(c)(2)) is amended by striking <quote>(e) and (f)</quote> and inserting <quote>(e), (f), and (k)(3)</quote>.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idc7e66b993f4b49cab01eb4dbd57fb06c"><enum>(2)</enum><text display-inline="yes-display-inline">Section 502(y) (21 U.S.C. 352(y)) is amended by striking “”(d), (e), or (f) of section 505–1” and inserting <quote>(d), (e), (f), or (k)(3) of section 505–1</quote>.</text> </paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="id66AAA82DC88343548C444D4924CEFFA0" section-type="subsequent-section"><enum>1132.</enum><header display-inline="yes-display-inline">Patient participation in medical product discussions</header><text display-inline="no-display-inline">Subchapter E of chapter V (21 U.S.C. 360bbb et seq.), as amended by section 1126, is further amended by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="id3b08a034950f4aea98d912ba12fb899c" style="OLC"> <section commented="no" display-inline="no-display-inline" id="id09E9E055580A474686814E3EA99A9F1F" section-type="subsequent-section"><enum>569C.</enum><header display-inline="yes-display-inline">Patient participation in medical product discussion</header> <subsection commented="no" display-inline="no-display-inline" id="idB8538203650E4069BBD91E6B7E2D3C89"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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—</text> <paragraph commented="no" display-inline="no-display-inline" id="id8d9098b4b49a4382bf80c87f2e2f0fb0"><enum>(1)</enum><text display-inline="yes-display-inline">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</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id5aec27d86b0c47a8bd1605c659d2aebe"><enum>(2)</enum><text display-inline="yes-display-inline">exploring means to provide for identification of patient representatives who do not have any, or have minimal, financial interests in the medical products industry.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idd8f549d906ee4f1bbd361d188ec76aa3"><enum>(b)</enum><header display-inline="yes-display-inline">Financial interest</header><text display-inline="yes-display-inline">In this section, the term <term>financial interest</term> means a financial interest under section 208(a) of title 18, United States Code.</text> </subsection></section><after-quoted-block>.</after-quoted-block></quoted-block> </section><section commented="no" display-inline="no-display-inline" id="id58C3DF620278485EB28EFD19B56C1BC5" section-type="subsequent-section"><enum>1133.</enum><header display-inline="yes-display-inline">Nanotechnology regulatory science program</header> <subsection commented="no" display-inline="no-display-inline" id="id126D421184694BF987B6213F96EBCC19"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Chapter X (21 U.S.C. 391 et seq.) is amended by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="id72A190B48EE04FD682A6A4FBCF7B477C" style="OLC"> <section commented="no" display-inline="no-display-inline" id="id76AEF6C6342C47C1833DEBB7A47BF39A" section-type="subsequent-section"><enum>1013.</enum><header display-inline="yes-display-inline">Nanotechnology regulatory science program</header> <subsection commented="no" display-inline="no-display-inline" id="id3e38dceab9bd473b8fb25ea1613d6a3a"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than 180 days after the date of enactment of the <short-title>Food and Drug Administration Safety and Innovation Act</short-title>, the Secretary, in consultation as appropriate with the Secretary of Agriculture, shall establish within the Food and Drug Administration a Nanotechnology Regulatory Science Program (referred to in this section as the <quote>program</quote>) to enhance scientific knowledge regarding nanomaterials included or intended for inclusion in products regulated under this Act 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 materials, the effects of such materials on biological systems, and interaction of such materials with biological systems.</text> </subsection><subsection commented="no" display-inline="no-display-inline" id="id222bf25ebba440ce97015b95cacba7ea"><enum>(b)</enum><header display-inline="yes-display-inline">Program purposes</header><text display-inline="yes-display-inline">The purposes of the program established under subsection (a) may include—</text> <paragraph commented="no" display-inline="no-display-inline" id="idd217666b24eb4757affc19f972f1454a"><enum>(1)</enum><text display-inline="yes-display-inline">assessing scientific literature and data on general nanomaterials interactions with biological systems and on specific nanomaterials of concern to the Food and Drug Administration;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="ided359a25c02d479e97dbd5ad1c7a7a1a"><enum>(2)</enum><text display-inline="yes-display-inline">in cooperation with other Federal agencies, developing and organizing 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;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id71d1bc5ca3c7412389af5c71b9c86d78"><enum>(3)</enum><text display-inline="yes-display-inline">promoting Food and Drug Administration programs and participate in collaborative efforts, to further the understanding of the science of novel properties of nanomaterials that might contribute to toxicity;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id2fb55fe7f6574024b2b5288baf6df711"><enum>(4)</enum><text display-inline="yes-display-inline">promoting and participating in collaborative efforts to further the understanding of measurement and detection methods for nanomaterials;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id6c1f6ed964b843f5bf77e9df47e08695"><enum>(5)</enum><text display-inline="yes-display-inline">collecting, synthesizing, interpreting, and disseminating scientific information and data related to the interactions of nanomaterials with biological systems;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id56957059d268472588a30bf019246159"><enum>(6)</enum><text display-inline="yes-display-inline">building 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;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id85964d4faca2467eb813d00b6d038663"><enum>(7)</enum><text display-inline="yes-display-inline">ensuring 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;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idf9b2a9952e914a10a28073feeca4cad4"><enum>(8)</enum><text display-inline="yes-display-inline">encouraging the Food and Drug Administration to participate in international and national consensus standards activities pertaining to nanomaterials; and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idfd027180cc4745dc9152c20e49901cb6"><enum>(9)</enum><text display-inline="yes-display-inline">carrying out other activities that the Secretary determines are necessary and consistent with the purposes described in paragraphs (1) through (8).</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id608c8e99230440f9bcfe125953542632"><enum>(c)</enum><header display-inline="yes-display-inline">Program Administration</header> <paragraph commented="no" display-inline="no-display-inline" id="id4d074ab582164fdfb78525271b65e84a"><enum>(1)</enum><header display-inline="yes-display-inline">Designated individual</header><text display-inline="yes-display-inline">In carrying out the program under this section, the Secretary, acting through the Commissioner of Food and Drugs, may designate an appropriately qualified individual who shall supervise the planning, management, and coordination of the program.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="iddf51dd68d8cf4498ad68da4b7b827e99"><enum>(2)</enum><header display-inline="yes-display-inline">Duties</header><text display-inline="yes-display-inline">The duties of the individual designated under paragraph (1) may include—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id79733a75bfce42c3af52493fe17e5d6b"><enum>(A)</enum><text display-inline="yes-display-inline">developing a detailed strategic plan for achieving specific short- and long-term technical goals for the program;</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idadcb6fde731e4edd86d1de6765be4d71"><enum>(B)</enum><text display-inline="yes-display-inline">coordinating and integrating the strategic plan with activities by the Food and Drug Administration and other departments and agencies participating in the National Nanotechnology Initiative; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id72a91f7fad244e95810b32d0b5f78fd0"><enum>(C)</enum><text display-inline="yes-display-inline">developing Food and Drug Administration programs, contracts, memoranda of agreement, joint funding agreements, and other cooperative arrangements necessary for meeting the long-term challenges and achieving the specific technical goals of the program.</text> </subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id286a519b9bd6437490fbf7110764e188"><enum>(d)</enum><header display-inline="yes-display-inline">Report</header><text display-inline="yes-display-inline">Not later than March 15, 2015, the Secretary shall publish on the Internet Web site of the Food and Drug Administration a report on the program carried out under this section. Such report shall include—</text> <paragraph commented="no" display-inline="no-display-inline" id="idac058d1a4e7f43f59eb587f8ecd73500"><enum>(1)</enum><text display-inline="yes-display-inline">a review of the specific short- and long-term goals of the program;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id58f80f544fe842f99cfa03717d9fe48a"><enum>(2)</enum><text display-inline="yes-display-inline">an assessment of current and proposed funding levels for the program, including an assessment of the adequacy of such funding levels to support program activities; and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idc02ae0c7e4894394802df07851dec56c"><enum>(3)</enum><text display-inline="yes-display-inline">a review of the coordination of activities under the program with other departments and agencies participating in the National Nanotechnology Initiative.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idbe33b2dd58f5406f9c0d38ebc5f3df43"><enum>(e)</enum><header display-inline="yes-display-inline">Effect of section</header><text display-inline="yes-display-inline">Nothing in this section shall affect the authority of the Secretary under any other provision of this Act or other statutes administered by the Food and Drug Administration.</text> </subsection></section><after-quoted-block>.</after-quoted-block></quoted-block> </subsection><subsection commented="no" display-inline="no-display-inline" id="id9e76536724ef4af19a785b5a1416e0f2"><enum>(b)</enum><header display-inline="yes-display-inline">Effective date; sunset</header><text display-inline="yes-display-inline">The Nanotechnology Regulatory Science Program authorized under section 1013 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)) shall take effect on October 1, 2012, or the date of the enactment of this Act, whichever is later. Such Program shall cease to be effective October 1, 2017.</text> </subsection></section><section commented="no" display-inline="no-display-inline" id="id22316519AF344B1DAA25E91879D6EBEE" section-type="subsequent-section"><enum>1134.</enum><header display-inline="yes-display-inline">Online pharmacy report to Congress</header><text display-inline="no-display-inline">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 websites that violate Federal or State law, including—</text> <paragraph commented="no" display-inline="no-display-inline" id="id6305EAB60EB24403BDC8165D20890209"><enum>(1)</enum><text display-inline="yes-display-inline">the methods by which Internet websites are used to sell prescription drugs in violation of Federal or State law or established industry standards;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idFDF22C1FC265404C9F0E43E603900BA5"><enum>(2)</enum><text display-inline="yes-display-inline">the harmful health effects that patients experience when they consume prescription drugs purchased through such pharmacy Internet websites;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id6D918E8C3CD348A2B7DD8BE18CBE3BEA"><enum>(3)</enum><text display-inline="yes-display-inline">efforts by the Federal Government and State and local governments to investigate and prosecute the owners or operators of pharmacy Internet websites, to address the threats such websites pose, and to protect patients;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idBC6BD405FD2546F7B9AF83F5E757D923"><enum>(4)</enum><text display-inline="yes-display-inline">the level of success that Federal, State, and local governments have experienced in investigating and prosecuting such cases;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id3BA77559446747EDA908CD12D44ED09D"><enum>(5)</enum><text display-inline="yes-display-inline">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 websites;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idD91609E9C232496FB7BD2642112CFCAE"><enum>(6)</enum><text display-inline="yes-display-inline">additional authorities that could assist Federal, State, and local governments in investigating and prosecuting the owners and operators of pharmacy Internet websites;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idC1D3FBFD508B4CADBC0FA4F2397FEBBC"><enum>(7)</enum><text display-inline="yes-display-inline">laws, policies, and activities that would educate consumers about how to distinguish pharmacy Internet websites that comply with Federal and State laws and established industry standards from those pharmacy Internet websites that do not comply with such laws and standards; and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id7DEBC69C1CE94D46AD9FE3B35B6AEB20"><enum>(8)</enum><text display-inline="yes-display-inline">laws, policies, and activities that would encourage private sector actors to take steps to address the prevalence of illegitimate pharmacy Internet websites.</text> </paragraph></section><section commented="no" display-inline="no-display-inline" id="id4BFF9DD0C0F54EEDAB6DB4D3EAC1ED03" section-type="subsequent-section"><enum>1135.</enum><header display-inline="yes-display-inline">Medication and device errors</header><text display-inline="no-display-inline">The Secretary of Health and Human Services shall continue and further coordinate activities of the Department of Health and Human Services related to the prevention of medication and device errors, including consideration of medication and device errors that affect the pediatric patient population. In developing initiatives to address medication and device errors, the Secretary shall consider the root causes of medication and device errors, including pediatric medication and device errors, in the clinical setting and consult with relevant stakeholders on effective strategies to reduce and prevent medication and device errors in the clinical setting.</text> </section><section commented="no" display-inline="no-display-inline" id="idB18155B58298433E8D641A70A82D0359" section-type="subsequent-section"><enum>1136.</enum><header display-inline="yes-display-inline">Compliance provision</header><text display-inline="no-display-inline">The budgetary effects of this Act, for the purpose of complying with the Statutory Pay-As-You-Go-Act of 2010, shall be determined by reference to the latest statement titled <quote>Budgetary Effects of PAYGO Legislation</quote> for this Act, submitted for printing in the Congressional Record by the Chairman of the Senate Budget Committee, provided that such statement has been submitted prior to the vote on passage.</text> </section><section id="id1F8BF9929630404F8F830AA57193C66B"><enum>1137.</enum><header>Ensuring adequate information regarding pharmaceuticals for all populations, particularly underrepresented subpopulations, including racial subgroups</header> <subsection commented="no" id="idF544BEFF8FAB46FDAC58247A074AB625"><enum>(a)</enum><header>Communication plan</header><text>The Secretary of Health and Human Services (referred to in this section as the <quote>Secretary</quote>), 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, patients, and payors on the benefits and risks of medical products, with particular focus on underrepresented subpopulations, including racial subgroups.</text> </subsection><subsection commented="no" id="id0568BB635D9F4F6D9A64C356A1A6E9AB"><enum>(b)</enum><header>Content</header><text>The communication plan described under subsection (a)—</text> <paragraph commented="no" id="idAAC5C9229FAD44FEA0F84DD2573A064A"><enum>(1)</enum><text>shall take into account—</text> <subparagraph commented="no" id="idE3449D3EB0C54D7F9D149547E09228B8"><enum>(A)</enum><text>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;</text> </subparagraph><subparagraph commented="no" id="id8A8586A99E0C4FF8965D36E11DB6CD4D"><enum>(B)</enum><text>the nature of the medical product; and</text> </subparagraph><subparagraph commented="no" id="idB0E2BC6D1EF6486FA1CD03B3684F3274"><enum>(C)</enum><text>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;</text> </subparagraph></paragraph><paragraph commented="no" id="idB2C7B15CBCF9470FAF97A7F1186F9F0B"><enum>(2)</enum><text>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 healthcare 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</text> </paragraph><paragraph commented="no" id="id1FD069FEEB9248CEB14D8755B0129591"><enum>(3)</enum><text>shall include a process for implementation of any improvements or other modifications determined to be necessary.</text> </paragraph></subsection><subsection commented="no" id="idD3436C3DA6F941E5B8731CAE962450F7"><enum>(c)</enum><header>Issuance and posting of communication plan</header> <paragraph commented="no" id="idD56C6903C9B7402B8EDCC7A39D7705A1"><enum>(1)</enum><header>Communication plan</header><text>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.</text> </paragraph><paragraph commented="no" id="id3669B3DC201C4FB88AD5BC78870DB2BB"><enum>(2)</enum><header>Posting of communication plan on the Office of Minority Health website</header><text>The Secretary, acting through the Commissioner of Food and Drugs, shall publicly post the communication plan on the Internet website of the Office of Minority Health of the Food and Drug Administration, and provide links to any other appropriate webpage, and seek public comment on the communication plan.</text> </paragraph></subsection></section><section id="id949AFDF5ED7747CA94B46DFDA34D7130"><enum>1138.</enum><header>Report on small businesses</header><text display-inline="no-display-inline">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—</text> <paragraph id="idf99f7b7e5d84421ca165b2730da511ae"><enum>(1)</enum><text>a listing of and staffing levels of all small business offices at the Food and Drug Administration, including the small business liaison program;</text> </paragraph><paragraph id="idc1a20c6fd8e046bbb924d4b8e068cbef"><enum>(2)</enum><text>the status of partnership efforts between the Food and Drug Administration and the Small Business Administration;</text> </paragraph><paragraph id="id9613ae8bb5f54a20808ce5f8194a345b"><enum>(3)</enum><text>a summary of outreach efforts to small businesses and small business associations, including availability of toll-free telephone help lines;</text> </paragraph><paragraph id="id5f0b29eebacd4bf2b6eba3b52dda3db9"><enum>(4)</enum><text>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, the amount of tax credits issued for clinical research, and the number of companies receiving protocol assistance for the development of drugs for rare diseases and disorders;</text> </paragraph><paragraph id="id7a3063feedda436b81841bdf33d9b971"><enum>(5)</enum><text>with respect to waivers and reductions for small business under the Prescription Drug User Fee Act, the number of small businesses applying for and receiving waivers and reductions from drug user fees under subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379f et seq.);</text> </paragraph><paragraph id="id4858cb7772c842c795bb1985f92d4aa0"><enum>(6)</enum><text>the number of small businesses submitting applications and receiving approval for unsolicited grant applications from the Food and Drug Administration;</text> </paragraph><paragraph id="id960c0520de0648c7b2908dc1a862ea60"><enum>(7)</enum><text>the number of small businesses submitting applications and receiving approval for solicited grant applications from the Food and Drug Administration;</text> </paragraph><paragraph id="idef495443c322413fbd24905e31010053"><enum>(8)</enum><text>barriers small businesses encounter in the drug and medical device approval process; and</text> </paragraph><paragraph id="idcf45761d2a404adeb131f8ffa8050954"><enum>(9)</enum><text>recommendations for changes in the user fee structure to help alleviate generic drug shortages.</text> </paragraph></section><section id="idA42B5D9A8A3C42099B425FB394223584"><enum>1139.</enum><header>Protections for the commissioned corps of the public health service act</header> <subsection id="id0CDF442627B641A3849B2AF270449564"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 221(a) of the Public Health Service Act (42 U.S.C. 213a(a)) is amended by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="idEA149E4C2D9D44FBA772857AA54DFCF6" style="OLC"> <paragraph id="id43515D7DB45A44519061A3995E12DACB"><enum>(18)</enum><text>Section 1034, Protected Communications; Prohibition of Retaliatory Personnel Actions.</text> </paragraph><after-quoted-block>.</after-quoted-block></quoted-block> </subsection><subsection id="id7323990AB7A8428F9551AE297C9275E1"><enum>(b)</enum><header>Conforming amendment</header><text>Section 221(b) of the Public Health Service Act (42 U.S.C. 213a(b)) is amended by adding at the end the following: <quote>For purposes of paragraph (18) of subsection (a), the term <quote>Inspector General</quote> in section 1034 of such title 10 shall mean the Inspector General of the Department of Health and Human Services.</quote>.</text> </subsection></section><section id="idBA054046D42746D3AB722B9E619F00D4"><enum>1140.</enum><header>Regulations on clinical trial registration; GAO Study of clinical trial registration and reporting requirements</header> <subsection id="id5225D3418F89405E867BF0F3AA6CE769"><enum>(a)</enum><header>Definitions</header><text>In this section—</text> <paragraph id="idD836C63384FB4F4D92E66159B1C73015"><enum>(1)</enum><text>the term <term>applicable clinical trial</term> has the meaning given such term under section 402(j) of the Public Health Service Act (42 U.S.C. 282(j));</text> </paragraph><paragraph id="id794308691BAD48FD964DC50BC7CF1300"><enum>(2)</enum><text>the term <term>Director</term> means the Director of the National Institutes of Health;</text> </paragraph><paragraph id="idC533F9E2C9634D3EB2E2C00F8F130708"><enum>(3)</enum><text>the term <term>responsible party</term> has the meaning given such term under such section 402(j); and</text> </paragraph><paragraph id="idAAE47FEF9EDE4400999862A5F5066ED3"><enum>(4)</enum><text>the term <term>Secretary</term> means the Secretary of Health and Human Services.</text> </paragraph></subsection><subsection id="idB6E7F6E1FD394411BEF3E8C729846902"><enum>(b)</enum><header>Required regulations</header> <paragraph id="id81A462A848B14C0A952AFEA68C79638E"><enum>(1)</enum><header>Proposed rulemaking</header><text>Not later than 180 days after the date of enactment of this Act, the Secretary, acting through the Director, shall issue a notice of proposed rulemaking for a proposed rule on the registration of applicable clinical trials by responsible parties under section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)) (as amended by section 801 of the Food and Drug Administration Amendments Act of 2007).</text> </paragraph><paragraph id="idCD0530CA33F3482AA821BFFD6FBD35C8"><enum>(2)</enum><header>Final rule</header><text>Not later than 180 days after the issuance of the notice of proposed rulemaking under paragraph (1), the Secretary, acting through the Director, shall issue the final rule on the registration of applicable clinical trials by responsible parties under such section 402(j).</text> </paragraph><paragraph id="id1A3222A93BF0409AA444200F339DC813"><enum>(3)</enum><header>Letter to Congress</header><text>If the final rule described in paragraph (2) is not issued by the date required under such paragraph, the Secretary shall submit to Congress a letter that describes the reasons why such final rule has not been issued.</text> </paragraph></subsection><subsection id="id95997B2FA035444E82FD3C80643D81B3"><enum>(c)</enum><header>Report by GAO</header> <paragraph id="idAE446092F65A48F08AC35A537FC08EC7"><enum>(1)</enum><header>In general</header><text>Not later than 2 years after the issuance of the final rule under subsection (b), 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 on the implementation of the registration and reporting requirements for applicable drug and device clinical trials under section 402(j) the Public Health Service Act (42 U.S.C. 282(j)) (as amended by section 801 of the Food and Drug Administration Amendments Act of 2007).</text> </paragraph><paragraph id="id99FA7318420B46588A78EF17319681B6"><enum>(2)</enum><header>Content</header><text>The report under paragraph (1) shall include—</text> <subparagraph id="id4495614859BF48A5AFA25FC4E8AD3663"><enum>(A)</enum><text>information on the rate of compliance and non-compliance (by category of sponsor, category of trial (phase II, III, or IV), whether the applicable clinical trial is conducted domestically, in foreign sites, or a combination of sites, and such other categories as the Comptroller General determines useful) with the requirements of—</text> <clause id="id28a59ea8e3bd496f859b66404dc149ea"><enum>(i)</enum><text>registering applicable clinical trials under such section 402(j);</text> </clause><clause id="ide4b4f5d7e2e74d129b3a3108af9fbada"><enum>(ii)</enum><text>reporting the results of such trials under such section; and</text> </clause><clause id="id17b97e23572748f8a9b3f8a22a26a55c"><enum>(iii)</enum><text>the completeness of the reporting of the required data under such section; and</text> </clause></subparagraph><subparagraph id="id0F36DD8AA60047E58EA99D3340939EAA"><enum>(B)</enum><text>information on the promulgation of regulations for the registration of applicable clinical trials by the responsible parties under such section 402(j).</text> </subparagraph></paragraph><paragraph id="idFD69AE89B673478A9B164EDB78B0132D"><enum>(3)</enum><header>Recommendations</header><text>If the Comptroller General finds problems with timely compliance or completeness of the data being reported under such section 402(j), or finds that the implementation of registration and reporting requirements under such section 402(j) for applicable drug and device clinical trials could be improved, the Comptroller General shall, after consulting with the Commissioner of Food and Drugs, applicable stakeholders, and experts in the conduct of clinical trials, make recommendations for administrative or legislative actions to increase the compliance with the requirements of such section 402(j).</text> </paragraph></subsection></section><section id="id315A226E813140A19B4835657239FF9D"><enum>1141.</enum><header>Hydrocodone amendment</header><text display-inline="no-display-inline">The Controlled Substances Act is amended—</text> <paragraph id="id857F8A3BFC98450ABF2FC83970CB7617"><enum>(1)</enum><text>in schedule III(d) in section 202(c) (21 U.S.C. 812(c)), by—</text> <subparagraph id="id05EF2FC48CA64CC59896C391F21970A2"><enum>(A)</enum><text>striking paragraphs (3) and (4); and</text> </subparagraph><subparagraph id="idCA683581E4D640FBBF61F8A70B33BDED"><enum>(B)</enum><text>redesignating paragraphs (5), (6), (7), and (8) as paragraphs (3), (4), (5), and (6), respectively; and</text> </subparagraph></paragraph><paragraph id="id1B1F4270309F4B59A3F3B49A2AD22ADD"><enum>(2)</enum><text>in section 401(b)(1) (21 U.S.C. 841(b)(1)), by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="idEEB37F5693F74295B016EE94BB2B10C2" style="OLC"> <subparagraph id="idC179F687AE8A4AD3A5897FC7B0337679" indent="up1"><enum>(F)</enum><text>In the case of any material, compound, mixture, or preparation containing—</text> <clause id="id6666E20A406A4AA997884897E3AB13E3"><enum>(i)</enum><text>not more than 300 milligrams of dihydrocodeinone per 100 milliliters or not more than 15 milligrams per dosage unit, with a fourfold or greater quantity of an isoquinoline alkaloid of opium; or</text> </clause><clause id="id8132E3799F9347779776625A5FEE87D1"><enum>(ii)</enum><text>not more than 300 milligrams of dihydrocodeinone per 100 milliliters or not more than 15 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts,</text> </clause><continuation-text continuation-text-level="subparagraph" indent="paragraph">subparagraph (C) shall not apply and such case shall be subject to subparagraph (E).</continuation-text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph></section><section id="idEF771AA7F6CB4228B719039D9C261C82"><enum>1142.</enum><header>Compliance date for rule relating to sunscreen drug products for over-the-counter human use</header><text display-inline="no-display-inline">In accordance with the final rule issued by the Commissioner of Food and Drug entitled <quote>Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the- Counter Human Use; Delay of Compliance Dates</quote> (77 Fed. Reg. 27591 (May 11, 2012)), a product subject to the final rule issued by the Commissioner entitled <quote>Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use</quote> (76 Fed. Reg. 35620 (June 17, 2011)), shall comply with such rule not later than—</text> <paragraph id="id4C0A0BD15CA34A9CA37F4439558A63BA"><enum>(1)</enum><text display-inline="yes-display-inline">December 17, 2013, for products subject to such rule with annual sales of less than $25,000 and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idE449443B139F4A118BEA2B047FBDFE26"><enum>(2)</enum><text display-inline="yes-display-inline">December 17, 2012, for all other products subject to such rule.</text> </paragraph></section><section id="idF02F635A8C8D42EFB434288D43A164F3"><enum>1143.</enum><header>Recommendations on interoperability standards</header> <subsection id="id3160541F45294A8AAE56B5630672E2E5"><enum>(a)</enum><header>In general</header><text>The Attorney General and the Secretary of Health and Human Services may collaborate to facilitate the development of recommendations on interoperability standards to inform and facilitate the exchange of prescription information across State lines by States receiving grant funds under—</text> <paragraph id="id95b851109ca9493298f3059269f58c65"><enum>(1)</enum><text>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</text> </paragraph><paragraph id="id15e60dc24a884817bc6f7b238652a591"><enum>(2)</enum><text>the Controlled Substance Monitoring Program established under section 399O of the Public Health Service Act (42 U.S.C. 280g–3).</text> </paragraph></subsection><subsection id="id7b265f7d4e754e8aaadd3600d97495ad"><enum>(b)</enum><header>Requirements</header><text>The Attorney General and 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)—</text> <paragraph id="id9609bddd99264c1a82203e3c092488e9"><enum>(1)</enum><text>open standards that are freely available, without cost and without restriction, in order to promote broad implementation;</text> </paragraph><paragraph id="idfcb5893d2fc24e87a9cdc19d6c8329a8"><enum>(2)</enum><text>the use of exchange intermediaries, or hubs, as necessary to facilitate interstate interoperability by accommodating State-to-hub and direct State-to-State communication;</text> </paragraph><paragraph id="id99b8c0b411884d6ea07087a4bfb98253"><enum>(3)</enum><text>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; and</text> </paragraph><paragraph id="id4f198235310c4c46890e79cf4244b4e1"><enum>(4)</enum><text>access control methodologies to share protected information solely in accordance with State laws and regulations.</text> </paragraph></subsection><subsection id="id4D2BDAA92E034F3890C6E950B1EB0B1D"><enum>(c)</enum><header>Report</header> <paragraph id="id8E6BA7ED0802458D94CAE8B53C7FFD5C"><enum>(1)</enum><header>In general</header><text>Not later than 1 year after the date of enactment of this Act, the Attorney General, in consultation with the Secretary of Health and Human Services, shall submit to the Committee on the Judiciary and the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on the Judiciary and the Committee on Energy and Commerce of the House of Representatives a report on enhancing the interoperability of State prescription monitoring programs with other technologies and databases used for detecting and reducing fraud, diversion, and abuse of prescription drugs.</text> </paragraph><paragraph id="id16F6077AD14B469391E5F2F514AF8DA4"><enum>(2)</enum><header>Contents</header><text>The report required under paragraph (1) shall include—</text> <subparagraph id="id2ee807d3dad5477ea54dc1c3ed2d9242"><enum>(A)</enum><text>an assessment of legal, technical, fiscal, privacy, or security challenges that have an impact on interoperability;</text> </subparagraph><subparagraph id="id810a2e596e6a485291f07f5324e3495b"><enum>(B)</enum><text>a discussion of how State prescription 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; and</text> </subparagraph><subparagraph id="id1f1cecfa6e034c95bcfefa79786b2754"><enum>(C)</enum><text>any recommendations for addressing challenges that impact interoperability of State prescription monitoring programs in order to reduce fraud, diversion, and abuse of prescription drugs.</text> </subparagraph></paragraph></subsection></section></subtitle><subtitle id="id200A51169ED74B7B808B5225139464B0"><enum>D</enum><header>Synthetic drugs</header> <section id="idF98876EC23C04AC7B212D9EA4C4BA4F1"><enum>1151.</enum><header>Short title</header><text display-inline="no-display-inline">This subtitle may be cited as the <quote><short-title>Synthetic Drug Abuse Prevention Act of 2012 </short-title></quote>.</text> </section><section id="H68BBF0BF5CF040A1B2AF2897A9C6F97B"><enum>1152.</enum><header>Addition of synthetic drugs to schedule I of the Controlled Substances Act</header> <subsection id="HA3AFB6ADE2EE454F99C5DE64040049C8"><enum>(a)</enum><header>Cannabimimetic agents</header><text>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:</text> <quoted-block id="H5732835EC4294BDDA3E8E2416EA9A097" style="OLC"> <subsection id="HE4B3A00200D346FE94240557C4465056"><enum>(d)</enum><paragraph commented="no" display-inline="yes-display-inline" id="H298A745894464136B030FF9FBE8E6564"><enum>(1)</enum><text>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.</text> </paragraph><paragraph id="HDADB90D64937455C9FBF0FD33FE5F22A" indent="up1"><enum>(2)</enum><text>In paragraph (1):</text> <subparagraph id="HCC93119C0CA14B40B8B3C78AB60633E4"><enum>(A)</enum><text>The term <quote>cannabimimetic agents</quote> 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:</text> <clause id="H4AF0CEBCC50443A9858EC9C212A14AA5"><enum>(i)</enum><text>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.</text> </clause><clause id="H6812DD8577594CFE878F0030071ECD8F"><enum>(ii)</enum><text>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.</text> </clause><clause id="H1675BFBB90414F58AE0072DBA64C1C27"><enum>(iii)</enum><text>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.</text> </clause><clause id="HE4881DE80E8245C9A2D5AFD7384340A9"><enum>(iv)</enum><text>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.</text> </clause><clause id="HBB03F0533E424673AE8958AC98EE6439"><enum>(v)</enum><text>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.</text> </clause></subparagraph><subparagraph id="HC6922C3BA3BD497E8956DDEDEC838731"><enum>(B)</enum><text>Such term includes—</text> <clause id="H5E002E3D3CC5411A94D4E1DA517A0F4C"><enum>(i)</enum><text>5-(1,1-dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (CP–47,497);</text> </clause><clause id="HBD79902BAC5C4E57963CAEEDF002053C"><enum>(ii)</enum><text>5-(1,1-dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP–47,497 C8-homolog);</text> </clause><clause id="HFB635EFD755B4074ADB1D4ECA0765C03"><enum>(iii)</enum><text>1-pentyl-3-(1-naphthoyl)indole (JWH–018 and AM678);</text> </clause><clause id="HDC6A23E1EB3D4968863832A245C14470"><enum>(iv)</enum><text>1-butyl-3-(1-naphthoyl)indole (JWH–073);</text> </clause><clause id="H7DD4927A77B74353BAB5A6816EAAD0BE"><enum>(v)</enum><text>1-hexyl-3-(1-naphthoyl)indole (JWH–019);</text> </clause><clause id="H8313A0FFD094415995A7A03708AFC1D0"><enum>(vi)</enum><text>1-[2-(4-morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH–200);</text> </clause><clause id="H498CE563AD754CAE8D2349CF1BB70073"><enum>(vii)</enum><text>1-pentyl-3-(2-methoxyphenylacetyl)indole (JWH–250);</text> </clause><clause id="H1561527489DC4D0E9A4930C0A8BEFD9F"><enum>(viii)</enum><text>1-pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH–081);</text> </clause><clause id="H183522F1845C44AD8835E6B50A872CE2"><enum>(ix)</enum><text>1-pentyl-3-(4-methyl-1-naphthoyl)indole (JWH–122);</text> </clause><clause id="H6D9C270EA9014BA694FD4F43B0C2514B"><enum>(x)</enum><text>1-pentyl-3-(4-chloro-1-naphthoyl)indole (JWH–398);</text> </clause><clause id="H7AC8AEBA5D7A4771A3FF1B6D56306C49"><enum>(xi)</enum><text>1-(5-fluoropentyl)-3-(1-naphthoyl)indole (AM2201);</text> </clause><clause id="H5F4D3ECC1EAD4DE3B0C67BA611EE683F"><enum>(xii)</enum><text>1-(5-fluoropentyl)-3-(2-iodobenzoyl)indole (AM694);</text> </clause><clause id="H5E0CD81F09B54D17B74A029FF3B392A4"><enum>(xiii)</enum><text>1-pentyl-3-[(4-methoxy)-benzoyl]indole (SR–19 and RCS–4);</text> </clause><clause id="HF147B180F29848718A4B044F48FAF81D"><enum>(xiv)</enum><text>1-cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR–18 and RCS–8); and</text> </clause><clause id="HB3173BFF5E284B2687EC9D9A33A5151E"><enum>(xv)</enum><text>1-pentyl-3-(2-chlorophenylacetyl)indole (JWH–203).</text> </clause></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block> </subsection><subsection id="H34A1E2B0A68E4A3BBFC9953BBE8FB37C"><enum>(b)</enum><header>Other drugs</header><text>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:</text> <quoted-block id="H30A9FE56407341AD8E0DC38E8604AD0E" style="OLC"> <paragraph id="H73212616CC3C4A04807B4177566D61DA"><enum>(18)</enum><text>4-methylmethcathinone (Mephedrone).</text> </paragraph><paragraph id="HA1007F55F387449BA37B7AB7BB7BC210"><enum>(19)</enum><text>3,4-methylenedioxypyrovalerone (MDPV).</text> </paragraph><paragraph id="H07535EA376464D08ADBD884D3E43C839"><enum>(20)</enum><text display-inline="yes-display-inline">2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C–E).</text> </paragraph><paragraph id="HF21C3215310D41F2BEB83499CC5DC297"><enum>(21)</enum><text>2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C–D).</text> </paragraph><paragraph id="HBA068EEA46384F4692F87B5C7EBCB45C"><enum>(22)</enum><text>2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C–C).</text> </paragraph><paragraph id="H1E9775CEF2F343D6A7694EEC0E36D4C4"><enum>(23)</enum><text>2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C–I).</text> </paragraph><paragraph id="H21E21EF50F5D40369CCD3AA3773EBADA"><enum>(24)</enum><text>2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C–T–2).</text> </paragraph><paragraph id="HFE65502D8F9B40239B5FADEAF337CF0A"><enum>(25)</enum><text>2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C–T–4).</text> </paragraph><paragraph id="H46EA7C6A228F4FFB81C52F24F75AE767"><enum>(26)</enum><text>2-(2,5-Dimethoxyphenyl)ethanamine (2C–H).</text> </paragraph><paragraph id="HDAA9B9AA336A4DC384E2019C864E68BA"><enum>(27)</enum><text>2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C–N).</text> </paragraph><paragraph id="H807A25741C944E9D9E7420A30841DDE4"><enum>(28)</enum><text>2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine (2C–P).</text> </paragraph><after-quoted-block>.</after-quoted-block></quoted-block> </subsection></section><section id="H8BAB9D3FF75A4FEDA005645C27937DC2"><enum>1153.</enum><header>Temporary scheduling to avoid imminent hazards to public safety expansion</header><text display-inline="no-display-inline">Section 201(h)(2) of the Controlled Substances Act (21 U.S.C. 811(h)(2)) is amended—</text> <paragraph id="H4BE74B2348E841DA9962E1808314A57F"><enum>(1)</enum><text>by striking <quote>one year</quote> and inserting <quote>2 years</quote>; and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="HE6AFFC5890F74491B345550B88D9594C"><enum>(2)</enum><text>by striking <quote>six months</quote> and inserting <quote>1 year</quote>.</text> </paragraph></section><section id="id65F2F78CFC574A10A9A99A592C8C94BE"><enum>1154.</enum><header>Prohibition on imposing mandatory minimum sentences</header><text display-inline="no-display-inline">Section 401(b)(1)(C) of the Controlled Substances Act (21 U.S.C. 841(b)(1)(C)) is amended by adding at the end the following: <quote>Any mandatory minimum term of imprisonment required to be imposed under this subparagraph shall not apply with respect to any controlled substance added to schedule I by the <short-title>Synthetic Drug Abuse Prevention Act of 2012</short-title>.</quote>.</text> </section></subtitle> Passed the Senate May 24, 2012. Secretary