112TH CONGRESS 

2D SESSION S. 3187 

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 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 
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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Food and Drug Ad3 ministration Safety and Innovation Act’’. 

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

5 (a) TABLE OF CONTENTS.—The table of contents of 

6 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. 
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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. 
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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. 
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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. 

1 (b) REFERENCES IN ACT.—Except as otherwise spec2 ified, amendments made by this Act to a section or other 

3 provision of law are amendments to such section or other 

4 provision of the Federal Food, Drug, and Cosmetic Act 

5 (21 U.S.C. 301 et seq.). 

6 TITLE I—FEES RELATING TO 

7 DRUGS 

8 SEC. 101. SHORT TITLE; FINDING. 

9 (a) SHORT TITLE.—This title may be cited as the 

10 ‘‘Prescription Drug User Fee Amendments of 2012’’. 
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1 (b) FINDING.—The Congress finds that the fees au2 thorized by the amendments made in this title will be dedi3 cated toward expediting the drug development process and 

4 the process for the review of human drug applications, in5 cluding postmarket drug safety activities, as set forth in 

6 the goals identified for purposes of part 2 of subchapter 

7 C of chapter VII of the Federal Food, Drug, and Cosmetic 

8 Act, in the letters from the Secretary of Health and 

9 Human Services to the Chairman of the Committee on 

10 Health, Education, Labor, and Pensions of the Senate and 

11 the Chairman of the Committee on Energy and Commerce 

12 of the House of Representatives, as set forth in the Con13 gressional Record. 

14 SEC. 102. DEFINITIONS. 

15 Paragraph (7) of section 735 (21 U.S.C. 379g) is 

16 amended, in the matter preceding subparagraph (A), by 

17 striking ‘‘incurred’’. 

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

19 Section 736 (21 U.S.C. 379h) is amended— 

20 (1) in subsection (a)— 

21 (A) in the matter preceding paragraph (1), 

22 by striking ‘‘fiscal year 2008’’ and inserting 

23 ‘‘fiscal year 2013’’; 

24 (B) in paragraph (1), in clauses (i) and (ii) 

25 of subparagraph (A), by striking ‘‘subsection 
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1 (c)(5)’’ each place such term appears and in2 serting ‘‘subsection (c)(4)’’; 

3 (C) in the matter following clause (ii) in 

4 paragraph (2)(A)— 

5 (i) by striking ‘‘subsection (c)(5)’’ and 

6 inserting ‘‘subsection (c)(4)’’; and 

7 (ii) by striking ‘‘payable on or before 

8 October 1 of each year’’ and inserting 

9 ‘‘due on the later of the first business day 

10 on or after October 1 of each fiscal year or 

11 the first business day after the enactment 

12 of an appropriations Act providing for the 

13 collection and obligation of fees for such 

14 fiscal year under this section’’; and 

15 (D) in paragraph (3)— 

16 (i) in subparagraph (A)— 

17 (I) by striking ‘‘subsection 

18 (c)(5)’’ and inserting ‘‘subsection 

19 (c)(4)’’; and 

20 (II) by striking ‘‘payable on or 

21 before October 1 of each year.’’ and 

22 inserting ‘‘due on the later of the first 

23 business day on or after October 1 of 

24 each fiscal year or the first business 

25 day after the enactment of an appro-
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1 priations Act providing for the collec2 tion and obligation of fees for such 

3 fiscal year under this section.’’; and 

4 (ii) by amending subparagraph (B) to 

5 read as follows: 

6 ‘‘(B) EXCEPTION.—A prescription drug 

7 product shall not be assessed a fee under sub8 paragraph (A) if such product is— 

9 ‘‘(i) identified on the list compiled 

10 under section 505(j)(7) with a potency de11 scribed in terms of per 100 mL; 

12 ‘‘(ii) the same product as another 

13 product that— 

14 ‘‘(I) was approved under an ap15 plication filed under section 505(b) or 

16 505(j); and 

17 ‘‘(II) is not in the list of discon18 tinued products compiled under sec19 tion 505(j)(7); 

20 ‘‘(iii) the same product as another 

21 product that was approved under an abbre22 viated application filed under section 507 

23 (as in effect on the day before the date of 

24 enactment of the Food and Drug Adminis25 tration Modernization Act of 1997); or 
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1 ‘‘(iv) the same product as another 

2 product that was approved under an abbre3 viated new drug application pursuant to 

4 regulations in effect prior to the implemen5 tation of the Drug Price Competition and 

6 Patent Term Restoration Act of 1984.’’; 

7 (2) in subsection (b)— 

8 (A) in paragraph (1)— 

9 (i) in the matter preceding subpara10 graph (A), by striking ‘‘fiscal years 2008 

11 through 2012’’ and inserting ‘‘fiscal years 

12 2013 through 2017’’; 

13 (ii) in subparagraph (A), by striking 

14 ‘‘$392,783,000; and’’ and inserting 

15 ‘‘$693,099,000;’’; and 

16 (iii) by striking subparagraph (B) and 

17 inserting the following: 

18 ‘‘(B) the dollar amount equal to the infla19 tion adjustment for fiscal year 2013 (as deter20 mined under paragraph (3)(A)); and 

21 ‘‘(C) the dollar amount equal to the work22 load adjustment for fiscal year 2013 (as deter23 mined under paragraph (3)(B)).’’; and 

24 (B) by striking paragraphs (3) and (4) and 

25 inserting the following: 
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1 ‘‘(3) FISCAL YEAR 2013 INFLATION AND WORK2 LOAD ADJUSTMENTS.—For purposes of paragraph 

3 (1), the dollar amount of the inflation and workload 

4 adjustments for fiscal year 2013 shall be determined 

5 as follows: 

6 ‘‘(A) INFLATION ADJUSTMENT.—The infla7 tion adjustment for fiscal year 2013 shall be 

8 the sum of— 

9 ‘‘(i) $652,709,000 multiplied by the 

10 result of an inflation adjustment calcula11 tion determined using the methodology de12 scribed in subsection (c)(1)(B); and 

13 ‘‘(ii) $652,709,000 multiplied by the 

14 result of an inflation adjustment calcula15 tion determined using the methodology de16 scribed in subsection (c)(1)(C). 

17 ‘‘(B) WORKLOAD ADJUSTMENT.—Subject 

18 to subparagraph (C), the workload adjustment 

19 for fiscal 2013 shall be— 

20 ‘‘(i) $652,709,000 plus the amount of 

21 the inflation adjustment calculated under 

22 subparagraph (A); multiplied by 

23 ‘‘(ii) the amount (if any) by which a 

24 percentage workload adjustment for fiscal 

25 year 2013, as determined using the meth-
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1 odology described in subsection (c)(2)(A), 

2 would exceed the percentage workload ad3 justment (as so determined) for fiscal year 

4 2012, if both such adjustment percentages 

5 were calculated using the 5-year base pe6 riod consisting of fiscal years 2003 

7 through 2007. 

8 ‘‘(C) LIMITATION.—Under no cir9 cumstances shall the adjustment under sub10 paragraph (B) result in fee revenues for fiscal 

11 year 2013 that are less than the sum of the 

12 amount under paragraph (1)(A) and the 

13 amount under paragraph (1)(B).’’; 

14 (3) by striking subsection (c) and inserting the 

15 following: 

16 ‘‘(c) ADJUSTMENTS.— 

17 ‘‘(1) INFLATION ADJUSTMENT.—For fiscal year 

18 2014 and subsequent fiscal years, the revenues es19 tablished in subsection (b) shall be adjusted by the 

20 Secretary by notice, published in the Federal Reg21 ister, for a fiscal year by the amount equal to the 

22 sum of— 

23 ‘‘(A) one; 

24 ‘‘(B) the average annual percent change in 

25 the cost, per full-time equivalent position of the 
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1 Food and Drug Administration, of all personnel 

2 compensation and benefits paid with respect to 

3 such positions for the first 3 years of the pre4 ceding 4 fiscal years, multiplied by the propor5 tion of personnel compensation and benefits 

6 costs to total costs of the process for the review 

7 of human drug applications (as defined in sec8 tion 735(6)) for the first 3 years of the pre9 ceding 4 fiscal years; and 

10 ‘‘(C) the average annual percent change 

11 that occurred in the Consumer Price Index for 

12 urban consumers (Washington-Baltimore, DC– 

13 MD–VA–WV; Not Seasonally Adjusted; All 

14 items; Annual Index) for the first 3 years of the 

15 preceding 4 years of available data, multiplied 

16 by the proportion of all costs other than per17 sonnel compensation and benefits costs to total 

18 costs of the process for the review of human 

19 drug applications (as defined in section 735(6)) 

20 for the first 3 years of the preceding 4 fiscal 

21 years. 

22 The adjustment made each fiscal year under this 

23 paragraph shall be added on a compounded basis to 

24 the sum of all adjustments made each fiscal year 

25 after fiscal year 2013 under this paragraph. 
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1 ‘‘(2) WORKLOAD ADJUSTMENT.—For fiscal 

2 year 2014 and subsequent fiscal years, after the fee 

3 revenues established in subsection (b) are adjusted 

4 for a fiscal year for inflation in accordance with 

5 paragraph (1), the fee revenues shall be adjusted 

6 further for such fiscal year to reflect changes in the 

7 workload of the Secretary for the process for the re8 view of human drug applications. With respect to 

9 such adjustment: 

10 ‘‘(A) The adjustment shall be determined 

11 by the Secretary based on a weighted average 

12 of the change in the total number of human 

13 drug applications (adjusted for changes in re14 view activities, as described in the notice that 

15 the Secretary is required to publish in the Fed16 eral Register under this subparagraph), efficacy 

17 supplements, and manufacturing supplements 

18 submitted to the Secretary, and the change in 

19 the total number of active commercial investiga20 tional new drug applications (adjusted for 

21 changes in review activities, as so described) 

22 during the most recent 12-month period for 

23 which data on such submissions is available. 

24 The Secretary shall publish in the Federal Reg25 ister the fee revenues and fees resulting from 
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1 the adjustment and the supporting methodolo2 gies. 

3 ‘‘(B) Under no circumstances shall the ad4 justment result in fee revenues for a fiscal year 

5 that are less than the sum of the amount under 

6 subsection (b)(1)(A) and the amount under 

7 subsection (b)(1)(B), as adjusted for inflation 

8 under paragraph (1). 

9 ‘‘(C) The Secretary shall contract with an 

10 independent accounting or consulting firm to 

11 periodically review the adequacy of the adjust12 ment and publish the results of those reviews. 

13 The first review shall be conducted and pub14 lished by the end of fiscal year 2013 (to exam15 ine the performance of the adjustment since fis16 cal year 2009), and the second review shall be 

17 conducted and published by the end of fiscal 

18 year 2015 (to examine the continued perform19 ance of the adjustment). The reports shall 

20 evaluate whether the adjustment reasonably 

21 represents actual changes in workload volume 

22 and complexity and present options to dis23 continue, retain, or modify any elements of the 

24 adjustment. The reports shall be published for 

25 public comment. After review of the reports and 
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1 receipt of public comments, the Secretary shall, 

2 if warranted, adopt appropriate changes to the 

3 methodology. If the Secretary adopts changes to 

4 the methodology based on the first report, the 

5 changes shall be effective for the first fiscal 

6 year for which fees are set after the Secretary 

7 adopts such changes and each subsequent fiscal 

8 year. 

9 ‘‘(3) FINAL YEAR ADJUSTMENT.—For fiscal 

10 year 2017, the Secretary may, in addition to adjust11 ments under this paragraph and paragraphs (1) and 

12 (2), further increase the fee revenues and fees estab13 lished in subsection (b) if such an adjustment is nec14 essary to provide for not more than 3 months of op15 erating reserves of carryover user fees for the proc16 ess for the review of human drug applications for 

17 the first 3 months of fiscal year 2018. If such an 

18 adjustment is necessary, the rationale for the 

19 amount of the increase shall be contained in the an20 nual notice establishing fee revenues and fees for fis21 cal year 2017. If the Secretary has carryover bal22 ances for such process in excess of 3 months of such 

23 operating reserves, the adjustment under this para24 graph shall not be made. 
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1 ‘‘(4) ANNUAL FEE SETTING.—The Secretary 

2 shall, not later than 60 days before the start of each 

3 fiscal year that begins after September 30, 2012, es4 tablish, for the next fiscal year, application, product, 

5 and establishment fees under subsection (a), based 

6 on the revenue amounts established under subsection 

7 (b) and the adjustments provided under this sub8 section. 

9 ‘‘(5) LIMIT.—The total amount of fees charged, 

10 as adjusted under this subsection, for a fiscal year 

11 may not exceed the total costs for such fiscal year 

12 for the resources allocated for the process for the re13 view of human drug applications.’’; and 

14 (4) in subsection (g)— 

15 (A) in paragraph (1), by striking ‘‘Fees 

16 authorized’’ and inserting ‘‘Subject to para17 graph (2)(C), fees authorized’’; 

18 (B) in paragraph (2)— 

19 (i) in subparagraph (A)— 

20 (I) in clause (i), by striking 

21 ‘‘shall be retained’’ and inserting 

22 ‘‘subject to subparagraph (C), shall be 

23 collected and available’’; and 
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1 (II) in clause (ii), by striking 

2 ‘‘shall only be collected and available’’ 

3 and inserting ‘‘shall be available’’; and 

4 (ii) by adding at the end the following 

5 new subparagraph: 

6 ‘‘(C) PROVISION FOR EARLY PAYMENTS.— 

7 Payment of fees authorized under this section 

8 for a fiscal year, prior to the due date for such 

9 fees, may be accepted by the Secretary in ac10 cordance with authority provided in advance in 

11 a prior year appropriations Act.’’; 

12 (C) in paragraph (3), by striking ‘‘fiscal 

13 years 2008 through 2012’’ and inserting ‘‘fiscal 

14 years 2013 through 2017’’; and 

15 (D) in paragraph (4)— 

16 (i) by striking ‘‘fiscal years 2008 

17 through 2010’’ and inserting ‘‘fiscal years 

18 2013 through 2015’’; 

19 (ii) by striking ‘‘fiscal year 2011’’ and 

20 inserting ‘‘fiscal year 2016’’; 

21 (iii) by striking ‘‘fiscal years 2008 

22 though 2011’’ and inserting ‘‘fiscal years 

23 2013 through 2016’’; and 

24 (iv) by striking ‘‘fiscal year 2012’’ 

25 and inserting ‘‘fiscal year 2017’’. 
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1 SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS. 

2 Section 736B (21 U.S.C. 379h–2) is amended— 

3 (1) by amending subsection (a) to read as fol4 lows: 

5 ‘‘(a) PERFORMANCE REPORT.—Beginning with fiscal 

6 year 2013, not later than 120 days after the end of each 

7 fiscal year for which fees are collected under this part, 

8 the Secretary shall prepare and submit to the Committee 

9 on Energy and Commerce of the House of Representatives 

10 and the Committee on Health, Education, Labor, and 

11 Pensions of the Senate a report concerning the progress 

12 of the Food and Drug Administration in achieving the 

13 goals identified in the letters described in section 101(b) 

14 of the Prescription Drug User Fee Amendments of 2012 

15 during such fiscal year and the future plans of the Food 

16 and Drug Administration for meeting the goals. The re17 port under this subsection for a fiscal year shall include 

18 information on all previous cohorts for which the Sec19 retary has not given a complete response on all human 

20 drug applications and supplements in the cohort.’’; 

21 (2) in subsection (b), by striking ‘‘2008’’ and 

22 inserting ‘‘2013’’; and 

23 (3) in subsection (d), by striking ‘‘2012’’ each 

24 place it appears and inserting ‘‘2017’’. 
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1 SEC. 105. SUNSET DATES. 

2 (a) AUTHORIZATION.—Sections 735 and 736 of the 

3 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g; 

4 379h) shall cease to be effective October 1, 2017. 

5 (b) REPORTING REQUIREMENTS.—Section 736B of 

6 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

7 379h–2) shall cease to be effective January 31, 2018. 

8 (c) PREVIOUS SUNSET PROVISION.—Section 106 of 

9 the Prescription Drug User Fee Amendments of 2007 

10 (Title I of Public Law 110–85) is repealed. 

11 (d) TECHNICAL CLARIFICATIONS.— 

12 (1) Effective September 30, 2007, section 509 

13 of the Prescription Drug User Fee Amendments Act 

14 of 2002 (Title V of Public Law 107–188) is re15 pealed. 

16 (2) Effective September 30, 2002, section 107 

17 of the Food and Drug Administration Modernization 

18 Act of 1997 (Public Law 105–115) is repealed. 

19 (3) Effective September 30, 1997, section 105 

20 of the Prescription Drug User Fee Act of 1992 

21 (Public Law 102–571) is repealed. 

22 SEC. 106. EFFECTIVE DATE. 

23 The amendments made by this title shall take effect 

24 on October 1, 2012, or the date of the enactment of this 

25 Act, whichever is later, except that fees under part 2 of 

26 subchapter C of chapter VII of the Federal Food, Drug, 
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1 and Cosmetic Act shall be assessed for all human drug 

2 applications received on or after October 1, 2012, regard3 less of the date of the enactment of this Act. 

4 SEC. 107. SAVINGS CLAUSE. 

5 Notwithstanding the amendments made by this title, 

6 part 2 of subchapter C of chapter VII of the Federal Food, 

7 Drug, and Cosmetic Act, as in effect on the day before 

8 the date of the enactment of this title, shall continue to 

9 be in effect with respect to human drug applications and 

10 supplements (as defined in such part as of such day) that 

11 on or after October 1, 2007, but before October 1, 2012, 

12 were accepted by the Food and Drug Administration for 

13 filing with respect to assessing and collecting any fee re14 quired by such part for a fiscal year prior to fiscal year 

15 2012. 

16 TITLE II—FEES RELATING TO 

17 DEVICES 

18 SEC. 201. SHORT TITLE; FINDINGS. 

19 (a) SHORT TITLE.—This title may be cited as the 

20 ‘‘Medical Device User Fee Amendments of 2012’’. 

21 (b) FINDINGS.—The Congress finds that the fees au22 thorized under the amendments made by this title will be 

23 dedicated toward expediting the process for the review of 

24 device applications and for assuring the safety and effec25 tiveness of devices, as set forth in the goals identified for 
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1 purposes of part 3 of subchapter C of chapter VII of the 

2 Federal Food, Drug, and Cosmetic Act in the letters from 

3 the Secretary of Health and Human Services to the Chair4 man of the Committee on Health, Education, Labor, and 

5 Pensions of the Senate and the Chairman of the Com6 mittee on Energy and Commerce of the House of Rep7 resentatives, as set forth in the Congressional Record. 

8 SEC. 202. DEFINITIONS. 

9 Section 737 (21 U.S.C. 379i) is amended— 

10 (1) in paragraph (9), by striking ‘‘incurred’’ 

11 after ‘‘expenses’’; 

12 (2) in paragraph (10), by striking ‘‘October 

13 2001’’ and inserting ‘‘October 2011’’; and 

14 (3) in paragraph (13), by striking ‘‘is required 

15 to register’’ and all that follows through the end of 

16 paragraph (13) and inserting the following: ‘‘is reg17 istered (or is required to register) with the Secretary 

18 under section 510 because such establishment is en19 gaged in the manufacture, preparation, propagation, 

20 compounding, or processing of a device.’’. 

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

22 (a) TYPES OF FEES.—Section 738(a) (21 U.S.C. 

23 379j(a)) is amended— 

24 (1) in paragraph (1), by striking ‘‘fiscal year 

25 2008’’ and inserting ‘‘fiscal year 2013’’; 
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1 (2) in paragraph (2)(A)— 

2 (A) in the matter preceding clause (i)— 

3 (i) by striking ‘‘subsections (d) and 

4 (e)’’ and inserting ‘‘subsections (d), (e), 

5 and (f)’’; 

6 (ii) by striking ‘‘October 1, 2002’’ and 

7 inserting ‘‘October 1, 2012’’; and 

8 (iii) by striking ‘‘subsection (c)(1)’’ 

9 and inserting ‘‘subsection (c)’’; and 

10 (B) in clause (viii), by striking ‘‘1.84’’ and 

11 inserting ‘‘2’’; and 

12 (3) in paragraph (3)— 

13 (A) in subparagraph (A)— 

14 (i) by inserting ‘‘and subsection (f)’’ 

15 after ‘‘subparagraph (B)’’; and 

16 (ii) by striking ‘‘2008’’ and inserting 

17 ‘‘2013’’; and 

18 (B) in subparagraph (C), by striking ‘‘ini19 tial registration’’ and all that follows through 

20 ‘‘section 510.’’ and inserting ‘‘later of— 

21 ‘‘(i) the initial or annual registration 

22 (as applicable) of the establishment under 

23 section 510; or 

24 ‘‘(ii) the first business day after the 

25 date of enactment of an appropriations Act 
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1 providing for the collection and obligation 

2 of fees for such year under this section.’’. 

3 (b) FEE AMOUNTS.—Section 738(b) (21 U.S.C. 

4 379j(b)) is amended to read as follows: 

5 ‘‘(b) FEE AMOUNTS.— 

6 ‘‘(1) IN GENERAL.—Subject to subsections (c), 

7 (d), (e), (f), and (i), for each of fiscal years 2013 

8 through 2017, fees under subsection (a) shall be de9 rived from the base fee amounts specified in para10 graph (2), to generate the total revenue amounts 

11 specified in paragraph (3). 

12 ‘‘(2) BASE FEE AMOUNTS.—For purposes of 

13 paragraph (1), the base fee amounts specified in this 

14 paragraph are as follows: 

‘‘Fee Type 

Fiscal 

Year 

2013 

Fiscal 

Year 

2014 

Fiscal 

Year 

2015 

Fiscal 

Year 

2016 

Fiscal 

Year 

2017 

Premarket Application ........................ $248,000 $252,960 $258,019 $263,180 $268,443 

Establishment Registration ................ $2,575 $3,200 $3,750 $3,872 $3,872 

15 ‘‘(3) TOTAL REVENUE AMOUNTS.—For pur16 poses of paragraph (1), the total revenue amounts 

17 specified in this paragraph are as follows: 

18 ‘‘(A) $97,722,301 for fiscal year 2013. 

19 ‘‘(B) $112,580,497 for fiscal year 2014. 

20 ‘‘(C) $125,767,107 for fiscal year 2015. 

21 ‘‘(D) $129,339,949 for fiscal year 2016. 

22 ‘‘(E) $130,184,348 for fiscal year 2017.’’. 
24 

†S 3187 ES

1 (c) ANNUAL FEE SETTING; ADJUSTMENTS.—Section 

2 738(c) (21 U.S.C. 379j(c)) is amended— 

3 (1) in the subsection heading, by inserting ‘‘; 

4 ADJUSTMENTS’’ after ‘‘SETTING’’; 

5 (2) by striking paragraphs (1) and (2); 

6 (3) by redesignating paragraphs (3) and (4) as 

7 paragraphs (4) and (5), respectively; and 

8 (4) by inserting before paragraph (4), as so re9 designated, the following: 

10 ‘‘(1) IN GENERAL.—The Secretary shall, 60 

11 days before the start of each fiscal year after Sep12 tember 30, 2012, establish fees under subsection (a), 

13 based on amounts specified under subsection (b) and 

14 the adjustments provided under this subsection, and 

15 publish such fees, and the rationale for any adjust16 ments to such fees, in the Federal Register. 

17 ‘‘(2) INFLATION ADJUSTMENTS.— 

18 ‘‘(A) ADJUSTMENT TO TOTAL REVENUE

19 AMOUNTS.—For fiscal year 2014 and each sub20 sequent fiscal year, the Secretary shall adjust 

21 the total revenue amount specified in subsection 

22 (b)(3) for such fiscal year by multiplying such 

23 amount by the applicable inflation adjustment 

24 under subparagraph (B) for such year. 
25 

†S 3187 ES

1 ‘‘(B) APPLICABLE INFLATION ADJUST2 MENT TO TOTAL REVENUE AMOUNTS.—The ap3 plicable inflation adjustment for a fiscal year 

4 is— 

5 ‘‘(i) for fiscal year 2014, the base in6 flation adjustment under subparagraph (C) 

7 for such fiscal year; and 

8 ‘‘(ii) for fiscal year 2015 and each 

9 subsequent fiscal year, the product of— 

10 ‘‘(I) the base inflation adjust11 ment under subparagraph (C) for 

12 such fiscal year; and 

13 ‘‘(II) the product of the base in14 flation adjustment under subpara15 graph (C) for each of the fiscal years 

16 preceding such fiscal year, beginning 

17 with fiscal year 2014. 

18 ‘‘(C) BASE INFLATION ADJUSTMENT TO

19 TOTAL REVENUE AMOUNTS.— 

20 ‘‘(i) IN GENERAL.—Subject to further 

21 adjustment under clause (ii), the base in22 flation adjustment for a fiscal year is the 

23 sum of one plus— 

24 ‘‘(I) the average annual percent 

25 change in the cost, per full-time equiv-
26 

†S 3187 ES

1 alent position of the Food and Drug 

2 Administration, of all personnel com3 pensation and benefits paid with re4 spect to such positions for the first 3 

5 years of the preceding 4 fiscal years, 

6 multiplied by 0.60; and 

7 ‘‘(II) the average annual percent 

8 change that occurred in the Consumer 

9 Price Index for urban consumers 

10 (Washington-Baltimore, DC–MD–VA– 

11 WV; Not Seasonally Adjusted; All 

12 items; Annual Index) for the first 3 

13 years of the preceding 4 years of 

14 available data multiplied by 0.40. 

15 ‘‘(ii) LIMITATIONS.—For purposes of 

16 subparagraph (B), if the base inflation ad17 justment for a fiscal year under clause 

18 (i)— 

19 ‘‘(I) is less than 1, such adjust20 ment shall be considered to be equal 

21 to 1; or 

22 ‘‘(II) is greater than 1.04, such 

23 adjustment shall be considered to be 

24 equal to 1.04. 
27 

†S 3187 ES

1 ‘‘(D) ADJUSTMENT TO BASE FEE

2 AMOUNTS.—For each of fiscal years 2014 

3 through 2017, the base fee amounts specified in 

4 subsection (b)(2) shall be adjusted as needed, 

5 on a uniform proportionate basis, to generate 

6 the total revenue amounts under subsection 

7 (b)(3), as adjusted for inflation under subpara8 graph (A). 

9 ‘‘(3) VOLUME-BASED ADJUSTMENTS TO ESTAB10 LISHMENT REGISTRATION BASE FEES.—For each of 

11 fiscal years 2014 through 2017, after the base fee 

12 amounts specified in subsection (b)(2) are adjusted 

13 under paragraph (2)(D), the base establishment reg14 istration fee amounts specified in such subsection 

15 shall be further adjusted, as the Secretary estimates 

16 is necessary in order for total fee collections for such 

17 fiscal year to generate the total revenue amounts, as 

18 adjusted under paragraph (2).’’. 

19 (d) FEE WAIVER OR REDUCTION.—Section 738 (21 

20 U.S.C. 379j) is amended by— 

21 (1) redesignating subsections (f) through (k) as 

22 subsections (g) through (l), respectively; and 

23 (2) by inserting after subsection (e) the fol24 lowing new subsection: 

25 ‘‘(f) FEE WAIVER OR REDUCTION.— 
28 

†S 3187 ES

1 ‘‘(1) IN GENERAL.—The Secretary may, at the 

2 Secretary’s sole discretion, grant a waiver or reduc3 tion of fees under subsection (a)(2) or (a)(3) if the 

4 Secretary finds that such waiver or reduction is in 

5 the interest of public health. 

6 ‘‘(2) LIMITATION.—The sum of all fee waivers 

7 or reductions granted by the Secretary in any fiscal 

8 year under paragraph (1) shall not exceed 2 percent 

9 of the total fee revenue amounts established for such 

10 year under subsection (c). 

11 ‘‘(3) DURATION.—The authority provided by 

12 this subsection terminates October 1, 2017.’’. 

13 (e) CONDITIONS.—Section 738(h)(1)(A) (21 U.S.C. 

14 379j(h)(1)(A)), as redesignated by subsection (d)(1), is 

15 amended by striking ‘‘$205,720,000’’ and inserting 

16 ‘‘$280,587,000’’. 

17 (f) CREDITING AND AVAILABILITY OF FEES.—Sec18 tion 738(i) (21 U.S.C. 379j(i)), as redesignated by sub19 section (d)(1), is amended— 

20 (1) in paragraph (1), by striking ‘‘Fees author21 ized’’ and inserting ‘‘Subject to paragraph (2)(C), 

22 fees authorized’’; 

23 (2) in paragraph (2)— 

24 (A) in subparagraph (A)— 
29 

†S 3187 ES

1 (i) in clause (i), by striking ‘‘shall be 

2 retained’’ and inserting ‘‘subject to sub3 paragraph (C), shall be collected and avail4 able’’; and 

5 (ii) in clause (ii)— 

6 (I) by striking ‘‘collected and’’ 

7 after ‘‘shall only be’’; and 

8 (II) by striking ‘‘fiscal year 

9 2002’’ and inserting ‘‘fiscal year 

10 2009’’; and 

11 (B) by adding at the end, the following: 

12 ‘‘(C) PROVISION FOR EARLY PAYMENTS.— 

13 Payment of fees authorized under this section 

14 for a fiscal year, prior to the due date for such 

15 fees, may be accepted by the Secretary in ac16 cordance with authority provided in advance in 

17 a prior year appropriations Act.’’; 

18 (3) by amending paragraph (3) to read as fol19 lows: 

20 ‘‘(3) AUTHORIZATIONS OF APPROPRIATIONS.— 

21 For each of the fiscal years 2013 through 2017, 

22 there is authorized to be appropriated for fees under 

23 this section an amount equal to the total revenue 

24 amount specified under subsection (b)(3) for the fis25 cal year, as adjusted under subsection (c) and, for 
30 

†S 3187 ES

1 fiscal year 2017 only, as further adjusted under 

2 paragraph (4).’’; and 

3 (4) in paragraph (4)— 

4 (A) by striking ‘‘fiscal years 2008, 2009, 

5 and 2010’’ and inserting ‘‘fiscal years 2013, 

6 2014, and 2015’’; 

7 (B) by striking ‘‘fiscal year 2011’’ and in8 serting ‘‘fiscal year 2016’’; 

9 (C) by striking ‘‘June 30, 2011’’ and in10 serting ‘‘June 30, 2016’’; 

11 (D) by striking ‘‘the amount of fees speci12 fied in aggregate in’’ and inserting ‘‘the cumu13 lative amount appropriated pursuant to’’; 

14 (E) by striking ‘‘aggregate amount in’’ be15 fore ‘‘excess shall be credited’’; and 

16 (F) by striking ‘‘fiscal year 2012’’ and in17 serting ‘‘fiscal year 2017’’. 

18 (g) CONFORMING AMENDMENT.—Section 

19 515(c)(4)(A) (21 U.S.C. 360e(c)(4)(A)) is amended by 

20 striking ‘‘738(g)’’ and inserting ‘‘738(h)’’. 

21 SEC. 204. REAUTHORIZATION; REPORTING REQUIREMENTS. 

22 (a) REAUTHORIZATION.—Section 738A(b) (21 

23 U.S.C. 379j–1(b)) is amended— 

24 (1) in paragraph (1), by striking ‘‘2012’’ and 

25 inserting ‘‘2017’’; and 
31 

†S 3187 ES

1 (2) in paragraph (5), by striking ‘‘2012’’ and 

2 inserting ‘‘2017’’. 

3 (b) REPORTS.—Section 738A(a) (21 U.S.C. 379j– 

4 1(a)) is amended— 

5 (1) by striking ‘‘2008 through 2012’’ each place 

6 it appears and inserting ‘‘2013 through 2017’’; and 

7 (2) by striking ‘‘section 201(c) of the Food and 

8 Drug Administration Amendments Act of 2007’’ and 

9 inserting ‘‘section 201(b) of the Medical Device User 

10 Fee Amendments of 2012’’. 

11 SEC. 205. SAVINGS CLAUSE. 

12 Notwithstanding the amendments made by this title, 

13 part 3 of subchapter C of chapter VII of the Federal Food, 

14 Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as in 

15 effect on the day before the date of the enactment of this 

16 title, shall continue to be in effect with respect to submis17 sions described in section 738(a)(2)(A) of the Federal 

18 Food, Drug, and Cosmetic Act (as in effect as of such 

19 day) that on or after October 1, 2007, but before October 

20 1, 2012, were accepted by the Food and Drug Administra21 tion for filing with respect to assessing and collecting any 

22 fee required by such part for a fiscal year prior to fiscal 

23 year 2013. 
32 

†S 3187 ES

1 SEC. 206. EFFECTIVE DATE. 

2 The amendments made by this title shall take effect 

3 on October 1, 2012, or the date of the enactment of this 

4 Act, whichever is later, except that fees under part 3 of 

5 subchapter C of chapter VII of the Federal Food, Drug, 

6 and Cosmetic Act shall be assessed for submissions de7 scribed in section 738(a)(2)(A) of the Federal Food, 

8 Drug, and Cosmetic Act received on or after October 1, 

9 2012, regardless of the date of the enactment of this Act. 

10 SEC. 207. SUNSET DATES. 

11 (a) AUTHORIZATIONS.—Sections 737 and 738 (21 

12 U.S.C. 739i; 739j) shall cease to be effective October 1, 

13 2017. 

14 (b) REPORTING REQUIREMENTS.—Section 738A (21 

15 U.S.C. 739j–1) shall cease to be effective January 31, 

16 2018. 

17 (c) PREVIOUS SUNSET PROVISION.—Section 217 of 

18 the Medical Device User Fee Amendments of 2007 (Title 

19 II of Public Law 110–85) is repealed. 

20 (d) TECHNICAL CLARIFICATION.—Effective Sep21 tember 30, 2007, section 107 of the Medical Device User 

22 Fee and Modernization Act of 2002 (Public Law 107– 

23 250) is repealed. 
33 

†S 3187 ES

1 SEC. 208. STREAMLINED HIRING AUTHORITY TO SUPPORT 

2 ACTIVITIES RELATED TO THE PROCESS FOR 

3 THE REVIEW OF DEVICE APPLICATIONS. 

4 Subchapter A of chapter VII (21 U.S.C. 371 et seq.) 

5 is amended by inserting after section 713 the following 

6 new section: 

7 ‘‘SEC. 714. STREAMLINED HIRING AUTHORITY. 

8 ‘‘(a) IN GENERAL.—In addition to any other per9 sonnel authorities under other provisions of law, the Sec10 retary may, without regard to the provisions of title 5, 

11 United States Code, governing appointments in the com12 petitive service, appoint employees to positions in the Food 

13 and Drug Administration to perform, administer, or sup14 port activities described in subsection (b), if the Secretary 

15 determines that such appointments are needed to achieve 

16 the objectives specified in subsection (c). 

17 ‘‘(b) ACTIVITIES DESCRIBED.—The activities de18 scribed in this subsection are activities under this Act re19 lated to the process for the review of device applications 

20 (as defined in section 737(8)). 

21 ‘‘(c) OBJECTIVES SPECIFIED.—The objectives speci22 fied in this subsection are with respect to the activities 

23 under subsection (b), the goals referred to in section 

24 738A(a)(1). 
34 

†S 3187 ES

1 ‘‘(d) INTERNAL CONTROLS.—The Secretary shall in2 stitute appropriate internal controls for appointments 

3 under this section. 

4 ‘‘(e) SUNSET.—The authority to appoint employees 

5 under this section shall terminate on the date that is three 

6 years after the date of enactment of this section.’’. 

7 TITLE III—FEES RELATING TO 

8 GENERIC DRUGS 

9 SEC. 301. SHORT TITLE. 

10 (a) SHORT TITLE.—This title may be cited as the 

11 ‘‘Generic Drug User Fee Amendments of 2012’’. 

12 (b) FINDING.—The Congress finds that the fees au13 thorized by the amendments made in this title will be dedi14 cated to human generic drug activities, as set forth in the 

15 goals identified for purposes of part 7 of subchapter C 

16 of chapter VII of the Federal Food, Drug, and Cosmetic 

17 Act, in the letters from the Secretary of Health and 

18 Human Services to the Chairman of the Committee on 

19 Health, Education, Labor, and Pensions of the Senate and 

20 the Chairman of the Committee on Energy and Commerce 

21 of the House of Representatives, as set forth in the Con22 gressional Record. 
35 

†S 3187 ES

1 SEC. 302. AUTHORITY TO ASSESS AND USE HUMAN GE2 NERIC DRUG FEES. 

3 Subchapter C of chapter VII (21 U.S.C. 379f et seq.) 

4 is amended by adding at the end the following: 

5 ‘‘PART 7—FEES RELATING TO GENERIC DRUGS 

6 ‘‘SEC. 744A. DEFINITIONS. 

7 ‘‘For purposes of this part: 

8 ‘‘(1) The term ‘abbreviated new drug applica9 tion’— 

10 ‘‘(A) means an application submitted 

11 under section 505(j), an abbreviated application 

12 submitted under section 507 (as in effect on the 

13 day before the date of enactment of the Food 

14 and Drug Administration Modernization Act of 

15 1997), or an abbreviated new drug application 

16 submitted pursuant to regulations in effect 

17 prior to the implementation of the Drug Price 

18 Competition and Patent Term Restoration Act 

19 of 1984; and 

20 ‘‘(B) does not include an application for a 

21 positron emission tomography drug. 

22 ‘‘(2) The term ‘active pharmaceutical ingre23 dient’ means— 

24 ‘‘(A) a substance, or a mixture when the 

25 substance is unstable or cannot be transported 

26 on its own, intended— 
36 

†S 3187 ES

1 ‘‘(i) to be used as a component of a 

2 drug; and 

3 ‘‘(ii) to furnish pharmacological activ4 ity or other direct effect in the diagnosis, 

5 cure, mitigation, treatment, or prevention 

6 of disease, or to affect the structure or any 

7 function of the human body; or 

8 ‘‘(B) a substance intended for final crys9 tallization, purification, or salt formation, or 

10 any combination of those activities, to become a 

11 substance or mixture described in subparagraph 

12 (A). 

13 ‘‘(3) The term ‘adjustment factor’ means a fac14 tor applicable to a fiscal year that is the Consumer 

15 Price Index for all urban consumers (all items; 

16 United States city average) for October of the pre17 ceding fiscal year divided by such Index for October 

18 2011. 

19 ‘‘(4) The term ‘affiliate’ means a business enti20 ty that has a relationship with a second business en21 tity if, directly or indirectly— 

22 ‘‘(A) one business entity controls, or has 

23 the power to control, the other business entity; 

24 or 
37 

†S 3187 ES

1 ‘‘(B) a third party controls, or has power 

2 to control, both of the business entities. 

3 ‘‘(5)(A) The term ‘facility’— 

4 ‘‘(i) means a business or other entity— 

5 ‘‘(I) under one management, either di6 rect or indirect; and 

7 ‘‘(II) at one geographic location or ad8 dress engaged in manufacturing or proc9 essing an active pharmaceutical ingredient 

10 or a finished dosage form; and 

11 ‘‘(ii) does not include a business or other 

12 entity whose only manufacturing or processing 

13 activities are one or more of the following: re14 packaging, relabeling, or testing. 

15 ‘‘(B) For purposes of subparagraph (A), sepa16 rate buildings within close proximity are considered 

17 to be at one geographic location or address if the ac18 tivities in them are— 

19 ‘‘(i) closely related to the same business 

20 enterprise; 

21 ‘‘(ii) under the supervision of the same 

22 local management; and 

23 ‘‘(iii) capable of being inspected by the 

24 Food and Drug Administration during a single 

25 inspection. 
38 

†S 3187 ES

1 ‘‘(C) If a business or other entity would meet 

2 the definition of a facility under this paragraph but 

3 for being under multiple management, the business 

4 or other entity is deemed to constitute multiple fa5 cilities, one per management entity, for purposes of 

6 this paragraph. 

7 ‘‘(6) The term ‘finished dosage form’ means— 

8 ‘‘(A) a drug product in the form in which 

9 it will be administered to a patient, such as a 

10 tablet, capsule, solution, or topical application; 

11 ‘‘(B) a drug product in a form in which re12 constitution is necessary prior to administration 

13 to a patient, such as oral suspensions or 

14 lyophilized powders; or 

15 ‘‘(C) any combination of an active pharma16 ceutical ingredient with another component of a 

17 drug product for purposes of production of a 

18 drug product described in subparagraph (A) or 

19 (B). 

20 ‘‘(7) The term ‘generic drug submission’ means 

21 an abbreviated new drug application, an amendment 

22 to an abbreviated new drug application, or a prior 

23 approval supplement to an abbreviated new drug ap24 plication. 
39 

†S 3187 ES

1 ‘‘(8) The term ‘human generic drug activities’ 

2 means the following activities of the Secretary asso3 ciated with generic drugs and inspection of facilities 

4 associated with generic drugs: 

5 ‘‘(A) The activities necessary for the re6 view of generic drug submissions, including re7 view of drug master files referenced in such 

8 submissions. 

9 ‘‘(B) The issuance of— 

10 ‘‘(i) approval letters which approve 

11 abbreviated new drug applications or sup12 plements to such applications; or 

13 ‘‘(ii) complete response letters which 

14 set forth in detail the specific deficiencies 

15 in such applications and, where appro16 priate, the actions necessary to place such 

17 applications in condition for approval. 

18 ‘‘(C) The issuance of letters related to 

19 Type II active pharmaceutical drug master files 

20 which— 

21 ‘‘(i) set forth in detail the specific de22 ficiencies in such submissions, and where 

23 appropriate, the actions necessary to re24 solve those deficiencies; or 
40 

†S 3187 ES

1 ‘‘(ii) document that no deficiencies 

2 need to be addressed. 

3 ‘‘(D) Inspections related to generic drugs. 

4 ‘‘(E) Monitoring of research conducted in 

5 connection with the review of generic drug sub6 missions and drug master files. 

7 ‘‘(F) Postmarket safety activities with re8 spect to drugs approved under abbreviated new 

9 drug applications or supplements, including the 

10 following activities: 

11 ‘‘(i) Collecting, developing, and re12 viewing safety information on approved 

13 drugs, including adverse event reports. 

14 ‘‘(ii) Developing and using improved 

15 adverse-event data-collection systems, in16 cluding information technology systems. 

17 ‘‘(iii) Developing and using improved 

18 analytical tools to assess potential safety 

19 problems, including access to external data 

20 bases. 

21 ‘‘(iv) Implementing and enforcing sec22 tion 505(o) (relating to postapproval stud23 ies and clinical trials and labeling changes) 

24 and section 505(p) (relating to risk evalua25 tion and mitigation strategies) insofar as 
41 

†S 3187 ES

1 those activities relate to abbreviated new 

2 drug applications. 

3 ‘‘(v) Carrying out section 505(k)(5) 

4 (relating to adverse-event reports and 

5 postmarket safety activities). 

6 ‘‘(G) Regulatory science activities related 

7 to generic drugs. 

8 ‘‘(9) The term ‘positron emission tomography 

9 drug’ has the meaning given to the term ‘com10 pounded positron emission tomography drug’ in sec11 tion 201(ii), except that paragraph (1)(B) of such 

12 section shall not apply. 

13 ‘‘(10) The term ‘prior approval supplement’ 

14 means a request to the Secretary to approve a 

15 change in the drug substance, drug product, produc16 tion process, quality controls, equipment, or facilities 

17 covered by an approved abbreviated new drug appli18 cation when that change has a substantial potential 

19 to have an adverse effect on the identity, strength, 

20 quality, purity, or potency of the drug product as 

21 these factors may relate to the safety or effective22 ness of the drug product. 

23 ‘‘(11) The term ‘resources allocated for human 

24 generic drug activities’ means the expenses for— 
42 

†S 3187 ES

1 ‘‘(A) officers and employees of the Food 

2 and Drug Administration, contractors of the 

3 Food and Drug Administration, advisory com4 mittees, and costs related to such officers and 

5 employees and to contracts with such contrac6 tors; 

7 ‘‘(B) management of information, and the 

8 acquisition, maintenance, and repair of com9 puter resources; 

10 ‘‘(C) leasing, maintenance, renovation, and 

11 repair of facilities and acquisition, maintenance, 

12 and repair of fixtures, furniture, scientific 

13 equipment, and other necessary materials and 

14 supplies; and 

15 ‘‘(D) collecting fees under subsection (a) 

16 and accounting for resources allocated for the 

17 review of abbreviated new drug applications and 

18 supplements and inspection related to generic 

19 drugs. 

20 ‘‘(12) The term ‘Type II active pharmaceutical 

21 ingredient drug master file’ means a submission of 

22 information to the Secretary by a person that in23 tends to authorize the Food and Drug Administra24 tion to reference the information to support approval 

25 of a generic drug submission without the submitter 
43 

†S 3187 ES

1 having to disclose the information to the generic 

2 drug submission applicant. 

3 ‘‘SEC. 744B. AUTHORITY TO ASSESS AND USE HUMAN GE4 NERIC DRUG FEES. 

5 ‘‘(a) TYPES OF FEES.—Beginning in fiscal year 

6 2013, the Secretary shall assess and collect fees in accord7 ance with this section as follows: 

8 ‘‘(1) ONE-TIME BACKLOG FEE FOR ABBRE9 VIATED NEW DRUG APPLICATIONS PENDING ON OC10 TOBER 1, 2012.— 

11 ‘‘(A) IN GENERAL.—Each person that 

12 owns an abbreviated new drug application that 

13 is pending on October 1, 2012, and that has 

14 not received a tentative approval prior to that 

15 date, shall be subject to a fee for each such ap16 plication, as calculated under subparagraph 

17 (B). 

18 ‘‘(B) METHOD OF FEE AMOUNT CALCULA19 TION.—The amount of each one-time backlog 

20 fee shall be calculated by dividing $50,000,000 

21 by the total number of abbreviated new drug 

22 applications pending on October 1, 2012, that 

23 have not received a tentative approval as of that 

24 date. 
44 

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1 ‘‘(C) NOTICE.—Not later than October 31, 

2 2012, the Secretary shall publish in the Federal 

3 Register a notice announcing the amount of the 

4 fee required by subparagraph (A). 

5 ‘‘(D) FEE DUE DATE.—The fee required 

6 by subparagraph (A) shall be due no later than 

7 30 calendar days after the date of the publica8 tion of the notice specified in subparagraph (C). 

9 ‘‘(2) DRUG MASTER FILE FEE.— 

10 ‘‘(A) IN GENERAL.—Each person that 

11 owns a Type II active pharmaceutical ingre12 dient drug master file that is referenced on or 

13 after October 1, 2012, in a generic drug sub14 mission by any initial letter of authorization 

15 shall be subject to a drug master file fee. 

16 ‘‘(B) ONE-TIME PAYMENT.—If a person 

17 has paid a drug master file fee for a Type II 

18 active pharmaceutical ingredient drug master 

19 file, the person shall not be required to pay a 

20 subsequent drug master file fee when that Type 

21 II active pharmaceutical ingredient drug master 

22 file is subsequently referenced in generic drug 

23 submissions. 

24 ‘‘(C) NOTICE.— 
45 

†S 3187 ES

1 ‘‘(i) FISCAL YEAR 2013.—Not later 

2 than October 31, 2012, the Secretary shall 

3 publish in the Federal Register a notice 

4 announcing the amount of the drug master 

5 file fee for fiscal year 2013. 

6 ‘‘(ii) FISCAL YEAR 2014 THROUGH

7 2017.—Not later than 60 days before the 

8 start of each of fiscal years 2014 through 

9 2017, the Secretary shall publish in the 

10 Federal Register the amount of the drug 

11 master file fee established by this para12 graph for such fiscal year. 

13 ‘‘(D) AVAILABILITY FOR REFERENCE.— 

14 ‘‘(i) IN GENERAL.—Subject to sub15 section (g)(2)(C), for a generic drug sub16 mission to reference a Type II active phar17 maceutical ingredient drug master file, the 

18 drug master file must be deemed available 

19 for reference by the Secretary. 

20 ‘‘(ii) CONDITIONS.—A drug master 

21 file shall be deemed available for reference 

22 by the Secretary if— 

23 ‘‘(I) the person that owns a Type 

24 II active pharmaceutical ingredient 

25 drug master file has paid the fee re-
46 

†S 3187 ES

1 quired under subparagraph (A) within 

2 20 calendar days after the applicable 

3 due date under subparagraph (E); 

4 and 

5 ‘‘(II) the drug master file has not 

6 failed an initial completeness assess7 ment by the Secretary, in accordance 

8 with criteria to be published by the 

9 Secretary. 

10 ‘‘(iii) LIST.—The Secretary shall 

11 make publicly available on the Internet 

12 Web site of the Food and Drug Adminis13 tration a list of the drug master file num14 bers that correspond to drug master files 

15 that have successfully undergone an initial 

16 completeness assessment, in accordance 

17 with criteria to be published by the Sec18 retary, and are available for reference. 

19 ‘‘(E) FEE DUE DATE.— 

20 ‘‘(i) IN GENERAL.—Subject to clause 

21 (ii), a drug master file fee shall be due no 

22 later than the date on which the first ge23 neric drug submission is submitted that 

24 references the associated Type II active 

25 pharmaceutical ingredient drug master file. 
47 

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1 ‘‘(ii) LIMITATION.—No fee shall be 

2 due under subparagraph (A) for a fiscal 

3 year until the later of— 

4 ‘‘(I) 30 calendar days after publi5 cation of the notice provided for in 

6 clause (i) or (ii) of subparagraph (C), 

7 as applicable; or 

8 ‘‘(II) 30 calendar days after the 

9 date of enactment of an appropria10 tions Act providing for the collection 

11 and obligation of fees under this sec12 tion. 

13 ‘‘(3) ABBREVIATED NEW DRUG APPLICATION

14 AND PRIOR APPROVAL SUPPLEMENT FILING FEE.— 

15 ‘‘(A) IN GENERAL.—Each applicant that 

16 submits, on or after October 1, 2012, an abbre17 viated new drug application or a prior approval 

18 supplement to an abbreviated new drug applica19 tion shall be subject to a fee for each such sub20 mission in the amount established under sub21 section (d). 

22 ‘‘(B) NOTICE.— 

23 ‘‘(i) FISCAL YEAR 2013.—Not later 

24 than October 31, 2012, the Secretary shall 

25 publish in the Federal Register a notice 
48 

†S 3187 ES

1 announcing the amount of the fees under 

2 subparagraph (A) for fiscal year 2013. 

3 ‘‘(ii) FISCAL YEARS 2014 THROUGH

4 2017.—Not later than 60 days before the 

5 start of each of fiscal years 2014 through 

6 2017, the Secretary shall publish in the 

7 Federal Register the amount of the fees 

8 under subparagraph (A) for such fiscal 

9 year. 

10 ‘‘(C) FEE DUE DATE.— 

11 ‘‘(i) IN GENERAL.—Except as pro12 vided in clause (ii), the fees required by 

13 subparagraphs (A) and (F) shall be due no 

14 later than the date of submission of the 

15 abbreviated new drug application or prior 

16 approval supplement for which such fee ap17 plies. 

18 ‘‘(ii) SPECIAL RULE FOR 2013.—For 

19 fiscal year 2013, such fees shall be due on 

20 the later of— 

21 ‘‘(I) the date on which the fee is 

22 due under clause (i); 

23 ‘‘(II) 30 calendar days after pub24 lication of the notice referred to in 

25 subparagraph (B)(i); or 
49 

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1 ‘‘(III) if an appropriations Act is 

2 not enacted providing for the collec3 tion and obligation of fees under this 

4 section by the date of submission of 

5 the application or prior approval sup6 plement for which the fees under sub7 paragraphs (A) and (F) apply, 30 cal8 endar days after the date that such an 

9 appropriations Act is enacted. 

10 ‘‘(D) REFUND OF FEE IF ABBREVIATED

11 NEW DRUG APPLICATION IS NOT CONSIDERED

12 TO HAVE BEEN RECEIVED.—The Secretary 

13 shall refund 75 percent of the fee paid under 

14 subparagraph (A) for any abbreviated new drug 

15 application or prior approval supplement to an 

16 abbreviated new drug application that the Sec17 retary considers not to have been received with18 in the meaning of section 505(j)(5)(A) for a 

19 cause other than failure to pay fees. 

20 ‘‘(E) FEE FOR AN APPLICATION THE SEC21 RETARY CONSIDERS NOT TO HAVE BEEN RE22 CEIVED, OR THAT HAS BEEN WITHDRAWN.—An 

23 abbreviated new drug application or prior ap24 proval supplement that was submitted on or 

25 after October 1, 2012, and that the Secretary 
50 

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1 considers not to have been received, or that has 

2 been withdrawn, shall, upon resubmission of the 

3 application or a subsequent new submission fol4 lowing the applicant’s withdrawal of the appli5 cation, be subject to a full fee under subpara6 graph (A). 

7 ‘‘(F) ADDITIONAL FEE FOR ACTIVE PHAR8 MACEUTICAL INGREDIENT INFORMATION NOT

9 INCLUDED BY REFERENCE TO TYPE II ACTIVE

10 PHARMACEUTICAL INGREDIENT DRUG MASTER

11 FILE.—An applicant that submits a generic 

12 drug submission on or after October 1, 2012, 

13 shall pay a fee, in the amount determined under 

14 subsection (d)(3), in addition to the fee re15 quired under subparagraph (A), if— 

16 ‘‘(i) such submission contains infor17 mation concerning the manufacture of an 

18 active pharmaceutical ingredient at a facil19 ity by means other than reference by a let20 ter of authorization to a Type II active 

21 pharmaceutical drug master file; and 

22 ‘‘(ii) a fee in the amount equal to the 

23 drug master file fee established in para24 graph (2) has not been previously paid 

25 with respect to such information. 
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1 ‘‘(4) GENERIC DRUG FACILITY FEE AND ACTIVE

2 PHARMACEUTICAL INGREDIENT FACILITY FEE.— 

3 ‘‘(A) IN GENERAL.—Facilities identified, 

4 or intended to be identified, in at least one ge5 neric drug submission that is pending or ap6 proved to produce a finished dosage form of a 

7 human generic drug or an active pharma8 ceutical ingredient contained in a human ge9 neric drug shall be subject to fees as follows: 

10 ‘‘(i) GENERIC DRUG FACILITY.—Each 

11 person that owns a facility which is identi12 fied or intended to be identified in at least 

13 one generic drug submission that is pend14 ing or approved to produce one or more 

15 finished dosage forms of a human generic 

16 drug shall be assessed an annual fee for 

17 each such facility. 

18 ‘‘(ii) ACTIVE PHARMACEUTICAL IN19 GREDIENT FACILITY.—Each person that 

20 owns a facility which produces, or which is 

21 pending review to produce, one or more ac22 tive pharmaceutical ingredients identified, 

23 or intended to be identified, in at least one 

24 generic drug submission that is pending or 

25 approved or in a Type II active pharma-
52 

†S 3187 ES

1 ceutical ingredient drug master file ref2 erenced in such a generic drug submission, 

3 shall be assessed an annual fee for each 

4 such facility. 

5 ‘‘(iii) FACILITIES PRODUCING BOTH

6 ACTIVE PHARMACEUTICAL INGREDIENTS

7 AND FINISHED DOSAGE FORMS.—Each 

8 person that owns a facility identified, or 

9 intended to be identified, in at least one 

10 generic drug submission that is pending or 

11 approved to produce both one or more fin12 ished dosage forms subject to clause (i) 

13 and one or more active pharmaceutical in14 gredients subject to clause (ii) shall be 

15 subject to fees under both such clauses for 

16 that facility. 

17 ‘‘(B) AMOUNT.—The amount of fees estab18 lished under subparagraph (A) shall be estab19 lished under subsection (d). 

20 ‘‘(C) NOTICE.— 

21 ‘‘(i) FISCAL YEAR 2013.—For fiscal 

22 year 2013, the Secretary shall publish in 

23 the Federal Register a notice announcing 

24 the amount of the fees provided for in sub-
53 

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1 paragraph (A) within the timeframe speci2 fied in subsection (d)(1)(B). 

3 ‘‘(ii) FISCAL YEARS 2014 THROUGH

4 2017.—Within the timeframe specified in 

5 subsection (d)(2), the Secretary shall pub6 lish in the Federal Register the amount of 

7 the fees under subparagraph (A) for such 

8 fiscal year. 

9 ‘‘(D) FEE DUE DATE.— 

10 ‘‘(i) FISCAL YEAR 2013.—For fiscal 

11 year 2013, the fees under subparagraph 

12 (A) shall be due on the later of— 

13 ‘‘(I) not later than 45 days after 

14 the publication of the notice under 

15 subparagraph (B); or 

16 ‘‘(II) if an appropriations Act is 

17 not enacted providing for the collec18 tion and obligation of fees under this 

19 section by the date of the publication 

20 of such notice, 30 days after the date 

21 that such an appropriations Act is en22 acted. 

23 ‘‘(ii) FISCAL YEARS 2014 THROUGH

24 2017.—For each of fiscal years 2014 

25 through 2017, the fees under subpara-
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1 graph (A) for such fiscal year shall be due 

2 on the later of— 

3 ‘‘(I) the first business day on or 

4 after October 1 of each such year; or 

5 ‘‘(II) the first business day after 

6 the enactment of an appropriations 

7 Act providing for the collection and 

8 obligation of fees under this section 

9 for such year. 

10 ‘‘(5) DATE OF SUBMISSION.—For purposes of 

11 this Act, a generic drug submission or Type II phar12 maceutical master file is deemed to be ‘submitted’ to 

13 the Food and Drug Administration— 

14 ‘‘(A) if it is submitted via a Food and 

15 Drug Administration electronic gateway, on the 

16 day when transmission to that electronic gate17 way is completed, except that a submission or 

18 master file that arrives on a weekend, Federal 

19 holiday, or day when the Food and Drug Ad20 ministration office that will review that submis21 sion is not otherwise open for business shall be 

22 deemed to be submitted on the next day when 

23 that office is open for business; or 

24 ‘‘(B) if it is submitted in physical media 

25 form, on the day it arrives at the appropriate 
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1 designated document room of the Food and 

2 Drug Administration. 

3 ‘‘(b) FEE REVENUE AMOUNTS.— 

4 ‘‘(1) IN GENERAL.— 

5 ‘‘(A) FISCAL YEAR 2013.—For fiscal year 

6 2013, fees under subsection (a) shall be estab7 lished to generate a total estimated revenue 

8 amount under such subsection of $299,000,000. 

9 Of that amount— 

10 ‘‘(i) $50,000,000 shall be generated 

11 by the one-time backlog fee for generic 

12 drug applications pending on October 1, 

13 2012, established in subsection (a)(1); and 

14 ‘‘(ii) $249,000,000 shall be generated 

15 by the fees under paragraphs (2) through 

16 (4) of subsection (a). 

17 ‘‘(B) FISCAL YEARS 2014 THROUGH 2017.— 

18 For each of the fiscal years 2014 through 2017, 

19 fees under paragraphs (2) through (4) of sub20 section (a) shall be established to generate a 

21 total estimated revenue amount under such sub22 section that is equal to $299,000,000, as ad23 justed pursuant to subsection (c). 

24 ‘‘(2) TYPES OF FEES.—In establishing fees 

25 under paragraph (1) to generate the revenue 
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†S 3187 ES

1 amounts specified in paragraph (1)(A)(ii) for fiscal 

2 year 2013 and paragraph (1)(B) for each of fiscal 

3 years 2014 through 2017, such fees shall be derived 

4 from the fees under paragraphs (2) through (4) of 

5 subsection (a) as follows: 

6 ‘‘(A) 6 percent shall be derived from fees 

7 under subsection (a)(2) (relating to drug mas8 ter files). 

9 ‘‘(B) 24 percent shall be derived from fees 

10 under subsection (a)(3) (relating to abbreviated 

11 new drug applications and supplements). The 

12 amount of a fee for a prior approval supplement 

13 shall be half the amount of the fee for an ab14 breviated new drug application. 

15 ‘‘(C) 56 percent shall be derived from fees 

16 under subsection (a)(4)(A)(i) (relating to ge17 neric drug facilities). The amount of the fee for 

18 a facility located outside the United States and 

19 its territories and possessions shall be not less 

20 than $15,000 and not more than $30,000 high21 er than the amount of the fee for a facility lo22 cated in the United States and its territories 

23 and possessions, as determined by the Secretary 

24 on the basis of data concerning the difference 

25 in cost between inspections of facilities located 
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1 in the United States, including its territories 

2 and possessions, and those located outside of 

3 the United States and its territories and posses4 sions. 

5 ‘‘(D) 14 percent shall be derived from fees 

6 under subsection (a)(4)(A)(ii) (relating to active 

7 pharmaceutical ingredient facilities). The 

8 amount of the fee for a facility located outside 

9 the United States and its territories and posses10 sions shall be not less than $15,000 and not 

11 more than $30,000 higher than the amount of 

12 the fee for a facility located in the United 

13 States, including its territories and possessions, 

14 as determined by the Secretary on the basis of 

15 data concerning the difference in cost between 

16 inspections of facilities located in the United 

17 States and its territories and possessions and 

18 those located outside of the United States and 

19 its territories and possessions. 

20 ‘‘(c) ADJUSTMENTS.— 

21 ‘‘(1) INFLATION ADJUSTMENT.—For fiscal year 

22 2014 and subsequent fiscal years, the revenues es23 tablished in subsection (b) shall be adjusted by the 

24 Secretary by notice, published in the Federal Reg-
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1 ister, for a fiscal year, by an amount equal to the 

2 sum of— 

3 ‘‘(A) one; 

4 ‘‘(B) the average annual percent change in 

5 the cost, per full-time equivalent position of the 

6 Food and Drug Administration, of all personnel 

7 compensation and benefits paid with respect to 

8 such positions for the first 3 years of the pre9 ceding 4 fiscal years multiplied by the propor10 tion of personnel compensation and benefits 

11 costs to total costs of human generic drug ac12 tivities for the first 3 years of the preceding 4 

13 fiscal years; and 

14 ‘‘(C) the average annual percent change 

15 that occurred in the Consumer Price Index for 

16 urban consumers (Washington-Baltimore, DC– 

17 MD–VA–WV; Not Seasonally Adjusted; All 

18 items; Annual Index) for the first 3 years of the 

19 preceding 4 years of available data multiplied 

20 by the proportion of all costs other than per21 sonnel compensation and benefits costs to total 

22 costs of human generic drug activities for the 

23 first 3 years of the preceding 4 fiscal years. 

24 The adjustment made each fiscal year under this 

25 subsection shall be added on a compounded basis to 
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1 the sum of all adjustments made each fiscal year 

2 after fiscal year 2013 under this subsection. 

3 ‘‘(2) FINAL YEAR ADJUSTMENT.—For fiscal 

4 year 2017, the Secretary may, in addition to adjust5 ments under paragraph (1), further increase the fee 

6 revenues and fees established in subsection (b) if 

7 such an adjustment is necessary to provide for not 

8 more than 3 months of operating reserves of carry9 over user fees for human generic drug activities for 

10 the first 3 months of fiscal year 2018. Such fees 

11 may only be used in fiscal year 2018. If such an ad12 justment is necessary, the rationale for the amount 

13 of the increase shall be contained in the annual no14 tice establishing fee revenues and fees for fiscal year 

15 2017. If the Secretary has carryover balances for 

16 such activities in excess of 3 months of such oper17 ating reserves, the adjustment under this subpara18 graph shall not be made. 

19 ‘‘(d) ANNUAL FEE SETTING.— 

20 ‘‘(1) FISCAL YEAR 2013.—For fiscal year 

21 2013— 

22 ‘‘(A) the Secretary shall establish, by Octo23 ber 31, 2012, the one-time generic drug backlog 

24 fee for generic drug applications pending on Oc25 tober 1, 2012, the drug master file fee, the ab-
60 

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1 breviated new drug application fee, and the 

2 prior approval supplement fee under subsection 

3 (a), based on the revenue amounts established 

4 under subsection (b); and 

5 ‘‘(B) the Secretary shall establish, not 

6 later than 45 days after the date to comply 

7 with the requirement for identification of facili8 ties in subsection (f)(2), the generic drug facil9 ity fee and active pharmaceutical ingredient fa10 cility fee under subsection (a) based on the rev11 enue amounts established under subsection (b). 

12 ‘‘(2) FISCAL YEARS 2014 THROUGH 2017.—Not 

13 more than 60 days before the first day of each of 

14 fiscal years 2014 through 2017, the Secretary shall 

15 establish the drug master file fee, the abbreviated 

16 new drug application fee, the prior approval supple17 ment fee, the generic drug facility fee, and the active 

18 pharmaceutical ingredient facility fee under sub19 section (a) for such fiscal year, based on the revenue 

20 amounts established under subsection (b) and the 

21 adjustments provided under subsection (c). 

22 ‘‘(3) FEE FOR ACTIVE PHARMACEUTICAL IN23 GREDIENT INFORMATION NOT INCLUDED BY REF24 ERENCE TO TYPE II ACTIVE PHARMACEUTICAL IN25 GREDIENT DRUG MASTER FILE.—In establishing the 
61 

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1 fees under paragraphs (1) and (2), the amount of 

2 the fee under subsection (a)(3)(F) shall be deter3 mined by multiplying— 

4 ‘‘(A) the sum of— 

5 ‘‘(i) the total number of such active 

6 pharmaceutical ingredients in such submis7 sion; and 

8 ‘‘(ii) for each such ingredient that is 

9 manufactured at more than one such facil10 ity, the total number of such additional fa11 cilities; and 

12 ‘‘(B) the amount equal to the drug master 

13 file fee established in subsection (a)(2) for such 

14 submission. 

15 ‘‘(e) LIMIT.—The total amount of fees charged, as 

16 adjusted under subsection (c), for a fiscal year may not 

17 exceed the total costs for such fiscal year for the resources 

18 allocated for human generic drug activities. 

19 ‘‘(f) IDENTIFICATION OF FACILITIES.— 

20 ‘‘(1) PUBLICATION OF NOTICE; DEADLINE FOR

21 COMPLIANCE.—Not later than October 1, 2012, the 

22 Secretary shall publish in the Federal Register a no23 tice requiring each person that owns a facility de24 scribed in subsection (a)(4)(A), or a site or organi25 zation required to be identified by paragraph (4), to 
62 

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1 submit to the Secretary information on the identity 

2 of each such facility, site, or organization. The no3 tice required by this paragraph shall specify the type 

4 of information to be submitted and the means and 

5 format for submission of such information. 

6 ‘‘(2) REQUIRED SUBMISSION OF FACILITY

7 IDENTIFICATION.—Each person that owns a facility 

8 described in subsection (a)(4)(A) or a site or organi9 zation required to be identified by paragraph (4) 

10 shall submit to the Secretary the information re11 quired under this subsection each year. Such infor12 mation shall— 

13 ‘‘(A) for fiscal year 2013, be submitted not 

14 later than 60 days after the publication of the 

15 notice under paragraph (1); and 

16 ‘‘(B) for each subsequent fiscal year, be 

17 submitted, updated, or reconfirmed on or before 

18 June 1 of the previous year. 

19 ‘‘(3) CONTENTS OF NOTICE.—At a minimum, 

20 the submission required by paragraph (2) shall in21 clude for each such facility— 

22 ‘‘(A) identification of a facility identified or 

23 intended to be identified in an approved or 

24 pending generic drug submission; 
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1 ‘‘(B) whether the facility manufactures ac2 tive pharmaceutical ingredients or finished dos3 age forms, or both; 

4 ‘‘(C) whether or not the facility is located 

5 within the United States and its territories and 

6 possessions; 

7 ‘‘(D) whether the facility manufactures 

8 positron emission tomography drugs solely, or 

9 in addition to other drugs; and 

10 ‘‘(E) whether the facility manufactures 

11 drugs that are not generic drugs. 

12 ‘‘(4) CERTAIN SITES AND ORGANIZATIONS.— 

13 ‘‘(A) IN GENERAL.—Any person that owns 

14 or operates a site or organization described in 

15 subparagraph (B) shall submit to the Secretary 

16 information concerning the ownership, name, 

17 and address of the site or organization. 

18 ‘‘(B) SITES AND ORGANIZATIONS.—A site 

19 or organization is described in this subpara20 graph if it is identified in a generic drug sub21 mission and is— 

22 ‘‘(i) a site in which a bioanalytical 

23 study is conducted; 

24 ‘‘(ii) a clinical research organization; 
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1 ‘‘(iii) a contract analytical testing site; 

2 or 

3 ‘‘(iv) a contract repackager site. 

4 ‘‘(C) NOTICE.—The Secretary may, by no5 tice published in the Federal Register, specify 

6 the means and format for submission of the in7 formation under subparagraph (A) and may 

8 specify, as necessary for purposes of this sec9 tion, any additional information to be sub10 mitted. 

11 ‘‘(D) INSPECTION AUTHORITY.—The Sec12 retary’s inspection authority under section 

13 704(a)(1) shall extend to all such sites and or14 ganizations. 

15 ‘‘(g) EFFECT OF FAILURE TO PAY FEES.— 

16 ‘‘(1) GENERIC DRUG BACKLOG FEE.—Failure 

17 to pay the fee under subsection (a)(1) shall result in 

18 the Secretary placing the person that owns the ab19 breviated new drug application subject to that fee on 

20 an arrears list, such that no new abbreviated new 

21 drug applications or supplement submitted on or 

22 after October 1, 2012, from that person, or any af23 filiate of that person, will be received within the 

24 meaning of section 505(j)(5)(A) until such out25 standing fee is paid. 
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1 ‘‘(2) DRUG MASTER FILE FEE.— 

2 ‘‘(A) Failure to pay the fee under sub3 section (a)(2) within 20 calendar days after the 

4 applicable due date under subparagraph (E) of 

5 such subsection (as described in subsection 

6 (a)(2)(D)(ii)(I)) shall result in the Type II ac7 tive pharmaceutical ingredient drug master file 

8 not being deemed available for reference. 

9 ‘‘(B)(i) Any generic drug submission sub10 mitted on or after October 1, 2012, that ref11 erences, by a letter of authorization, a Type II 

12 active pharmaceutical ingredient drug master 

13 file that has not been deemed available for ref14 erence shall not be received within the meaning 

15 of section 505(j)(5)(A) unless the condition 

16 specified in clause (ii) is met. 

17 ‘‘(ii) The condition specified in this clause 

18 is that the fee established under subsection 

19 (a)(2) has been paid within 20 calendar days of 

20 the Secretary providing the notification to the 

21 sponsor of the abbreviated new drug application 

22 or supplement of the failure of the owner of the 

23 Type II active pharmaceutical ingredient drug 

24 master file to pay the drug master file fee as 

25 specified in subparagraph (C). 
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1 ‘‘(C)(i) If an abbreviated new drug applica2 tion or supplement to an abbreviated new drug 

3 application references a Type II active pharma4 ceutical ingredient drug master file for which a 

5 fee under subsection (a)(2)(A) has not been 

6 paid by the applicable date under subsection 

7 (a)(2)(E), the Secretary shall notify the sponsor 

8 of the abbreviated new drug application or sup9 plement of the failure of the owner of the Type 

10 II active pharmaceutical ingredient drug master 

11 file to pay the applicable fee. 

12 ‘‘(ii) If such fee is not paid within 20 cal13 endar days of the Secretary providing the noti14 fication, the abbreviated new drug application 

15 or supplement to an abbreviated new drug ap16 plication shall not be received within the mean17 ing of 505(j)(5)(A). 

18 ‘‘(3) ABBREVIATED NEW DRUG APPLICATION

19 FEE AND PRIOR APPROVAL SUPPLEMENT FEE.— 

20 Failure to pay a fee under subparagraph (A) or (F) 

21 of subsection (a)(3) within 20 calendar days of the 

22 applicable due date under subparagraph (C) of such 

23 subsection shall result in the abbreviated new drug 

24 application or the prior approval supplement to an 

25 abbreviated new drug application not being received 
67 

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1 within the meaning of section 505(j)(5)(A) until 

2 such outstanding fee is paid. 

3 ‘‘(4) GENERIC DRUG FACILITY FEE AND ACTIVE

4 PHARMACEUTICAL INGREDIENT FACILITY FEE.— 

5 ‘‘(A) IN GENERAL.—Failure to pay the fee 

6 under subsection (a)(4) within 20 calendar days 

7 of the due date as specified in subparagraph 

8 (D) of such subsection shall result in the fol9 lowing: 

10 ‘‘(i) The Secretary shall place the fa11 cility on a publicly available arrears list, 

12 such that no new abbreviated new drug ap13 plication or supplement submitted on or 

14 after October 1, 2012, from the person 

15 that is responsible for paying such fee, or 

16 any affiliate of that person, will be received 

17 within the meaning of section 505(j)(5)(A). 

18 ‘‘(ii) Any new generic drug submission 

19 submitted on or after October 1, 2012, 

20 that references such a facility shall not be 

21 received, within the meaning of section 

22 505(j)(5)(A) if the outstanding facility fee 

23 is not paid within 20 calendar days of the 

24 Secretary providing the notification to the 

25 sponsor of the failure of the owner of the 
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1 facility to pay the facility fee under sub2 section (a)(4)(C). 

3 ‘‘(iii) All drugs or active pharma4 ceutical ingredients manufactured in such 

5 a facility or containing an ingredient man6 ufactured in such a facility shall be deemed 

7 misbranded under section 502(aa). 

8 ‘‘(B) APPLICATION OF PENALTIES.—The 

9 penalties under this paragraph shall apply until 

10 the fee established by subsection (a)(4) is paid 

11 or the facility is removed from all generic drug 

12 submissions that refer to the facility. 

13 ‘‘(C) NONRECEIVAL FOR NONPAYMENT.— 

14 ‘‘(i) NOTICE.—If an abbreviated new 

15 drug application or supplement to an ab16 breviated new drug application submitted 

17 on or after October 1, 2012, references a 

18 facility for which a facility fee has not been 

19 paid by the applicable date under sub20 section (a)(4)(C), the Secretary shall notify 

21 the sponsor of the generic drug submission 

22 of the failure of the owner of the facility 

23 to pay the facility fee. 

24 ‘‘(ii) NONRECEIVAL.—If the facility 

25 fee is not paid within 20 calendar days of 
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1 the Secretary providing the notification 

2 under clause (i), the abbreviated new drug 

3 application or supplement to an abbre4 viated new drug application shall not be re5 ceived within the meaning of section 

6 505(j)(5)(A). 

7 ‘‘(h) LIMITATIONS.— 

8 ‘‘(1) IN GENERAL.—Fees under subsection (a) 

9 shall be refunded for a fiscal year beginning after 

10 fiscal year 2012, unless appropriations for salaries 

11 and expenses of the Food and Drug Administration 

12 for such fiscal year (excluding the amount of fees 

13 appropriated for such fiscal year) are equal to or 

14 greater than the amount of appropriations for the 

15 salaries and expenses of the Food and Drug Admin16 istration for the fiscal year 2009 (excluding the 

17 amount of fees appropriated for such fiscal year) 

18 multiplied by the adjustment factor (as defined in 

19 section 744A) applicable to the fiscal year involved. 

20 ‘‘(2) AUTHORITY.—If the Secretary does not 

21 assess fees under subsection (a) during any portion 

22 of a fiscal year and if at a later date in such fiscal 

23 year the Secretary may assess such fees, the Sec24 retary may assess and collect such fees, without any 

25 modification in the rate, for Type II active pharma-
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1 ceutical ingredient drug master files, abbreviated 

2 new drug applications and prior approval supple3 ments, and generic drug facilities and active phar4 maceutical ingredient facilities at any time in such 

5 fiscal year notwithstanding the provisions of sub6 section (a) relating to the date fees are to be paid. 

7 ‘‘(i) CREDITING AND AVAILABILITY OF FEES.— 

8 ‘‘(1) IN GENERAL.—Fees authorized under sub9 section (a) shall be collected and available for obliga10 tion only to the extent and in the amount provided 

11 in advance in appropriations Acts, subject to para12 graph (2). Such fees are authorized to remain avail13 able until expended. Such sums as may be necessary 

14 may be transferred from the Food and Drug Admin15 istration salaries and expenses appropriation account 

16 without fiscal year limitation to such appropriation 

17 account for salaries and expenses with such fiscal 

18 year limitation. The sums transferred shall be avail19 able solely for human generic drug activities. 

20 ‘‘(2) COLLECTIONS AND APPROPRIATION

21 ACTS.— 

22 ‘‘(A) IN GENERAL.—The fees authorized 

23 by this section— 

24 ‘‘(i) subject to subparagraphs (C) and 

25 (D), shall be collected and available in each 
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1 fiscal year in an amount not to exceed the 

2 amount specified in appropriation Acts, or 

3 otherwise made available for obligation for 

4 such fiscal year; and 

5 ‘‘(ii) shall be available for a fiscal year 

6 beginning after fiscal year 2012 to defray 

7 the costs of human generic drug activities 

8 (including such costs for an additional 

9 number of full-time equivalent positions in 

10 the Department of Health and Human 

11 Services to be engaged in such activities), 

12 only if the Secretary allocates for such 

13 purpose an amount for such fiscal year 

14 (excluding amounts from fees collected 

15 under this section) no less than 

16 $97,000,000 multiplied by the adjustment 

17 factor, as defined in section 744A(3), ap18 plicable to the fiscal year involved. 

19 ‘‘(B) COMPLIANCE.—The Secretary shall 

20 be considered to have met the requirements of 

21 subparagraph (A)(ii) in any fiscal year if the 

22 costs funded by appropriations and allocated for 

23 human generic activities are not more than 10 

24 percent below the level specified in such sub25 paragraph. 
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1 ‘‘(C) FEE COLLECTION DURING FIRST

2 PROGRAM YEAR.—Until the date of enactment 

3 of an Act making appropriations through Sep4 tember 30, 2013 for the salaries and expenses 

5 account of the Food and Drug Administration, 

6 fees authorized by this section for fiscal year 

7 2013, may be collected and shall be credited to 

8 such account and remain available until ex9 pended. 

10 ‘‘(D) PROVISION FOR EARLY PAYMENTS IN

11 SUBSEQUENT YEARS.—Payment of fees author12 ized under this section for a fiscal year (after 

13 fiscal year 2013), prior to the due date for such 

14 fees, may be accepted by the Secretary in ac15 cordance with authority provided in advance in 

16 a prior year appropriations Act. 

17 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

18 For each of the fiscal years 2013 through 2017, 

19 there is authorized to be appropriated for fees under 

20 this section an amount equivalent to the total rev21 enue amount determined under subsection (b) for 

22 the fiscal year, as adjusted under subsection (c), if 

23 applicable, or as otherwise affected under paragraph 

24 (2) of this subsection. 
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1 ‘‘(j) COLLECTION OF UNPAID FEES.—In any case 

2 where the Secretary does not receive payment of a fee as3 sessed under subsection (a) within 30 calendar days after 

4 it is due, such fee shall be treated as a claim of the United 

5 States Government subject to subchapter II of chapter 37 

6 of title 31, United States Code. 

7 ‘‘(k) CONSTRUCTION.—This section may not be con8 strued to require that the number of full-time equivalent 

9 positions in the Department of Health and Human Serv10 ices, for officers, employees, and advisory committees not 

11 engaged in human generic drug activities, be reduced to 

12 offset the number of officers, employees, and advisory 

13 committees so engaged. 

14 ‘‘(l) POSITRON EMISSION TOMOGRAPHY DRUGS.— 

15 ‘‘(1) EXEMPTION FROM FEES.—Submission of 

16 an application for a positron emission tomography 

17 drug or active pharmaceutical ingredient for a 

18 positron emission tomography drug shall not require 

19 the payment of any fee under this section. Facilities 

20 that solely produce positron emission tomography 

21 drugs shall not be required to pay a facility fee as 

22 established in subsection (a)(4). 

23 ‘‘(2) IDENTIFICATION REQUIREMENT.—Facili24 ties that produce positron emission tomography 

25 drugs or active pharmaceutical ingredients of such 
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1 drugs are required to be identified pursuant to sub2 section (f). 

3 ‘‘(m) DISPUTES CONCERNING FEES.—To qualify for 

4 the return of a fee claimed to have been paid in error 

5 under this section, a person shall submit to the Secretary 

6 a written request justifying such return within 180 cal7 endar days after such fee was paid. 

8 ‘‘(n) SUBSTANTIALLY COMPLETE APPLICATIONS.— 

9 An abbreviated new drug application that is not consid10 ered to be received within the meaning of section 

11 505(j)(5)(A) because of failure to pay an applicable fee 

12 under this provision within the time period specified in 

13 subsection (g) shall be deemed not to have been ‘substan14 tially complete’ on the date of its submission within the 

15 meaning of section 505(j)(5)(B)(iv)(II)(cc). An abbre16 viated new drug application that is not substantially com17 plete on the date of its submission solely because of failure 

18 to pay an applicable fee under the preceding sentence shall 

19 be deemed substantially complete and received within the 

20 meaning of section 505(j)(5)(A) as of the date such appli21 cable fee is received.’’. 

22 SEC. 303. REAUTHORIZATION; REPORTING REQUIREMENTS. 

23 Part 7 of subchapter C of chapter VII, as added by 

24 section 302 of this Act, is amended by inserting after sec25 tion 744B the following: 
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1 ‘‘SEC. 744C. REAUTHORIZATION; REPORTING REQUIRE2 MENTS. 

3 ‘‘(a) PERFORMANCE REPORT.—Beginning with fiscal 

4 year 2013, not later than 120 days after the end of each 

5 fiscal year for which fees are collected under this part, 

6 the Secretary shall prepare and submit to the Committee 

7 on Energy and Commerce of the House of Representatives 

8 and the Committee on Health, Education, Labor, and 

9 Pensions of the Senate a report concerning the progress 

10 of the Food and Drug Administration in achieving the 

11 goals identified in the letters described in section 301(b) 

12 of the Generic Drug User Fee Amendments of 2012 dur13 ing such fiscal year and the future plans of the Food and 

14 Drug Administration for meeting the goals. 

15 ‘‘(b) FISCAL REPORT.—Beginning with fiscal year 

16 2013, not later than 120 days after the end of each fiscal 

17 year for which fees are collected under this part, the Sec18 retary shall prepare and submit to the Committee on En19 ergy and Commerce of the House of Representatives and 

20 the Committee on Health, Education, Labor, and Pen21 sions of the Senate a report on the implementation of the 

22 authority for such fees during such fiscal year and the 

23 use, by the Food and Drug Administration, of the fees 

24 collected for such fiscal year. 

25 ‘‘(c) PUBLIC AVAILABILITY.—The Secretary shall 

26 make the reports required under subsections (a) and (b) 
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1 available to the public on the Internet Web site of the 

2 Food and Drug Administration. 

3 ‘‘(d) REAUTHORIZATION.— 

4 ‘‘(1) CONSULTATION.—In developing rec5 ommendations to present to the Congress with re6 spect to the goals, and plans for meeting the goals, 

7 for human generic drug activities for the first 5 fis8 cal years after fiscal year 2017, and for the reau9 thorization of this part for such fiscal years, the Sec10 retary shall consult with— 

11 ‘‘(A) the Committee on Energy and Com12 merce of the House of Representatives; 

13 ‘‘(B) the Committee on Health, Education, 

14 Labor, and Pensions of the Senate; 

15 ‘‘(C) scientific and academic experts; 

16 ‘‘(D) health care professionals; 

17 ‘‘(E) representatives of patient and con18 sumer advocacy groups; and 

19 ‘‘(F) the generic drug industry. 

20 ‘‘(2) PRIOR PUBLIC INPUT.—Prior to beginning 

21 negotiations with the generic drug industry on the 

22 reauthorization of this part, the Secretary shall— 

23 ‘‘(A) publish a notice in the Federal Reg24 ister requesting public input on the reauthoriza25 tion; 
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1 ‘‘(B) hold a public meeting at which the 

2 public may present its views on the reauthoriza3 tion, including specific suggestions for changes 

4 to the goals referred to in subsection (a); 

5 ‘‘(C) provide a period of 30 days after the 

6 public meeting to obtain written comments from 

7 the public suggesting changes to this part; and 

8 ‘‘(D) publish the comments on the Food 

9 and Drug Administration’s Internet Web site. 

10 ‘‘(3) PERIODIC CONSULTATION.—Not less fre11 quently than once every month during negotiations 

12 with the generic drug industry, the Secretary shall 

13 hold discussions with representatives of patient and 

14 consumer advocacy groups to continue discussions of 

15 their views on the reauthorization and their sugges16 tions for changes to this part as expressed under 

17 paragraph (2). 

18 ‘‘(4) PUBLIC REVIEW OF RECOMMENDA19 TIONS.—After negotiations with the generic drug in20 dustry, the Secretary shall— 

21 ‘‘(A) present the recommendations devel22 oped under paragraph (1) to the congressional 

23 committees specified in such paragraph; 

24 ‘‘(B) publish such recommendations in the 

25 Federal Register; 
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1 ‘‘(C) provide for a period of 30 days for 

2 the public to provide written comments on such 

3 recommendations; 

4 ‘‘(D) hold a meeting at which the public 

5 may present its views on such recommenda6 tions; and 

7 ‘‘(E) after consideration of such public 

8 views and comments, revise such recommenda9 tions as necessary. 

10 ‘‘(5) TRANSMITTAL OF RECOMMENDATIONS.— 

11 Not later than January 15, 2017, the Secretary 

12 shall transmit to the Congress the revised rec13 ommendations under paragraph (4), a summary of 

14 the views and comments received under such para15 graph, and any changes made to the recommenda16 tions in response to such views and comments. 

17 ‘‘(6) MINUTES OF NEGOTIATION MEETINGS.— 

18 ‘‘(A) PUBLIC AVAILABILITY.—Before pre19 senting the recommendations developed under 

20 paragraphs (1) through (5) to the Congress, the 

21 Secretary shall make publicly available, on the 

22 Internet Web site of the Food and Drug Ad23 ministration, minutes of all negotiation meet24 ings conducted under this subsection between 
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1 the Food and Drug Administration and the ge2 neric drug industry. 

3 ‘‘(B) CONTENT.—The minutes described 

4 under subparagraph (A) shall summarize any 

5 substantive proposal made by any party to the 

6 negotiations as well as significant controversies 

7 or differences of opinion during the negotiations 

8 and their resolution.’’. 

9 SEC. 304. SUNSET DATES. 

10 (a) AUTHORIZATION.—The amendments made by 

11 section 302 cease to be effective October 1, 2017. 

12 (b) REPORTING REQUIREMENTS.—The amendments 

13 made by section 303 cease to be effective January 31, 

14 2018. 

15 SEC. 305. EFFECTIVE DATE. 

16 The amendments made by this title shall take effect 

17 on October 1, 2012, or the date of the enactment of this 

18 title, whichever is later, except that fees under section 302 

19 shall be assessed for all human generic drug submissions 

20 and Type II active pharmaceutical drug master files re21 ceived on or after October 1, 2012, regardless of the date 

22 of enactment of this title. 

23 SEC. 306. AMENDMENT WITH RESPECT TO MISBRANDING. 

24 Section 502 (21 U.S.C. 352) is amended by adding 

25 at the end the following: 
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1 ‘‘(aa) If it is a drug, or an active pharmaceutical in2 gredient, and it was manufactured, prepared, propagated, 

3 compounded, or processed in a facility for which fees have 

4 not been paid as required by section 744A(a)(4) or for 

5 which identifying information required by section 744B(f) 

6 has not been submitted, or it contains an active pharma7 ceutical ingredient that was manufactured, prepared, 

8 propagated, compounded, or processed in such a facility.’’. 

9 SEC. 307. STREAMLINED HIRING AUTHORITY OF THE FOOD 

10 AND DRUG ADMINISTRATION TO SUPPORT 

11 ACTIVITIES RELATED TO HUMAN GENERIC 

12 DRUGS. 

13 Section 714 of the Federal Food, Drug, and Cosmetic 

14 Act, as added by section 208, is amended— 

15 (1) in subsection (b)— 

16 (A) by striking ‘‘are activities’’ and insert17 ing ‘‘are— 

18 ‘‘(1) activities’’; 

19 (B) by striking the period at the end and 

20 inserting ‘‘; and’’; and 

21 (C) by adding at the end the following: 

22 ‘‘(2) activities under this Act related to human 

23 generic drug activities (as defined in section 

24 744A).’’; and 
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1 (2) by amending subsection (c) to read as fol2 lows: 

3 ‘‘(c) OBJECTIVES SPECIFIED.—The objectives speci4 fied in this subsection are— 

5 ‘‘(1) with respect to the activities under sub6 section (b)(1), the goals referred to in section 

7 738A(a)(1); and 

8 ‘‘(2) with respect to the activities under sub9 section (b)(2), the performance goals with respect to 

10 section 744A (regarding assessment and use of 

11 human generic drug fees), as set forth in the letters 

12 described in section 301(b) of the Generic Drug 

13 User Fee Amendments of 2012.’’. 

14 TITLE IV—FEES RELATING TO 

15 BIOSIMILAR BIOLOGICAL 

16 PRODUCTS 

17 SEC. 401. SHORT TITLE; FINDING. 

18 (a) SHORT TITLE.—This title may be cited as the 

19 ‘‘Biosimilar User Fee Act of 2012’’. 

20 (b) FINDING.—The Congress finds that the fees au21 thorized by the amendments made in this title will be dedi22 cated to expediting the process for the review of biosimilar 

23 biological product applications, including postmarket safe24 ty activities, as set forth in the goals identified for pur25 poses of part 8 of subchapter C of chapter VII of the Fed-
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1 eral Food, Drug, and Cosmetic Act, in the letters from 

2 the Secretary of Health and Human Services to the Chair3 man of the Committee on Health, Education, Labor, and 

4 Pensions of the Senate and the Chairman of the Com5 mittee on Energy and Commerce of the House of Rep6 resentatives, as set forth in the Congressional Record. 

7 SEC. 402. FEES RELATING TO BIOSIMILAR BIOLOGICAL 

8 PRODUCTS. 

9 Subchapter C of chapter VII (21 U.S.C. 379f et seq.) 

10 is amended by inserting after part 7, as added by title 

11 III of this Act, the following: 

12 ‘‘PART 8—FEES RELATING TO BIOSIMILAR 

13 BIOLOGICAL PRODUCTS 

14 ‘‘SEC. 744G. DEFINITIONS. 

15 ‘‘For purposes of this part: 

16 ‘‘(1) The term ‘adjustment factor’ applicable to 

17 a fiscal year that is the Consumer Price Index for 

18 all urban consumers (Washington-Baltimore, DC– 

19 MD–VA–WV; Not Seasonally Adjusted; All items) of 

20 the preceding fiscal year divided by such Index for 

21 September 2011. 

22 ‘‘(2) The term ‘affiliate’ means a business enti23 ty that has a relationship with a second business en24 tity if, directly or indirectly— 
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1 ‘‘(A) one business entity controls, or has 

2 the power to control, the other business entity; 

3 or 

4 ‘‘(B) a third party controls, or has power 

5 to control, both of the business entities. 

6 ‘‘(3) The term ‘biosimilar biological product’ 

7 means a product for which a biosimilar biological 

8 product application has been approved. 

9 ‘‘(4)(A) Subject to subparagraph (B), the term 

10 ‘biosimilar biological product application’ means an 

11 application for licensure of a biological product 

12 under section 351(k) of the Public Health Service 

13 Act. 

14 ‘‘(B) Such term does not include— 

15 ‘‘(i) a supplement to such an application; 

16 ‘‘(ii) an application filed under section 

17 351(k) of the Public Health Service Act that 

18 cites as the reference product a bovine blood 

19 product for topical application licensed before 

20 September 1, 1992, or a large volume paren21 teral drug product approved before such date; 

22 ‘‘(iii) an application filed under section 

23 351(k) of the Public Health Service Act with 

24 respect to— 
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1 ‘‘(I) whole blood or a blood component 

2 for transfusion; 

3 ‘‘(II) an allergenic extract product; 

4 ‘‘(III) an in vitro diagnostic biological 

5 product; or 

6 ‘‘(IV) a biological product for further 

7 manufacturing use only; or 

8 ‘‘(iv) an application for licensure under 

9 section 351(k) of the Public Health Service Act 

10 that is submitted by a State or Federal Govern11 ment entity for a product that is not distributed 

12 commercially. 

13 ‘‘(5) The term ‘biosimilar biological product de14 velopment meeting’ means any meeting, other than 

15 a biosimilar initial advisory meeting, regarding the 

16 content of a development program, including a pro17 posed design for, or data from, a study intended to 

18 support a biosimilar biological product application. 

19 ‘‘(6) The term ‘biosimilar biological product de20 velopment program’ means the program under this 

21 part for expediting the process for the review of sub22 missions in connection with biosimilar biological 

23 product development. 
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1 ‘‘(7)(A) The term ‘biosimilar biological product 

2 establishment’ means a foreign or domestic place of 

3 business— 

4 ‘‘(i) that is at one general physical location 

5 consisting of one or more buildings, all of which 

6 are within five miles of each other; and 

7 ‘‘(ii) at which one or more biosimilar bio8 logical products are manufactured in final dos9 age form. 

10 ‘‘(B) For purposes of subparagraph (A)(ii), the 

11 term ‘manufactured’ does not include packaging. 

12 ‘‘(8) The term ‘biosimilar initial advisory meet13 ing’— 

14 ‘‘(A) means a meeting, if requested, that is 

15 limited to— 

16 ‘‘(i) a general discussion regarding 

17 whether licensure under section 351(k) of 

18 the Public Health Service Act may be fea19 sible for a particular product; and 

20 ‘‘(ii) if so, general advice on the ex21 pected content of the development pro22 gram; and 

23 ‘‘(B) does not include any meeting that in24 volves substantive review of summary data or 

25 full study reports. 
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1 ‘‘(9) The term ‘costs of resources allocated for 

2 the process for the review of biosimilar biological 

3 product applications’ means the expenses in connec4 tion with the process for the review of biosimilar bio5 logical product applications for— 

6 ‘‘(A) officers and employees of the Food 

7 and Drug Administration, contractors of the 

8 Food and Drug Administration, advisory com9 mittees, and costs related to such officers em10 ployees and committees and to contracts with 

11 such contractors; 

12 ‘‘(B) management of information, and the 

13 acquisition, maintenance, and repair of com14 puter resources; 

15 ‘‘(C) leasing, maintenance, renovation, and 

16 repair of facilities and acquisition, maintenance, 

17 and repair of fixtures, furniture, scientific 

18 equipment, and other necessary materials and 

19 supplies; and 

20 ‘‘(D) collecting fees under section 744H 

21 and accounting for resources allocated for the 

22 review of submissions in connection with bio23 similar biological product development, bio24 similar biological product applications, and sup25 plements. 
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1 ‘‘(10) The term ‘final dosage form’ means, with 

2 respect to a biosimilar biological product, a finished 

3 dosage form which is approved for administration to 

4 a patient without substantial further manufacturing 

5 (such as lyophilized products before reconstitution). 

6 ‘‘(11) The term ‘financial hold’— 

7 ‘‘(A) means an order issued by the Sec8 retary to prohibit the sponsor of a clinical in9 vestigation from continuing the investigation if 

10 the Secretary determines that the investigation 

11 is intended to support a biosimilar biological 

12 product application and the sponsor has failed 

13 to pay any fee for the product required under 

14 subparagraph (A), (B), or (D) of section 

15 744H(a)(1); and 

16 ‘‘(B) does not mean that any of the bases 

17 for a ‘clinical hold’ under section 505(i)(3) have 

18 been determined by the Secretary to exist con19 cerning the investigation. 

20 ‘‘(12) The term ‘person’ includes an affiliate of 

21 such person. 

22 ‘‘(13) The term ‘process for the review of bio23 similar biological product applications’ means the 

24 following activities of the Secretary with respect to 

25 the review of submissions in connection with bio-
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1 similar biological product development, biosimilar bi2 ological product applications, and supplements: 

3 ‘‘(A) The activities necessary for the re4 view of submissions in connection with bio5 similar biological product development, bio6 similar biological product applications, and sup7 plements. 

8 ‘‘(B) Actions related to submissions in con9 nection with biosimilar biological product devel10 opment, the issuance of action letters which ap11 prove biosimilar biological product applications 

12 or which set forth in detail the specific defi13 ciencies in such applications, and where appro14 priate, the actions necessary to place such ap15 plications in condition for approval. 

16 ‘‘(C) The inspection of biosimilar biological 

17 product establishments and other facilities un18 dertaken as part of the Secretary’s review of 

19 pending biosimilar biological product applica20 tions and supplements. 

21 ‘‘(D) Activities necessary for the release of 

22 lots of biosimilar biological products under sec23 tion 351(k) of the Public Health Service Act. 
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1 ‘‘(E) Monitoring of research conducted in 

2 connection with the review of biosimilar biologi3 cal product applications. 

4 ‘‘(F) Postmarket safety activities with re5 spect to biologics approved under biosimilar bio6 logical product applications or supplements, in7 cluding the following activities: 

8 ‘‘(i) Collecting, developing, and re9 viewing safety information on biosimilar bi10 ological products, including adverse-event 

11 reports. 

12 ‘‘(ii) Developing and using improved 

13 adverse-event data-collection systems, in14 cluding information technology systems. 

15 ‘‘(iii) Developing and using improved 

16 analytical tools to assess potential safety 

17 problems, including access to external data 

18 bases. 

19 ‘‘(iv) Implementing and enforcing sec20 tion 505(o) (relating to postapproval stud21 ies and clinical trials and labeling changes) 

22 and section 505(p) (relating to risk evalua23 tion and mitigation strategies). 
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1 ‘‘(v) Carrying out section 505(k)(5) 

2 (relating to adverse-event reports and 

3 postmarket safety activities). 

4 ‘‘(14) The term ‘supplement’ means a request 

5 to the Secretary to approve a change in a biosimilar 

6 biological product application which has been ap7 proved, including a supplement requesting that the 

8 Secretary determine that the biosimilar biological 

9 product meets the standards for interchangeability 

10 described in section 351(k)(4) of the Public Health 

11 Service Act. 

12 ‘‘SEC. 744H. AUTHORITY TO ASSESS AND USE BIOSIMILAR 

13 BIOLOGICAL PRODUCT FEES. 

14 ‘‘(a) TYPES OF FEES.—Beginning in fiscal year 

15 2013, the Secretary shall assess and collect fees in accord16 ance with this section as follows: 

17 ‘‘(1) BIOSIMILAR DEVELOPMENT PROGRAM

18 FEES.— 

19 ‘‘(A) INITIAL BIOSIMILAR BIOLOGICAL

20 PRODUCT DEVELOPMENT FEE.— 

21 ‘‘(i) IN GENERAL.—Each person that 

22 submits to the Secretary a meeting request 

23 described under clause (ii) or a clinical 

24 protocol for an investigational new drug 

25 protocol described under clause (iii) shall 
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1 pay for the product named in the meeting 

2 request or the investigational new drug ap3 plication the initial biosimilar biological 

4 product development fee established under 

5 subsection (b)(1)(A). 

6 ‘‘(ii) MEETING REQUEST.—The meet7 ing request described in this clause is a re8 quest for a biosimilar biological product 

9 development meeting for a product. 

10 ‘‘(iii) CLINICAL PROTOCOL FOR IND.— 

11 A clinical protocol for an investigational 

12 new drug protocol described in this clause 

13 is a clinical protocol consistent with the 

14 provisions of section 505(i), including any 

15 regulations promulgated under section 

16 505(i), (referred to in this section as ‘in17 vestigational new drug application’) de18 scribing an investigation that the Secretary 

19 determines is intended to support a bio20 similar biological product application for a 

21 product. 

22 ‘‘(iv) DUE DATE.—The initial bio23 similar biological product development fee 

24 shall be due by the earlier of the following: 
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1 ‘‘(I) Not later than 5 days after 

2 the Secretary grants a request for a 

3 biosimilar biological product develop4 ment meeting. 

5 ‘‘(II) The date of submission of 

6 an investigational new drug applica7 tion describing an investigation that 

8 the Secretary determines is intended 

9 to support a biosimilar biological 

10 product application. 

11 ‘‘(v) TRANSITION RULE.—Each per12 son that has submitted an investigational 

13 new drug application prior to the date of 

14 enactment of the Biosimilars User Fee Act 

15 of 2012 shall pay the initial biosimilar bio16 logical product development fee by the ear17 lier of the following: 

18 ‘‘(I) Not later than 60 days after 

19 the date of the enactment of the 

20 Biosimilars User Fee Act of 2012, if 

21 the Secretary determines that the in22 vestigational new drug application de23 scribes an investigation that is in24 tended to support a biosimilar biologi25 cal product application. 
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1 ‘‘(II) Not later than 5 days after 

2 the Secretary grants a request for a 

3 biosimilar biological product develop4 ment meeting. 

5 ‘‘(B) ANNUAL BIOSIMILAR BIOLOGICAL

6 PRODUCT DEVELOPMENT FEE.— 

7 ‘‘(i) IN GENERAL.—A person that 

8 pays an initial biosimilar biological product 

9 development fee for a product shall pay for 

10 such product, beginning in the fiscal year 

11 following the fiscal year in which the initial 

12 biosimilar biological product development 

13 fee was paid, an annual fee established 

14 under subsection (b)(1)(B) for biosimilar 

15 biological product development (referred to 

16 in this section as ‘annual biosimilar bio17 logical product development fee’). 

18 ‘‘(ii) DUE DATE.—The annual bio19 similar biological product development pro20 gram fee for each fiscal year will be due on 

21 the later of— 

22 ‘‘(I) the first business day on or 

23 after October 1 of each such year; or 

24 ‘‘(II) the first business day after 

25 the enactment of an appropriations 
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1 Act providing for the collection and 

2 obligation of fees for such year under 

3 this section. 

4 ‘‘(iii) EXCEPTION.—The annual bio5 similar development program fee for each 

6 fiscal year will be due on the date specified 

7 in clause (ii), unless the person has— 

8 ‘‘(I) submitted a marketing appli9 cation for the biological product that 

10 was accepted for filing; or 

11 ‘‘(II) discontinued participation 

12 in the biosimilar biological product de13 velopment program for the product 

14 under subparagraph (C). 

15 ‘‘(C) DISCONTINUATION OF FEE OBLIGA16 TION.—A person may discontinue participation 

17 in the biosimilar biological product development 

18 program for a product effective October 1 of a 

19 fiscal year by, not later than August 1 of the 

20 preceding fiscal year— 

21 ‘‘(i) if no investigational new drug ap22 plication concerning the product has been 

23 submitted, submitting to the Secretary a 

24 written declaration that the person has no 

25 present intention of further developing the 
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1 product as a biosimilar biological product; 

2 or 

3 ‘‘(ii) if an investigational new drug 

4 application concerning the product has 

5 been submitted, by withdrawing the inves6 tigational new drug application in accord7 ance with part 312 of title 21, Code of 

8 Federal Regulations (or any successor reg9 ulations). 

10 ‘‘(D) REACTIVATION FEE.— 

11 ‘‘(i) IN GENERAL.—A person that has 

12 discontinued participation in the biosimilar 

13 biological product development program for 

14 a product under subparagraph (C) shall 

15 pay a fee (referred to in this section as ‘re16 activation fee’) by the earlier of the fol17 lowing: 

18 ‘‘(I) Not later than 5 days after 

19 the Secretary grants a request for a 

20 biosimilar biological product develop21 ment meeting for the product (after 

22 the date on which such participation 

23 was discontinued). 

24 ‘‘(II) Upon the date of submis25 sion (after the date on which such 
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1 participation was discontinued) of an 

2 investigational new drug application 

3 describing an investigation that the 

4 Secretary determines is intended to 

5 support a biosimilar biological product 

6 application for that product. 

7 ‘‘(ii) APPLICATION OF ANNUAL

8 FEE.—A person that pays a reactivation 

9 fee for a product shall pay for such prod10 uct, beginning in the next fiscal year, the 

11 annual biosimilar biological product devel12 opment fee under subparagraph (B). 

13 ‘‘(E) EFFECT OF FAILURE TO PAY BIO14 SIMILAR DEVELOPMENT PROGRAM FEES.— 

15 ‘‘(i) NO BIOSIMILAR BIOLOGICAL

16 PRODUCT DEVELOPMENT MEETINGS.—If a 

17 person has failed to pay an initial or an18 nual biosimilar biological product develop19 ment fee as required under subparagraph 

20 (A) or (B), or a reactivation fee as re21 quired under subparagraph (D), the Sec22 retary shall not provide a biosimilar bio23 logical product development meeting relat24 ing to the product for which fees are owed. 
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1 ‘‘(ii) NO RECEIPT OF INVESTIGA2 TIONAL NEW DRUG APPLICATIONS.—Ex3 cept in extraordinary circumstances, the 

4 Secretary shall not consider an investiga5 tional new drug application to have been 

6 received under section 505(i)(2) if— 

7 ‘‘(I) the Secretary determines 

8 that the investigation is intended to 

9 support a biosimilar biological product 

10 application; and 

11 ‘‘(II) the sponsor has failed to 

12 pay an initial or annual biosimilar bio13 logical product development fee for 

14 the product as required under sub15 paragraph (A) or (B), or a reactiva16 tion fee as required under subpara17 graph (D). 

18 ‘‘(iii) FINANCIAL HOLD.—Notwith19 standing section 505(i)(2), except in ex20 traordinary circumstances, the Secretary 

21 shall prohibit the sponsor of a clinical in22 vestigation from continuing the investiga23 tion if— 

24 ‘‘(I) the Secretary determines 

25 that the investigation is intended to 
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1 support a biosimilar biological product 

2 application; and 

3 ‘‘(II) the sponsor has failed to 

4 pay an initial or annual biosimilar bio5 logical product development fee for 

6 the product as required under sub7 paragraph (A) or (B), or a reactiva8 tion fee for the product as required 

9 under subparagraph (D). 

10 ‘‘(iv) NO ACCEPTANCE OF BIOSIMILAR

11 BIOLOGICAL PRODUCT APPLICATIONS OR

12 SUPPLEMENTS.—If a person has failed to 

13 pay an initial or annual biosimilar biologi14 cal product development fee as required 

15 under subparagraph (A) or (B), or a reac16 tivation fee as required under subpara17 graph (D), any biosimilar biological prod18 uct application or supplement submitted by 

19 that person shall be considered incomplete 

20 and shall not be accepted for filing by the 

21 Secretary until all such fees owed by such 

22 person have been paid. 

23 ‘‘(F) LIMITS REGARDING BIOSIMILAR DE24 VELOPMENT PROGRAM FEES.— 
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1 ‘‘(i) NO REFUNDS.—The Secretary 

2 shall not refund any initial or annual bio3 similar biological product development fee 

4 paid under subparagraph (A) or (B), or 

5 any reactivation fee paid under subpara6 graph (D). 

7 ‘‘(ii) NO WAIVERS, EXEMPTIONS, OR

8 REDUCTIONS.—The Secretary shall not 

9 grant a waiver, exemption, or reduction of 

10 any initial or annual biosimilar biological 

11 product development fee due or payable 

12 under subparagraph (A) or (B), or any re13 activation fee due or payable under sub14 paragraph (D). 

15 ‘‘(2) BIOSIMILAR BIOLOGICAL PRODUCT APPLI16 CATION AND SUPPLEMENT FEE.— 

17 ‘‘(A) IN GENERAL.—Each person that sub18 mits, on or after October 1, 2012, a biosimilar 

19 biological product application or a supplement 

20 shall be subject to the following fees: 

21 ‘‘(i) A fee for a biosimilar biological 

22 product application that is equal to— 

23 ‘‘(I) the amount of the fee estab24 lished under subsection (b)(1)(D) for 
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1 a biosimilar biological product applica2 tion; minus 

3 ‘‘(II) the cumulative amount of 

4 fees paid, if any, under subparagraphs 

5 (A), (B), and (D) of paragraph (1) 

6 for the product that is the subject of 

7 the application. 

8 ‘‘(ii) A fee for a biosimilar biological 

9 product application for which clinical data 

10 (other than comparative bioavailability 

11 studies) with respect to safety or effective12 ness are not required, that is equal to— 

13 ‘‘(I) half of the amount of the fee 

14 established under subsection (b)(1)(D) 

15 for a biosimilar biological product ap16 plication; minus 

17 ‘‘(II) the cumulative amount of 

18 fees paid, if any, under subparagraphs 

19 (A), (B), and (D) of paragraph (1) 

20 for that product. 

21 ‘‘(iii) A fee for a supplement for which 

22 clinical data (other than comparative bio23 availability studies) with respect to safety 

24 or effectiveness are required, that is equal 

25 to half of the amount of the fee established 
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1 under subsection (b)(1)(D) for a biosimilar 

2 biological product application. 

3 ‘‘(B) REDUCTION IN FEES.—Notwith4 standing section 404 of the Biosimilars User 

5 Fee Act of 2012, any person who pays a fee 

6 under subparagraph (A), (B), or (D) of para7 graph (1) for a product before October 1, 2017, 

8 but submits a biosimilar biological product ap9 plication for that product after such date, shall 

10 be entitled to the reduction of any biosimilar bi11 ological product application fees that may be 

12 assessed at the time when such biosimilar bio13 logical product application is submitted, by the 

14 cumulative amount of fees paid under subpara15 graphs (A), (B), and (D) of paragraph (1) for 

16 that product. 

17 ‘‘(C) PAYMENT DUE DATE.—Any fee re18 quired by subparagraph (A) shall be due upon 

19 submission of the application or supplement for 

20 which such fee applies. 

21 ‘‘(D) EXCEPTION FOR PREVIOUSLY FILED

22 APPLICATION OR SUPPLEMENT.—If a biosimilar 

23 biological product application or supplement 

24 was submitted by a person that paid the fee for 

25 such application or supplement, was accepted 
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1 for filing, and was not approved or was with2 drawn (without a waiver), the submission of a 

3 biosimilar biological product application or a 

4 supplement for the same product by the same 

5 person (or the person’s licensee, assignee, or 

6 successor) shall not be subject to a fee under 

7 subparagraph (A). 

8 ‘‘(E) REFUND OF APPLICATION FEE IF AP9 PLICATION REFUSED FOR FILING OR WITH10 DRAWN BEFORE FILING.—The Secretary shall 

11 refund 75 percent of the fee paid under this 

12 paragraph for any application or supplement 

13 which is refused for filing or withdrawn without 

14 a waiver before filing. 

15 ‘‘(F) FEES FOR APPLICATIONS PRE16 VIOUSLY REFUSED FOR FILING OR WITHDRAWN

17 BEFORE FILING.—A biosimilar biological prod18 uct application or supplement that was sub19 mitted but was refused for filing, or was with20 drawn before being accepted or refused for fil21 ing, shall be subject to the full fee under sub22 paragraph (A) upon being resubmitted or filed 

23 over protest, unless the fee is waived under sub24 section (c). 
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1 ‘‘(3) BIOSIMILAR BIOLOGICAL PRODUCT ESTAB2 LISHMENT FEE.— 

3 ‘‘(A) IN GENERAL.—Except as provided in 

4 subparagraph (E), each person that is named 

5 as the applicant in a biosimilar biological prod6 uct application shall be assessed an annual fee 

7 established under subsection (b)(1)(E) for each 

8 biosimilar biological product establishment that 

9 is listed in the approved biosimilar biological 

10 product application as an establishment that 

11 manufactures the biosimilar biological product 

12 named in such application. 

13 ‘‘(B) ASSESSMENT IN FISCAL YEARS.—The 

14 establishment fee shall be assessed in each fis15 cal year for which the biosimilar biological prod16 uct named in the application is assessed a fee 

17 under paragraph (4) unless the biosimilar bio18 logical product establishment listed in the appli19 cation does not engage in the manufacture of 

20 the biosimilar biological product during such 

21 fiscal year. 

22 ‘‘(C) DUE DATE.—The establishment fee 

23 for a fiscal year shall be due on the later of— 

24 ‘‘(i) the first business day on or after 

25 October 1 of such fiscal year; or 
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1 ‘‘(ii) the first business day after the 

2 enactment of an appropriations Act pro3 viding for the collection and obligation of 

4 fees for such fiscal year under this section. 

5 ‘‘(D) APPLICATION TO ESTABLISHMENT.— 

6 ‘‘(i) Each biosimilar biological product 

7 establishment shall be assessed only one 

8 fee per biosimilar biological product estab9 lishment, notwithstanding the number of 

10 biosimilar biological products manufac11 tured at the establishment, subject to 

12 clause (ii). 

13 ‘‘(ii) In the event an establishment is 

14 listed in a biosimilar biological product ap15 plication by more than one applicant, the 

16 establishment fee for the fiscal year shall 

17 be divided equally and assessed among the 

18 applicants whose biosimilar biological prod19 ucts are manufactured by the establish20 ment during the fiscal year and assessed 

21 biosimilar biological product fees under 

22 paragraph (4). 

23 ‘‘(E) EXCEPTION FOR NEW PRODUCTS.— 

24 If, during the fiscal year, an applicant initiates 

25 or causes to be initiated the manufacture of a 
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1 biosimilar biological product at an establish2 ment listed in its biosimilar biological product 

3 application— 

4 ‘‘(i) that did not manufacture the bio5 similar biological product in the previous 

6 fiscal year; and 

7 ‘‘(ii) for which the full biosimilar bio8 logical product establishment fee has been 

9 assessed in the fiscal year at a time before 

10 manufacture of the biosimilar biological 

11 product was begun, 

12 the applicant shall not be assessed a share of 

13 the biosimilar biological product establishment 

14 fee for the fiscal year in which the manufacture 

15 of the product began. 

16 ‘‘(4) BIOSIMILAR BIOLOGICAL PRODUCT FEE.— 

17 ‘‘(A) IN GENERAL.—Each person who is 

18 named as the applicant in a biosimilar biologi19 cal product application shall pay for each such 

20 biosimilar biological product the annual fee es21 tablished under subsection (b)(1)(F). 

22 ‘‘(B) DUE DATE.—The biosimilar biologi23 cal product fee for a fiscal year shall be due on 

24 the later of— 
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1 ‘‘(i) the first business day on or after 

2 October 1 of each such year; or 

3 ‘‘(ii) the first business day after the 

4 enactment of an appropriations Act pro5 viding for the collection and obligation of 

6 fees for such year under this section. 

7 ‘‘(C) ONE FEE PER PRODUCT PER YEAR.— 

8 The biosimilar biological product fee shall be 

9 paid only once for each product for each fiscal 

10 year. 

11 ‘‘(b) FEE SETTING AND AMOUNTS.— 

12 ‘‘(1) IN GENERAL.—Subject to paragraph (2), 

13 the Secretary shall, 60 days before the start of each 

14 fiscal year that begins after September 30, 2012, es15 tablish, for the next fiscal year, the fees under sub16 section (a). Except as provided in subsection (c), 

17 such fees shall be in the following amounts: 

18 ‘‘(A) INITIAL BIOSIMILAR BIOLOGICAL

19 PRODUCT DEVELOPMENT FEE.—The initial bio20 similar biological product development fee under 

21 subsection (a)(1)(A) for a fiscal year shall be 

22 equal to 10 percent of the amount established 

23 under section 736(c)(4) for a human drug ap24 plication described in section 736(a)(1)(A)(i) 

25 for that fiscal year. 
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1 ‘‘(B) ANNUAL BIOSIMILAR BIOLOGICAL

2 PRODUCT DEVELOPMENT FEE.—The annual 

3 biosimilar biological product development fee 

4 under subsection (a)(1)(B) for a fiscal year 

5 shall be equal to 10 percent of the amount es6 tablished under section 736(c)(4) for a human 

7 drug application described in section 

8 736(a)(1)(A)(i) for that fiscal year. 

9 ‘‘(C) REACTIVATION FEE.—The reactiva10 tion fee under subsection (a)(1)(D) for a fiscal 

11 year shall be equal to 20 percent of the amount 

12 of the fee established under section 736(c)(4) 

13 for a human drug application described in sec14 tion 736(a)(1)(A)(i) for that fiscal year. 

15 ‘‘(D) BIOSIMILAR BIOLOGICAL PRODUCT

16 APPLICATION FEE.—The biosimilar biological 

17 product application fee under subsection (a)(2) 

18 for a fiscal year shall be equal to the amount 

19 established under section 736(c)(4) for a 

20 human drug application described in section 

21 736(a)(1)(A)(i) for that fiscal year. 

22 ‘‘(E) BIOSIMILAR BIOLOGICAL PRODUCT

23 ESTABLISHMENT FEE.—The biosimilar biologi24 cal product establishment fee under subsection 

25 (a)(3) for a fiscal year shall be equal to the 
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1 amount established under section 736(c)(4) for 

2 a prescription drug establishment for that fiscal 

3 year. 

4 ‘‘(F) BIOSIMILAR BIOLOGICAL PRODUCT

5 FEE.—The biosimilar biological product fee 

6 under subsection (a)(4) for a fiscal year shall be 

7 equal to the amount established under section 

8 736(c)(4) for a prescription drug product for 

9 that fiscal year. 

10 ‘‘(2) LIMIT.—The total amount of fees charged 

11 for a fiscal year under this section may not exceed 

12 the total amount for such fiscal year of the costs of 

13 resources allocated for the process for the review of 

14 biosimilar biological product applications. 

15 ‘‘(c) APPLICATION FEE WAIVER FOR SMALL BUSI16 NESS.— 

17 ‘‘(1) WAIVER OF APPLICATION FEE.—The Sec18 retary shall grant to a person who is named in a bio19 similar biological product application a waiver from 

20 the application fee assessed to that person under 

21 subsection (a)(2)(A) for the first biosimilar biologi22 cal product application that a small business or its 

23 affiliate submits to the Secretary for review. After a 

24 small business or its affiliate is granted such a waiv25 er, the small business or its affiliate shall pay— 
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1 ‘‘(A) application fees for all subsequent 

2 biosimilar biological product applications sub3 mitted to the Secretary for review in the same 

4 manner as an entity that is not a small busi5 ness; and 

6 ‘‘(B) all supplement fees for all supple7 ments to biosimilar biological product applica8 tions submitted to the Secretary for review in 

9 the same manner as an entity that is not a 

10 small business. 

11 ‘‘(2) CONSIDERATIONS.—In determining wheth12 er to grant a waiver of a fee under paragraph (1), 

13 the Secretary shall consider only the circumstances 

14 and assets of the applicant involved and any affiliate 

15 of the applicant. 

16 ‘‘(3) SMALL BUSINESS DEFINED.—In this sub17 section, the term ‘small business’ means an entity 

18 that has fewer than 500 employees, including em19 ployees of affiliates, and does not have a drug prod20 uct that has been approved under a human drug ap21 plication (as defined in section 735) or a biosimilar 

22 biological product application (as defined in section 

23 744G(4)) and introduced or delivered for introduc24 tion into interstate commerce. 
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1 ‘‘(d) EFFECT OF FAILURE TO PAY FEES.—A bio2 similar biological product application or supplement sub3 mitted by a person subject to fees under subsection (a) 

4 shall be considered incomplete and shall not be accepted 

5 for filing by the Secretary until all fees owed by such per6 son have been paid. 

7 ‘‘(e) CREDITING AND AVAILABILITY OF FEES.— 

8 ‘‘(1) IN GENERAL.—Subject to paragraph (2), 

9 fees authorized under subsection (a) shall be col10 lected and available for obligation only to the extent 

11 and in the amount provided in advance in appropria12 tions Acts. Such fees are authorized to remain avail13 able until expended. Such sums as may be necessary 

14 may be transferred from the Food and Drug Admin15 istration salaries and expenses appropriation account 

16 without fiscal year limitation to such appropriation 

17 account for salaries and expenses with such fiscal 

18 year limitation. The sums transferred shall be avail19 able solely for the process for the review of bio20 similar biological product applications. 

21 ‘‘(2) COLLECTIONS AND APPROPRIATION

22 ACTS.— 

23 ‘‘(A) IN GENERAL.—Subject to subpara24 graphs (C) and (D), the fees authorized by this 

25 section shall be collected and available in each 
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1 fiscal year in an amount not to exceed the 

2 amount specified in appropriation Acts, or oth3 erwise made available for obligation for such 

4 fiscal year. 

5 ‘‘(B) USE OF FEES AND LIMITATION.— 

6 The fees authorized by this section shall be 

7 available for a fiscal year beginning after fiscal 

8 year 2012 to defray the costs of the process for 

9 the review of biosimilar biological product appli10 cations (including such costs for an additional 

11 number of full-time equivalent positions in the 

12 Department of Health and Human Services to 

13 be engaged in such process), only if the Sec14 retary allocates for such purpose an amount for 

15 such fiscal year (excluding amounts from fees 

16 collected under this section) no less than 

17 $20,000,000, multiplied by the adjustment fac18 tor applicable to the fiscal year involved. 

19 ‘‘(C) FEE COLLECTION DURING FIRST

20 PROGRAM YEAR.—Until the date of enactment 

21 of an Act making appropriations through Sep22 tember 30, 2013, for the salaries and expenses 

23 account of the Food and Drug Administration, 

24 fees authorized by this section for fiscal year 

25 2013 may be collected and shall be credited to 
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1 such account and remain available until ex2 pended. 

3 ‘‘(D) PROVISION FOR EARLY PAYMENTS IN

4 SUBSEQUENT YEARS.—Payment of fees author5 ized under this section for a fiscal year (after 

6 fiscal year 2013), prior to the due date for such 

7 fees, may be accepted by the Secretary in ac8 cordance with authority provided in advance in 

9 a prior year appropriations Act. 

10 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

11 For each of fiscal years 2013 through 2017, there 

12 is authorized to be appropriated for fees under this 

13 section an amount equivalent to the total amount of 

14 fees assessed for such fiscal year under this section. 

15 ‘‘(f) COLLECTION OF UNPAID FEES.—In any case 

16 where the Secretary does not receive payment of a fee as17 sessed under subsection (a) within 30 days after it is due, 

18 such fee shall be treated as a claim of the United States 

19 Government subject to subchapter II of chapter 37 of title 

20 31, United States Code. 

21 ‘‘(g) WRITTEN REQUESTS FOR WAIVERS AND RE22 FUNDS.—To qualify for consideration for a waiver under 

23 subsection (c), or for a refund of any fee collected in ac24 cordance with subsection (a)(2)(A), a person shall submit 
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1 to the Secretary a written request for such waiver or re2 fund not later than 180 days after such fee is due. 

3 ‘‘(h) CONSTRUCTION.—This section may not be con4 strued to require that the number of full-time equivalent 

5 positions in the Department of Health and Human Serv6 ices, for officers, employers, and advisory committees not 

7 engaged in the process of the review of biosimilar biologi8 cal product applications, be reduced to offset the number 

9 of officers, employees, and advisory committees so en10 gaged.’’. 

11 SEC. 403. REAUTHORIZATION; REPORTING REQUIREMENTS. 

12 Part 8 of subchapter C of chapter VII, as added by 

13 section 402, is further amended by inserting after section 

14 744H the following: 

15 ‘‘SEC. 744I. REAUTHORIZATION; REPORTING REQUIRE16 MENTS. 

17 ‘‘(a) PERFORMANCE REPORT.—Beginning with fiscal 

18 year 2013, not later than 120 days after the end of each 

19 fiscal year for which fees are collected under this part, 

20 the Secretary shall prepare and submit to the Committee 

21 on Energy and Commerce of the House of Representatives 

22 and the Committee on Health, Education, Labor, and 

23 Pensions of the Senate a report concerning the progress 

24 of the Food and Drug Administration in achieving the 

25 goals identified in the letters described in section 401(b) 
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1 of the Biosimilar User Fee Act of 2012 during such fiscal 

2 year and the future plans of the Food and Drug Adminis3 tration for meeting such goals. The report for a fiscal year 

4 shall include information on all previous cohorts for which 

5 the Secretary has not given a complete response on all 

6 biosimilar biological product applications and supplements 

7 in the cohort. 

8 ‘‘(b) FISCAL REPORT.—Not later than 120 days after 

9 the end of fiscal year 2013 and each subsequent fiscal year 

10 for which fees are collected under this part, the Secretary 

11 shall prepare and submit to the Committee on Energy and 

12 Commerce of the House of Representatives and the Com13 mittee on Health, Education, Labor, and Pensions of the 

14 Senate a report on the implementation of the authority 

15 for such fees during such fiscal year and the use, by the 

16 Food and Drug Administration, of the fees collected for 

17 such fiscal year. 

18 ‘‘(c) PUBLIC AVAILABILITY.—The Secretary shall 

19 make the reports required under subsections (a) and (b) 

20 available to the public on the Internet Web site of the 

21 Food and Drug Administration. 

22 ‘‘(d) STUDY.— 

23 ‘‘(1) IN GENERAL.—The Secretary shall con24 tract with an independent accounting or consulting 

25 firm to study the workload volume and full costs as-
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1 sociated with the process for the review of biosimilar 

2 biological product applications. 

3 ‘‘(2) INTERIM RESULTS.—Not later than June 

4 1, 2015, the Secretary shall publish, for public com5 ment, interim results of the study described under 

6 paragraph (1). 

7 ‘‘(3) FINAL RESULTS.—Not later than Sep8 tember 30, 2016, the Secretary shall publish, for 

9 public comment, the final results of the study de10 scribed under paragraph (1). 

11 ‘‘(e) REAUTHORIZATION.— 

12 ‘‘(1) CONSULTATION.—In developing rec13 ommendations to present to the Congress with re14 spect to the goals described in subsection (a), and 

15 plans for meeting the goals, for the process for the 

16 review of biosimilar biological product applications 

17 for the first 5 fiscal years after fiscal year 2017, and 

18 for the reauthorization of this part for such fiscal 

19 years, the Secretary shall consult with— 

20 ‘‘(A) the Committee on Energy and Com21 merce of the House of Representatives; 

22 ‘‘(B) the Committee on Health, Education, 

23 Labor, and Pensions of the Senate; 

24 ‘‘(C) scientific and academic experts; 

25 ‘‘(D) health care professionals; 
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1 ‘‘(E) representatives of patient and con2 sumer advocacy groups; and 

3 ‘‘(F) the regulated industry. 

4 ‘‘(2) PUBLIC REVIEW OF RECOMMENDA5 TIONS.—After negotiations with the regulated indus6 try, the Secretary shall— 

7 ‘‘(A) present the recommendations devel8 oped under paragraph (1) to the congressional 

9 committees specified in such paragraph; 

10 ‘‘(B) publish such recommendations in the 

11 Federal Register; 

12 ‘‘(C) provide for a period of 30 days for 

13 the public to provide written comments on such 

14 recommendations; 

15 ‘‘(D) hold a meeting at which the public 

16 may present its views on such recommenda17 tions; and 

18 ‘‘(E) after consideration of such public 

19 views and comments, revise such recommenda20 tions as necessary. 

21 ‘‘(3) TRANSMITTAL OF RECOMMENDATIONS.— 

22 Not later than January 15, 2017, the Secretary 

23 shall transmit to the Congress the revised rec24 ommendations under paragraph (2), a summary of 

25 the views and comments received under such para-
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1 graph, and any changes made to the recommenda2 tions in response to such views and comments.’’. 

3 SEC. 404. SUNSET DATES. 

4 (a) AUTHORIZATION.—The amendment made by sec5 tion 402 shall cease to be effective October 1, 2017. 

6 (b) REPORTING REQUIREMENTS.—The amendment 

7 made by section 403 shall cease to be effective January 

8 31, 2018. 

9 SEC. 405. EFFECTIVE DATE. 

10 (a) IN GENERAL.—Except as provided under sub11 section (b), the amendments made by this title shall take 

12 effect on the later of— 

13 (1) October 1, 2012; or 

14 (2) the date of the enactment of this title. 

15 (b) EXCEPTION.—Fees under part 8 of subchapter 

16 C of chapter VII of the Federal Food, Drug, and Cosmetic 

17 Act, as added by this title, shall be assessed for all bio18 similar biological product applications received on or after 

19 October 1, 2012, regardless of the date of the enactment 

20 of this title. 

21 SEC. 406. SAVINGS CLAUSE. 

22 Notwithstanding the amendments made by this title, 

23 part 2 of subchapter C of chapter VII of the Federal Food, 

24 Drug, and Cosmetic Act, as in effect on the day before 

25 the date of the enactment of this title, shall continue to 
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1 be in effect with respect to human drug applications and 

2 supplements (as defined in such part as of such day) that 

3 were accepted by the Food and Drug Administration for 

4 filing on or after October 1, 2007, but before October 1, 

5 2012, with respect to assessing and collecting any fee re6 quired by such part for a fiscal year prior to fiscal year 

7 2013. 

8 SEC. 407. CONFORMING AMENDMENT. 

9 Section 735(1)(B) (21 U.S.C. 379g(1)(B)) is amend10 ed by striking ‘‘or (k)’’. 

11 TITLE V—PEDIATRIC DRUGS 

12 AND DEVICES 

13 SEC. 501. PERMANENCE. 

14 (a) PEDIATRIC STUDIES OF DRUGS.—Subsection (q) 

15 of section 505A (21 U.S.C. 355a) is amended— 

16 (1) in the subsection heading, by striking 

17 ‘‘SUNSET’’ and inserting ‘‘PERMANENCE’’; 

18 (2) in paragraph (1), by striking ‘‘on or before 

19 October 1, 2012,’’; and 

20 (3) in paragraph (2), by striking ‘‘on or before 

21 October 1, 2012,’’. 

22 (b) RESEARCH INTO PEDIATRIC USES FOR DRUGS

23 AND BIOLOGICAL PRODUCTS.—Section 505B (21 U.S.C. 

24 355c) is amended— 

25 (1) by striking subsection (m); and 
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1 (2) by redesignating subsection (n) as sub2 section (m). 

3 SEC. 502. WRITTEN REQUESTS. 

4 (a) FEDERAL FOOD, DRUG, AND COSMETIC ACT.— 

5 Subsection (h) of section 505A (21 U.S.C. 355a) is 

6 amended to read as follows: 

7 ‘‘(h) RELATIONSHIP TO PEDIATRIC RESEARCH RE8 QUIREMENTS.—Exclusivity under this section shall only be 

9 granted for the completion of a study or studies that are 

10 the subject of a written request and for which reports are 

11 submitted and accepted in accordance with subsection 

12 (d)(3). Written requests under this section may consist of 

13 a study or studies required under section 505B.’’. 

14 (b) PUBLIC HEALTH SERVICE ACT.—Section 

15 351(m)(1) of the Public Health Service Act (42 U.S.C. 

16 262(m)(1)) is amended by striking ‘‘(f), (i), (j), (k), (l), 

17 (p), and (q)’’ and inserting ‘‘(f), (h), (i), (j), (k), (l), (n), 

18 and (p)’’. 

19 SEC. 503. COMMUNICATION WITH PEDIATRIC REVIEW COM20 MITTEE. 

21 Not later than 1 year after the date of enactment 

22 of this Act, the Secretary of Health and Human Services 

23 (referred to in this title as the ‘‘Secretary’’) shall issue 

24 internal standard operating procedures that provide for 

25 the review by the internal review committee established 
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1 under section 505C of the Federal Food, Drug, and Cos2 metic Act (21 U.S.C. 355d) of any significant modifica3 tions to initial pediatric study plans, agreed initial pedi4 atric study plans, and written requests under sections 

5 505A and 505B of the Federal Food, Drug, and Cosmetic 

6 Act (21 U.S.C. 355c). Such internal standard operating 

7 procedures shall be made publicly available on the Internet 

8 website of the Food and Drug Administration. 

9 SEC. 504. ACCESS TO DATA. 

10 Not later than 3 years after the date of enactment 

11 of this Act, the Secretary shall make available to the pub12 lic, including through posting on the Internet website of 

13 the Food and Drug Administration, the medical, statis14 tical, and clinical pharmacology reviews of, and cor15 responding written requests issued to an applicant, spon16 sor, or holder for, pediatric studies submitted between 

17 January 4, 2002 and September 27, 2007 under sub18 section (b) or (c) of section 505A of the Federal Food, 

19 Drug, and Cosmetic Act (21 U.S.C. 355a) for which 6 

20 months of market exclusivity was granted and that re21 sulted in a labeling change. The Secretary shall make pub22 lic the information described in the preceding sentence in 

23 a manner consistent with how the Secretary releases infor24 mation under section 505A(k) of the Federal Food, Drug, 

25 and Cosmetic Act (21 U.S.C. 355a(k)). 
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1 SEC. 505. ENSURING THE COMPLETION OF PEDIATRIC 

2 STUDIES. 

3 (a) EXTENSION OF DEADLINE FOR DEFERRED

4 STUDIES.—Section 505B (21 U.S.C. 355c) is amended— 

5 (1) in subsection (a)(3)— 

6 (A) by redesignating subparagraph (B) as 

7 subparagraph (C); 

8 (B) by inserting after subparagraph (A) 

9 the following: 

10 ‘‘(B) DEFERRAL EXTENSION.— 

11 ‘‘(i) IN GENERAL.—On the initiative 

12 of the Secretary or at the request of the 

13 applicant, the Secretary may grant an ex14 tension of a deferral approved under sub15 paragraph (A) for submission of some or 

16 all assessments required under paragraph 

17 (1) if— 

18 ‘‘(I) the Secretary determines 

19 that the conditions described in sub20 clause (II) or (III) of subparagraph 

21 (A)(i) continue to be met; and 

22 ‘‘(II) the applicant submits a new 

23 timeline under subparagraph 

24 (A)(ii)(IV) and any significant up25 dates to the information required 

26 under subparagraph (A)(ii). 
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1 ‘‘(ii) TIMING AND INFORMATION.—If 

2 the deferral extension under this subpara3 graph is requested by the applicant, the 

4 applicant shall submit the deferral exten5 sion request containing the information de6 scribed in this subparagraph not less than 

7 90 days prior to the date that the deferral 

8 would expire. The Secretary shall respond 

9 to such request not later than 45 days 

10 after the receipt of such letter. If the Sec11 retary grants such an extension, the speci12 fied date shall be the extended date. The 

13 sponsor of the required assessment under 

14 paragraph (1) shall not be issued a letter 

15 described in subsection (d) unless the spec16 ified or extended date of submission for 

17 such required studies has passed or if the 

18 request for an extension is pending. For a 

19 deferral that has expired prior to the date 

20 of enactment of the Food and Drug Ad21 ministration Safety and Innovation Act or 

22 that will expire prior to 270 days after the 

23 date of enactment of such Act, a deferral 

24 extension shall be requested by an appli25 cant not later than 180 days after the date 
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1 of enactment of such Act. The Secretary 

2 shall respond to any such request as soon 

3 as practicable, but not later than 1 year 

4 after the date of enactment of such Act. 

5 Nothing in this clause shall prevent the 

6 Secretary from updating the status of a 

7 study or studies publicly if components of 

8 such study or studies are late or delayed.’’; 

9 and 

10 (C) in subparagraph (C), as so redesig11 nated— 

12 (i) in clause (i), by adding at the end 

13 the following: 

14 ‘‘(III) Projected completion date 

15 for pediatric studies. 

16 ‘‘(IV) The reason or reasons why 

17 a deferral or deferral extension con18 tinues to be necessary.’’; and 

19 (ii) in clause (ii)— 

20 (I) by inserting ‘‘, as well as the 

21 date of each deferral or deferral ex22 tension, as applicable,’’ after ‘‘clause 

23 (i)’’; and 

24 (II) by inserting ‘‘not later than 

25 90 days after submission to the Sec-
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1 retary or with the next routine quar2 terly update’’ after ‘‘Administration’’; 

3 and 

4 (2) in subsection (f)— 

5 (A) in the subsection heading, by inserting 

6 ‘‘DEFERRAL EXTENSIONS,’’ after ‘‘DEFER7 RALS,’’; 

8 (B) in paragraph (1), by inserting ‘‘, defer9 ral extension,’’ after ‘‘deferral’’; and 

10 (C) in paragraph (4)— 

11 (i) in the paragraph heading, by in12 serting ‘‘DEFERRAL EXTENSIONS,’’ after 

13 ‘‘DEFERRALS,’’; and 

14 (ii) by inserting ‘‘, deferral exten15 sions,’’ after ‘‘deferrals’’. 

16 (b) TRACKING OF EXTENSIONS; ANNUAL INFORMA17 TION.—Section 505B(f)(6)(D) (21 U.S.C. 355c(f)(6)(D)) 

18 is amended to read as follows: 

19 ‘‘(D) aggregated on an annual basis— 

20 ‘‘(i) the total number of deferrals and 

21 deferral extensions requested and granted 

22 under this section and, if granted, the rea23 sons for each such deferral or deferral ex24 tension; 
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1 ‘‘(ii) the timeline for completion of the 

2 assessments; and 

3 ‘‘(iii) the number of assessments com4 pleted and pending;’’. 

5 (c) ACTION ON FAILURE TO COMPLETE STUDIES.— 

6 (1) ISSUANCE OF LETTER.—Subsection (d) of 

7 section 505B (21 U.S.C. 355c) is amended to read 

8 as follows: 

9 ‘‘(d) SUBMISSION OF ASSESSMENTS.—If a person 

10 fails to submit a required assessment described in sub11 section (a)(2), fails to meet the applicable requirements 

12 in subsection (a)(3), or fails to submit a request for ap13 proval of a pediatric formulation described in subsection 

14 (a) or (b), in accordance with applicable provisions of sub15 sections (a) and (b), the following shall apply: 

16 ‘‘(1) Beginning 270 days after the date of en17 actment of the Food and Drug Administration Safe18 ty and Innovation Act, the Secretary shall issue a 

19 non-compliance letter to such person informing them 

20 of such failure to submit or meet the requirements 

21 of the applicable subsection. Such letter shall require 

22 the person to respond in writing within 45 calendar 

23 days of issuance of such letter. Such response may 

24 include the person’s request for a deferral extension 

25 if applicable. Such letter and the person’s written re-
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1 sponse to such letter shall be made publicly available 

2 on the Internet Web site of the Food and Drug Ad3 ministration 60 calendar days after issuance, with 

4 redactions for any trade secrets and confidential 

5 commercial information. If the Secretary determines 

6 that the letter was issued in error, the requirements 

7 of this paragraph shall not apply. 

8 ‘‘(2) The drug or biological product that is the 

9 subject of an assessment described in subsection 

10 (a)(2), applicable requirements in subsection (a)(3), 

11 or request for approval of a pediatric formulation, 

12 may be considered misbranded solely because of that 

13 failure and subject to relevant enforcement action 

14 (except that the drug or biological product shall not 

15 be subject to action under section 303), but such 

16 failure shall not be the basis for a proceeding— 

17 ‘‘(A) to withdraw approval for a drug 

18 under section 505(e); or 

19 ‘‘(B) to revoke the license for a biological 

20 product under section 351 of the Public Health 

21 Service Act.’’. 

22 (2) TRACKING OF LETTERS ISSUED.—Subpara23 graph (D) of section 505B(f)(6) (21 U.S.C. 

24 355c(f)(6)), as amended by subsection (b), is further 

25 amended— 
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1 (A) in clause (ii), by striking ‘‘; and’’ and 

2 inserting a semicolon; 

3 (B) in clause (iii), by adding ‘‘and’’ at the 

4 end; and 

5 (C) by adding at the end the following: 

6 ‘‘(iv) the number of postmarket non7 compliance letters issued pursuant to sub8 section (d), and the recipients of such let9 ters;’’. 

10 SEC. 506. PEDIATRIC STUDY PLANS. 

11 (a) IN GENERAL.—Subsection (e) of section 505B 

12 (21 U.S.C. 355c) is amended to read as follows: 

13 ‘‘(e) PEDIATRIC STUDY PLANS.— 

14 ‘‘(1) IN GENERAL.—An applicant subject to 

15 subsection (a) shall submit to the Secretary an ini16 tial pediatric study plan prior to the submission of 

17 the assessments described under subsection (a)(2). 

18 ‘‘(2) TIMING; CONTENT; MEETING.— 

19 ‘‘(A) TIMING.—An applicant shall submit 

20 an initial pediatric study plan to the Secretary 

21 not later than 60 calendar days after the date 

22 of the end of phase II meeting or such other 

23 equivalent time agreed upon between the Sec24 retary and the applicant. Nothing in this para25 graph shall preclude the Secretary from accept-
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1 ing the submission of an initial pediatric study 

2 plan earlier than the date described under the 

3 preceding sentence. 

4 ‘‘(B) CONTENT OF INITIAL PLAN.—The 

5 initial pediatric study plan shall include— 

6 ‘‘(i) an outline of the pediatric study 

7 or studies that the applicant plans to con8 duct (including, to the extent practicable 

9 study objectives and design, age groups, 

10 relevant endpoints, and statistical ap11 proach); 

12 ‘‘(ii) any request for a deferral, partial 

13 waiver, or waiver under this section, if ap14 plicable, along with any supporting infor15 mation; and 

16 ‘‘(iii) other information specified in 

17 the regulations promulgated under para18 graph (4). 

19 ‘‘(C) MEETING.—The Secretary— 

20 ‘‘(i) shall meet with the applicant to 

21 discuss the initial pediatric study plan as 

22 soon as practicable, but not later than 90 

23 calendar days after the receipt of such plan 

24 under subparagraph (A); 
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1 ‘‘(ii) may determine that a written re2 sponse to the initial pediatric study plan is 

3 sufficient to communicate comments on the 

4 initial pediatric study plan, and that no 

5 meeting is necessary; and 

6 ‘‘(iii) if the Secretary determines that 

7 no meeting is necessary, shall so notify the 

8 applicant and provide written comments of 

9 the Secretary as soon as practicable, but 

10 not later than 90 calendar days after the 

11 receipt of the initial pediatric study plan. 

12 ‘‘(3) AGREED INITIAL PEDIATRIC STUDY

13 PLAN.—Not later than 90 calendar days following 

14 the meeting under paragraph (2)(C)(i) or the receipt 

15 of a written response from the Secretary under para16 graph (2)(C)(iii), the applicant shall document 

17 agreement on the initial pediatric study plan in a 

18 submission to the Secretary marked ‘Agreed Initial 

19 Pediatric Study Plan’, and the Secretary shall con20 firm such agreement to the applicant in writing not 

21 later than 30 calendar days of receipt of such agreed 

22 initial pediatric study plan. 

23 ‘‘(4) DEFERRAL AND WAIVER.—If the agreed 

24 initial pediatric study plan contains a request from 

25 the applicant for a deferral, partial waiver, or waiver 
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1 under this section, the written confirmation under 

2 paragraph (3) shall include a recommendation from 

3 the Secretary as to whether such request meets the 

4 standards under paragraphs (3) or (4) of subsection 

5 (a). 

6 ‘‘(5) AMENDMENTS TO THE PLAN.—At the ini7 tiative of the Secretary or the applicant, the agreed 

8 initial pediatric study plan may be amended at any 

9 time. The requirements of paragraph (2)(C) shall 

10 apply to any such proposed amendment in the same 

11 manner and to the same extent as such require12 ments apply to an initial pediatric study plan under 

13 paragraph (1). The requirements of paragraphs (3) 

14 and (4) shall apply to any agreement resulting from 

15 such proposed amendment in the same manner and 

16 to the same extent as such requirements apply to an 

17 agreed initial pediatric study plan. 

18 ‘‘(6) INTERNAL COMMITTEE.—The Secretary 

19 shall consult the internal committee under section 

20 505C on the review of the initial pediatric study 

21 plan, agreed initial pediatric plan, and any signifi22 cant amendments to such plans. 

23 ‘‘(7) REQUIRED RULEMAKING.—Not later than 

24 1 year after the date of enactment of the Food and 

25 Drug Administration Safety and Innovation Act, the 
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1 Secretary shall promulgate proposed regulations and 

2 issue proposed guidance to implement the provisions 

3 of this subsection.’’. 

4 (b) CONFORMING AMENDMENTS.—Section 505B (21 

5 U.S.C. 355c)is amended— 

6 (1) by amending subclause (II) of subsection 

7 (a)(3)(A)(ii) to read as follows: 

8 ‘‘(II) a pediatric study plan as 

9 described in subsection (e);’’; and 

10 (2) in subsection (f)— 

11 (A) in the subsection heading, by striking 

12 ‘‘PEDIATRIC PLANS,’’ and inserting ‘‘PEDI13 ATRIC STUDY PLANS,’’; 

14 (B) in paragraph (1), by striking ‘‘all pedi15 atric plans’’ and inserting ‘‘initial pediatric 

16 study plans, agreed initial pediatric study 

17 plans,’’; and 

18 (C) in paragraph (4)— 

19 (i) in the paragraph heading, by strik20 ing ‘‘PEDIATRIC PLANS,’’ and inserting 

21 ‘‘PEDIATRIC STUDY PLANS,’’; and 

22 (ii) by striking ‘‘pediatric plans’’ and 

23 inserting ‘‘initial pediatric study plans, 

24 agreed initial pediatric study plans,’’. 

25 (c) EFFECTIVE DATES.— 
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1 (1) PEDIATRIC STUDY PLANS.—Subsection (e) 

2 of section 505B of the Federal Food, Drug, and 

3 Cosmetic Act (other than paragraph (4) of such sub4 section), as amended by subsection (a), shall take ef5 fect 180 days after the date of enactment of this 

6 Act, without regard to whether the Secretary has 

7 promulgated final regulations under paragraph (4) 

8 of such subsection by such date. 

9 (2) CONFORMING AMENDMENTS.—The amend10 ments made by subsection (b) shall take effect 180 

11 days after the date of enactment of this Act. 

12 SEC. 507. REAUTHORIZATIONS. 

13 (a) PEDIATRIC ADVISORY COMMITTEE.—Section 

14 14(d) of the Best Pharmaceuticals for Children Act (42 

15 U.S.C. 284m note) is amended by striking ‘‘Notwith16 standing section 14 of the Federal Advisory Committee 

17 Act, the advisory committee shall continue to operate dur18 ing the five-year period beginning on the date of the enact19 ment of the Best Pharmaceuticals for Children Act of 

20 2007’’ and inserting ‘‘Section 14 of the Federal Advisory 

21 Committee Act shall not apply to the advisory committee’’. 

22 (b) PEDIATRIC SUBCOMMITTEE OF THE ONCOLOGIC

23 DRUGS ADVISORY COMMITTEE.—Section 15(a)(3) of the 

24 Best Pharmaceuticals for Children Act (42 U.S.C. 284m 

25 note) is amended by striking ‘‘during the five-year period 
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1 beginning on the date of the enactment of the Best Phar2 maceuticals for Children Act of 2007’’ and inserting ‘‘for 

3 the duration of the operation of the Oncologic Drugs Advi4 sory Committee’’. 

5 (c) HUMANITARIAN DEVICE EXEMPTION EXTEN6 SION.—Section 520(m)(6)(A)(iv) of the Federal Food, 

7 Drug, and Cosmetic Act (21 U.S.C. 360j(m)(6)(A)(iv)) is 

8 amended by striking ‘‘2012’’ and inserting ‘‘2017’’. 

9 (d) DEMONSTRATION GRANTS TO IMPROVE PEDI10 ATRIC DEVICE AVAILABILITY.—Section 305(e) of Pedi11 atric Medical Device Safety and Improvement Act (Public 

12 Law 110–85; 42 U.S.C. 282 note)) is amended by striking 

13 ‘‘$6,000,000 for each of fiscal years 2008 through 2012’’ 

14 and inserting ‘‘$4,500,000 for each of fiscal years 2013 

15 through 2017’’. 

16 (e) PROGRAM FOR PEDIATRIC STUDY OF DRUGS IN

17 PHSA.—Section 409I(e)(1) of the Public Health Service 

18 Act (42 U.S.C. 284m(e)(1)) is amended by striking ‘‘to 

19 carry out this section’’ and all that follows through the 

20 end of paragraph (1) and inserting ‘‘to carry out this sec21 tion $25,000,000 for each of fiscal years 2012 through 

22 2017.’’. 

23 SEC. 508. REPORT. 

24 (a) IN GENERAL.—Not later than October 31, 2016, 

25 and at the end of each subsequent 5-year period, the Sec-
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1 retary shall submit to Congress a report that evaluates 

2 the effectiveness of sections 505A and 505B of the Fed3 eral Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 

4 355c) and section 409I of the Public Health Service Act 

5 (42 U.S.C. 284m) in ensuring that medicines used by chil6 dren are tested in pediatric populations and properly la7 beled for use in children. 

8 (b) CONTENTS.—The report under subsection (a) 

9 shall include— 

10 (1) the number and importance of drugs and 

11 biological products for children for which studies 

12 have been requested or required (as of the date of 

13 such report) under 505A and 505B of the Federal 

14 Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 

15 355c) and section 409I of the Public Health Service 

16 Act (42 U.S.C. 284m), including— 

17 (A) the number of labeling changes made 

18 to drugs and biological products pursuant to 

19 such sections since the date of enactment of 

20 this Act; and 

21 (B) the importance of such drugs and bio22 logical products in the improvement of the 

23 health of children; 
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1 (2) the number of required studies under such 

2 section 505B that have not met the initial deadline 

3 provided under such section, including— 

4 (A) the number of deferrals and deferral 

5 extensions granted and the reasons such exten6 sions were granted; 

7 (B) the number of waivers and partial 

8 waivers granted; and 

9 (C) the number of letters issued under 

10 subsection (d) of such section 505B; 

11 (3) the number of written requests issued, de12 clined, and referred to the National Institutes of 

13 Health under such section 505A since the date of 

14 enactment of this Act (including the reasons for 

15 such declination), and a description and status of re16 ferrals made under subsection (n) of such section 

17 505A; 

18 (4) the number of proposed pediatric study 

19 plans submitted and agreed to as identified in the 

20 marketing application under such section 505B; 

21 (5) any labeling changes recommended by the 

22 Pediatric Advisory Committee as a result of the re23 view by such Committee of adverse events reports; 

24 (6) the number and current status of pediatric 

25 postmarketing requirements; 
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1 (7) the number and importance of drugs and 

2 biological products for children that are not being 

3 tested for use in pediatric populations, notwith4 standing the existence of the programs under such 

5 sections 505A and 505B and section 409I of the 

6 Public Health Service Act; 

7 (8) the possible reasons for the lack of testing 

8 reported under paragraph (7); 

9 (9) the number of drugs and biological products 

10 for which testing is being done (as of the date of the 

11 report) and for which a labeling change is required 

12 under the programs described in paragraph (7), in13 cluding— 

14 (A) the date labeling changes are made; 

15 (B) which labeling changes required the 

16 use of the dispute resolution process; and 

17 (C) for labeling changes that required such 

18 dispute resolution process, a description of— 

19 (i) the disputes; 

20 (ii) the recommendations of the Pedi21 atric Advisory Committee; and 

22 (iii) the outcomes of such process; and 

23 (D) an assessment of the effectiveness in 

24 improving information about pediatric uses of 

25 drugs and biological products; 
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1 (10)(A) the efforts made by the Secretary to in2 crease the number of studies conducted in the neo3 natal population (including efforts made to encour4 age the conduct of appropriate studies in neonates 

5 by companies with products that have sufficient 

6 safety and other information to make the conduct of 

7 the studies ethical and safe); and 

8 (B) the results of such efforts; 

9 (11)(A) the number and importance of drugs 

10 and biological products for children with cancer that 

11 are being tested as a result of the programs de12 scribed in paragraph (7); and 

13 (B) any recommendations for modifications to 

14 such programs that would lead to new and better 

15 therapies for children with cancer, including a de16 tailed rationale for each recommendation; 

17 (12) an assessment of progress made in ad18 dressing the recommendations and findings of any 

19 prior report issued by the Comptroller General, the 

20 Institute of Medicine, or the Secretary regarding the 

21 topics addressed in the report under this section, in22 cluding with respect to— 

23 (A) improving public access to information 

24 from pediatric studies conducted under such 

25 sections 505A and 505B; and 
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1 (B) improving the timeliness of pediatric 

2 studies and pediatric study planning under such 

3 sections 505A and 505B; 

4 (13) any recommendations for modification to 

5 the programs that would improve pediatric drug re6 search and increase pediatric labeling of drugs and 

7 biological products; and 

8 (14) an assessment of the successes of and limi9 tations to studying drugs for rare diseases under 

10 such sections 505A and 505B. 

11 (c) CONSULTATION ON RECOMMENDATIONS.—At 

12 least 180 days before the report is due under subsection 

13 (a), and no sooner than 4 years after the date of enact14 ment of this Act, the Secretary shall consult with rep15 resentatives of patient groups, including pediatric patient 

16 groups, consumer groups, regulated industry, scientific 

17 and medical communities, academia, and other interested 

18 parties to obtain any recommendations or information rel19 evant to the effectiveness of the programs described in 

20 subsection (b)(7), including suggestions for modifications 

21 to such programs. 

22 SEC. 509. TECHNICAL AMENDMENTS. 

23 (a) PEDIATRIC STUDIES OF DRUGS IN FFDCA.— 

24 Section 505A (21 U.S.C. 355a) is amended— 
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1 (1) in subsection (k)(2), by striking ‘‘subsection 

2 (f)(3)(F)’’ and inserting ‘‘subsection (f)(6)(F)’’; 

3 (2) in subsection (n)— 

4 (A) in the subsection heading, by striking 

5 ‘‘COMPLETED’’ and inserting ‘‘SUBMITTED’’; 

6 and 

7 (B) in paragraph (1)— 

8 (i) in the matter preceding subpara9 graph (A), by striking ‘‘have not been com10 pleted’’ and inserting ‘‘have not been sub11 mitted by the date specified in the written 

12 request issued or if the applicant or holder 

13 does not agree to the request’’; 

14 (ii) in subparagraph (A)— 

15 (I) in the first sentence, by in16 serting ‘‘, or for which a period of ex17 clusivity eligible for extension under 

18 subsection (b)(1) or (c)(1) of this sec19 tion or under subsection (m)(2) or 

20 (m)(3) of section 351 of the Public 

21 Health Service Act has not ended’’ 

22 after ‘‘expired’’; and 

23 (II) by striking ‘‘Prior to’’ and 

24 all that follows through the period at 

25 the end; and 
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1 (iii) in subparagraph (B), by striking 

2 ‘‘no listed patents or has 1 or more listed 

3 patents that have expired,’’ and inserting 

4 ‘‘no unexpired listed patents and for which 

5 no unexpired periods of exclusivity eligible 

6 for extension under subsection (b)(1) or 

7 (c)(1) of this section or under subsection 

8 (m)(2) or (m)(3) of section 351 of the 

9 Public Health Service Act apply,’’; and 

10 (3) in subsection (o)(2), by amendment sub11 paragraph (B) to read as follows: 

12 ‘‘(B) a statement of any appropriate pedi13 atric contraindications, warnings, precautions, 

14 or other information that the Secretary con15 siders necessary to assure safe use.’’. 

16 (b) RESEARCH INTO PEDIATRIC USES FOR DRUGS

17 AND BIOLOGICAL PROJECTS IN FFDCA.—Section 505B 

18 (21 U.S.C. 355c) is amended— 

19 (1) in subsection (a)— 

20 (A) in paragraph (1)— 

21 (i) in the matter preceding subpara22 graph (A), by inserting ‘‘for a drug’’ after 

23 ‘‘(or supplement to an application)’’; 

24 (ii) in subparagraph (A), by striking 

25 ‘‘for a’’ and inserting ‘‘, including, with re-
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1 spect to a drug, an application (or supple2 ment to an application) for a’’; 

3 (iii) in subparagraph (B), by striking 

4 ‘‘for a’’ and inserting ‘‘, including, with re5 spect to a drug, an application (or supple6 ment to an application) for a’’; and 

7 (iv) in the matter following subpara8 graph (B), by inserting ‘‘(or supplement)’’ 

9 after ‘‘application’’; and 

10 (B) in paragraph (4)(C)— 

11 (i) in the first sentence, by inserting 

12 ‘‘partial’’ before ‘‘waiver is granted’’; and 

13 (ii) in the second sentence, by striking 

14 ‘‘either a full or’’ and inserting ‘‘such a’’; 

15 (2) in subsection (b)(1), in the matter pre16 ceding subparagraph (A), by striking ‘‘After pro17 viding notice’’ and all that follows through ‘‘studies), 

18 the’’ and inserting ‘‘The’’; 

19 (3) in subsection (g)— 

20 (A) in paragraph (1)(A), by inserting 

21 ‘‘that receives a priority review or 330 days 

22 after the date of the submission of an applica23 tion or supplement that receives a standard re24 view’’ after ‘‘after the date of the submission of 

25 the application or supplement’’; and 
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1 (B) in paragraph (2), by striking ‘‘the 

2 label of such product’’ and inserting ‘‘the label3 ing of such product’’; and 

4 (4) in subsection (h)(1)— 

5 (A) by inserting ‘‘an application (or sup6 plement to an application) that contains’’ after 

7 ‘‘date of submission of’’; and 

8 (B) by inserting ‘‘, if the application (or 

9 supplement) receives a priority review, or not 

10 later than 330 days after the date of submis11 sion of an application (or supplement to an ap12 plication) that contains a pediatric assessment 

13 under this section, if the application (or supple14 ment) receives a standard review,’’ after ‘‘under 

15 this section,’’. 

16 (c) INTERNAL REVIEW COMMITTEE.—The heading of 

17 section 505C (21 U.S.C. 355d) is amended by inserting 

18 ‘‘AND DEFERRAL EXTENSIONS’’ after ‘‘DEFERRALS’’. 

19 (d) PROGRAM FOR PEDIATRIC STUDIES OF DRUGS.— 

20 Section 409I(c) of the Public Health Service Act (42 

21 U.S.C. 284m(c)) is amended— 

22 (1) in paragraph (1)— 

23 (A) in the matter preceding subparagraph 

24 (A), by inserting ‘‘or section 351(m) of this 

25 Act,’’ after ‘‘Cosmetic Act,’’; 
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1 (B) in subparagraph (A)(i), by inserting 

2 ‘‘or section 351(k) of this Act’’ after ‘‘Cosmetic 

3 Act’’; and 

4 (C) by amending subparagraph (B) to read 

5 as follows: 

6 ‘‘(B) there remains no patent listed pursu7 ant to section 505(b)(1) of the Federal Food, 

8 Drug, and Cosmetic Act, and every three-year 

9 and five-year period referred to in subsection 

10 (c)(3)(E)(ii), (c)(3)(E)(iii), (c)(3)(E)(iv), 

11 (j)(5)(F)(ii), (j)(5)(F)(iii), or (j)(5)(F)(iv) of 

12 section 505 of the Federal Food, Drug, and 

13 Cosmetic Act, or applicable twelve-year period 

14 referred to in section 351(k)(7) of this Act, and 

15 any seven-year period referred to in section 527 

16 of the Federal Food, Drug, and Cosmetic Act 

17 has ended for at least one form of the drug; 

18 and’’; and 

19 (2) in paragraph (2)— 

20 (A) in the paragraph heading, by striking 

21 ‘‘FOR DRUGS LACKING EXCLUSIVITY’’; and 

22 (B) by striking ‘‘under section 505 of the 

23 Federal Food, Drug, and Cosmetic Act’’; and 

24 (C) by striking ‘‘505A of such Act’’ and 

25 inserting ‘‘505A of the Federal Food, Drug, 
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1 and Cosmetic Act or section 351(m) of this 

2 Act’’. 

3 (e) PEDIATRIC SUBCOMMITTEE OF THE ONCOLOGIC

4 ADVISORY COMMITTEE.—Section 15(a) of the Best Phar5 maceuticals for Children Act (Public Law 107–109), as 

6 amended by section 502(e) of the Food and Drug Admin7 istration Amendments Act of 2007 (Public Law 110–85), 

8 is amended in paragraph (1)(D), by striking ‘‘section 

9 505B(f)’’ and inserting ‘‘ ‘section 505C’ ’’. 

10 (f) FOUNDATION OF NATIONAL INSTITUTES OF

11 HEALTH.—Section 499(c)(1)(C) of the Public Health 

12 Service Act (42 U.S.C. 290b(c)(1)(C)) is amended by 

13 striking ‘‘for which the Secretary issues a certification in 

14 the affirmative under section 505A(n)(1)(A) of the Fed15 eral Food, Drug, and Cosmetic Act’’. 

16 (g) APPLICATION.—Notwithstanding any provision of 

17 section 505A and 505B of the Federal Food, Drug, and 

18 Cosmetic Act (21 U.S.C. 355a, 355c) stating that a provi19 sion applies beginning on the date of the enactment of the 

20 Best Pharmaceuticals for Children Act of 2007 or the date 

21 of the enactment of the Pediatric Research Equity Act of 

22 2007, any amendment made by this title to such a provi23 sion applies beginning on the date of the enactment of this 

24 Act. 
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1 SEC. 510. RELATIONSHIP BETWEEN PEDIATRIC LABELING 

2 AND NEW CLINICAL INVESTIGATION EXCLU3 SIVITY. 

4 (a) IN GENERAL.—Section 505 (21 U.S.C. 351) is 

5 amended by adding at the end the following: 

6 ‘‘(w) RELATIONSHIP BETWEEN PEDIATRIC LABEL7 ING AND NEW CLINICAL INVESTIGATION EXCLUSIVITY.— 

8 The period of market exclusivity described in clauses (iii) 

9 and (iv) of subsection (c)(3)(E) and clauses (iii) and (iv) 

10 of subsection (j)(5)(F) shall not apply to a pediatric study 

11 conducted under section 505A or 505B that results, pur12 suant to section 505B(g)(2), in the inclusion in the label13 ing of the product a determination that the product is not 

14 indicated for use in pediatric populations or subpopula15 tions or information indicating that the results of a study 

16 were inconclusive or did not demonstrate that the product 

17 is safe or effective in pediatric populations or subpopula18 tions.’’. 

19 (b) PEDIATRIC STUDIES OF DRUGS.—Section 

20 505A(m) (21 U.S.C. 355a(m)) is amended— 

21 (1) by striking ‘‘(m) CLARIFICATION OF INTER22 ACTION OF MARKET EXCLUSIVITY UNDER THIS

23 SECTION AND MARKET EXCLUSIVITY AWARDED TO

24 AN APPLICANT FOR APPROVAL OF A DRUG UNDER

25 SECTION 505(j).—If a’’ and all that follows through 
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1 the end of the matter that precedes paragraph (1) 

2 and inserting the following: 

3 ‘‘(m) CLARIFICATION OF INTERACTION OF MARKET

4 EXCLUSIVITY UNDER THIS SECTION AND MARKET EX5 CLUSIVITY AWARDED TO AN APPLICATION OR SUPPLE6 MENT UNDER SUBSECTION (C) OR (J) OF SECTION 505.— 

7 ‘‘(1) 180-DAY EXCLUSIVITY PERIOD.—If a 180- 

8 day period under section 505(j)(5)(B)(iv) overlaps 

9 with a 6-month exclusivity period under this section, 

10 so that the applicant for approval of a drug under 

11 section 505(j) entitled to the 180-day period under 

12 that section loses a portion of the 180-day period to 

13 which the applicant is entitled for the drug, the 180- 

14 day period shall be extended from—’’; 

15 (2) by redesignating paragraphs (1) and (2) as 

16 subparagraphs (A) and (B) and moving such sub17 paragraphs, as so redesignated, 2 ems to the right; 

18 and 

19 (3) by adding at the end the following: 

20 ‘‘(2) 3-YEAR EXCLUSIVITY PERIOD.—The 3-year 

21 period of exclusivity under clauses (iii) and (iv) of 

22 subsection 505(c)(3)(E) and clauses (iii) and (iv) of 

23 subsection 505(j)(5)(F) are not available for ap24 proval of applications or supplements to applications 

25 based on reports of pediatric studies conducted 
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1 under sections 505A or 505B that resulted, pursu2 ant to section 505A(j) or 505B(g)(2), in the inclu3 sion in the labeling of the product a determination 

4 that the product is not indicated for use in pediatric 

5 populations or subpopulations or information indi6 cating that the results of an assessment were incon7 clusive or did not demonstrate that the product is 

8 safe or effective in pediatric populations or sub9 population.’’. 

10 (c) PROMPT APPROVAL OF DRUGS.—Section 505A(o) 

11 (21 U.S.C. 355a(o)) is amended— 

12 (1) in the heading, by striking ‘‘SECTION

13 505(J)’’ and inserting ‘‘SUBSECTIONS (C) AND (J) 

14 OF SECTION 505’’; 

15 (2) in paragraph (1), by striking ‘‘under section 

16 505(j)’’ and inserting ‘‘under subsection (b)(2), (c), 

17 or (j) of section 505’’; 

18 (3) in paragraph (2), in the matter preceding 

19 subparagraph (A), by inserting ‘‘clauses (iii) and (iv) 

20 of section 505(c)(3)(E) or’’ after ‘‘Notwith21 standing’’; and 

22 (4) in paragraph (3)— 

23 (A) in subparagraph (B), by inserting 

24 ‘‘that differ from adult formulations’’ before the 

25 semicolon at the end; and 
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1 (B) in subparagraph (C)— 

2 (i) by striking ‘‘under section 505(j)’’ 

3 and inserting ‘‘under subsection (c) or (j) 

4 of section 505’’; and 

5 (ii) by inserting ‘‘clauses (iii) or (iv) 

6 of section 505(c)(3)(E) or’’ after ‘‘exclu7 sivity under’’. 

8 SEC. 511. PEDIATRIC RARE DISEASES. 

9 (a) PUBLIC MEETING.—Not later than 18 months 

10 after the date of enactment of this Act, the Secretary shall 

11 hold a public meeting to discuss ways to encourage and 

12 accelerate the development of new therapies for pediatric 

13 rare diseases. 

14 (b) REPORT.—Not later than 180 days after the date 

15 of the public meeting under subsection (a), the Secretary 

16 shall issue a report that includes a strategic plan for en17 couraging and accelerating the development of new thera18 pies for treating pediatric rare diseases. 

19 TITLE VI—MEDICAL DEVICE 

20 REGULATORY IMPROVEMENTS 

21 SEC. 601. RECLASSIFICATION PROCEDURES. 

22 (a) CLASSIFICATION CHANGES.— 

23 (1) IN GENERAL.—Section 513(e)(1) (21 

24 U.S.C. 360c(e)(1)) is amended to read as follows: 
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1 ‘‘(e)(1)(A) Based on new information respecting a de2 vice, the Secretary may, upon the initiative of the Sec3 retary or upon petition of an interested person, change 

4 the classification of such device, and revoke, on account 

5 of the change in classification, any regulation or require6 ment in effect under section 514 or 515 with respect to 

7 such device, by administrative order published in the Fed8 eral Register following publication of a proposed reclassi9 fication order in the Federal Register, a meeting of a de10 vice classification panel described in subsection (b), and 

11 consideration of comments to a public docket, notwith12 standing subchapter II of Chapter 5 of title 5 of the 

13 United States Code. An order under this subsection 

14 changing the classification of a device from class III to 

15 class II may provide that such classification shall not take 

16 effect until the effective date of a performance standard 

17 established under section 514 for such device. 

18 ‘‘(B) Authority to issue such administrative order 

19 shall not be delegated below the Commissioner. The Com20 missioner shall issue such an order as proposed by the Di21 rector of the Center for Devices and Radiological Health 

22 unless the Commissioner, in consultation with the Office 

23 of the Secretary of Health and Human Services, concludes 

24 that the order exceeds the legal authority of the Food and 
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1 Drug Administration or that the order would be lawful, 

2 but unlikely to advance the public health.’’. 

3 (2) TECHNICAL AND CONFORMING AMEND4 MENTS.— 

5 (A) Section 513(e)(2) (21 U.S.C. 

6 360c(e)(2)) is amended by striking ‘‘regulation 

7 promulgated’’ and inserting ‘‘an order issued’’. 

8 (B) Section 514(a)(1) (21 U.S.C. 

9 360d(a)(1)) is amended by striking ‘‘under a 

10 regulation under section 513(e) but such regu11 lation’’ and inserting ‘‘under an administrative 

12 order under section 513(e) (or a regulation pro13 mulgated under such section prior to the date 

14 of enactment of the Food and Drug Adminis15 tration Safety and Innovation Act) but such 

16 order (or regulation)’’; 

17 (C) Section 517(a)(1) (21 U.S.C. 

18 360g(a)(1)) is amended by striking ‘‘or chang19 ing the classification of a device to class I’’ and 

20 inserting ‘‘, an administrative order changing 

21 the classification of a device to class I,’’. 

22 (3) DEVICES RECLASSIFIED PRIOR TO THE

23 DATE OF ENACTMENT OF THIS ACT.— 

24 (A) IN GENERAL.—The amendments made 

25 by this subsection shall have no effect on a reg-
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1 ulation promulgated with respect to the classi2 fication of a device under section 513(e) of the 

3 Federal Food, Drug, and Cosmetic Act prior to 

4 the date of enactment of this Act. 

5 (B) APPLICABILITY OF OTHER PROVI6 SIONS.—In the case of a device reclassified 

7 under section 513(e) of the Federal Food, 

8 Drug, and Cosmetic Act by regulation prior to 

9 the date of enactment of this Act, section 

10 517(a)(1) of the Federal Food, Drug, and Cos11 metic Act (21 U.S.C. 360g(a)(1)) shall apply to 

12 such regulation promulgated under section 

13 513(e) of such Act with respect to such device 

14 in the same manner such section 517(a)(1) ap15 plies to an administrative order issued with re16 spect to a device reclassified after the date of 

17 enactment of this Act. 

18 (b) DEVICES MARKETED BEFORE MAY 28, 1976.— 

19 (1) PREMARKET APPROVAL.—Section 515 (21 

20 U.S.C. 360e) is amended— 

21 (A) in subsection (a), by striking ‘‘regula22 tion promulgated under subsection (b)’’ and in23 serting ‘‘an order issued under subsection (b) 

24 (or a regulation promulgated under such sub25 section prior to the date of enactment of the 
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1 Food and Drug Administration Safety and In2 novation Act)’’; 

3 (B) in subsection (b)— 

4 (i) in paragraph (1)— 

5 (I) in the heading, by striking 

6 ‘‘Regulation’’ and inserting ‘‘Order’’; 

7 and 

8 (II) in the matter following sub9 paragraph (B)— 

10 (aa) by striking ‘‘by regula11 tion, promulgated in accordance 

12 with this subsection’’ and insert13 ing ‘‘by administrative order fol14 lowing publication of a proposed 

15 order in the Federal Register, a 

16 meeting of a device classification 

17 panel described in section 513(b), 

18 and consideration of comments 

19 from all affected stakeholders, in20 cluding patients, payors, and pro21 viders, notwithstanding sub22 chapter II of chapter 5 of title 5, 

23 United States Code’’; and 

24 (bb) by adding at the end 

25 the following: 
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1 ‘‘Authority to issue such administrative order shall not be 

2 delegated below the Commissioner. Before publishing such 

3 administrative order, the Commissioner shall consult with 

4 the Office of the Secretary. The Commissioner shall issue 

5 such an order as proposed by the Director of the Center 

6 for Devices and Radiological Health unless the Commis7 sioner, in consultation with the Office of the Secretary, 

8 concludes that the order exceeds the legal authority of the 

9 Food and Drug Administration or that the order would 

10 be lawful, but unlikely to advance the public health.’’; 

11

12 (ii) in paragraph (2)— 

13 (I) by striking subparagraph (B); 

14 and 

15 (II) in subparagraph (A)— 

16 (aa) by striking ‘‘(2)(A) A 

17 proceeding for the promulgation 

18 of a regulation under paragraph 

19 (1) respecting a device shall be 

20 initiated by the publication in the 

21 Federal Register of a notice of 

22 proposed rulemaking. Such notice 

23 shall contain—’’ and inserting 

24 ‘‘(2) A proposed order required 
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1 under paragraph (1) shall con2 tain—’’; 

3 (bb) by redesignating 

4 clauses (i) through (iv) as sub5 paragraphs (A) through (D), re6 spectively; 

7 (cc) in subparagraph (A), as 

8 so redesignated, by striking ‘‘reg9 ulation’’ and inserting ‘‘order’’; 

10 and 

11 (dd) in subparagraph (C), as 

12 so redesignated, by striking ‘‘reg13 ulation’’ and inserting ‘‘order’’; 

14 (iii) in paragraph (3)— 

15 (I) by striking ‘‘proposed regula16 tion’’ each place such term appears 

17 and inserting ‘‘proposed order’’; 

18 (II) by striking ‘‘paragraph (2) 

19 and after’’ and inserting ‘‘paragraph 

20 (2),’’; 

21 (III) by inserting ‘‘and a meeting 

22 of a device classification panel de23 scribed in section 513(b),’’ after ‘‘such 

24 proposed regulation and findings,’’; 
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1 (IV) by striking ‘‘(A) promulgate 

2 such regulation’’ and inserting ‘‘(A) 

3 issue an administrative order under 

4 paragraph (1)’’; 

5 (V) by striking ‘‘paragraph 

6 (2)(A)(ii)’’ and inserting ‘‘paragraph 

7 (2)(B)’’; and 

8 (VI) by striking ‘‘promulgation of 

9 the regulation’’ and inserting 

10 ‘‘issuance of the administrative 

11 order’’; and 

12 (iv) by striking paragraph (4); and 

13 (C) in subsection (i)— 

14 (i) in paragraph (2)— 

15 (I) in the matter preceding sub16 paragraph (A)— 

17 (aa) by striking ‘‘December 

18 1, 1995’’ and inserting ‘‘the date 

19 that is 2 years after the date of 

20 enactment of the Food and Drug 

21 Administration Safety and Inno22 vation Act’’; and 

23 (bb) by striking ‘‘publish a 

24 regulation in the Federal Reg25 ister’’ and inserting ‘‘issue an ad-
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1 ministrative order following pub2 lication of a proposed order in 

3 the Federal Register, a meeting 

4 of a device classification panel 

5 described in section 513(b), and 

6 consideration of comments from 

7 all affected stakeholders, includ8 ing patients, payors, and pro9 viders, notwithstanding sub10 chapter II of chapter 5 of title 5, 

11 United States Code,’’; 

12 (II) in subparagraph (B), by 

13 striking ‘‘final regulation has been 

14 promulgated under section 515(b)’’ 

15 and inserting ‘‘administrative order 

16 has been issued under subsection (b) 

17 (or no regulation has been promul18 gated under such subsection prior to 

19 the date of enactment of the Food 

20 and Drug Administration Safety and 

21 Innovation Act)’’; 

22 (III) in the matter following sub23 paragraph (B), by striking ‘‘regula24 tion requires’’ and inserting ‘‘adminis-
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1 trative order issued under this para2 graph requires’’; and 

3 (IV) by striking the third and 

4 fourth sentences; and 

5 (ii) in paragraph (3)— 

6 (I) by striking ‘‘regulation requir7 ing’’ each place such term appears 

8 and inserting ‘‘order requiring’’; and 

9 (II) by striking ‘‘promulgation of 

10 a section 515(b) regulation’’ and in11 serting ‘‘issuance of an administrative 

12 order under subsection (b)’’. 

13 (2) TECHNICAL AND CONFORMING AMEND14 MENTS.—Section 501(f) (21 U.S.C. 351(f)) is 

15 amended— 

16 (A) in subparagraph (1)(A)— 

17 (i) in subclause (i), by striking ‘‘a reg18 ulation promulgated’’ and inserting ‘‘an 

19 order issued’’; and 

20 (ii) in subclause (ii), by striking ‘‘pro21 mulgation of such regulation’’ and insert22 ing ‘‘issuance of such order’’; 

23 (B) in subparagraph (2)(B)— 
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1 (i) by striking ‘‘a regulation promul2 gated’’ and inserting ‘‘an order issued’’; 

3 and 

4 (ii) by striking ‘‘promulgation of such 

5 regulation’’ and inserting ‘‘issuance of 

6 such order’’; and 

7 (C) by adding at the end the following: 

8 ‘‘(3) In the case of a device with respect to which 

9 a regulation was promulgated under section 515(b) prior 

10 to the date of enactment of the Food and Drug Adminis11 tration Safety and Innovation Act, a reference in this sub12 section to an order issued under section 515(b) shall be 

13 deemed to include such regulation.’’. 

14 (3) APPROVAL BY REGULATION PRIOR TO THE

15 DATE OF ENACTMENT OF THIS ACT.—The amend16 ments made by this subsection shall have no effect 

17 on a regulation that was promulgated prior to the 

18 date of enactment of this Act requiring that a device 

19 have an approval under section 515 of the Federal 

20 Food, Drug, and Cosmetic Act (21 U.S.C. 360e) of 

21 an application for premarket approval. 

22 (c) REPORTING.—The Secretary of Health and 

23 Human Services shall annually post on the Internet 

24 website of the Food and Drug Administration— 
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1 (1) the number and type of class I and class II 

2 devices reclassified as class II or class III in the pre3 vious calendar year under section 513(e)(1) of the 

4 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

5 360c(e)(1)); 

6 (2) the number and type of class II and class 

7 III devices reclassified as class I or class II in the 

8 previous calendar year under such section 513(e)(1); 

9 and 

10 (3) the number and type of devices reclassified 

11 in the previous calendar year under section 515 of 

12 the Federal Food, Drug, and Cosmetic Act (21 

13 U.S.C. 360e). 

14 SEC. 602. CONDITION OF APPROVAL STUDIES. 

15 Section 515(d)(1)(B)(ii) (21 U.S.C. 

16 360e(d)(1)(B)(ii)) is amended— 

17 (1) by striking ‘‘(ii)’’ and inserting ‘‘(ii)(I)’’; 

18 and 

19 (2) by adding at the end the following: 

20 ‘‘(II) An order approving an application for a device 

21 may require as a condition to such approval that the appli22 cant conduct a postmarket study regarding the device.’’. 

23 SEC. 603. POSTMARKET SURVEILLANCE. 

24 Section 522 (21 U.S.C. 360l) is amended— 
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1 (1) in subsection (a)(1)(A), in the matter pre2 ceding clause (i), by inserting ‘‘, at the time of ap3 proval or clearance of a device or at any time there4 after,’’ after ‘‘by order’’; and 

5 (2) in subsection (b)(1), by inserting ‘‘The 

6 manufacturer shall commence surveillance under this 

7 section not later than 15 months after the day on 

8 which the Secretary issues an order under this sec9 tion.’’ after the second sentence. 

10 SEC. 604. SENTINEL. 

11 Section 519 (21 U.S.C. 360i) is amended by adding 

12 at the end the following: 

13 ‘‘(h) INCLUSION OF DEVICES IN THE POSTMARKET

14 RISK IDENTIFICATION AND ANALYSIS SYSTEM.— 

15 ‘‘(1) IN GENERAL.— 

16 ‘‘(A) APPLICATION TO DEVICES.—The Sec17 retary shall amend the procedures established 

18 and maintained under clauses (i), (ii), (iii), and 

19 (v) of section 505(k)(3)(C) in order to expand 

20 the postmarket risk identification and analysis 

21 system established under such section to include 

22 and apply to devices. 

23 ‘‘(B) EXCEPTION.—Subclause (II) of 

24 clause (i) of section 505(k)(3)(C) shall not 

25 apply to devices. 
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1 ‘‘(C) CLARIFICATION.—With respect to de2 vices, the private sector health-related electronic 

3 data provided under section 

4 505(k)(3)(C)(i)(III)(bb) may include medical 

5 device utilization data, health insurance claims 

6 data, and procedure and device registries. 

7 ‘‘(2) DATA.—In expanding the system as de8 scribed in paragraph (1)(A), the Secretary shall use 

9 relevant data with respect to devices cleared under 

10 section 510(k) or approved under section 515, in11 cluding claims data, patient survey data, and any 

12 other data deemed appropriate by the Secretary. 

13 ‘‘(3) STAKEHOLDER INPUT.—To help ensure ef14 fective implementation of the system described in 

15 paragraph (1)(A), the Secretary shall engage outside 

16 stakeholders in development of the system through a 

17 public hearing, advisory committee meeting, public 

18 docket, or other like public measures, as appro19 priate. 

20 ‘‘(4) VOLUNTARY SURVEYS.—Chapter 35 of 

21 title 44, United States Code, shall not apply to the 

22 collection of voluntary information from health care 

23 providers, such as voluntary surveys or question24 naires, initiated by the Secretary for purposes of 

25 postmarket risk identification for devices.’’. 
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1 SEC. 605. RECALLS. 

2 (a) ASSESSMENT OF DEVICE RECALL INFORMA3 TION.— 

4 (1) IN GENERAL.— 

5 (A) ASSESSMENT PROGRAM.—The Sec6 retary of Health and Human Services (referred 

7 to in this section as the ‘‘Secretary’’) shall en8 hance the Food and Drug Administration’s re9 call program to routinely and systematically as10 sess— 

11 (i) information submitted to the Sec12 retary pursuant to a device recall order 

13 under section 518(e) of the Federal Food, 

14 Drug, and Cosmetic Act (21 U.S.C. 

15 360h(e)); and 

16 (ii) information required to be re17 ported to the Secretary regarding a correc18 tion or removal of a device under section 

19 519(g) of such Act (21 U.S.C. 360i(g)). 

20 (B) USE.—The Secretary shall use the as21 sessment of information described under sub22 paragraph (A) to proactively identify strategies 

23 for mitigating health risks presented by defec24 tive or unsafe devices. 

25 (2) DESIGN.—The program under paragraph 

26 (1) shall, at a minimum, identify— 
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1 (A) trends in the numbers and types of de2 vice recalls; 

3 (B) the types of devices in each device 

4 class that are most frequently recalled; 

5 (C) the causes of device recalls; and 

6 (D) any other information as the Secretary 

7 determines appropriate. 

8 (b) AUDIT CHECK PROCEDURES.—The Secretary 

9 shall clarify procedures for conducting device recall audit 

10 checks to improve the ability of investigators to perform 

11 these checks in a consistent manner. 

12 (c) ASSESSMENT CRITERIA.—The Secretary shall de13 velop explicit criteria for assessing whether a person sub14 ject to a recall order under section 518(e) of the Federal 

15 Food, Drug, and Cosmetic Act (21 U.S.C. 360h(e)) or to 

16 a requirement under section 519(g) of such Act (21 

17 U.S.C. 360i(g)) has performed an effective recall under 

18 such section 518(e) or an effective correction or removal 

19 action under such section 519(g), respectively. 

20 (d) TERMINATION OF RECALLS.—The Secretary shall 

21 document the basis for the termination by the Food and 

22 Drug Administration of— 

23 (1) an individual device recall ordered under 

24 section 518(e) of the Federal Food, Drug, and Cos25 metic Act (21 U.S.C. 360h(e)); and 
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1 (2) any correction or removal action for which 

2 a report is required to be submitted to the Secretary 

3 under section 519(g) of such Act (21 U.S.C. 

4 360i(g)). 

5 SEC. 606. CLINICAL HOLDS ON INVESTIGATIONAL DEVICE 

6 EXEMPTIONS. 

7 Section 520(g) (21 U.S.C. 360j(g)) is amended by 

8 adding at the end the following: 

9 ‘‘(8)(A) At any time, the Secretary may prohibit the 

10 sponsor of an investigation from conducting the investiga11 tion (referred to in this paragraph as a ‘clinical hold’) if 

12 the Secretary makes a determination described in sub13 paragraph (B). The Secretary shall specify the basis for 

14 the clinical hold, including the specific information avail15 able to the Secretary which served as the basis for such 

16 clinical hold, and confirm such determination in writing. 

17 ‘‘(B) For purposes of subparagraph (A), a determina18 tion described in this subparagraph with respect to a clin19 ical hold is a determination that— 

20 ‘‘(i) the device involved represents an unreason21 able risk to the safety of the persons who are the 

22 subjects of the clinical investigation, taking into ac23 count the qualifications of the clinical investigators, 

24 information about the device, the design of the clin25 ical investigation, the condition for which the device 
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1 is to be investigated, and the health status of the 

2 subjects involved; or 

3 ‘‘(ii) the clinical hold should be issued for such 

4 other reasons as the Secretary may by regulation es5 tablish. 

6 ‘‘(C) Any written request to the Secretary from the 

7 sponsor of an investigation that a clinical hold be removed 

8 shall receive a decision, in writing and specifying the rea9 sons therefor, within 30 days after receipt of such request. 

10 Any such request shall include sufficient information to 

11 support the removal of such clinical hold.’’. 

12 SEC. 607. UNIQUE DEVICE IDENTIFIER. 

13 Section 519(f) (21 U.S.C. 360i(f)) is amended— 

14 (1) by striking ‘‘The Secretary shall promul15 gate’’ and inserting ‘‘Not later than December 31, 

16 2012, the Secretary shall issue proposed’’; and 

17 (2) by adding at the end the following: ‘‘The 

18 Secretary shall finalize the proposed regulations not 

19 later than 6 months after the close of the comment 

20 period and shall implement the final regulations with 

21 respect to devices that are implantable, life-saving, 

22 and life sustaining not later than 2 years after the 

23 regulations are finalized.’’. 
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1 SEC. 608. CLARIFICATION OF LEAST BURDENSOME STAND2 ARD. 

3 (a) PREMARKET APPROVAL.—Section 513(a)(3)(D) 

4 (21 U.S.C. 360c(a)(3)(D)) is amended— 

5 (1) by redesignating clause (iii) as clause (v); 

6 and 

7 (2) by inserting after clause (ii) the following: 

8 ‘‘(iii) For purposes of clause (ii), the term ‘necessary’ 

9 means the minimum required information that would sup10 port a determination by the Secretary that an application 

11 provides reasonable assurance of the effectiveness of the 

12 device. 

13 ‘‘(iv) Nothing in this subparagraph shall alter the cri14 teria for evaluating an application for premarket approval 

15 of a device.’’. 

16 (b) PREMARKET NOTIFICATION UNDER SECTION

17 510(K).—Section 513(i)(1)(D) (21 U.S.C. 360c(i)(1)(D)) 

18 is amended— 

19 (1) by striking ‘‘(D) Whenever’’ and inserting 

20 ‘‘(D)(i) Whenever’’; and 

21 (2) by adding at the end the following: 

22 ‘‘(ii) For purposes of clause (i), the term ‘necessary’ 

23 means the minimum required information that would sup24 port a determination of substantial equivalence between 

25 a new device and a predicate device. 
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1 ‘‘(iii) Nothing in this subparagraph shall alter the 

2 standard for determining substantial equivalence between 

3 a new device and a predicate device.’’. 

4 SEC. 609. CUSTOM DEVICES. 

5 Section 520(b) (21 U.S.C. 360j(b)) is amended to 

6 read as follows: 

7 ‘‘(b) CUSTOM DEVICES.— 

8 ‘‘(1) IN GENERAL.—The requirements of sec9 tions 514 and 515 shall not apply to a device that— 

10 ‘‘(A) is created or modified in order to 

11 comply with the order of an individual physician 

12 or dentist (or any other specially qualified per13 son designated under regulations promulgated 

14 by the Secretary after an opportunity for an 

15 oral hearing); 

16 ‘‘(B) in order to comply with an order de17 scribed in subparagraph (A), necessarily devi18 ates from an otherwise applicable performance 

19 standard under section 514 or requirement 

20 under section 515; 

21 ‘‘(C) is not generally available in the 

22 United States in finished form through labeling 

23 or advertising by the manufacturer, importer, 

24 or distributor for commercial distribution; 
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1 ‘‘(D) is designed to treat a unique pathol2 ogy or physiological condition that no other de3 vice is domestically available to treat; 

4 ‘‘(E)(i) is intended to meet the special 

5 needs of such physician or dentist (or other spe6 cially qualified person so designated) in the 

7 course of the professional practice of such phy8 sician or dentist (or other specially qualified 

9 person so designated); or 

10 ‘‘(ii) is intended for use by an individual 

11 patient named in such order of such physician 

12 or dentist (or other specially qualified person so 

13 designated); 

14 ‘‘(F) is assembled from components or 

15 manufactured and finished on a case-by-case 

16 basis to accommodate the unique needs de17 scribed in clause (i) or (ii) of subparagraph (E); 

18 and 

19 ‘‘(G) may have common, standardized de20 sign characteristics, chemical and material com21 positions, and manufacturing processes as com22 mercially distributed devices. 

23 ‘‘(2) LIMITATIONS.—Paragraph (1) shall apply 

24 to a device only if— 
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1 ‘‘(A) such device is for the purpose of 

2 treating a sufficiently rare condition, such that 

3 conducting clinical investigations on such device 

4 would be impractical; 

5 ‘‘(B) production of such device under para6 graph (1) is limited to no more than 5 units per 

7 year of a particular device type, provided that 

8 such replication otherwise complies with this 

9 section; and 

10 ‘‘(C) the manufacturer of such device cre11 ated or modified as described in paragraph (1) 

12 notifies the Secretary on an annual basis, in a 

13 manner prescribed by the Secretary, of the 

14 manufacture of such device. 

15 ‘‘(3) EXCEPTION.—Paragraph (1) shall not 

16 apply to oral facial devices. 

17 ‘‘(4) GUIDANCE.—Not later than 2 years after 

18 the date of enactment of this section, the Secretary 

19 shall issue final guidance on replication of multiple 

20 devices described in paragraph (2)(B).’’. 

21 SEC. 610. AGENCY DOCUMENTATION AND REVIEW OF CER22 TAIN DECISIONS REGARDING DEVICES. 

23 Chapter V (21 U.S.C. 351 et seq.) is amended by 

24 inserting after section 517 the following: 
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1 ‘‘SEC. 517A. AGENCY DOCUMENTATION AND REVIEW OF 

2 CERTAIN DECISIONS REGARDING DEVICES. 

3 ‘‘(a) DOCUMENTATION OF RATIONALE FOR DE4 NIAL.—If the Secretary renders a final decision to deny 

5 clearance of a premarket notification under section 510(k) 

6 or approval of a premarket application under section 515, 

7 or when the Secretary disapproves an application for an 

8 investigational exemption under 520(g), the written cor9 respondence to the applicant communicating that decision 

10 shall provide a substantive summary of the scientific and 

11 regulatory rationale for the decision. 

12 ‘‘(b) REVIEW OF DENIAL.— 

13 ‘‘(1) IN GENERAL.—A person who has sub14 mitted a report under section 510(k), an application 

15 under section 515, or an application for an exemp16 tion under section 520(g) and for whom clearance of 

17 the report or approval of the application is denied 

18 may request a supervisory review of the decision to 

19 deny such clearance or approval. Such review shall 

20 be conducted by an individual at the organizational 

21 level above the organization level at which the deci22 sion to deny the clearance of the report or approval 

23 of the application is made. 

24 ‘‘(2) SUBMISSION OF REQUEST.—A person re25 questing a supervisory review under paragraph (1) 

26 shall submit such request to the Secretary not later 
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1 than 30 days after such denial and shall indicate in 

2 the request whether such person seeks an in-person 

3 meeting or a teleconference review. 

4 ‘‘(3) TIMEFRAME.— 

5 ‘‘(A) IN GENERAL.—Except as provided in 

6 subparagraph (B), the Secretary shall schedule 

7 an in-person or teleconference review, if so re8 quested, not later than 30 days after such re9 quest is made. The Secretary shall issue a deci10 sion to the person requesting a review under 

11 this subsection not later than 45 days after the 

12 request is made under paragraph (1), or, in the 

13 case of a person who requests an in-person 

14 meeting or teleconference, 30 days after such 

15 meeting or teleconference. 

16 ‘‘(B) EXCEPTION.—Subparagraph (A) 

17 shall not apply in cases that involve consulta18 tion with experts outside of the Food and Drug 

19 Administration, or in cases in which the spon20 sor seeks to introduce evidence not already in 

21 the administrative record at the time the denial 

22 decision was made.’’. 
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1 SEC. 611. GOOD GUIDANCE PRACTICES RELATING TO DE2 VICES. 

3 Subparagraph (C) of section 701(h)(1) (21 U.S.C. 

4 371(h)(1)) is amended— 

5 (1) by striking ‘‘(C) For guidance documents’’ 

6 and inserting ‘‘(C)(i) For guidance documents’’; and 

7 (2) by adding at the end the following: 

8 ‘‘(ii) With respect to devices, if a notice to in9 dustry guidance letter, a notice to industry advisory 

10 letter, or any similar notice sets forth initial inter11 pretations of a regulation or policy or sets forth 

12 changes in interpretation or policy, such notice shall 

13 be treated as a guidance document for purposes of 

14 this subparagraph.’’. 

15 SEC. 612. MODIFICATION OF DE NOVO APPLICATION PROC16 ESS. 

17 (a) IN GENERAL.—Section 513(f)(2) (21 U.S.C. 

18 360c(f)(2)) is amended— 

19 (1) by redesignating subparagraphs (B) and 

20 (C) as subparagraphs (C) and (D), respectively; 

21 (2) by amending subparagraph (A) to read as 

22 follows: 

23 ‘‘(A) In the case of a type of device that has not pre24 viously been classified under this Act, a person may do 

25 one of the following: 
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1 ‘‘(i) Submit a report under section 510(k), and, 

2 if the device is classified into class III under para3 graph (1), such person may request, not later than 

4 30 days after receiving written notice of such a clas5 sification, the Secretary to classify the device under 

6 the criteria set forth in subparagraphs (A) through 

7 (C) of subsection (a)(1). The person may, in the re8 quest, recommend to the Secretary a classification 

9 for the device. Any such request shall describe the 

10 device and provide detailed information and reasons 

11 for the recommended classification. 

12 ‘‘(ii) Submit a request for initial classification 

13 of the device under this subparagraph, if the person 

14 declares that there is no legally marketed device 

15 upon which to base a substantial equivalence deter16 mination as that term is defined in subsection (i). 

17 Subject to subparagraph (B), the Secretary shall 

18 classify the device under the criteria set forth in sub19 paragraphs (A) through (C) of subsection (a)(1). 

20 The person submitting the request for classification 

21 under this subparagraph may recommend to the 

22 Secretary a classification for the device and shall, if 

23 recommending classification in class II, include in 

24 the request an initial draft proposal for applicable 

25 special controls, as described in subsection 
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1 (a)(1)(B), that are necessary, in conjunction with 

2 general controls, to provide reasonable assurance of 

3 safety and effectiveness and a description of how the 

4 special controls provide such assurance. Requests 

5 under this clause shall be subject to the electronic 

6 copy requirements of section 745A(b).’’; 

7 (3) by inserting after subparagraph (A) the fol8 lowing: 

9 ‘‘(B) The Secretary may decline to undertake a clas10 sification request submitted under clause (2)(A)(ii) if the 

11 Secretary identifies a legally marketed device that could 

12 provide a reasonable basis for review of substantial equiva13 lence under paragraph (1), or when the Secretary deter14 mines that the device submitted is not of low-moderate 

15 risk or that general controls would be inadequate to con16 trol the risks and special controls to mitigate the risks 

17 cannot be developed.’’; and 

18 (4) in subparagraph (C), as so redesignated— 

19 (A) in clause (i), by striking ‘‘Not later 

20 than 60 days after the date of the submission 

21 of the request under subparagraph (A),’’ and 

22 inserting ‘‘Not later than 120 days after the 

23 date of the submission of the request under 

24 subparagraph (A)(i) or 150 days after the date 
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1 of the submission of the request under subpara2 graph (A)(ii),’’; and 

3 (B) in clause (ii), by inserting ‘‘or is classi4 fied in’’ after ‘‘remains in’’. 

5 (b) GAO REPORT.—Not later than 2 years after the 

6 date of enactment of this Act, the Comptroller General 

7 of the United States shall complete a study and submit 

8 to Congress a report on the effectiveness of the review 

9 pathway under section 513(f)(2)(A) of the Federal Food, 

10 Drug, and Cosmetic Act, as amended by this Act. 

11 (c) CONFORMING AMENDMENT.—Section 

12 513(f)(1)(B) (21 U.S.C. 360c(f)(1)(B)) is amended by in13 serting ‘‘a request under paragraph (2) or’’ after ‘‘re14 sponse to’’. 

15 SEC. 613. HUMANITARIAN DEVICE EXEMPTIONS. 

16 (a) IN GENERAL.—Section 520(m) (21 U.S.C. 

17 360j(m)) is amended— 

18 (1) in paragraph (6)— 

19 (A) in subparagraph (A)— 

20 (i) by striking clause (i) and inserting 

21 the following: 

22 ‘‘(i) The device with respect to which the ex23 emption is granted— 

24 ‘‘(I) is intended for the treatment or diag25 nosis of a disease or condition that occurs in 
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1 pediatric patients or in a pediatric subpopula2 tion, and such device is labeled for use in pedi3 atric patients or in a pediatric subpopulation in 

4 which the disease or condition occurs; or 

5 ‘‘(II) is intended for the treatment or diag6 nosis of a disease or condition that does not 

7 occur in pediatric patients or that occurs in pe8 diatric patients in such numbers that the devel9 opment of the device for such patients is impos10 sible, highly impracticable, or unsafe.’’; and 

11 (ii) by striking clause (ii) and insert12 ing the following: 

13 ‘‘(ii) During any calendar year, the number of 

14 such devices distributed during that year under each 

15 exemption granted under this subsection does not 

16 exceed the annual distribution number for such de17 vice. In this paragraph, the term ‘annual distribu18 tion number’ means the number of such devices rea19 sonably needed to treat, diagnose, or cure a popu20 lation of 4,000 individuals in the United States. The 

21 Secretary shall determine the annual distribution 

22 number when the Secretary grants such exemp23 tion.’’; and 

24 (B) by amending subparagraph (C) to read 

25 as follows: 
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1 ‘‘(C) A person may petition the Secretary to modify 

2 the annual distribution number determined by the Sec3 retary under subparagraph (A)(ii) with respect to a device 

4 if additional information arises, and the Secretary may 

5 modify such annual distribution number.’’; 

6 (2) in paragraph (7), by striking ‘‘regarding a 

7 device’’ and inserting ‘‘regarding a device described 

8 in paragraph (6)(A)(i)(I)’’; and 

9 (3) in paragraph (8), by striking ‘‘of all devices 

10 described in paragraph (6)’’ and inserting ‘‘of all de11 vices described in paragraph (6)(A)(i)(I)’’. 

12 (b) APPLICABILITY TO EXISTING DEVICES.—A spon13 sor of a device for which an exemption was approved under 

14 paragraph (2) of section 520(m) of the Federal Food, 

15 Drug, and Cosmetic Act (21 U.S.C. 360j(m)) before the 

16 date of enactment of this Act may seek a determination 

17 under subclause (I) or (II) of section 520(m)(6)(A)(i) (as 

18 amended by subsection (a)). If the Secretary of Health 

19 and Human Services determines that such subclause (I) 

20 or (II) applies with respect to a device, clauses (ii), (iii), 

21 and (iv) of subparagraph (A) and subparagraphs (B), (C), 

22 (D), and (E) of paragraph (6) of such section 520(m) 

23 shall apply to such device, and the Secretary shall deter24 mine the annual distribution number for purposes of 
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1 clause (ii) of such subparagraph (A) when making the de2 termination under this subsection. 

3 (c) REPORT.—Not later than January 1, 2017, the 

4 Comptroller General of the United States shall submit to 

5 Congress a report that evaluates and describes— 

6 (1) the effectiveness of the amendments made 

7 by subsection (a) in stimulating innovation with re8 spect to medical devices, including any favorable or 

9 adverse impact on pediatric device development; 

10 (2) the impact of such amendments on pediatric 

11 device approvals for devices that received a humani12 tarian use designation under section 520(m) of the 

13 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

14 360j(m)) prior to the date of enactment of this Act; 

15 (3) the status of public and private insurance 

16 coverage of devices granted an exemption under 

17 paragraph (2) of such section 520(m) (as amended 

18 by subsection (a)) and costs to patients of such de19 vices; 

20 (4) the impact that paragraph (4) of such sec21 tion 520(m) has had on access to and insurance cov22 erage of devices granted an exemption under para23 graph (2) of such section 520(m); and 
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1 (5) the effect of the amendments made by sub2 section (a) on patients described in such section 

3 520(m). 

4 SEC. 614. REAUTHORIZATION OF THIRD-PARTY REVIEW 

5 AND INSPECTIONS. 

6 (a) THIRD PARTY REVIEW.—Section 523(c) (21 

7 U.S.C. 360m(c)) is amended by striking ‘‘2012’’ and in8 serting ‘‘2017’’. 

9 (b) THIRD PARTY INSPECTIONS.—Section 

10 704(g)(11) (21 U.S.C. 374(g)(11)) is amended by striking 

11 ‘‘2012’’ and inserting ‘‘2017’’. 

12 SEC. 615. 510(K) DEVICE MODIFICATIONS. 

13 Having acknowledged to Congress potential unin14 tended consequences that may result from the implemen15 tation of the Food and Drug Administration guidance en16 titled ‘‘Guidance for Industry and FDA Staff—510(k) De17 vice Modifications: Deciding When to Submit a 510(k) for 

18 a Change to an Existing Device’’, the Secretary of Health 

19 and Human Services shall withdraw such guidance 

20 promptly and ensure that, before any future guidance doc21 ument on this issue is made final, affected stakeholders 

22 are provided with an opportunity to comment. 

23 SEC. 616. HEALTH INFORMATION TECHNOLOGY. 

24 (a) LIMITATION.—Notwithstanding any other provi25 sion of law, the Secretary of Health and Human Services 
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1 (referred to in this section as the ‘‘Secretary’’) may issue 

2 final guidance on medical mobile applications only after 

3 the requirements under subsections (b) and (c) are met. 

4 (b) REPORT.—Not later than 18 months after the 

5 date of enactment of this Act, the Secretary, in consulta6 tion with the Commissioner of Food and Drugs, the Na7 tional Coordinator for Health Information Technology, 

8 and the Chairman of the Federal Communications Com9 mission, shall submit to the Committee on Health, Edu10 cation, Labor, and Pensions of the Senate and the Com11 mittee on Energy and Commerce of the House of Rep12 resentatives a report that contains a proposed strategy 

13 and recommendations on an appropriate, risk-based regu14 latory framework pertaining to medical device regulation 

15 and health information technology software, including mo16 bile applications, that promotes innovation and protects 

17 patient safety. 

18 (c) WORKING GROUP.— 

19 (1) IN GENERAL.—In carrying out subsection 

20 (b), the Secretary shall convene a working group of 

21 external stakeholders and experts to provide appro22 priate input on the strategy and recommendations 

23 required for the report under subsection (b). 

24 (2) REPRESENTATIVES.—The Secretary shall 

25 determine the number of representatives partici-
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1 pating in the working group, and shall ensure that 

2 the working group is geographically diverse and in3 cludes representatives of patients, consumers, health 

4 care providers, startup companies, health plans or 

5 other third-party payers, venture capital investors, 

6 information technology vendors, small businesses, 

7 purchasers, employers, and other stakeholders with 

8 relevant expertise, as determined by the Secretary. 

9 (3) OTHER REQUIREMENTS.— 

10 (A) FACA.—The Federal Advisory Com11 mittee Act (5 U.S.C. App.) shall apply to the 

12 working group under this section. 

13 (B) FFDCA ADVISORY COMMITTEES.— 

14 The requirements for advisory committees 

15 under section 712 of the Federal Food, Drug, 

16 and Cosmetic Act (21 U.S.C. 379d–1), as 

17 amended by section 1121, shall not apply to the 

18 working group under this section. 

19 TITLE VII—DRUG SUPPLY CHAIN 

20 Subtitle A—Drug Supply Chain 

21 SEC. 701. REGISTRATION OF DOMESTIC DRUG ESTABLISH22 MENTS. 

23 Section 510 (21 U.S.C. 360) is amended— 

24 (1) in subsection (b)— 
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1 (A) in paragraph (1), by striking ‘‘On or 

2 before’’ and all that follows through the period 

3 at the end and inserting the following: ‘‘During 

4 the period beginning on October 1 and ending 

5 on December 31 of each year, every person who 

6 owns or operates any establishment in any 

7 State engaged in the manufacture, preparation, 

8 propagation, compounding, or processing of a 

9 drug or drugs shall register with the Sec10 retary— 

11 ‘‘(A) the name of such person, places of busi12 ness of such person, all such establishments, the 

13 unique facility identifier of each such establishment, 

14 and a point of contact e-mail address; and 

15 ‘‘(B) the name and place of business of each 

16 importer that takes physical possession of and sup17 plies a drug (other than an excipient) to such per18 son, including all establishments of each such drug 

19 importer, the unique facility identifier of each such 

20 drug importer establishment, and a point of contact 

21 e-mail address for each such drug importer.’’; and 

22 (B) by adding at the end the following: 

23 ‘‘(3) The Secretary may specify the unique facility 

24 identifier system that shall be used by registrants under 

25 paragraph (1).’’; and 
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1 (2) in subsection (c), by striking ‘‘with the Sec2 retary his name, place of business, and such estab3 lishment’’ and inserting ‘‘with the Secretary— 

4 ‘‘(1) with respect to drugs, the information de5 scribed under subsection (b)(1); and 

6 ‘‘(2) with respect to devices, the information de7 scribed under subsection (b)(2).’’. 

8 SEC. 702. REGISTRATION OF FOREIGN ESTABLISHMENTS. 

9 (a) ENFORCEMENT OF REGISTRATION OF FOREIGN

10 ESTABLISHMENTS.—Section 502(o) (21 U.S.C. 352(o)) is 

11 amended by striking ‘‘in any State’’. 

12 (b) REGISTRATION OF FOREIGN DRUG ESTABLISH13 MENTS.—Section 510(i) (U.S.C. 360(i)) is amended— 

14 (1) in paragraph (1)— 

15 (A) by amending the matter preceding sub16 paragraph (A) to read as follows: ‘‘Every per17 son who owns or operates any establishment 

18 within any foreign country engaged in the man19 ufacture, preparation, propagation, 

20 compounding, or processing of a drug or device 

21 that is imported or offered for import into the 

22 United States shall, through electronic means 

23 in accordance with the criteria of the Sec24 retary—’’; 
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1 (B) by amending subparagraph (A) to read 

2 as follows: 

3 ‘‘(A) upon first engaging in any such activity, 

4 immediately submit a registration to the Secretary 

5 that includes— 

6 ‘‘(i) with respect to drugs, the name and 

7 place of business of such person, all such estab8 lishments, the unique facility identifier of each 

9 such establishment, a point of contact e-mail 

10 address, the name of the United States agent of 

11 each such establishment, the name and place of 

12 business of each drug importer with which such 

13 person conducts business to import or offer to 

14 import drugs into the United States, including 

15 all establishments of each such drug importer, 

16 the unique facility identifier of each such estab17 lishment, and a point of contact e-mail address 

18 for each such drug importer; and 

19 ‘‘(ii) with respect to devices, the name and 

20 place of business of the establishment, the name 

21 of the United States agent for the establish22 ment, the name of each importer of such device 

23 in the United States that is known to the estab24 lishment, and the name of each person who im25 ports or offers for import such device to the 
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1 United States for purposes of importation; 

2 and’’; and 

3 (C) by amending subparagraph (B) to read 

4 as follows: 

5 ‘‘(B) each establishment subject to the require6 ments of subparagraph (A) shall thereafter register 

7 with the Secretary during the period beginning on 

8 October 1 and ending on December 31 of each 

9 year.’’; and 

10 (2) by adding at the end the following: 

11 ‘‘(4) The Secretary may specify the unique facility 

12 identifier system that shall be used by registrants under 

13 paragraph (1) with respect to drugs.’’. 

14 SEC. 703. IDENTIFICATION OF DRUG EXCIPIENT INFORMA15 TION WITH PRODUCT LISTING. 

16 Section 510(j)(1) (21 U.S.C. 360(j)(1)) is amend17 ed— 

18 (1) in subparagraph (C), by striking ‘‘; and’’ 

19 and inserting a semicolon; 

20 (2) in subparagraph (D), by striking the period 

21 at the end and inserting ‘‘; and’’; and 

22 (3) by adding at the end the following: 

23 ‘‘(E) in the case of a drug contained in the ap24 plicable list, the name and place of business of each 

25 manufacturer of an excipient of the listed drug with 
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1 which the person listing the drug conducts business, 

2 including all establishments used in the production 

3 of such excipient, the unique facility identifier of 

4 each such establishment, and a point of contact e5 mail address for each such excipient manufacturer.’’. 

6 SEC. 704. ELECTRONIC SYSTEM FOR REGISTRATION AND 

7 LISTING. 

8 Section 510(p) (21 U.S.C. 360(p)) is amended— 

9 (1) by striking ‘‘(p) Registrations and listings’’ 

10 and inserting the following: 

11 ‘‘(p) ELECTRONIC REGISTRATION AND LISTING.— 

12 ‘‘(1) IN GENERAL.—Registration and listing’’; 

13 and 

14 (2) by adding at the end the following: 

15 ‘‘(2) ELECTRONIC DATABASE.—Not later than 

16 2 years after the Secretary specifies a unique facility 

17 identifier system under subsections (b) and (i), the 

18 Secretary shall maintain an electronic database, 

19 which shall not be subject to inspection under sub20 section (f), populated with the information submitted 

21 as described under paragraph (1) that— 

22 ‘‘(A) enables personnel of the Food and 

23 Drug Administration to search the database by 

24 any field of information submitted in a registra-
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1 tion described under paragraph (1), or com2 bination of such fields; and 

3 ‘‘(B) uses the unique facility identifier sys4 tem to link with other relevant databases within 

5 the Food and Drug Administration, including 

6 the database for submission of information 

7 under section 801(r). 

8 ‘‘(3) RISK-BASED INFORMATION AND COORDI9 NATION.—The Secretary shall ensure the accuracy 

10 and coordination of relevant Food and Drug Admin11 istration databases in order to identify and inform 

12 risk-based inspections under section 510(h).’’. 

13 SEC. 705. RISK-BASED INSPECTION FREQUENCY. 

14 Section 510(h) (21 U.S.C. 360(h)) is amended to 

15 read as follows: 

16 ‘‘(h) INSPECTIONS.— 

17 ‘‘(1) IN GENERAL.—Every establishment that is 

18 required to be registered with the Secretary under 

19 this section shall be subject to inspection pursuant 

20 to section 704. 

21 ‘‘(2) BIENNIAL INSPECTIONS FOR DEVICES.— 

22 Every establishment described in paragraph (1), in 

23 any State, that is engaged in the manufacture, prop24 agation, compounding, or processing of a device or 

25 devices classified in class II or III shall be so in-
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1 spected by one or more officers or employees duly 

2 designated by the Secretary, or by persons accred3 ited to conduct inspections under section 704(g), at 

4 least once in the 2-year period beginning with the 

5 date of registration of such establishment pursuant 

6 to this section and at least once in every successive 

7 2-year period thereafter. 

8 ‘‘(3) RISK-BASED SCHEDULE FOR DRUGS.—The 

9 Secretary, acting through one or more officers or 

10 employees duly designated by the Secretary, shall in11 spect establishments described in paragraph (1) that 

12 are engaged in the manufacture, preparation, propa13 gation, compounding, or processing of a drug or 

14 drugs (referred to in this subsection as ‘drug estab15 lishments’) in accordance with a risk-based schedule 

16 established by the Secretary. 

17 ‘‘(4) RISK FACTORS.—In establishing the risk18 based scheduled under paragraph (3), the Secretary 

19 shall inspect establishments according to the known 

20 safety risks of such establishments, which shall be 

21 based on the following factors: 

22 ‘‘(A) The compliance history of the estab23 lishment. 

24 ‘‘(B) The record, history, and nature of re25 calls linked to the establishment. 
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1 ‘‘(C) The inherent risk of the drug manu2 factured, prepared, propagated, compounded, or 

3 processed at the establishment. 

4 ‘‘(D) The certifications described under 

5 sections 801(r) and 809 for the establishment. 

6 ‘‘(E) Whether the establishment has been 

7 inspected in the preceding 4-year period. 

8 ‘‘(F) Any other criteria deemed necessary 

9 and appropriate by the Secretary for purposes 

10 of allocating inspection resources. 

11 ‘‘(5) EFFECT OF STATUS.—In determining the 

12 risk associated with an establishment for purposes of 

13 establishing a risk-based schedule under paragraph 

14 (3), the Secretary shall not consider whether the 

15 drugs manufactured, prepared, propagated, com16 pounded, or processed by such establishment are 

17 drugs described in section 503(b). 

18 ‘‘(6) ANNUAL REPORT ON INSPECTIONS OF ES19 TABLISHMENTS.—Not later than February 1 of each 

20 year, the Secretary shall submit a report to Con21 gress regarding— 

22 ‘‘(A)(i) the number of domestic and foreign 

23 establishments registered pursuant to this sec24 tion in the previous fiscal year; and 
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1 ‘‘(ii) the number of such domestic estab2 lishments and the number of such foreign es3 tablishments that the Secretary inspected in the 

4 previous fiscal year; 

5 ‘‘(B) with respect to establishments that 

6 manufacture, prepare, propagate, compound, or 

7 process an active ingredient of a drug, a fin8 ished drug product, or an excipient of a drug, 

9 the number of each such type of establishment; 

10 and 

11 ‘‘(C) the percentage of the budget of the 

12 Food and Drug Administration used to fund 

13 the inspections described under subparagraph 

14 (A). 

15 ‘‘(7) PUBLIC AVAILABILITY OF ANNUAL RE16 PORTS.—The Secretary shall make the report re17 quired under paragraph (6) available to the public 

18 on the Internet Web site of the Food and Drug Ad19 ministration.’’. 

20 SEC. 706. RECORDS FOR INSPECTION. 

21 Section 704(a) (21 U.S.C. 374(a)) is amended by 

22 adding at the end the following: 

23 ‘‘(4)(A) Any records or other information that the 

24 Secretary is entitled to inspect under this section from a 

25 person that owns or operates an establishment that is en-
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1 gaged in the manufacture, preparation, propagation, 

2 compounding, or processing of a drug shall, upon the re3 quest of the Secretary, be provided to the Secretary by 

4 such person within a reasonable time frame, within rea5 sonable limits and in a reasonable manner, and in elec6 tronic form, at the expense of such person. The Sec7 retary’s request shall include a clear description of the 

8 records requested. 

9 ‘‘(B) Upon receipt of the records requested under 

10 subparagraph (A), the Secretary shall provide to the per11 son confirmation of the receipt of such records. 

12 ‘‘(C) Nothing in this paragraph supplants the author13 ity of the Secretary to conduct inspections otherwise per14 mitted under this Act in order to ensure compliance by 

15 an establishment with this Act.’’. 

16 SEC. 707. FAILURE TO ALLOW FOREIGN INSPECTION. 

17 Section 801(a) (21 U.S.C. 381(a)) is amended by 

18 adding at the end the following: ‘‘Notwithstanding any 

19 other provision of this subsection, the Secretary of Home20 land Security shall, upon request from the Secretary of 

21 Health and Human Services refuse to admit into the 

22 United States any article if the article was manufactured, 

23 prepared, propagated, compounded, processed, or held at 

24 an establishment that has refused to permit the Secretary 

25 of Health and Human Services to enter or inspect the es-
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1 tablishment in the same manner and to the same extent 

2 as the Secretary may inspect establishments under section 

3 704.’’. 

4 SEC. 708. EXCHANGE OF INFORMATION. 

5 Section 708 (21 U.S.C. 379) is amended— 

6 (1) by striking ‘‘CONFIDENTIAL INFORMATION’’ 

7 and all that follows through ‘‘The Secretary’’ and in8 serting ‘‘CONFIDENTIAL INFORMATION. 

9 ‘‘(a) CONTRACTORS.—The Secretary’’; and 

10 (2) by adding at the end the following: 

11 ‘‘(b) ABILITY TO RECEIVE AND PROTECT CON12 FIDENTIAL INFORMATION OBTAINED FROM FOREIGN

13 GOVERNMENTS.— 

14 ‘‘(1) IN GENERAL.—The Secretary shall not be 

15 required to disclose under section 552 of title 5, 

16 United States Code (commonly referred to as the 

17 Freedom of Information Act), or any other provision 

18 of law, any information described in subsection 

19 (c)(3) obtained from a foreign government agency, 

20 if— 

21 ‘‘(A) the information is provided or made 

22 available to the United States Government vol23 untarily and on the condition that the informa24 tion not be released to the public; and 
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1 ‘‘(B) the information is covered by, and 

2 subject to, a certification and written agreement 

3 under subsections (c)(1) and (c)(2). 

4 ‘‘(2) TIME LIMITATIONS.—The written agree5 ment described in subsection (c)(2) shall specify the 

6 time period for which the non-disclosure require7 ments under paragraph (1) shall apply to the volun8 tarily disclosed information. The non-disclosure re9 quirements under paragraph (1) shall not apply 

10 after the date specified, but all other applicable legal 

11 protections, including section 552 of title 5, United 

12 States Code and section 319L(e)(1) of the Public 

13 Health Service Act, shall continue to apply to such 

14 information, as appropriate. If no date is specified 

15 in the written agreement, the non-disclosure protec16 tions described in paragraph (1) shall not exceed 3 

17 years. 

18 ‘‘(3) DISCLOSURES NOT AFFECTED.—Nothing 

19 in this section authorizes any official to withhold, or 

20 to authorize the withholding of, information from 

21 Congress or information required to be disclosed 

22 pursuant to an order of a court of the United 

23 States. 

24 ‘‘(4) PUBLIC INFORMATION.—For purposes of 

25 section 552 of title 5, United States Code, this sub-
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1 section shall be considered a statute described in 

2 section 552(b)(3)(B). 

3 ‘‘(c) AUTHORITY TO ENTER INTO MEMORANDA OF

4 UNDERSTANDING FOR PURPOSES OF INFORMATION EX5 CHANGE.—The Secretary may enter into written agree6 ments regarding the exchange of information referenced 

7 in section 301(j) subject to the following criteria: 

8 ‘‘(1) CERTIFICATION.—The Secretary may only 

9 enter into written agreements under this subsection 

10 with foreign governments that the Secretary has cer11 tified as having the authority and demonstrated abil12 ity to protect trade secret information from disclo13 sure. Responsibility for this certification shall not be 

14 delegated to any officer or employee other than the 

15 Commissioner. 

16 ‘‘(2) WRITTEN AGREEMENT.—The written 

17 agreement under this subsection shall include a com18 mitment by the foreign government to protect infor19 mation exchanged under this subsection from disclo20 sure unless and until the sponsor gives written per21 mission for disclosure or the Secretary makes a dec22 laration of a public health emergency pursuant to 

23 section 319 of the Public Health Service Act that is 

24 relevant to the information. 
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1 ‘‘(3) INFORMATION EXCHANGE.—The Secretary 

2 may provide to a foreign government that has been 

3 certified under paragraph (1) and that has executed 

4 a written agreement under paragraph (2) informa5 tion referenced in section 301(j) in the following cir6 cumstances: 

7 ‘‘(A) Information concerning the inspection 

8 of a facility may be provided if— 

9 ‘‘(i) the Secretary reasonably believes, 

10 or that the written agreement described in 

11 paragraph (2) establishes, that the govern12 ment has authority to otherwise obtain 

13 such information; and 

14 ‘‘(ii) the written agreement executed 

15 under paragraph (2) limits the recipient’s 

16 use of the information to the recipient’s 

17 civil regulatory purposes. 

18 ‘‘(B) Information not described in sub19 paragraph (A) may be provided as part of an 

20 investigation, or to alert the foreign government 

21 to the potential need for an investigation, if the 

22 Secretary has reasonable grounds to believe 

23 that a drug has a reasonable probability of 

24 causing serious adverse health consequences or 

25 death to humans or animals. 
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1 ‘‘(4) EFFECT OF SUBSECTION.—Nothing in this 

2 subsection affects the ability of the Secretary to 

3 enter into any written agreement authorized by 

4 other provisions of law to share confidential informa5 tion.’’. 

6 SEC. 709. ENHANCING THE SAFETY AND QUALITY OF THE 

7 DRUG SUPPLY. 

8 Section 501 (21 U.S.C. 351) is amended by adding 

9 at the end the following flush text: 

10 ‘‘For purposes of subsection (a)(2)(B), the term ‘current 

11 good manufacturing practice’ includes the implementation 

12 of oversight and controls over the manufacture of drugs 

13 to ensure quality, including managing the risk of and es14 tablishing the safety of raw materials, materials used in 

15 the manufacturing of drugs, and finished drug products.’’. 

16 SEC. 710. ACCREDITATION OF THIRD-PARTY AUDITORS FOR 

17 DRUG ESTABLISHMENTS. 

18 (a) IN GENERAL.—Chapter VIII (21 U.S.C. 381 et 

19 seq.) is amended by adding at the end the following: 

20 ‘‘SEC. 809. ACCREDITATION OF THIRD-PARTY AUDITORS 

21 FOR DRUG ESTABLISHMENTS. 

22 ‘‘(a) DEFINITIONS.—In this section: 

23 ‘‘(1) ACCREDITATION BODY.—The term ‘ac24 creditation body’ means an authority that performs 

25 accreditation of third-party auditors. 
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1 ‘‘(2) ACCREDITED THIRD-PARTY AUDITOR.— 

2 The term ‘accredited third-party auditor’ means a 

3 third-party auditor (which may be an individual) ac4 credited by an accreditation body to conduct drug 

5 safety and quality audits. 

6 ‘‘(3) AUDIT AGENT.—The term ‘audit agent’ 

7 means an individual who is an employee or agent of 

8 an accredited third-party auditor and, although not 

9 individually accredited, is qualified to conduct drug 

10 safety and quality audits on behalf of an accredited 

11 third-party auditor. 

12 ‘‘(4) CONSULTATIVE AUDIT.—The term ‘con13 sultative audit’ means an audit of an eligible entity 

14 intended for internal purposes only to determine 

15 whether an establishment is in compliance with the 

16 provisions of this Act and applicable industry prac17 tices, or any other such service. 

18 ‘‘(5) DRUG SAFETY AND QUALITY AUDIT.—The 

19 term ‘drug safety and quality audit’— 

20 ‘‘(A) means an audit of an eligible entity 

21 to certify that the eligible entity meets the re22 quirements of this Act applicable to drugs, in23 cluding the requirements of section 501 with re24 spect to drugs; and 

25 ‘‘(B) is not a consultative audit. 
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1 ‘‘(6) ELIGIBLE ENTITY.—The term ‘eligible en2 tity’ means an entity, including a foreign drug estab3 lishment registered under section 510(c), in the drug 

4 supply chain that chooses to be audited by an ac5 credited third-party auditor or the audit agent of 

6 such accredited third-party auditor. 

7 ‘‘(7) THIRD-PARTY AUDITOR.—The term ‘third8 party auditor’ means a foreign government, agency 

9 of a foreign government or any other third party 

10 (which may be an individual), as the Secretary de11 termines appropriate in accordance with the criteria 

12 described in subsection (c)(1), that is eligible to be 

13 considered for accreditation to conduct drug safety 

14 and quality audits. 

15 ‘‘(b) ACCREDITATION SYSTEM.— 

16 ‘‘(1) RECOGNITION OF ACCREDITATION BOD17 IES.— 

18 ‘‘(A) IN GENERAL.—Not later than 2 years 

19 after date of enactment of the Food and Drug 

20 Administration Safety and Innovation Act, the 

21 Secretary shall establish a system for the rec22 ognition of accreditation bodies that accredit 

23 third-party auditors to conduct drug safety and 

24 quality audits. 

25 ‘‘(B) DIRECT ACCREDITATION.— 
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1 ‘‘(i) IN GENERAL.—If, by the date 

2 that is 2 years after the date of establish3 ment of the system described in subpara4 graph (A), the Secretary has not identified 

5 and recognized an accreditation body to 

6 meet the requirements of this section, the 

7 Secretary may directly accredit third-party 

8 auditors. 

9 ‘‘(ii) CERTAIN DIRECT ACCREDITA10 TIONS.—Notwithstanding subparagraph 

11 (A) or clause (i), the Secretary may di12 rectly accredit any foreign government or 

13 any agency of a foreign government as a 

14 third-party auditor at any time after the 

15 date of enactment of the Food and Drug 

16 Administration Safety and Innovation Act. 

17 ‘‘(2) NOTIFICATION.—Each accreditation body 

18 recognized by the Secretary shall submit to the Sec19 retary— 

20 ‘‘(A) a list of all accredited third-party 

21 auditors accredited by such body (including the 

22 name, contact information, and scope and dura23 tion of accreditation for each such auditor), and 

24 the audit agents of such auditors; and 
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1 ‘‘(B) updated lists as needed to ensure the 

2 list held by the Secretary is accurate. 

3 ‘‘(3) REVOCATION OF RECOGNITION AS AN AC4 CREDITATION BODY.—The Secretary shall promptly 

5 revoke, after the opportunity for an informal hear6 ing, the recognition of any accreditation body found 

7 not to be in compliance with the requirements of this 

8 section. 

9 ‘‘(4) REINSTATEMENT.—The Secretary shall es10 tablish procedures to reinstate recognition of an ac11 creditation body if the Secretary determines, based 

12 on evidence presented by such accreditation body, 

13 that revocation was inappropriate or that the body 

14 meets the requirements for recognition under this 

15 section. 

16 ‘‘(5) MODEL ACCREDITATION STANDARDS.— 

17 ‘‘(A) IN GENERAL.—Not later than 18 

18 months after the date of enactment of the Food 

19 and Drug Administration Safety and Innova20 tion Act, the Secretary shall develop model 

21 standards, including standards for drug safety 

22 and quality audit results, reports, and certifi23 cations, and each recognized accreditation body 

24 shall ensure that third-party auditors and audit 

25 agents of such auditors meet such standards in 
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1 order to qualify such third-party auditors as ac2 credited third-party auditors under this section. 

3 ‘‘(B) CONTENT.—The standards developed 

4 under subparagraph (A) may— 

5 ‘‘(i) include a description of required 

6 standards relating to the training proce7 dures, competency, management respon8 sibilities, quality control, and conflict of in9 terest requirements of accredited third10 party auditors; and 

11 ‘‘(ii) set forth procedures for the peri12 odic renewal of the accreditation of accred13 ited third-party auditors. 

14 ‘‘(C) REQUIREMENT TO PROVIDE RESULTS

15 AND REPORTS TO THE SECRETARY.—An ac16 creditation body (or, in the case of direct ac17 creditation under subsection (b)(1)(B), the Sec18 retary) may not accredit a third-party auditor 

19 unless such third-party auditor agrees to pro20 vide to the Secretary, upon request, the results 

21 and reports of any drug safety and quality 

22 audit conducted pursuant to the accreditation 

23 provided under this section. 

24 ‘‘(6) DISCLOSURE.—The Secretary shall main25 tain on the Internet Web site of the Food and Drug 
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1 Administration a list of recognized accreditation 

2 bodies and accredited third-party auditors under this 

3 section. 

4 ‘‘(c) ACCREDITED THIRD-PARTY AUDITORS.— 

5 ‘‘(1) REQUIREMENTS FOR ACCREDITATION AS A

6 THIRD-PARTY AUDITOR.— 

7 ‘‘(A) FOREIGN GOVERNMENTS.—Prior to 

8 accrediting a foreign government or an agency 

9 of a foreign government as an accredited third10 party auditor, the accreditation body (or, in the 

11 case of direct accreditation under subsection 

12 (b)(1)(B), the Secretary) shall perform such re13 views and audits of drug safety programs, sys14 tems, and standards of the government or agen15 cy of the government as the Secretary deems 

16 necessary, including requirements under the 

17 standards developed under subsection (b)(5), to 

18 determine that the foreign government or agen19 cy of the foreign government is capable of ade20 quately ensuring that eligible entities or drugs 

21 certified by such government or agency meet 

22 the requirements of this Act. 

23 ‘‘(B) OTHER THIRD PARTIES.—Prior to 

24 accrediting any other third party to be an ac25 credited third-party auditor, the accreditation 
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1 body (or, in the case of direct accreditation 

2 under subsection (b)(1)(B), the Secretary) shall 

3 perform such reviews and audits of the training 

4 and qualifications of audit agents used by that 

5 party and conduct such reviews of internal sys6 tems and such other investigation of the party 

7 as the Secretary deems necessary, including re8 quirements under the standards developed 

9 under subsection (b)(5), to determine that the 

10 third-party auditor is capable of adequately en11 suring that an eligible entity or drug certified 

12 by such third-party auditor meets the require13 ments of this Act. 

14 ‘‘(2) USE OF AUDIT AGENTS.—An accredited 

15 third-party auditor may conduct drug safety and 

16 quality audits and may employ or use audit agents 

17 to conduct drug safety and quality audits, but must 

18 ensure that such audit agents comply with all re19 quirements the Secretary deems necessary, including 

20 requirements under paragraph (1) and subsection 

21 (b)(5). 

22 ‘‘(3) REVOCATION OF ACCREDITATION.— 

23 ‘‘(A) IN GENERAL.—The Secretary shall 

24 promptly revoke, after the opportunity for an 
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1 informal hearing, the accreditation of an ac2 credited third-party auditor— 

3 ‘‘(i) if, following an evaluation, the 

4 Secretary finds that the accredited third5 party auditor is not in compliance with the 

6 requirements of this section; or 

7 ‘‘(ii) following a refusal to allow 

8 United States officials to conduct such au9 dits and investigations as may be necessary 

10 to determine compliance with the require11 ments set forth in this section. 

12 ‘‘(B) ADDITIONAL BASIS FOR REVOCATION

13 OF ACCREDITATION.—The Secretary may re14 voke accreditation from an accredited third15 party auditor in the case that such third-party 

16 auditor is accredited by an accreditation body 

17 for which recognition as an accreditation body 

18 under subsection (b)(3) is revoked, if the Sec19 retary determines that there is good cause for 

20 the revocation of accreditation. 

21 ‘‘(4) REACCREDITATION.—The Secretary shall 

22 establish procedures to reinstate the accreditation of 

23 a third-party auditor for which accreditation has 

24 been revoked under paragraph (3)— 
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1 ‘‘(A) if the Secretary determines, based on 

2 evidence presented, that— 

3 ‘‘(i) the third-party auditor satisfies 

4 the requirements of this section; and 

5 ‘‘(ii) adequate grounds for revocation 

6 no longer exist; and 

7 ‘‘(B) in the case of a third-party auditor 

8 accredited by an accreditation body for which 

9 recognition as an accreditation body is revoked 

10 under subsection (b)(3)— 

11 ‘‘(i) if the third-party auditor becomes 

12 accredited not later than 1 year after rev13 ocation of accreditation under paragraph 

14 (3), through direct accreditation under 

15 subsection (b)(1)(B), or by an accredita16 tion body in good standing; or 

17 ‘‘(ii) under such other conditions as 

18 the Secretary may require. 

19 ‘‘(5) REQUIREMENT TO ISSUE CERTIFICATION

20 OF ELIGIBLE ENTITIES FOR COMPLIANCE WITH CUR21 RENT GOOD MANUFACTURING PRACTICE.— 

22 ‘‘(A) IN GENERAL.—An accreditation body 

23 (or, in the case of direct accreditation under 

24 subsection (b)(1)(B), the Secretary) may not 

25 accredit a third-party auditor unless such third- 
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1 party auditor agrees to issue a written and, as 

2 appropriate, electronic, document or certifi3 cation, as the Secretary may require under this 

4 Act, regarding compliance with section 501. 

5 The Secretary may consider any such document 

6 or certification to satisfy requirements under 

7 section 801(r) and to target inspection re8 sources under section 510(h). 

9 ‘‘(B) REQUIREMENTS FOR ISSUING CER10 TIFICATION.— 

11 ‘‘(i) IN GENERAL.—An accredited 

12 third-party auditor shall issue a drug cer13 tification described in subparagraph (A) 

14 only after conducting a drug safety and 

15 quality audit and such other activities that 

16 may be necessary to establish compliance 

17 with the provisions of section 501. 

18 ‘‘(ii) PROVISION OF CERTIFICATION.— 

19 Only an accredited third-party auditor or 

20 the Secretary may provide a drug certifi21 cation described in subparagraph (A). 

22 ‘‘(C) RECORDS.—Following any accredita23 tion of a third-party auditor, the Secretary 

24 may, at any time, require the accredited third25 party auditor or any audit agent of such audi-
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1 tor to submit to the Secretary a drug safety 

2 and quality audit report and such other reports 

3 or documents required as part of the drug safe4 ty and quality audit process, for any eligible en5 tity for which the accredited third-party auditor 

6 or audit agent of such auditor performed a 

7 drug safety and quality audit. The Secretary 

8 may require documentation that the eligible en9 tity is in compliance with any applicable reg10 istration requirements. 

11 ‘‘(D) LIMITATION.—The requirement 

12 under subparagraph (C) shall not include any 

13 report or other documents resulting from a con14 sultative audit, except that the Secretary may 

15 access the results of a consultative audit in ac16 cordance with section 704. 

17 ‘‘(E) DECLARATION OF AUDIT TYPE.—Be18 fore an accredited third-party auditor begins 

19 any audit or provides any consultative service to 

20 an eligible entity, both the accredited third21 party auditor and eligible entity shall establish 

22 in writing whether the audit is intended to be 

23 a drug safety and quality audit. Any audit, in24 spection, or consultative service of any type pro25 vided by an accredited third-party auditor on 
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1 behalf of an eligible entity shall be presumed to 

2 be a drug safety and quality audit in the ab3 sence of such a written agreement. Once a drug 

4 safety and quality audit is initiated, it shall be 

5 subject to the requirements of this section, and 

6 no person may withhold from the Secretary any 

7 document subject to subparagraph (C) on the 

8 grounds that the audit was a consultative audit 

9 or otherwise not a drug safety and quality 

10 audit. 

11 ‘‘(F) RULE OF CONSTRUCTION.—Nothing 

12 in this section shall be construed to limit the 

13 authority of the Secretary under section 704. 

14 ‘‘(6) REQUIREMENTS REGARDING SERIOUS

15 RISKS TO THE PUBLIC HEALTH.—If, at any time 

16 during a drug safety and quality audit, an accredited 

17 third-party auditor or an audit agent of such auditor 

18 discovers a condition that could cause or contribute 

19 to a serious risk to the public health, such auditor 

20 shall immediately notify the Secretary of— 

21 ‘‘(A) the identity and location of the eligi22 ble entity subject to the drug safety and quality 

23 audit; and 

24 ‘‘(B) such condition. 

25 ‘‘(7) LIMITATIONS.— 
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1 ‘‘(A) IN GENERAL.—An audit agent of an 

2 accredited third-party auditor may not perform 

3 a drug safety and quality audit of an eligible 

4 entity if such audit agent has performed a drug 

5 safety and quality audit or consultative audit of 

6 such eligible entity during the previous 13- 

7 month period. 

8 ‘‘(B) WAIVER.—The Secretary may waive 

9 the application of subparagraph (A) if the Sec10 retary determines that there is insufficient ac11 cess to accredited third-party auditors in a 

12 country or region or that the use of the same 

13 audit agent or accredited third-party auditor is 

14 otherwise necessary. 

15 ‘‘(8) CONFLICTS OF INTEREST.— 

16 ‘‘(A) ACCREDITATION BODIES.—A recog17 nized accreditation body shall— 

18 ‘‘(i) not be owned, managed, or con19 trolled by any person that owns or operates 

20 a third-party auditor to be accredited by 

21 such body; 

22 ‘‘(ii) in carrying out accreditation of 

23 third-party auditors under this section, 

24 have procedures to ensure against the use 

25 of any officer or employee of such body 
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1 that has a financial conflict of interest re2 garding a third-party auditor to be accred3 ited by such body; and 

4 ‘‘(iii) annually make available to the 

5 Secretary disclosures of the extent to 

6 which such body and the officers and em7 ployees of such body have maintained com8 pliance with clauses (i) and (ii) relating to 

9 financial conflicts of interest. 

10 ‘‘(B) ACCREDITED THIRD-PARTY AUDI11 TORS.—An accredited third-party auditor 

12 shall— 

13 ‘‘(i) not be owned, managed, or con14 trolled by any person that owns or operates 

15 an eligible entity to be certified by such 

16 auditor; 

17 ‘‘(ii) in carrying out drug safety and 

18 quality audits of eligible entities under this 

19 section, have procedures to ensure against 

20 the use of any officer or employee of such 

21 auditor that has a financial conflict of in22 terest regarding an eligible entity to be 

23 certified by such auditor; and 

24 ‘‘(iii) annually make available to the 

25 Secretary disclosures of the extent to 
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1 which such auditor and the officers and 

2 employees of such auditor have maintained 

3 compliance with clauses (i) and (ii) relat4 ing to financial conflicts of interest. 

5 ‘‘(C) AUDIT AGENTS.—An audit agent 

6 shall— 

7 ‘‘(i) not own or operate an eligible en8 tity to be audited by such agent; 

9 ‘‘(ii) in carrying out audits of eligible 

10 entities under this section, have procedures 

11 to ensure that such agent does not have a 

12 financial conflict of interest regarding an 

13 eligible entity to be audited by such agent; 

14 and 

15 ‘‘(iii) annually make available to the 

16 Secretary disclosures of the extent to 

17 which such agent has maintained compli18 ance with clauses (i) and (ii) relating to fi19 nancial conflicts of interest. 

20 ‘‘(d) FALSE STATEMENTS.—Any statement or rep21 resentation made— 

22 ‘‘(1) by an employee or agent of an eligible enti23 ty to an accredited third-party auditor or audit 

24 agent; or 
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1 ‘‘(2) by an accreditation body, accredited third2 party auditor, or audit agent of such auditor to the 

3 Secretary, shall be subject to section 1001 of title 

4 18, United States Code. 

5 ‘‘(e) MONITORING.—To ensure compliance with the 

6 requirements of this section, the Secretary— 

7 ‘‘(1) shall periodically, or at least once every 4 

8 years, reevaluate the accreditation bodies described 

9 in subsection (b)(1); 

10 ‘‘(2) shall periodically, or at least once every 4 

11 years, evaluate the performance of each accredited 

12 third-party auditor, through the review of regulatory 

13 audit reports by such auditors, the compliance his14 tory as available of eligible entities certified by such 

15 auditors, and any other measures deemed necessary 

16 by the Secretary; 

17 ‘‘(3) may at any time, conduct an onsite audit 

18 of any eligible entity certified by an accredited third19 party auditor, with or without the auditor present; 

20 and 

21 ‘‘(4) shall take any other measures deemed nec22 essary by the Secretary. 

23 ‘‘(f) EFFECT OF AUDIT.—The results of a drug safe24 ty and quality audit by an accredited third-party auditor 

25 under this section— 
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1 ‘‘(1) may be used by the eligible entity— 

2 ‘‘(A) as documentation of compliance with 

3 section 501(a)(2)(B) or section 801(r); and 

4 ‘‘(B) for other purposes as determined ap5 propriate by the Secretary; and 

6 ‘‘(2) shall be used by the Secretary in estab7 lishing the risk-based inspection schedules under sec8 tion 510(h). 

9 ‘‘(g) COSTS.— 

10 ‘‘(1) AUTHORIZED FEES OF SECRETARY.—The 

11 Secretary may assess fees on accreditation bodies 

12 and accredited third-party auditors in such an 

13 amount necessary to establish and administer the 

14 recognition and accreditation program under this 

15 section. The Secretary may require accredited third16 party auditors and audit agents to reimburse the 

17 Food and Drug Administration for the work per18 formed to carry out this section. The Secretary shall 

19 not generate surplus revenue from such a reimburse20 ment mechanism. Fees authorized under this para21 graph shall be collected and available for obligation 

22 only to the extent and in the amount provided in ad23 vance in appropriation Acts. Such fees are author24 ized to remain available until expended. 
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1 ‘‘(2) AUTHORIZED FEES FOR RECOGNIZED AC2 CREDITATION BODIES.—An accreditation body rec3 ognized by the Secretary under subsection (b) may 

4 assess a reasonable fee to accredit third-party audi5 tors. 

6 ‘‘(h) LIMITATIONS.— 

7 ‘‘(1) NO EFFECT ON SECTION 704 INSPEC8 TIONS.—The drug safety and quality audits per9 formed under this section shall not be considered in10 spections under section 704. 

11 ‘‘(2) NO EFFECT ON INSPECTION AUTHOR12 ITY.—Nothing in this section affects the authority of 

13 the Secretary to inspect any eligible entity pursuant 

14 to this Act. 

15 ‘‘(i) REGULATIONS.— 

16 ‘‘(1) IN GENERAL.—Not later than 18 months 

17 after the date of enactment of the Food and Drug 

18 Administration Safety and Innovation Act, the Sec19 retary shall adopt final regulations implementing 

20 this section. 

21 ‘‘(2) PROCEDURE.—In promulgating the regula22 tions implementing this section, the Secretary 

23 shall— 

24 ‘‘(A) issue a notice of proposed rulemaking 

25 that includes the proposed regulation; 
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1 ‘‘(B) provide a period of not less than 60 

2 days for comments on the proposed regulation; 

3 and 

4 ‘‘(C) publish the final regulation not less 

5 than 30 days before the effective date of the 

6 regulation. 

7 ‘‘(3) CONTENT.—Such regulations shall in8 clude— 

9 ‘‘(A) requirements that, to the extent prac10 ticable, drug safety and quality audits per11 formed under this section be unannounced; 

12 ‘‘(B) a structure to decrease the potential 

13 for conflicts of interest, including timing and 

14 public disclosure, for fees paid by eligible enti15 ties to accredited third-party auditors; and 

16 ‘‘(C) appropriate limits on financial affili17 ations between an accredited third-party audi18 tor or audit agents of such auditor and any per19 son that owns or operates an eligible entity to 

20 be audited by such auditor, as described in sub21 paragraphs (A) and (B). 

22 ‘‘(4) RESTRICTIONS.—Notwithstanding any 

23 other provision of law, the Secretary shall promul24 gate regulations implementing this section only as 

25 described in paragraph (2).’’. 
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1 (b) REPORT ON ACCREDITED THIRD-PARTY AUDI2 TORS.—Not later than January 20, 2017, the Comptroller 

3 General of the United States shall submit to Congress a 

4 report that addresses the following, with respect to the pe5 riod beginning on the date of implementation of section 

6 809 of the Federal Food, Drug, and Cosmetic Act (as 

7 added by subsection (a)) and ending on the date of such 

8 report: 

9 (1) The extent to which drug safety and quality 

10 audits completed by accredited third-party auditors 

11 under such section 809 are being used by the Sec12 retary of Health and Human Services (referred to in 

13 this subsection as the ‘‘Secretary’’) in establishing or 

14 applying the risk-based inspection schedules under 

15 section 510(h) of such Act (as amended by section 

16 705). 

17 (2) The extent to which drug safety and quality 

18 audits completed by accredited third-party auditors 

19 or agents are assisting the Food and Drug Adminis20 tration in evaluating compliance with sections 

21 501(a)(2)(B) of such Act (21 U.S.C. 351(a)(2)(B)) 

22 and 801(r) of such Act (as added by section 711). 

23 (3) Whether the Secretary has been able to ac24 cess drug safety and quality audit reports completed 
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1 by accredited third-party auditors under such section 

2 809. 

3 (4) Whether accredited third-party auditors ac4 credited under such section 809 have adhered to the 

5 conflict of interest provisions set forth in such sec6 tion. 

7 (5) The extent to which the Secretary has au8 dited recognized accreditation bodies or accredited 

9 third-party auditors to ensure compliance with the 

10 requirements of such section 809. 

11 (6) The number of waivers under subsection 

12 (c)(7)(B) of such section 809 issued during the most 

13 recent 12-month period and the official justification 

14 by the Secretary for each determination that there 

15 was insufficient access to an accredited third-party 

16 auditor. 

17 (7) The number of times a manufacturer has 

18 used the same accredited third-party auditor for 2 or 

19 more consecutive drug safety and quality audits 

20 under such section 809. 

21 (8) Recommendations to Congress regarding 

22 the accreditation program under such section 809, 

23 including whether Congress should continue, modify, 

24 or terminate the program. 
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1 SEC. 711. STANDARDS FOR ADMISSION OF IMPORTED 

2 DRUGS. 

3 Section 801 (21 U.S.C. 381) is amended— 

4 (1) in subsection (o), by striking ‘‘drug or’’; 

5 and 

6 (2) by adding at the end the following: 

7 ‘‘(r)(1) The Secretary may require, as a condition of 

8 granting admission to a drug imported or offered for im9 port into the United States, that the importer electroni10 cally submit information demonstrating that the drug 

11 complies with applicable requirements of this Act. 

12 ‘‘(2) The information described under paragraph (1) 

13 may include— 

14 ‘‘(A) information demonstrating the regulatory 

15 status of the drug, such as the new drug application, 

16 abbreviated new drug application, or investigational 

17 new drug or drug master file number; 

18 ‘‘(B) facility information, such as proof of reg19 istration and the unique facility identifier; 

20 ‘‘(C) indication of compliance with current good 

21 manufacturing practice, testing results, certifications 

22 relating to satisfactory inspections, and compliance 

23 with the country of export regulations; and 

24 ‘‘(D) any other information deemed necessary 

25 and appropriate by the Secretary to assess compli26 ance of the article being offered for import. 
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1 ‘‘(3) Information requirements referred to in para2 graph (2)(C) may, at the discretion of the Secretary, be 

3 satisfied— 

4 ‘‘(A) by certifications from accredited third par5 ties, as described under section 809; 

6 ‘‘(B) through representation by a foreign gov7 ernment, if such inspection is conducted using 

8 standards and practices as determined appropriate 

9 by the Secretary; or 

10 ‘‘(C) other appropriate documentation or evi11 dence as described by the Secretary. 

12 ‘‘(4)(A) Not later than 18 months after the date of 

13 enactment of the Food and Drug Administration Safety 

14 and Innovation Act, the Secretary shall adopt final regula15 tions implementing this subsection. Such requirements 

16 shall be appropriate for the type of import, such as wheth17 er the drug is for import into the United States for use 

18 in preclinical research or in a clinical investigation under 

19 an investigational new drug exemption under 505(i). 

20 ‘‘(B) In promulgating the regulations implementing 

21 this subsection, the Secretary shall— 

22 ‘‘(i) issue a notice of proposed rulemaking that 

23 includes the proposed regulation; 

24 ‘‘(ii) provide a period of not less than 60 days 

25 for comments on the proposed regulation; and 
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1 ‘‘(iii) publish the final regulation not less than 

2 30 days before the effective date of the regulation. 

3 ‘‘(C) Notwithstanding any other provision of law, the 

4 Secretary shall promulgate regulations implementing this 

5 subsection only as described in subparagraph (B).’’. 

6 SEC. 712. NOTIFICATION. 

7 (a) PROHIBITED ACTS.—Section 301 (21 U.S.C. 

8 331) is amended by adding at the end the following: 

9 ‘‘(aaa) The failure to notify the Secretary in violation 

10 of section 568.’’. 

11 (b) NOTIFICATION.— 

12 (1) IN GENERAL.—Subchapter E of chapter V 

13 (21 U.S.C. 360bbb et seq.) is amended by adding at 

14 the end the following: 

15 ‘‘SEC. 568. NOTIFICATION. 

16 ‘‘(a) NOTIFICATION TO SECRETARY.—With respect 

17 to a drug, the Secretary may require notification to the 

18 Secretary by a covered person if the covered person 

19 knows— 

20 ‘‘(1) of a substantial loss or theft of such drug; 

21 or 

22 ‘‘(2) that such drug— 

23 ‘‘(A) has been or is being counterfeited; 

24 and 
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1 ‘‘(B)(i) is a counterfeit product in com2 merce in the United States; or 

3 ‘‘(ii) is offered for import into the United 

4 States. 

5 ‘‘(b) MANNER OF NOTIFICATION.—Notification 

6 under this section shall be made in a reasonable time, in 

7 such reasonable manner, and by such reasonable means 

8 as the Secretary may require by regulation or specify in 

9 guidance. 

10 ‘‘(c) DEFINITION.—In this section, the term ‘covered 

11 person’ means— 

12 ‘‘(1) a person who is required to register under 

13 section 510 with respect to an establishment en14 gaged in the manufacture, preparation, propagation, 

15 compounding, or processing of a drug; or 

16 ‘‘(2) a person engaged in the wholesale distribu17 tion (as defined in section 503(e)(3)(B)) of a drug.’’. 

18 (2) APPLICABILITY.—Notifications under sec19 tion 568 of the Federal Food, Drug, and Cosmetic 

20 Act (as added by paragraph (1)) apply to losses, 

21 thefts, or counterfeiting, as described in subsection 

22 (a) of such section 568, that occur on or after the 

23 date of enactment of this Act. 
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1 SEC. 713. PROTECTION AGAINST INTENTIONAL ADULTERA2 TION. 

3 Section 303(b) (21 U.S.C. 333(b)) is amended by 

4 adding at the end the following: 

5 ‘‘(7) Notwithstanding subsection (a)(2), any person 

6 that knowingly and intentionally adulterates a drug such 

7 that the drug is adulterated under subsection (a)(1), (b), 

8 (c), or (d) of section 501 and has a reasonable probability 

9 of causing serious adverse health consequences or death 

10 to humans or animals shall be imprisoned for not more 

11 than 20 years or fined not more than $1,000,000, or 

12 both.’’. 

13 SEC. 714. ENHANCED CRIMINAL PENALTY FOR COUNTER14 FEITING DRUGS. 

15 (a) FFDCA.—Section 303(b) (21 U.S.C. 333(b)), as 

16 amended by section 713, is further amended by adding 

17 at the end the following: 

18 ‘‘(8) Notwithstanding subsection (a)(2), any person 

19 who knowingly and intentionally violates section 301(i) 

20 shall be imprisoned for not more than 20 years or fined 

21 not more than $4,000,000 or both.’’. 

22 (b) TITLE 18.—Section 2320(b) of title 18, United 

23 States Code, is amended— 

24 (1) by redesignating paragraphs (2) and (3) as 

25 paragraphs (3) and (4), respectively; and 
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1 (2) by inserting after paragraph (1) the fol2 lowing: 

3 ‘‘(2) COUNTERFEIT DRUGS.— 

4 ‘‘(A) IN GENERAL.—Whoever commits an 

5 offense under subsection (a) with respect to a 

6 drug (as defined in section 201 of the Federal 

7 Food, Drug, and Cosmetic Act (21 U.S.C. 

8 321)) shall— 

9 ‘‘(i) if an individual, be fined not more 

10 than $4,000,000, imprisoned not more 

11 than 20 years, or both; and 

12 ‘‘(ii) if a person other than an indi13 vidual, be fined not more than 

14 $10,000,000. 

15 ‘‘(B) MULTIPLE OFFENSES.—In the case 

16 of an offense by a person under this paragraph 

17 that occurs after that person is convicted of an18 other offense under this paragraph, the person 

19 convicted— 

20 ‘‘(i) if an individual, shall be fined not 

21 more than $8,000,000, imprisoned not 

22 more than 20 years, or both; and 

23 ‘‘(ii) if other than an individual, shall 

24 be fined not more than $20,000,000.’’. 

25 (c) SENTENCING.— 
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1 (1) DIRECTIVE TO SENTENCING COMMISSION.— 

2 Pursuant to its authority under section 994(p) of 

3 title 28, United States Code, and in accordance with 

4 this section, the United States Sentencing Commis5 sion shall review and amend, if appropriate, its 

6 guidelines and its policy statements applicable to 

7 persons convicted of an offense described in section 

8 2320(b)(2) of title 18, United States Code, as 

9 amended by subsection (b), in order to reflect the in10 tent of Congress that such penalties be increased in 

11 comparison to those currently provided by the guide12 lines and policy statements. 

13 (2) REQUIREMENTS.—In carrying out this sub14 section, the Commission shall— 

15 (A) ensure that the sentencing guidelines 

16 and policy statements reflect the intent of Con17 gress that the guidelines and policy statements 

18 reflect the serious nature of the offenses de19 scribed in paragraph (1) and the need for an ef20 fective deterrent and appropriate punishment to 

21 prevent such offenses; 

22 (B) consider the extent to which the guide23 lines may or may not appropriately account for 

24 the potential and actual harm to the public re25 sulting from the offense; 
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1 (C) assure reasonable consistency with 

2 other relevant directives and with other sen3 tencing guidelines; 

4 (D) account for any additional aggravating 

5 or mitigating circumstances that might justify 

6 exceptions to the generally applicable sentencing 

7 ranges; 

8 (E) make any necessary conforming 

9 changes to the sentencing guidelines; and 

10 (F) assure that the guidelines adequately 

11 meet the purposes of sentencing as set forth in 

12 section 3553(a)(2) of title 18, United States 

13 Code. 

14 SEC. 715. EXTRATERRITORIAL JURISDICTION. 

15 Chapter III (21 U.S.C. 331 et seq.) is amended by 

16 adding at the end the following: 

17 ‘‘SEC. 311. EXTRATERRITORIAL JURISDICTION. 

18 ‘‘There is extraterritorial jurisdiction over any viola19 tion of this Act relating to any article regulated under this 

20 Act if such article was intended for import into the United 

21 States or if any act in furtherance of the violation was 

22 committed in the United States.’’. 
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1 SEC. 716. COMPLIANCE WITH INTERNATIONAL AGREE2 MENTS. 

3 Nothing in this title (or an amendment made by this 

4 title) shall be construed in a manner inconsistent with the 

5 obligations of the United States under the Agreement Es6 tablishing the World Trade Organization, or any other 

7 treaty or international agreement to which the United 

8 States is a party. 

9 Subtitle B—Pharmaceutical 

10 Distribution Integrity 

11 SEC. 721. SHORT TITLE. 

12 This subtitle may be referred to as the ‘‘Securing 

13 Pharmaceutical Distribution Integrity to Protect the Pub14 lic Health Act of 2012’’ or the ‘‘Securing Pharmaceutical 

15 Distribution Integrity Act of 2012’’. 

16 SEC. 722. SECURING THE PHARMACEUTICAL DISTRIBUTION 

17 SUPPLY CHAIN. 

18 (a) IN GENERAL.—Chapter V (21 U.S.C. 351 et seq.) 

19 is amended by adding at the end the following: 

20 ‘‘Subchapter H—Pharmaceutical Distribution 

21 Integrity 

22 ‘‘SEC. 581. DEFINITIONS. 

23 ‘‘In this subchapter: 

24 ‘‘(1) DATA CARRIER.—The term ‘data carrier’ 

25 means a machine-readable graphic that is intended 

26 to be affixed to, or imprinted upon, an individual 
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1 saleable unit and a homogeneous case of product. 

2 The data carrier shall comply with a form and for3 mat developed by a widely recognized international 

4 standards development organization to ensure inter5 operability among distribution chain participants. 

6 ‘‘(2) INDIVIDUAL SALEABLE UNIT.—The term 

7 ‘individual saleable unit’ means the smallest con8 tainer of product put into interstate commerce by 

9 the manufacturer that is intended by the manufac10 turer for individual sale to a pharmacy or other dis11 penser of such product. 

12 ‘‘(3) PRODUCT.—The term ‘product’ means a 

13 finished drug subject to section 503(b)(1). 

14 ‘‘(4) PRODUCT TRACING.—The term ‘product 

15 tracing’ means— 

16 ‘‘(A) identifying the immediate previous 

17 source and immediate subsequent recipient of a 

18 product in wholesale distribution at the lot level 

19 where a change of ownership of such product 

20 has occurred between non-affiliated entities, ex21 cept as otherwise described in this subchapter; 

22 ‘‘(B) identifying the immediate subsequent 

23 recipient of the product at the lot level when a 

24 manufacturer or repackager introduces such 

25 product into interstate commerce; 
228 

†S 3187 ES

1 ‘‘(C) identifying that manufacturer and 

2 dispenser of a product at the lot level when a 

3 manufacturer ships a product at the lot level, 

4 without regard to the change in ownership in5 volving the wholesale distributor; and 

6 ‘‘(D) identifying the immediate previous 

7 source of a product at the lot level for dis8 pensers. 

9 ‘‘(5) RXTEC.—The term ‘RxTEC’ means a data 

10 carrier that includes the standardized numerical 

11 identifier (SNI), the lot number, and the expiration 

12 date of a product. The standard data carrier RxTEC 

13 shall be a 2D data matrix barcode affixed to each 

14 individual saleable unit of a product and a linear or 

15 2D data matrix barcode on a homogenous case of a 

16 product. Such information shall be both machine 

17 readable and human readable. 

18 ‘‘(6) SUSPECT PRODUCT.—The term ‘suspect 

19 product’ means a product that, based on credible 

20 evidence— 

21 ‘‘(A) is potentially counterfeit, diverted, or 

22 stolen; 

23 ‘‘(B) is reasonably likely to be intentionally 

24 adulterated such that the product would result 
229 

†S 3187 ES

1 in serious adverse health consequences or death 

2 to humans; or 

3 ‘‘(C) appears otherwise unfit for distribu4 tion such that the product would result in seri5 ous adverse health consequence or death to hu6 mans. 

7 ‘‘(7) VERIFICATION.—The term ‘verification’ 

8 means the process of determining whether a product 

9 has the standardized numerical identifier or lot 

10 number, consistent with section 582, and expiration 

11 date assigned by the manufacturer, or the repack12 ager as applicable, and identifying whether a prod13 uct has the appearance of being a counterfeit, di14 verted, or stolen product, or a product otherwise 

15 unfit for distribution. Verification of the RxTEC 

16 data may occur by using either a human-readable, 

17 machine-readable, or other method such as through 

18 purchase records or invoices. 

19 ‘‘SEC. 582. ENSURING THE SAFETY OF THE PHARMA20 CEUTICAL DISTRIBUTION SUPPLY CHAIN 

21 THROUGH THE ESTABLISHMENT OF AN 

22 RXTEC SYSTEM. 

23 ‘‘(a) MANUFACTURER REQUIREMENTS.— 

24 ‘‘(1) PRODUCT TRACING.—A manufacturer, not 

later than 41 25 ⁄2 years after the date of enactment of 
230 

†S 3187 ES

1 the Securing Pharmaceutical Distribution Integrity 

2 Act of 2012 and in accordance with this section, 

3 shall— 

4 ‘‘(A) apply RxTEC to the individual sale5 able units and homogeneous case of all products 

6 intended to be introduced into interstate com7 merce; 

8 ‘‘(B) maintain change of ownership and 

9 transaction information, including RxTEC data 

10 that associate unit and lot level data for each 

11 individual saleable unit of product and homoge12 nous case introduced in interstate commerce; 

13 and 

14 ‘‘(C) maintain, where a change of owner15 ship has occurred between non-affiliated entities 

16 or, in the case of a return from the immediate 

17 previous source, change of ownership and trans18 action information relating to a product, includ19 ing— 

20 ‘‘(i) RxTEC data; 

21 ‘‘(ii) the business name and address 

22 of the immediate previous source, if appli23 cable, and the immediate subsequent re24 cipient of the product; 
231 

†S 3187 ES

1 ‘‘(iii) the proprietary or established 

2 name or names of the product; 

3 ‘‘(iv) the National Drug Code number 

4 of the product; 

5 ‘‘(v) container size; 

6 ‘‘(vi) number of containers; 

7 ‘‘(vii) the lot number or numbers of 

8 the product; and 

9 ‘‘(viii) the date of the transaction; 

10 ‘‘(D) provide the following change of own11 ership and trans action information to the im12 mediate subsequent recipient of such product— 

13 ‘‘(i) the proprietary or established 

14 name or names of the product; 

15 ‘‘(ii) the National Drug Code number 

16 of the product; 

17 ‘‘(iii) container size; 

18 ‘‘(iv) number of containers; 

19 ‘‘(v) the lot number or numbers of the 

20 product; and 

21 ‘‘(vi) a signed statement that the 

22 manufacturer did not knowingly and inten23 tionally adulterate or knowingly and inten24 tionally counterfeit such product; and 
232 

†S 3187 ES

1 ‘‘(E) upon request by the Secretary, other 

2 appropriate Federal official, or State official, in 

3 the event of a recall or as determined necessary 

4 by the Secretary, or such other Federal or 

5 State official, to investigate a suspect product, 

6 provide in a reasonable time and in a reason7 able manner— 

8 ‘‘(i) RxTEC data by lot; and 

9 ‘‘(ii) change of ownership and trans10 action information pursuant to subpara11 graphs (C) and (D) necessary to identify 

12 the immediate previous source or imme13 diate subsequent recipient of such product, 

14 as applicable. 

15 ‘‘(2) VERIFICATION REQUIREMENTS.—A manufacturer, not later than 41 16 ⁄2 years after the date of 

17 enactment of the Securing Pharmaceutical Distribu18 tion Integrity Act of 2012 and in accordance with 

19 this section, shall— 

20 ‘‘(A) utilize RxTEC data at the lot level, 

21 as part of ongoing activities to significantly 

22 minimize or prevent the incidences of a suspect 

23 product in the pharmaceutical distribution sup24 ply chain, as applicable and appropriate, 

25 which— 
233 

†S 3187 ES

1 ‘‘(i) may include responding to an 

2 alert regarding a suspect product from a 

3 trading partner or the Secretary, routine 

4 monitoring of a suspect product at the lot 

5 level while such product is in the posses6 sion of the manufacturer, and checking in7 ventory for a suspect product at the re8 quest of a trading partner or the Secretary 

9 in case of returns; and 

10 ‘‘(ii) shall take into consideration— 

11 ‘‘(I) the likelihood that a par12 ticular product has a high potential 

13 risk with respect to pharmaceutical 

14 distribution supply chain security; 

15 ‘‘(II) the history and severity of 

16 incidences of counterfeit, diversion, 

17 and theft of such product; 

18 ‘‘(III) the point in the pharma19 ceutical distribution supply chain 

20 where counterfeit, diversion, or theft 

21 has occurred or is most likely to 

22 occur; 

23 ‘‘(IV) the likelihood that such ac24 tivities will reduce the possibility of 
234 

†S 3187 ES

1 the counterfeit, diversion, and theft of 

2 such product; 

3 ‘‘(V) whether the product could 

4 mitigate or prevent a drug shortage as 

5 defined in section 506C; and 

6 ‘‘(VI) any guidance the Secretary 

7 issues regarding high-risk scenarios 

8 that could increase the risk of a sus9 pect product entering the pharma10 ceutical distribution supply chain; and 

11 ‘‘(B) conduct unit level verification upon 

12 the request of a licensed or registered repack13 ager, wholesale distributor, dispenser, or the 

14 Secretary, regarding such product. 

15 ‘‘(3) NOTIFICATION OF PRODUCT REMOVAL.— 

‘‘(A) IN GENERAL.—Not later than 41 16 ⁄2

17 years after the date of enactment of the Secur18 ing Pharmaceutical Distribution Integrity Act 

19 of 2012 and in accordance with this section, a 

20 manufacturer, upon confirming that a product 

21 does not have the standardized numerical iden22 tifier or lot number, consistent with this sec23 tion, and expiration date assigned by the manu24 facturer, or has the appearance of being a coun25 terfeit, diverted, or stolen product, or a product 
235 

†S 3187 ES

1 otherwise unfit for distribution such that the 

2 product would result in serious adverse health 

3 consequences or death to humans, shall— 

4 ‘‘(i) promptly notify the Secretary and 

5 impacted trading partners, as applicable 

6 and appropriate; and 

7 ‘‘(ii) take steps to remove such prod8 uct from the pharmaceutical distribution 

9 supply chain. 

10 ‘‘(B) REDISTRIBUTION.—Any product sub11 ject to a notification under this subsection may 

12 not be redistributed as a saleable product un13 less the manufacturer, in consultation with the 

14 Secretary, determines such product may reenter 

15 the pharmaceutical distribution supply chain. 

16 ‘‘(4) LIMITATION.—Nothing in this section 

17 shall require a manufacturer to aggregate unit level 

18 data to cases or pallets. 

19 ‘‘(b) REPACKAGER REQUIREMENTS.— 

20 ‘‘(1) PRODUCT TRACING.—A repackager, not 

later than 51 21 ⁄2 years after the date of enactment of 

22 the Securing Pharmaceutical Distribution Integrity 

23 Act of 2012 and in accordance with this section, 

24 shall— 
236 

†S 3187 ES

1 ‘‘(A) apply RxTEC to the individual sale2 able unit and the homogenous case of all prod3 uct intended to be introduced into interstate 

4 commerce; 

5 ‘‘(B) maintain change of ownership and 

6 transaction information, including RxTEC data, 

7 that associate unit and lot level data for each 

8 individual saleable unit of product and each ho9 mogenous case of product introduced in inter10 state commerce, including RxTEC data received 

11 for such products and for which a repackager 

12 applies a new RxTEC; 

13 ‘‘(C) receive only products encoded with 

14 RxTEC data from a licensed or registered man15 ufacturer or wholesaler; 

16 ‘‘(D) maintain, where a change of owner17 ship has occurred between non-affiliated entities 

18 in wholesale distribution, change of ownership 

19 and transaction information relating to a prod20 uct, including— 

21 ‘‘(i) RxTEC data; 

22 ‘‘(ii) the business name and address 

23 of the immediate previous source and the 

24 immediate subsequent recipient of the 

25 product; 
237 

†S 3187 ES

1 ‘‘(iii) the proprietary or established 

2 name or names of the product; 

3 ‘‘(iv) the National Drug Code number 

4 of the product; 

5 ‘‘(v) container size; 

6 ‘‘(vi) number of containers; 

7 ‘‘(vii) the lot number or numbers of 

8 the product; and 

9 ‘‘(viii) the date of the transaction; 

10 ‘‘(E) provide the following change of own11 ership and transaction information to the im12 mediate subsequent recipient of such product— 

13 ‘‘(i) the proprietary or established 

14 name or names of the product; 

15 ‘‘(ii) the National Drug Code number 

16 of the product; 

17 ‘‘(iii) container size; 

18 ‘‘(iv) number of containers; 

19 ‘‘(v) the lot number or numbers of the 

20 product; and 

21 ‘‘(vi) a signed statement that the re22 packager— 

23 ‘‘(I) is licensed or registered; 
238 

†S 3187 ES

1 ‘‘(II) received the product from a 

2 manufacturer that is licensed or reg3 istered; 

4 ‘‘(III) received a signed state5 ment from the manufacturer of such 

6 product consistent with subsection 

7 (a)(1)(D)(vi); and 

8 ‘‘(IV) did not knowingly and in9 tentionally adulterate or knowingly 

10 and intentionally counterfeit such 

11 product; and 

12 ‘‘(F) upon request by the Secretary, other 

13 appropriate Federal official, or State official, in 

14 the event of a recall, or as determined necessary 

15 by the Secretary or such other Federal or State 

16 official to investigate a suspect product, provide 

17 in a reasonable time and in a reasonable man18 ner— 

19 ‘‘(i) RxTEC data by lot; and 

20 ‘‘(ii) change of ownership and trans21 action information pursuant to subpara22 graph (C) or (E) necessary to identify the 

23 immediate previous source or the imme24 diate subsequent recipient of such product, 

25 as applicable. 
239 

†S 3187 ES

1 ‘‘(2) VERIFICATION REQUIREMENTS.—A repackager, not later than 51 2 ⁄2 years after the date of 

3 enactment of the Securing Pharmaceutical Distribu4 tion Integrity Act of 2012 and in accordance with 

5 this section, shall— 

6 ‘‘(A) utilize RxTEC data at the lot level, 

7 as part of ongoing activities to significantly 

8 minimize or prevent the incidences of suspect 

9 product in the pharmaceutical distribution sup10 ply chain, as applicable and appropriate, 

11 which— 

12 ‘‘(i) may include— 

13 ‘‘(I) responding to alerts regard14 ing a suspect product from a trading 

15 partner or the Secretary, routine mon16 itoring of a suspect product at the lot 

17 level while such product is in the pos18 session of the repackager; and 

19 ‘‘(II) checking inventory for a 

20 suspect product at the request of a 

21 trading partner or the Secretary in 

22 the case of returns; and 

23 ‘‘(ii) shall take into consideration— 

24 ‘‘(I) the likelihood that a par25 ticular product has a high potential 
240 

†S 3187 ES

1 risk with respect to pharmaceutical 

2 distribution supply chain security; 

3 ‘‘(II) the history and severity of 

4 incidences of counterfeit, diversion, 

5 and theft of such product; 

6 ‘‘(III) the point in the pharma7 ceutical distribution supply chain 

8 where counterfeit, diversion, and theft 

9 has occurred or is most likely to 

10 occur; 

11 ‘‘(IV) the likelihood that such ac12 tivities will reduce the possibility of 

13 counterfeit, diversion, and theft of 

14 such product; 

15 ‘‘(V) whether the product could 

16 mitigate or prevent a drug shortage as 

17 defined in section 506C; and 

18 ‘‘(VI) any guidance the Secretary 

19 issues regarding high-risk scenarios 

20 that could increase the risk of a sus21 pect product entering the pharma22 ceutical distribution supply chain; and 

23 ‘‘(B) conduct unit level verification upon 

24 the request of a licensed or registered manufac-
241 

†S 3187 ES

1 turer, wholesale distributor, dispenser, or the 

2 Secretary, regarding such product. 

3 ‘‘(3) NOTIFICATION AND PRODUCT REMOVAL.— 

‘‘(A) IN GENERAL.—Not later than 51 4 ⁄2

5 years after the date of enactment of the Secur6 ing Pharmaceutical Distribution Integrity Act 

7 of 2012 and in accordance with this section, a 

8 repackager, upon confirming that a product 

9 does not have the standardized numerical iden10 tifier or lot number, consistent with this sec11 tion, and expiration date assigned by the manu12 facturer, or has the appearance of being a coun13 terfeit, diverted, or stolen product, or a product 

14 otherwise unfit for distribution such that it 

15 would result in serious adverse health con16 sequences or death to humans, shall— 

17 ‘‘(i) promptly notify the Secretary and 

18 impacted trading partners, as applicable 

19 and appropriate; and 

20 ‘‘(ii) take steps to remove such prod21 uct from the pharmaceutical distribution 

22 supply chain. 

23 ‘‘(B) REDISTRIBUTION.—Any product sub24 ject to a notification under this subsection may 

25 not be redistributed as a saleable product un-
242 

†S 3187 ES

1 less the repackager, in consultation with the 

2 Secretary, and manufacturer as applicable, de3 termines such product may reenter the pharma4 ceutical distribution supply chain. 

5 ‘‘(4) LIMITATION.—Nothing in this section 

6 shall require a repackager to aggregate unit level 

7 data to cases or pallets. 

8 ‘‘(c) WHOLESALE DISTRIBUTOR REQUIREMENTS.— 

9 ‘‘(1) PRODUCT TRACING REQUIREMENTS.—A 

10 wholesale distributor engaged in wholesale distribution, not later than 61 11 ⁄2 years after the date of en12 actment of the Securing Pharmaceutical Distribu13 tion Integrity Act of 2012 and in accordance with 

14 this section, shall— 

15 ‘‘(A) receive only products encoded with 

16 RxTEC from a licensed or registered manufac17 turer, wholesaler, or repackager; 

18 ‘‘(B) maintain, in wholesale distribution 

19 where a change of ownership has occurred be20 tween non-affiliated entities, change of owner21 ship and transaction information, including— 

22 ‘‘(i) RxTEC data by lot; 

23 ‘‘(ii) the business name and address 

24 of the immediate previous source and the 
243 

†S 3187 ES

1 immediate subsequent recipient of the 

2 product; 

3 ‘‘(iii) the proprietary or established 

4 name or names of the product; 

5 ‘‘(iv) the National Drug Code number 

6 of the product; 

7 ‘‘(v) container size; 

8 ‘‘(vi) number of containers; 

9 ‘‘(vii) the lot number or numbers of 

10 the product; and 

11 ‘‘(viii) the date of the transaction; 

12 ‘‘(C) provide the following change of own13 ership and transaction information to the im14 mediate subsequent recipient of such product— 

15 ‘‘(i) the proprietary or established 

16 name or names of the product; 

17 ‘‘(ii) the National Drug Code number 

18 of the product; 

19 ‘‘(iii) container size; 

20 ‘‘(iv) number of containers; 

21 ‘‘(v) the lot number or numbers of the 

22 product; 

23 ‘‘(vi) the date of the transaction; and 

24 ‘‘(vii) a signed statement that the 

25 wholesale distributor— 
244 

†S 3187 ES

1 ‘‘(I) is licensed or registered; 

2 ‘‘(II) received the product from a 

3 registered or licensed manufacturer, 

4 repackager, or wholesale distributor, 

5 as applicable; 

6 ‘‘(III) received a signed state7 ment from the immediate subsequent 

8 recipient of such product that such 

9 trading partner did not knowingly and 

10 intentionally adulterate or knowingly 

11 and intentionally counterfeit such 

12 product; and 

13 ‘‘(IV) did not knowingly and in14 tentionally adulterate or knowingly 

15 and intentionally counterfeit such 

16 product; and 

17 ‘‘(D) upon request by the Secretary, other 

18 appropriate Federal official, or State official, in 

19 the event of a recall, return, or as determined 

20 necessary by the Secretary, or such other Fed21 eral or State official, to investigate a suspect 

22 product, provide in a reasonable time and in a 

23 reasonable manner— 

24 ‘‘(i) RxTEC data by lot; and 
245 

†S 3187 ES

1 ‘‘(ii) change of ownership and trans2 action information pursuant to subpara3 graphs (B) and (C), as necessary to iden4 tify the immediate previous source or the 

5 immediate subsequent recipient of such 

6 product. 

7 ‘‘(2) VERIFICATION REQUIREMENTS.— 

8 ‘‘(A) IN GENERAL.—A wholesale dis9 tributor engaged in wholesale distribution, not 

later than 61 10 ⁄2 years after the date of enact11 ment of the Securing Pharmaceutical Distribu12 tion Integrity Act of 2012 and in accordance 

13 with this section, shall— 

14 ‘‘(i) utilize RxTEC data at the lot 

15 level, as part of ongoing activities to sig16 nificantly minimize or prevent the inci17 dence of suspect product in the pharma18 ceutical distribution supply chain, as appli19 cable and appropriate, which— 

20 ‘‘(I) may include responding to 

21 an alert regarding a suspect product 

22 from a trading partner or the Sec23 retary, routine monitoring of a sus24 pect product at the lot level while 

25 such product is in the possession of 
246 

†S 3187 ES

1 the wholesale distributor, and check2 ing inventory for a suspect product at 

3 the request of a trading partner or 

4 the Secretary; and 

5 ‘‘(II) shall take into consider6 ation— 

7 ‘‘(aa) the likelihood that a 

8 particular product has a high po9 tential risk with respect to phar10 maceutical distribution supply 

11 chain security; 

12 ‘‘(bb) the history and sever13 ity of incidences of counterfeit, 

14 diversion, and theft of such prod15 uct; 

16 ‘‘(cc) the point in the phar17 maceutical distribution supply 

18 chain where counterfeit, diver19 sion, and theft has occurred or is 

20 most likely to occur; 

21 ‘‘(dd) the likelihood that 

22 such activities will reduce the 

23 possibility of counterfeit, diver24 sion, and theft of such product; 
247 

†S 3187 ES

1 ‘‘(ee) whether the product 

2 could mitigate or prevent a drug 

3 shortage as defined in section 

4 506C; and 

5 ‘‘(ff) any guidance the Sec6 retary issues regarding high-risk 

7 scenarios that could increase the 

8 risk of suspect product entering 

9 the pharmaceutical distribution 

10 supply chain; 

11 ‘‘(ii) conduct lot-level verification in 

12 the event of a recall, including upon the re13 quest of a licensed or registered manufac14 turer, repackager, dispenser, or the Sec15 retary, regarding such product and recall; 

16 ‘‘(iii) conduct verification of a re17 turned product to validate the return at 

18 the lot level for a sealed homogenous case 

19 of such product or at the individual sale20 able unit of such product if the unit is not 

21 in a sealed homogenous case; and 

22 ‘‘(iv) conduct unit level verification of 

23 a suspect product— 

24 ‘‘(I) upon the request of a li25 censed or registered manufacturer, re-
248 

†S 3187 ES

1 packager, wholesaler, dispenser, or the 

2 Secretary, regarding such product; or 

3 ‘‘(II) upon the determination 

4 that a product is a suspect product. 

5 ‘‘(B) LIMITATION.—Nothing in this para6 graph shall require a wholesale distributor to 

7 verify product at the unit level except as re8 quired under clauses (iii) and (iv) of subpara9 graph (A). 

10 ‘‘(3) NOTIFICATION AND PRODUCT REMOVAL.— 

‘‘(A) IN GENERAL.—Not later than 61 11 ⁄2

12 years after the date of enactment of the Secur13 ing Pharmaceutical Distribution Integrity Act 

14 of 2012 and in accordance with this section, a 

15 wholesale distributor, upon confirming that a 

16 product does not have the standardized numer17 ical identifier or lot number, consistent with 

18 this section, and expiration date assigned by the 

19 manufacturer, or has the appearance of being a 

20 counterfeit, diverted, or stolen product, or a 

21 product otherwise unfit for distribution such 

22 that the product would result in serious adverse 

23 health consequences or death to humans, 

24 shall— 
249 

†S 3187 ES

1 ‘‘(i) promptly notify the Secretary and 

2 impacted trading partners, as applicable 

3 and appropriate; and 

4 ‘‘(ii) take steps to remove such prod5 uct from the pharmaceutical distribution 

6 supply chain. 

7 ‘‘(B) REDISTRIBUTION.—Any product sub8 ject to a notification under this subsection may 

9 not be redistributed as a saleable product un10 less the wholesaler, in consultation with the 

11 Secretary, and manufacturer or repackager as 

12 applicable, determines such product may reen13 ter the pharmaceutical distribution supply 

14 chain. 

15 ‘‘(C) CONFIDENTIAL DATA.—A wholesale 

16 distributor may confidentially maintain RxTEC 

17 data for a direct trading partner and provide 

18 access to such information to such trading part19 ner in lieu of data transmission, if mutually 

20 agreed upon by such trading partners. 

21 ‘‘(d) DISPENSER REQUIREMENTS.— 

22 ‘‘(1) PRODUCT TRACING REQUIREMENTS.—A 

dispenser, not later than 71 23 ⁄2 years after the date of 

24 enactment of the Securing Pharmaceutical Distribu-
250 

†S 3187 ES

1 tion Integrity Act of 2012 and in accordance with 

2 this section, shall— 

3 ‘‘(A) receive product only from a licensed 

4 or registered manufacturer, repackager, or 

5 wholesale distributor; 

6 ‘‘(B) receive only products encoded with 

7 RxTEC lot level data from a manufacturer, re8 packager, or wholesale distributor selling the 

9 drug product to the dispenser; 

10 ‘‘(C) maintain RxTEC lot level data or 

11 allow the wholesale distributor to confidentially 

12 maintain and store the RxTEC lot level data 

13 sufficient to identify the product provided to the 

14 dispenser from the immediate previous source 

15 where a change of ownership has occurred be16 tween non-affiliated entities (if such arrange17 ment is mutually agreed upon by the dispenser 

18 and the wholesale distributor); 

19 ‘‘(D) use the RxTEC lot level data main20 tained by the dispenser or maintained by the 

21 wholesale distributor on behalf of the dispenser 

22 (if such arrangement is mutually agreed upon 

23 by the dispenser and the wholesale distributor), 

24 as necessary to respond to a request from the 
251 

†S 3187 ES

1 Secretary in the event of a suspect product or 

2 recall; 

3 ‘‘(E) maintain lot level data upon change 

4 of ownership between non-affiliated entities and 

5 for recalled product; and 

6 ‘‘(F) for investigation purposes only, and 

7 upon request by the Secretary, other appro8 priate Federal official, or State official, for the 

9 purpose of investigating a suspect or recalled 

10 product, provide the RxTEC data by lot and 

11 the immediate previous source or immediate 

12 subsequent receipt of the suspect or recalled 

13 product, as applicable. 

14 ‘‘(2) VERIFICATION REQUIREMENTS.—Not later 

than 71 15 ⁄2 years after the date of enactment of the 

16 Securing Pharmaceutical Distribution Integrity Act 

17 of 2012 and in accordance with this section, a dis18 penser shall be required to conduct lot level 

19 verification of suspect product only. 

20 ‘‘(3) NOTIFICATION AND PRODUCT REMOVAL.— 

‘‘(A) IN GENERAL.—Not later than 71 21 ⁄2

22 years after the date of enactment of the Secur23 ing Pharmaceutical Distribution Integrity Act 

24 of 2012 and in accordance with this section, a 

25 dispenser, upon confirming that a product is a 
252 

†S 3187 ES

1 suspect product or a product otherwise unfit for 

2 distribution, shall— 

3 ‘‘(i) promptly notify the Secretary and 

4 impacted trading partners, as applicable 

5 and appropriate; and 

6 ‘‘(ii) take steps to remove such prod7 uct from the pharmaceutical distribution 

8 supply chain. 

9 ‘‘(B) REDISTRIBUTION.—Any product sub10 ject to a notification under this paragraph may 

11 not be redistributed as a saleable product un12 less the dispenser, in consultation with the Sec13 retary, and manufacturer, repackager, or whole14 saler as applicable, determines such product 

15 may reenter the pharmaceutical distribution 

16 supply chain. 

17 ‘‘(C) LIMITATIONS.—Nothing in this sec18 tion shall— 

19 ‘‘(i) require a dispenser to verify prod20 uct at the unit level; or 

21 ‘‘(ii) require a dispenser to adopt spe22 cific technologies or business systems for 

23 compliance with this section. 

24 ‘‘(e) ENSURING FLEXIBILITY.—The requirements 

25 under this section shall— 
253 

†S 3187 ES

1 ‘‘(1) require the maintenance and transmission 

2 only of information that is reasonably available and 

3 appropriate; 

4 ‘‘(2) be based on current scientific and techno5 logical capabilities and shall neither require nor re6 strict the use of additional data carrier technologies; 

7 ‘‘(3) not prescribe or proscribe specific tech8 nologies or systems for the maintenance and trans9 mission of data other than the standard data carrier 

10 for RxTEC or specific methods of verification; 

11 ‘‘(4) not require a record of the complete pre12 vious distribution history of the drug from the point 

13 of origin of such drug; 

14 ‘‘(5) take into consideration whether the public 

15 health benefits of imposing any additional regula16 tions outweigh the cost of compliance with such re17 quirements; 

18 ‘‘(6) be scale-appropriate and practicable for 

19 entities of varying sizes and capabilities; 

20 ‘‘(7) with respect to cost and recordkeeping 

21 burdens, not require the creation and maintenance 

22 of duplicative records where the information is con23 tained in other company records kept in the normal 

24 course of business; 
254 

†S 3187 ES

1 ‘‘(8) to the extent practicable, not require spe2 cific business systems for compliance with such re3 quirements; 

4 ‘‘(9) include a process by which the Secretary 

5 may issue a waiver of such regulations for an indi6 vidual entity if the Secretary determines that such 

7 requirements would result in an economic hardship 

8 or for emergency medical reasons, including a public 

9 health emergency declaration pursuant to section 

10 319 of the Public Health Service Act; and 

11 ‘‘(10) include a process by which the Secretary 

12 may determine exceptions to the standard data car13 rier RxTEC requirement if a drug is packaged in a 

14 container too small or otherwise unable to accommo15 date a label with sufficient space to bear the infor16 mation required for compliance with this section. 

17 ‘‘(f) REGULATIONS AND GUIDANCE.— 

18 ‘‘(1) IN GENERAL.—The Secretary may issue 

19 guidance consistent with this section regarding the 

20 circumstances surrounding suspect product and 

21 verification practices. 

22 ‘‘(2) PROCEDURE.—The Secretary, in promul23 gating any regulation pursuant to this section, 

24 shall— 
255 

†S 3187 ES

1 ‘‘(A) issue a notice of proposed rulemaking 

2 that includes a copy of the proposed regulation; 

3 ‘‘(B) provide a period of not less than 60 

4 days for comments on the proposed regulation; 

5 and 

6 ‘‘(C) publish the final regulation not less 

7 than 30 days before the effective date of the 

8 regulation. 

9 ‘‘(3) RESTRICTIONS.—Notwithstanding any 

10 other provision of law, the Secretary shall promul11 gate regulations implementing this section only as 

12 described in paragraph (2). 

13 ‘‘(g) STANDARDS.—The Secretary shall, in consulta14 tion with other appropriate Federal officials, manufactur15 ers, repackagers, wholesale distributors, dispensers, and 

16 other supply chain stakeholders, prioritize and develop 

17 standards for the interoperable exchange of ownership and 

18 transaction information for tracking and tracing prescrip19 tion drugs.’’. 

20 (b) PROHIBITED ACT.—Section 301 (21 U.S.C. 331), 

21 as amended by section 712, is further amended by insert22 ing at the end the following: 

23 ‘‘(bbb) The violation of any requirement under sec24 tion 582.’’. 
256 

†S 3187 ES

1 (c) SMALL ENTITY COMPLIANCE GUIDE.—Not later 

2 than 180 days after enactment of this Act, the Secretary 

3 of Health and Human Services (referred to in this title 

4 as the ‘‘Secretary’’) shall issue a compliance guide setting 

5 forth in plain language the requirements under section 

6 582 of the Federal Food, Drug, and Cosmetic Act, as 

7 added by subsection (a), in order to assist small entities 

8 in complying with such section. 

9 (d) LIMITATIONS.— 

10 (1) SAVINGS CLAUSE.—Nothing in this subtitle 

11 or the amendments made by this subtitle shall pre12 empt any State or local law or regulation. 

13 (2) EFFECT ON CALIFORNIA LAW.—Notwith14 standing any other provision of Federal or State 

15 law, including any provision of this subtitle or of 

16 subchapter H of chapter V of the Federal Food, 

17 Drug, and Cosmetic Act, as added by subsection (a), 

18 such subchapter H shall not trigger California Busi19 ness and Professions Code, section 4034.1. 

20 (3) EFFECTIVE DATE.—Subsection (c) and the 

21 amendments made by subsections (a) and (b) shall 

22 take effect on January 1, 2022, or on the date on 

23 which Congress enacts a law providing for express 

24 preemption of any State law regulating the distribu25 tion of drugs, whichever is later. 
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1 SEC. 723. INDEPENDENT ASSESSMENT. 

2 (a) IN GENERAL.—The Secretary shall contract with 

3 a private, independent consulting firm capable of per4 forming the technical analysis, management assessment, 

5 and program evaluation tasks required to conduct a com6 prehensive assessment of the process for the review of 

7 drug applications under subsections (b) and (j) of section 

8 505 of the Federal Food, Drug, and Cosmetic Act (21 

9 U.S.C. 355(b), (j)) and subsections (a) and (k) of section 

10 351 of the Public Health Service Act (42 U.S.C. 262(a), 

11 (k)). The assessment shall address the premarket review 

12 process of drugs by the Food and Drug Administration, 

13 using an assessment framework that draws from appro14 priate quality system standards, including management 

15 responsibility, documents controls and records manage16 ment, and corrective and preventive action. 

17 (b) PARTICIPATION.—Representatives of the Food 

18 and Drug Administration and manufacturers of drugs 

19 subject to user fees under part 2 of subchapter C of chap20 ter VII of the Federal Food, Drug, and Cosmetic Act (21 

21 U.S.C. 379g et seq.) shall participate in a comprehensive 

22 assessment of the process for the review of drug applica23 tions under section 505 of the Federal Food, Drug, and 

24 Cosmetic Act and section 351 of the Public Health Service 

25 Act. The assessment shall be conducted in phases. 
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1 (c) FIRST CONTRACT.—The Secretary shall award 

2 the contract for the first assessment under this section 

3 not later than March 31, 2013. Such contractor shall 

4 evaluate the implementation of recommendations and pub5 lish a written assessment not later than February 1, 2016. 

6 (d) FINDINGS AND RECOMMENDATIONS.— 

7 (1) IN GENERAL.—The Secretary shall publish 

8 the findings and recommendations under this section 

9 that are likely to have a significant impact on review 

10 times not later than 6 months after the contract is 

11 awarded. Final comprehensive findings and rec12 ommendations shall be published not later than 1 

13 year after the contract is awarded. 

14 (2) IMPLEMENTATION PLAN.—The Food and 

15 Drug Administration shall publish an implementa16 tion plan not later than 6 months after the date of 

17 receipt of each set of recommendation. 

18 (e) SCOPE OF ASSESSMENT.—The assessment under 

19 this section shall include the following: 

20 (1) Identification of process improvements and 

21 best practices for conducting predictable, efficient, 

22 and consistent premarket reviews that meet regu23 latory review standards. 
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1 (2) Analysis of elements of the review process 

2 that consume or save time to facilitate a more effi3 cient process. Such analysis shall include— 

4 (A) consideration of root causes for ineffi5 ciencies that may affect review performance and 

6 total time to decision; 

7 (B) recommended actions to correct any 

8 failures to meet user fee program goals; and 

9 (C) consideration of the impact of com10 bination products on the review process. 

11 (3) Assessment of methods and controls of the 

12 Food and Drug Administration for collecting and re13 porting information on premarket review process re14 source use and performance. 

15 (4) Assessment of effectiveness of the reviewer 

16 training program of the Food and Drug Administra17 tion. 

18 (5) Recommendations for ongoing periodic as19 sessments and any additional, more detailed or fo20 cused assessments. 

21 (f) REQUIREMENTS.—The Secretary shall— 

22 (1) analyze the recommendations for improve23 ment opportunities identified in the assessment, de24 velop and implement a corrective action plan, and 

25 ensure it effectiveness; 
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1 (2) incorporate the findings and recommenda2 tions of the contractors, as appropriate, into the 

3 management of the premarket review program of the 

4 Food and Drug Administration; and 

5 (3) incorporate the results of the assessment in 

6 a Good Review Management Practices guidance doc7 ument, which shall include initial and ongoing train8 ing of Food and Drug Administration staff, and 

9 periodic audits of compliance with the guidance. 

10 TITLE VIII—GENERATING 

11 ANTIBIOTIC INCENTIVES NOW 

12 SEC. 801. EXTENSION OF EXCLUSIVITY PERIOD FOR DRUGS. 

13 (a) IN GENERAL.—Chapter V (21 U.S.C. 351 et seq.) 

14 is amended by inserting after section 505D the following: 

15 ‘‘SEC. 505E. EXTENSION OF EXCLUSIVITY PERIOD FOR NEW 

16 QUALIFIED INFECTIOUS DISEASE PRODUCTS. 

17 ‘‘(a) EXTENSION.—If the Secretary approves an ap18 plication pursuant to section 505 for a drug that has been 

19 designated as a qualified infectious disease product under 

20 subsection (d), the 4- and 5-year periods described in sub21 sections (c)(3)(E)(ii) and (j)(5)(F)(ii) of section 505, the 

22 3-year periods described in clauses (iii) and (iv) of sub23 section (c)(3)(E) and clauses (iii) and (iv) of subsection 

24 (j)(5)(F) of section 505, or the 7-year period described 

25 in section 527, as applicable, shall be extended by 5 years. 
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1 ‘‘(b) RELATION TO PEDIATRIC EXCLUSIVITY.—Any 

2 extension under subsection (a) of a period shall be in addi3 tion to any extension of the period under section 505A 

4 with respect to the drug. 

5 ‘‘(c) LIMITATIONS.—Subsection (a) does not apply to 

6 the approval of— 

7 ‘‘(1) a supplement to an application under sec8 tion 505(b) for any qualified infectious disease prod9 uct for which an extension described in subsection 

10 (a) is in effect or has expired; 

11 ‘‘(2) a subsequent application filed with respect 

12 to a product approved under section 505 for a 

13 change that results in a new indication, route of ad14 ministration, dosing schedule, dosage form, delivery 

15 system, delivery device, or strength; or 

16 ‘‘(3) an application for a product that is not ap17 proved for the use for which it received a designa18 tion under subsection (d). 

19 ‘‘(d) DESIGNATION.— 

20 ‘‘(1) IN GENERAL.—The manufacturer or spon21 sor of a drug may request the Secretary to designate 

22 a drug as a qualified infectious disease product at 

23 any time before the submission of an application 

24 under section 505(b) for such drug. The Secretary 

25 shall, not later than 60 days after the submission of 
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1 such a request, determine whether the drug is a 

2 qualified infectious disease product. 

3 ‘‘(2) LIMITATION.—Except as provided in para4 graph (3), a designation under this subsection shall 

5 not be withdrawn for any reason, including modifica6 tions to the list of qualifying pathogens under sub7 section (f)(2)(C). 

8 ‘‘(3) REVOCATION OF DESIGNATION.—The Sec9 retary may revoke a designation of a drug as a 

10 qualified infectious disease product if the Secretary 

11 finds that the request for such designation contained 

12 an untrue statement of material fact. 

13 ‘‘(e) REGULATIONS.— 

14 ‘‘(1) IN GENERAL.—Not later than 2 years 

15 after the date of enactment of the Food and Drug 

16 Administration Safety and Innovation Act, the Sec17 retary shall adopt final regulations implementing 

18 this section. 

19 ‘‘(2) PROCEDURE.—In promulgating a regula20 tion implementing this section, the Secretary shall— 

21 ‘‘(A) issue a notice of proposed rulemaking 

22 that includes the proposed regulation; 

23 ‘‘(B) provide a period of not less than 60 

24 days for comments on the proposed regulation; 

25 and 
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1 ‘‘(C) publish the final regulation not less 

2 than 30 days before the effective date of the 

3 regulation. 

4 ‘‘(3) RESTRICTIONS.—Notwithstanding any 

5 other provision of law, the Secretary shall promul6 gate regulations implementing this section only as 

7 described in paragraph (2), except that the Sec8 retary may issue interim guidance for sponsors seek9 ing designation under subsection (d) prior to the 

10 promulgation of such regulations. 

11 ‘‘(4) DESIGNATION PRIOR TO REGULATIONS.— 

12 The Secretary may designate drugs as qualified in13 fectious disease products under subsection (d) prior 

14 to the promulgation of regulations under this sub15 section. 

16 ‘‘(f) QUALIFYING PATHOGEN.— 

17 ‘‘(1) DEFINITION.—In this section, the term 

18 ‘qualifying pathogen’ means a pathogen identified 

19 and listed by the Secretary under paragraph (2) that 

20 has the potential to pose a serious threat to public 

21 health, such as— 

22 ‘‘(A) resistant gram positive pathogens, in23 cluding methicillin-resistant Staphylococcus 

24 aureus, vancomycin-resistant Staphylococcus 

25 aureus, and vancomycin-resistant enterococcus; 
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1 ‘‘(B) multi-drug resistant gram negative 

2 bacteria, including Acinetobacter, Klebsiella, 

3 Pseudomonas, and E. coli species; 

4 ‘‘(C) multi-drug resistant tuberculosis; and 

5 ‘‘(D) Clostridium difficile. 

6 ‘‘(2) LIST OF QUALIFYING PATHOGENS.— 

7 ‘‘(A) IN GENERAL.—The Secretary shall 

8 establish and maintain a list of qualifying 

9 pathogens, and shall make public the method10 ology for developing such list. 

11 ‘‘(B) CONSIDERATIONS.—In establishing 

12 and maintaining the list of pathogens described 

13 under this section the Secretary shall— 

14 ‘‘(i) consider— 

15 ‘‘(I) the impact on the public 

16 health due to drug-resistant orga17 nisms in humans; 

18 ‘‘(II) the rate of growth of drug19 resistant organisms in humans; 

20 ‘‘(III) the increase in resistance 

21 rates in humans; and 

22 ‘‘(IV) the morbidity and mor23 tality in humans; and 

24 ‘‘(ii) consult with experts in infectious 

25 diseases and antibiotic resistance, includ-
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1 ing the Centers for Disease Control and 

2 Prevention, the Food and Drug Adminis3 tration, medical professionals, and the clin4 ical research community. 

5 ‘‘(C) REVIEW.—Every 5 years, or more 

6 often as needed, the Secretary shall review, pro7 vide modifications to, and publish the list of 

8 qualifying pathogens under subparagraph (A) 

9 and shall by regulation revise the list as nec10 essary, in accordance with subsection (e). 

11 ‘‘(g) QUALIFIED INFECTIOUS DISEASE PRODUCT.— 

12 The term ‘qualified infectious disease product’ means an 

13 antibacterial or antifungal drug for human use intended 

14 to treat serious or life-threatening infections, including 

15 those caused by— 

16 ‘‘(1) an antibacterial or antifungal resistant 

17 pathogen, including novel or emerging infectious 

18 pathogens; or 

19 ‘‘(2) qualifying pathogens listed by the Sec20 retary under subsection (f).’’. 

21 (b) APPLICATION.—Section 505E of the Federal 

22 Food, Drug, and Cosmetic Act, as added by subsection 

23 (a), applies only with respect to a drug that is first ap24 proved under section 505(c) of such Act (21 U.S.C. 

25 355(c)) on or after the date of the enactment of this Act. 
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1 SEC. 802. PRIORITY REVIEW. 

2 (a) AMENDMENT.—Chapter V (21 U.S.C. 351 et 

3 seq.) is amended by inserting after section 524 the fol4 lowing: 

5 ‘‘SEC. 524A. PRIORITY REVIEW FOR QUALIFIED INFECTIOUS 

6 DISEASE PRODUCTS. 

7 ‘‘If the Secretary designates a drug under section 

8 505E(d) as a qualified infectious disease product, then the 

9 Secretary shall give priority review to any application sub10 mitted for approval for such drug under section 505(b).’’. 

11 (b) APPLICATION.—Section 524A of the Federal 

12 Food, Drug, and Cosmetic Act, as added by subsection 

13 (a), applies only with respect to an application that is sub14 mitted under section 505(b) of such Act (21 U.S.C. 

15 355(b)) on or after the date of the enactment of this Act. 

16 SEC. 803. FAST TRACK PRODUCT. 

17 Section 506(a)(1) (21 U.S.C. 356(a)(1)), as amended 

18 by section 901(b), is amended by inserting ‘‘, or if the 

19 Secretary designates the drug as a qualified infectious dis20 ease product under section 505E(d)’’ before the period at 

21 the end of the first sentence. 

22 SEC. 804. GAO STUDY. 

23 (a) IN GENERAL.—The Comptroller General of the 

24 United States shall— 

25 (1) conduct a study— 
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1 (A) on the need for, and public health im2 pact of, incentives to encourage the research, 

3 development, and marketing of qualified infec4 tious disease biological products and antifungal 

5 products; and 

6 (B) consistent with trade and confiden7 tiality data protections, assessing, for all anti8 bacterial and antifungal drugs, including bio9 logical products, the average or aggregate— 

10 (i) costs of all clinical trials for each 

11 phase; 

12 (ii) percentage of success or failure at 

13 each phase of clinical trials; and 

14 (iii) public versus private funding lev15 els of the trials for each phase; and 

16 (2) not later than 1 year after the date of en17 actment of this Act, submit a report to Congress on 

18 the results of such study, including any rec19 ommendations of the Comptroller General on appro20 priate incentives for addressing such need. 

21 (b) CONTENTS.—The part of the study described in 

22 subsection (a)(1)(A) shall include— 

23 (1) an assessment of any underlying regulatory 

24 issues related to qualified infectious disease prod-
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1 ucts, including qualified infectious disease biological 

2 products; 

3 (2) an assessment of the management by the 

4 Food and Drug Administration of the review of 

5 qualified infectious disease products, including quali6 fied infectious disease biological products and the 

7 regulatory certainty of related regulatory pathways 

8 for such products; 

9 (3) a description of any regulatory impediments 

10 to the clinical development of new qualified infec11 tious disease products, including qualified infectious 

12 disease biological products, and the efforts of the 

13 Food and Drug Administration to address such im14 pediments; and 

15 (4) recommendations with respect to— 

16 (A) improving the review and predictability 

17 of regulatory pathways for such products; and 

18 (B) overcoming any regulatory impedi19 ments identified in paragraph (3). 

20 (c) DEFINITIONS.—In this section: 

21 (1) The term ‘‘biological product’’ has the 

22 meaning given to such term in section 351 of the 

23 Public Health Service Act (42 U.S.C. 262). 

24 (2) The term ‘‘qualified infectious disease bio25 logical product’’ means a biological product intended 
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1 to treat a serious or life-threatening infection de2 scribed in section 505E(g) of the Federal Food, 

3 Drug, and Cosmetic Act, as added by section 801. 

4 (3) The term ‘‘qualified infectious disease prod5 uct’’ has the meaning given such term in section 

6 505E(g) of the Federal Food, Drug, and Cosmetic 

7 Act, as added by section 801. 

8 SEC. 805. CLINICAL TRIALS. 

9 (a) REVIEW AND REVISION OF GUIDANCE DOCU10 MENTS.— 

11 (1) IN GENERAL.—The Secretary of Health and 

12 Human Services (referred to in this section as the 

13 ‘‘Secretary’’) shall review and, as appropriate, revise 

14 not fewer than 3 guidance documents per year, 

15 which shall include— 

16 (A) reviewing the guidance documents of 

17 the Food and Drug Administration for the con18 duct of clinical trials with respect to anti19 bacterial and antifungal drugs; and 

20 (B) as appropriate, revising such guidance 

21 documents to reflect developments in scientific 

22 and medical information and technology and to 

23 ensure clarity regarding the procedures and re24 quirements for approval of antibacterial and 

25 antifungal drugs under chapter V of the Fed-
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1 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

2 351 et seq.). 

3 (2) ISSUES FOR REVIEW.—At a minimum, the 

4 review under paragraph (1) shall address the appro5 priate animal models of infection, in vitro tech6 niques, valid micro-biological surrogate markers, the 

7 use of non-inferiority versus superiority trials, trial 

8 enrollment, data requirements, and appropriate delta 

9 values for non-inferiority trials. 

10 (3) RULE OF CONSTRUCTION.—Except to the 

11 extent to which the Secretary makes revisions under 

12 paragraph (1)(B), nothing in this section shall be 

13 construed to repeal or otherwise effect the guidance 

14 documents of the Food and Drug Administration. 

15 (b) RECOMMENDATIONS FOR INVESTIGATIONS.— 

16 (1) REQUEST.—The sponsor of a drug intended 

17 to be designated as a qualified infectious disease 

18 product may request that the Secretary provide writ19 ten recommendations for nonclinical and clinical in20 vestigations which the Secretary believes may be 

21 necessary to be conducted with the drug before such 

22 drug may be approved under section 505 of the Fed23 eral Food, Drug, and Cosmetic Act (21 U.S.C. 355) 

24 for use in treating, detecting, preventing, or identi-
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1 fying a qualifying pathogen, as defined in section 

2 505E of such Act. 

3 (2) RECOMMENDATIONS.—If the Secretary has 

4 reason to believe that a drug for which a request is 

5 made under this subsection is a qualified infectious 

6 disease product, the Secretary shall provide the per7 son making the request written recommendations for 

8 the nonclinical and clinical investigations which the 

9 Secretary believes, on the basis of information avail10 able to the Secretary at the time of the request, 

11 would be necessary for approval under section 505 

12 of the Federal Food, Drug, and Cosmetic Act (21 

13 U.S.C. 355) of such drug for the use described in 

14 paragraph (1). 

15 (c) GAO STUDY.—Not later than January 1, 2016, 

16 the Comptroller General of the United States shall submit 

17 to Congress a report— 

18 (1) regarding the review and revision of the 

19 clinical trial guidance documents required under 

20 subsection (a) and the impact such review and revi21 sion has had on the review and approval of qualified 

22 infectious disease products; 

23 (2) assessing— 

24 (A) the effectiveness of the results-oriented 

25 metrics managers employ to ensure that review-
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1 ers of such products are familiar with, and con2 sistently applying, clinical trial guidance docu3 ments; and 

4 (B) the predictability of related regulatory 

5 pathways and review; 

6 (3) identifying any outstanding regulatory im7 pediments to the clinical development of qualified in8 fectious disease products; 

9 (4) reporting on the progress the Food and 

10 Drug Administration has made in addressing the im11 pediments identified under paragraph (3); and 

12 (5) containing recommendations regarding how 

13 to improve the review of, and regulatory pathway 

14 for, such products. 

15 (d) QUALIFIED INFECTIOUS DISEASE PRODUCT.— 

16 For purposes of this section, the term ‘‘qualified infectious 

17 disease product’’ has the meaning given such term in sec18 tion 505E(g) of the Federal Food, Drug, and Cosmetic 

19 Act, as added by section 801. 

20 SEC. 806. REGULATORY CERTAINTY AND PREDICTABILITY. 

21 (a) INITIAL STRATEGY AND IMPLEMENTATION

22 PLAN.—Not later than 1 year after the date of enactment 

23 of this Act, the Secretary of Health and Human Services 

24 (referred to in this section as the ‘‘Secretary’’) shall sub25 mit to Congress a strategy and implementation plan with 
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1 respect to the requirements of this Act. The strategy and 

2 implementation plan shall include— 

3 (1) a description of the regulatory challenges to 

4 clinical development, approval, and licensure of 

5 qualified infectious disease products; 

6 (2) the regulatory and scientific priorities of the 

7 Secretary with respect to such challenges; and 

8 (3) the steps the Secretary will take to ensure 

9 regulatory certainty and predictability with respect 

10 to qualified infectious disease products, including 

11 steps the Secretary will take to ensure managers and 

12 reviewers are familiar with related regulatory path13 ways, requirements of the Food and Drug Adminis14 tration, guidance documents related to such prod15 ucts, and applying such requirements consistently. 

16 (b) SUBSEQUENT REPORT.—Not later than 3 years 

17 after the date of enactment of this Act, the Secretary shall 

18 submit to Congress a report on— 

19 (1) the progress made toward the priorities 

20 identified under subsection (a)(2); 

21 (2) the number of qualified infectious disease 

22 products that have been submitted for approval or li23 censure on or after the date of enactment of this 

24 Act; 
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1 (3) a list of qualified infectious disease products 

2 with information on the types of exclusivity granted 

3 for each product, consistent with the information 

4 published under section 505(j)(7)(A)(iii) of the Fed5 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

6 355(j)(7)(A)(iii)); 

7 (4) the number of such qualified infectious dis8 ease products and that have been approved or li9 censed on or after the date of enactment of this Act; 

10 and 

11 (5) the number of calendar days it took for the 

12 approval or licensure of the qualified infectious dis13 ease products approved or licensed on or after the 

14 date of enactment of this Act. 

15 (c) QUALIFIED INFECTIOUS DISEASE PRODUCT.— 

16 For purposes of this section, the term ‘‘qualified infectious 

17 disease product’’ has the meaning given such term in sec18 tion 505E(g) of the Federal Food, Drug, and Cosmetic 

19 Act, as added by section 801. 

20 TITLE IX—DRUG APPROVAL AND 

21 PATIENT ACCESS 

22 SEC. 901. ENHANCEMENT OF ACCELERATED PATIENT AC23 CESS TO NEW MEDICAL TREATMENTS. 

24 (a) FINDINGS; SENSE OF CONGRESS.— 

25 (1) FINDINGS.—Congress finds as follows: 
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1 (A) The Food and Drug Administration 

2 (referred to in this section as the ‘‘FDA’’) 

3 serves a critical role in helping to assure that 

4 new medicines are safe and effective. Regu5 latory innovation is 1 element of the Nation’s 

6 strategy to address serious and life-threatening 

7 diseases or conditions by promoting investment 

8 in and development of innovative treatments for 

9 unmet medical needs. 

10 (B) During the 2 decades following the es11 tablishment of the accelerated approval mecha12 nism, advances in medical sciences, including 

13 genomics, molecular biology, and bioinformatics, 

14 have provided an unprecedented understanding 

15 of the underlying biological mechanism and 

16 pathogenesis of disease. A new generation of 

17 modern, targeted medicines is under develop18 ment to treat serious and life-threatening dis19 eases, some applying drug development strate20 gies based on biomarkers or pharmacogenomics, 

21 predictive toxicology, clinical trial enrichment 

22 techniques, and novel clinical trial designs, such 

23 as adaptive clinical trials. 

24 (C) As a result of these remarkable sci25 entific and medical advances, the FDA should 
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1 be encouraged to implement more broadly effec2 tive processes for the expedited development 

3 and review of innovative new medicines in4 tended to address unmet medical needs for seri5 ous or life-threatening diseases or conditions, 

6 including those for rare diseases or conditions, 

7 using a broad range of surrogate or clinical 

8 endpoints and modern scientific tools earlier in 

9 the drug development cycle when appropriate. 

10 This may result in fewer, smaller, or shorter 

11 clinical trials for the intended patient popu12 lation or targeted subpopulation without com13 promising or altering the high standards of the 

14 FDA for the approval of drugs. 

15 (D) Patients benefit from expedited access 

16 to safe and effective innovative therapies to 

17 treat unmet medical needs for serious or life18 threatening diseases or conditions. 

19 (E) For these reasons, the statutory au20 thority in effect on the day before the date of 

21 enactment of this Act governing expedited ap22 proval of drugs for serious or life-threatening 

23 diseases or conditions should be amended in 

24 order to enhance the authority of the FDA to 

25 consider appropriate scientific data, methods, 
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1 and tools, and to expedite development and ac2 cess to novel treatments for patients with a 

3 broad range of serious or life-threatening dis4 eases or conditions. 

5 (2) SENSE OF CONGRESS.—It is the sense of 

6 Congress that the Food and Drug Administration 

7 should apply the accelerated approval and fast track 

8 provisions set forth in section 506 of the Federal 

9 Food, Drug, and Cosmetic Act (21 U.S.C. 356), as 

10 amended by this section, to help expedite the devel11 opment and availability to patients of treatments for 

12 serious or life-threatening diseases or conditions 

13 while maintaining safety and effectiveness standards 

14 for such treatments. 

15 (b) EXPEDITED APPROVAL OF DRUGS FOR SERIOUS

16 OR LIFE-THREATENING DISEASES OR CONDITIONS.—Sec17 tion 506 (21 U.S.C. 356) is amended to read as follows: 

18 ‘‘SEC. 506. EXPEDITED APPROVAL OF DRUGS FOR SERIOUS 

19 OR LIFE-THREATENING DISEASES OR CONDI20 TIONS. 

21 ‘‘(a) DESIGNATION OF DRUG AS FAST TRACK PROD22 UCT.— 

23 ‘‘(1) IN GENERAL.—The Secretary shall, at the 

24 request of the sponsor of a new drug, facilitate the 

25 development and expedite the review of such drug if 
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1 it is intended, whether alone or in combination with 

2 one or more other drugs, for the treatment of a seri3 ous or life-threatening disease or condition, and it 

4 demonstrates the potential to address unmet medical 

5 needs for such a disease or condition. (In this sec6 tion, such a drug is referred to as a ‘fast track prod7 uct’.) 

8 ‘‘(2) REQUEST FOR DESIGNATION.—The spon9 sor of a new drug may request the Secretary to des10 ignate the drug as a fast track product. A request 

11 for the designation may be made concurrently with, 

12 or at any time after, submission of an application 

13 for the investigation of the drug under section 505(i) 

14 or section 351(a)(3) of the Public Health Service 

15 Act. 

16 ‘‘(3) DESIGNATION.—Within 60 calendar days 

17 after the receipt of a request under paragraph (2), 

18 the Secretary shall determine whether the drug that 

19 is the subject of the request meets the criteria de20 scribed in paragraph (1). If the Secretary finds that 

21 the drug meets the criteria, the Secretary shall des22 ignate the drug as a fast track product and shall 

23 take such actions as are appropriate to expedite the 

24 development and review of the application for ap25 proval of such product. 
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1 ‘‘(b) ACCELERATED APPROVAL OF A DRUG FOR A

2 SERIOUS OR LIFE-THREATENING DISEASE OR CONDI3 TION, INCLUDING A FAST TRACK PRODUCT.— 

4 ‘‘(1) IN GENERAL.— 

5 ‘‘(A) ACCELERATED APPROVAL.—The Sec6 retary may approve an application for approval 

7 of a product for a serious or life-threatening 

8 disease or condition, including a fast track 

9 product, under section 505(c) or section 351(a) 

10 of the Public Health Service Act upon a deter11 mination that the product has an effect on a 

12 surrogate endpoint that is reasonably likely to 

13 predict clinical benefit, or on a clinical endpoint 

14 that can be measured earlier than irreversible 

15 morbidity or mortality, that is reasonably likely 

16 to predict an effect on irreversible morbidity or 

17 mortality or other clinical benefit, taking into 

18 account the severity, rarity, or prevalence of the 

19 condition and the availability or lack of alter20 native treatments. The approval described in 

21 the preceding sentence is referred to in this sec22 tion as ‘accelerated approval’. 

23 ‘‘(B) EVIDENCE.—The evidence to support 

24 that an endpoint is reasonably likely to predict 

25 clinical benefit under subparagraph (A) may in-
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1 clude epidemiological, pathophysiological, thera2 peutic, pharmacologic, or other evidence devel3 oped using biomarkers, for example, or other 

4 scientific methods or tools. 

5 ‘‘(2) LIMITATION.—Approval of a product 

6 under this subsection may be subject to 1 or both 

7 of the following requirements: 

8 ‘‘(A) That the sponsor conduct appropriate 

9 post-approval studies to verify and describe the 

10 predicted effect on irreversible morbidity or 

11 mortality or other clinical benefit. 

12 ‘‘(B) That the sponsor submit copies of all 

13 promotional materials related to the product 

14 during the preapproval review period and, fol15 lowing approval and for such period thereafter 

16 as the Secretary determines to be appropriate, 

17 at least 30 days prior to dissemination of the 

18 materials. 

19 ‘‘(3) EXPEDITED WITHDRAWAL OF AP20 PROVAL.—The Secretary may withdraw approval of 

21 a product approved under accelerated approval using 

22 expedited procedures (as prescribed by the Secretary 

23 in regulations which shall include an opportunity for 

24 an informal hearing) if— 
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1 ‘‘(A) the sponsor fails to conduct any re2 quired post-approval study of the drug with due 

3 diligence; 

4 ‘‘(B) a study required to verify and de5 scribe the predicted effect on irreversible mor6 bidity or mortality or other clinical benefit of 

7 the product fails to verify and describe such ef8 fect or benefit; 

9 ‘‘(C) other evidence demonstrates that the 

10 product is not safe or effective under the condi11 tions of use; or 

12 ‘‘(D) the sponsor disseminates false or 

13 misleading promotional materials with respect 

14 to the product. 

15 ‘‘(c) REVIEW OF INCOMPLETE APPLICATIONS FOR

16 APPROVAL OF A FAST TRACK PRODUCT.— 

17 ‘‘(1) IN GENERAL.—If the Secretary deter18 mines, after preliminary evaluation of clinical data 

19 submitted by the sponsor, that a fast track product 

20 may be effective, the Secretary shall evaluate for fil21 ing, and may commence review of portions of, an ap22 plication for the approval of the product before the 

23 sponsor submits a complete application. The Sec24 retary shall commence such review only if the appli25 cant— 
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1 ‘‘(A) provides a schedule for submission of 

2 information necessary to make the application 

3 complete; and 

4 ‘‘(B) pays any fee that may be required 

5 under section 736. 

6 ‘‘(2) EXCEPTION.—Any time period for review 

7 of human drug applications that has been agreed to 

8 by the Secretary and that has been set forth in goals 

9 identified in letters of the Secretary (relating to the 

10 use of fees collected under section 736 to expedite 

11 the drug development process and the review of 

12 human drug applications) shall not apply to an ap13 plication submitted under paragraph (1) until the 

14 date on which the application is complete. 

15 ‘‘(d) AWARENESS EFFORTS.—The Secretary shall— 

16 ‘‘(1) develop and disseminate to physicians, pa17 tient organizations, pharmaceutical and bio18 technology companies, and other appropriate persons 

19 a description of the provisions of this section appli20 cable to accelerated approval and fast track prod21 ucts; and 

22 ‘‘(2) establish a program to encourage the de23 velopment of surrogate and clinical endpoints, in24 cluding biomarkers, and other scientific methods and 

25 tools that can assist the Secretary in determining 
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1 whether the evidence submitted in an application is 

2 reasonably likely to predict clinical benefit for seri3 ous or life-threatening conditions for which signifi4 cant unmet medical needs exist. 

5 ‘‘(e) CONSTRUCTION.— 

6 ‘‘(1) PURPOSE.—The amendments made by the 

7 Food and Drug Administration Safety and Innova8 tion Act to this section are intended to encourage 

9 the Secretary to utilize innovative and flexible ap10 proaches to the assessment of products under accel11 erated approval for treatments for patients with seri12 ous or life-threatening diseases or conditions and 

13 unmet medical needs. 

14 ‘‘(2) CONSTRUCTION.—Nothing in this section 

15 shall be construed to alter the standards of evidence 

16 under subsection (c) or (d) of section 505 (including 

17 the substantial evidence standard in section 505(d)) 

18 of this Act or under section 351(a) of the Public 

19 Health Service Act. Such sections and standards of 

20 evidence apply to the review and approval of prod21 ucts under this section, including whether a product 

22 is safe and effective. Nothing in this section alters 

23 the ability of the Secretary to rely on evidence that 

24 does not come from adequate and well-controlled in25 vestigations for the purpose of determining whether 
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1 an endpoint is reasonably likely to predict clinical 

2 benefit as described in subsection (b)(1)(B).’’. 

3 (c) GUIDANCE; AMENDED REGULATIONS.— 

4 (1) DRAFT GUIDANCE.—Not later than 1 year 

5 after the date of enactment of this Act, the Sec6 retary of Health and Human Services (referred to in 

7 this section as the ‘‘Secretary’’) shall issue draft 

8 guidance to implement the amendments made by 

9 this section. In developing such guidance, the Sec10 retary shall specifically consider issues arising under 

11 the accelerated approval and fast track processes 

12 under section 506 of the Federal Food, Drug, and 

13 Cosmetic Act, as amended by subsection (b), for 

14 drugs designated for a rare disease or condition 

15 under section 526 of such Act (21 U.S.C. 360bb) 

16 and shall also consider any unique issues associated 

17 with very rare diseases. 

18 (2) FINAL GUIDANCE.—Not later than 1 year 

19 after the issuance of draft guidance under para20 graph (1), and after an opportunity for public com21 ment, the Secretary shall issue final guidance. 

22 (3) CONFORMING CHANGES.—The Secretary 

23 shall issue, as necessary, conforming amendments to 

24 the applicable regulations under title 21, Code of 

25 Federal Regulations, governing accelerated approval. 
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1 (4) NO EFFECT OF INACTION ON REQUESTS.— 

2 If the Secretary fails to issue final guidance or 

3 amended regulations as required by this subsection, 

4 such failure shall not preclude the review of, or ac5 tion on, a request for designation or an application 

6 for approval submitted pursuant to section 506 of 

7 the Federal Food, Drug, and Cosmetic Act, as 

8 amended by subsection (b). 

9 (d) INDEPENDENT REVIEW.—The Secretary may, in 

10 conjunction with other planned reviews, contract with an 

11 independent entity with expertise in assessing the quality 

12 and efficiency of biopharmaceutical development and regu13 latory review programs to evaluate the Food and Drug Ad14 ministration’s application of the processes described in 

15 section 506 of the Federal Food, Drug, and Cosmetic Act, 

16 as amended by subsection (b), and the impact of such 

17 processes on the development and timely availability of in18 novative treatments for patients suffering from serious or 

19 life-threatening conditions. Any such evaluation shall in20 clude consultation with regulated industries, patient advo21 cacy and disease research foundations, and relevant aca22 demic medical centers. 

23 SEC. 902. BREAKTHROUGH THERAPIES. 

24 (a) IN GENERAL.—Section 506 (21 U.S.C. 356), as 

25 amended by section 901, is further amended— 
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1 (1) by redesignating subsections (a) through (c) 

2 as subsections (b) through (d), respectively; 

3 (2) by redesignating subsection (d) as sub4 section (f); 

5 (3) by inserting before subsection (b), as so re6 designated, the following: 

7 ‘‘(a) DESIGNATION OF A DRUG AS A BREAKTHROUGH

8 THERAPY.— 

9 ‘‘(1) IN GENERAL.—The Secretary shall, at the 

10 request of the sponsor of a drug, expedite the devel11 opment and review of such drug if the drug is in12 tended, alone or in combination with 1 or more other 

13 drugs, to treat a serious or life-threatening disease 

14 or condition and preliminary clinical evidence indi15 cates that the drug may demonstrate substantial im16 provement over existing therapies on 1 or more clini17 cally significant endpoints, such as substantial treat18 ment effects observed early in clinical development. 

19 (In this section, such a drug is referred to as a 

20 ‘breakthrough therapy’.) 

21 ‘‘(2) REQUEST FOR DESIGNATION.—The spon22 sor of a drug may request the Secretary to designate 

23 the drug as a breakthrough therapy. A request for 

24 the designation may be made concurrently with, or 

25 at any time after, the submission of an application 
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1 for the investigation of the drug under section 505(i) 

2 or section 351(a)(3) of the Public Health Service 

3 Act. 

4 ‘‘(3) DESIGNATION.— 

5 ‘‘(A) IN GENERAL.—Not later than 60 cal6 endar days after the receipt of a request under 

7 paragraph (2), the Secretary shall determine 

8 whether the drug that is the subject of the re9 quest meets the criteria described in paragraph 

10 (1). If the Secretary finds that the drug meets 

11 the criteria, the Secretary shall designate the 

12 drug as a breakthrough therapy and shall take 

13 such actions as are appropriate to expedite the 

14 development and review of the application for 

15 approval of such drug. 

16 ‘‘(B) ACTIONS.—The actions to expedite 

17 the development and review of an application 

18 under subparagraph (A) may include, as appro19 priate— 

20 ‘‘(i) holding meetings with the sponsor 

21 and the review team throughout the devel22 opment of the drug; 

23 ‘‘(ii) providing timely advice to, and 

24 interactive communication with, the spon25 sor regarding the development of the drug 
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1 to ensure that the development program to 

2 gather the non-clinical and clinical data 

3 necessary for approval is as efficient as 

4 practicable; 

5 ‘‘(iii) involving senior managers and 

6 experienced review staff, as appropriate, in 

7 a collaborative, cross-disciplinary review; 

8 ‘‘(iv) assigning a cross-disciplinary 

9 project lead for the Food and Drug Ad10 ministration review team to facilitate an 

11 efficient review of the development pro12 gram and to serve as a scientific liaison be13 tween the review team and the sponsor; 

14 and 

15 ‘‘(v) taking steps to ensure that the 

16 design of the clinical trials is as efficient as 

17 practicable, when scientifically appropriate, 

18 such as by minimizing the number of pa19 tients exposed to a potentially less effica20 cious treatment.’’; 

21 (4) in subsection (f)(1), as so redesignated, by 

22 striking ‘‘applicable to accelerated approval’’ and in23 serting ‘‘applicable to breakthrough therapies, accel24 erated approval, and’’; and 

25 (5) by adding at the end the following: 
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1 ‘‘(g) REPORT.—Beginning in fiscal year 2013, the 

2 Secretary shall annually prepare and submit to the Com3 mittee on Health, Education, Labor, and Pensions of the 

4 Senate and the Committee on Energy and Commerce of 

5 the House of Representatives, and make publicly available, 

6 with respect to this section for the previous fiscal year— 

7 ‘‘(1) the number of drugs for which a sponsor 

8 requested designation as a breakthrough therapy; 

9 ‘‘(2) the number of products designated as a 

10 breakthrough therapy; and 

11 ‘‘(3) for each product designated as a break12 through therapy, a summary of the actions taken 

13 under subsection (a)(3).’’. 

14 (b) GUIDANCE; AMENDED REGULATIONS.— 

15 (1) IN GENERAL.— 

16 (A) GUIDANCE.—Not later than 18 

17 months after the date of enactment of this Act, 

18 the Secretary of Health and Human Services 

19 (referred to in this section as the ‘‘Secretary’’) 

20 shall issue draft guidance on implementing the 

21 requirements with respect to breakthrough 

22 therapies, as set forth in section 506(a) of the 

23 Federal Food, Drug, and Cosmetic Act (21 

24 U.S.C. 356(a)), as amended by this section. 

25 The Secretary shall issue final guidance not 
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1 later than 1 year after the close of the comment 

2 period for the draft guidance. 

3 (B) AMENDED REGULATIONS.— 

4 (i) IN GENERAL.—If the Secretary de5 termines that it is necessary to amend the 

6 regulations under title 21, Code of Federal 

7 Regulations in order to implement the 

8 amendments made by this section to sec9 tion 506(a) of the Federal Food, Drug, 

10 and Cosmetic Act, the Secretary shall 

11 amend such regulations not later than 2 

12 years after the date of enactment of this 

13 Act. 

14 (ii) PROCEDURE.—In amending regu15 lations under clause (i), the Secretary 

16 shall— 

17 (I) issue a notice of proposed 

18 rulemaking that includes the proposed 

19 regulation; 

20 (II) provide a period of not less 

21 than 60 days for comments on the 

22 proposed regulation; and 

23 (III) publish the final regulation 

24 not less than 30 days before the effec25 tive date of the regulation. 
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1 (iii) RESTRICTIONS.—Notwithstanding 

2 any other provision of law, the Secretary 

3 shall promulgate regulations implementing 

4 the amendments made by section only as 

5 described in clause (ii). 

6 (2) REQUIREMENTS.—Guidance issued under 

7 this section shall— 

8 (A) specify the process and criteria by 

9 which the Secretary makes a designation under 

10 section 506(a)(3) of the Federal Food, Drug, 

11 and Cosmetic Act; and 

12 (B) specify the actions the Secretary shall 

13 take to expedite the development and review of 

14 a breakthrough therapy pursuant to such des15 ignation under such section 506(a)(3), includ16 ing updating good review management practices 

17 to reflect breakthrough therapies. 

18 (c) INDEPENDENT REVIEW.—Not later than 3 years 

19 after the date of enactment of this Act, the Comptroller 

20 General of the United States, in consultation with appro21 priate experts, shall assess the manner by which the Food 

22 and Drug Administration has applied the processes de23 scribed in section 506(a) of the Federal Food, Drug, and 

24 Cosmetic Act, as amended by this section, and the impact 

25 of such processes on the development and timely avail-
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1 ability of innovative treatments for patients affected by se2 rious or life-threatening conditions. Such assessment shall 

3 be made publicly available upon completion. 

4 (d) CONFORMING AMENDMENTS.—Section 506B(e) 

5 (21 U.S.C. 356b) is amended by striking ‘‘section 

6 506(b)(2)(A)’’ each place such term appears and inserting 

7 ‘‘section 506(c)(2)(A)’’. 

8 SEC. 903. CONSULTATION WITH EXTERNAL EXPERTS ON 

9 RARE DISEASES, TARGETED THERAPIES, AND 

10 GENETIC TARGETING OF TREATMENTS. 

11 Subchapter E of chapter V (21 U.S.C. 360bbb et 

12 seq.), as amended by section 712, is further amended by 

13 adding at the end the following: 

14 ‘‘SEC. 569. CONSULTATION WITH EXTERNAL EXPERTS ON 

15 RARE DISEASES, TARGETED THERAPIES, AND 

16 GENETIC TARGETING OF TREATMENTS. 

17 ‘‘(a) IN GENERAL.—For the purpose of promoting 

18 the efficiency of and informing the review by the Food 

19 and Drug Administration of new drugs and biological 

20 products for rare diseases and drugs and biological prod21 ucts that are genetically targeted, the following shall 

22 apply: 

23 ‘‘(1) CONSULTATION WITH STAKEHOLDERS.— 

24 Consistent with sections X.C and IX.E.4 of the 

25 PDUFA Reauthorization Performance Goals and 
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1 Procedures Fiscal Years 2013 through 2017, as ref2 erenced in the letters described in section 101(b) of 

3 the Prescription Drug User Fee Amendments of 

4 2012, the Secretary shall ensure that opportunities 

5 exist, at a time the Secretary determines appro6 priate, for consultations with stakeholders on the 

7 topics described in subsection (c). 

8 ‘‘(2) CONSULTATION WITH EXTERNAL EX9 PERTS.—The Secretary shall develop and maintain a 

10 list of external experts who, because of their special 

11 expertise, are qualified to provide advice on rare dis12 ease issues, including topics described in subsection 

13 (c). The Secretary may, when appropriate to address 

14 a specific regulatory question, consult such external 

15 experts on issues related to the review of new drugs 

16 and biological products for rare diseases and drugs 

17 and biological products that are genetically targeted, 

18 including the topics described in subsection (c), 

19 when such consultation is necessary because the Sec20 retary lacks specific scientific, medical, or technical 

21 expertise necessary for the performance of its regu22 latory responsibilities and the necessary expertise 

23 can be provided by the external experts. 

24 ‘‘(b) EXTERNAL EXPERTS.—For purposes of sub25 section (a)(2), external experts are those who possess sci-
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1 entific or medical training that the Secretary lacks with 

2 respect to one or more rare diseases. 

3 ‘‘(c) TOPICS FOR CONSULTATION.—Topics for con4 sultation pursuant to this section may include— 

5 ‘‘(1) rare diseases; 

6 ‘‘(2) the severity of rare diseases; 

7 ‘‘(3) the unmet medical need associated with 

8 rare diseases; 

9 ‘‘(4) the willingness and ability of individuals 

10 with a rare disease to participate in clinical trials; 

11 ‘‘(5) an assessment of the benefits and risks of 

12 therapies to treat rare diseases; 

13 ‘‘(6) the general design of clinical trials for rare 

14 disease populations and subpopulations; and 

15 ‘‘(7) demographics and the clinical description 

16 of patient populations. 

17 ‘‘(d) CLASSIFICATION AS SPECIAL GOVERNMENT EM18 PLOYEES.—The external experts who are consulted under 

19 this section may be considered special government employ20 ees, as defined under section 202 of title 18, United States 

21 Code. 

22 ‘‘(e) PROTECTION OF PROPRIETARY INFORMA23 TION.—Nothing in this section shall be construed to alter 

24 the protections offered by laws, regulations, and policies 

25 governing disclosure of confidential commercial or trade 
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1 secret information, and any other information exempt 

2 from disclosure pursuant to section 552(b) of title 5, 

3 United States Code, as such provisions would be applied 

4 to consultation with individuals and organizations prior to 

5 the date of enactment of this section. 

6 ‘‘(f) OTHER CONSULTATION.—Nothing in this sec7 tion shall be construed to limit the ability of the Secretary 

8 to consult with individuals and organizations as authorized 

9 prior to the date of enactment of this section. 

10 ‘‘(g) NO RIGHT OR OBLIGATION.—Nothing in this 

11 section shall be construed to create a legal right for a con12 sultation on any matter or require the Secretary to meet 

13 with any particular expert or stakeholder. Nothing in this 

14 section shall be construed to alter agreed upon goals and 

15 procedures identified in the letters described in section 

16 101(b) of the Prescription Drug User Fee Amendments 

17 of 2012. Nothing in this section is intended to increase 

18 the number of review cycles as in effect before the date 

19 of enactment of this section.’’. 

20 SEC. 904. ACCESSIBILITY OF INFORMATION ON PRESCRIP21 TION DRUG CONTAINER LABELS BY VIS22 UALLY-IMPAIRED AND BLIND CONSUMERS. 

23 (a) ESTABLISHMENT OF WORKING GROUP.— 

24 (1) IN GENERAL.—The Architectural and 

25 Transportation Barriers Compliance Board (referred 
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1 to in this section as the ‘‘Access Board’’) shall con2 vene a stakeholder working group (referred to in this 

3 section as the ‘‘working group’’) to develop best 

4 practices on access to information on prescription 

5 drug container labels for individuals who are blind 

6 or visually impaired. 

7 (2) MEMBERS.—The working group shall be 

8 comprised of representatives of national organiza9 tions representing blind and visually-impaired indi10 viduals, national organizations representing the el11 derly, and industry groups representing stake12 holders, including retail, mail order, and independent 

13 community pharmacies, who would be impacted by 

14 such best practices. Representation within the work15 ing group shall be divided equally between consumer 

16 and industry advocates. 

17 (3) BEST PRACTICES.— 

18 (A) IN GENERAL.—The working group 

19 shall develop, not later than 1 year after the 

20 date of the enactment of this Act, best practices 

21 for pharmacies to ensure that blind and vis22 ually-impaired individuals have safe, consistent, 

23 reliable, and independent access to the informa24 tion on prescription drug container labels. 
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1 (B) PUBLIC AVAILABILITY.—The best 

2 practices developed under subparagraph (A) 

3 may be made publicly available, including 

4 through the Internet websites of the working 

5 group participant organizations, and through 

6 other means, in a manner that provides access 

7 to interested individuals, including individuals 

8 with disabilities. 

9 (C) LIMITATIONS.—The best practices de10 veloped under subparagraph (A) shall not be 

11 construed as accessibility guidelines or stand12 ards of the Access Board, and shall not confer 

13 any rights or impose any obligations on working 

14 group participants or other persons. Nothing in 

15 this section shall be construed to limit or condi16 tion any right, obligation, or remedy available 

17 under the Americans with Disabilities Act of 

18 1990 (42 U.S.C. 12101 et seq.) or any other 

19 Federal or State law requiring effective commu20 nication, barrier removal, or nondiscrimination 

21 on the basis of disability. 

22 (4) CONSIDERATIONS.—In developing and 

23 issuing the best practices under paragraph (3)(A), 

24 the working group shall consider— 

25 (A) the use of— 
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1 (i) Braille; 

2 (ii) auditory means, such as— 

3 (I) ‘‘talking bottles’’ that provide 

4 audible container label information; 

5 (II) digital voice recorders at6 tached to the prescription drug con7 tainer; and 

8 (III) radio frequency identifica9 tion tags; 

10 (iii) enhanced visual means, such as— 

11 (I) large font labels or large font 

12 ‘‘duplicate’’ labels that are affixed or 

13 matched to a prescription drug con14 tainer; 

15 (II) high-contrast printing; and 

16 (III) sans-serf font; and 

17 (iv) other relevant alternatives as de18 termined by the working group; 

19 (B) whether there are technical, financial, 

20 manpower, or other factors unique to phar21 macies with 20 or fewer retail locations which 

22 may pose significant challenges to the adoption 

23 of the best practices; and 

24 (C) such other factors as the working 

25 group determines to be appropriate. 
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1 (5) INFORMATION CAMPAIGN.—Upon comple2 tion of development of the best practices under sub3 section (a)(3), the National Council on Disability, in 

4 consultation with the working group, shall conduct 

5 an informational and educational campaign designed 

6 to inform individuals with disabilities, pharmacists, 

7 and the public about such best practices. 

8 (6) FACA WAIVER.—The Federal Advisory 

9 Committee Act (5 U.S.C. App.) shall not apply to 

10 the working group. 

11 (b) GAO STUDY.— 

12 (1) IN GENERAL.—Beginning 18 months after 

13 the completion of the development of best practices 

14 under subsection (a)(3)(A), the Comptroller General 

15 of the United States shall conduct a review of the 

16 extent to which pharmacies are utilizing such best 

17 practices, and the extent to which barriers to acces18 sible information on prescription drug container la19 bels for blind and visually-impaired individuals con20 tinue. 

21 (2) REPORT.—Not later than September 30, 

22 2016, the Comptroller General of the United States 

23 shall submit to Congress a report on the review con24 ducted under paragraph (1). Such report shall in25 clude recommendations about how best to reduce the 
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1 barriers experienced by blind and visually-impaired 

2 individuals to independently accessing information 

3 on prescription drug container labels. 

4 (c) DEFINITIONS.—In this section— 

5 (1) the term ‘‘pharmacy’’ includes a pharmacy 

6 that receives prescriptions and dispenses prescription 

7 drugs through an Internet website or by mail; 

8 (2) the term ‘‘prescription drug’’ means a drug 

9 subject to section 503(b)(1) of the Federal Food, 

10 Drug, and Cosmetic Act (21 U.S.C. 353(b)(1)); and 

11 (3) the term ‘‘prescription drug container label’’ 

12 means the label with the directions for use that is 

13 affixed to the prescription drug container by the 

14 pharmacist and dispensed to the consumer. 

15 SEC. 905. RISK-BENEFIT FRAMEWORK. 

16 Section 505(d) (21 U.S.C. 355(d)) is amended by 

17 adding at the end the following: ‘‘The Secretary shall im18 plement a structured risk-benefit assessment framework 

19 in the new drug approval process to facilitate the balanced 

20 consideration of benefits and risks, a consistent and sys21 tematic approach to the discussion and regulatory deci22 sionmaking, and the communication of the benefits and 

23 risks of new drugs. Nothing in the preceding sentence 

24 shall alter the criteria for evaluating an application for 

25 premarket approval of a drug.’’. 
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1 SEC. 906. INDEPENDENT STUDY ON MEDICAL INNOVATION 

2 INDUCEMENT MODEL. 

3 (a) IN GENERAL.—The Secretary of Health and 

4 Human Services shall enter into an agreement with the 

5 National Academies to provide expert consultation and 

6 conduct a study that evaluates the feasibility and possible 

7 consequences of the use of innovation inducement prizes 

8 to reward successful medical innovations. Under the 

9 agreement, the National Academies shall submit to the 

10 Secretary a report on such study not later than 15 months 

11 after the date of enactment of this Act. 

12 (b) REQUIREMENTS.— 

13 (1) IN GENERAL.—The study conducted under 

14 subsection (a) shall model at least 3 separate seg15 ments on the medical technologies market as can16 didate targets for the new incentive system and con17 sider different medical innovation inducement prize 

18 design issues, including the challenges presented in 

19 the implementation of prizes for end products, open 

20 source dividend prizes, and prizes for upstream re21 search. 

22 (2) MARKET SEGMENTS.—The segments on the 

23 medical technologies market that shall be considered 

24 under paragraph (1) include— 

25 (A) all pharmaceutical and biologic drugs 

26 and vaccines; 
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1 (B) drugs and vaccines used solely for the 

2 treatment of HIV/AIDS; and 

3 (C) antibiotics. 

4 (c) ELEMENTS.—The study conducted under sub5 section (a) shall include consideration of each of the fol6 lowing: 

7 (1) Whether a system of large innovation in8 ducement prizes could work as a replacement for the 

9 existing product monopoly/patent-based system, as 

10 in effect on the date of enactment of this Act. 

11 (2) How large the innovation prize funds would 

12 have to be in order to induce at least as much re13 search and development investment in innovation as 

14 is induced under the current system of time-limited 

15 market exclusivity, as in effect on the date of enact16 ment of this Act. 

17 (3) Whether a system of large innovation in18 ducement prizes would be more or less expensive 

19 than the current system of time-limited market ex20 clusivity, as in effect on the date of enactment of 

21 this Act, calculated over different time periods. 

22 (4) Whether a system of large innovation in23 ducement prizes would expand access to new prod24 ucts and improve health outcomes. 
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1 (5) The type of information and decisionmaking 

2 skills that would be necessary to manage end prod3 uct prizes. 

4 (6) Whether there would there be major advan5 tages in rewarding the incremental impact of innova6 tions, as benchmarked against existing products. 

7 (7) How open-source dividend prizes could be 

8 managed, and whether such prizes would increase 

9 access to knowledge, materials, data and tech10 nologies. 

11 (8) Whether a system of competitive inter12 mediaries for interim research prizes would provide 

13 an acceptable solution to the valuation challenges for 

14 interim prizes. 

15 SEC. 907. ORPHAN PRODUCT GRANTS PROGRAM. 

16 (a) REAUTHORIZATION OF PROGRAM.—Section 5(c) 

17 of the Orphan Drug Act (21 U.S.C. 360ee(c)) is amended 

18 by striking ‘‘2008 through 2012’’ and inserting ‘‘2013 

19 through 2017’’. 

20 (b) HUMAN CLINICAL TESTING.—Section 

21 5(b)(1)(A)(ii)) of the Orphan Drug Act (21 U.S.C. 

22 360ee(b)(1)(A)(ii)) is amended by striking ‘‘after the date 

23 such drug is designated under section 526 of such Act 

24 and’’. 
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1 SEC. 908. REPORTING OF INCLUSION OF DEMOGRAPHIC 

2 SUBGROUPS IN CLINICAL TRIALS AND DATA 

3 ANALYSIS IN APPLICATIONS FOR DRUGS, BIO4 LOGICS, AND DEVICES. 

5 (a) REPORT.— 

6 (1) IN GENERAL.—Not later than 1 year after 

7 the date of enactment of this Act, the Secretary, act8 ing through the Commissioner, shall publish on the 

9 Internet website of the Food and Drug Administra10 tion a report, consistent with the regulations of the 

11 Food and Drug Administration pertaining to the 

12 protection of sponsors’ confidential commercial infor13 mation as of the date of enactment of this Act, ad14 dressing the extent to which clinical trial participa15 tion and the inclusion of safety and effectiveness 

16 data by demographic subgroups including sex, age, 

17 race, and ethnicity, is included in applications sub18 mitted to the Food and Drug Administration, and 

19 shall provide such publication to Congress. 

20 (2) CONTENTS OF REPORT.—The report de21 scribed in paragraph (1) shall contain the following: 

22 (A) A description of existing tools to en23 sure that data to support demographic analyses 

24 are submitted in applications for drugs, biologi25 cal products, and devices, and that these anal26 yses are conducted by applicants consistent 
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1 with applicable Food and Drug Administration 

2 requirements and Guidance for Industry. The 

3 report shall address how the Food and Drug 

4 Administration makes available information 

5 about differences in safety and effectiveness of 

6 medical products according to demographic sub7 groups, such as sex, age, racial, and ethnic sub8 groups, to healthcare providers, researchers, 

9 and patients. 

10 (B) An analysis of the extent to which de11 mographic data subset analyses on sex, age, 

12 race, and ethnicity is presented in applications 

13 for new drug applications for new molecular en14 tities under section 505 of the Federal Food, 

15 Drug, and Cosmetic Act (21 U.S.C. 355), in 

16 biologics license applications under section 351 

17 of the Public Health Service Act (42 U.S.C. 

18 262), and in premarket approval applications 

19 under section 515 of the Federal Food, Drug, 

20 and Cosmetic Act (21 U.S.C. 360e) for prod21 ucts approved or licensed by the Food and 

22 Drug Administration, consistent with applicable 

23 requirements and Guidance for Industry, and 

24 consistent with the regulations of the Food and 

25 Drug Administration pertaining to the protec-
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1 tion of sponsors’ confidential commercial infor2 mation as of the date of enactment of this Act. 

3 (C) An analysis of the extent to which de4 mographic subgroups, including sex, age, racial, 

5 and ethnic subgroups, are represented in clin6 ical studies to support applications for approved 

7 or licensed new molecular entities, biological 

8 products, and devices. 

9 (D) An analysis of the extent to which a 

10 summary of product safety and effectiveness 

11 data by demographic subgroups including sex, 

12 age, race, and ethnicity is readily available to 

13 the public in a timely manner by means of the 

14 product labeling or the Food and Drug Admin15 istration’s Internet website. 

16 (b) ACTION PLAN.— 

17 (1) IN GENERAL.—Not later than 1 year after 

18 the publication of the report described in subsection 

19 (a), the Secretary, acting through the Commissioner, 

20 shall publish an action plan on the Internet website 

21 of the Food and Drug Administration, and provide 

22 such publication to Congress. 

23 (2) CONTENT OF ACTION PLAN.—The plan de24 scribed in paragraph (1) shall include— 
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1 (A) recommendations, as appropriate, to 

2 improve the completeness and quality of anal3 yses of data on demographic subgroups in sum4 maries of product safety and effectiveness data 

5 and in labeling; 

6 (B) recommendations, as appropriate, on 

7 the inclusion of such data, or the lack of avail8 ability of such data in labeling; 

9 (C) recommendations, as appropriate, to 

10 otherwise improve the public availability of such 

11 data to patients, healthcare providers, and re12 searchers; and 

13 (D) a determination with respect to each 

14 recommendation identified in subparagraphs 

15 (A) through (C) that distinguishes between 

16 product types referenced in subsection 

17 (a)(2)(B) insofar as the applicability of each 

18 such recommendation to each type of product. 

19 (c) DEFINITIONS.—In this section: 

20 (1) The term ‘‘Commissioner’’ means the Com21 missioner of Food and Drugs. 

22 (2) The term ‘‘device’’ has the meaning given 

23 such term in section 201(h) of the Federal Food, 

24 Drug, and Cosmetic Act (21 U.S.C. 321(h)). 
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1 (3) The term ‘‘drug’’ has the meaning given 

2 such term in section 201(g) of the Federal Food, 

3 Drug, and Cosmetic Act (21 U.S.C. 321(g)). 

4 (4) The term ‘‘biological product’’ has the 

5 meaning given such term in section 351(i) of the 

6 Public Health Service Act (42 U.S.C. 262(i)). 

7 (5) The term ‘‘Secretary’’ means the Secretary 

8 of Health and Human Services. 

9 TITLE X—DRUG SHORTAGES 

10 SEC. 1001. DRUG SHORTAGES. 

11 (a) IN GENERAL.—Section 506C (21 U.S.C. 356c) 

12 is amended to read as follows: 

13 ‘‘SEC. 506C. DISCONTINUANCE OR INTERRUPTION IN THE 

14 PRODUCTION OF LIFE-SAVING DRUGS. 

15 ‘‘(a) IN GENERAL.—A manufacturer of a drug— 

16 ‘‘(1) that is— 

17 ‘‘(A) life-supporting; 

18 ‘‘(B) life-sustaining; 

19 ‘‘(C) intended for use in the prevention of 

20 a debilitating disease or condition; 

21 ‘‘(D) a sterile injectable product; or 

22 ‘‘(E) used in emergency medical care or 

23 during surgery; and 

24 ‘‘(2) that is not a radio pharmaceutical drug 

25 product, a human tissue replaced by a recombinant 
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1 product, a product derived from human plasma pro2 tein, or any other product as designated by the Sec3 retary, 

4 shall notify the Secretary, in accordance with subsection 

5 (b), of a permanent discontinuance in the manufacture of 

6 the drug or an interruption of the manufacture of the drug 

7 that could lead to a meaningful disruption in the supply 

8 of that drug in the United States. 

9 ‘‘(b) TIMING.—A notice required under subsection (a) 

10 shall be submitted to the Secretary— 

11 ‘‘(1) at least 6 months prior to the date of the 

12 discontinuance or interruption; or 

13 ‘‘(2) if compliance with paragraph (1) is not 

14 possible, as soon as practicable. 

15 ‘‘(c) EXPEDITED INSPECTIONS AND REVIEWS.—If, 

16 based on notifications described in subsection (a) or any 

17 other relevant information, the Secretary concludes that 

18 there is, or is likely to be, a drug shortage of a drug de19 scribed in subsection (a), the Secretary may— 

20 ‘‘(1) expedite the review of a supplement to a 

21 new drug application submitted under section 

22 505(b), an abbreviated new drug application sub23 mitted under section 505(j), or a supplement to such 

24 an application submitted under section 505(j) that 

25 could help mitigate or prevent such shortage; or 
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1 ‘‘(2) expedite an inspection or reinspection of 

2 an establishment that could help mitigate or prevent 

3 such drug shortage. 

4 ‘‘(d) COORDINATION.— 

5 ‘‘(1) TASK FORCE AND STRATEGIC PLAN.— 

6 ‘‘(A) IN GENERAL.— 

7 ‘‘(i) TASK FORCE.—As soon as prac8 ticable after the date of enactment of the 

9 Food and Drug Administration Safety and 

10 Innovation Act, the Secretary shall estab11 lish a Task Force to develop and imple12 ment a strategic plan for enhancing the 

13 Secretary’s response to preventing and 

14 mitigating drug shortages. 

15 ‘‘(ii) STRATEGIC PLAN.—The strategic 

16 plan described in clause (i) shall include— 

17 ‘‘(I) plans for enhanced inter18 agency and intraagency coordination, 

19 communication, and decisionmaking; 

20 ‘‘(II) plans for ensuring that 

21 drug shortages are considered when 

22 the Secretary initiates a regulatory 

23 action that could precipitate a drug 

24 shortage or exacerbate an existing 

25 drug shortage; 
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1 ‘‘(III) plans for effective commu2 nication with outside stakeholders, in3 cluding who the Secretary should alert 

4 about potential or actual drug short5 ages, how the communication should 

6 occur, and what types of information 

7 should be shared; and 

8 ‘‘(IV) plans for considering the 

9 impact of drug shortages on research 

10 and clinical trials. 

11 ‘‘(iii) CONSULTATION.—In carrying 

12 out this subparagraph, the Task Force 

13 shall ensure consultation with the appro14 priate offices within the Food and Drug 

15 Administration, including the Office of the 

16 Commissioner, the Center for Drug Eval17 uation and Research, the Office of Regu18 latory Affairs, and employees within the 

19 Department of Health and Human Serv20 ices with expertise regarding drug short21 ages. The Secretary shall engage external 

22 stakeholders and experts as appropriate. 

23 ‘‘(B) TIMING.—Not later than 1 year after 

24 the date of enactment Food and Drug Adminis-
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1 tration Safety and Innovation Act, the Task 

2 Force shall— 

3 ‘‘(i) publish the strategic plan de4 scribed in subparagraph (A); and 

5 ‘‘(ii) submit such plan to Congress. 

6 ‘‘(2) COMMUNICATION.—The Secretary shall 

7 ensure that, prior to any enforcement action or 

8 issuance of a warning letter that the Secretary de9 termines could reasonably be anticipated to lead to 

10 a meaningful disruption in the supply in the United 

11 States of a drug described under subsection (a), 

12 there is communication with the appropriate office 

13 of the Food and Drug Administration with expertise 

14 regarding drug shortages regarding whether the ac15 tion or letter could cause, or exacerbate, a shortage 

16 of the drug. 

17 ‘‘(3) ACTION.—If the Secretary determines, 

18 after the communication described in paragraph (2), 

19 that an enforcement action or a warning letter could 

20 reasonably cause or exacerbate a shortage of a drug 

21 described under subsection (a), then the Secretary 

22 shall evaluate the risks associated with the impact of 

23 such shortage upon patients and those risks associ24 ated with the violation involved before taking such 

25 action or issuing such letter, unless there is immi-
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1 nent risk of serious adverse health consequences or 

2 death to humans. 

3 ‘‘(4) REPORTING BY OTHER ENTITIES.—The 

4 Secretary shall identify or establish a mechanism by 

5 which healthcare providers and other third-party or6 ganizations may report to the Secretary evidence of 

7 a drug shortage. 

8 ‘‘(5) REVIEW AND CONSTRUCTION.—No deter9 mination, finding, action, or omission of the Sec10 retary under this subsection shall— 

11 ‘‘(A) be subject to judicial review; or 

12 ‘‘(B) be construed to establish a defense to 

13 an enforcement action by the Secretary. 

14 ‘‘(e) RECORDKEEPING AND REPORTING.— 

15 ‘‘(1) RECORDKEEPING.—The Secretary shall 

16 maintain records related to drug shortages, includ17 ing with respect to each of the following: 

18 ‘‘(A) The number of manufacturers that 

19 submitted a notification to the Secretary under 

20 subsection (a) in each calendar year. 

21 ‘‘(B) The number of drug shortages that 

22 occurred in each calendar year and a list of 

23 drug names, drug types, and classes that were 

24 the subject of such shortages. 
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1 ‘‘(C) A list of the known factors contrib2 uting to the drug shortages described in sub3 paragraph (B). 

4 ‘‘(D)(i) A list of major actions taken by 

5 the Secretary to prevent or mitigate the drug 

6 shortages described in subparagraph (B). 

7 ‘‘(ii) The Secretary shall include in the list 

8 under clause (i) the following: 

9 ‘‘(I) The number of applications for 

10 which the Secretary expedited review under 

11 subsection (c)(1) in each calendar year. 

12 ‘‘(II) The number of establishment in13 spections or reinspections that the Sec14 retary expedited under subsection (c)(2) in 

15 each calendar year. 

16 ‘‘(E) The number of notifications sub17 mitted to the Secretary under subsection (a) in 

18 each calendar year. 

19 ‘‘(F) The names of manufacturers that the 

20 Secretary has learned did not comply with the 

21 notification requirement under subsection (a) in 

22 each calendar year. 

23 ‘‘(G) The number of times in each cal24 endar year that the Secretary determined under 

25 subsection (d)(3) that an enforcement action or 
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1 a warning letter could reasonably cause or exac2 erbate a shortage of a drug described under 

3 subsection (a), but did not evaluate the risks 

4 associated with the impact of such shortage 

5 upon patients and those risks associated with 

6 the violation involved before taking such action 

7 or issuing such letter on the grounds that there 

8 was imminent risk of serious adverse health 

9 consequences or death to humans, and a sum10 mary of the determinations. 

11 ‘‘(H) A summary of the communications 

12 made and actions taken under subsection (d) in 

13 each calendar year. 

14 ‘‘(I) Any other information the Secretary 

15 deems appropriate to better prevent and miti16 gate drug shortages. 

17 ‘‘(2) TREND ANALYSIS.—The Secretary is au18 thorized to retain a third party to conduct a study, 

19 if the Secretary believes such a study would help 

20 clarify the causes, trends, or solutions related to 

21 drug shortages. 

22 ‘‘(3) ANNUAL SUMMARY.—Not later than 18 

23 months after the date of enactment of the Food and 

24 Drug Administration Safety and Innovation Act, and 

25 annually thereafter, the Secretary shall submit to 
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1 the Committee on Health, Education, Labor, and 

2 Pensions of the Senate and the Committee on En3 ergy and Commerce of the House of Representatives 

4 a report summarizing, with respect to the 1-year pe5 riod preceding such report, the information de6 scribed in paragraph (1). Such report shall not in7 clude any information that is exempt from disclosure 

8 under subsection (a) of section 552 of title 5, United 

9 States Code, by reason of subsection (b)(4) of such 

10 section. 

11 ‘‘(f) DEFINITIONS.—For purposes of this section— 

12 ‘‘(1) the term ‘drug’— 

13 ‘‘(A) means a drug (as defined in section 

14 201(g)) that is intended for human use; and 

15 ‘‘(B) does not include biological products 

16 (as defined in section 351 of the Public Health 

17 Service Act), unless otherwise provided by the 

18 Secretary in the regulations promulgated under 

19 subsection (h); 

20 ‘‘(2) the term ‘drug shortage’ or ‘shortage’, 

21 with respect to a drug, means a period of time when 

22 the demand or projected demand for the drug within 

23 the United States exceeds the supply of the drug; 

24 and 

25 ‘‘(3) the term ‘meaningful disruption’— 
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1 ‘‘(A) means a change in production that is 

2 reasonably likely to lead to a reduction in the 

3 supply of a drug by a manufacturer that is 

4 more than negligible and impacts the ability of 

5 the manufacturer to fill orders or meet expected 

6 demand for its product; and 

7 ‘‘(B) does not include interruptions in 

8 manufacturing due to matters such as routine 

9 maintenance or insignificant changes in manu10 facturing so long as the manufacturer expects 

11 to resume operations in a short period of time. 

12 ‘‘(g) DISTRIBUTION.—To the maximum extent prac13 ticable, the Secretary may distribute information on drug 

14 shortages and on the permanent discontinuation of the 

15 drugs described in this section to appropriate provider and 

16 patient organizations, except that any such distribution 

17 shall not include any information that is exempt from dis18 closure under section 552 of title 5, United States Code, 

19 by reason of subsection (b)(4) of such section. 

20 ‘‘(h) REGULATIONS.— 

21 ‘‘(1) IN GENERAL.—Not later than 18 months 

22 after the date of enactment of the Food and Drug 

23 Administration Safety and Innovation Act, the Sec24 retary shall adopt a final regulation implementing 

25 this section. 
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1 ‘‘(2) INCLUSION OF BIOLOGICAL PRODUCTS.— 

2 ‘‘(A) IN GENERAL.—The Secretary may by 

3 regulation apply this section to biological prod4 ucts (as defined in section 351 of the Public 

5 Health Service Act) if the Secretary determines 

6 such inclusion would benefit the public health. 

7 ‘‘(B) RULE FOR VACCINES.—If the Sec8 retary applies this section to vaccines pursuant 

9 to subparagraph (A), the Secretary shall— 

10 ‘‘(i) consider whether the notification 

11 requirement under subsection (a) may be 

12 satisfied by submitting a notification to the 

13 Centers for Disease Control and Preven14 tion under the vaccine shortage notification 

15 program of such Centers; and 

16 ‘‘(ii) explain the determination made 

17 by the Secretary under clause (i) in the 

18 regulation. 

19 ‘‘(3) PROCEDURE.—In promulgating a regula20 tion implementing this section, the Secretary shall— 

21 ‘‘(A) issue a notice of proposed rulemaking 

22 that includes the proposed regulation; 

23 ‘‘(B) provide a period of not less than 60 

24 days for comments on the proposed regulation; 

25 and 
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1 ‘‘(C) publish the final regulation not less 

2 than 30 days before the regulation’s effective 

3 date. 

4 ‘‘(4) RESTRICTIONS.—Notwithstanding any 

5 other provision of Federal law, in implementing this 

6 section, the Secretary shall only promulgate regula7 tions as described in paragraph (3).’’. 

8 (b) EFFECT OF NOTIFICATION.—The submission of 

9 a notification to the Secretary of Health and Human Serv10 ices (referred to in this section as the ‘‘Secretary’’) for 

11 purposes of complying with the requirement in section 

12 506C(a) of the Federal Food, Drug, and Cosmetic Act (as 

13 amended by subsection (a)) shall not be construed— 

14 (1) as an admission that any product that is 

15 the subject of such notification violates any provision 

16 of the Federal Food, Drug, and Cosmetic Act (21 

17 U.S.C. 301 et seq.); or 

18 (2) as evidence of an intention to promote or 

19 market the product for an indication or use for 

20 which the product has not been approved by the Sec21 retary. 

22 (c) INTERNAL REVIEW.—Not later than 2 years after 

23 the date of enactment of this Act, the Secretary shall— 

24 (1) analyze and review the regulations promul25 gated under the Federal Food, Drug, and Cosmetic 
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1 Act (21 U.S.C. 301 et seq.), the guidances or poli2 cies issued under such Act related to drugs intended 

3 for human use, and the practices of the Food and 

4 Drug Administration regarding enforcing such Act 

5 related to manufacturing of such drugs, to identify 

6 any such regulations, guidances, policies, or prac7 tices that cause, exacerbate, prevent, or mitigate 

8 drug shortages (as defined in section 506C of the 

9 Federal Food, Drug, and Cosmetic Act (as amended 

10 by subsection (a)); and 

11 (2) determine how regulations, guidances, poli12 cies, or practices identified under paragraph (1) 

13 should be modified, streamlined, expanded, or dis14 continued in order to reduce or prevent such drug 

15 shortages, taking into consideration the effect of any 

16 changes on the public health. 

17 (d) STUDY ON MARKET FACTORS CONTRIBUTING TO

18 DRUG SHORTAGES AND STOCKPILING.— 

19 (1) IN GENERAL.—Not later than 1 year after 

20 the date of enactment of this Act, the Comptroller 

21 General of the United States, in consultation with 

22 the Secretary, the Department of Health and 

23 Human Services Office of the Inspector General, the 

24 Attorney General, and Chairman of the Federal 

25 Trade Commission, shall publish a report reviewing 
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1 any findings that drug shortages (as so defined) 

2 have led market participants to stockpile affected 

3 drugs or sell them at significantly increased prices, 

4 the impact of such activities on Federal revenue, and 

5 any economic factors that have exacerbated or cre6 ated a market for such actions. 

7 (2) CONTENT.—The report under paragraph 

8 (1) shall include— 

9 (A) an analysis of the incidence of any of 

10 the activities described in paragraph (1) and 

11 the effect of such activities on the public health; 

12 (B) an evaluation of whether in such cases 

13 there is a correlation between drugs in shortage 

14 and— 

15 (i) the number of manufacturers pro16 ducing such drugs; 

17 (ii) the pricing structure, including 

18 Federal reimbursements, for such drugs 

19 before such drugs were in shortage, and to 

20 the extent possible, revenue received by 

21 each such manufacturer of such drugs; 

22 (iii) pricing structure and revenue, to 

23 the extent possible, for the same drugs 

24 when sold under the conditions described 

25 in paragraph (1); and 
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1 (iv) the impact of contracting prac2 tices by market participants (including 

3 manufacturers, distributors, group pur4 chasing organizations, and providers) on 

5 competition, access to drugs, and pricing 

6 of drugs; 

7 (C) whether the activities described in 

8 paragraph (1) are consistent with applicable 

9 law; and 

10 (D) recommendations to Congress on what, 

11 if any, additional reporting or enforcement ac12 tions are necessary. 

13 (3) TRADE SECRET AND CONFIDENTIAL INFOR14 MATION.—Nothing in this subsection alters or 

15 amends section 1905 of title 18, United States Code, 

16 or section 552(b)(4) of title 5, United States Code. 

17 (e) GUIDANCE REGARDING REPACKAGING.—Not 

18 later than 1 year after the date of enactment of this Act, 

19 the Secretary shall issue guidance that clarifies the policy 

20 of the Food and Drug Administration regarding hospital 

21 pharmacies repackaging and safely transferring repack22 aged drugs among hospitals within a common health sys23 tem during a drug shortage, as identified by the Secretary. 
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1 TITLE XI—OTHER PROVISIONS 

2 Subtitle A—Reauthorizations 

3 SEC. 1101. REAUTHORIZATION OF PROVISION RELATING TO 

4 EXCLUSIVITY OF CERTAIN DRUGS CON5 TAINING SINGLE ENANTIOMERS. 

6 (a) IN GENERAL.—Section 505(u)(4) (21 U.S.C. 

7 355(u)(4)) is amended by striking ‘‘2012’’ and inserting 

8 ‘‘2017’’. 

9 (b) AMENDMENT.—Section 505(u)(1)(A)(ii)(II) (21 

10 U.S.C. 355(u)(1)(A)(ii)(II)) is amended by inserting 

11 ‘‘clinical’’ after ‘‘any’’. 

12 SEC. 1102. REAUTHORIZATION OF THE CRITICAL PATH 

13 PUBLIC-PRIVATE PARTNERSHIPS. 

14 Section 566(f) (21 U.S.C. 360bbb–5(f)) is amended 

15 by striking ‘‘2012’’ and inserting ‘‘2017’’. 

16 Subtitle B—Medical Gas Product 

17 Regulation 

18 SEC. 1111. REGULATION OF MEDICAL GAS PRODUCTS. 

19 (a) REGULATION.—Chapter V (21 U.S.C. 351 et 

20 seq.) is amended by adding at the end the following: 

21 ‘‘Subchapter G—Medical Gas Products 

22 ‘‘SEC. 575. DEFINITIONS. 

23 ‘‘In this subchapter: 

24 ‘‘(1) The term ‘designated medical gas product’ 

25 means any of the following: 
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1 ‘‘(A) Oxygen, that meets the standards set 

2 forth in an official compendium. 

3 ‘‘(B) Nitrogen, that meets the standards 

4 set forth in an official compendium. 

5 ‘‘(C) Nitrous oxide, that meets the stand6 ards set forth in an official compendium. 

7 ‘‘(D) Carbon dioxide, that meets the stand8 ards set forth in an official compendium. 

9 ‘‘(E) Helium, that meets the standards set 

10 forth in an official compendium. 

11 ‘‘(F) Carbon monoxide, that meets the 

12 standards set forth in an official compendium. 

13 ‘‘(G) Medical air, that meets the standards 

14 set forth in an official compendium. 

15 ‘‘(H) Any other medical gas product 

16 deemed appropriate by the Secretary, unless 

17 any period of exclusivity under section 

18 505(c)(3)(E)(ii) or 505(j)(5)(F)(ii), or the ex19 tension of any such period under section 505A, 

20 applicable to such medical gas product has not 

21 expired. 

22 ‘‘(2) The term ‘medical gas product’ means a 

23 drug that— 

24 ‘‘(A) is manufactured or stored in a lique25 fied, nonliquefied, or cryogenic state; and 
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1 ‘‘(B) is administered as a gas. 

2 ‘‘SEC. 576. REGULATION OF MEDICAL GAS PRODUCTS. 

3 ‘‘(a) CERTIFICATION OF DESIGNATED MEDICAL GAS

4 PRODUCTS.— 

5 ‘‘(1) SUBMISSION.— 

6 ‘‘(A) IN GENERAL.—Beginning on the date 

7 of enactment of this section, any person may 

8 file with the Secretary a request for a certifi9 cation of a designated medical gas product. 

10 ‘‘(B) CONTENT.—A request under sub11 paragraph (A) shall contain— 

12 ‘‘(i) a description of the medical gas 

13 product; 

14 ‘‘(ii) the name and address of the 

15 sponsor; 

16 ‘‘(iii) the name and address of the fa17 cility or facilities where the gas product is 

18 or will be manufactured; and 

19 ‘‘(iv) any other information deemed 

20 appropriate by the Secretary to determine 

21 whether the medical gas product is a des22 ignated medical gas product. 

23 ‘‘(2) GRANT OF CERTIFICATION.—A certifi24 cation described under paragraph (1)(A) shall be de25 termined to have been granted unless, not later than 
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1 60 days after the filing of a request under para2 graph (1), the Secretary finds that— 

3 ‘‘(A) the medical gas product subject to 

4 the certification is not a designated medical gas 

5 product; 

6 ‘‘(B) the request does not contain the in7 formation required under paragraph (1) or oth8 erwise lacks sufficient information to permit the 

9 Secretary to determine that the gas product is 

10 a designated medical gas product; or 

11 ‘‘(C) granting the request would be con12 trary to public health. 

13 ‘‘(3) EFFECT OF CERTIFICATION.— 

14 ‘‘(A) IN GENERAL.— 

15 ‘‘(i) APPROVED USES.—A designated 

16 medical gas product for which a certifi17 cation is granted under paragraph (2) is 

18 deemed, alone or in combination with an19 other designated gas product or products 

20 as medically appropriate, to have in effect 

21 an approved application under section 505 

22 or 512, subject to all applicable post23 approval requirements, for the following in24 dications for use: 
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1 ‘‘(I) Oxygen for the treatment or 

2 prevention of hypoxemia or hypoxia. 

3 ‘‘(II) Nitrogen for use in hypoxic 

4 challenge testing. 

5 ‘‘(III) Nitrous oxide for analge6 sia. 

7 ‘‘(IV) Carbon dioxide for use in 

8 extracorporeal membrane oxygenation 

9 therapy or respiratory stimulation. 

10 ‘‘(V) Helium for the treatment of 

11 upper airway obstruction or increased 

12 airway resistance. 

13 ‘‘(VI) Medical air to reduce the 

14 risk of hyperoxia. 

15 ‘‘(VII) Carbon monoxide for use 

16 in lung diffusion testing. 

17 ‘‘(VIII) Any other indication for 

18 use for a designated medical gas prod19 uct or combination of designated med20 ical gas products deemed appropriate 

21 by the Secretary, unless any period of 

22 exclusivity under clause (iii) or (iv) of 

23 section 505(c)(3)(E), under clause 

24 (iii) or (iv) of section 505(j)(5)(F), or 

25 under section 527, or the extension of 
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1 any such period under section 505A, 

2 applicable to such indication for use 

3 for such gas product or combination 

4 of products has not expired. 

5 ‘‘(ii) LABELING.—The requirements 

6 established in sections 503(b)(4) and 

7 502(f) shall be deemed to have been met 

8 for a designated medical gas product if the 

9 labeling on final use containers of such gas 

10 product bears the information required by 

11 section 503(b)(4) and a warning statement 

12 concerning the use of the gas product, as 

13 determined by the Secretary by regulation, 

14 as well as appropriate directions and warn15 ings concerning storage and handling. 

16 ‘‘(B) INAPPLICABILITY OF EXCLUSIVITY

17 PROVISIONS.— 

18 ‘‘(i) EFFECT ON INELIGIBILITY.—No 

19 designated medical gas product deemed 

20 under paragraph (3)(A)(i) to have in effect 

21 an approved application shall be eligible for 

22 any periods of exclusivity under sections 

23 505(c), 505(j), or 527, or the extension of 

24 any such period under section 505A, on 

25 the basis of such deemed approval. 
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1 ‘‘(ii) EFFECT ON CERTIFICATION.— 

2 No period of exclusivity under sections 

3 505(c), 505(j), or section 527, or the ex4 tension of any such period under section 

5 505A, with respect to an application for a 

6 drug shall prohibit, limit, or otherwise af7 fect the submission, grant, or effect of a 

8 certification under this section, except as 

9 provided in paragraph (3)(A)(i)(VIII). 

10 ‘‘(4) WITHDRAWAL, SUSPENSION, OR REVOCA11 TION OF APPROVAL.— 

12 ‘‘(A) IN GENERAL.—Nothing in this sub13 chapter limits the authority of the Secretary to 

14 withdraw or suspend approval of a drug, includ15 ing a designated medical gas product deemed 

16 under this section to have in effect an approved 

17 application, under section 505 or section 512. 

18 ‘‘(B) REVOCATION.—The Secretary may 

19 revoke the grant of a certification under this 

20 section if the Secretary determines that the re21 quest for certification contains any material 

22 omission or falsification. 

23 ‘‘(b) PRESCRIPTION REQUIREMENT.— 

24 ‘‘(1) IN GENERAL.—A designated medical gas 

25 product shall be subject to section 503(b)(1) unless 
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1 the Secretary exercises the authority provided in sec2 tion 503(b)(3) to remove such gas product from the 

3 requirements of section 503(b)(1) or the use in ques4 tion is authorized pursuant to another provision of 

5 this Act relating to use of medical products in emer6 gencies. 

7 ‘‘(2) EXCEPTION FOR OXYGEN.— 

8 ‘‘(A) IN GENERAL.—Notwithstanding para9 graph (1), oxygen may be provided without a 

10 prescription for the following uses: 

11 ‘‘(i) The use in the event of depres12 surization or other environmental oxygen 

13 deficiency. 

14 ‘‘(ii) The use in the event of oxygen 

15 deficiency or use in emergency resuscita16 tion, when administered by properly 

17 trained personnel. 

18 ‘‘(B) LABELING.—For oxygen provided 

19 pursuant to subparagraph (A), the require20 ments established in section 503(b)(4) shall be 

21 deemed to have been met if the labeling of the 

22 oxygen bears a warning that the medical gas 

23 product can be used for emergency use only and 

24 for all other medical applications a prescription 

25 is required. 
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1 ‘‘(c) INAPPLICABILITY OF DRUGS FEES TO DES2 IGNATED MEDICAL GAS PRODUCTS.—A designated med3 ical gas product deemed under this section to have in ef4 fect an approved application shall not be assessed fees 

5 under section 736(a) on the basis of such deemed ap6 proval.’’. 

7 SEC. 1112. REGULATIONS. 

8 (a) REVIEW OF REGULATIONS.—Not later than 18 

9 months after the date of enactment of this Act, the Sec10 retary of Health and Human Services (referred to in this 

11 section as the ‘‘Secretary’’) shall, after obtaining input 

12 from medical gas product manufacturers, and any other 

13 interested members of the public, submit a report to the 

14 Committee on Health, Education, Labor, and Pensions of 

15 the Senate and the Committee on Energy and Commerce 

16 of the House of Representatives regarding any changes to 

17 the Federal drug regulations in title 21, Code of Federal 

18 Regulations that the Secretary determines to be necessary. 

19 (b) AMENDED REGULATIONS.—If the Secretary de20 termines that changes to the Federal drug regulations in 

21 title 21, Code of Federal Regulations are necessary under 

22 subsection (a), the Secretary shall issue final regulations 

23 implementing such changes not later than 4 years after 

24 the date of enactment of this Act. 
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1 SEC. 1113. APPLICABILITY. 

2 Nothing in this subtitle or the amendments made by 

3 this subtitle shall apply to— 

4 (1) a drug that is covered by an application 

5 under section 505 or 512 of the Federal Food, 

6 Drug, and Cosmetic Act (21 U.S.C. 355, 360b) ap7 proved prior to May 1, 2012; or 

8 (2) any of the gases listed in subparagraphs (A) 

9 through (G) of section 575(1) of such Act (as added 

10 by section 1111), or any mixture of any such gases, 

11 for an indication that— 

12 (A) is not included in, or is different from, 

13 those specified in subclauses (I) through (VII) 

14 of section 576(a)(3)(i) of such Act (as added by 

15 section 1111); and 

16 (B) is approved on or after May 1, 2012, 

17 pursuant to an application submitted under sec18 tion 505 or 512 of such Act. 

19 Subtitle C—Miscellaneous 

20 Provisions 

21 SEC. 1121. ADVISORY COMMITTEE CONFLICTS OF INTER22 EST. 

23 Section 712 (21 U.S.C. 379d–1) is amended— 

24 (1) in subsection (b)— 

25 (A) by striking paragraph (2); and 

26 (B) in paragraph (1)— 
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1 (i) by redesignating subparagraph (B) 

2 as paragraph (2) and moving such para3 graph, as so redesignated, 2 ems to the 

4 left; 

5 (ii) in subparagraph (A), by redesig6 nating clauses (i) through (iii) as subpara7 graphs (A) through (C), respectively, and 

8 moving such subparagraphs, as so redesig9 nated, 2 ems to the left; 

10 (iii) in subparagraph (A), as so redes11 ignated, by inserting ‘‘, including strategies 

12 to increase the number of special Govern13 ment employees across medical and sci14 entific specialties in areas where the Sec15 retary would benefit from specific sci16 entific, medical, or technical expertise nec17 essary for the performance of its regu18 latory responsibilities’’ before the semicolon 

19 at the end; 

20 (iv) by striking ‘‘(1) RECRUITMENT.— 

21 ’’ and inserting ‘‘(1) RECRUITMENT IN

22 GENERAL.—The Secretary shall—’’; 

23 (v) by striking ‘‘(A) IN GENERAL.— 

24 The Secretary shall—’’; 
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1 (vi) by redesignating clauses (i) 

2 through (iii) of paragraph (2) (as so redes3 ignated) as subparagraphs (A) through 

4 (C), respectively, and moving such sub5 paragraphs, as so redesignated, 2 ems to 

6 the left; 

7 (vii) in paragraph (2) (as so redesig8 nated), in the matter before subparagraph 

9 (A) (as so redesignated), by striking ‘‘sub10 paragraph (A)’’ and inserting ‘‘paragraph 

11 (1)’’; and 

12 (viii) by adding at the end the fol13 lowing: 

14 ‘‘(3) RECRUITMENT THROUGH REFERRALS.—In 

15 carrying out paragraph (1), the Secretary shall, in 

16 order to further the goal of including in advisory 

17 committees highly qualified and specialized experts 

18 in the specific diseases to be considered by such ad19 visory committees, at least every 180 days, request 

20 referrals from a variety of stakeholders, such as the 

21 Institute of Medicine, the National Institutes of 

22 Health, product developers, patient groups, disease 

23 advocacy organizations, professional societies, med24 ical societies, including the American Academy of 
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1 Medical Colleges, and other governmental organiza2 tions.’’; 

3 (2) by amending subsection (c)(2)(C) to read as 

4 follows: 

5 ‘‘(C) CONSIDERATION BY SECRETARY.— 

6 The Secretary shall ensure that each determina7 tion made under subparagraph (B) considers 

8 the type, nature, and magnitude of the financial 

9 interests at issue and the public health interest 

10 in having the expertise of the member with re11 spect to the particular matter before the advi12 sory committee.’’; 

13 (3) in subsection (e), by inserting ‘‘, and shall 

14 make publicly available,’’ after ‘‘House of Represent15 atives’’; and 

16 (4) by adding at the end the following: 

17 ‘‘(g) GUIDANCE ON REPORTED FINANCIAL INTEREST

18 OR INVOLVEMENT.—The Secretary shall issue guidance 

19 that describes how the Secretary reviews the financial in20 terests and involvement of advisory committee members 

21 that are reported under subsection (c)(1) but that the Sec22 retary determines not to meet the definition of a disquali23 fying interest under section 208 of title 18, United States 

24 Code for the purposes of participating in a particular mat25 ter.’’. 
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1 SEC. 1122. GUIDANCE DOCUMENT REGARDING PRODUCT 

2 PROMOTION USING THE INTERNET. 

3 Not later than 2 years after the date of enactment 

4 this Act, the Secretary of Health and Human Services 

5 shall issue guidance that describes Food and Drug Admin6 istration policy regarding the promotion, using the Inter7 net (including social media), of medical products that are 

8 regulated by such Administration. 

9 SEC. 1123. ELECTRONIC SUBMISSION OF APPLICATIONS. 

10 Subchapter D of chapter VII (21 U.S.C. 379k et 

11 seq.) is amended by inserting after section 745 the fol12 lowing: 

13 ‘‘SEC. 745A. ELECTRONIC FORMAT FOR SUBMISSIONS. 

14 ‘‘(a) DRUGS AND BIOLOGICS.— 

15 ‘‘(1) IN GENERAL.—Beginning no earlier than 

16 24 months after the issuance of a final guidance 

17 issued after public notice and opportunity for com18 ment, submissions under subsection (b), (i), or (j) of 

19 section 505 of this Act or subsection (a) or (k) of 

20 section 351 of the Public Health Service Act shall 

21 be submitted in such electronic format as specified 

22 by the Secretary in such guidance. 

23 ‘‘(2) GUIDANCE CONTENTS.—In the guidance 

24 under paragraph (1), the Secretary may— 

25 ‘‘(A) provide a timetable for establishment 

26 by the Secretary of further standards for elec-
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1 tronic submission as required by such para2 graph; and 

3 ‘‘(B) set forth criteria for waivers of and 

4 exemptions from the requirements of this sub5 section. 

6 ‘‘(3) EXCEPTION.—This subsection shall not 

7 apply to submissions described in section 561. 

8 ‘‘(b) DEVICES.— 

9 ‘‘(1) IN GENERAL.—Beginning after the 

10 issuance of final guidance implementing this para11 graph, pre-submissions and submissions for devices 

12 under section 510(k), 513(f)(2)(A), 515(c), 515(d), 

13 515(f), 520(g), 520(m), or 564 of this Act or section 

14 351 of the Public Health Service Act, and any sup15 plements to such pre-submissions or submissions, 

16 shall include an electronic copy of such pre-submis17 sions or submissions. 

18 ‘‘(2) GUIDANCE CONTENTS.—In the guidance 

19 under paragraph (1), the Secretary may— 

20 ‘‘(A) provide standards for the electronic 

21 copy required under such paragraph; and 

22 ‘‘(B) set forth criteria for waivers of and 

23 exemptions from the requirements of this sub24 section.’’. 
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1 SEC. 1124. COMBATING PRESCRIPTION DRUG ABUSE. 

2 (a) IN GENERAL.—To combat the significant rise in 

3 prescription drug abuse and the consequences of such 

4 abuse, the Secretary of Health and Human Services (re5 ferred to in this section as the ‘‘Secretary’’), acting 

6 through the Commissioner of Food and Drugs (referred 

7 to in this section as the ‘‘Commissioner’’) and in coordina8 tion with other Federal agencies, as appropriate, shall re9 view current Federal initiatives and identify gaps and op10 portunities with respect to ensuring the safe use and dis11 posal of prescription drugs with the potential for abuse. 

12 (b) REPORT.—Not later than 1 year after the date 

13 of enactment of this Act, the Secretary shall post a report 

14 on the Internet website of the Food and Drug Administra15 tion on the findings of the review under subsection (a). 

16 Such report shall include findings and recommendations 

17 on— 

18 (1) how best to leverage and build upon existing 

19 Federal and federally funded data sources, such as 

20 prescription drug monitoring program data and the 

21 sentinel initiative of the Food and Drug Administra22 tion under section 505(k)(3) of the Federal Food, 

23 Drug, and Cosmetic Act (21 U.S.C. 351(k)(3)), as 

24 it relates to collection of information relevant to ad25 verse events, patient safety, and patient outcomes, to 
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1 create a centralized data clearinghouse and early 

2 warning tool; 

3 (2) how best to develop and disseminate widely 

4 best practices models and suggested standard re5 quirements to States for achieving greater interoper6 ability and effectiveness of prescription drug moni7 toring programs, especially with respect to provider 

8 participation, producing standardized data on ad9 verse events, patient safety, and patient outcomes; 

10 and 

11 (3) how best to develop provider, pharmacist, 

12 and patient education tools and a strategy to widely 

13 disseminate such tools and assess the efficacy of 

14 such tools. 

15 (c) GUIDANCE ON ABUSE-DETERRENT PRODUCTS.— 

16 Not later than 6 months after the date of enactment of 

17 this Act, the Secretary, acting through the Commissioner, 

18 shall promulgate guidance on the development of abuse19 deterrent drug products. 

20 (d) STUDY AND REPORT ON PRESCRIPTION DRUG

21 ABUSE.—Not later than 1 year after the date of enact22 ment of this Act, the Secretary shall seek to enter into 

23 an agreement with the Institute of Medicine to conduct 

24 a study and report on prescription drug abuse. Such re25 port shall evaluate trends in prescription drug abuse, as-
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1 sess opportunities to inform and educate the public, pa2 tients, and health care providers on issues related to pre3 scription drug abuse and misuse, and identify potential 

4 barriers, if any, to prescription drug monitoring program 

5 participation and implementation. 

6 SEC. 1125. TANNING BED LABELING. 

7 Not later than 18 months after the date of enactment 

8 of this Act, the Secretary of Health and Human Services 

9 shall determine whether to amend the warning label re10 quirements for sunlamp products to include specific re11 quirements to more clearly and effectively convey the risks 

12 that such products pose for the development of irreversible 

13 damage to the eyes and skin, including skin cancer. 

14 SEC. 1126. OPTIMIZING GLOBAL CLINICAL TRIALS. 

15 Subchapter E of chapter V (21 U.S.C. 360bbb et 

16 seq.), as amended by section 903, is further amended by 

17 adding at the end the following: 

18 ‘‘SEC. 569A. OPTIMIZING GLOBAL CLINICAL TRIALS. 

19 ‘‘(a) IN GENERAL.—The Secretary shall— 

20 ‘‘(1) work with other regulatory authorities of 

21 similar standing, medical research companies, and 

22 international organizations to foster and encourage 

23 uniform, scientifically-driven clinical trial standards 

24 with respect to medical products around the world; 

25 and 
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1 ‘‘(2) enhance the commitment to provide con2 sistent parallel scientific advice to manufacturers 

3 seeking simultaneous global development of new 

4 medical products in order to— 

5 ‘‘(A) enhance medical product develop6 ment; 

7 ‘‘(B) facilitate the use of foreign data; and 

8 ‘‘(C) minimize the need to conduct duplica9 tive clinical studies, preclinical studies, or non10 clinical studies. 

11 ‘‘(b) MEDICAL PRODUCT.—In this section, the term 

12 ‘medical product’ means a drug, as defined in subsection 

13 (g) of section 201, a device, as defined in subsection (h) 

14 of such section, or a biological product, as defined in sec15 tion 351(i) of the Public Health Service Act. 

16 ‘‘(c) SAVINGS CLAUSE.—Nothing in this section shall 

17 alter the criteria for evaluating the safety or effectiveness 

18 of a medical product under this Act. 

19 ‘‘SEC. 569B. USE OF CLINICAL INVESTIGATION DATA FROM 

20 OUTSIDE THE UNITED STATES. 

21 ‘‘(a) IN GENERAL.—In determining whether to ap22 prove, license, or clear a drug or device pursuant to an 

23 application submitted under this chapter, the Secretary 

24 shall accept data from clinical investigations conducted 

25 outside of the United States, including the European 
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1 Union, if the applicant demonstrates that such data are 

2 adequate under applicable standards to support approval, 

3 licensure, or clearance of the drug or device in the United 

4 States. 

5 ‘‘(b) NOTICE TO SPONSOR.—If the Secretary finds 

6 under subsection (a) that the data from clinical investiga7 tions conducted outside the United States, including in the 

8 European Union, are inadequate for the purpose of mak9 ing a determination on approval, clearance, or licensure 

10 of a drug or device pursuant to an application submitted 

11 under this chapter, the Secretary shall provide written no12 tice to the sponsor of the application of such finding and 

13 include the rationale for such finding.’’. 

14 SEC. 1127. ADVANCING REGULATORY SCIENCE TO PRO15 MOTE PUBLIC HEALTH INNOVATION. 

16 (a) IN GENERAL.—Not later than 1 year after the 

17 date of enactment of this Act, the Secretary of Health and 

18 Human Services (referred to in this section as the ‘‘Sec19 retary’’) shall develop a strategy and implementation plan 

20 for advancing regulatory science for medical products in 

21 order to promote the public health and advance innovation 

22 in regulatory decisionmaking. 

23 (b) REQUIREMENTS.—The strategy and implementa24 tion plan developed under subsection (a) shall be con25 sistent with the user fee performance goals in the Pre-
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1 scription Drug User Fee Agreement commitment letter, 

2 the Generic Drug User Fee Agreement commitment letter, 

3 and the Biosimilar User Fee Agreement commitment let4 ter transmitted by the Secretary to Congress on January 

5 13, 2012, and the Medical Device User Fee Agreement 

6 commitment letter transmitted by the Secretary to Con7 gress on April 20, 2012, and shall— 

8 (1) identify a clear vision of the fundamental 

9 role of efficient, consistent, and predictable, science10 based decisions throughout regulatory decision11 making of the Food and Drug Administration with 

12 respect to medical products; 

13 (2) identify the regulatory science priorities of 

14 the Food and Drug Administration directly related 

15 to fulfilling the mission of the agency with respect 

16 to decisionmaking concerning medical products and 

17 allocation of resources towards such regulatory 

18 science priorities; 

19 (3) identify regulatory and scientific gaps that 

20 impede the timely development and review of, and 

21 regulatory certainty with respect to, the approval, li22 censure, or clearance of medical products, including 

23 with respect to companion products and new tech24 nologies, and facilitating the timely introduction and 
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1 adoption of new technologies and methodologies in a 

2 safe and effective manner; 

3 (4) identify clear, measurable metrics by which 

4 progress on the priorities identified under paragraph 

5 (2) and gaps identified under paragraph (3) will be 

6 measured by the Food and Drug Administration, in7 cluding metrics specific to the integration and adop8 tion of advances in regulatory science described in 

9 paragraph (5) and improving medical product deci10 sionmaking, in a predictable and science-based man11 ner; and 

12 (5) set forth how the Food and Drug Adminis13 tration will ensure that advances in regulatory 

14 science for medical products are adopted, as appro15 priate, on an ongoing basis and in an manner inte16 grated across centers, divisions, and branches of the 

17 Food and Drug Administration, including by senior 

18 managers and reviewers, including through the— 

19 (A) development, updating, and consistent 

20 application of guidance documents that support 

21 medical product decisionmaking; and 

22 (B) the adoption of the tools, methods, and 

23 processes under section 566 of the Federal 

24 Food, Drug, and Cosmetic Act (21 U.S.C. 

25 360bbb–5). 
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1 (c) ANNUAL PERFORMANCE REPORTS.—As part of 

2 the annual performance reports submitted to Congress 

3 under sections 736B(a) (as amended by section 104), 

4 738A(a) (as amended by section 204), 744C(a) (as added 

5 by section 303), and 744I(a) (as added by section 403) 

6 of the Federal Food, Drug, and Cosmetic Act for each 

7 of fiscal years 2013 through 2017, the Secretary shall an8 nually report on the progress made with respect to— 

9 (1) advancing the regulatory science priorities 

10 identified under paragraph (2) of subsection (b) and 

11 resolving the gaps identified under paragraph (3) of 

12 such subsection, including reporting on specific 

13 metrics identified under paragraph (4) of such sub14 section; 

15 (2) the integration and adoption of advances in 

16 regulatory science as set forth in paragraph (5) of 

17 such subsection; and 

18 (3) the progress made in advancing the regu19 latory science goals outlined in the Prescription 

20 Drug User Fee Agreement commitment letter, the 

21 Generic Drug User Fee Agreement commitment let22 ter, and the Biosimilar User Fee Agreement commit23 ment letter transmitted by the Secretary to Congress 

24 on January 13, 2012, and the Medical Device User 
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1 Fee Agreement transmitted by the Secretary to Con2 gress on April 20, 2012. 

3 (d) INDEPENDENT ASSESSMENT.—Not later than 

4 January 1, 2016, the Comptroller General of the United 

5 States shall submit to Congress a report— 

6 (1) detailing the progress made by the Food 

7 and Drug Administration in meeting the priorities 

8 and addressing the gaps identified in subsection (b), 

9 including any outstanding gaps; and 

10 (2) containing recommendations, as appro11 priate, on how regulatory science initiatives for med12 ical products can be strengthened and improved to 

13 promote the public health and advance innovation in 

14 regulatory decisionmaking. 

15 (e) MEDICAL PRODUCT.—In this section, the term 

16 ‘‘medical product’’ means a drug, as defined in subsection 

17 (g) of section 201 of the Federal Food, Drug, and Cos18 metic Act (21 U.S.C. 321), a device, as defined in sub19 section (h) of such section, or a biological product, as de20 fined in section 351(i) of the Public Health Service Act. 

21 SEC. 1128. INFORMATION TECHNOLOGY. 

22 (a) HHS REPORT.—Not later than 1 year after the 

23 date of enactment of this Act, the Secretary of Health and 

24 Human Services shall— 

25 (1) report to Congress on— 
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1 (A) the milestones and a completion date 

2 for developing and implementing a comprehen3 sive information technology strategic plan to 

4 align the information technology systems mod5 ernization projects with the strategic goals of 

6 the Food and Drug Administration, including 

7 results-oriented goals, strategies, milestones, 

8 performance measures; 

9 (B) efforts to finalize and approve a com10 prehensive inventory of the information tech11 nology systems of the Food and Drug Adminis12 tration that includes information describing 

13 each system, such as costs, system function or 

14 purpose, and status information, and incor15 porate use of the system portfolio into the in16 formation investment management process of 

17 the Food and Drug Administration; 

18 (C) the ways in which the Food and Drug 

19 Administration uses the plan described in sub20 paragraph (A) to guide and coordinate the 

21 modernization projects and activities of the 

22 Food and Drug Administration, including the 

23 interdependencies among projects and activities; 

24 and 
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1 (D) the extent to which the Food and 

2 Drug Administration has fulfilled or is imple3 menting recommendations of the Government 

4 Accountability Office with respect to the Food 

5 and Drug Administration and information tech6 nology; and 

7 (2) develop— 

8 (A) a documented enterprise architecture 

9 program management plan that includes the 

10 tasks, activities, and timeframes associated with 

11 developing and using the architecture and ad12 dresses how the enterprise architecture program 

13 management will be performed in coordination 

14 with other management disciplines, such as or15 ganizational strategic planning, capital planning 

16 and investment control, and performance man17 agement; and 

18 (B) a skills inventory, needs assessment, 

19 gap analysis, and initiatives to address skills 

20 gaps as part of a strategic approach to informa21 tion technology human capital planning. 

22 (b) GAO REPORT.—Not later than January 1, 2016, 

23 the Comptroller General of the United States shall issue 

24 a report regarding the strategic plan described in sub25 section (a)(1)(A) and related actions carried out by the 
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1 Food and Drug Administration. Such report shall assess 

2 the progress the Food and Drug Administration has made 

3 on— 

4 (1) the development and implementation of a 

5 comprehensive information technology strategic plan, 

6 including the results-oriented goals, strategies, mile7 stones, and performance measures identified in sub8 section (a)(1)(A); 

9 (2) the effectiveness of the comprehensive infor10 mation technology strategic plan described in sub11 section (a)(1)(A), including the results-oriented 

12 goals and performance measures; and 

13 (3) the extent to which the Food and Drug Ad14 ministration has fulfilled recommendations of the 

15 Government Accountability Office with respect to 

16 such agency and information technology. 

17 SEC. 1129. REPORTING REQUIREMENTS. 

18 Subchapter A of chapter VII (21 U.S.C. 371 et seq.), 

19 as amended by section 208, is further amended by adding 

20 at the end the following: 

21 ‘‘SEC. 715. REPORTING REQUIREMENTS. 

22 ‘‘(a) NEW DRUGS.—Beginning with fiscal year 2013 

23 and ending with fiscal year 2017, not later than 120 days 

24 after the end of each fiscal year for which fees are col25 lected under part 2 of subchapter C, the Secretary shall 
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1 prepare and submit to the Committee on Health Edu2 cation, Labor, and Pensions of the Senate and the Com3 mittee on Energy and Commerce of the House of Rep4 resentatives a report concerning, for all applications for 

5 approval of a new drug under section 505(b) of this Act 

6 or a new biological product under section 351(a) of the 

7 Public Health Service Act filed in the previous fiscal 

8 year— 

9 ‘‘(1) the number of such applications that met 

10 the goals identified for purposes of part 2 of sub11 chapter C in the letters from the Secretary of 

12 Health and Human Services to the Chairman of the 

13 Committee on Health, Education, Labor, and Pen14 sions of the Senate and the Chairman of the Com15 mittee on Energy and Commerce of the House of 

16 Representatives, as set forth in the Congressional 

17 Record; 

18 ‘‘(2) the percentage of such applications that 

19 were approved; 

20 ‘‘(3) the percentage of such applications that 

21 were issued complete response letters; 

22 ‘‘(4) the percentage of such applications that 

23 were subject to a refuse-to-file action; 

24 ‘‘(5) the percentage of such applications that 

25 were withdrawn; and 
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1 ‘‘(6) the average total time to decision by the 

2 Secretary for all applications for approval of a new 

3 drug under section 505(b) of this Act or a new bio4 logical product under section 351(a) of the Public 

5 Health Service Act filed in the previous fiscal year, 

6 including the number of calendar days spent during 

7 the review by the Food and Drug Administration 

8 and the number of calendar days spent by the spon9 sor responding to a complete response letter.’’. 

10 ‘‘(b) GENERIC DRUGS.—Beginning with fiscal year 

11 2013 and ending after fiscal year 2017, not later than 

12 120 days after the end of each fiscal year for which fees 

13 are collected under part 7 of subchapter C, the Secretary 

14 shall prepare and submit to the Committee on Health 

15 Education, Labor, and Pensions of the Senate and the 

16 Committee on Energy and Commerce of the House of 

17 Representatives a report concerning, for all applications 

18 for approval of a generic drug under section 505(j), 

19 amendments to such applications, and prior approval sup20 plements with respect to such applications filed in the pre21 vious fiscal year— 

22 ‘‘(1) the number of such applications that met 

23 the goals identified for purposes of part 7 of sub24 chapter C, in the letters from the Secretary of 

25 Health and Human Services to the Chairman of the 
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1 Committee on Health, Education, Labor, and Pen2 sions of the Senate and the Chairman of the Com3 mittee on Energy and Commerce of the House of 

4 Representatives, as set forth in the Congressional 

5 Record; 

6 ‘‘(2) the average total time to decision by the 

7 Secretary for applications for approval of a generic 

8 drug under section 505(j), amendments to such ap9 plications, and prior approval supplements with re10 spect to such applications filed in the previous fiscal 

11 year, including the number of calendar days spent 

12 during the review by the Food and Drug Adminis13 tration and the number of calendar days spent by 

14 the sponsor responding to a complete response let15 ter; 

16 ‘‘(3) the total number of applications under sec17 tion 505(j), amendments to such applications, and 

18 prior approval supplements with respect to such ap19 plications that were pending with the Secretary for 

20 more than 10 months on the date of enactment of 

21 the Food and Drug Administration Safety and Inno22 vation Act; and 

23 ‘‘(4) the number of applications described in 

24 paragraph (3) on which the Food and Drug Admin-
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1 istration took final regulatory action in the previous 

2 fiscal year. 

3 ‘‘(c) BIOSIMILAR BIOLOGICAL PRODUCTS.— 

4 ‘‘(1) IN GENERAL.—Beginning with fiscal year 

5 2014, not later than 120 days after the end of each 

6 fiscal year for which fees are collected under part 8 

7 of subchapter C, the Secretary shall prepare and 

8 submit to the Committee on Health Education, 

9 Labor, and Pensions of the Senate and the Com10 mittee on Energy and Commerce of the House of 

11 Representatives a report concerning— 

12 ‘‘(A) the number of applications for ap13 proval filed under section 351(k) of the Public 

14 Health Service Act; and 

15 ‘‘(B) the percentage of applications de16 scribed in subparagraph (A) that were approved 

17 by the Secretary. 

18 ‘‘(2) ADDITIONAL INFORMATION.—As part of 

19 the performance report described in paragraph (1), 

20 the Secretary shall include an explanation of how the 

21 Food and Drug Administration is managing the bio22 logical product review program to ensure that the 

23 user fees collected under part 2 are not used to re24 view an application under section 351(k) of the Pub25 lic Health Service Act.’’. 
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1 SEC. 1130. STRATEGIC INTEGRATED MANAGEMENT PLAN. 

2 (a) STRATEGIC INTEGRATED MANAGEMENT PLAN.— 

3 Not later than 1 year after the date of enactment of this 

4 Act, the Secretary of Health and Human Services (re5 ferred to in this section as the ‘‘Secretary’’) shall submit 

6 to Congress a strategic integrated management plan for 

7 the Center for Drug Evaluation and Research, the Center 

8 for Biologics Evaluation and Research, and the Center for 

9 Devices and Radiological Health. Such strategic manage10 ment plan shall— 

11 (1) identify strategic institutional goals and pri12 orities for the Center for Drug Evaluation and Re13 search, the Center for Biologics Evaluation and Re14 search, and the Center for Devices and Radiological 

15 Health; 

16 (2) describe the actions the Secretary will take 

17 to recruit, retain, train, and continue to develop the 

18 workforce at the Center for Drug Evaluation and 

19 Research, the Center for Biologics Evaluation and 

20 Research, and the Center for Devices and Radio21 logical Health to fulfill the public health mission of 

22 the Food and Drug Administration; and 

23 (3) identify results-oriented, outcome-based 

24 measures that the Secretary will use to measure the 

25 progress of achieving the strategic goals and prior26 ities identified under paragraph (1) and the effec-
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1 tiveness of the actions identified under paragraph 

2 (2), including metrics to ensure that managers and 

3 reviewers of the Center for Drug Evaluation and Re4 search, the Center for Biologics Evaluation and Re5 search, and the Center for Devices and Radiological 

6 Health are familiar with and appropriately and con7 sistently apply the requirements under the Federal 

8 Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 

9 seq.), including new requirements under parts 2, 3, 

10 7, and 8 of subchapter C of title VII of the Federal 

11 Food, Drug, and Cosmetic Act (21 U.S.C. 379f et 

12 seq.). 

13 (b) REPORT.—Not later than January 1, 2016, the 

14 Comptroller General of the United States shall issue a re15 port regarding the strategic management plan described 

16 in subsection (a) and related actions carried out by the 

17 Food and Drug Administration. Such report shall— 

18 (1) assess the effectiveness of the actions de19 scribed in subsection (a)(2) in recruiting, retaining, 

20 training, and developing the workforce at the Center 

21 for Drug Evaluation and Research, the Center for 

22 Biologics Evaluation and Research, and the Center 

23 for Devices and Radiological Health in fulfilling the 

24 public health mission of the Food and Drug Admin25 istration; 
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1 (2) assess the effectiveness of the measures 

2 identified under subsection (a)(3) in gauging 

3 progress against the strategic goals and priorities 

4 identified under subsection (a)(1); 

5 (3) assess the extent to which the Center for 

6 Drug Evaluation and Research, the Center for Bio7 logics Evaluation and Research, and the Center for 

8 Devices and Radiological Health are using the iden9 tified results-oriented set of performance measures 

10 in tracking their workload by strategic goals and the 

11 effectiveness of such measures; 

12 (4) assess the extent to which performance in13 formation is collected, analyzed, and acted on by 

14 managers; and 

15 (5) make recommendations, as appropriate, re16 garding how the strategic management plan and re17 lated actions of the Center for Drug Evaluation and 

18 Research, the Center for Biologics Evaluation and 

19 Research, and the Center for Devices and Radio20 logical Health could be improved to fulfill the public 

21 health mission of the Food and Drug Administration 

22 in as efficient and effective manner as possible. 

23 SEC. 1131. DRUG DEVELOPMENT AND TESTING. 

24 (a) IN GENERAL.—Section 505–1 (21 U.S.C. 355– 

25 1) is amended by adding at the end the following: 
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1 ‘‘(k) DRUG DEVELOPMENT AND TESTING.— 

2 ‘‘(1) IN GENERAL.—Notwithstanding any other 

3 provision of law, if a drug is a covered drug, no ele4 ments to ensure safe use shall prohibit, or be con5 strued or applied to prohibit, supply of such drug to 

6 any eligible drug developer for the purpose of con7 ducting testing necessary to support an application 

8 under subsection (b)(2) or (j) of section 505 of this 

9 Act or section 351(k) of the Public Health Service 

10 Act, if the Secretary has issued a written notice de11 scribed in paragraph (2), and the eligible drug devel12 oper has agreed to comply with the terms of the no13 tice. 

14 ‘‘(2) WRITTEN NOTICE.—For purposes of this 

15 subsection, the Secretary shall, within a reasonable 

16 period of time, consider and respond to a request by 

17 an eligible drug developer for a written notice au18 thorizing the supply of a covered drug for purposes 

19 of testing as described in paragraph (1), and the 

20 Secretary shall issue a written notice to such eligible 

21 drug developer and the holder of an application for 

22 a covered drug authorizing the supply of such drug 

23 to such eligible drug developer for purposes of test24 ing if— 
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1 ‘‘(A) the eligible drug developer has agreed 

2 to comply with any conditions the Secretary 

3 considers necessary; 

4 ‘‘(B) in the event the eligible drug devel5 oper is conducting bioequivalence or other clin6 ical testing, the eligible drug developer has sub7 mitted, and the Secretary has approved, a pro8 tocol that includes protections that the Sec9 retary finds will provide assurance of safety 

10 comparable to the assurance of safety provided 

11 by the elements to ensure safe use in the risk 

12 evaluation and mitigation strategy for the cov13 ered drug as applicable to such testing; and 

14 ‘‘(C) the eligible drug developer is in com15 pliance with applicable laws and regulations re16 lated to such testing, including any applicable 

17 requirements related to Investigational New 

18 Drug Applications or informed consent. 

19 ‘‘(3) ADDITIONAL REQUIRED ELEMENT.—The 

20 Secretary shall require as an element of each risk 

21 evaluation and mitigation strategy with elements to 

22 ensure safe use approved by the Secretary that the 

23 holder of an application for a covered drug shall not 

24 restrict the resale of the covered drug to an eligible 

25 drug developer that receives a written notice from 
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1 the Secretary under paragraph (2) unless, at any 

2 time, the Secretary provides written notice to the 

3 holder of the application directing otherwise based 

4 on a shortage of such drug for patients, national se5 curity concerns related to access to such drug, or 

6 such other reason as the Secretary may specify. 

7 ‘‘(4) VIOLATION AND PENALTIES.—For pur8 poses of subsection (f)(8) and sections 301, 

9 303(f)(4), 502(y), and 505(p), it shall be a violation 

10 of the risk evaluation and mitigation strategy for the 

11 holder of the application for a covered drug to vio12 late the element described in paragraph (3), or in 

13 the case of a holder of an application that is a sole 

14 distributor or supplier of a covered drug, to prevent 

15 the sale thereof after receipt of a written notice by 

16 the Secretary issued under paragraph (2). The Sec17 retary shall provide written notice to the Committee 

18 on Health, Education, Labor, and Pensions of the 

19 Senate and the Committee on Energy and Com20 merce of the House of Representatives within 30 

21 days of the Secretary becoming aware that a holder 

22 of an application of a covered drug has restricted 

23 the sale of such a covered drug to any eligible drug 

24 developer after receipt of written notice as provided 

25 in paragraph (2). 
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1 ‘‘(5) LIABILITY.—Unless the holder of the ap2 plication for a covered drug and the eligible devel3 oper are the same entity, the holder of an applica4 tion for a covered drug shall not be liable for any 

5 claim arising out of the eligible drug developer’s 

6 testing necessary to support an application under 

7 subsection (b)(2) or (j) of section 505 of this Act or 

8 section 351(k) of the Public Health Service Act for 

9 a drug obtained under this subsection. Nothing in 

10 this subsection shall be construed to expand or limit 

11 the liability of the eligible drug developer or the 

12 holder of an application for a covered drug for any 

13 other claim. 

14 ‘‘(6) CERTIFICATION.—In any request for sup15 ply of a covered drug for purposes of testing as de16 scribed in paragraph (1), an eligible drug developer 

17 shall certify to the Secretary that— 

18 ‘‘(A) the eligible drug developer will comply 

19 with all conditions the Secretary considers nec20 essary, any protocol approved by the Secretary, 

21 and all applicable laws and regulations per22 taining to such testing; and 

23 ‘‘(B) the eligible drug developer intends to 

24 submit an application under subsection (b)(2) 

25 or (j) of section 505 of this Act or section 
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1 351(k) of the Public Health Service Act for the 

2 drug for which it is requesting written notice 

3 pursuant to paragraph (2), and will use the 

4 covered drug only for the purpose of conducting 

5 testing to support such an application. 

6 ‘‘(7) DEFINITIONS.— 

7 ‘‘(A) COVERED DRUG.—Notwithstanding 

8 subsection (b)(2), for purposes of this sub9 section, the term ‘covered drug’ means a drug, 

10 including a biological product licensed under 

11 section 351(a) of the Public Health Service Act, 

12 that is subject to a risk evaluation and mitiga13 tion strategy with elements to ensure safe use 

14 under subsection (f), or a drug, including a bio15 logical product licensed under section 351(a) of 

16 the Public Health Service Act, required to have 

17 a risk evaluation and mitigation strategy with 

18 elements to ensure safe use under section 

19 909(b) of the Food and Drug Administration 

20 Amendments Act of 2007. 

21 ‘‘(B) ELIGIBLE DRUG DEVELOPER.—For 

22 purposes of this subsection, the term ‘eligible 

23 drug developer’ means a sponsor that has sub24 mitted, or intends to submit, an application 

25 under subsection (b)(2) or (j) of section 505 of 
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1 this Act or section 351(k) of the Public Health 

2 Service Act to market a version of the covered 

3 drug in the United States. 

4 ‘‘(8) EFFECT ON OTHER LAW.—Notwith5 standing the provisions of this subsection, the anti6 trust statutes enforced by the Federal Trade Com7 mission, including the Federal Trade Commission 

8 Act (15 U.S.C. 41–58), the Sherman Act (15 U.S.C. 

9 1–7), and any other statute properly under such 

10 Commission’s jurisdiction, shall apply to the conduct 

11 described in this subsection to the same extent as 

12 such statutes did on the day before the date of en13 actment of this subsection.’’. 

14 (b) TECHNICAL AND CONFORMING AMENDMENTS.— 

15 (1) Section 505–1(c)(2) (21 U.S.C. 355– 

16 1(c)(2)) is amended by striking ‘‘(e) and (f)’’ and in17 serting ‘‘(e), (f), and (k)(3)’’. 

18 (2) Section 502(y) (21 U.S.C. 352(y)) is 

19 amended by striking ‘‘’’(d), (e), or (f) of section 

20 505–1’’ and inserting ‘‘(d), (e), (f), or (k)(3) of sec21 tion 505–1’’. 
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1 SEC. 1132. PATIENT PARTICIPATION IN MEDICAL PRODUCT 

2 DISCUSSIONS. 

3 Subchapter E of chapter V (21 U.S.C. 360bbb et 

4 seq.), as amended by section 1126, is further amended by 

5 adding at the end the following: 

6 ‘‘SEC. 569C. PATIENT PARTICIPATION IN MEDICAL PROD7 UCT DISCUSSION. 

8 ‘‘(a) IN GENERAL.—The Secretary shall develop and 

9 implement strategies to solicit the views of patients during 

10 the medical product development process and consider the 

11 perspectives of patients during regulatory discussions, in12 cluding by— 

13 ‘‘(1) fostering participation of a patient rep14 resentative who may serve as a special government 

15 employee in appropriate agency meetings with med16 ical product sponsors and investigators; and 

17 ‘‘(2) exploring means to provide for identifica18 tion of patient representatives who do not have any, 

19 or have minimal, financial interests in the medical 

20 products industry. 

21 ‘‘(b) FINANCIAL INTEREST.—In this section, the 

22 term ‘financial interest’ means a financial interest under 

23 section 208(a) of title 18, United States Code.’’. 
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1 SEC. 1133. NANOTECHNOLOGY REGULATORY SCIENCE PRO2 GRAM. 

3 (a) IN GENERAL.—Chapter X (21 U.S.C. 391 et 

4 seq.) is amended by adding at the end the following: 

5 ‘‘SEC. 1013. NANOTECHNOLOGY REGULATORY SCIENCE 

6 PROGRAM. 

7 ‘‘(a) IN GENERAL.—Not later than 180 days after 

8 the date of enactment of the Food and Drug Administra9 tion Safety and Innovation Act, the Secretary, in consulta10 tion as appropriate with the Secretary of Agriculture, shall 

11 establish within the Food and Drug Administration a 

12 Nanotechnology Regulatory Science Program (referred to 

13 in this section as the ‘program’) to enhance scientific 

14 knowledge regarding nanomaterials included or intended 

15 for inclusion in products regulated under this Act or other 

16 statutes administered by the Food and Drug Administra17 tion, to address issues relevant to the regulation of those 

18 products, including the potential toxicology of such mate19 rials, the effects of such materials on biological systems, 

20 and interaction of such materials with biological systems. 

21 ‘‘(b) PROGRAM PURPOSES.—The purposes of the pro22 gram established under subsection (a) may include— 

23 ‘‘(1) assessing scientific literature and data on 

24 general nanomaterials interactions with biological 

25 systems and on specific nanomaterials of concern to 

26 the Food and Drug Administration; 
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1 ‘‘(2) in cooperation with other Federal agencies, 

2 developing and organizing information using data3 bases and models that will facilitate the identifica4 tion of generalized principles and characteristics re5 garding the behavior of classes of nanomaterials 

6 with biological systems; 

7 ‘‘(3) promoting Food and Drug Administration 

8 programs and participate in collaborative efforts, to 

9 further the understanding of the science of novel 

10 properties of nanomaterials that might contribute to 

11 toxicity; 

12 ‘‘(4) promoting and participating in collabo13 rative efforts to further the understanding of meas14 urement and detection methods for nanomaterials; 

15 ‘‘(5) collecting, synthesizing, interpreting, and 

16 disseminating scientific information and data related 

17 to the interactions of nanomaterials with biological 

18 systems; 

19 ‘‘(6) building scientific expertise on nanomate20 rials within the Food and Drug Administration, in21 cluding field and laboratory expertise, for monitoring 

22 the production and presence of nanomaterials in do23 mestic and imported products regulated under this 

24 Act; 
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1 ‘‘(7) ensuring ongoing training, as well as dis2 semination of new information within the centers of 

3 the Food and Drug Administration, and more broad4 ly across the Food and Drug Administration, to en5 sure timely, informed consideration of the most cur6 rent science pertaining to nanomaterials; 

7 ‘‘(8) encouraging the Food and Drug Adminis8 tration to participate in international and national 

9 consensus standards activities pertaining to nano10 materials; and 

11 ‘‘(9) carrying out other activities that the Sec12 retary determines are necessary and consistent with 

13 the purposes described in paragraphs (1) through 

14 (8). 

15 ‘‘(c) PROGRAM ADMINISTRATION.— 

16 ‘‘(1) DESIGNATED INDIVIDUAL.—In carrying 

17 out the program under this section, the Secretary, 

18 acting through the Commissioner of Food and 

19 Drugs, may designate an appropriately qualified in20 dividual who shall supervise the planning, manage21 ment, and coordination of the program. 

22 ‘‘(2) DUTIES.—The duties of the individual des23 ignated under paragraph (1) may include— 
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1 ‘‘(A) developing a detailed strategic plan 

2 for achieving specific short- and long-term tech3 nical goals for the program; 

4 ‘‘(B) coordinating and integrating the stra5 tegic plan with activities by the Food and Drug 

6 Administration and other departments and 

7 agencies participating in the National Nano8 technology Initiative; and 

9 ‘‘(C) developing Food and Drug Adminis10 tration programs, contracts, memoranda of 

11 agreement, joint funding agreements, and other 

12 cooperative arrangements necessary for meeting 

13 the long-term challenges and achieving the spe14 cific technical goals of the program. 

15 ‘‘(d) REPORT.—Not later than March 15, 2015, the 

16 Secretary shall publish on the Internet Web site of the 

17 Food and Drug Administration a report on the program 

18 carried out under this section. Such report shall include— 

19 ‘‘(1) a review of the specific short- and long20 term goals of the program; 

21 ‘‘(2) an assessment of current and proposed 

22 funding levels for the program, including an assess23 ment of the adequacy of such funding levels to sup24 port program activities; and 
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1 ‘‘(3) a review of the coordination of activities 

2 under the program with other departments and 

3 agencies participating in the National Nanotechnol4 ogy Initiative. 

5 ‘‘(e) EFFECT OF SECTION.—Nothing in this section 

6 shall affect the authority of the Secretary under any other 

7 provision of this Act or other statutes administered by the 

8 Food and Drug Administration.’’. 

9 (b) EFFECTIVE DATE; SUNSET.—The Nanotechnol10 ogy Regulatory Science Program authorized under section 

11 1013 of the Federal Food, Drug, and Cosmetic Act (as 

12 added by subsection (a)) shall take effect on October 1, 

13 2012, or the date of the enactment of this Act, whichever 

14 is later. Such Program shall cease to be effective October 

15 1, 2017. 

16 SEC. 1134. ONLINE PHARMACY REPORT TO CONGRESS. 

17 Not later than 1 year after the date of enactment 

18 of this Act, the Comptroller General of the United States 

19 shall submit to the Committee on Health, Education, 

20 Labor, and Pensions of the Senate and the Committee on 

21 Energy and Commerce of the House of Representatives 

22 a report that describes any problems posed by pharmacy 

23 Internet websites that violate Federal or State law, includ24 ing— 
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1 (1) the methods by which Internet websites are 

2 used to sell prescription drugs in violation of Federal 

3 or State law or established industry standards; 

4 (2) the harmful health effects that patients ex5 perience when they consume prescription drugs pur6 chased through such pharmacy Internet websites; 

7 (3) efforts by the Federal Government and 

8 State and local governments to investigate and pros9 ecute the owners or operators of pharmacy Internet 

10 websites, to address the threats such websites pose, 

11 and to protect patients; 

12 (4) the level of success that Federal, State, and 

13 local governments have experienced in investigating 

14 and prosecuting such cases; 

15 (5) whether the law, as in effect on the date of 

16 the report, provides sufficient authorities to Federal, 

17 State, and local governments to investigate and 

18 prosecute the owners and operators of pharmacy 

19 Internet websites; 

20 (6) additional authorities that could assist Fed21 eral, State, and local governments in investigating 

22 and prosecuting the owners and operators of phar23 macy Internet websites; 

24 (7) laws, policies, and activities that would edu25 cate consumers about how to distinguish pharmacy 
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1 Internet websites that comply with Federal and 

2 State laws and established industry standards from 

3 those pharmacy Internet websites that do not com4 ply with such laws and standards; and 

5 (8) laws, policies, and activities that would en6 courage private sector actors to take steps to ad7 dress the prevalence of illegitimate pharmacy Inter8 net websites. 

9 SEC. 1135. MEDICATION AND DEVICE ERRORS. 

10 The Secretary of Health and Human Services shall 

11 continue and further coordinate activities of the Depart12 ment of Health and Human Services related to the preven13 tion of medication and device errors, including consider14 ation of medication and device errors that affect the pedi15 atric patient population. In developing initiatives to ad16 dress medication and device errors, the Secretary shall 

17 consider the root causes of medication and device errors, 

18 including pediatric medication and device errors, in the 

19 clinical setting and consult with relevant stakeholders on 

20 effective strategies to reduce and prevent medication and 

21 device errors in the clinical setting. 

22 SEC. 1136. COMPLIANCE PROVISION. 

23 The budgetary effects of this Act, for the purpose of 

24 complying with the Statutory Pay-As-You-Go-Act of 2010, 

25 shall be determined by reference to the latest statement 
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1 titled ‘‘Budgetary Effects of PAYGO Legislation’’ for this 

2 Act, submitted for printing in the Congressional Record 

3 by the Chairman of the Senate Budget Committee, pro4 vided that such statement has been submitted prior to the 

5 vote on passage. 

6 SEC. 1137. ENSURING ADEQUATE INFORMATION REGARD7 ING PHARMACEUTICALS FOR ALL POPU8 LATIONS, PARTICULARLY UNDERREP9 RESENTED SUBPOPULATIONS, INCLUDING 

10 RACIAL SUBGROUPS. 

11 (a) COMMUNICATION PLAN.—The Secretary of 

12 Health and Human Services (referred to in this section 

13 as the ‘‘Secretary’’), acting through the Commissioner of 

14 Food and Drugs, shall review and modify, as necessary, 

15 the Food and Drug Administration’s communication plan 

16 to inform and educate health care providers, patients, and 

17 payors on the benefits and risks of medical products, with 

18 particular focus on underrepresented subpopulations, in19 cluding racial subgroups. 

20 (b) CONTENT.—The communication plan described 

21 under subsection (a)— 

22 (1) shall take into account— 

23 (A) the goals and principles set forth in 

24 the Strategic Action Plan to Reduce Racial and 
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1 Ethnic Health Disparities issued by the Depart2 ment of Health and Human Services; 

3 (B) the nature of the medical product; and 

4 (C) health and disease information avail5 able from other agencies within such Depart6 ment, as well as any new means of commu7 nicating health and safety benefits and risks re8 lated to medical products; 

9 (2) taking into account the nature of the med10 ical product, shall address the best strategy for com11 municating safety alerts, labeled indications for the 

12 medical products, changes to the label or labeling of 

13 medical products (including black box warnings, 

14 health advisories, health and safety benefits and 

15 risks), particular actions to be taken by healthcare 

16 professionals and patients, any information identi17 fying particular subpopulations, and any other rel18 evant information as determined appropriate to en19 hance communication, including varied means of 

20 electronic communication; and 

21 (3) shall include a process for implementation 

22 of any improvements or other modifications deter23 mined to be necessary. 

24 (c) ISSUANCE AND POSTING OF COMMUNICATION

25 PLAN.— 
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1 (1) COMMUNICATION PLAN.—Not later than 1 

2 year after the date of enactment of this Act, the 

3 Secretary, acting through the Commissioner of Food 

4 and Drugs, shall issue the communication plan de5 scribed under this section. 

6 (2) POSTING OF COMMUNICATION PLAN ON THE

7 OFFICE OF MINORITY HEALTH WEBSITE.—The Sec8 retary, acting through the Commissioner of Food 

9 and Drugs, shall publicly post the communication 

10 plan on the Internet website of the Office of Minor11 ity Health of the Food and Drug Administration, 

12 and provide links to any other appropriate webpage, 

13 and seek public comment on the communication 

14 plan. 

15 SEC. 1138. REPORT ON SMALL BUSINESSES. 

16 Not later than 1 year after the date of enactment 

17 of this Act, the Commissioner of Food and Drugs shall 

18 submit a report to Congress that includes— 

19 (1) a listing of and staffing levels of all small 

20 business offices at the Food and Drug Administra21 tion, including the small business liaison program; 

22 (2) the status of partnership efforts between 

23 the Food and Drug Administration and the Small 

24 Business Administration; 
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1 (3) a summary of outreach efforts to small 

2 businesses and small business associations, including 

3 availability of toll-free telephone help lines; 

4 (4) with respect to the program under the Or5 phan Drug Act (Public Law 97–414), the number of 

6 applications made by small businesses and number 

7 of applications approved for research grants, the 

8 amount of tax credits issued for clinical research, 

9 and the number of companies receiving protocol as10 sistance for the development of drugs for rare dis11 eases and disorders; 

12 (5) with respect to waivers and reductions for 

13 small business under the Prescription Drug User 

14 Fee Act, the number of small businesses applying 

15 for and receiving waivers and reductions from drug 

16 user fees under subchapter C of chapter VII of the 

17 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

18 379f et seq.); 

19 (6) the number of small businesses submitting 

20 applications and receiving approval for unsolicited 

21 grant applications from the Food and Drug Admin22 istration; 

23 (7) the number of small businesses submitting 

24 applications and receiving approval for solicited 
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1 grant applications from the Food and Drug Admin2 istration; 

3 (8) barriers small businesses encounter in the 

4 drug and medical device approval process; and 

5 (9) recommendations for changes in the user 

6 fee structure to help alleviate generic drug short7 ages. 

8 SEC. 1139. PROTECTIONS FOR THE COMMISSIONED CORPS 

9 OF THE PUBLIC HEALTH SERVICE ACT. 

10 (a) IN GENERAL.—Section 221(a) of the Public 

11 Health Service Act (42 U.S.C. 213a(a)) is amended by 

12 adding at the end the following: 

13 ‘‘(18) Section 1034, Protected Communications; 

14 Prohibition of Retaliatory Personnel Actions.’’. 

15 (b) CONFORMING AMENDMENT.—Section 221(b) of 

16 the Public Health Service Act (42 U.S.C. 213a(b)) is 

17 amended by adding at the end the following: ‘‘For pur18 poses of paragraph (18) of subsection (a), the term ‘In19 spector General’ in section 1034 of such title 10 shall 

20 mean the Inspector General of the Department of Health 

21 and Human Services.’’. 

22 SEC. 1140. REGULATIONS ON CLINICAL TRIAL REGISTRA23 TION; GAO STUDY OF CLINICAL TRIAL REG24 ISTRATION AND REPORTING REQUIREMENTS. 

25 (a) DEFINITIONS.—In this section— 
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1 (1) the term ‘‘applicable clinical trial’’ has the 

2 meaning given such term under section 402(j) of the 

3 Public Health Service Act (42 U.S.C. 282(j)); 

4 (2) the term ‘‘Director’’ means the Director of 

5 the National Institutes of Health; 

6 (3) the term ‘‘responsible party’’ has the mean7 ing given such term under such section 402(j); and 

8 (4) the term ‘‘Secretary’’ means the Secretary 

9 of Health and Human Services. 

10 (b) REQUIRED REGULATIONS.— 

11 (1) PROPOSED RULEMAKING.—Not later than 

12 180 days after the date of enactment of this Act, the 

13 Secretary, acting through the Director, shall issue a 

14 notice of proposed rulemaking for a proposed rule on 

15 the registration of applicable clinical trials by re16 sponsible parties under section 402(j) of the Public 

17 Health Service Act (42 U.S.C. 282(j)) (as amended 

18 by section 801 of the Food and Drug Administration 

19 Amendments Act of 2007). 

20 (2) FINAL RULE.—Not later than 180 days 

21 after the issuance of the notice of proposed rule22 making under paragraph (1), the Secretary, acting 

23 through the Director, shall issue the final rule on 

24 the registration of applicable clinical trials by re25 sponsible parties under such section 402(j). 
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1 (3) LETTER TO CONGRESS.—If the final rule 

2 described in paragraph (2) is not issued by the date 

3 required under such paragraph, the Secretary shall 

4 submit to Congress a letter that describes the rea5 sons why such final rule has not been issued. 

6 (c) REPORT BY GAO.— 

7 (1) IN GENERAL.—Not later than 2 years after 

8 the issuance of the final rule under subsection (b), 

9 the Comptroller General of the United States shall 

10 submit to the Committee on Health, Education, 

11 Labor, and Pensions of the Senate and the Com12 mittee on Energy and Commerce of the House of 

13 Representatives a report on the implementation of 

14 the registration and reporting requirements for ap15 plicable drug and device clinical trials under section 

16 402(j) the Public Health Service Act (42 U.S.C. 

17 282(j)) (as amended by section 801 of the Food and 

18 Drug Administration Amendments Act of 2007). 

19 (2) CONTENT.—The report under paragraph 

20 (1) shall include— 

21 (A) information on the rate of compliance 

22 and non-compliance (by category of sponsor, 

23 category of trial (phase II, III, or IV), whether 

24 the applicable clinical trial is conducted domes25 tically, in foreign sites, or a combination of 
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1 sites, and such other categories as the Comp2 troller General determines useful) with the re3 quirements of— 

4 (i) registering applicable clinical trials 

5 under such section 402(j); 

6 (ii) reporting the results of such trials 

7 under such section; and 

8 (iii) the completeness of the reporting 

9 of the required data under such section; 

10 and 

11 (B) information on the promulgation of 

12 regulations for the registration of applicable 

13 clinical trials by the responsible parties under 

14 such section 402(j). 

15 (3) RECOMMENDATIONS.—If the Comptroller 

16 General finds problems with timely compliance or 

17 completeness of the data being reported under such 

18 section 402(j), or finds that the implementation of 

19 registration and reporting requirements under such 

20 section 402(j) for applicable drug and device clinical 

21 trials could be improved, the Comptroller General 

22 shall, after consulting with the Commissioner of 

23 Food and Drugs, applicable stakeholders, and ex24 perts in the conduct of clinical trials, make rec25 ommendations for administrative or legislative ac-
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1 tions to increase the compliance with the require2 ments of such section 402(j). 

3 SEC. 1141. HYDROCODONE AMENDMENT. 

4 The Controlled Substances Act is amended— 

5 (1) in schedule III(d) in section 202(c) (21 

6 U.S.C. 812(c)), by— 

7 (A) striking paragraphs (3) and (4); and 

8 (B) redesignating paragraphs (5), (6), (7), 

9 and (8) as paragraphs (3), (4), (5), and (6), re10 spectively; and 

11 (2) in section 401(b)(1) (21 U.S.C. 841(b)(1)), 

12 by adding at the end the following: 

13 ‘‘(F) In the case of any material, compound, 

14 mixture, or preparation containing— 

15 ‘‘(i) not more than 300 milligrams of 

16 dihydrocodeinone per 100 milliliters or not 

17 more than 15 milligrams per dosage unit, with 

18 a fourfold or greater quantity of an isoquinoline 

19 alkaloid of opium; or 

20 ‘‘(ii) not more than 300 milligrams of 

21 dihydrocodeinone per 100 milliliters or not 

22 more than 15 milligrams per dosage unit, with 

23 one or more active, nonnarcotic ingredients in 

24 recognized therapeutic amounts, 
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1 subparagraph (C) shall not apply and such case 

2 shall be subject to subparagraph (E).’’. 

3 SEC. 1142. COMPLIANCE DATE FOR RULE RELATING TO 

4 SUNSCREEN DRUG PRODUCTS FOR OVER5 THE-COUNTER HUMAN USE. 

6 In accordance with the final rule issued by the Com7 missioner of Food and Drug entitled ‘‘Labeling and Effec8 tiveness Testing; Sunscreen Drug Products for Over-the9 Counter Human Use; Delay of Compliance Dates’’ (77 

10 Fed. Reg. 27591 (May 11, 2012)), a product subject to 

11 the final rule issued by the Commissioner entitled ‘‘Label12 ing and Effectiveness Testing; Sunscreen Drug Products 

13 for Over-the-Counter Human Use’’ (76 Fed. Reg. 35620 

14 (June 17, 2011)), shall comply with such rule not later 

15 than— 

16 (1) December 17, 2013, for products subject to 

17 such rule with annual sales of less than $25,000 and 

18 (2) December 17, 2012, for all other products 

19 subject to such rule. 

20 SEC. 1143. RECOMMENDATIONS ON INTEROPERABILITY 

21 STANDARDS. 

22 (a) IN GENERAL.—The Attorney General and the 

23 Secretary of Health and Human Services may collaborate 

24 to facilitate the development of recommendations on inter25 operability standards to inform and facilitate the exchange 
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1 of prescription information across State lines by States re2 ceiving grant funds under— 

3 (1) the Harold Rogers Prescription Drug Moni4 toring Program established under the Departments 

5 of Commerce, Justice, and State, the Judiciary, and 

6 Related Agencies Appropriations Act, 2002 (Public 

7 Law 107–77; 115 Stat. 748); and 

8 (2) the Controlled Substance Monitoring Pro9 gram established under section 399O of the Public 

10 Health Service Act (42 U.S.C. 280g–3). 

11 (b) REQUIREMENTS.—The Attorney General and the 

12 Secretary of Health and Human Services shall consider 

13 the following in facilitating the development of rec14 ommendations on interoperability of prescription drug 

15 monitoring programs under subsection (a)— 

16 (1) open standards that are freely available, 

17 without cost and without restriction, in order to pro18 mote broad implementation; 

19 (2) the use of exchange intermediaries, or hubs, 

20 as necessary to facilitate interstate interoperability 

21 by accommodating State-to-hub and direct State-to22 State communication; 

23 (3) the support of transmissions that are fully 

24 secured as required, using industry standard meth25 ods of encryption, to ensure that Protected Health 
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1 Information and Personally Identifiable Information 

2 are not compromised at any point during such trans3 mission; and 

4 (4) access control methodologies to share pro5 tected information solely in accordance with State 

6 laws and regulations. 

7 (c) REPORT.— 

8 (1) IN GENERAL.—Not later than 1 year after 

9 the date of enactment of this Act, the Attorney Gen10 eral, in consultation with the Secretary of Health 

11 and Human Services, shall submit to the Committee 

12 on the Judiciary and the Committee on Health, 

13 Education, Labor, and Pensions of the Senate and 

14 the Committee on the Judiciary and the Committee 

15 on Energy and Commerce of the House of Rep16 resentatives a report on enhancing the interoper17 ability of State prescription monitoring programs 

18 with other technologies and databases used for de19 tecting and reducing fraud, diversion, and abuse of 

20 prescription drugs. 

21 (2) CONTENTS.—The report required under 

22 paragraph (1) shall include— 

23 (A) an assessment of legal, technical, fis24 cal, privacy, or security challenges that have an 

25 impact on interoperability; 
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1 (B) a discussion of how State prescription 

2 monitoring programs could increase the produc3 tion and distribution of unsolicited reports to 

4 prescribers and dispensers of prescription 

5 drugs, law enforcement officials, and health 

6 professional licensing agencies, including the 

7 enhancement of such reporting through inter8 operability with other States and relevant tech9 nology and databases; and 

10 (C) any recommendations for addressing 

11 challenges that impact interoperability of State 

12 prescription monitoring programs in order to 

13 reduce fraud, diversion, and abuse of prescrip14 tion drugs. 

15 Subtitle D—Synthetic Drugs 

16 SEC. 1151. SHORT TITLE. 

17 This subtitle may be cited as the ‘‘Synthetic Drug 

18 Abuse Prevention Act of 2012’’. 

19 SEC. 1152. ADDITION OF SYNTHETIC DRUGS TO SCHEDULE 

20 I OF THE CONTROLLED SUBSTANCES ACT. 

21 (a) CANNABIMIMETIC AGENTS.—Schedule I, as set 

22 forth in section 202(c) of the Controlled Substances Act 

23 (21 U.S.C. 812(c)) is amended by adding at the end the 

24 following: 
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1 ‘‘(d)(1) Unless specifically exempted or unless listed 

2 in another schedule, any material, compound, mixture, or 

3 preparation which contains any quantity of 

4 cannabimimetic agents, or which contains their salts, iso5 mers, and salts of isomers whenever the existence of such 

6 salts, isomers, and salts of isomers is possible within the 

7 specific chemical designation. 

8 ‘‘(2) In paragraph (1): 

9 ‘‘(A) The term ‘cannabimimetic agents’ means 

10 any substance that is a cannabinoid receptor type 1 

11 (CB1 receptor) agonist as demonstrated by binding 

12 studies and functional assays within any of the fol13 lowing structural classes: 

14 ‘‘(i) 2-(3-hydroxycyclohexyl)phenol with 

15 substitution at the 5-position of the phenolic 

16 ring by alkyl or alkenyl, whether or not sub17 stituted on the cyclohexyl ring to any extent. 

18 ‘‘(ii) 3-(1-naphthoyl)indole or 3-(1- 

19 naphthylmethane)indole by substitution at the 

20 nitrogen atom of the indole ring, whether or not 

21 further substituted on the indole ring to any ex22 tent, whether or not substituted on the naph23 thoyl or naphthyl ring to any extent. 

24 ‘‘(iii) 3-(1-naphthoyl)pyrrole by substi25 tution at the nitrogen atom of the pyrrole ring, 
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1 whether or not further substituted in the 

2 pyrrole ring to any extent, whether or not sub3 stituted on the naphthoyl ring to any extent. 

4 ‘‘(iv) 1-(1-naphthylmethylene)indene by 

5 substitution of the 3-position of the indene ring, 

6 whether or not further substituted in the indene 

7 ring to any extent, whether or not substituted 

8 on the naphthyl ring to any extent. 

9 ‘‘(v) 3-phenylacetylindole or 3- 

10 benzoylindole by substitution at the nitrogen 

11 atom of the indole ring, whether or not further 

12 substituted in the indole ring to any extent, 

13 whether or not substituted on the phenyl ring 

14 to any extent. 

15 ‘‘(B) Such term includes— 

16 ‘‘(i) 5-(1,1-dimethylheptyl)-2-[(1R,3S)-3- 

17 hydroxycyclohexyl]-phenol (CP–47,497); 

18 ‘‘(ii) 5-(1,1-dimethyloctyl)-2-[(1R,3S)-3- 

19 hydroxycyclohexyl]-phenol (cannabicyclohexanol 

20 or CP–47,497 C8-homolog); 

21 ‘‘(iii) 1-pentyl-3-(1-naphthoyl)indole 

22 (JWH–018 and AM678); 

23 ‘‘(iv) 1-butyl-3-(1-naphthoyl)indole (JWH– 

24 073); 
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1 ‘‘(v) 1-hexyl-3-(1-naphthoyl)indole (JWH– 

2 019); 

3 ‘‘(vi) 1-[2-(4-morpholinyl)ethyl]-3-(1-naph4 thoyl)indole (JWH–200); 

5 ‘‘(vii) 1-pentyl-3-(2- 

6 methoxyphenylacetyl)indole (JWH–250); 

7 ‘‘(viii) 1-pentyl-3-[1-(4- 

8 methoxynaphthoyl)]indole (JWH–081); 

9 ‘‘(ix) 1-pentyl-3-(4-methyl-1-naph10 thoyl)indole (JWH–122); 

11 ‘‘(x) 1-pentyl-3-(4-chloro-1-naph12 thoyl)indole (JWH–398); 

13 ‘‘(xi) 1-(5-fluoropentyl)-3-(1-naph14 thoyl)indole (AM2201); 

15 ‘‘(xii) 1-(5-fluoropentyl)-3-(2- 

16 iodobenzoyl)indole (AM694); 

17 ‘‘(xiii) 1-pentyl-3-[(4-methoxy)-ben18 zoyl]indole (SR–19 and RCS–4); 

19 ‘‘(xiv) 1-cyclohexylethyl-3-(2- 

20 methoxyphenylacetyl)indole (SR–18 and RCS– 

21 8); and 

22 ‘‘(xv) 1-pentyl-3-(2- 

23 chlorophenylacetyl)indole (JWH–203).’’. 

24 (b) OTHER DRUGS.—Schedule I of section 202(c) of 

25 the Controlled Substances Act (21 U.S.C. 812(c)) is 
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1 amended in subsection (c) by adding at the end the fol2 lowing: 

3 ‘‘(18) 4-methylmethcathinone (Mephedrone). 

4 ‘‘(19) 3,4-methylenedioxypyrovalerone (MDPV). 

5 ‘‘(20) 2-(2,5-Dimethoxy-4- 

6 ethylphenyl)ethanamine (2C–E). 

7 ‘‘(21) 2-(2,5-Dimethoxy-4- 

8 methylphenyl)ethanamine (2C–D). 

9 ‘‘(22) 2-(4-Chloro-2,5- 

10 dimethoxyphenyl)ethanamine (2C–C). 

11 ‘‘(23) 2-(4-Iodo-2,5- 

12 dimethoxyphenyl)ethanamine (2C–I). 

13 ‘‘(24) 2-[4-(Ethylthio)-2,5- 

14 dimethoxyphenyl]ethanamine (2C–T–2). 

15 ‘‘(25) 2-[4-(Isopropylthio)-2,5- 

16 dimethoxyphenyl]ethanamine (2C–T–4). 

17 ‘‘(26) 2-(2,5-Dimethoxyphenyl)ethanamine (2C– 

18 H). 

19 ‘‘(27) 2-(2,5-Dimethoxy-4-nitro20 phenyl)ethanamine (2C–N). 

21 ‘‘(28) 2-(2,5-Dimethoxy-4-(n)- 

22 propylphenyl)ethanamine (2C–P).’’. 
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1 SEC. 1153. TEMPORARY SCHEDULING TO AVOID IMMINENT 

2 HAZARDS TO PUBLIC SAFETY EXPANSION. 

3 Section 201(h)(2) of the Controlled Substances Act 

4 (21 U.S.C. 811(h)(2)) is amended— 

5 (1) by striking ‘‘one year’’ and inserting ‘‘2 

6 years’’; and 

7 (2) by striking ‘‘six months’’ and inserting ‘‘1 

8 year’’. 

9 SEC. 1154. PROHIBITION ON IMPOSING MANDATORY MIN10 IMUM SENTENCES. 

11 Section 401(b)(1)(C) of the Controlled Substances 

12 Act (21 U.S.C. 841(b)(1)(C)) is amended by adding at 

13 the end the following: ‘‘Any mandatory minimum term of 

14 imprisonment required to be imposed under this subpara15 graph shall not apply with respect to any controlled sub16 stance added to schedule I by the Synthetic Drug Abuse 

17 Prevention Act of 2012.’’. 

Passed the Senate May 24, 2012. 

Attest: 

Secretary. 

112TH CONGRESS 

2D SESSION S. 3187 

AN ACT 

To amend the Federal Food, Drug, and Cosmetic 

biosimilars, and for other purposes. tablish user-fee programs for generic drugs and for prescription drugs and medical devices, to esAct to revise and extend the user-fee programs